1. Processing of Requirements for Hospital Pharmacy Internship 2. Requirements for Opening a Hospital Pharmacy 3.

The Hospital Pharmacy Organization and Its Personnel 4. The Hospital Pharmacys Layout and Its Location

5. Pharmacy & Therapeutics Committee

PROCESSING OF REQUIREMENTS FOR HOSPITAL PHARMACY INTERNSHIP

PATRICIA ROSE ABALOS, RPh, MS Phar cand

Discussion Outline

Importance: Hospital Pharmacy Internship Policies for Hospital Pharmacy Internship Workflow Process Procedures in Processing Requirements

Why we should take Hospital Pharmacy Internship program?

Republic Act no. 5921 Pharmacy Law
Article III Examination Section 18. Candidate for Board

Qualifications: a. Natural-born citizen of the Philippines b. Of good moral character c. Shall have completed an Internship Program Prescription pharmacy Pharmaceutical manufacturing laboratory Hospital pharmacy d. BS Pharmacy graduate

Policies for Hospital Pharmacy Internship

Who can undergo a Hospital Pharmacy Internship?
o Students enrolled in Internship 2

What are the prerequisites required prior to internship in hospital?

o o o Pharmaceutics 1 Internship 1 Pharmacy 5a (Hospital Pharmacy)

How many hours should be rendered for Hospital Pharmacy Internship?

o Total of 200 hours

Policies for Hospital Pharmacy Internship

What are the documents which shall be submitted to Internship coordinator 2 weeks after the internship?
o o o o o o o Original: Certificate of Internship (COI) Pharmacy Internship Daily Time Record (PIDTR) Duplicate: Certificate of Internship Performance Rating Report for Student Trainees (PRRST) Internship Activity Report (IAR) Checklist of Internship Activities Hospital Pharmacy Profile (HPP)

What are the further requirements for the completion of Hospital Pharmacy Internship?
o Internship examination to be given by coordinator

WORKFLOW

WHEN APPLYING
RIRL Submission of Requirements

WHILE UNDERGOING
OJT Document Processing Document Submission & Filing

To Internship Coordinator 1. RIRL

To the Hospital 1. Recommendation Letter 2. Other Requirements set by Hospital To Internship Coordinator 1. Acceptance Form

By Intern 1. PIDTR 2. HPP 3. Checklist of Internship Activities 4. IAR

By Pharmacist 1. PRRST 2. IAR

Kept by Student 1. Original COI 2. PIDTR

Kept by Internship Coordinator 1. Duplicate COI 2. PRRST 3. IAR 4. HPP 5. Checklist of IAR

Request for Internship Recommendation Letter (RIRL)

Release of RIRL

Fill out RIRL Intern Coor

Intern Coor review & signs RIRL College Sec

Dean review & signs Recommendation Letter Release of Recommendation Letter and Internship Forms

Pharmacy Internship Daily Time Record (PIDTR)

Student shall fill out PIDTR Pharmacist shall provide in the PIDTR
3 copies Typewritten Min: 4hrs per day & Max: 8hrs per day Monday to Saturday Entry PRC license number & date issued Latest PTR number & date issued

Hospital Pharmacy shall Certificate of Internship with Hospital logo and letterhead issue Student shall submit to 3 copies of PIDTR Internship Coordinator Original & Duplicate of COI
Other Internship forms Countersign Forward to Dean for signature

Internship Coordinator

Hospital Pharmacy Profile (HPP) & Checklist of Internship Activities

Student shall fill out & Submit to Internship Coordinator

Hospital Pharmacy Profile Checklist of Internship Activities

Internship Coordinator

Review the content Interview the student for verification

Internship Activity Report (IAR)

Student Fill out IAR Pharmacist Evaluate & Sign Students IAR Submit to Department Head Student Submit IAR to Internship Coordinator for review and filing

Performance Rating Report for Student Trainee (PRRST)

Pharmacist Fill out PRRST

Pharmacist Evaluate & Sign Students PRRST Student Submit PRRST to Internship Coordinator for review and filing

Requirements for Opening a Hospital Pharmacy

PATRICIA ROSE ABALOS, RPh, MS Phar cand

Discussion Outline

Requirements for the Opening & Operations of Drugstores and Pharmacies

Definition: Different Types of Drug Outlets General Requirements

Other Specific Requirements

Renewal of License to Operate

Requirements for the Opening & Operations of Drugstores and Pharmacies

Section 39 of RA 5921 Pharmacy Law
(As amended by PD 1363 on May 2, 1978)

The minimum requirements necessary for the opening and operation of drugstores and pharmacies shall be in accordance with the rules and regulations to be prescribed by the Food and Drug Administration in accordance with the provisions of this Act. No application for the opening of a retail drugstore shall be approved unless it is signed by a Filipino registered pharmacist, either as owner or as supervising pharmacist pursuant to section 27 of this Act.

Display of Certificate Required

Section 28 of RA 5921 Pharmacy Law It shall be the duty of every pharmacist engaged in the practice of pharmacy, either on his own account or under the employ of another, to display his certificate of registration in a prominent and conspicuous place in the pharmacy, drugstore, hospital pharmacy or drug establishment which he operates or in which he is employed.

No pharmacist shall with his knowledge, allow his certificate of registration to be displayed in such establishments where he is not actually employed or operating therein in his professional capacity.

Definition: Different Types of Drug Outlets

Chapter II of AO 56 s. 1989
(Revised Regulations for the Licensing of Drug Establishments & Outlets)

Drugstores Pharmacy or Botica Hospital Pharmacy or Dispensary

Drug outlet where registered drugs, chemical products, active principles, proprietary medicines or pharmaceutical specialties; and dental, medicinal, galenical or veterinary preparation are compounded and/ or dispensed

Retail Outlet for Nonprescription drugs N0n-traditional Outlet such as Supermarket and stores

Drug outlet where registered non-prescription or OTC drugs are sold in the original packages, bottles or containers; or in smaller quantities not in their original containers

Definition: Dispensary
AO 60 s. 1968

Dispensary includes

Hospital Pharmacy or
Clinic Dispensary

Where drugs, chemical-drug products, active principles, medicinal and galenical preparations, proprietary medicines and pharmaceutical specialties are sold and dispensed Located in the hospital or clinic dispensary

General Requirements: Applications

Notarized Petition Form Proof of Registration as an Establishment
Single Proprietorship Bureau of Trade Regulation and Consumer Protection Partnership or Corporation SEC

Board Registration Certificate and PRC ID Certificate of Attendance to an FDA sponsored/ accredited Seminar on Licensing of Drug Outlets Notarized Joint Affidavit of Undertaking duly accomplished by Pharmacist and Owner Tentative list of products intended to be sold Authenticated copy of Contract Lease of the space to be occupied

Specific Requirements
Premises
Signboard Well-ventilated area nlt 15 sqm Place suitable for compounding prescription & washing and sterilizing bottles Adequate Storage of Drugs & Biological products Suitable cabinet for poisons & Dangerous Drugs

Reference Books & Documents

PNDF RA 3720 RA 6675 RA 5921 RA 8203 RA 9994 RA 9711 RA 9502 USP NF Remington: The Science and Practice of Pharmacy Goodman & Gilman Pharmacological Basis of Therapeutics

Record Books Duly Registered with FDA

Prescription Book Dangerous Drug Book Exempt Preparation Book Poison Book Record Book for Selected Non-Rx Drugs subject to abuse as determined by FDA and/ or DDB

Specific Requirements
Utensils, Apparatus and Other Equipment
Refrigerator for Biologicals & Other Drug Products needing Refrigeration Prescription balance Glass volumetric Mortar and Pestle

A full time validly Registered Pharmacist

Physically present while the drugstore is open to business

Other Additional Requirements

Invoices indicating the lot number or batch number of the Manufacturers stock pursuant to FDA Memorandum Circular No. 001 s. 1983 File of Prescription Dry seal or rubber stamp Red & White labels

Renewal of License to Operate

Validity

Schedule of Fees

Initial Period of Validity: 1 year

Initial: Php 50.00

Validity of Subsequent Renewal: 2years

Renewal: Php 1,000.00

The Hospital Pharmacy Organization and Its Personnel

PATRICIA ROSE ABALOS, RPh, MS Phar cand

Discussion Outline

Purpose & Importance: Hospital Pharmacy Organization

Administrative Pharmacy

Structure

of

Hospital

Sample Hospital Pharmacy Organzational Chart

Purpose & Functions: Hospital Pharmacy Organization

Must satisfy the needs of the Pharmacists Designed to meet specific requirements of the Pharmacy Service Serves to establish the authority relationships between positions

Shows administrative authority flow essential in employee selection & categorization

Assign special task that achieve the pharmacys objectives

Accrediting & Regulating Agencies

Department of Health Food and Drug Administration Licensure Act of the Bureau of Licensing and Regulations Hospital Operations and Management Services

Five Essentials of Good Management

PLANNING
ORGANIZING DIRECTING COORDINATING CONTROLLING

Administrative Structure of Hospital Pharmacy

DIRECTOR OF PHARMACY
Aka Chief Pharmacist or Pharmacy Manager Oversees both personnel and budgetary matters Secretary of Pharmacy & Therapeutics Committee As member of Hospital team may be involved in community outreach programs Sets quality standards for the department, Evaluates policies and procedures and Implements changes & innovations Develops management strategies to assure Cost Effective pharmaceutical services and for Implementing Total Quality Management concepts Ensures Compliance with accrediting & regulating Agencies

Administrative Structure of Hospital Pharmacy

ASSISTANT DIRECTOR OF PHARMACY
Aka Associate Director of Pharmacy or Assistant Chief Pharmacist Aids the Pharmacy Director in the operation of Pharmacy Supervises in daily Pharmacy Operations In the absence of Pharmacy Director assumes the administrative responsibility

Administrative Structure of Hospital Pharmacy

STAFF PHARMACISTS DISTRIBUTIVE DUTIES Physician Order Review and Filling Unit-dose chart checking Extemporaneous compounding Purchasing, Inventory, Narcotic Drug Distribution and Control STAFF PHARMACISTS CLINICAL DUTIES Therapeutic Assessment Advice Physicians, Participate in patient rounds Patient Discharge counseling and In Service education Monitoring and Evaluating drug therapy and Intervening when appropriate

PHARMACY TECHNICIANS & OTHER SUPPORT PERSONNEL Work under the direct supervision of a Pharmacist

The Hospital Pharmacys Lay-Out and Its Location

PATRICIA ROSE ABALOS, RPh, MS Phar cand

Discussion Outline

Areas of Hospital Pharmacy Value of Proper Store Design, Traffic Flow and Dcor Sample Hospital Pharmacy Lay-out

HOSPITAL
Serves as central point for the coordination and delivery of patient care to its community
Organized structure that assembles: 1. Health professional 2. Diagnostic and therapeutic facilities, equipment and supplies 3. Physical facilities into a coordinated system for delivering healthcare to the public

FUNCTIONS OF HOSPITAL PHARMACY

Department or division of the hospital wherein the following functions are performed by legally qualified, professionally competent pharmacists and their assistants: 1. Procurement 2. Storage 3. Compounding 4. Manufacturing 5. Packaging 6. Controlling 7. Dispensing 8. Distribution of medications

STRATEGIC PHARMACY DESIGN

Provides detailed recommendation for optimizing everything and everyone in pharmacy

Leads to improved and enhanced pharmacy efficiency

Better Management of staff, cost and safety

OVERALL PLANNING PROCESS

Master Program

Sets goals and objectives

Functional Program

Specifies the operational demands upon the facilities

Equipment Planning & Architectural Design

Translates Master Program & Functional Program into physical space, equipment and furnishings

Physical Features of Hospital Pharmacy

Location Convenient for providing service to many departments and personnel All sections are not distant Equipment Extreme care in choosing items Must provide good service Has minimal maintenance Price within budget

AREAS OF PHARMACY

1. BULK STORES 2. OUTPATIENT PHARMACY 3. INPATIENT PHARMACY

AREAS OF PHARMACY: BULK STORES

Due to increasing volume & diversity prescriptions Implementation of JIT system of

JIT (JUST-IN-TIME) system supplies items as close to the time of use as possible in an effort to reduce large inventories, decrease space requirements, and lessen financial outlay Growth and emphasis: less volume of individual items, but more deliveries more often May reduce the amount of space required for bulk storage, but increase the amount of space needed for vendor bins, carts, pallets, and totes.

AREAS OF PHARMACY: BULK STORES

4 FUNCTIONS OF BULK STORES
Ordering Provides link to pharmaceutical vendors for JIT delivery and stock Has computers and printers that are linked to prime vendors and to other areas of the pharmacy for inventory control Receiving Aka Breakout area supplies are removed from their outer containers or vendor bins Storing General Storage Pharmaceutical s must be separated and stored by category Controlled Substance storage Narcotics and other governmentcontrolled substances are stored in a vault or locked Distribution Restocking both outpatient and inpatient pharmacies

AREAS OF PHARMACY: BULK STORES

AREAS OF PHARMACY: OUTPATIENT PHARMACY

Responsible for filling outpatient prescriptions and for providing pharmacy stock to clinics and off-site centers Functions much like a retail pharmacy It has completely different products and distribution systems than the Inpatient Pharmacy Size is contingent on the number of outpatients served by the hospital

AREAS OF PHARMACY: OUTPATIENT PHARMACY

4 FUNCTIONS OF OUTPATIENT PHARMACY
Ordering Receiving Storing Distribution Order Entry Prescriptions come into order entry as hard copies at the dispensing windows, electronically via computers, or by automated phone-in system Filling Workstations where pharmacists manually fill prescriptions Dispensing Dispensing windows are for outpatient prescription drop-off and pick-up

Provides the link to Bulk Stores for delivery of stock Requires an administrative station with computers and printers

Supplies from Bulk Stores are received here on a daily basis or several times a day Should be in close proximity to Bulk Stores

Active Stores Where supplies received from Bulk Stores are stored Manufacturing compounding of special prescriptions that are not available commercially Prepackaging Medications are divided and packaged as needed in smaller containers for outpatient use

AREAS OF PHARMACY: OUTPATIENT PHARMACY

AREAS OF PHARMACY: INPATIENT PHARMACY

responsible for filling orders for unit dose medications and intravenous (IV) medications for inpatients on patient units
Hospital-dispensed medications are packaged in single doses for accuracy and efficiency of dosage administration Unit dose single-dose packages

AREAS OF PHARMACY: INPATIENT PHARMACY

4 FUNCTIONS OF INPATIENT PHARMACY
Ordering
Provides link to Bulk Stores for delivery and stock Patient Unit Support area may house the mainframe computer linked to automated dispensing machines for controlled substances located on the patient units

Receiving
Supplies from Bulk Stores are received here and taken either to unit dose picking or to IV/admixture storage

Storing
Manufacturing compounding of special prescriptions that are not available commercially Prepackaging Medications are divided and packaged as unit dose for inpatient use

Distribution
Order Entry Communication hub Written medication orders are received and reviewed by the pharmacists Orders are compared with the patients medication history or profile Unit dose Picking workstation provides a space of limited dimensions containing a maximum quantity of drugs and allows the pharmacist or technician to pick the appropriate drugs IV Admixture

AREAS OF PHARMACY: INPATIENT PHARMACY

Pharmacy and Therapeutics Committee

PATRICIA ROSE ABALOS, RPh, MS Phar cand

Discussion Outline
What is Pharmacy Committee?
Primary Purpose of Therapeutics Committee

and

Therapeutics

Pharmacy

and

Members of the Pharmacy and Therapeutics Committee Issues discussed by Therapeutics Committee Pharmacy and

What is a Pharmacy and Therapeutics Committee?

An advisory group of the medical staff which serves as the organizational line of communication between medical staff and pharmacy department Policy recommending body to the medical staff and the administration of the hospital on matter related to drug use Composed of Physicians, Pharmacists and other health professionals with the guidance of medical staff

Purpose of the Pharmacy and Therapeutics Committee

1. ADVISORY Recommends the adoption of, or assist in the formulation of, broad professional policies regarding evaluation, selection and therapeutic use of drugs in hospitals 2. EDUCATIONAL Recommends, or assists in the formulation of programs assigned to meet the needs of the professional staff for complete knowledge on matters related to drugs and drug use

ADMINISTRATIVE ORDER 51 s. 1988 Section 9 Therapeutics Committee

Subject: Implementing Guidelines for DOH Compliance with Republic Act 6675 (Generics Act of 1988)

9.1 REQUIREMENT

Therapeutic Committee shall be organized at the regional Health Offices, City Health Offices, special hospitals, national medical centers, regional hospitals and sanitaria

ADMINISTRATIVE ORDER 51 s. 1988 Section 9 Therapeutics Committee

9.2 FUNCTIONS 1. Regularly maintain a list, specified in generic terminology, of the drugs that the agency will keep on stock, use, buy or prescribe

Shall be limited in the DOH formulary

Any new item outside the formulary should be recommended to the National Drug Committee for inclusion in the DOH formulary before the agency can include such item in its own list

ADMINISTRATIVE ORDER 51 s. 1988 Section 9 Therapeutics Committee

9.2 FUNCTIONS

2. Recommend drug selection, procurement and stocking policies

utilization,

3. Evaluate and recommend appropriate action on: Requests for inclusion or exclusion of any drug product in the DOH formulary as well as in the agency drug list Reports ADRs and other incidents related to safety efficacy or quality of drugs Use of agency resources for drug products

ADMINISTRATIVE ORDER 51 s. 1988 Section 9 Therapeutics Committee

9.2 FUNCTIONS

4. Identify and define Information, education or training needs of the agency related to the implementation of RA 6675, the national drug policy, pharmacological science and rational drug use
5. Plan an orderly, systematic and thorough process of institutionalizing rational drug use that have immediate, medium and long term dimensions Plans should target 100% adoption of generic terminology in procurement, prescribing and dispensing

ADMINISTRATIVE ORDER 51 s. 1988 Section 9 Therapeutics Committee

9.3 COMPOSITION
1.

1. Shall have at least 5 members except at District Hospitals which may have at least 3 members 2. Shall be designated by head of the agency and shall be a mix of the following professionals: Physician Pharmacist Nurse Dentist non-voting member 3. Head of agency shall not be a member

ADMINISTRATIVE ORDER 51 s. 1988 Section 9 Therapeutics Committee

9.3 COMPOSITION
1.

4. Members shall elect their chairman usually from among the Physicians Secretary usually the Chief Pharmacist Meeting at least 6 times per year and when necessary 5. Regional Directors are instructed to contract Pharmacologists coming form schools to serve as consultants to Regional Therapeutics Committee of the Regional Medical Centers