ASHP Guidelines: Minimum Standard for Pharmacies in Hospitals (2013)
STANDARD I. PRACTICE MANAGEMENT
Purpose: Establish a minimum standard for hospital pharmacies to guide services and outcomes; aligns with ASHP guidance and hospital needs; elements are foundational for safe, effective, and cost-conscious medication use.
Elements of Care (core areas that are interlinked to outcomes):
. Practice management
. Medication-use policy development
. Optimizing medication therapy
. Drug product procurement and inventory management
. Preparing, packaging, and labeling medications
. Medication delivery
. Monitoring medication use
. Evaluating the effectiveness of the medication-use system
. Research
Terminology (key language used throughout guidelines):
The term "shall" indicates a minimum standard of practice.
The term "should" indicates a best practice that is strongly encouraged but not universally applicable.
Terminology
SHALL: Minimum standard of practice mandated by the document or related binding authorities.
SHOULD: Best practice strongly encouraged by ASHP but may not apply in all institutions or circumstances.
ELEMENTS OF CARE
Purpose: Define the nine critical areas that together ensure safe, effective, and cost-conscious medication use in hospitals.
The nine elements are the backbone of the minimum standard and are interdependent for successful outcomes.
STANDARD II. MEDICATION-USE POLICY DEVELOPMENT
A. Policy Development
All committees that decide on medication management and use must include at least one pharmacist (e.g., P&T, infection-control, patient care, medication-use evaluation, medication safety, nutrition, pain management, information technology).
Pharmacists should be involved in developing, implementing, and assessing care plans, standing orders, and order sets involving medication therapy.
B. Formulary Management
Formulary: Maintained and regularly updated by the P&T committee; evaluate impact and compliance via drug-utilization reviews; review safety information.
P&T to develop and maintain written criteria for drug product selection, including special populations (pediatric, geriatric).
Prepare and maintain adequate product specifications to aid purchasing; disseminate the formulary electronically or by other means; include policies for dietary supplements and nonformulary medications.
C. Drug Information
Drug information requests: Pharmacists provide patient-specific and general drug information; ensure quality of responses; timely dissemination of drug information.
Dissemination: Pharmacists keep staff informed about medication use via publications, presentations, and programs; electronic communications preferred for timeliness.
STANDARD III. OPTIMIZING MEDICATION THERAPY
Core idea: Pharmacists collaborate with medical and nursing staff to develop policies based on best practices to ensure high-quality medication therapy.
A. Creating a Relationship With the Patient
Pharmacists should provide direct patient care where feasible (inpatient and outpatient) and engage in medication therapy management, collaborative drug therapy management, immunization, and related activities as allowed.
Continuity of care: Pharmacists and departments should lead policies for admissions, discharges, and transfers to maintain consistent medication therapy across transitions.
Patient confidentiality: Systems must protect patient information; training for staff on confidentiality laws and regulations.
B. Acquiring Essential Patient Data
Obtain or have access to comprehensive medication histories; ideal to have pharmacist-conducted histories; EMRs should make histories and reconciliation data available to all care providers.
C. Consulting With Other Health Professionals About Medication Therapy
Pharmacists provide oral and written consultations on medication therapy; document recommendations and actions in the medical record; communicate changes to the care team.
Medication therapy decisions: Pharmacist authority to initiate, monitor, and modify therapy and to order labs should be defined and approved by the appropriate committee.
STANDARD IV. DRUG PRODUCT PROCUREMENT AND INVENTORY MANAGEMENT
The pharmacy is responsible for procurement, distribution, and control of all hospital drug products; policies developed with input from relevant staff.
A. Selecting Sources of Pharmaceutical Products
Medication acquisition policies covering formulary evaluation, utilization review, therapeutic interchange, bidding, group purchasing, shortages, outsourcing, and cost-effective services.
Benchmarking of medication costs against industry standards.
Manufacturers and suppliers: Criteria for selecting suppliers to ensure quality and price; ultimate responsibility remains with the hospital.
Manufacturers’ representatives: Written policies; limit access to patient care areas; all promotional materials reviewed/approved by pharmacy.
B. Managing Inventory
Storage conditions must preserve drug integrity and safety; manage shortages with subminimum inventory levels and alerts; monitor shortages via reliable sources (ASHP and FDA).
Samples: Eliminate use of samples for inpatient treatment; if permitted, there are safety procedures.
Patient care area stock: Use automated dispensing devices to reduce nonpharmacy storage; limit nonpharmacy storage to emergency/essential items; access controlled by P&T-led decisions.
Controlled substances: Policies to prevent diversion; comply with laws; ensure secure distribution.
Patient’s own medications: Identify and document if used during hospitalization; administered only under order and proper procedures.
C. Inspecting Storage Areas and Inventory Items
Routine inspection of stocks to remove outdated, recalled, or mislabeled items; correct safety or deterioration risks.
D. Returning Recalled, Expired, and Other Unusable Items
Written recall procedures; remove recalled items, contact care teams, notify patients if exposed; report defects to FDA MedWatch.
STANDARD V. PREPARING, PACKAGING, AND LABELING MEDICATIONS
A. Preparing Medications
Compounding: Non-commercially available formulas must be prepared by trained personnel with QA procedures; master formulas and batch records maintained; lot numbers assigned.
Sterile preparations: Prefer manufactured sterile products when possible; prepare and label sterile meds in appropriate environments; authenticate compounding outside the pharmacy is minimized; if used, there must be aseptic prep procedures, QA, expiration dating, and competency evaluations.
Hazardous drugs: Policies for safety, equipment, and training in handling; adhere to laws and regulations.
B. Packaging
Unit dose packaging: Prefer single-unit packages ready to administer; minimize manipulation by final users.
Bar-coding: Unit dose packages should have bar codes; use bar codes across inventory, preparation, dispensing, and administration; ensure scanability and database quality.
STANDARD VI. MEDICATION DISPENSING AND DELIVERY
A. Medication Dispensing
Prescribing: Medications should be ordered by clinicians with appropriate privileges; standardize terminology and abbreviations; discourage nonstandard terms.
Diagnostic/therapeutic purpose: Pharmacists should have access to patient diagnosis or intended therapeutic purpose.
Medication orders: All orders should be in the medical record; receive a copy of the prescriber’s order; avoid oral orders where possible; use secure order transmission; maintain records of orders and processing; ensure no inappropriate continued orders.
Order review: Prospective pharmacist review before first dose or prior to automated dispensing; emergency cases may delay review; retrospective review procedures in place; interventions documented in the medical record; changes communicated to care team.
B. Medication Delivery and Administration
Drug delivery systems and automated devices: Policies/QA programs to ensure safety, accuracy, security, and confidentiality; assess error potential; pharmacists supervise stocking/recording in automated devices.
Automated cabinets: Prefer profile-based tech with remote order entry; ensure systems support patient care even in downtime.
Medication administration: Only trained, authorized personnel may administer; document all doses given, refused, or omitted; unadministered meds returned to pharmacy; provide staff with necessary information about therapy and administration.
STANDARD VII. MONITORING MEDICATION USE
A. Reviewing Patient Responses to Medication Therapy
Pharmacists conduct ongoing medication therapy monitoring, including: therapeutic appropriateness, duplication or omissions, dose/delivery method, patient adherence, interactions, adverse effects, allergies, lab data for efficacy/safety, physical signs, and overall effectiveness.
B. Educating and Counseling Patients and Family
Pharmacists participate in patient education; ensure patients receive adequate medication information to support adherence; coordinate with nursing/medical staff; review external drug information for accuracy; provide interpretation services if needed.
STANDARD VIII. EVALUATING THE EFFECTIVENESS OF THE MEDICATION-USE SYSTEM
There should be an ongoing, system-wide quality assessment and improvement program for pharmacy services and the medication-use system.
A. Assessing Pharmacy Services and Practices
Document pharmacist-provided patient care and medication-therapy outcomes; monitor workload and financial performance; integrate with hospital leadership.
B. Improving the Medication-Use Process
Medication-use evaluation: Ongoing monitoring of drug utilization and costs; define evaluation parameters (disease state, pharmacologic category, high-use/high-cost drugs); identify areas for improvement and intervene.
Medication safety: Lead and participate in multidisciplinary efforts to prevent, detect, and resolve drug-related problems; maintain and revise policies on medication errors and adverse events; monitor errors/near-misses in a just culture; implement corrective actions.
Antimicrobial stewardship and infection prevention/control: Policies to optimize antimicrobial use, reduce infections, and educate staff/patients; pharmacists participate in stewardship and related committees; monitor microbial sensitivities and resistance trends; help adjust prescribing patterns to minimize resistance.
STANDARD IX. RESEARCH
Pharmacists should initiate, participate in, and support clinical and practice-related research aligned with hospital goals and resources.
Policies for investigational drugs and devices: Safe use, informed consent, and regulatory compliance; manage procurement/distribution/control of investigational drugs; ensure IRB approval and protocol adherence; provide information on safe use and potential adverse effects to staff.
Institutional Review Board (IRB): Pharmacist membership if one exists; access to information on investigational studies; dissemination of safety information to prescribers and staff.
References and ongoing guidance: The guidelines build on a broad set of ASHP policies and external standards to inform practice in hospitals.
Additional Notes
24-hour Pharmacy Services: The guidelines advocate for -hour service where possible; if not feasible, an on-call pharmacist should be available; remote medication order processing can be used but is not a substitute for on-site coverage; after-hours access should be tightly controlled and monitored.
Compliance and Quality: Practice standards must align with state and federal laws, accreditation requirements, and hospital policies; regular review and revision of policies/procedures is required; staff training and competency assessments are ongoing.
Roles and Governance: The director of pharmacy has strategic and operational responsibilities, including mission alignment, resource mobilization, policy implementation, and ensuring compliance with laws and standards; pharmacists must be appropriately credentialed and supported by qualified technicians and staff.
IT and Data: Comprehensive pharmacy computer systems should integrate with hospital information systems (CPOE, EHR, medication administration, billing); data security and back-up plans are essential; pharmacists contribute to order sets, templates, and decision-support tools.
Ethical and Professional Conduct: Ethical standards and conflict-of-interest policies should be communicated and acknowledged; continuous professional development is expected for all personnel.
Formulary and Nonformulary Medications: Clear policies for formulary management, including nonformulary use and potential therapeutic substitutions; regulatory considerations for nonformulary therapies and safety reviews are required.
Title: ASHP Guidelines: Minimum Standard for Pharmacies in Hospitals (Am J Health-Syst Pharm. 2013; 70:1619-1630)