Final Draft: ASHP Best Practices Self-Assessment Tool

1.0 Develop and Maintain the Systems to Provide Pharmacy Services

The pharmacy has a written mission statement that is consistent with the mission of the health care organization and emphasizes contributions
to patient care and safety.

The pharmacy maintains and periodically assesses and updates policies, procedures, and operational guidance for all of the department's
functions and responsibilities.

Pharmacy personnel receive appropriate orientation and training for assigned functions and responsibilities and their performances are
periodically assessed for continuing demonstrated competency.

The pharmacy has the necessary facility space, equipment, and supplies to operate according to applicable laws and regulations and generally
accepted standards effectively, efficiently, and safely.

The pharmacy has sufficient numbers and categories of personnel to perform required functions and responsibilities according to applicable laws
and regulations and generally accepted standards effectively, efficiently, and safely.

The pharmacy is prepared to respond to natural or man-caused disasters and to continue ongoing services as an integral component of the
health care organization's emergency preparedness plan.

The pharmacy stocks the required pharmaceuticals and supplies consistent with the health care organization and community emergency
preparedness plans for responding to a local disaster for the interim period while awaiting state and federal assistance.

Pharmacists use a systematic approach to address medication information needs by effectively searching, retrieving, and evaluating current
scientific publications, textbooks, and computerized databases to communicate and apply information to the patient care situation.

Up-to-date written and electronic resources (including internet access) are available for providing medication information services, including
services to support at least the following services: pharmacokinetics, sterile preparations, medication therapy monitoring, patient counseling,
drug and nutrient interaction screening, nutritional assessment, OTC and alternative product information, age-specific dosing references.

Well-developed pharmacy position descriptions contain detailed information on the knowledge, skills, experience, and abilities that pharmacists
and support personnel should possess.

The pharmacy manager is an integral part of the financial planning for the provision of pharmacy services.

A process exists to routinely monitor pharmacy workload and financial performance.

The pharmacy is responsible for product specifications, procurement, distribution, and control of all drug products used within the institution.

In the absence of 24-hour pharmacy services, designated nonpharmacists have access to a limited supply of drug products for urgent
prescriptions or medication orders.

Written policies and procedures regulate limited and safe access to after-hours medications and are approved by the Pharmacy & Therapeutics
Committee in collaboration with nursing and medical staff.

For any outsourced services, the health care organization has performed an internal needs assessment, cost analysis, and evaluation of
contractors.

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AUTOMATED SYSTEMS

The pharmacy ensures that automated systems operate as designed and are well-maintained to prevent errors and service interruptions.

The pharmacy has a written plan that assigns responsibility for the automated equipment and database and addresses issues of security.

Breaches of security within the automated system can be detected and are acted upon.

A medical staff committee has approved a limited list of emergency (overridable) medications.

Use of emergency stock is limited to situations where the delay required for a pharmacist's review of the order would potentially harm the patient.

The organization has procedures for ensuring that all staff members receive adequate education and training concerning automated medication
storage and distribution equipment upon installation of the system and on an ongoing basis.

2.0 Develop Medication-Use Policy

Policies, procedures, and operational guidance are maintained, communicated, and adhered to by all personnel responsible for the development
of medication-use policy.

Pharmacy personnel are oriented, trained, and demonstrate competency for activities related to the development of medication-use policy within
the health care organization.

A pharmacist is a member and actively participates in those committees responsible for establishing medication related policies and procedures
such as Pharmacy and Therapeutics Committee, Infection Control, and Institutional Review Board, Patient Safety,etc.

The Pharmacy & Therapeutics Committee is composed of physicians, pharmacists, and other health professionals who meet regularly to
evaluate the clinical use of drugs, develop policies for managing drug use and administration, and manage the formulary system.

The Pharmacy & Therapeutics Committee effectively recommends policies on the therapeutic use of drugs to the medical and administrative
staff.

Through the Pharmacy and Therapeutics Committee, drug control policies are routinely communicated throughout the institution via newsletters,
bulletins, or other educational tools.

The drug formulary system is an ongoing process whereby a health care organization, through its physicians, pharmacists, and other health care
professionals, establishes policies on the use of drug products and therapies, and identifies drug products and therapies that are the most
medically appropriate and cost-effective to improve the health outcomes of a given patient population.

Formulary selection is a collaborative effort with pharmacy, medical, and nursing staff and considers well documented drug and drug class
reviews, therapeutic equivalence, generic substitution, unlabeled use of medications, therapeutic interchange, and nonformulary drug usage.

The medication use policy system provides for the procuring, prescribing, dispensing, administering and monitoring of drugs.

Medication Use Evaluations (MUEs) are conducted that are proactive, criteria based, designed and managed by the Pharmacy and Therapeutics
Committee or an interdisciplinary team, and systematically carried out.

Pharmacists participate in the quality or performance improvement, risk management, and infection control programs of their healthcare
organizations.

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The pharmacist is a part of the interdisciplinary team that is responsible for the establishment of strategies for minimizing the development of
resistant strains of microorganisms.

Pharmacists, in conjunction with the appropriate interdisciplinary committee, ensure that policies and procedures for the control and use of
investigational drugs in clinical research are followed.

Pharmacists, in conjunction with appropriate interdisciplinary committees, routinely utilize published clinical guidelines to develop the hospital's
clinical practice guidelines.

Pharmacists participate in the selection, evaluation, use, and monitoring decisions regarding drug delivery systems such as administration
devices, and automated storage and distribution devices.

3.0 Purchase and Maintain the Availability of Pharmaceutical Products

Policies, procedures, and operational guidance are maintained, communicated, and adhered to by all personnel responsible for purchasing and
inventory control functions.

Pharmacy personnel are oriented, trained, and demonstrate competency as required for the purchase and inventory control of drug products.

The pharmacy department has a contingency planning strategy for a prolonged drug-product shortage that addresses at least the following
issues: alternative therapies, temporary therapeutic guidelines, conservation of medication, reallocation to priority patients and communication
and education to the medical community.

Patients or family members are counseled by a pharmacist when a drug shortage will delay or compromise care, especially when patients have
been stabilized on the drug product and alternatives may not be as effective (e.g. antiepileptics or antarrhythmics)

A procedure exists for the handling of drug product recalls that includes inspection of all areas where medications are stored and documentation
is readily retrievable, identifying patients affected by the recalled lot numbers.

The use of drug product samples within the health care organization is permitted only under the control of the pharmacy, ensuring proper
storage, maintenance of records, and product integrity.

All stocks of medications are inspected routinely to ensure the absence of outdated, unusable, or mislabeled products.

The pharmacy routinely purchases commercially available ready-to-use oral and injectable products, whenever possible in order to optimize safe
medication use.

The investigational drugs are stored under appropriate environmental control in a limited-access area separate from routine drug stocks and are
inventoried on a regular basis.

4.0 Optimize Medication Therapy

Policies, procedures, and operational guidance are maintained, communicated, and adhered to by all personnel responsible for clinical
pharmacy services.

Personnel are oriented, trained, and demonstrate competency as required for the provision of clinical pharmacy services.

Pharmacists maintain medication profiles on all patients and have routine, immediate access to clinical information, allowing monitoring based
on age, sex, medication history, allergy status, diagnosis, pertinent laboratory data, and other appropriate information.

There are computerzied pharmacy systems in place that enable automated checking for appropriate dosage ranges, duplicate therapies,
allergies, drug interactions, and other ADR prevention parameters.

Written medication orders containing unapproved abbreviations are not accepted.

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Clinical pharmacokinetic monitoring is provided for selected patients based on direct patient assessment for their specific pharmacotherapy,
disease states, and treatment goals.

Pharmacists conduct medication histories on high-risk patients as defined by the health care organization.

Pharmacists have access to the medical history in the patient record.

All medication orders are reviewed for appropriateness by a pharmacist prior to administration of the first dose, except when a licensed
independent practitioner controls the ordering, preparation and administration of the medication or in emergencies or when the resulting delay
would result in harm to the patient.

Pharmacists have authority under a collaborative drug therapy management protocol to initiate new medication orders.

Pharmacists have authority under a collaborative drug therapy management protocol to adjust a dosage.

Pharmacists routinely document medication therapy interventions and recommendations as a permanent part of the medical record.

Computerized physician order-entry is electronically interfaced to the pharmacy's computer system.

For high-risk medication therapies (eg. antineoplastic agents) and patient groups (eg.neonates, pediatrics) , there is a more vigilant process for
ensuring patient safety, such as a two-pharmacist check, prior to dispensing.

High-risk patient populations such as pediatrics and geriatrics are monitored by qualified pharmacists who are trained for the provision of
specialized care and prevention of medication-related errors.

Upon request or initiated by protocol, pharmacists provide and document consults to other health professionals regarding medication therapy
selection and management.

Drug products and drug delivery devices brought into the hospital by patients shall be identified and documented in the patient's medical record,
and administered only pursuant to a prescriber's order.

5.0 Prepare, Package, and Label Medications

Policies, procedures, and operational guidance are maintained, communicated, and adhered to by all personnel responsible for compounding
sterile and nonsterile preparations, including hazardous drugs , and in packaging and labeling medications.

Pharmacy personnel are oriented, trained, and demonstrate competency in compounding sterile and nonsterile preparations, including
hazardous drugs , and in packaging and labeling medications.

Medications are stored and prepared in proper conditions of sanitation, temperature, light, moisture, ventilation, segregation, and security to
ensure medication integrity and personnel safety.

STERILE PREPARTIONS

Compounding of sterile preparations is the responsibility of pharmacists; however, when sterile preparations are compounded outside the
pharmacy it is for emergency situations or for immediate administration by appropriately trained personnel.

Policies, procedures, and operational guidance appropriately describe the 3 risk levels of compounding sterile preparations and include specific
compounding and environmental monitoring requirements for each risk level applicable for your services.

Pharmacy personnel receive suitable didactic and experiential training and competency evaluation for sterile and nonsterile compounded
preparations during orientation and annually thereafter.

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Sterile compouding and hazardous drug work areas and equipment, including Class 100 rooms, laminar air-flow work benches, barrier isolators,
and biological safety cabinets are appropriately separated from other work areas in the pharmacy.

Sterile compounding and hazardous drug work areas and equipment, including Class 100 rooms, laminar air-flow work benches, barrier
isolators, and biological safety cabinets, and room(s) ceilings, walls, and floors are maintained and cleaned regularly.

Pharmacy personnel scrub hands with an antimicrobial cleanser prior to each compounding session, as appropriate for each risk level, and wear
appropriate garb when compounding.

Before, during, and after compounding of sterile preparations, pharmacists check the identity and verify amounts and sequence of the additives
versus the medication order.

Ingredients used to compound sterile preparations are determined, by the pharmacist, to be stable, compatible, and appropriate for the final
preparation, according to manufacturer or USP guidelines.

All sterile preparations are inspected for container leaks, container integrity, particulates in the solution, appropriate color, solution integrity, and
volume after compounding and again when dispensed.

All pharmacy-compounded sterile preparations bear a beyond-use date and medication label in accordance with written policies and
procedures.

HANDLING HAZARDOUS DRUGS

Policies, procedures, and operational guidance appropriately describe the requirements for handling hazardous drugs to prevent contamination
of the work environment and to protect personnel, patients, or family members from exposure to hazardous drugs during preparation, packaging,
distribution, and administration.

Pharmacy personnel are oriented, trained, and demonstrate competency in the accurate and safe preparation of hazardous drugs.

Hazardous drugs, oral and injectable, are compounded and packaged in a vented Class II biological safety cabinet or barrier isolator.

Sufficient information, including Material Safety Data Sheets, is maintained on the safe use of all hazardous products.

Personnel demonstrate knowledge of appropriate procedures to be followed in case of accidental skin or eye contact with hazardous drugs
(designated eyewash station, eyewash irrigant solution or emergency showers).

All hazardous drugs are labeled with a warning label stating the need for special handling.

Policies and procedures for administering hazardous drugs and use of Chemo Spill Kits are readily available and designed to prevent the
accidental exposure of patients and staff or contamination of the work environment.

Standardized guidelines are readily available for reconstituting, diluting, admixing, packaging and labeling commonly used antineoplastics and
other medications that are routinely administered with antineoplastics.

NONSTERILE COMPOUNDING

When compounding nonsterile preparations for individual patients, policies and procedures address facilties and equipment, ingredient selection,
training, documentation and record keeping, stability and beyond-use dating, packaging and labeling and limited batch compounding.

Packaging for nonsterile compounded medications clearly identifies contents,strength and beyond-use date with mechanically-printed labeling,
while also protecting ingredients from environmental deterioration.

Standardized methods are established for labeling multidose vials and reconstituted drug products with concentration, diluent, and beyond-use
date.

AUTOMATED COMPOUNDERS

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Policies, procedures, and operational guidance ensure the safety and optimal performance of automated compounders and monitoring data are
recorded and reported.

Pharmacy personnel are oriented, trained, and demonstrate competency in the operation of automated compounders.

6.0 Dispense and Deliver Medications

Policies, procedures, and operational guidance are maintained, communicated, and adhered to by all personnel responsible for dispensing and
delivering medications.

Personnel are oriented, trained, and demonstrate competency as required for dispensing and delivering medications.

Pharmacists are responsible for ensuring that drug product supplies, regardless of automation, are adequately controlled and that medication
use is documented.

When medication carts are utilized, the carts are exchanged at least every 24 hours, so that not more than a 24-hour supply of doses is available
in the patient care area at any time.

When automated medication storage and distribution devices are used, the pharmacy has criteria for determining the drug products and
quantitites that will be stored under different levels of access and control.

When automated medication storage and distribution devices are used, they do not hinder the pharmacist's review of medication orders prior to
first dose, and pharmacy personnel supervise the stocking of medications in dispensing machines.

Policies and procedures are followed, including a written log, for repackaging medications (e.g., dose-specific unit dose packaging) into sealed
containers labeled with medication name, strength, dose, beyond-use date, lot number, and the initials of the re-packager.

Standard drug administration times are used by the hospital.

Written accountability procedures exist to ensure control and documentation of the receipt, storage, distribution and administration of controlled
substances and other medications with a potential for abuse.

The pharmacist verifies the accuracy of the health-system's medication administration record (manual or computer-generated MARs) prior to
medication administration to ensure patient safety.

Medications are dispensed in single-unit packages; in as ready-to-administer form as possible to minimize the potential for errors. (For
examples, warfarin 1.5 mg is ordered and a package containing warfarin 1.5 mg is dispensed, or a dose of megestrol oral suspension
800mg/20ml is dispensed in a unit-dose container rather than a bulk liquid container.)

Bar-coding technology is used to help identify patients, products, and care providers in conjunction with pharmacy-generated medication
administration records (MAR's) or labels to assist nurses in interpreting and documenting medication activities.

7.0 Control Medications Outside the Pharmacy

Policies, procedures, and operational guidance are maintained, communicated, and adhered to by all personnel when controlling medications
outside the pharmacy.

Personnel are oriented, trained, and demonstrate competency as required for control of medications outside the pharmacy.

The pharmacist is responsible for drug-use policies and routine inspection of all medication inventory, including satellite locations and patient-
care departmental inventories.

There is adequate security, accountability and control of medications in the Surgical Services and Anesthesia environment. Pharmacists
provide pharmaceutical services, including drug use control, to surgery and anesthesiology, ideally with direct presence.

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Floor stocks of medications are limited to medications for emergency use and routinely used personal care items (mouthwash, antiseptic
solutions) to prevent potential medication errors.

Proper handling of pharmacy-compounded sterile preparations outside the pharmacy is addressed through written instructional materials.

The pharmacy has a policy and procedure to address the identification, storage, security, and use of patients' home medications when brought
into the hospital setting.

8.0 Monitor Medication Use

The pharmacy has a comprehensive, ongoing program for ADRs, including mechanisms for monitoring, detecting, evaluating, documenting, and
reporting ADRs as well as intervening and providing educational feedback to prescribers, other health care professionals, and patients.

Information regarding suspected ADRs and medication errors is reported to the pharmacy for complete data collection, analysis and reporting.

High-risk groups are identified and monitored for ADRs, such as pediatric patients, geriatric patients, patients with organ failure, and patients
receiving multiple drugs.

High-risk medications are identified and monitored, such as aminoglycosides, amphotericin, antineoplastics, corticosteriods, digoxin, heparin,
lidocaine, phenytoin, theophylline, thrombolytic agents, and warfarin.

Pharmacists provide effective patient education and counseling to patients in all practice settings in collaboration with other providers.

Education and counseling by the pharmacist takes place in an environment conducive to patient involvement, learning and acceptance - one that
supports pharmacists' efforts to establish caring relationships with patients.

Pharmacists document clinical care plans (clinical interventions and recommendations) in the medical record that are designed to improve
patient outcomes.

Medication therapy monitoring is conducted for appropriateness, patient compliance, drug, food, laboratory test and disease-state interactions,
adverse events, and improvement in physical symptoms.

All acute care patients are monitored for medication therapy outcomes daily.

Pharmacists monitor all patients in the intensive care setting daily.

Routine patient monitoring includes an ongoing review of the medication profile after a new medication order has been processed and therapy
administered.

There is a plan for daily patient monitoring by pharmacists, including a process guided by a list of high-alert medications that require daily
monitoring and laboratory values (including serum drug levels) necessitating close patient follow-up for dosage adjustments.

Pharmacists provide education on drug products and therapies to health care professionals and other heath-system personnel.

In collaboration with study investigators, pharmacists educate patients and monitor investigational drug therapy (including adverse drug reaction
monitoring).
The investigational drug study program includes the provision of patient education materials by pharmacists or other members of the research
team.

9.0 Evaluate the Delivery of Pharmacy Services

System-wide quality improvement reports and activities are regularly reviewed by pharmacy managers in the assessment of trends and other
long term measures of performance.

There is an ongoing, systematic program for quality assessment and improvement of the medication-use process, including prescribing,
distribution, administration, and monitoring of medications and patient outcomes.

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The pharmacy reviews system-wide documentation on medication errors to analyze and aggregate data, identify trends, and develop methods
for improving the medication management system.

The organization has a system in place to detemine that its objectives have been met and quality has been maintained for all outsourcing
contracted services.

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