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Minimum Standard for Hospital
Pharmacy: ASHP Guideline
Department of Clinical Pharmacy
CLNM 508
2022-2023
Introduction
• Pharmacists work closely with other health
practitioners to meet the needs of the public.
• The primary purpose - to serve as a guide for the
provision of pharmaceutical services in hospitals.
• As providers of pharmaceutical care, pharmacists are
concerned with the outcomes of their services and
not just the provision of these services.
2
• The SIX minimum standards critical to overall
successful performance in a hospital include:
1. Leadership and practice management,
2. Drug information and education,
3. Activities to ensure rational medication therapy,
4. Drug distribution and control,
5. Facilities,
6. Participation in drug therapy research.
3
Standard I:
Leadership and Practice
Management
• Education and training, director: professionally
competent, legally qualified pharmacist.
• Pharmacy mission: reflects both patient care and
operational responsibilities.
• Support personnel: Sufficient support personnel
(pharmacy technicians, clerical, secretarial).
4
• Work schedules and assignments. The director
→ensure work schedules, procedures, and
assignments.
• Education and training: to fulfill responsibilities, to
maintain or enhance competence.
• Orientation of personnel: established procedure for
orienting new personnel to the pharmacy, the
hospital, and their respective positions.
5
• Performance evaluation. Procedures for the routine
evaluation of the performance of pharmacy
personnel.
• Position descriptions
• Operations manual. An operations manual governing
pharmacy functions (e.g., administrative,
operational, and clinical) shall exist.
• Drug expenditures. Policies and procedures for
managing drug expenditures. E.g. competitive
bidding, group purchasing, utilization-review
programs, and cost-effective patient services.
6
• Workload and financial performance.
• Committee involvement.
• Quality assessment and improvement: ongoing,
systematic program
• 24-hour pharmaceutical services
• Laws and regulations
• Patient confidentiality
7
Standard II:
Drug information and Education
• The pharmacist shall provide patient-specific drug
information and accurate and comprehensive
information about drugs to other pharmacists, other
health professionals, and patients as appropriate.
• Drug information requests. Responses to general
and patient-specific drug information requests shall
be provided in an accurate and timely manner.
8
• Patient education
• Dissemination of drug information. Pharmacists
should keep the hospital’s staff informed about the
use of medications on an ongoing basis through
appropriate publications, presentations, and
programs. Pharmacists should ensure timely
dissemination of drug product information (e.g.,
recall notices, labeling changes).
9
Standard III:
Optimizing Medication Therapy
• This must include processes designed to ensure the
safe and effective use of medications and increase
the probability of desired patient outcomes.
• The pharmacist, in concert with the medical and
nursing staff, must develop policies and procedures
for ensuring the quality of medication therapy.
10
• Medical record documentation.
• Medication histories. Pharmacists should prepare or
have immediate access to comprehensive medication
histories for each patient’s medical record or other
databases (e.g., medication profile), or both.
• Medication orders. All prescribers’ medication
orders (except in emergency situations) must be reviewed
for appropriateness by a pharmacist before the first
dose is dispensed.
11
• Medication-therapy monitoring. MTM includes an assessment of:
a. The therapeutic appropriateness of the patient’s medication regimen.
b. Therapeutic duplication in the patient’s medication regimen.
c. The appropriateness of the route and method of administration of the
medication.
d. The degree of patient compliance with the prescribed medication regimen.
e. Medication–medication, medication–food, medication–laboratory test, and
medication– disease interactions.
f. Clinical and pharmacokinetic laboratory data to evaluate the efficacy of
medication therapy and to anticipate toxicity and adverse effects.
g. Physical signs and clinical symptoms relevant to the patient’s medication
therapy.
12
• Pharmacist consultations. oral and written
consultations to other health professionals.
• Medication-use evaluation. An ongoing medication
use evaluation program
• Medication-use policy development. The pharmacist
shall be a member of the P&T committee, the
institutional review board, and the infection control,
patient care, medication-use evaluation, and other
committees that make decisions concerning
medication use.
13
• Work redesign initiatives.
• Microbial resistance. Policies and procedures
addressing microbial resistance to anti-infectives
shall exist.
• Medication-therapy decisions. initiate, monitor, and
modify medication therapy for individual patients,
consistent with laws, regulations, and hospital policy,
shall be clearly delineated and approved by the P&T
committee (or comparable body).
• Immunization programs
• Substance-abuse programs
14
Standard IV:
Medication Distribution and Control
• The pharmacy shall be responsible for the
procurement, distribution, and control of all drug
products used in the hospital (including medication-
related devices and pharmaceutical diagnostics) for
inpatient and ambulatory patients.
• Medication orders. All patient medication orders
shall be contained in the patient’s medical record.
15
• Formulary
• Prescribing: by legally permitted only
• Medication administration. Only personnel who are
authorized by the hospital and appropriately trained.
• Extemporaneous compounding. Drug formulations,
dosage forms, strengths, and packaging that are not
available commercially but are needed for patient care
shall be prepared by appropriately trained personnel in
accordance with applicable practice standards and
regulations (e.g., FDA, state board of pharmacy).
• Sterile products. All sterile medications shall be
prepared and labeled in a suitable environment by
appropriately trained personnel.
16
• Unit dose packaging
• Medication storage., e.g. temperature, light,
moisture, ventilation, segregation, and security to
ensure medication integrity and personnel safety.
• Adverse drug reactions. An ongoing program for
monitoring, reporting, and preventing adverse drug
reactions shall be developed.
• Medication errors. Pharmacists, with physicians and
other appropriate hospital personnel, shall establish
policies and procedures with respect to medication
error prevention and reporting.
17
• Patient’s own medications.
• Vendors’ representatives. Written policies governing the
activities of representatives of vendors of drug products
(including related supplies and devices) within the hospital shall
exist.
• Manufacturers and suppliers: prepare & follow
guidelines.
• Cytotoxic and hazardous drug products; control
substances
• Floor stock. Floor stocks of medications generally shall be
limited to medications for emergency use and routinely
used safe items (e.g., mouthwash, antiseptic solutions).
• Disaster services & medical emergencies
18
Standard V:
Facilities, Equipment,
and Information Resources
• Medication storage, packaging & compounding
• Consultation space & Drug information.
• Record maintenance.
• Computerized systems. to support secretarial
functions, maintain patient medication profile
records, perform necessary patient billing
procedures, manage drug product inventories etc.
19
Standard VI:
Research
• The pharmacist should initiate, participate in, and
support medical and pharmaceutical research
appropriate to the goals, objectives, and resources of
the specific hospital.
• Distribution and control
• Institutional review board.
• Drug information
20
Thank you
21

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2. Minimum Standard for Hospital Pharmacy_ASHP_2022-2023.pptx

  • 1. Minimum Standard for Hospital Pharmacy: ASHP Guideline Department of Clinical Pharmacy CLNM 508 2022-2023
  • 2. Introduction • Pharmacists work closely with other health practitioners to meet the needs of the public. • The primary purpose - to serve as a guide for the provision of pharmaceutical services in hospitals. • As providers of pharmaceutical care, pharmacists are concerned with the outcomes of their services and not just the provision of these services. 2
  • 3. • The SIX minimum standards critical to overall successful performance in a hospital include: 1. Leadership and practice management, 2. Drug information and education, 3. Activities to ensure rational medication therapy, 4. Drug distribution and control, 5. Facilities, 6. Participation in drug therapy research. 3
  • 4. Standard I: Leadership and Practice Management • Education and training, director: professionally competent, legally qualified pharmacist. • Pharmacy mission: reflects both patient care and operational responsibilities. • Support personnel: Sufficient support personnel (pharmacy technicians, clerical, secretarial). 4
  • 5. • Work schedules and assignments. The director →ensure work schedules, procedures, and assignments. • Education and training: to fulfill responsibilities, to maintain or enhance competence. • Orientation of personnel: established procedure for orienting new personnel to the pharmacy, the hospital, and their respective positions. 5
  • 6. • Performance evaluation. Procedures for the routine evaluation of the performance of pharmacy personnel. • Position descriptions • Operations manual. An operations manual governing pharmacy functions (e.g., administrative, operational, and clinical) shall exist. • Drug expenditures. Policies and procedures for managing drug expenditures. E.g. competitive bidding, group purchasing, utilization-review programs, and cost-effective patient services. 6
  • 7. • Workload and financial performance. • Committee involvement. • Quality assessment and improvement: ongoing, systematic program • 24-hour pharmaceutical services • Laws and regulations • Patient confidentiality 7
  • 8. Standard II: Drug information and Education • The pharmacist shall provide patient-specific drug information and accurate and comprehensive information about drugs to other pharmacists, other health professionals, and patients as appropriate. • Drug information requests. Responses to general and patient-specific drug information requests shall be provided in an accurate and timely manner. 8
  • 9. • Patient education • Dissemination of drug information. Pharmacists should keep the hospital’s staff informed about the use of medications on an ongoing basis through appropriate publications, presentations, and programs. Pharmacists should ensure timely dissemination of drug product information (e.g., recall notices, labeling changes). 9
  • 10. Standard III: Optimizing Medication Therapy • This must include processes designed to ensure the safe and effective use of medications and increase the probability of desired patient outcomes. • The pharmacist, in concert with the medical and nursing staff, must develop policies and procedures for ensuring the quality of medication therapy. 10
  • 11. • Medical record documentation. • Medication histories. Pharmacists should prepare or have immediate access to comprehensive medication histories for each patient’s medical record or other databases (e.g., medication profile), or both. • Medication orders. All prescribers’ medication orders (except in emergency situations) must be reviewed for appropriateness by a pharmacist before the first dose is dispensed. 11
  • 12. • Medication-therapy monitoring. MTM includes an assessment of: a. The therapeutic appropriateness of the patient’s medication regimen. b. Therapeutic duplication in the patient’s medication regimen. c. The appropriateness of the route and method of administration of the medication. d. The degree of patient compliance with the prescribed medication regimen. e. Medication–medication, medication–food, medication–laboratory test, and medication– disease interactions. f. Clinical and pharmacokinetic laboratory data to evaluate the efficacy of medication therapy and to anticipate toxicity and adverse effects. g. Physical signs and clinical symptoms relevant to the patient’s medication therapy. 12
  • 13. • Pharmacist consultations. oral and written consultations to other health professionals. • Medication-use evaluation. An ongoing medication use evaluation program • Medication-use policy development. The pharmacist shall be a member of the P&T committee, the institutional review board, and the infection control, patient care, medication-use evaluation, and other committees that make decisions concerning medication use. 13
  • 14. • Work redesign initiatives. • Microbial resistance. Policies and procedures addressing microbial resistance to anti-infectives shall exist. • Medication-therapy decisions. initiate, monitor, and modify medication therapy for individual patients, consistent with laws, regulations, and hospital policy, shall be clearly delineated and approved by the P&T committee (or comparable body). • Immunization programs • Substance-abuse programs 14
  • 15. Standard IV: Medication Distribution and Control • The pharmacy shall be responsible for the procurement, distribution, and control of all drug products used in the hospital (including medication- related devices and pharmaceutical diagnostics) for inpatient and ambulatory patients. • Medication orders. All patient medication orders shall be contained in the patient’s medical record. 15
  • 16. • Formulary • Prescribing: by legally permitted only • Medication administration. Only personnel who are authorized by the hospital and appropriately trained. • Extemporaneous compounding. Drug formulations, dosage forms, strengths, and packaging that are not available commercially but are needed for patient care shall be prepared by appropriately trained personnel in accordance with applicable practice standards and regulations (e.g., FDA, state board of pharmacy). • Sterile products. All sterile medications shall be prepared and labeled in a suitable environment by appropriately trained personnel. 16
  • 17. • Unit dose packaging • Medication storage., e.g. temperature, light, moisture, ventilation, segregation, and security to ensure medication integrity and personnel safety. • Adverse drug reactions. An ongoing program for monitoring, reporting, and preventing adverse drug reactions shall be developed. • Medication errors. Pharmacists, with physicians and other appropriate hospital personnel, shall establish policies and procedures with respect to medication error prevention and reporting. 17
  • 18. • Patient’s own medications. • Vendors’ representatives. Written policies governing the activities of representatives of vendors of drug products (including related supplies and devices) within the hospital shall exist. • Manufacturers and suppliers: prepare & follow guidelines. • Cytotoxic and hazardous drug products; control substances • Floor stock. Floor stocks of medications generally shall be limited to medications for emergency use and routinely used safe items (e.g., mouthwash, antiseptic solutions). • Disaster services & medical emergencies 18
  • 19. Standard V: Facilities, Equipment, and Information Resources • Medication storage, packaging & compounding • Consultation space & Drug information. • Record maintenance. • Computerized systems. to support secretarial functions, maintain patient medication profile records, perform necessary patient billing procedures, manage drug product inventories etc. 19
  • 20. Standard VI: Research • The pharmacist should initiate, participate in, and support medical and pharmaceutical research appropriate to the goals, objectives, and resources of the specific hospital. • Distribution and control • Institutional review board. • Drug information 20