JURISPRUDENCE EXAM BLUEPRINT

SECTION A CONDITIONS FOR SALE (10)

NAPRA Drug Schedules

Governing of drug schedules
o A schedule is essentially a list.
NAPRA schedules are followed by Ontario
o NAPRA list harmonize scheduling across provinces.
o Federal F, G, and N schedules were in place before NAPRA.
Schedule is determined by the National Drug Schedule Advisory Committee (NDSAC)

A drug is any substance or preparation containing any substance referred to in schedules:

Provincial Federal
I, II, III F, G, N

Weve adopted these within Ontario These are applied nationwide throughout
Canada and are uniform from one province to
another

As of December 2013 Schedule F of the Food

and Drug Regulations has been repealed
replaced by the Prescription Drug List (PDL)
Federal F, G, and N schedules were in place before NAPRA.
The definition of a drug includes all of these schedules NAPRA and federal ones.
The sale of a substance defined as a drug is restricted in some way.

A drug is NOT defined as:

A substance offered for sale as a food (e.g. cheese), drink or cosmetic (tooth paste, lipstick)
A substance listed in schedule U
o Unscheduled drugs can be sold in any retail outlet.

NAPRA Application
Ontario has adopted it
Moving from one jurisdiction to another used to be very confusing because there were different rules in different provinces.
Also confusing to patients (needed prescription in one province, but not another)
Now harmonized nationally.

NAPRA uses a Cascading Model

Assessed based on risk to the public and supervision needed.

Summary:
Schedule Availability
I Prescription only

II No prescription needed, but requires professional intervention from the

pharmacist at point of sale

III No prescription needed, and can be sold from the self-selection area
(pharmacist must be present)

U Can be sold in any retail location

Rx status Restrictions on Sales Comments

I Require Provided to the public by the Drugs not in schedule F may still be deemed important for
prescription pharmacist following diagnosis and the pharmacist to be involved in dispensing (schedule F
 Rx status Restrictions on Sales
(But not all professional intervention of a
schedule I drugs practitioner
under NAPRA are Sales controlled in a
listed under regulated environment as
schedule F by the defined by provincial
Food and Drugs pharmacy legislation
Act)
II Do not require Requires professional intervention
prescription of the pharmacist at the point of sale
E.g. requires that the
pharmacist acknowledge
the patient and give some
instruction and consider
appropriateness
Can be visible display on shelves
behind pharmacy counter.
Pharmacy N OTC products must not
be visible
E.g. Tylenol 1
Must be kept where
patients cannot see or
access the product
They must request it
III Do not require Sold from the self-selection area of
prescription the pharmacy (should be accessible
to the patient and clearly identified
as the professional services area of
the pharmacy
The 10 meter rule must be 10m
or less away from the pharmacy
counter
The pharmacist should be
able to intervene or select
the correct product for
them
Hard for the pharmacist to
observe if it is too far away
Only available for sale in pharmacies
Sales monitored by the OCP
U Unscheduled Can be sold without professional
supervision
Not drugs by E.g. can be sold at a gas
definition station or at a convenience
store
Adequate information is available for
the patient to make a safe and
effective choice
E.g. should be a fairly safe
product so the patient
Comments
federally deemed to require prescriptions)
NAPRA is fairly recent, and was not adopted by
every province until the last couple of years
Some products have a Rx symbol on the product (only
those listed under schedule F)
But even if it doesnt have an Rx on the bottle, it
may still require a prescription.
Only available from a registered member e.g. OCP
registered
Must be retained within an area of the pharmacy
where there is no public access, and no
opportunity for patient self-selection
E.g. Behind the Counter
A pharmacy technician would not likely be sufficient -
they dont often have the clinical knowledge required to
counsel on a lot of drugs. Wed want a registered
pharmacist to counsel a patient who is seeking to purchase
a schedule II drug.
The pharmacy technician might not be aware of
past prescriptions, and this is a cognitive issue
the pharmacist would be responsible for not
intervening in that sale if something went wrong
A pharmacy intern or registered pharmacy
student (under supervision of a pharmacist) can
also do this (they are members of the College)
Subject to local professional discretionary requirements
that may increase degree of control
May keep Gravol behind the counter (stolen by
some teenagers to try to decrease pupil sizes
after using illegal drugs)
May keep Plan B behind the counter (may be
stolen in some areas)
The pharmacist should be available, accessible and
approachable to assist the patient in making appropriate
self-medication selections
If the pharmacist is not available, or the pharmacist
leaves, schedule III products should be locked up and
brought back to the dispensary
Patients would not be able to buy these products
without a pharmacist there
Drugs have a NPN or a DIN
Should not be sold without one of these numbers
Some vitamins may still be in the process of
receiving their NPNs (Natural Products Number)
Example:
Ibuprofen <400mg per unit is schedule U (in
package sizes of up to 18,000mg)
Ibuprofen >400mg is schedule I
Ibuprofen <400mg per unit is schedule III (if sold
in package sizes larger than 18,000mg)
 Rx status Restrictions on Sales
would not encounter harm
in taking the drug
Adequate labelling to tell entitled to ask questions about these and other
the patient how to use the
drug easily without needing
advice
Can be sold in any retail
outlet in the province of
Ontario
Comments
Regardless of the schedule, though, patients are always
medications
It is our professional responsibility to answer drug
information questions
Drugs may be placed in more than one schedule based on
form, strength, package size

Another example:
80mg ASA schedule II
81mg ASA schedule III
Drug companies developed 81mg tablet to
circumvent scheduling issue (kids would be given
ASA got very sick)

Needles are devices not drugs, but not sold in most

places harm reduction strategy

SECTION B NARCOTICS/CONTROLLED DRUGS (21)

NARCOTICS

Definition:
Any substance including or in any substance contained in the schedule to the Narcotic Control Regulations.
N symbol on the stock bottle label
o E.g. Codeine, morphine, meperidine, oxycodone

Subtypes
Straight Narcotic [Schedule N] Verbal Prescription Narcotic Exempted Codeine Preparations
Types: Narcotic combinations Non-prescription
Single ingredient With 1 narcotic only, and 2 or Schedule II
Could be injectable more other medicinal Can contain up to 8mg codeine
Multiple narcotic ingredients ingredients. per tablet/capsule, or 20mg
Compounded with 1 non-narcotic E.g. Tylenol 3 codeine per 30mL liquid & 2
ingredient or one of the 5 Acetaminophen/Caffeine/ other medicinal ingredients
narcotics Codeine o Warning on label
Contains codeine and
5 Narcotics CANNOT TRANSFER [Incl. part fills and should not be
Hydrocodone logged Rx] administered to children
Morphine except on advice of a
Oxycodone physician or dentist
Pentazocine
Diacetylmorphine [Heroin] Schedule II cannot be displayed visibly
in the pharmacy
CANNOT TRANSFER [incl. part fills and Pharmacists can make a decision
logged Rx] not to supply if they believe the
medication is being used for
reasons other than
medical/dental

Verbal or Written Prescription

Straight narcotics CANNOT be prescribed verbally
Combination 1 narcotic + 2 or more medicinal ingredients other than the narcotic, not parenteral, and cannot contain one
of the 5 narcotics
 o Can be written or given verbally
o E.g. Tylenol 3, Dimetapp C
Controlled drugs:
o May be verbal
Who can receive a verbal prescription?
o Pharmacist
o Pharmacy intern
o Registered pharmacy student [under direct supervision of a pharmacist]

Narcotic advertising is not allowed

Cannot visibly display them, they must be hidden
Cannot directly or indirectly advertise the sale of a narcotic.

Prescription Requirements
Definition of a prescription:
o A direction given by a practitioner that a stated amount of narcotic (or controlled drug) be dispensed for the
person named.
o MUST CLEARLY STATE the quantity to be dispensed (or be easily calculable)

E.g. 1 tablet TID for 7 days is OK

1 tablet TID PRN for 7 days is unacceptable
A pharmacist may only supply narcotics if he or she has received an order signed and dated by a practitioner
o Must be verified if the signature is not known by the pharmacist.
The pharmacist may supply methadone to a dealer, pharmacist or patient if the physician is authorized [CDSA section 56
exempted] by the CPSO and OCS.
Requirements:
Name, address of patient Name, address of prescriber
Name, strength, quantity, form of drug Professional identification number (e.g.
Manufacturer of drug CPSO #)
Directions for use Price charged
Date of dispensing Signature of pharmacist and pharmacy
technician [and person receiving the
verbal order if different]

Refills and Transfers

Narcotics
REFILLS ARE NOT Controlled Drugs, Part 1
PERMITTED FOR
NARCOTICS
MAY prescribe as part-fills
and dispensed in divided
portions
o E.g. Tylenol 3, M:
200, dispense 50
every 20 days
Part-fills: The total quantity FILLS AND LOGGED RX]
dispensed must be
indicated as well as the
part-fill quantity.
TRANSFERS ARE NOT PERMITTED
[INCL. PART-FILLS AND LOGGED RX]
Controlled Substances Benzodiazepines + Targeted Drugs
Refills permitted
May be refilled if the prescriber has
indicated in writing or faxed the number TRANSFER PERMITTED ONCE ONLY
of refills and dates for, or intervals
between refills Prescriptions for benzodiazpines and
Verbal prescriptions: part-fills OK, no targeted substances are valid for 1 year
refills allowed. from the date prescribed.
TRANSFERS ARE NOT PERMITTED [INCL. PART-
Controlled Drugs, Part II, Part III (plus
preparations)
Refills permitted for written or verbal if
the prescriber has authorized the
number of refills and dates for, or
intervals between intervals
Controlled drugs may be prescribed as
part-fills
TRANSFERS NOT PERMITTED (incl. Part-
Fills and logged Rx)

Record Keeping
 Purchase Records record purchases in the Narcotic and Controlled Drug Register or invoices filed in chronological order
(for auditing)
o Must be readily available
Sales records record of sales in Narcotic and Controlled Drug Register or in a computer where the print out may be readily
obtained on request or be available on the premises.
o Required for: Narcotics, controlled drugs part I (not required for part II or III or benzodiazepines/targeted
substances)
How long do prescription records need to be retained
o Original prescriber-generated prescriptions must be retained for 2 years
o Scanned electronic copies become part of the patient record  at least 10 years from last recorded professional
pharmacy service provided or until 10 years after the day on which the patient reached (or would have reached)
18 years (whichever is longer)

If lacking technology to scan electronic copies, the paper records need to be retained for at least 10 years
from last recorded professional service/or until 10 years after the day the patient reached age 18.

Loss/Disposal
Premise: Pharmacists must protect these drugs when controlled substances (narcotics, controlled drugs, benzodiazepines)
are in our possession

Narcotic Reporting of Losses Disposal

Pharmacists must report to the Office of Controlled Substances
(Minister) any loss or theft of a narcotic within 10 days of its
discovery
Pharmacists make take all reasonable steps to protect narcotics
on his/her premises or under his/her control against loss or
theft.
E.g. alarms, cameras, etc.
At least Every 6 months physical count and reconciliation of
all narcotics, controlled drugs and targeted substances
Requirements
In order to reduce losses through forgeries or double
doctoring, pharmacists must verify signatures where
the doctor is not known to them
File a report within 10 days of discovery of loss, theft or
forgery
o Discovery is the key word.
Reporting the forgery is the same as reporting a loss
o Report forgeries even if the forged
prescription was not filld
Forms are available on the Health Canada website for reporting
1) Loss or theft, and 2) Forgery
Destruction:
o Requires prior authorization from Health
Canadas Office of Controlled Substances
o Authorization accounts for drugs destroyed
and no longer in the inventory.
o Deduct destroyed drugs from purchases.
o Keep narcotics and controlled drugs returned
by patients in a secure location until they can
be destroyed.
Destruction requests:
o Include:

1. Total quantity easily calculable
(concentration and volume)

2. Trade names of the substances

3. Include pharmacists signature with
his/her OCP number
o Benzodiazepines and targeted substances do
not require prior authorization or approval, but
a record of destruction is required

Record 1) Name, 2) Strength, 3)
Quantity of targeted substance and 4)
Date of destruction
Process
o Witnessed by another pharmacist, technician
or another practitioner (record names on a
joint statement)
o Alter and denature drugs to render
consumption improbable or impossible

Record keeping
At least every 6 months physical count, reconciliation
of all controlled substances
2 years minimum records of narcotic, controlled
drugs, benzodiazepines and targeted substances
o Keep authorizations to destroy and records of
destruction with Narcotic and Controlled Drug
Purchase records
METHADONE

Key Requirements for Dispensing

Notify OCP
Report to the College within 7
days that they are dispensing
methadone.
Also notify OCP whether they are
accepting new patients, and the names of
pharmacists trained to dispense
methadone.
Hours of operation, days
Report any changes to this
status
Ensure required reference materials are
available
Methadone for MMT (CamH,
CPSO Standards/guidelines and
CPSO Policy)
Methadone for Pain (Canadian
Guideline for Safe and Effective
Use of Opioids for Chronic Non-
Cancer Pain)
Optional resources:
OPA Methadone ToolKit for
Pharmacist
MMT Drug Infoline [free for
dispensers and prescribers]
CPSOs Methadone Infoline [for
MDs]
CamH Addiction Clinical
Consultation Service
Adhere to OCP Methadone Treatment
and Dispensing Policy
Adhere to the OCP Methadone
Treatment and Dispensing Policy
Verify with Health Canada that
the MD holds a current/valid
exemption that applies to
methadone maintenance
treatment (MMT) for opioid
dependence or for malignant and
chronic non-malignant pain.
Physicians must apply to Health Canada
for exemption under section 56 of the
CDSA [may also seek authorization via
CPSO]  for methadone maintenance
treatment or to treat malignant/chronic
non-malignant pain
Practice in accordance with the
provisions of the regulations
Follow DPRA, standards of practice, Code
of Ethics for pharmacists, OCP Policies
and Guidelines, federal legislation, etc.
Ensure staff are appropriate trained
Designated manger must be
appropriately trained within the first 6
months of beginning methadone practice
At least 1 staff pharmacist within
a year.
Update training every 5 years (at least)
CamH Opioid Dependence
Treatment Program
OPAs Methadone Education
Program [online]
Patient Agreement
Pharmacy-patient agreement
Include:
o Expectations
o Consent to
access/sharing of health
information with other
healthcare professionals
o Notice that methadone
may be withheld if they
appear intoxicated
o Consent to provide
identification when
requested
o Notice that missed, lost,
stolen or wasted doses
will not be replaced
without a prescription

Methadone Maintenance Treatment and Dispensing Policy

Background:
o Prescribers: require exemption under section 56 of the Controlled Drugs and Substances Act (CDSA)

Exemptions apply to MMT for opioid dependence or for malignant and chronic non-malignant pain

May also seek authorization via CPSO to delegate the administration component of MMT in a medical
office or clinic to qualified health care professionals under a delegation exemption.
o Pharmacists may dispense methadone in individually labeled and fully diluted daily doses for opioid dependenc
treatment pursuant to a written prescription from an exempted physician.

Health Canada has issued an exemption to allow pharmacists to transfer custody of such doses in a secure
manner to a physician or their delegate at the treatment location.
MD and RPH play an important and complementary role in the interdisciplinary model of methadone maintenance
treatment
o RPH role optimize drug therapy, establish therapeutic alliance with apteints

Responsive to changes in the patients methadone treatment and be able to provide methadone in a
timely manner.
Model:
o Methadone diluted in orange juice (does not lend itself to injection)
 o Dispensed to patient accredited by OCP
o Or transfer doses to physician or delegate for custody of and administration to patients
o Or taken to the treatment location and ingestion is observed by the pharmacist.

Pharmacy may open the pharmacy for a restricted time or collaborate with a hospital or another
pharmacy to provide weekly access to patients who require daily doses.

Narcotic Control Regulations

Pharmacist, physician and his/her delegate must take all reasonable steps necessary to protect methadone on the premises
or under their control from loss or theft.
When dispensing, pharmacists are responsible for the safety/integrity of the drug until it has been dispensed to the patient
or transferred in custody to an exempted physician or his/her delegate.
o Accountability and responsibility for the administration of methadone doses while with a delegate still rests with
the physician.

Requirements for Dispensing Methadone in a Pharmacy

Written prescription
By an exempted prescriber
CPSO or Office of Controlled
Substances (Health Canada) may
be contacted to confirm this.
Preparation Preparing stock solution
In accordance with CAMH guidelines, Compounding log file:
prescribers instructions, standards of Date
practice, DPRA and Narcotic Control Name of RPH and technician
Regulations responsible
Quantity, lot number of
methadone used
Final quantity of stock solution

Stock only one solution.

Preparing final dosage form
Dilute and dispense in roughly 100mL
vehicle that does not lend itself to
injection
E.g. Orange-flavoured Tang
Use measuring pump to ensure accuracy
Child-proof safety caps a must
Administration
In accordance with CAMH guideline
Labeling Transferring Custody
In accordance with DPRA Section 156. MD/delegate must sign patient manifest
daily to confirm receipt of the right dose
Also include:
Total mg dose of methadone Directly hand doses to the physician or
Date for ingestion for carries delegate or use a method of
Keep refrigerated transportation that can be tracked to
Drink entire contents of bottle ensure safekeeping
notation
One of the following:
Methadone may cause serious
harm to someone other than the
intended patient. Not to be used
by anyone other than the patient
for whom it was intended. MAY
BE FATAL TO CHILD OR ADULT.
Methadone may cause serious
harm to someone other than the
intended patient. MAY BE FATAL
TO CHILD OR ADULT.
Documentation Changes in dosing
Document daily in the patient record New prescription required

Pharmacist: Include:
Observes ingestion in the Patient name
pharmacy Daily dose
Observes 1 dose ingestion and
st
Time, date
provides authorized carries Place
Takes dose to patient and
observes ingestion (or observes MD/delegate records must be provided to
st
1 dose and provides authorized the dispensing pharmacist daily
carries)
Unused doses Daily reconciliation (for transfer of Maintaining privacy, confidentiality
custody only)
Remain in pharmacy and are managed in Daily reconciliation of methadone Patient administration in a private area
accordance with laws, standards, and OCP dispensed to/received from a treatment and manner
policy location is conducted in a manner to allow Ensure privacy/confidentiality
for Immediate detection of losses or
Or are returned to the pharmacy by the diverted quantities
physician or delegate (daily is preferred)
Signed for
Entered into the appropriate
record
Destroyed in accordance with
laws

Narcotic Safety and Awareness Act, 2010

Purpose Prescription Dispenser Requirements Identify Verification
Requirements
To promote appropriate Record: Must keep record including: Dispenser must ensure that identify
prescribing and dispensing verification requirements are met
practices for monitored Registration number on Address, DOB, gender of before dispensing a monitored drug
drugs the certification of patient
registration issued to the Regulations require that the
Identify, reduce prescriber by his/her Patients identifying number dispenser keep a record of
abuse/misuse/ and regulatory College (e.g. and type of ID the identifying number of
diversion CPSO number) the patient and type of ID
Prescribers registration used (record on prescription
Reduce risk of Patients identifying number record, not the prescription
addiction/death number and type of ID itself)
(e.g. Health card, Passport) If the patient is not picking up
Collect, use and disclose the prescription, need the
information, incl. personal All other information name and address of agent
information required of a prescription picking it up along with their
identifying number and type of
ID checked
NSSA regulations:
Exemptions provided to allow prescriptions to be prescribed/dispensed if the patient does not have appropriate
identification only patient can pick up/accept a delivery, not an a gent
Ensures all opioids (incl. those not currently listed in the CDSA such as tramadol or tapentadol) are monitored in Ontario
Exempts prescribers in certain settings (e.g. hospitals or prisons) from NSAA requirements

Section What it stipulates

5 Prescriber must record patients ID and type on Rx
Dispenser must keep a record of the patients ID and type
If verbal or information is missing on Rx, pharmacist may document the
information after confirming with the prescriber the ID type and number
7 Specifies the types of identifying numbers that are acceptable

List of approved forms of patient ID may change occasionally (on MOHLC website)
Health card (Ontario or other province/territory)
Valid drivers license
Ontario photo card
Birth certificate (Canadian)
Valid passport (Canadian or other country)
Certificate of Canadian Citizenship
Others

Requires dispensers to record the name, address, and form of ID and number for
persons who pick up narcotics/controlled substances from the pharmacy
 Same rule applies for monitored drugs being delivered if the person receiving the
delivery is not the patient, the name, address and ID number must be recorded of that
third party

SECTION C FILLING AND LABELLING (23)

Drug and Pharmacies Regulation Act (DPRA) Nadia Sutcliffe, OCP

Legislation
Laws Act + Regulations
Act Overview document
Outlines What is to be done
Rarely changed must be put through legislation
Regulations Supports act explains how rules and laws should be followed
More detailed rules How to do
More easily changed
Schedule A list
May be found in an Act, or in Regulations
Drug and Provincial
Pharmacies Governs pharmacies (ownership, closing, operation, opening)
Regulation Act Governs sales of drugs
College committees
By-laws, and enforcement

Works together with other legislation

Defines terms, how they should be used or interpreted

DPRA Section 118 the DPRA DOES NOT APPLY TO HOSPITAL PHARMACIES
Hospital, health or custodial institutions are not covered by the DPRA
The Public Hospitals Act defines how hospital pharmacies should operate
Section 118 allows practitioners who have the Controlled Act of dispensing to dispense to their own
patients
o Incl. physicians, dentists, vets
o Not many dispensing physicians exist, but maybe in small communities
o Must follow all laws and regulations that deal with drug dispensing
o OCP does not inspect them, their own professional regulatory bodies do
Select Definitions License A pharmacists certification of registration
in the DPRA Pharmacist Person registered, licensed with the College
Pharmacy Premises
Prescriber Authorized to prescribe
Prescription Direction from prescriber
Drug A item restricted in its sale to the public
Prescribers Physicians Chiropodists (DCh)
under the DPRA Veterinarians (medications Podiatrists (DPM)
specifically for veterinary Optometrists (new class of prescribers specific lists of
[Prescription purposes) drugs)
Authorization] Nurse practitioners (deal with a
list) (Under their scopes of practice)
Midwives (lists)
Dentists
The definition of a prescriber or practitioners differs in the CDSA
Only certain prescribers can prescribe these medications
Only physicians, veterinarians, and dentists
Does not include other classes listed above
Prescriptions An order for a specific individual (patient)

Ordered by an appropriate prescriber, after a diagnosis

May be for a treatment, device or medication (within the prescribers scope of practice) e.g. splints,
braces

Verbal or written prescriptions (or faxed)

Must be signed by the prescriber if written
Must be a unique signature, cannot just be a rubber tamp (easily duplicated)
Must be signed each time for each patient

Must verify it is a current document

1 year limitation exists on filling prescriptions for targeted substances e.g. benzodiazepines
Prescription Following requirements: For narcotics, controlled, targeted substances:
Requirements 1. Prescriber name and designation (e.g. MD) Must also include:
2. Address, phone number of office Prescriber licensing number
3. Patient name Patient identification number and type
4. Date of prescription of ID (e.g. health card)
5. Drug and strength of drug
6. Directions
7. Quantity
8. Doctors signature
Electronic or emailed prescriptions are not authorized. Must b e written, verbal (or faxed)
John Smith, MD
123 Office Street, Toronto, ON M5R 2R4 We can now fill prescriptions from physicians/prescribers
(416)-555-1212 from anywhere in Canada
Must use professional judgement - make a
judgement of whether the patient needs the
medication or not

Name: Ian Payne We cannot fill prescriptions that originate outside Canada
Address: 104 Drive Street, Toronto
Rules may differ between provinces as well
Date: August 1, 2013

Biaxin XL
S: 1000mg QD
M: 7 days

DPRA Section 156 Every person who dispenses a drug shall ensure that the following information is recorded on the prescription

1. Name and address of the person for whom the patient is prescribed
Record of 2. Name, strength, and quantity of the prescribed drug
Dispensing 3. Directions for use as prescribed
4. Name, address of the prescriber
5. Identity of the manufacturer of the drug dispensed (e.g. Apotex, Cobalt)
6. A prescription number (identification number or other designation)
7. Signature of the person dispensing the drug (and also the signature of the person receiving the verbal
prescription)
8. Date on which the drug is dispensed
9. Price charged

Many times, it is not the actual prescriber calling, so it is always a good idea to document document who you
spoke with if receiving a verbal prescription also
 PHYSICAL copies must be kept for at least 2 years

DPRA Part X, Hard copies take up a lot of room, so you can store them in another secure location
Section 54-56 of There is nothing that says what you HAVE to keep, but there are suggestions
the Regulations
Refers to making scanned electronic copies of prescriptions, hardcopies, and other records/documents, and
Record Keeping retaining them as part of the patient record.
Must keep SCANNED copies for a period of 10 years from the last recorded professional pharmacy
service (or if the patient is under 18, for 10 years after the patient turns 18)

Records must be readily retrievable and stored securely to ensure patient confidentiality and privacy are
protected
New pharmacies must have scanning technology right now
Existing pharmacies must acquire this service by May 2012 e.g. scan MedsCheck services for patients
also

Remote dispensing Locations Record Keeping

Must also have:
o A record of all testing done on any automated pharmacy system to first use, and all on-site
inspections conducted
o Record of all maintenance
o Record of all technical malfunctions that happen (incl. cause of malfunction, amount of time
and steps taken to repair it)
o Documentation received from the manufacturer or vendor of the automated pharmacy
system (incl. name of manufacturer, model number, descriptions, owner manuals, etc.)
o Written policies/procedures with respect to normal operations

Remote dispensing locations have been useful in rural areas, for example e.g. no pharmacists available
Some in the GTA are available operated by physicians, e.g. at Sunnybrook
Record of Rx 102945 1 August, Comments
Dispensing 2013 DIN is not required, but its a good identifier
All pharmacy software includes this on the hard copy
- Hard Copy Payne, I Identifies drug, strength
104 Drive Street, Toronto Phone numbers are good to have, but not required

Take 2 tablets once daily for 7 days
10 Biaxin XL ABT (Abbott)
Dr. J. Smith
123 Office Street, Toronto
Signature of pharmacist
$50.00 (Cost of medication)
Registered technicians must be regulated to sign prescriptions
The Signature:
Not a stamp
Must be more than a mark or initial
Distinctive
Original not a stamp
With prescribers
No JPEG images allowed, scanned signatures are not acceptable
Digital/electronic signatures
Must be real, genuine, distinct

You could fax back for an authentic signature, and to verify verbally
Section 156 The container in which the drug is Labelling for a compliance pack:
dispensed must be marked with: Each drug must be labelled with an identifier or descriptor
- Prescription Rx number on the o Incl. info on shape, colour, relative size and unique
Label prescription markings of the tablet or capsule
Name, address, phone of Label each drug with the generic drug name
the pharmacy in which
 the prescription is PRN medications must be dispensed in a separate container as they
dispensed cannot be placed in compliance packs
Identification of the drug
name, strength,
manufacturer (if placebo
or drug study, might use
A or B)
Quantity of drug
dispensed
Name, owner of
pharmacy
Date the prescription is
dispensed
Name of prescriber
Name of patient
Direction for use
Auxiliary labels are NOT required
But common in practice to help adherence
Expiry dates are a bad idea for the vial bottle

For remote dispensing locations, labels must also include:

Name, address, phone number of the accredited pharmacy
RDL address
Toll-free number where the patient can contact the accredited
pharmacy
Unique identifier attached to the Rx number that identifies that
a RDL was used (vs. the actual pharmacy)
Misrepresentation Cannot sell a drug under the pretence that it contains a substance it does not
E.g. you have to say EXACTLY what is in the container
DPRA Section 150 You cant label it Apotex Clarithromycin but actually put in Teva-Clarithromycin
Do not use the patented name if it is not the brand name e.g. must disclose what you dispensed
Identify ingredients used in extemp. Preparations

Sometimes a pharmacy changes generic DSP if they are both generic products, your label must explicitly
indicate what is being dispensed
Part VII of the Child resistant package a container that meets the standards for child resistant packages as prescribed by the
DPRA Regulations Food and Drug Regulations under the FDA
Sect. 44 and 45
Default dispense drugs in child resistant packages (certified/designated by the Canadian Standards
Association)

Exemption from requirement of child resistant package if:

The patient can ASK for this you must document this request was made
The prescriber directs otherwise
A child resistant package is not suitable because of the physical form of the drug (e.g. some materials
deteriorate if you take it out of the original packaging so you dispense as is in its original package)
The professional judgement of the member based on particular circumstances
o E.g. they have one hand, or have bad arthritis
DPRA Section 157 If a patient requests a copy of the original prescription, the pharmacist must provide it to them
You would have to mark it as a copy

The patient (unless directed by the prescriber) is entitled to a copy of it marked as such
If its marked copy, they must not be able to get a newprescription filled

There would be no authority to refill on a copy

DPRA, Section 43, What can we transfer?
Part VI of the Okay Not allowed
Regulations Targeted substances once Schedule G or N medications
Pharmacy A can transfer to pharmacy B
Prescription But after that, they must continue at Cannot transfer controlled drugs or narcotics
Transfers pharmacy B I.e. you cant fill part of it at one pharmacy,
Pharmacy B cannot transfer to pharmacy C and then transfer to another

E.g. Lorazepam, clonazepam, diazepam On hold controlled substances or narcotics cannot be

transferred
Would have to get a new prescription or continue at
the second pharmacy
Also, cannot be refilled beyond 12 months
from the date of the ORIGINAL prescription
(verify date of original prescription)
Expiry is one year from the date the
prescription was WRITTEN, not when it was
first filled
According to the DPRA, you can transfer If it has previously been transferred e.g. if
prescriptions unless it is a controlled drug or narcotic pharmacy A has transferred a prescription to
pharmacy B, if pharmacy C calls pharmacy A, they
cant transfer
Cannot transfer if a prescription has
previously been transferred by that
pharmacy

What information do we provide to the pharmacy receiving the transfer?

Name and address of the patient
Name and quantity of drug prescribed (and strength if applicable)
Directions for use as per the prescriber
The name and address of the prescriber
Identity of the manufacturer
Identification number of the prescription (Rx number)
Date of first fill, and date of last refill
Total quantity of drug remaining
Quantity most recently dispensed if different from the quantity prescribed (e.g. last received 30 or
something)
Name of the member responsible for the transfer
o At this time, must be a pharmacist
o Registered technicians in the future may be able to receive transfers

A prescription shall not be transferred from a pharmacy unless a record is made in that pharmacy containing:
Date of transfer of the prescription
Identification of the pharmacy to which the prescription was transferred
Name of the member responsible for the transfer of the prescription (pharmacist)
Where the prescription was transferred verbally  the name of the person to whom the transfer was
made

Once a prescription has been transferred:

Originating pharmacy cannot fill the prescription any longer
Member cannot fill transferred prescription until all information is received, and recorded by a
member practicing at the pharmacy (all necessary information)

Transfers can occur into or out of PROVINCE

CAN RECEIVE WITHIN CANADA ONLY
Can be transferred into or out of province
But you can possibly transfer TO the U.S. situations have occurred. If their jurisdiction allows
 transfers from out of country, thats fine. But once youve transferred to the U.S., you cant transfer it
back i.e. you cant refill in Canada.

Section 158 Out CANNOT FILL PRESCRIPTIONS FROM AMERICAN OR INTERNATIONAL PRESCRIBERS CANADIAN ONLY
of Province
Prescriptions If the prescription originates from another territory or province (i.e. not Ontario), the member must make a
professional judgement
Dispense if in their professional judgement, the patient needs the drug (medically)
Section 152 A schedule I medication, if mailed
Registered mail only
Mailing/Delivery Or delivered in a method that is traceable and auditable
of Drugs With a receipt for the drug signed by the patient or patients agent
Section 160 No person shall sell by wholesale a drug for sale by retail to a person who is not entitled to sell the drug by retail

Whole sale of Definition of Drug matters here

Drugs
I.e. people wholesaling drugs in Ontario must register with the OCP as a drug wholesaler

This type of establishment would be a supplier for drugs that are not regulated by the CDSA
Refill The following cannot be authorized:
Authorization Narcotics
Verbal prescription narcotics
DPRA Controlled drugs
Regulation 42
Renewal if:
Based on circumstances of the patient [previously-diagnosed chronic and long-term condition] & has
tolerated the medication without serious side effects

The total amount of the drug dispensed cannot be more than the amount previously prescribed (including any
refills), or a 6 month supply (whichever is less)

A unique Rx number must be assigned to the authorized refill, and the name of the original prescriber must be
recorded in the patient record as the name of the authorizing pharmacist

Document  prescription or copy should be kept together and linked with the original prescription
Document members rationale for prescribing with the renewed or adapted prescription and be easily
retrievable

Considerations
Only consider adapting or renewing if:
o 1. Member deems the drug safe and effective and in consideration of the patients history
(symptoms, lab tests, medical history, allergies, contraindications, etc.)
o 2. Drug is prescribed in a circumstance that is within the members area of practice,
knowledge and skills

Other considerations
Member must have weighed potential risks/benefits
Determined renewal or adaption is in the best interest of the patient
Member is in possession of the existing order or prescription to be renewed or adapted, or has access
to information contained in the original copy (copy, verbal confirmation or medical record)

Notification:
Notify original prescriber, and if known and different from the original prescriber the patients
primary health care provider

Record on the prescription:

Name/address of patient
 Name, strength, quantity of drug
Direction for use (dose, frequency, route, special instructions)
Name, address, phone number and OCP number of the member
Signature of the member
Date the prescription was issued
Number of refills the member has authorized (if applicable)
Reference to the original prescription that the member renewed or adapted, including name/contact
details of the original prescriber
Compounding Must have the knowledge, skills and appropriate facilities needed to ensure products are prepared in a non-
contaminated environment, and free of particulate matter

Must have:
Accurate knowledge and expertise
Confirm need for a compounded product
Maintain access to contemporary equipment
Use quality ingredients
Appropriate labelling
Suitable containers for each unique product
Safe and acceptable storage
Documentation to ensure accurate checking, duplicating and tracing
Adherence with health, safety and environmental practice

Pharmacist shall:
Assist patients, counsel them on appropriate use
Determine whether sterile compounding is required
Ensure quality/accuracy of ingredients
Calculate required quantities, dilutions, percentages or other pharmaceutical calculations
Be knowledgeable of the purpose of each ingredient
Recognize potential for incompatibilities
Determine equipment needed
Prepare product in a logical, safe and pharmaceutically elegant manner ensuring personnel safety
Document required information to maintain accurate records

Sanitation
Written procedures detailing minimum requirements for health/hygiene for compounding personnel
 suitable dress, hand washing, open sores

Labelling
Federal and provincial requirements followed
Labels include:
o Active ingredients (and concentrations)
o Lot numbers if applicable
o Estimated expiry date and/or best before date
o Storage instructions as needed
Closing a You must follow the following steps:
Pharmacy
1. Submit a Notice of Intent (must be received within 7 days of closing)
Must include pharmacy name, accreditation number, owner, address, and expected date of
closing
May be mailed, faxed, or emailed

2. On closing day OCP Client Services will contact the pharmacy to confirm whether it has officially
closed
Once confirmation has received, will no longer appear on the Public Register

3. File a Pharmacy Closing Statement within 30 days of closing

 DPRA Closing of a Pharmacy
All signs and symbols relating to the practice of pharmacy within or outside the premises must be
removed
Must remove and dispose of all drugs according to law, and submit in writing to the Registrar such
information
Opening a Follow these steps:
Pharmacy
1. Submit an Application for Certificate of Accreditation a Pharmacy at least 45 days before the
proposed opening date
Floor plan must include dimensions of total area, dimensions of dispensary, location of required
two sinks, and location of acoustically private consultation area
If independent need Articles of Incorporation, Share Certificates

2. Schedule an inspection (may take up to 2 weeks)

3. The inspection itself notification will be sent to Client Services and Ontario Drug Benefit following
issuance of a Certificate of Accreditation (by Registrar)

4. Opening Day
Client Services will contact the pharmacy to confirm whether the pharmacy is open to the public
Once confirmed, the pharmacy will be made active and will appear on the Colleges Public Register

For logged prescriptions MUST CHECK HARD COPY AGAINST ORIGINA PRESCRIPTION
o Do not only check against the hardcopy only
o Process for filling a refill and logged prescription are not the same!

SECTION D BILLING AND PRICING (10)

ODB PRINCIPLES
To meet the needs of patients, consumers and tax payers in Ontario
o Involve consumers and patients in a meaningful way
o Operate transparently to the fullest extent for all who have an interest
o Ensure optimal use of resources, value for money and cost-effectiveness
o Use best clinical and economic evidence to fund decisions for drugs.
ODB relies on the DIDFA to achieve cost-savings
 ODB only applies for ODB-eligible drugs and recipients.
DIDFA applies to all prescriptions in Ontario.
ODB operates under an Executive Officer
o Performs functions or duties under both ODB and DIDFA
o Administers ODB public drug programs
o Replaces the Minister of Health for this purpose.
ODB Act Overview:
Eligibility Section 2
Member of a Designated Class
Seniors
Eligible Home Care recipients
Nursing Home residents
Homes for Special Care residents
Homes for the Aged and Rest Home residents
Residents of approved charitable homes Health care sector divided into groups:
Also those entitled to receive benefits under the Family Benefits Act,
Ontario Disability Support Program Act (ODSP), Ontario Works Act
Social assistance
Family benefits
Billing Restrictions Section 4
No operator of a pharmacy or physician can charge or accept payments
from anyone except for the Executive Operator for the purposes of this
Act
Co-payments permitted
Regulations provide the EO with the authority to determine the
maximum amount
Collection of co-payment is not mandatory Pharmacist may charge
Refusal to Dispense Prohibited Section 10
Cannot refuse to dispense to an eligible person to avoid provision of
this Act
(E.g. disagree with fee, or holiday supply)
May refuse for reasons of professional judgement (document
situation and why)
Interchangeable Products Section 6
Where interchangeable products are dispensed, you must charge for
the lowest priced interchangeable product listed
You can dispense a higher priced interchangeable product, but you will
only be paid for the lowest priced interchangeable product listed
Application of the Act Section 3
Only applies to:
Supplying of LISTED DRUG PRODUCTS
Eligible persons
Does not apply to the cash or private sector
Private insurance, private sector, or cash paying
Public funded by government or public sector
Payment of Claims Section 5
EO obligated to pay for those claims where provisions of
the Act and Regulations are met
EO may pay different amounts, subject to prescribed
requirements e.g. compliance packaging
No Substitution by Patient
Patient choice is protected in the ODB Program same
principle as DIDFA
If brand or more expensive listed interchangeable is
requested by the patient (i.e. no sub) the pharmacist may
charge the difference between the more expensive
interchangeable product and what ODB will pay
Also document the patients request
Drug benefit price + Mark-up + Dispensing Fee (Co-
payment) is what the executive officer will pay
No Substitution by a Physician ODB Act
Provides for the payment of eligible drugs where the
physician has indicated No Sub
Requirements must be met:
1. No Sub must be indicated in writing on the
written Rx
2. Physician must provide a Canada Vigilance
Adverse Reaction Reporting Form
3. If Verbal RPh must ensure the MD provides a
Canada Vigilance ADR Reporting Form
Dispensing Fees Section 6(2)
No dispensing fee where the listed drug product does not require a
prescription for sale, and to which this clause applies
For other cases
Amount EO to Pay Section 6
If acquisition cost of a listed drug product is greater than
the sum of the drug benefit price, and the mark-up on that
price, the EO shall also pay the difference between
acquisition cost and the sum

The lesser of: Document

1) the dispensing fee prescribed by the regulations Provide invoice to prove you purchased the drug at a
2) The amount the operator sets under subsection 8(1) of the higher price
DIDFA Usual and customary dispensing fee
ODB Limited Use Section 23 ODB Unlisted Drugs, Special Cases Section 16
For some drugs or classes only reimbursed in certain specified clinical Exceptional Access Program
criteria or indications
For unlisted drugs and special cases
Pharmacy may charge patient for the drug if they do not meet clinical
criteria Patient requires drug not listed
MD applies to EO
Amount the same as if the drug were covered EO may make Act apply to that drug
Price determined by EO

If the patient requires a listed drug for a condition that is

not an approved condition (e.g. does not meet LU
conditions) EO may make the Act apply

EO can also apply the act retroactively

ODB Regulations
ODBA Regulation 201/96 Section 2
Eligible Persons
65 years of age or older
Resident of a home licensed
under section 5 of Homes for
Special Care Act
Eligible for Pension under Part I
of the Old Age Security Act
Persons receiving professional
service referred to in the Long
term Care Act, or via CCAC
Residents of charitable homes for
the aged or nursing homes
ODBA Regulation 201/96
Extemporaneous Preparations
Cannot be equivalent to a manufactured
product
Topical or dermatological preparations
restricted to specific substances that can
be added
ODBA Relating to Seniors ODBA Regulation 201/96 Section 3
Trillium
Not covered until: Catastrophic Drug Program
First day of the month they Persons with high drug expenditures
receive pension in relation to income
First day of the month following Insured under the Health Insurance
th
their 65 birthday and covered Act
by OHIP All other forms of health insurance
expended
E.g. birthday is May 15, not eligible until Application to the EO
st
Runs from August 1 of one year to
st
June 1
st
July 31 of the next
Must meet annual deductible 4
installments
Once deductible is met co-pay is $2
for each prescription (waived by
most pharmacies)
Limits on amounts paid by the EO ODB Act Regulation 201/96 Co-
Payments
Administer and control costs Co-Payment:
Payment of portion of the cost of
Ontario Works Act 35 day supply limit prescription which is shared by
(may supply up to 100 days under specific patient
conditions)
Deductible:
All other eligible recipients can receive up Amount that must be paid
to 100 days initially by the patient in order
for an eligible person to receive
Limits amounts paid where eligibility benefits
period ends max of 30 days beyond end

Amounts Charged to Person other than
EO Section 21
Quantity exceeds the maximum quantity
the EO will pay for under section 8
Requires the pharmacist to inform the
person why the person is being charged
Must give the person the choice
of getting the additional quantity
and paying or receiving max
allowable quantity
Eligible person opts out and wants to pay
must inform them they could receive
benefits, though
If the pharmacy does not submit online
claims charge the amount payable
under section 5(4) of the ODBA
Manual Claims
If drug was supplied >7 days before
Claim reversal >7 days after original
submission
2+ over-ride codes
Claim >$10,000
Mixture which requires more than 100
minutes of preparation time
Must be made within 6 months of date of
service
DIDFA/Interchangeability/Off-Formulary
Overview:
Provincial legislation
Interchangeable products are listed in the Comparative Drug Index(CDI)/ODB Formulary
of eligibility
30 day program
On all new Rx or prescriptions
the patient has not had in the
past 12 months
Limits initial Rx to a 30 day
quantity if a larger amount has
been authorized
Allows trial period allows for
efficacy monitoring
Allows for exceptions if patient
cannot come back in 30 days
(must document)
ODBA Nutritional Products Additional
Benefits (Part IX)
Not a formulary benefit
But additional benefit for ODB
eligible people if sole source of
nutrition, functional impaired
criteria met, and supported by
Nutrition Product Form (2 years
record keeping)
Pharmacist may charge patient for
difference ODB does not pay the full
amount
Nurse Practitioners
RN(EC) Extended class nurses have
limited prescribing privileges
Only eligible listed drugs in the formulary
will be reimbursed
Co-payment as $2 or U&C whichever is
less
Co-payment subject to
conditions listed in regulation
Separates eligible persons who have
attained 65 years based on income:
Eligible people who earn
<$16,018
Eligible individuals who live with
a spouse and who earn less than
$24,175 combined
Co-payment remains $2
Higher income seniors
$100 deductible yearly
Amount decreases from August
to July pro-rated
Diabetic Testing Agents
Most testing agents Blood glucose strips
covered by ODB
Limit imposed
3,000 strips/365 days (on insulin)
400 strips/365 days (on
medications with high
hypoglycaemia risk)
200 strips/365 days (meds have
low risk of causing
hypoglycaemia or diet/lifestyle
interventions only)
Requires prescription
ODB only pays max amount, pharmacist
may collect the difference
ODB Program
WILL ONLY PAY FOR ELIGIBLE DRUGS (I.E.
ON FORMULARY) TO ELIGIBLE
RECIPIENTS
 Purpose:
1. To make it mandatory to offer the patient a lower-priced medication alternative (interchangeable) if available.
2. Does not apply to dispensing in hospitals

Interchangeable products
A drug of combination of drugs identified by a specific product name or manufacturer and designated as interchangeable
with one or more other such products.
Evidence of interchangeability:
o Provided by manufacturer
o Executive Officer designates or removes interchangeable status

DIDFA Section 4
If a prescription directs the dispensing of a specific interchangeable product, the dispenser may dispense in its place
another interchangeable product
o E.g. PMS-Fluoxetine, but you stock APO-Fluoxetine, you may dispense the Apo-brand provided it is
interchangeable.
o E.g. Prozac 20m, you can dispense Apo-Fluoxetine in its place (ODB formulary lists interchangeables)
4(2) If a prescription directs the dispensing of a specific interchangeable product, the dispenser on request of the patient
shall dispense in its place another interchangeable product
o E.g. Prozac 20mg on prescription, and the patient requests a generic brand, then you can dispense whatever is
interchangeable in your formulary
4(3) If the prescription directs the dispensing of a specific interchangeable product, then the dispenser shall not supply that
product without informing the patient of the right to request an interchangeable product
o E.g. Co-Metformin, but the patient has the right to request Ratio-Metformin
o If Prozac is on the prescription, you must inform the patient there is an interchangeable available
o Does not apply if: You charge the same amount for brand name as you would the generic, or the product is being
supplied pursuant to a repeat
4(5) If the prescription directs the dispensing of a product not designated as an interchangeable product and there is an
interchangeable product that contains a drug or drugs in the same amounts of the same active ingredients in the same
dosage form, then the dispenser may dispense the interchangeable product
o This is referred to as substitution INTO the formulary
4(1, 2, 3,5) DO NOT APPLY IF:
o NO SUB, PAS DE REMPL or NO SUBSTITUTION or PAS DE REMPLACEMENT have been hand written by
the prescriber  can be received verbally
o Or direction recorded by the dispenser that there be no sub (e.g. upon patient request)
4(7) If the prescription directs the dispensing of a drug for which there are interchangeable products without identifying a
specific product name or manufacturer, then the dispenser shall dispense an interchangeable drug
o E.g. Furosemide 40mg, you can use any brand in your formulary that is also on the ODB formulary
4(8) If an interchangeable product is dispensed in accordance with this act, then the prescriber or patient cannot complain
that an interchangeable product other than the one prescribed was dispensed
Not interchangeable (unless you have substituted into formulary) if it is not listed in the CDI/ODB formulary


DIDFA Section 9(1)

The entire quantity of drug prescribed must be dispensed at one time
o Unless the patient in writing authorizes the drug to be dispensed in smaller quantities
E.g. Rx: Loec 20mg, M:100 (you dispense 100 tablets at one time)
DIDFA Regulation 936:
o You may dispense less than the entire quantity if:

Professional judgement is exercised

Lesser quantity is being paid for under agreement between insurer or another
person/beneficiary/subscriber to provide payment

DIDFA Regulation 936

Section 4(1) Section 5(1)
The dispenser shall provide a receipt Pharmacy operators must retain each
invoice and purchase record (incl. price
Must set out reductions in the form of rebates,
Dispensing fee + cost of drug + total discounts, refunds, etc.) that relates to
price of prescription the purchase of pharmacy drug products
Section 5(2)
An invoice or record referred to in
subsection (1) must be retained by the
operator for at least 2 years from
receipt of invoice or record (but longer
as per CRA)

Section 4(2)
This Does not apply to a drug that does
not require a prescription (e.g. schedule
II or III item)

DIDFA Regulation 936 - Signage

Must post yellow Notice to Patients Sign in an obvious place in the dispensary
o Must be readable by the person presenting the prescription
o Must be informed of the right to request an interchangeable product
For the purposes of section 6(4) Posting must be clear and prominent
o Usual and Customary dispensing fee (Yellow OCP Fee Posting Sign)
A PERSON MAY CHARGE MORE THAN THE USUAL AND CUSTOMARY DISPENSING FEE FOR A PRODUCT THAT IS SUPPLIED
PURSUANT TO A PRESCRIPTION IF:
o The person explains why the excess fee is being charged to the patient prior to dispensing
o The charging of the additional fee is not an act of professional misconduct

SECTION E PHARMACY OPERATIONS (15)

New Standards of Operation

Size requirements
Must have floor area sufficient for sale
and orderly operation of pharmacy.
Not less than 18.6 metres
squared or 200 square feet
Internet Access
Sufficient access is necessary to allow
members practising to meet the
professions standards of practice incl.
access to library requirements
Electronically transmitted Rxs?
2006/2007 College policy on faxed
prescriptions and guidelines for
prescriptions transmitted via fax or
digitized image files to assist members to
ensure the prescriptions they receive are
authentic and legally constructed
Consultation room requirements
Now a requirement for new and
existing pharmacies to have a
separate and distinct patient
consultation area
Not necessary to have a room,
but recommended that members
consider including
visually/acoustically private areas
Library requirements
See below
e-Prescribing
The regulation does not permit e-
prescribing
Refrigeration requirements
Fridge to store drugs must accurately
display temperature inside the
temperature
Must maintain between 2 and 8
degrees Celsius
Anything other than drugs or
medications requiring
refrigeration should not be
stored in the refrigerator (e.g.
food)  affects stability of drug
products
Scanners
Must use as of May 11, 2012
All new pharmacies must have equipment
to allow for scanning of original
prescriptions and documents, and
maintain those scanned copies in the
patient record

Supervision
No pharmacy operations can occur unless under the supervision of a physically present pharmacist
o If the pharmacist leaves, there must be a way to completely restrict the public via physical impediments from
access to any drugs referred to in schedule I, II or III that are in the pharmacy
o Lock and Leave  must be inspected (arranged by the Registrar)
Is managed by a pharmacist who is designated as the designated manager by the pharmacy owner
No person shall compound, dispense, or sell any drugs in a pharmacy other than:
o 1. Pharmacist
o 2. Intern acting under the supervision of a pharmacist who is physically present
o 3. A registered pharmacy student acting under the supervision of a pharmacist who is physically present
o 4. A pharmacy technician acting under the supervision of a pharmacist who is physically present
o [If a pharmacist or intern is physically present in the pharmacy and available to the purchaser for consultation, the
above does not apply to the sale of a schedule III drug]

Required Reference Guide/Library for Pharmacies in Ontario [as of October 2013]

A Canadian Compendium [Current Edition]
o 1. Print CPS (2014)
o 2. Online subscription to e-CPS
o 3. Online subscription to CPhAs e-Therapeutics + acceptable to replace:

CPS

Therapeutic Choices

Drug Interactions Text
A Drug Interaction Publication [Current edition]
o 1. DI Analysis and Management (Hansten & Horn)
o 2.DI Facts (Tatro)
o 3. Evaluations of Drug Interactions (Zucchero & Hogan)
o 4. Online subscription to CPhAs e-therapeutics acceptable to replace:

Therapeutic Choices

DI Text
 o 5. Lexi-Interact
o 6. Comparable pharmacy computer software program of the above texts updated quaterly that incorporates
updates of:

Medispan, First Databank
A Pharmacotherapy Text
o 1. Applied Therapeutics Koda-Kimble
o 2. DiPiros Pharmacotherapy
o 3. Textbook of Therapeutics
o 4. Therapeutic Choices
o 5. Online subscription to CPhAs e-therapeutics (replaces Therapeutic Choices and DI text)
A Patient Counselling Guide
o 1. PatientConnect Drug and Disease Information
o 2. Detailed DI for the Consumer
o 3. Lexicomp Patient Education
An Annual Subscription to a DI service:
o DIRC [OPA]
o LONDIS (LHS)
o METRODIS (Sunnybrook)
o OVRDIS (Ottawa)
o SIH

Ownership
Must be a pharmacist OR a corporation where the majority of directors of the direction are pharmacists
Rights to operate a pharmacy are not affected by:
o 1. Suspension of certificate of registration of a pharmacist or
o 2. Revocation of the certificate of registration of a pharmacist until after a period of 6 months has elapsed
Fees:
o $1000 + HST new opening
o $500 + HST change in ownership
o $500 + HST relocation

Accreditation
Issuance:
o Registrar issues certificates of accreditation and renewals
o Proposed operation must quality under the DPRA and regulations
o Refer to Accreditation Committee every application for a certificate or renewal that the Registrar proposes to
refuse or which he/she considers terms/conditions or limitations should be attached
Accreditation Committee:
o Determines eligibility of the applicant and pharmacy or proposed pharmacy and its operation
o May direct the Registrar to accept/refuse to issue the certificate or to impose terms, conditions or limitations as
the Committee directs
Procedure:
o Health Professions Procedural Code provisions apply
Revocation of certificate and other disciplinary measures:
o Accreditation Committee must have reason to believe the pharmacy or its operations fail to confirm with the
requirements of the DPRA and regulations or to any term, condition or limitation to which its certificate was
subject, or an act of propriety misconduct has been committed
o Accreditation Committee refers certificate issuant, designated manager or directors of a corporation (who were
issued the certificate of accreditation) to the Discipline Committee for a hearing and determination.

Inspection
An inspector appointed under a by-law may enter any pharmacy or other shop in performance of his/her duties under the
DPRA at all reasonable times
What they can do:
o Review any pharmacy practice-related document or object
o A justice of the peace may on application of an inspector make without notice issue a warrant authorizing the
inspector to enter/search a place/examine any document if there are reasonable and probable grounds to
believe:
 1. Person has committed proprietary misconduct or is in breach of the DPRA
2. There is something relevant to the inspection at this place.
o The inspector may copy (at the OCPs expense) documents or objects that the inspector may examine or under
warrant
o May remove a document or object if:
Not practical to copy
A copy is not sufficient for inspection
The object is a drug and the inspector has provided a receipt
o Return of documents/objects/copies
Return within a reasonable time
Or if copy was not sufficient  provide person with a copy of it within a reasonable time
o Copy as evidence
Dopy of document/object certified by the inspector to be a true copy shall be receivedin evidence in any
proceeding  same evidentiary value as the actual document/object itself
Notice or non-notice:
o Warrant may only be executed between 8AM and 8M unless the warrant specifies otherwise.
o May be assisted by other person and may enter a place by force if there is authority of a warrant.
Inspector shall produce his/her identification upon request to any person on site
No person shall obstruct an inspector (acting under OCP request or under warrant) or conceal or destroy anything that is
relevant to an inspection

Designated Manager
As defined in the Drug and Pharmacies Regulation Act (DPRA), the designated manager is the pharmacist designated by
the owner of the pharmacy as the pharmacist responsible for managing the pharmacy.
o DM must be in part A of the register who is responsible for human resources management (incl. supervision of
professional and lay staff)
o Hospital pharmacies are exempt (governed by the Public Hospitals Act)

Part B pharmacists are permitted to supervise members in hospitals or health care facilities as managers,
but remain non-practicing pharmacists.
DM responsibilities are equal to that of the person or directors of a corporation who have been issued a certificate of
accreditation to ensure that pharmacy conforms to the requirements set out in legislation and regulations.
o If the Accreditation Committee believes a DM has contravened DPRA provisions, the Committee may refer
allegations of professional misconduct against the DM for breaches of the DPRA to the Discipline Committee
DM also has authority and accountability over decisions affecting pharmacy operations.

Required Signage
The D is responsible to ensure that all signage is appropriately and prominently displayed
The following MUST be visible to the public:
o The Colleges Point of Care symbol

(required under the DPRA)  in at least one main public entrance to the
pharmacy
o The DMs name and/or certificate of registration
o The notice concerning a customers right to request an interchangeable product in the format specified by
regulation
o The Usual and Customary Dispensing Fee
All pharmacy personnel must be identifiable by name and that all members are clearly distinguished by the public from
other pharmacy staff.

Advertising [DPRA Part VIII]

Advertisement of drug services
 o Shall not advertise (any medium) an advertisement relating to drug services that is:

False, misleading, deceptive (inclusion or omission of information)

Not readily comprehensible to the audience

Is not dignified or in good taste

Contains anything that is non-verifiable

Contain testimonials, comparative statements or endorsements

Contain a reference to a members area of practice or to a procedure or treatment available from a
member practising unless the adverse discloses whether the member has an area of expertise, and
particular expertise

Contain references to a particular brand of equipment used to assist in providing drug services

Contains information that is not relevant to the choice of pharmacy

Contains any representations as to the safety/effectiveness/indication for use of any drug referred to in
Schedule I
If price information is advertised for schedule I drugs, it must include price information for at least 15 different drugs (10
of which belong to a different class)
If an advertisement includes price information for schedule I drugs:
o Must include:

1. Quantity advertised at the price

2. Total cost to purchaser incl. dispensing fee

3. Time period the deal is available

Also include:
1. Strength
2. Brand name
3. Dosage form

Equal prominence must be given to each drug (and for all information required)
The pharmacy may publish, display, distribute, an advertisement that relates solely to the co-payment or dispensing fee
charged by the pharmacy for supplying a drug listed under the ODB Act to an eligible person under that Act

SECTION F COLLEGE STRUCTURES/ENTRY TO PRACTICE/SCOPE OF PRACTICE (19)

Who is governed by the OCP?

Pharmacists
Registered pharmacy technicians
Pharmacy interns
Registered pharmacy students

OCP Council [Mandated under the RHPA]

9-17 elected members
o 2-4 technicians
o At least 1 hospital pharmacy technician, and at least 2 hospital pharmacists per OCP by-laws
Deans of the schools of pharmacy (Waterloo, U of T)
9-16 public members
o Appointed by the government

OCP Vision OCP Values OCP Mandate

To lead advancement of pharmacy to Transparency To protect the public
optimize health/wellness via patient- Accountability
centered care. Excellence

Council/Committee Structure
Elections Role of Council Members, Meetings Committees
Power of Council
Every August Roles: 4 meetings/year Statutory Committees
Confidentiality Executive
President, VP Conflict of interest Council brings member views ICRC
Committees Dealing with forward Discipline
Nominating Questions Quality Assurance
Committee Current issues OCP Council Report and Council Patient Relations
mailings Fitness to Practice
Power of council: Registration
Make regulations for Strategic plan: Accreditation (under the
approval by Outlines operational Pharmacy Act)
provincial plan of action for 3
government years Standing committees
Plan for OCP to focus As per OCP by-laws
resources Professional Practice
Refer to website for Communications
current plan Elections

Controlled Acts (RHPA, 27-29)

Tasks for potential for harm if not done correctly by a competent person
13+1 Controlled Acts
No profession can perform all of them (but more than one may perform the same one act)

Who can Perform Controlled Acts?

Members of a regulated, authorized profession
May be delegated by Member in accordance with profession-specific regulations
Uncontrolled acts can be performed by all, including unregulated workers

RHPA Statute Law Amendment Act, 2009 (BILL 179)

Pharmacy Act update
Regulations passed August 1, 2012
Allows pharmacists more authorized acts, expanded scope of practice

Pharmacy Act
Incl. Health Professions Procedural Code
Scope of Practice
Authorized Acts
OCP
OCP Council
Protected Titles

Pharmacy Act
Authorized Acts Scope of Practice Certificates of Registration
Subject to the terms, conditions, and limitations imposed The scope of practice of pharmacy is: Registered Pharmacy Student
on his/her certificate of registration to: Pharmacist
1. The custody, compounding, Intern
1. Dispense, sell, compound a drug or supervise the dispensing, and prescribing Pharmacy Technician
part of a pharmacy where drugs are kept of drugs
Protected titles:
2. Administering by inhalation or injection a 2. The provision of health care Pharmacist
substance specified in the regulations (for aids and devices Pharmacy Technician
patient education or demo only, must comply Apothecary
with conditions), and be a part A pharmacist, 3. Provision of information and Druggist
intern or registered pharmacy student education pertaining to the Pharmaceutical
above chemist
3. Administering by inhalation or injection a
substance specified in the regulations only part 4. The promotion of health, Falsely using these titles:
A pharmacists may administer the flu vaccine prevention and treatment Up to $25,000 fine for the first
(ages 5+), must be administered in accordance of disease, disorders and offence
with ONs Universal Influenza Immunization dysfunctions through $50,000 for a second
Program, Informed consent, have approved monitoring and or subsequent
training management of medication offence
therapy
 4. Prescribing a drug specified in the regulations (for
smoking cessation only) must comply with
conditions Part A pharmacist, intern or
registered pharmacy student as per the terms,
conditions/limitations

5. Prescribing a drug, other than smoking cessation

ones in accordance with regulations Adapting,
Renewing (but NOT CDSA or monitored drugs
under the Narcotic Safety and Awareness Act)
no therapeutic substitution (Part A pharmacist,
intern, registered pharmacy student)

6. Performing a procedure on tissue below the

dermis (lancet-like device to obtain blood) Part
A pharmacist, intern, registered pharmacy
student, or pharmacy technician (technician only
if the Part A pharmacist is physically present, the
technician is under the direction of a Part A
pharmacist)

Scopes of Practice
Registered Pharmacy Student Intern
May perform authorized acts under direct supervision May perform the authorized acts independently with a
mutual agreement from the preceptor
I.e. can dispense prescriptions, take verbal prescriptions (if the
pharmacist is comfortable), speak with patients under direct Interns require supervision a pharmacist must always be
supervision available for consultation if necessary
Regulation Conditions of Registration Scope of Practice Pharmacists vs. Pharmacy
Technicians
OCP members May dispense and Practice within the scope of their profession RPh RPhT
compound under defined (defined in NAPRA Competencies and NAPRA entry Yes Yes
to Practice
Health System terms and conditions: Standards of Practice) Competencies
Improvements Act May do final check Standards of Yes Yes
(2007) and release if the Regarding provision of education or Practice
pharmacist is information: Scope of Same Same
Practice
Voluntary physically present in Shall NOT provide information or Code of Ethics Same Same
registration an accredited education relating to drug use (either to Personal Yes Yes
RPhT pharmacy (except in or for a patient) where the provision of Professional
designation remote dispensing information requires therapeutic Liability
Insurance
location) knowledge, clinical analysis or clinical
Quality Yes In the
Protected title In other situations assessment Assurance future
under supervision or maybe
Have the authority direction of a E.g. a pharmacy technician can educate the Complaints, Same Same
to perform pharmacist patient on how to use and maintain a Discipline
Process
controlled acts of If remote dispensing glucometer, but questions that involve
dispensing and location pharmacist therapeutic decision-making must be
Same scope of practice, but
compounding in does not need to be referred to a pharmacist (e.g. how often
extent defined differently
collaboration with physically present to should they test)
through regulations, standards of
a pharmacist supervise but
practice and competencies
pharmacist must May confirm accuracy and completeness of
actively supervise the new & repeat prescriptions
pharmacy technician
(and RDL must be Perform a check of technical accuracy
accredited)
Shall not supervise May accept written or verbal (excluding
pharmacies, and shall CDSA or narcotic prescriptions) prescriptions
not delegate new or repeats
 controlled acts
Can Transfer prescriptions (as of December
2013)

Legal Authority for Scope of Practice/Authorized Acts

Pharmacist
Provide information and education to patients
Dispense, sell, compound drugs
Responsible for therapeutics
Accept verbal Rx transfers
Pharmacy Technician
Not if clinical or therapeutic
Can perform final check
Ensure collaboration with RPh
No verbal, narcotic, controlled or targeted prescriptions

Awaiting amendments to FDA for transfers

Supervise pharmacies No
Delegate controlled acts No
Prescribe specified drug products for smoking No
cessation
Renew and adapt prescriptions No
Alter doses, dosage forms, regimen, or route
of administration
(Not CDSA or NSAA drugs)
Cannot perform therapeutic substitutions
Perform a procedure on tissue below dermis (with Only under direction of a Part A RPh (must be physically
a lancet-type device) present) when performing this procedure
Administer a substance by injection or inhalation No
for the purpose of education and demonstration
Administer influenza vaccine to patients (5+ years No
in age)
With approved training only
Accept verbal prescriptions (not straight Yes
narcotics) Exceptions: narcotics, controlled substances

Preceptors
Pharmacists or Pharmacy Technicians registered with the OCP who:
o Are prepared to take responsibility for supervising/assessing a student/intern/technician applicant
o Have declared potential conflict of interests with student/intern/technician
o Have attended a preceptor training workshop offered by the College

Preceptors for Structured Practical Training

o Licensed to practice pharmacy
o Licensed for at least 1 year
o Provide direct patient care for at least 18 hours a week as a pharmacist
o In good standing with the OCP
Pharmacy technicians can be preceptors for technician applicants

Maintaining Registration
Professional liability insurance is mandatory:
o A registration requirement for part A pharmacists, students, interns, pharmacy technicians
o $2 million policy
Part A Pharmacist Part B Pharmacist Pharmacy Technician
Direct patient care Still a Member Only one part

600 hours over 3 years No patient care Active, practicing member

Eligible for Practice Review Must successful complete Practice

Review to move to Part A

Registration Requirements
Pharmacist Pharmacy Technician
Undergraduate from Waterloo or U of T: Bridging program
o Passed PEBC Evaluating Exam before January 2012
1. Pre-register as student (supporting document, OCP
confirms enrolment and year of study) 3. Pre-register with OCP
 2. Obtain professional liability insurance, pay pre- 4. Bridging education program (by January 2015)
registration and student application fees, notify college & structured practical evaluation
if you plan to work/volunteer in a pharmacy outside of 5. Jurisprudence exam
your program. 6. PEBC qualifying exam (part I and II) for
3. Graduate pharmacy technicians
4. Register as an intern (+ professional liability insurance, 7. Apply for certificate of registration as a
pay intern application fee) pharmacy technician [obtain professional
5. Structured practical training (SPT) internship liability insurance, submit evidence of language
6. Jurisprudence exam proficiency, pay fees]
7. PEBC qualifying exam (parts I and II) for pharmacists
8. Apply for certification (+ professional liability insurance, Graduate from a CCAPP Pharmacy Technician Program
application fees)
1. Pre-register with the College
Similar process for undergraduates/graduates from CCAPP/ACPE 2. Structured practical training
pharmacy programs from within Canada. 3. Jurisprudence exam
For graduates  pre-register + register as 4. PEBC qualifying exam (Part I and II) for pharmacy
intern + SPT + jurisprudence  PEBC  technicians
Application 5. Apply for certificate of registration [+ professional
liability insurance, final fees, update personal/practice
International Pharmacy Graduate information]
Supporting Documentation
1. PEBC document evaluation and PEBC evaluating exam
2. Enrol in the U of T IPG Program Evidence of Identify and citizenship or status in Canada
3. Pre-register with the College Passport (Canadian or international)
4. Register as a Student For non-citizens: record of landing, PR card, study/work
5. SPT studentship permit
6. Complete IPG program (CPS I and CPSII) Canadians: passport, birth certificate, citizenship card or
7. Register as an intern citizenship certificate
8. SPT internship
9. Pass jurisprudence exam Declaration of good character
10. PEBC qualifying exam (Parts I and II) for pharmacists
11. Apply for certification (+ professional liability insurance, Evidence of Graduation
application fees) Original or notarized degree/diploma certificate
Arrange for a letter to be sent from the school directly
International Pharmacy Graduate Passed PEB Qualifying to OCP
st
Exam (both parts) on 1 attempt Make a request to PEBC to send your document
evaluation information to OCP
1. Pre-register with the College Have the university directly notify OCP
2. Apply to register as a Student (+ professional liability
insurance, submit request to Registration Panel) Evidence of licensure in Good Standing
3. Structured Practical Training (SPT) Studentship + any If currently or ever been licensed as a pharmacist or
additional educational training technician
4. Register as intern
5. SPT internship Language proficiency
6. Pass jurisprudence exam Not necessary for students/graduates of CCAPP/ACPE
7. Apply for certification (+ professional liability insurance, programs
and application fees) IPGs must prove they can understand, speak and write
in English or French
Currently licensed in Canada (Outside Ontario)

1. Pre-register with the College (submit supporting

documentation)
2. Jurisprudence exam
3. Apply for certification (+ professional liability insurance,
fees)

Expanded Scope of Practice

Delegated Health care professionals can delegate controlled acts to any other health professional or non-health professional
Authority/ MD can delegate act of prescribing to a pharmacist they believe will perform the act competently/safely.
Medical
Directives in Involves written agreement Medical Directive
Ontario Must include details about how it will be performed, by whom, and under what circumstances
Regularly reviewed

Both MD and pharmacist accountable to patient for decisions/actions

Pharmacist must document all action
Communicate performance of procedure and patients response to the MD
Pharmacist 2009- Regulated Health Profession Statute Law Amendment Act) Bill 179
Expanded Expands scope of practice of 11 regulated professions, incl. pharmacy
Scope of October 2012 approval of regulations pertaining to expanded scope of practice for pharmacists
Practice
What we can now do:
1. Adapt existing prescriptions (alter dose, form, regimen, route)
2. Extend existing prescriptions (chronic)
3. Perform procedures below dermis, to support self-care, and disease monitoring
4. Initiate prescriptions for smoking cessation schedule I [bupropion, varenicline]
5. Administer by injection/inhalation of specified substances for purpose of patient
education/demonstration.
6. Administer influenza vaccine to patients older than age 5, in accordance with Ontairos Universal
Influenza Immunization Program (IIUP)
Expanded Acts What it means What we cannot do
Scope of Adapting Altering dose, dosage form, regimen, route of administration Cannot for narcotics
Practice prescriptions For existing prescription or controlled
substances
Assessment:
Is it appropriate to adapt? [Under federal
Consider risks and benefits to patient regulation]
Consider other relevant factors

Requirements:
Provide written prescription [drug name, strength, quantity,
etc.
o Can take prescription anywhere, does not have to
be filled at your pharmacy
Maintain patient record [incl. rationale, patients voluntary
consent]
Notify original prescriber when adaptation is clinically
significant, or notification is necessary to support patient
care

Previous Situation:
1. Detect problem
2. Consult with prescriber [MD authorization]
3. Change Rx
4. Dispense medication

Expanded Scope [Only in community Hospital Act overrides this]

1. Detect problem
2. Change Rx based on clinical assessment by pharmacist
3. Dispense medication
4. Notify prescriber
Extending Prescribe additional quantity of a drug that has been Not meant to
Prescriptions previously prescribed for a patient circumvent doctor,
this is to ensure
When prescription has been extended, quantity shall not exceed the patient continuity of
care.
 lesser of:
Quantity originally prescribed, incl. refills that were You cannot extend a
authorized by the previous prescriber prescription that was
6 months supply previously extended
o So if original script was for 2months, you can extend by a pharmacist so
for maximum of 2 months. they cannot keep
o If original was for 1 year, you can extend for a max renewing via
of 6 months. pharmacists.

Requirements
Assess appropriateness of extending the prescription
Fulfill reporting and record-keeping requirements

Previous situation:
1. Identify need for extension
2. Consult with MD
3. Extend Rx
4. Dispense medication

Expanded scope
1. Identify need for extension
2. Extend Rx after clinical assessment
3. Dispense
4. Notify prescriber

PAPE Agreement vs. Exanded Scope

Bill 179 provisions outlined in DPRA regulation revoked
So we no longer have to contact prescriber before hand
Bill 179 Expanded Scope pharmacist makes judgement of
suitability
Does not expect that we have to make reasonable attempts
to contact the prescriber first

Initiating ONTARIO Smoking Cessation only In Ontario cannot

Prescriptions Rx drug therapy to assist patients in their efforts to quit prescribe other
smoking. schedule I
No prior prescription in place [initiation of new drug therapy] medications
Same requirements as with prescription
adaptations/extensions
2 drugs only: bupropion, varenicline
Administering Patients are liking this convenient, accessible Cannot administer to
Flu Vaccines patients under age 5
Can administer to patients 5 years or age or older
Via participation in the Universal Influenza Immunization
Program (UIIP)  pharmacy must be approved for this
program

Requirements
Appropriate infection control procedures
Ensure safeguards, and resources are available to safely
manage outcome after administration (e.g. anaphylactic
reactions)
Must maintain patient record confirm informed consent,
and document act
Self-declare to OCP competence in administering
immunizations need injection administration course
First aid/CPR certification that is current
 Pharmacy must be approved by local public health unit to
participate in UIIP

OPA resources: ToolKit, workflow diagrams, assistance with UIIP

st
applications, discounts on 1 aid training, etc.

SECTION G ETHICS/STANDARDS/RESPONSIBILITIES (22)

Standards of Practice/Documentation
The 2007 professional competencies fulfilled by pharmacists:
Patient care
Drug information
Drug distribution
Management
Education
o The four domains of Model Standards of Practice are:
1. Expertise in medications and medication use
2. Collaboration
3. Safety and quality
4. Professionalism and Ethics

Medication Expertise Collaboration Safety/Quality Professionalism/Ethics

Maintain competence Work constructively with Continuing professional Professionalism and
Fulfill CE other members of the inter- development, quality application of ethical
requirements, adhere professional team assurance and quality principles in their every day
to current laws, Treat colleagues with improvement work
regulations respect Fulfill professional Treat each other with
Maintain certification Act as a positive role development sensitivity, personal
and credentials model requirements and professional
required for practice Fulfill roles and Ensure staff or integrity
incl. expanded scope obligations to support personnel are Accept responsibility
activities colleagues in a timely delegated and for actions and
manner undertake activities decisions
Apply medication and that are appropriate Adhere to laws,
medication use expertise In patient care with their training regulations, policies
Practice within limits Refer to other HCPs and consistent with Caring, empathetic,
of competence, use when required legislation, regulation professional attitude
evidence-based Recognize and work and policies Maintain professional
information within limits of Adhere to applicable boundaries
Provide patient- competence laws, regulations and Protect privacy when
friendly education Maintain CPR and policies collecting/using
and information emergency First Aid Accept responsibility relevant information
Review new certification for ensuring that Educate and enable
prescriptions for Provide information practice environment patient privacy when
clinical on services to in which they work collecting and using
appropriateness promote wellness and supports their relevant information
Rectify medication health provision of quality Educate and enable
errors, assess pharmacy patients to support
appropriateness of Managing a pharmacy care/services their ability to provide
refills, manage refill Organize and support self-care
requests that may staffing and workflow Management Ensure confidentiality
pose harm to the changes necessary to Standard operating of patient information
patient enable pharmacists to procedures to ensure is maintained
Address compliance work collaboratively a safe/effective
issues Maintain professional system of medication
Extend refills for relationships with supply and support
 chronic medications other HCPs the staffs ability to
after gathering continuously improve
information Communicate effectively patient care
Educating patients Be proficient in
Prescribe medications written/verbal English Respond to safety risks
after assessment or French Manage errors,
Recommend OTC Effective verbal, non- incidents and unsafe
products after verbal, listening and practices
collecting and written Disclose alleged or
interpreting patient communication skills actual errors,
information Sensitivity, respect, incidents and unsafe
Recommend self-care empathy practices promptly to
where appropriate those affected
Complete medication In patient care Record and report
reviews, etc. Listen and respect alleged and actual
patient beliefs errors
Documentation Patient-friendly Report occurrence of
Clear, accurate, education and addres adverse events/close
legible records concerns and calls
Make records in a communication Review incidents to
timely manner challenges determine patterns
Document decisions Respond to questions and causal factors
and actions incl. that contributed
their review,
assessment,
education, actions,
ordering lab tests,
administration of
medications

Record Retention
Time Frames Disposal of records If a pharmacy is sold If a pharmacy is closed
Entire patient record retained Physically segregate records Pharmacies are responsible Pharmacy retains obligations
as a whole. marked for disposal from until personal health to health information until
other records in a secure area information is completely responsibility is transferred to
Scanned electronic copies transferred to the next legally another legally authorize
created via scanning original Clearly mark for disposal authorized person person
document
Transfer records securely and The pharmacy records are Notify OCP of the disposition
rd
Original prescriber generated document transfer if a 3 transferred to the purchaser of the records (location)
prescriptions kept for at least party is to dispose of these of the pharmacy
2 years (retrievable) records Patients must continue to have
Records and Written contract is access to their records
documents pertaining recommended
to patient care other Pharmacy must make
than original written appropriate arrangements for
Rx maintained for at secure transfer or retention of
least 10 years from patient records
the last recorded
service or 10 years
after patient reaches
age 18 (or would
have reached) 
which ever is longer

Professional Judgement
Refusal to Fill for Moral/Religious grounds Out of Province Prescriptions Professional Judgement (OCP)
 1. Pharmacists shall hold the
health/safety of the public as their
first consideration
2. If pharmacists object on conscious
grounds to fill  they must explain
the basis of their objections
They may decline providing certain
products or services if it conflicts with their
own moral or religious beliefs or believes
their conscience would be harmed
Convey objections to
pharmacy manager
BUT pharmacist must ensure an alternate
source  minimize inconvenience or
suffering to the patient or caregiver
E.g. refer to another
pharmacist or pharmacy
Members have the authority to refuse Key to implementing expanded scope
to fill a prescription based on the
patients circumstances and the Pharmacists will now more than ever
application of his/her professional need to use professional judgement to
judgement assess their patients health statuses and
make appropriate decisions regarding
Members can accept prescriptions medication management
written by any prescriber licensed in a
province or territory of Canada Do so for the benefit of the patient based
Based on professional on individual nature of the patients
judgement need/history
They can accept
written, verbal or Standards of Practice and Code of Ethics
faxed prescriptions are the two most important tools when
incl. refills if any using professional judgement.
No restrictions
regarding new Key factors that apply when exercising
narcotic, controlled or professional judgement:
targeted substances 1. Best interest of the patient
provided professional 2. Pharmacists
judgement and due knowledge/expertise
diligence is used in 3. Whether the decision is
verifying authenticity reasonable and acceptable and
4. Documenting rationale and
actions [accountability]

Mandatory Reporting [As per the Regulated Health Professions Act]

Reasonable grounds
Employers Facility Operators Healthcare Professionals
Mandatory duty to report if they have Mandatory duty to report if they suspect Mandatory duty to report if they believe
revoked privileges or sexual abuse of a patient by a healthcare another health professional has sexually
terminated/suspended a regulated health professional or if they suspect a health abused a patient
professional for reasons of professional professional to be
misconduct, incompetence or incapacity. incapacitated/incompetent

Obligation remains even if the regulated

health professional resigned or
relinquished privileges before the
employer did so.

Self-Reporting
As per the Pharmacy Act
A pharmacist, pharmacy technician, registered pharmacy student or intern is required to self-report to the College
(Manager of Investigations and Resolutions) if he or she:
o Has been found guilty of or charged with any o Has a finding of professional misconduct,
offence in any jurisdiction incompetence or incapacity or any similar finding
o Has a finding of professional negligence or in relation to the practice of pharmacy or any
malpractice profession or occupation in any jurisdiction
o Is the subject of a current investigation, inquiry or
proceeding for professional misconduct,
incompetence, or incapacity or any similar
investigation or proceeding in relation to
pharmacy or any other profession/occupation

OCP Mandate
To serve and protect public interest.
What it does:
 o Sets entrance to practice requirements
o Quality assurance
o Enforcing standards by investigation an discipline proceedings

Code of Ethics
A set of principles that form the basis of ethical conduct of members.
o Guidance for when members exercise professional judgement

The importance of practicing ethically

Maintain public trust
Maintain our professions reputation
Deliver appropriate patient care
Retain ability to self-govern
Protect public interest

Ethical Principles
Principle Description
One The patients well-being is first and foremost

The patient trusts member to act in their interest

Member develops professional relationships within scope of practice

Right to self-determination for patient (participate in health decisions)

Two Member exercises professional judgement in the best interest of the patient

Consistent with scope of practice

To meet patient needs

Three Each member preserves confidentiality of information about individual patients acquired in the course of his/her
professional practice

Must not divulge this information except where authorized by the patient, or required by law, or to protect patient
or another person from harm
E.g. suicidal patient
Four Respect for autonomy, individuality, and dignity of each patient

Provide care with respect for human rights, without discrimination

Cannot deny access to pharmaceutical services because of the members personal/religious beliefs
Must refer to another pharmacist who can meet the patients needs
E.g. Plan B or birth control must refer to another pharmacist who will provide these if the patient wants
them

Other ethical principles

Honesty, integrity
Commitment to continuous competence improvement
Collaboration with multidisciplinary teams
Enable other members to practice in accordance with high standards of professional practice

Personal Health Information Protection Act (PHIPA, 2004)

Applies to personal health information:
o Collection
o Use
o Disclosure
Refers to Health Information Custodians
 o Contains specific rules on how health care practitioners may collect, use, retain, disclose, or dispose of personal
information
www.ipc.on.ca Information and Privacy Commissioner

Circle of Care: Sharing Personal Health Information for Healthcare Purposes

Describes when health information custodians can assume a patients implied consent to collect, use, or disclose personal
health information
The term Circle of Care is not defined in PHIPA, but is commonly used to describe the ability of certain health information
custodians to assume an individuals implied consent to collect, use, or disclose personal health information:
Must satisfy all of 6 conditions:
o 1. Health information custodian falls within a category of custodians entitled to rely on implied consent.
o 2. Personal health information is received from the patient, decision maker or another custodian.
o 3. Information is collected/used/disclosed to provide or assist in provision of health care.
o 4. Purpose must be for the provision of health care
o 5. Disclosure from one custodian must be to another health information custodian.
o 6. The custodian must not be aware that the individual has expressedly withheld or withdrawn consent.

Professional Misconduct

Investigation process

Screening Information Gathering Public Release? Do members need a Complaints

lawyer?
Complaints and Information comes in the Complaints and report Recommended to seek If the issue is brought
member-specific form of: matters are independent legal forward as a complaint,
concerns are screened Complaints confidential advice and then the person who
by the Inquiries, Mandatory reports Identifying representation when complained
Complaints and Information from information is involved in College (Complainant) is
Reports Committee other sources not published proceedings involved in the process
(ICRC) He/she will be
If brought forward via Not published willy- Up to the individual informed of
Mandatory report the nilly in Pharmacy Member the outcome
only parties are the Connection and can appeal
member and the OCP dispositions

An investigator for the ICRC

may be required in some
matters to obtain necessary
information
An investigator can
be appointed at
any time that the
ICRC receives a
complaint and
requests that the
Registrar conduct
an investigation

Mandatory Reporting Provisions:

Facility operator shall report to the OCP on grounds of:
o Incompetent or incapacitated practising member (reasonable grounds)

Incapacitated a member suffers from a physical or mental condition/disorder that makes it desirable in
the interest of the public that the members certificate or registration be subject to terms, conditions, or
limitations, or that the member no longer be permitted to practice.

E.g. substance abuse, mental illness, mood disorders, physical, cognitive or sensory disabilities
Report to the OCP if a person has terminated employment or revoked/suspended/imposed restrictions on the privileges of
a member for professional misconduct or incompetence.
o Report even if the member resigned or relinquished privileges prior to this action.
 Members must report a finding of guilt, professional negligence or malpractice to the College as soon as reasonable after
this finding.

Investigating the issue:

1. Identifying involved members
2. Collecting relevant information
3. Providing this information to involved parties who can provide a response.

ICRC Dispositions Possible Results

No action
Written caution or reminder
Invite the Member to undertake to do something
Require member to receive an oral caution at the college
Require the member to complete a specific CE or remediation program (SCERP)
Refer allegations of professional/incompetence to the Discipline Committee
Appoint another ICRC panel and inquire into the health of the member
o Can request for the Health Professions Appeal and Review Board to review the ICRC disposition

Discipline Proceedings
Jurisdiction of the Committee Make-up Professional Misconduct Incompetence Discipline Hearings
Discipline Committee
Hears matters referred by 25 members Five types in the code: If a members Parties:
screening committees: From this Guilty relevant to professional care Member (and
ICRC (members) group, a panel suitability to of a patient Counsel if
Accreditation is appointed to practice displayed lack of applicable)
Committee hear Theft knowledge, skill, College
(pharmacies) allegations Fraud or judgement to (prosecutor
Forgery an extent that represents it)
Adjucates allegations of Panel: Others demonstrates that
professional misconduct Usually 3 Guilty by another the member is Panel has no prior
and incompetence pharmacists or College in Ontario unfit to continue to knowledge or
pharmacy or another practice, or that involvement
technicians jurisdiction the members
And 2 public Failing to co- practice should be Usually Open (closed also
members operate with restricted possible)
Quality Assurance
Committee or one Uncontested (most) vs.
of its assessors contested
Guilty of sexual
abuse of a patient Panel hears evidence and
Guilty of devices:
professional What are the
misconduct facts
(Defined by Does the
Regulation 681/93 conduct amount
of the Pharmacy to professional
Act) misconduct or
incompetence?
(Legally)
If it is
professional
misconduct
and/or
incompetence,
what happens?
Penalty decided

Penalties
Penalties for Members Penalties for Pharmacies
Public reprimand Revocation of Certificate of Accreditation
Suspension Suspension
Terms, conditions or limitations on license Terms, conditions, or limitations on Certificate of Accreditation
Fine payable to the province (up to $35,000) Fine up to $100,000
Revocation of license
Repayment of the victims fund if sexual abuse

Fitness to Practice Proceedings

Beginning the Process
Information regarding the
members potential
incapacity comes to the
Colleges attention via:
Health Inquiries Panel (HIP)
HIP informs member that it will
make inquiries
HIP conducts
appropriate inquiries
Hearing before the Professionals Health Program
Fitness to Practice
Committee
Hearing is confidential PHP carries out monitoring of
restrictions imposed by Fitness to
Closed to the public not Practice Committee on behalf of the
punitive College

Mandatory report, self-
report, other
OR
Panel of the ICRC can refer
the member to further panel
to conduct health inquiries
HIP may order an assessment
of the member by an
independent medical examiner
HIP produces a report of its
inquiries and provides copy to
member
HIP may refer member
to  Fitness to
Practice Committee
for a hearing
Fitness to Practice Available anonymously/directly to
Committee decides pharmacists, technicians, pharmacy
whether the member is students, co-workers and families
incapacitated
Also decides on Early intervention for stress and
appropriate other difficulties which could cause
restrictions to incapacity
impose

Sexual Abuse Prevention

RHPA Definition of Sexual
Abuse
Sexual abuse of a patient by
a member
A) Sexual Intercourse or
other forms of physical
sexual relations
B) Touching of a sexual
nature of the patient by the
member
C) Behaviour or remarks of a
sexual nature by the
member toward the patient
Mandatory Report of Sexual
Abuse of a Patient
Section 85.1
The Member must file a report
of sexual abuse if:
The member has reasonable
grounds (obtained in the
course of practising) to believe
that another Member of the
same or different college has
sexually abused a patient
How to report Sexual Mandatory Penalties for finding of
Abuse Professional Misconduct for sexual
abuse of a patient
How should the member Reprimand
file this report? Revocation of certificate of
registration if sexual
In writing within 30 days intercourse or other sexual
(unless imminent risk to contact
victim or other victims) If revoked, cannot apply to
be reinstated for 5 years
To the Registrar of the May order the member to
members college reimburse the College for
funding provided to the
Must contain your name, victim/patient for therapy or
the name of the Member counselling
being reported, and an
explanation of the alleged
abuse
Name of the
patient may be
included only if
he/she has
provided consent

Patient Relations Program

The Regulated Health Professions Act (RHPA) requires that each health regulatory college design measures to prevent
and/or deal with sexual abuse of patients.
Measures may include:
 o Education
o Guidelines for conduct of members with patients
o Training College staff
o Provision of information to the public

Sexual Harassment vs. Sexual Abuse

Sexual harassment is not the same as sexual abuse as per the RHPA
Could still result in:
o Complaint of professional misconduct to the College
o Sexual discrimination complaints (to the Human Rights Tribunal)
o Law suits
o Criminal proceedings

Reporting Requirements [Forgeries, Losses]

Narcotic Reporting of Losses
Pharmacists must report to the Office of Controlled Substances (Minister) any loss or theft of a narcotic within 10 days of its
discovery

Pharmacists make take all reasonable steps to protect narcotics on his/her premises or under his/her control against loss or theft.
E.g. alarms, cameras, etc.

At least Every 6 months physical count and reconciliation of all narcotics, controlled drugs and targeted substances

Requirements
In order to reduce losses through forgeries or double doctoring, pharmacists must verify signatures where the doctor is
not known to them
File a report within 10 days of discovery of loss, theft or forgery
o Discovery is the key word.
Reporting the forgery is the same as reporting a loss
o Report forgeries even if the forged prescription was not filld

Forms are available on the Health Canada website for reporting 1) Loss or theft, and 2) Forgery

Who imposes restrictions or revocations of certificates?

The registrar who is directed by the Discipline Committee

After a proceeding, is your name made public or not?

DPRA 140, Subsection 2 - Names are published if:
o Proceeding results can be obtained by a member of the public from the Colleges register
o The person, designated manager or director requests publication of his/her name
Names are withheld if:
o Shall not be published unless required under subsection 2.

Samples Policy [Highlights]

Schedule I drugs require a prescription for sale, and are provided to the public by pharmacists following
diagnosis/professional intervention of a prescriber.
o Schedule I samples can only be provided pursuant to a prescription
Cannot charge for the sample
May charge professional fee
Must communicate to the patient that a medication sample was used in dispensing.
Document to reflect a sample was dispensed.
Label as per s. 156 of the Drug and Pharmacies Regulation Act
Schedule II narcotic substances may not be provided as drug samples
o Non-narcotic schedule II drugs may be provided to the public free of charge, labelled as per Food and Drugs Act
regulations
Schedule III samples can only be provided in a pharmacy when the pharmacist is present.
o No charge, and with appropriate labelling as per Food and Drugs Act regulations.
 Schedule I drugs can be sold without professional supervision. Samples of these products does not fall under purvue of the
OCP.

Introduction to Pharmacy Law Jurisprudence Marie Rocchi

The Law Ensures a uniform system of rules under which society operates
Pharmacists have a greater series of obligations and responsibilities a higher standard

Three branches of the Canadian government:

Legislative House of Commons, Senate
Executive Prime Minister, Cabinet, Ministries
Judicial Judges

Laws enacted at the Legislative branch pass laws (statutes)

MPs may introduce legislation

Acts
Sets framework of regulatory schemes, delegates authority to develop details
Introduced as bills proposals, pass vote in House of Commons three readings
st nd
o 1  2 reading, debated by legislature
rd
o 3 reading acceptance of major elements
o Amendment phase to clarify components
o Final reading voted upon
o House of Commons  Senate  Governor General

Public Law Private Law

E.g. criminal activity, tax laws, Constitutional law Governs individuals

Professional regulations a matter of publicconcern E.g. buying houses, civil law

Legislation Laws act + regulations
By goverments

Act overview document, outlines what is to be done or not done

Regulations supporting, more detailed rules to be followed, more easily changed

E.g. created by others with authority OCP
The OCP may be a subordinate body of the provincial government bylaws, rules, orders in council

Schedule list, may be found in an Act, or in regulations

Pharmacy Provincial Federal
Legislation 1. Drug and Pharmacies Regulation Act and Regulations Health Canada oversees and enforces
2. Regulated Health Professions Act and Regulations
3. Pharmacy Act and Regulations 1. Food and Drugs Act and
4. Drug Interchangeability and Dispensing Fee Act and Regulations
Regulations 2. Controlled Drugs and Substances
5. ODB Act and Regulations Act and Regulations
6. Transparent Drug System for Patients Act (Bill 102) 3. Narcotic Control Regulations
(subject to the CDSA)
Health Disciplines Act (1975)
Was in place until 1991 replaced by the Regulated Health
Professions Act
Under the HDA there were five regulated professions 1)
Pharmacy, 2) Medicine, 3) Dentistry, 4) Nursing, and 5)
Veterinary Medicine
Main principle more direct involvement/control by the
government in the governing of the health professions
Regulated Goals What it does Significance Comments
Health Regulation Sets out: Accountability to Complemented by
Professions Act & 1. Scopes of Practice the public profession-specific
and Code De-regulation of health 2. Controlled Acts acts and regulations
professions in the public Allowing patients (e.g. the Pharmacy
interest No one profession has a monopoly choice in Act)
healthcare, and
Regulation by continuing Expanded the number of regulated reduces The Drug and
to protect the public from health professions, and imposed self- monopolies Pharmacies
incompetent/unethical regulation structure within Regulation Act
individuals (as with the professions (complements RHPA)
Health Disciplines Act) Governs all regulated health defines prescribing,
professions in Ontario dispensing, selling or
De-regulation consumer compounding of drugs
choice It defines controlled acts
Requires all regulated
professions to have
Standards of Practice

26 regulated health
professions outlines
Controlled acts

Pharmacy Act Goals What it does Significance Comments

and Regulations Governs pharmacists Governs: Accountability of Defines authorized
1. Scope of practice pharmacists acts incl.
2. Restricted Titles dispensing,
3. Registration Protects patients administering by
4. Quality Assurance from injection or inhalation,
5. Professional misconduct incompetent or prescribing of drugs,
unethical performing
Classes of registered members: pharmacists procedures on tissue
Pharmacists below the dermis
Registered pharmacy
students
Registered pharmacy
technician
Intern
Technician and
Pharmacist are protected
titles
Drug and Goals What it does Significance Comments
Pharmacies Governs pharmacy Pharmacy operations: The OCP also Does not apply to
Regulation Act operations E.g. ownership, accreditation, regulates the hospital pharmacies
and Regulations supervision, openings, profession under
Governs drug distribution closings the authority of
(e.g. mailing, records, Supervision of pharmacists, the Drugs and
sales, transfers, labels) designations Pharmacies
Inspections, entries/searches Regulation Act
(and the RHPA)
Drug distribution:
E.g. ownership, accreditation,
supervision, openings,
closings
Prescriptions from out-of-
province
Records of pharmacies, sales
Governing of 1. NAPRA schedules followed by Ontario
Drug Schedules 2. Food and Drug Act and Regulations
(Lists) 3. Controlled Drugs and Substances Act

Governing 1. ODB Act and Regulations

Costs and 2. Drug Interchangeability and Dispensing Fee Act (DIDFA)
Benefits 3. Transparent Drug System for Patients Act (TDSPA)
Bill 179 Includes changes to:
1. Drug and Pharmacies Regulation Act
Regulated 2. Pharmacy Act, 1991
Health 3. ODB Act
Professions 4. Commitment to Future of Medicine Act (CFMA)
Statute Law 5. Regulated Health Professions Act
Amendment 6. Others
Act, 2009
These amendments led to the Enhanced Scope of Practice
Before and Before After
After Bill 179 The practice of pharmacy is: The practice of pharmacy is:
The custody, The custody, compounding, dispensing and prescribing of drugs
compounding, Provision of health care aids and devices
dispensing of drugs Provision of non-prescription drugs
Provision of health care Provision of information and education related to drug use
aids and devices The promotion of health, prevention, and treatment of disease,
Provision of non- disorders and dysfunctions through monitoring and management of
prescription drugs medication therapy
Provision of
information related to Changes speak to our role in providing education as well as information
drug use Also acknowledges pharmacys unique role in MTM

Current status
2011 draft regulation to the Pharmacy Act ratified by the OCP
Council
Progress Bill 179 received Royal Assent on December 15, 2009

Remote dispensing
Consultations conducted
Principles approved
Drafting regulations

Expanded scope required:

Stakeholder consultations
Focus groups of practitioners
Inter-professional meetings with other health fields regulatory colleges
Regulation vs. Regulatory Bodies Advocacy Bodies
Advocacy E.g. OCP, OMA E.g. OPA, CPhA, CSHP

Set standards and hold pharmacists accountable, Represent the views of pharmacists, lobby regulators and
develop regulations and standards politicians to influence policy and regulation, and put
forth positions
Regulatory relates to the public
Advocacy relates to the profession, and pharmacists
Five core 1. Medication therapy review (MTR)
elements of a 2. Personal medication record (PMR)
MTM Service 3. Medication-related action plan (MAP)
Model 4. Intervention and/or referral
5. Documentation and follow-up
 MTM is the emerging practice model given the definition of our new expanded scope of practice

Pharmacy Laws and Regulations (Nadia Sutcliffe, OCP)

Section 117 A DRUG is any substance or preparation containing any substance
(Definition)
Referred to in schedules
Provincial Federal
I, II, III F, G, N

Weve adopted these within These are applied nationwide

Ontario throughout Canada and are
uniform from one province to
another

A schedule is a list
NAPRA Drug Schedules have been developed to harmonize scheduling across provinces
The federal F, G, and N schedules were in place before NAPRA
The definition of a drug includes all of these schedules NAPRA and federal schedules

A DRUG does not include:

Substances offered for sale as a food (cheese), drink or cosmetic (toothpaste, lipstick)
Or a substance listed in schedule U
Unscheduled drugs can be sold in any retail outlet

The sale of a substance that is legally classified as a drug is restricted in some way
Depending on where you find it
National Drug We have adopted NAPRA drug regulations
Schedules National Association of Pharmacy Regulatory Authorities

Adopted provincially
Many years ago, there were different rules in different provinces
It was very confusing for pharmacists moving from one jurisdiction to another
Also was confusing to patients, because they would need a prescription in one province, but maybe not
in another

Harmonized nationally
You can determine how you can access a drug in any province via NAPRA

The National Drug Schedule Advisory Committee (NDSAC) determines schedule

Takes into account studies, side effects, potential uses, dangers of non-prescription usage
Determines if the drug requires intervention of pharmacists

Uses a cascading model

I Highest, prescription-only
II
III Can be sold in a pharmacy
provided a pharmacist is present
U Can be sold anywhere, not a
drug by definition
Based on risk to public, and supervision needed
Schedules Rx status Restrictions on Sales Comments
I Require Provided to the public by the Drugs not in schedule F may still be deemed
prescription (but pharmacist following diagnosis important for the pharmacist to be involved in
not all schedule I and professional intervention dispensing (schedule F federally deemed to
 drugs under of a practitioner
NAPRA are listed
under schedule F Sales controlled in a regulated
by the Food and environment as defined by
Drugs Act) provincial pharmacy legislation
II Do not require Requires professional
prescription intervention of the pharmacist
at the point of sale
E.g. if someone requests a
schedule II product such as
ferrous gluconate, the
pharmacist should acknowledge
the patient and give them some
instruction and make sure the
drug is right for the patient
Can be visible (except schedule
N items) by visible i.e. you
can display these on the shelves
behind the pharmacy counter.
But schedule N should not be
(e.g. OTC codeine products
cannot be visible to the general
public) must be kept where
patients cannot see/cannot
access the product
III Do not require Sold from the self-selection
prescription area of the pharmacy (should
be accessible to the patient and
clearly identified as the
professional services area of
the pharmacy
The 10 meter rule must be
10m or less away from the
pharmacy counter
The pharmacist should
be able to intervene or
select the correct
product for them
Hard for the
pharmacist to observe
if it is too far away
require prescriptions)
NAPRA is fairly recent, and was not adopted
by every province until the last couple of years
A lot of times, when you look at a prescription
container, you may see a Rx symbol on the
product, but only if listed under schedule F.
Even if there isnt a Rx on the product, there
may still be a prescription required. Check
NAPRA.
Some anomalies do not have a Rx on the
container but still require a prescription
Only available from a registered member
e.g. OCP registered
Must be retained within an area of the
pharmacy where there is no public access, and
no opportunity for patient self-selection
E.g. Behind the Counter
A pharmacy technician would not likely be
sufficient - they dont often have the clinical
knowledge required to counsel on a lot of
drugs. Wed want a registered pharmacist to
counsel a patient who is seeking to purchase a
schedule II drug.
The pharmacy technician might not be aware
of past prescriptions, and this is a cognitive
issue the pharmacist would be responsible
for not intervening in that sale if something
went wrong
A pharmacy intern or registered pharmacy
student (under supervision of a pharmacist)
can also do this (they are members of the
College)
Subject to local professional discretionary
requirements that may increase degree of
control
E.g. dimenhydrinate,
diphenhydramine
May keep Gravol behind the counter
(stolen by some teenagers to try to
decrease pupil sizes after using illegal
drugs)
May keep Plan B behind the counter
(may be stolen in some areas)
The pharmacist should be available, accessible
and approachable to assist the patient in
making appropriate self-medication selections
If the pharmacist is not available, or the
pharmacist leaves, schedule III products
 Only available for sale in should be locked up and brought back to the
pharmacies dispensary
Sales monitored by the Patients would not be able to buy
OCP these products without a pharmacist
there

U Unscheduled Can be sold without Drugs have a NPN or a DIN

professional supervision Should not be sold without one of
Not drugs by E.g. can be sold at a these numbers
definition gas station or at a Some vitamins may still be in the
convenience store process of receiving their NPNs
(Natural Products Number)
Adequate information is
available for the patient to Example:
make a safe and effective Ibuprofen <400mg per unit is
choice schedule U (in package sizes of up to
E.g. should be a fairly 18,000mg)
safe product so the Ibuprofen >400mg is schedule I
patient would not Ibuprofen <400mg per unit is
encounter harm in schedule III (if sold in package sizes
taking the drug larger than 18,000mg)
Adequate labelling to
tell the patient how to Regardless of the schedule, though, patients
use the drug easily are always entitled to ask questions about
without needing advice these and other medications
Can be sold in any It is our professional responsibility to
retail outlet in the answer drug information questions
province of Ontario
Drugs may be placed in more than one
schedule based on form, strength, package
size

Another example:
80mg ASA schedule II
81mg ASA schedule III
Drug companies developed 81mg
tablet to circumvent scheduling issue
(kids would be given ASA got very
sick)

Needles are devices not drugs, but not sold

in most places harm reduction strategy
Federal Food and Drugs Act
Legislation Schedules A, B, C, D
Food and Drug Regulations Part C, D, E, G, J
o Schedule F Parts I, II
o Schedule G Parts I-III
o Controlled Drugs and Substances Act (Schedules I-VIII)

Narcotic Regulations Schedule N

Benzodiazepines and other targeted substances
Food and Drugs Level of What it Schedules Comment
Act government governs
Federal Governs food, Schedules are listed in the Act, and in Regulations We control these aspects
drug and (DPRA as well) in order to protect the
cosmetic public (from
manufacturing, Schedule Covers inappropriate advertising
 labelling, A Diseases for which treatments may not as well)
advertising, be promoted
sale (etc.) in Uses the DIN system
Canada Restricted direct to consumer product registration
advertising refers to prescription system (one for each
products (e.g. cant advertise on TV) product, strength, etc.)
B Publications describing official drug
standards Not all aspects of this act
pertain to pharmacy
USP (U.S. Pharmacopoeia), NF, BP practice. Pharmacy
(British Pharmacopoeia) practice must also
practice provincial laws.
So our raw chemicals are up to
nationally-recognied standards
C Radiopharmaceuticals

Restricted access, use, sales (not in

retail settings)
D Allergenic substances, blood
derivatives, drugs obtained by
recombinant DNA procedures,
immunizing agents (vaccines), insulin,
biologicals
F Not the same as schedule F of the
Regulations

Repealed in 1984
G Controlled drugs

Repealed in 1997 now use the CDSA

Controlled Drug and Substances Act
H Repealed 1997 restricted drugs (illicit
drugs)

Would cover MDA, STP, LSD

Now use CDSA

Food and Drugs These regulations are not schedules
Act You have to cross-reference in some cases
Regulations
Part What it Covers
C Schedule F drugs (prescription drugs)

Sets out a list of items which require prescriptions in order to be sold in Canada

Defines rules for:

Dispensing (labelling, Rx records, refilling, verbal prescriptions, prescription transfers)
For manufacturers DINs, Pr symbol

Provincial laws (e.g. DPRA) are more detailed, often more strict in many cases

Part 2 of Schedule F for animal use

Can be sold without prescription if manufactured
But must be labelled for veterinary use traditionally wouldnt find these in many
pharmacies, possibly in rural ones

Wouldnt need to report sales for non-narcotic/controlled substances, e.g. you dont have to tell
the government how many Synthroid tablets you sold

FDA Labelling Requirements - C.01.005

Main panel of the inner and outer labels of a drug sold in a solid dosage form must
clearly display the Drug Identification Number (DIN) assigned by the Director to the
Manufacturer

FDA Verbal Prescriptions C.01.041

If receiving a verbal prescription from a prescriber, there is federal legislation to tell you
how to reduce the prescription into writing
You must keep records for at least 2 years from the date of filing
Some record-keeping requirements exist you should be documenting the verbal
prescription in writing
Receiving pharmacist has to sign (the person who took the verbal prescription must
sign)

Schedule F Parts What it does

Part I Requires prescription across Canada

Has Pr symbol on package/stock bottle

No additional sales reporting
required, but must maintain
prescription file for at least 2 years

E.g. Antibiotics, thyroid replacement

medications, antihypertensives
Part II May be sold without prescription if the drug
is for animal use, and in a form not suitable
for human use
Or labelled For veterinary use only

Otherwise, requires prescription

E.g. penicillin, tetracycline, furosemide

Animals can often use human medications,

but humans cant normally use animal
medications/prescriptions
D Vitamins, minerals

We dont use this anymore, we refer to NAPRA

 States maximum dosages that can be sold without professional supervision
Over these max dosages, we refer to provincial drug schedules for guidance
E.g. can buy 0.1-0.4mg folic acid OTC, but need prescription to get 5mg folic acid
But no longer used, replaced with NAPRA listings
E Saccharin (rarely used now, we know its carcinogenic)
Cyclamate

Artificial sweeteners

Restricted advertising, labelling and sales for public protection

Youd never find these added to a food product
Regulation E.01.002 No person shallsell any saccharin sweetenerexcept on the
premises of a pharmacy
If you advertise it, you cant advertise it as a sweetener you can only say you ARE
selling the product, and its price

Provincial laws are often more detailed and strict than federal ones e.g. the sale of iron
Iron supplements have NPNs now under federal legislation can be sold anywhere
But under provincial legislation schedule II with ferrous fumarate, for example, so
there is a higher standard
G Controlled drugs schedule G (use CDSA)
National Schedule I Schedule II Schedule III
Schedules
Schedule N Exempted codeine Non-prescription
Schedule G (I, II, III) preparations But can be sold in OTC aisle
DRUGS
Schedule F (I, II) Others Must be sold invpremises
according to
jurisprudence Others where a pharmacist is
E.g. hydroquinone products available for consultation if
definitions
Some arent listed federally Ultraquin, Tylenol I (8mg codeine per required
under schedules, but are dosage form + acetaminophen +
covered under NAPRA caffeine)
schedules
Some are NOT These include:
Drugs by U schedule under NAPRA
definition Schedule A, schedule B
Cosmetics
Foods Ensure, Boost, Slimfast
Natural health products (unless they contain a scheduled item e.g. iron supplements)
Homeopathic products
Controlled This provides a framework for the control of import, export, production, distribution and use of substances that
Drugs and can alter mental processes
Substances Act May cause harm to health and society if used/distributed without supervision

A Controlled Substance is anything scheduled under the CDSA

A Controlled Drug Schedule G item (within the FDA)
Schedules: Schedules I to VIII under CDSA
Not currently used in pharmacy practice
For assigning penalties for possession, trafficking, and manufacturing

Under the CDSA, a practitioner is defined as one entitled and registered to practice:
Medicine
Dentistry
Veterinary medicine
Narcotics Definition Subgroups Verbal or Written Rx? Exempted Codeine Products
 Any substance 1. Straight single Contains in addition to a OTC, non-prescription Narcotics
incl. or in ingredient, narcotic 2 or more
anything that injectable, medicinal ingredients Can contain 8mg maximum codeine
contains any multiple narcotic other than the narcotic in per tablet or capsule, or 20mg per
substance in the ingredients, a recognized therapeutic 30mL of liquid
schedule to the narcotic use
Narcotic Control compound with 1 AND
Regulations non-narcotic Not parenteral use
ingredient or 1 of Must contain 2 other medicinal
N symbol on 5 narcotics Cannot contain 1 of the ingredients not less than the regular
stock bottle label 5 narcotics: minimum dose for one ingredient, or
Hydrocodone one half the regular minimum single
E.g. Codeine, 2. Verbal Methadone dose for each
Morphine, Prescription Oxycodone
Meperidine, Narcotic Diacetylmorphine Must have warning on label:
Oxycodone combinations (heroin) Contains codeine and
with 1 narcotic Pentazocine should not be administered
only, and 2+ to children except on advice
medicinal Prescription can be of physician or dentist
ingredients written (or faxed) or given
verbally Pharmacist should make a decision
not to supply if there is reasonable
3. Exempted
E.g. Tylenol 3, Dimetapp C grounds to believe the medication is
Codeine
being used for reasons other than
Preparation
medical or dental ones
non-prescription
E.g. Tylenol 1, 222/Ac & C 8mg
(Schedule II under FDA)
Double No person shall seek or obtain a substance included in schedules I, II, III, or IV
Doctoring
Or seek authorization to obtain a substance included in schedule I, II, III, or IV (CDSA drugs) unless the person
discloses to the practitioner of past narcotic/controlled substance prescriptions within the past 30 days
Narcotic Not allowed
Advertising Also includes visibility or display of items in the dispensary must be hidden
Cannot directly or indirectly advertise the sale of a narcotic
Narcotic Definition of a prescription:
Control A direction given by a practitioner that a stated amount of a narcotic (or controlled drug) be dispensed
Regulations for the person named

I.e. Must clearly state the Quantity to be dispensed (or can be calculated)

Appropriate: 1 tablet TID for 7 days

Not appropriate: 1 tablet TID prn for 7 days (cannot calculate how much to dispense)
Narcotic Prescription Requirements Refills Allowed? Reasonable Steps to Protect Emergency Supply Rules
Control Narcotics
Regulations Pharmacist may supply NO REPEATS To prevent against loss or A pharmacist may supply
narcotics if he/she has ALLOWED theft another pharmacist with
received an order signed and a quantity of a narcotic
dated by a practitioner Cannot use a written Incl. appropriate storage for emergency purposes
or verbal (may put in safe) (enough to fill one
And must be verified if the prescription order to prescription) upon
signature is not known tot eh dispense a narcotic Inventory counts, receipt of a written order
pharmacist after the quantity reconciliation signed and dated by that
specified has been other pharmacist
May supply methadone to a dispensed Alarms
dealer, hospital or pharmacist (Relates to store
or patient if the physician is Can use PART-FILLS Cameras, etc. transfers also)
authorized (CDSA section E.g.
 56) by the CPSO and OCS prescribe
total
quantity,
and then
set an
amount for
each part fill
(optional
interval)

Eg. Can use:

Tylenol 3
M: 500
Sig: I TID PRN
Dispense in 100s
(Could set interval of
every 30 days)
Controlled Schedules Targeted Substances Prescription Requirements
Drugs
Verbal vs. Written
Schedule G to the Food and Schedule IV to the Food and Drug Regulations (G.03.006):
Drug Regulations CDSA Prescriptions shall not be refilled unless:
Symbol on
Subdivided into parts I, II, III stock bottle The practitioner has directed (orally or written) that:
The prescription be refilled
is The number of times it may be refilled
symbol on stock The dates for or the intervals between refills
Rx records filed with
bottles
either narcotic/CD or If the original prescription was verbal, a refill is not
regular (consistency allowed off that verbal prescription
Part I:
matters more)
E.g.
Methylphenidate If the original prescription was written a refill is allowed
Benzodiazepines or
Dextroamphetamine targeted substances Verbal prescriptions may be received by a pharmacist,
Refills not allowed if regulations: intern or registered pharmacy student
verbal but can Refills
authorize part-fills permitted if
verbally the number
of refills is
Part II: specified
Phenobarbital A record
Butorphanol must be
Written or verbal kept of each
prescriptions OK refill
And less
Part III than one
Testosterone year must
have
passed
between
the day the
original
prescription
was issued
Intervals
must be
followed
Notification Read Notification letter carefully

Issued by Health Canada

Restricts prescribing by physician named, or ordering of the Narcotic/controlled substance/targeted
substance by a pharmacist
Ordering of Can only be done by an authorized pharmacist
Controlled By a Narcotic Signer
Substances Notification of OCP by pharmacy owner
By written order, through computer from remote input device
By verbal order for verbal prescription narcotic that specifies name and quantity of narcotic

From the CDSA:

Narcotic Control Narcotic Control Narcotic Control Narcotic Control Reg. Narcotic Control Reg.
Reg. Sect 27 Reg. Sect 30 Reg. Sect 38 Sect 40 Sect 42
For order from Upon receipt, If prescriber writes Must maintain special Pharmacist must report
remote input pharmacist must a narcotic for narcotic prescription any loss or theft of
device or verbal enter in a book, office or personal file in sequence as to narcotics within 10 days
order, the licensed register or other use this must be date and number for a of discovery
dealer must record: included in the minimum of two years
receive a receipt sales report E.g. from inventory
within 5 working - Name/Quantity Controlled Drug Rx shortage, spillage,
days of drug Can be done records filed together breakage, forgery,
- Date received manually with narcotic Rx break in
Must state: - Name and
- Name/Quantity address of Except for verbal
- Date received supplier narcotics and
- Signature of propoxyphene,
pharmacist who must enter in sales
received order record
Patient
For all narcotics, name/address
CDs, and targeted Name,
substances quantity,
dosage form
(If not received Name, initials,
within 5 working address of
days, then licensed prescriber
dealer will refuse Name of
to supply further pharmacist
orders) Date supplied
Prescription
number

(Also for part I

controlled drugs)
Destructions For damaged, outdated, unserviceable drugs (N, G, Targeted Substance)

Fax/Letter to Office of Controlled Substances (Ottawa)

Get mailed back answer
Outline product name, exact quantity, lot number, expiry date, and reason

Drug Control Unit, Compliance, Monitoring and Liaison Division: Office of Controlled Substances, Health Canada
(in Ottawa)
Narcotic Safety Purpose Prescription Dispenser Requirements Identify Verification
and Awareness Requirements
Act, 2010 To promote appropriate Record: Must keep record including: Dispenser must ensure that
prescribing and dispensing identify verification
 practices for monitored Registration number Address, DOB, gender of requirements are met
drugs on the certification of patient before dispensing a
registration issued to monitored drug
Identify, reduce the prescriber by Patients identifying
abuse/misuse/ and his/her regulatory number and type of ID Regulations require
diversion College (e.g. CPSO that the dispenser
number) Prescribers registration keep a record of
Reduce risk of number the identifying
addiction/death Patients identifying number of the
number and type of If the patient is not picking patient and type of
Collect, use and disclose ID (e.g. Health card, up the prescription, need ID used (record on
information, incl. personal Passport) the name and address of prescription
information agent picking it up along record, not the
All other information with their identifying prescription itself)
required of a number and type of ID
prescription checked
NSSA NSSA regulations:
Regulations Exemptions provided to allow prescriptions to be prescribed/dispensed if the patient does not have
appropriate identification only patient can pick up/accept a delivery, not an a gent
Ensures all opioids (incl. those not currently listed in the CDSA such as tramadol or tapentadol) are
monitored in Ontario
Exempts prescribers in certain settings (e.g. hospitals or prisons) from NSAA requirements

Section What it stipulates

5 Prescriber must record patients ID and type on Rx
Dispenser must keep a record of the patients ID and type
If verbal or information is missing on Rx, pharmacist may
document the information after confirming with the prescriber
the ID type and number
7 Specifies the types of identifying numbers that are acceptable

List of approved forms of patient ID may change occasionally (on

MOHLC website)
Health card (Ontario or other province/territory)
Valid drivers license
Ontario photo card
Birth certificate (Canadian)
Valid passport (Canadian or other country)
Certificate of Canadian Citizenship
Others

Requires dispensers to record the name, address, and form of ID and

number for persons who pick up narcotics/controlled substances from
the pharmacy

Same rule applies for monitored drugs being delivered if the person
receiving the delivery is not the patient, the name, address and ID
number must be recorded of that third party
Summary:

What is a Drug?

NAPRA U schedule unscheduled cosmetics, foods, natural health products (aside from those that
contain scheduled ingredients), homeopathic products
Narcotic Key requirements when dispensing methadone:
Control Notify the OCP that the pharmacy is dispensing methadone (within 7 days reporting form exists onine)
Regulations, S. Adhere to the OCP Methadone Treatment and Dispensing Policy
27 Must also notify OCP of whether they are accepting new patients, the names of pharmacists trained to
dispense methadone
Key Hours of operation, days the pharmacy is open,
Requirements Must report any changes in this status
for Methadone Ensure staff is propery trained
Dispensing o The designated manager is required to be appropriately trained within the first 6 moths of
beginning methadone practice, and at least one staff pharmacist within a year
o Training must be updated every 5 years

CAMHs Opioid Dependence Treatment Program or the OPA Methadone Education
Program (complimentary)

Physicians who wish to prescribe methadone must apply via Health Canada for exemption under section 56 of the
CDSA
Physicians may also seek authorization via the CPSO
Exemptions can apply to methadone maintenance treatment (MMT) for opioid dependence or to treat
malignant/chronic non-malignant pain

Pharmacist must practice in accordance with the provisions of the DPRA, standards of practice of the profession of
pharmacy, Code of Ethics of Pharamcists, OCP Poicies and guideines, federal legislation, etc.

Models for dispensing methadone to patients for the treatment of opioid dependence:
Pharmacist prepares individually labelled doses of methadone pursuant to a prescription and diuted in
100mLs of vehicle that does not lend itself to injection, and then the pharmacist either:
o 1. Dispenses to patients in a pharmacy accredited by OCP pursuant to the DPRA
o Transfers doses securely to a physician or his/her delegate for custody or/administration
o Takes the doses to the patient at the treatment location and observes ingestion

Requirements 1. Written By an exempted prescriber

for Dispensing prescription for
Methadone in a methadone CPSO or Office of Controlled Substances may be contacted to confirm the prescriber has
Pharmacy the appropriate exemption
2. Preparation of Prepared in a manner and form required for dispensing to a patient
methadone
In accordance with:
CAMH guidelines Methadone Maintenance: A Pharmacists Guide to Treatment
Prescribers instructions
Standards of Practice
 Narcotic Control Regulations
DPRA and Regulations
2.1 Preparation Log file
of stock solution
Date prepared, name/signature of RPh and technician responsible for preparation

Concentration of stock bottle

Quantity and lot number of methadone used, and final quantity of stock solution
prepared
2.2 Preparation Daily doses of methadone must be diluted and dispensed in approx 100mL vehicle
of final dosage
form E.g. orange Tang or another drink

Use measuring pump to ensure accurate dilution

Graduated cylinders not recommended, syringes have 10% error rate

Child-proof safety caps a must

2.3 Labelling Total dosage of methadone in mg in thebottle

Date for ingestion for carries

Keep refrigerated auxiliary label

Drink entire contents of bottle notation

And must use warning label:

Methadone may cause serious harm to someone other than the intended
patientMAY BE FATAL TO CHILD OR ADULT
3. Transferring Physician or delegate must sign the patient manifest daily to confirm they have received
custody the correct dose

Pharmacists may hand doses directly to the MD, or use a safe method of transportation
4. Pharmacist observes ingestion in the pharmacy
Administration
of methadone Observes first dose and provides authorized carries for the patient
dose Or takes dose directly to patient and observes ingestion
5. Document so you know where each dose went for patient care and auditing purposes
Documentation
Incl. patient name, daily dose, date, time, place
6. Changes in New prescription is required each time there are changes in methadone dose
dosing
7. Unused doses Unused individually labelled doses of methadone:
Stay in pharmacy, managed with OCP policy, Standards of Practice, laws
Returned to pharmacy by MD or delegate daily, signed for upon receipt,
destroyed in pharmacy
8. Daily Daily of methadone dispensed to and received from a treatment location so allow
Reconciliation immediate detection of losses or diverted quantities
(pertains to
transfer of
custody)
9. Maintaining Administration in a pharmacy must be done in an area and manner that ensures patient
Patient privacy and confidentiality
Confidentiality
and Privacy