VHA Directive 1108.07-01.pdf

T-1

Department of Veterans Affairs VHA DIRECTIVE 1108.07(1) Veterans Health Administration Transmittal Sheet Washington, DC 20420 November 28, 2022

GENERAL PHARMACY SERVICE REQUIREMENTS

1. REASON FOR ISSUE: This Veterans Health Administration (VHA) directive establishes guidelines for areas of pharmacy practice not covered in other policies, providing comprehensive pharmacy services and oversight by Veterans Integrated Service Networks to ensure safe and efficient medical facility pharmacy operations.

2. SUMMARY OF CONTENT: This is directive:

a. Updates and streamlines policy for VHA pharmacy practice and pharmacy services to Veterans.

b. Amendment, dated October 4, 2023, updates language in Appendix A.

3. RELATED ISSUES: VA Handbook 0730, Security and Law Enforcement, dated August 11, 2000; VHA Directive 1068, Removal of Recalled Medical Products, Drugs, and Food from VA Medical Facilities, dated June 19, 2020; VHA Directive 1108.01(1), Controlled Substances Management, dated May 1, 2019; VHA Directive 1108.02(2), Inspected of Controlled Substances, dated November 28, 2016; VHA Directive 1108.08, VHA Formulary Management Process, dated July 29, 2022; VHA Directive 1108.12, Management and Monitoring of Pharmaceutical Compounded Sterile Preparations, dated November 5, 2018; VHA Directive 1131(5), Management of Infectious Diseases and Infection Prevention and Control Programs, dated November 7, 2017; VHA Directive 1660.01, Health Care Resources Sharing Authority-Selling, dated June 27, 2018; VHA Directive 1761, Supply Chain Management Operations, dated December 30, 2020; VHA Directive 7707, VHA Green Environmental Management System and Governing Environmental Policy, dated April 1, 2021; VHA Handbook 1108.04, Investigational Drugs and Supplies, dated February 29, 2012; VHA Handbook 1108.11(1), Clinical Pharmacy Services, dated July 1, 2015; and VHA Handbook 1400.04, Supervision of Associated Health Trainees, dated March 19, 2015.

4. RESPONSIBLE OFFICE: The Office of Patient Care Services, Pharmacy Benefits Management Services (12PBM), is responsible for the contents of this directive and for oversight of this directive at the Consolidated Mail Outpatient Pharmacies. Questions may be addressed to the Chief Consultant at 202-461-7360.

5. RESCISSIONS: VHA Handbook 1108.05(2), Outpatient Pharmacy Services, dated June 16, 2016; VHA Handbook 1108.09(2), Pharmacy Education and Training, dated June 24, 2016; VHA Directive 1108.03, Self-Medication Program (SMP), dated November 28, 2016; VHA Directive 1108.06(2), Inpatient Services, dated February 8, 2017; and VHA Directive 1108.07(1), Pharmacy General Requirements, dated March 10, 2017.

AMENDED

October 4, 2023

November 28, 2022 VHA DIRECTIVE 1108.07(1)

T-2

6. RECERTIFICATION: This VHA directive is scheduled for recertification on or before the last working day of November 30, 2027. This VHA directive will continue to serve as national VHA policy until it is recertified or rescinded.

BY DIRECTION OF THE OFFICE OF THE

UNDER SECRETARY FOR HEALTH:

/s/ M. Christopher Saslo

DNS, ARNP-BC, FNAAP

Assistant Under Secretary for Health For Patient Care Services/CNO

NOTE: All references herein to VA and VHA documents incorporate by reference subsequent VA and VHA documents on the same or similar subject matter.

DISTRIBUTION: Emailed to the VHA Publications Distribution List on November 28, 2022.

i

CONTENTS

GENERAL PHARMACY SERVICE REQUIREMENTS

1. PURPOSE

2. BACKGROUND

3. DEFINITIONS

4. POLICY

5. RESPONSIBILITIES

6. LICENSURE AND REGISTRATION REQUIREMENTS

7. SPACE AND STAFFING REQUIREMENTS

8. MEDICATION SECURITY

9. MEDICATION STORAGE

10. MEDICATION SAFETY

11. PROCUREMENT AND INVENTORY MANAGEMENT

12. INPATIENT PHARMACY

13. OUTPATIENT PHARMACY

14. SPECIAL MEDICATION DISPENSING CIRCUMSTANCES

15. TRAINING

16. RECORDS MANAGEMENT

17. REFERENCES

APPENDIX A

PHARMACY EDUCATION AND TRAINING ................................................................ A-1

APPENDIX B

PROCUREMENT, INVENTORY AND FISCAL PROCESSES ..................................... B-1

APPENDIX C

COMMUNITY CARE NETWORK OUTPATIENT PRESCRIPTIONS .......................... C-1

ii

APPENDIX D

UNIT DOSE OR OUTPATIENT REPACKAGING ....................................................... D-1

APPENDIX E

PRESCRIPTION CANCEL PROCESS FOR DUPLICATE PRESCRIPTIONS AT

OTHER VA MEDICAL FACILITIES .............................................................................. E-1

APPENDIX F

MEDICATION REFRIGERATOR AND FREEZER PROGRAM MANAGEMENT ......... F-1

GENERAL PHARMACY SERVICE REQUIREMENTS

1. PURPOSE

This Veterans Health Administration (VHA) directive establishes oversight responsibilities for the management of the Department of Veterans Affairs (VA) pharmacy services. This directive identifies the minimum requirements for VA pharmacy services, not covered in other policies to ensure both consistency of care throughout VA and the continued advancement of VA pharmacy as an industry leader. AUTHORITY:

Title 38 U.S.C. § 7301(b).

2. BACKGROUND

a. The Pharmacy Benefits Management (PBM) Service, as an essential component of the health care delivery team in VA, is charged with developing standards for the provision of patient-centered pharmacy services by VA Medical Facilities. The services described include (but are not limited to): procurement, storage, security, inventory management, inpatient and outpatient medication distribution, medication safety, Consolidated Mail Outpatient Pharmacy (CMOP), and pharmacy residency training programs.

b. Medical facility Pharmacy services must comply with relevant provisions of 21 C.F.R., including Part 1300 and relevant accreditation standards and regulatory requirements.

3. DEFINITIONS

a. Authorized Prescriber. An authorized prescriber ( ) is a provider authorized by law or VA policy to prescribe medications in accordance with their facility approved privileges or scope of practice. This includes physician, dentist, certified nurse practitioner (CNP), clinical nurse specialist (CNS), certified nurse midwife (CNM), certified registered nurse anesthetist (CRNA), physician assistant (PA) or clinical pharmacist practitioner (CPP) that are granted prescriptive authority for medications.

Prescriptions for medications may only be written by authorized prescribers.

b. Clinical Pharmacist. Clinical Pharmacist is the full performance level pharmacist position. All pharmacists are considered clinical pharmacists, and for purposes of this directive the term clinical pharmacist is used to encompass all pharmacist positions described in VA Handbook 5005/55, Part II/ Appendix G15, Licensed Pharmacist Qualification Standard GS-660, dated June 7, 2012. The role of each clinical pharmacist may differ based on their assignment and must be delineated in their functional statement or scope of practice as appropriate.

c. Clinical Pharmacist Practitioner. A clinical pharmacist practitioner (CPP) is a clinical pharmacist with a scope of practice authorized by the medical staff as an Advanced Practice Provider (APP) defined within medical staff bylaws. The CPP provides direct patient care and functions at the highest level of clinical practice, working with a high level of autonomy and independent decision-making within the parameters of their scope of practice, as defined by the individual medical facility, and performs functions as described in VHA Handbook 1108.11 Clinical Pharmacy Services.

For purposes of this directive, the term CPP is assigned to any pharmacist with a scope of practice regardless of their title assignment as outlined in VA Licensed Pharmacist Qualification Standard, VA Handbook 5005, Staffing, Part II, Appendix II G15, dated June 7, 2019.

d. Continuous Readiness. Continuous readiness is proactively maintaining a safe health care environment conducive to high-quality patient care.

e. Electronic Health Record. Electronic health record (EHR) is the digital collection of patient health information resulting from clinical patient care, medical testing and other care-related activities. Authorized VA health care providers may access EHR to facilitate and document medical care. EHR comprises existing and forthcoming VA software including Computerized Patient Record System (CPRS), Veterans Information Systems and Technology Architecture (VistA) and Cerner platforms. NOTE: The purpose of this definition is to adopt a short, general term (EHR) to use in VHA national policy in place of software-specific terms while VA transitions platforms.

f. Environmental Protection Agency Hazardous Waste. An Environmental Protection Agency (EPA) hazardous waste has the same meaning as a solid waste, as defined in 40 C.F.R. 261.2, and exhibits one or more characteristics identified in 40 C.F.R. part 261, subpart C or is listed in part 261, subpart D, available here:

https://www.ecfr.gov/cgi-bin/text-idx?SID=c64ed0ad8dd3e260183bd8430f219c77&mc=true&node=pt40.28.261&rgn=div 5#sp40.28.261.d.

g. EPA Hazardous Waste Pharmaceutical. An EPA Hazardous Waste Pharmaceutical is a pharmaceutical that is a solid waste, as defined in 40 C.F.R. 261.2, and exhibits one or more characteristics identified in part 261 subpart C or is listed in part 261 subpart D. A pharmaceutical is not a solid waste, as defined in 40 C.F.R.

261.2, and therefore not a hazardous waste pharmaceutical, if it is legitimately used or reused (e.g., lawfully donated for its intended purpose) or reclaimed. An over-the-counter pharmaceutical, dietary supplement or homeopathic drug is not a solid waste, as defined in 40 C.F.R. 261.2, and therefore not a hazardous waste pharmaceutical, if it has a reasonable expectation of being legitimately used or reused (e.g., lawfully redistributed for its intended purpose) or reclaimed.

h. Hazardous Drug. Drugs considered hazardous include those that exhibit one or more of the following six characteristics in humans or animals: carcinogenicity, teratogenicity or other developmental toxicity, reproductive toxicity, organ toxicity at low doses, genotoxicity and structure and toxicity that mimics existing drugs determined hazardous by the above criteria.

i. Health Professions Trainee. Health Professions Trainee (HPT) is an individual appointed under 38 U.S.C. §§ 7405 or 7406 who is participating in clinical or research training under supervision to satisfy program or degree requirements. HPT is a general term to describe undergraduate, graduate and continuing education students; interns, residents, fellows and VA advanced fellows; and pre-and post-doctoral fellows who spend all or part of their clinical training experiences at VA medical facilities. For the purposes of this directive, HPT refers to Pharmacy Fellows, Pharmacy Residents and Pharmacy Student Trainees.

j. Medication Management System. Medication Management System is the process for handling medications throughout the VA medical facility including procurement, receipt, security, storage, distribution and final disposition.

k. Non-Medication. Non-medication refers to products such as oral nutritional supplementation, expendable supplies, wound care and ostomy products that would not be defined as a drug per the Food and Drug Administration (FDA).

l. Pharmacy and Therapeutics Committee. For the purposes of this directive, the VA medical facility pharmacy and therapeutics (P&T) committee is composed of actively participating physicians, other prescribers, pharmacists, nurses, administrators, quality-improvement managers and other health care professionals and staff who participate in the medication-use process. The P&T committee is meant to serve in an evaluative, educational and advisory capacity to the medical staff and organizational administration in all matters that pertain to the use of medications.

m. Scope of Practice. For purposes of this directive, a scope of practice is a collaborating agreement between the VA medical facility Executive Committee of the Medical Staff (ECMS) or equivalent and CPPs whereby CPPs are permitted to perform comprehensive medication management services. The scope of practice permits autonomy and independent decision-making when performing the authorized duties.

The scope of practice may authorize CPPs to dispense, prescribe and administer controlled substances when they are authorized by their State license and they comply with the limitations and restrictions on that authority.

n. Unit-Dose Drug. Unit-Dose drugs are medications contained in single unit packages and dispensed in ready-to-administer forms.

4. POLICY

It is VHA policy to provide comprehensive, collaborative and patient-centered services to Veterans for the areas of pharmacy practice and pharmacy services covered by this policy at VA medical facilities.

5. RESPONSIBILITIES

a. Under Secretary for Health. The Under Secretary for Health is responsible for ensuring overall VHA compliance with this directive.

b. Assistant Under Secretary for Health for Operations. The Assistant Under Secretary for Health for Operations is responsible for:

(1) Communicating the contents of this directive to each of the Veterans Integrated Service Networks (VISNs).

(2) Assisting VISN Directors to resolve implementation and compliance challenges in all VA medical facilities within that VISN.

(3) Ensuring VISN Network Directors comply with this directive, relevant standards and applicable regulations.

c. Assistant Under Secretary for Health for Patient Care Services. The Assistant Under Secretary for Health for Patient Care Services is responsible for supporting the implementation and oversight of this directive across VHA.

d. Chief Consultant, Pharmacy Benefits Management Services. The Chief Consultant, PBM is responsible for:

(1) Serving as an advisor to the Under Secretary for Health, VA Central Office (VACO) program offices, other governmental agencies, VISNs and VA medical facilities on issues related to standards for pharmacy practice.

(2) Defining policy and guidance regarding pharmacy services to VISNs and VA medical facilities.

(3) Ensuring PBM subject matter experts with a focus on pharmacy services are available to VISNs and VA medical facilities to facilitate continuous readiness and to consult on compliance.

(4) Ensuring the PBM National Educational Needs Assessment (e.g., Pharmacy Workforce Assessment) is performed for all pharmacy staff.

e. Veterans Integrated Services Network Director. The VISN Director is responsible for:

(1) Ensuring all VA medical facilities within the VISN comply with this directive and appendices, accreditation standards and regulations pertaining to pharmacy services, including medication storage.

(2) Ensuring the VISN Pharmacist Executive has authority to provide recommendations related to CPP and professional practice and a role in overseeing the

-level CPP positions.

(3) Using the VHA Issue Brief process established by the Assistant Under Secretary for Health for Operations, ensuring the reporting of issues through the chain of command that impact the ability for VA medical facilities in the network to provide safe and efficient facility pharmacy operations (e.g., backlog of pending outpatient prescriptions, medication storage or security issues).

(4) Providing resources for the VISN Pharmacist Executive (VPE) and designees to conduct at least one site visit at each VA medical facility pharmacy annually to assess continuous readiness and compliance with pharmacy operational requirements.

(5) Ensuring the VPE develops action plans to address recommendations identified by the Office of the Inspector General, the Office of the Medical Inspector, the Government Accountability Office, other pharmacy operations oversight groups.

f. Veterans Integrated Services Network Pharmacist Executive. The VPE is responsible for:

(1) Assisting VISN VA medical facilities with compliance in the areas of pharmacy practice defined in this policy, including but not limited to:

(a) Medication procurement, security, storage, distribution/dispensing, inventory management and disposal.

(b) Compliance with regulations, accreditation requirements and all VA policies to promote an environment of continuous readiness.

(c) Pharmacy education and training which is a joint responsibility of the Office of Academic Affiliations, the VISN Academic Affiliations Office and the VA Medical Facility Associate Chief of Staff for Education/Designated Education Officer as outlined in VHA Handbook 1400.03, dated February 16, 2016.

(2) Providing oversight of the professional practice for all clinical pharmacists and CPPs with VISN-level positions, regardless of the organizational reporting structure of the CPPs or service. This includes hiring, competency assessment, functional statements, DPC responsibilities, recommendations for appointment and scope of practice, or privileges and PPE.

(3) Coordinating communication and required actions between VA medical facilities and VHA Central Office for pharmacy practice.

(4) Conducting at least one quality assurance site visit, in person or virtually, at each VA medical facility pharmacy annually to assess continuous readiness and compliance with pharmacy requirements and ensuring that the quality assurance site visit recommendations are communicated to the VA medical facility and VISN director with defined milestones and target dates.

(5) Ensuring facility action plans are developed and acted upon to address recommendations identified by the Government Accountability Office, Office of the Inspector General, Office of the Medical Inspector and other internal or external pharmacy operations oversight groups.

g. VA Medical Facility Director. The VA medical facility Director is responsible for:

(1) Ensuring overall VA medical facility compliance with this directive and taking appropriate corrective action for non-compliance.

(2) Using the Issue Brief process established by the Assistant Under Secretary for Health for Operations, ensuring the reporting of issues that impact the ability to provide safe and efficient facility pharmacy operations (e.g., backlog of pending outpatient prescriptions, medication storage or security issues).

(3) Providing status updates on the milestones and target dates to the VPE until recommendations identified by the Government Accountability Office, Office of the Inspector General, Office of the Medical Inspector, and other pharmacy operations oversight groups are fully implemented by the target dates. NOTE: If the timeline to implement the recommendations needs to be extended, the VA medical facility director shall submit a corrective action plan to the VPE. The corrective action plan requires approval by the network director.

(4) Ensuring all findings identified in annual VA Security and Law Enforcement review of the Pharmacy Service are corrected.

(5) Ensuring the medical facility Chief, Pharmacy Service is a licensed pharmacist and that the medical facility Chief, Pharmacy Service and Associate Chief, Pharmacy Service positions are at the appropriate grade level as referenced in VA Handbook

Pharmacist Qualification Standard GS-dated June 7, 2012.

(6) Ensuring a process for once monthly supervisory review of access to medication storage areas is in place. (e.g. Chief of Pharmacy for pharmacy areas, Nursing for unit, clinic or procedure areas) NOTE: Access must be removed as part of the facility employee separation or clearance process.

(7) Ensuring there is a minimum of one full time VA medical facility Associate Chief, Pharmacy Service who can act on behalf of the VA medical facility Chief, Pharmacy in their absence or if the position is vacant. Additional Associate Chiefs of Pharmacy and supervisory staff will be needed based on pharmacy program complexity. This provides continuous provision of diverse pharmacy services, oversight of a significant percentage

(8) Providing adequate staff, space, equipment, fixtures, and other resources to allow pharmacy services to maintain operational, clinical, research and educational responsibilities.

(9) Ensuring that Standard Operating Procedures (SOPs) are developed to address the transportation and provision of medication to patients in a home health setting if the VA medical facility participates in that program. NOTE: The P&T Committee must approve non patient specific medications that can be transported and administered to a patient in their home.

(10) Ensuring all funding for fees associated with the ASHP Residency Accreditation and review process are made available and paid.

(11) Pursuing Veterans Equitable Resource Allocation (VERA) dollars to fund VA medical facility residency programs. NOTE: Sites receive specific dollars for each resident trained. These dollars are to be utilized to run residency programs and includes things such as support staff, travel and lodging to conferences, textbooks and computers.

(12) Ensuring the Chief of Pharmacy addresses any recommendations identified by the U.S. Government Accountability Office, Office of the Inspector General, VA Office of the Inspector General, and other external and internal pharmacy operations oversight groups.

(13) Ensuring an Issue Brief is submitted in accordance with the processes defined by the Assistant Under Secretary for Health for Operations when the local pending prescription file has greater than 25 prescriptions more than 7 days old for 4 consecutive weeks. The report must include an action plan with a timeline for resolution.

NOTE: In addition to submitting an Issue Brief, the report and action plan must be provided to the VPE and the Chief Consultant, PBM.

(14) Ensuring an Associate Chief, Pharmacy Services position is included in the . NOTE: All staffing requirements noted in this policy must be included in the Pharmacy Service organizational chart.

h. VA Medical Facility Chief, Pharmacy Services. The VA medical facility Chief, Pharmacy Services is responsible for:

(1) Ensuring implementation of all pharmacy requirements in this directive, including all appendixes, to promote safe and efficient foundational pharmacy services which encompass a medication management system, patient-centered customer service and an environment of continuous readiness.

(2) Ensuring the security of pharmacy and other medication storage areas, including a monthly review of appropriate access to pharmacy space. NOTE: For further details, see paragraph 8.

(3) Approving all medication storage areas throughout the facility, including inpatient care areas and clinics. NOTE: For further details, see paragraph 9,

(4) Collaborating with VA medical facility leadership to ensure findings from the Annual Physical Security Review for Pharmacy Services are resolved.

(5) Serving as the VA medical facility subject matter expert on all pharmacy related matters including:

(a) Creating business plans for space, staffing, education, funding and other resources needed to support pharmacy services.

(b) Developing a continuous improvement process with ongoing evaluation.

(6) Implementing high reliability organization principles to promote an empowered and engaged pharmacy workforce, including:

(a) Developing and maintaining pharmacy staff competencies to perform assigned duties.

(b) Ensuring VA medical facility pharmacy services participate in the PBM National Educational Needs Assessment (e.g., Pharmacy Workforce Assessment) for all pharmacy staff.

(c) Ensuring time is available for pharmacy personnel to meet mandatory training requirements.

(7) If the VA medical facility has a pharmacy residency program, ensuring the designation of a VA medical facility Residency Program Director (RPD) who meets established ASHP standards outlined in Appendix A. NOTE: The RPD must have time available to devote to necessary educational and training activities on an ongoing basis.

In order to successfully implement and maintain an accredited pharmacy residency program, sufficient time must be allocated for program administration. Dedicated time will vary with the number of residents in the program and throughout the year but it should align with OAA Guidance on Protected Educational Time for VA Clinicians available at:

https://dvagov.sharepoint.com/sites/VHAOAA/general/Public%20Document/Forms/AllIte ms.aspx?viewpath=%2Fsites%2FVHAOAA%2Fgeneral%2FPublic%20Document%2FF orms%2FAllItems.aspx. This is an internal VA website that is not available to the public.

(8) Ensuring compliance with VA fiscal, procurement, and inventory requirements (See Appendix B).

(9) Ensuring resolution of prescriptions cancelled back by CMOP and communication to CMOP if changes in pharmaceutical demand occur in a timely manner.

(10) Development of action plans to address recommendations identified by the Office of the Inspector General, the Government Accountability Office, Medical Inspector and other pharmacy operations external and internal oversight groups.

6. LICENSURE AND REGISTRATION REQUIREMENTS

a. All pharmacists

b. Pharmacy Technician licenses or certifications must be current, active and readily available.

c. Pharmacy Residents should obtain licensure within 90 days of starting the PGY1 residency training program.

d.

employed by VA, to immediately inform the VA medical facility Chief, Pharmacy Services and the VA medical facility Chief, Human Resource Management Service if their license has been suspended, revoked or restricted in any way.

e. VA medical facility pharmacies must not register with a State Board of Pharmacy.

If a VA medical facility pharmacy is registered with a State Board of Pharmacy, they should discuss with their VISN Pharmacist Executive and develop a plan to revoke or allow registration to expire.

7. SPACE AND STAFFING REQUIREMENTS

a. Space Requirements.

(1) Pharmacy spaces, including temperature and humidity, must be maintained in compliance with Office of Construction and Facilities Management design guides and manuals located at http://www.cfm.va.gov/til/dGuide.asp.

(2) Workspaces where medications are prepared and processed are to be kept clean, orderly, well-lit and free of clutter, distraction and noise.

b. Staffing Requirements.

(1) A licensed pharmacist must be on duty during all hours of pharmacy operation.

(2) Pharmacy staffing and hours of operation must be evaluated by the Chief of Pharmacy at least annually to ensure adequate staffing for timely, high quality pharmacy services, taking into consideration facility hours of operation and complexity.

Staffing recommendations are available at:

https://dvagov.sharepoint.com/sites/VHAClinicalPharmacy/Pages/Homepage.aspx and https://dvagov.sharepoint.com/sites/VHAPBM/Pharmacy_Operations/SitePages/Pharm acy-Operations.aspx. NOTE: These are internal VA websites that are not available to the public.

(3) An Associate Chief, Pharmacy Services position must be included in the is necessary due to the diversity of professional pharmacy services, responsibility for the mana budget and the need for succession planning. Complexity level 1 and 2 facilities should have a minimum of two Associate Chief, Pharmacy Services positions.

(4) A full-time Administrative Officer or other administrative support position must be provided to the Chief of Pharmacy Services to effectively carry out office requirements.

It is recommended that VA medical facility pharmacies have both positions based on the complexity of pharmacy services provided.

(5) A full-time inventory management pharmacist must be designated who is responsible to the oversight of inventory management. This role must not be assigned as collateral duty to responsibilities of another primary role.

(6) There must be adequate pharmacy staff to deliver all services necessary to provide comprehensive, collaborative and patient-centered pharmaceutical care in VA medical facilities. Adequate VA medical facility pharmacy staffing should be ensured based on the appropriate professional, technical and administrative support commensurate with the size and scope of the service. An evaluation of pharmacy staffing should be performed annually and reported to the Executive Leadership Team at the medical facility.

(7) Prescriptions from community providers authorized for community care episodes prescribing guidance and community care contract requirements. Facilities must ensure adequate staff are in place to ensure compliance. For all requirements related to Community Care Network outpatient prescriptions, please see Appendix C.

8. MEDICATION SECURITY

a. Access to medications must be limited to those individuals approved by the VA medical facility. The issuance of door keys, security cards or numerical combination access that allow entry into pharmacy service must be restricted by the VA medical facility Chief, Pharmacy Services or designee, to employees who require access.

NOTE: Access must also be limited to secure storage area(s) containing expired or soon to be expired drugs.

b. Keys designated for pharmacy access must be specially mastered keys.

Pharmacy keys cannot be mastered to the facility grandmaster and can only be replaced at the request or concurrence of the Chief, Pharmacy Services or designee.

c. Physical security of the pharmacy must be maintained in accordance with current security procedures as defined in VA Handbook 0730, Security and Law Enforcement, dated August 11, 2000.

d. Pharmacy areas, including all doors, must always be secured and access strictly controlled. Based on pharmacy layout and visibility at entrance points, a local process must be established for how non-pharmacy visitors (including housekeeping) will be allowed entrance and accompanied in all pharmacy medication storage areas. NOTE:

Controlled substance storage areas must be secured in accordance with VA Handbook 0730, Security and Law Enforcement, dated August 11, 2000.

e. A monthly review of all pharmacy-controlled access points must be conducted and documented to assure all access is appropriate based on staff assignments and tours.

All keys, security cards and codes must be retrieved or removed when a pharmacy employee clears station or leaves pharmacy employment.

f. Prescription medications or medical supplies dispensed by mail must be securely packaged, properly addressed and maintained by the pharmacy service until the courier accepts the packages for delivery. NOTE: If a patient reports recurring losses, then alternate delivery processes should be considered with provider notification if clinically appropriate.

9. MEDICATION STORAGE

All medication storage areas throughout the facility, including wards and clinics, must be approved by the Chief, Pharmacy Services and meet the following requirements:

a.

(MSHI) recommendations.

b. Temperature must be maintained between 20o to 25oC (Centigrade) (68o to 77oF [Fahrenheit]) and continuously monitored.

c. Relative humidity (RH) should be maintained between 20 and 60 percent RH or

d. If flammable or combustible liquids are being stored in pharmacy, storage cabinets must comply with Occupational Safety & Health Administration (OSHA) requirements. See OSHA requirements at:

https://www.osha.gov/pls/oshaweb/owadisp.show_document?p_id=10673&p_table=ST

ANDARDS.

e. Medication refrigerators and freezers must follow processes outlined in Appendix F.

f. All approved medication storage areas (including pharmacy storage areas) must be inspected by pharmacy personnel monthly utilizing VA Form 10-0053 Medication Inspection Form for Wards and Clinics. Records of all monthly inspections are maintained with data tracking and trending. NOTE: A facility tool may be used if it includes all Form 10-0053 elements.

g. In Community Based Outpatient Clinics (CBOC) without on-site pharmacy staff, other trained clinic staff can conduct monthly medication storage area reviews.

Pharmacy personnel must review the CBOC medication storage area at least once every six months.

h. Sterile multi-dose products (e.g., parenterals, ophthalmics and insulin) must be labeled upon first use with an expiration date that does not exceed 28 days unless a shorter expiration date is recommended by the manufacturer.

i. Non-sterile multi-dose or multi-use topical medications (e.g., bulk oral powders, solutions, ointments) are valid for use until the manufacturer expiration date on the package unless the integrity of the product appears compromised.

j. Corrugated cardboard must be segregated from areas where medications are stored or prepared. NOTE: Work with facility infection control to review segregation plans.

10. MEDICATION SAFETY

a. The Pharmacy Service, in conjunction with the appropriate interprofessional representatives, must identify medication-related problems and implement measures to improve medication safety. Examples of areas for review include barcode medication administration, medication errors or appropriateness of medication use. For procedures see VHA Handbook 1050.01, VHA National Patient Safety Improvement Handbook, dated March 4, 2011.

b. A clinical pharmacist must review all prescriptions and medication orders for the following:

(1) Appropriateness of the drug, dose, frequency, route of administration and instructions for use.

(2) Therapeutic duplications.

(3) Actual or potential allergies and adverse drug reactions.

(4) Actual or potential interactions between medications (including OTCs and herbal supplements), foods, diagnostic agents, supplies or lab interferences.

(5) Therapeutic drug and laboratory monitoring when applicable.

(6) Contraindications.

(7) Applicable criteria for use, clinical practice guidelines or therapeutic indications for use.

(8) Look-alike and sound-alike drug pairs.

(9) Supply items, such as diabetic, enteral nutrition, wound care, incontinence or ostomy supplies are ordered by an authorized individual as outlined in paragraph 13.c.

(10) Special circumstances such as disability or delivery issues.

(11) Any other issues or concerns identified.

c. Allergy and adverse drug reaction (ADR) information must be recorded in the EHR. When the EHR is not available and medications are to be administered or dispensed, documentation must include an allergy assessment. Medications are only to be dispensed if an allergy assessment has been completed. NOTE: In emergent verifying pharmacist can exercise authority to override this practice on an order-by-order used to indicate an attempt to document allergy and adverse reaction information.

d. A CPP is prohibited from verifying their own prescriptions or orders.

e. The VA medical facility must have a local SOP defining dose and interval parameters when the following types of medication orders or prescriptions instructions are used (e.g., as needed, hold orders, automated stop orders, titrating orders, standing orders, taper orders and range orders). Stop dates will be managed at the enterprise level for Cerner implementations.

f. The VA medical facility must identify and implement processes for handling high-alert medications. NOTE: Facility listing should align with VHA enterprise-wide listing.

g. Look-alike and sound-alike drug names require special precautions and require a SOP as outlined in VHA Directive 1108.08(1) Formulary Management Process, dated November 2, 2016.

h. -approved abbreviations that are prohibited during prescribing. The list must include those required by accreditation agencies. An example is available at https://www.jointcommission.org/resources/news-and-multimedia/fact-sheets/facts-about-do-not-use-list/. NOTE: This linked document is outside VA control and may not conform to Section 508 of the Rehabilitation Act of 1973.

i. The VA medical facility must define an interprofessional escalation process with steps beyond prescriber electronic notification to ensure incomplete, illegible or unclear medication orders/prescriptions/consults are clarified in a timely manner. NOTE:

Pharmacy personnel are prohibited from discontinuing medication orders, prescriptions or consults without approval through the escalation process.

j. The VA medical facility reviews and approves medication standing orders, order sets and protocols. NOTE: Preprinted order sheets are only to be use when prescribing cannot utilize an electronic order entry pathway (e.g. chemotherapy protocol).

k. Verbal or telephone medication orders may only be accepted in an emergency.

The pharmacist or registered nurse receiving the verbal or telephone order must immediately transcribe and read the order back to the provider to verify the accuracy.

NOTE: The verbal order must be recorded in the EHR.

l. Remaining portions of partially used bulk inpatient medications (e.g., inhalers, eye drops, creams) that are provided to patients upon discharge must have required outpatient prescription labeling.

m. Risk Evaluation and Mitigation Strategies (REMS) must be fulfilled as required by FDA prior to dispensing or distribution.

n. The VA medical facility must develop and implement interprofessional processes that meet requirements for the safe handling of hazardous drugs including exposure assessment, receipt, storage, distribution, dispensing, administration and disposal.

These local processes must consider a VA medical faci and be in compliance with USP Chapter 800, Hazardous Drugs Handling in Healthcare Settings, VHA Directive 7702, Industrial Hygiene Exposure Assessment Program dated April 29, 2016 or later.

o. The VA medical facility must have processes in place for pharmaceutical waste disposal in accordance with VA, Federal and State requirements and accreditation standards. Additional pharmaceutical waste guidance is available at http://vaww.hefp.va.gov/resources/pharmaceutical-waste, VHA Directive 7707, VHA Green Environmental Management System (GEMS) & Governing Environmental Policy Statement, dated April 1, 2021 or later, and in VHA Directive 1114, Controlled Substance Patient Prescription Disposal, dated January 11, 2021. NOTE: This is an internal VA website that is not available to the public.

11. PROCUREMENT AND INVENTORY MANAGEMENT

a. Procurement.

(1) All procurement staff must complete training, receive ordering officer delegation through the National Acquisition Center (NAC) and follow all requirements in VHA Directive 1761, Supply Chain Management Operations, dated December 30, 2020.

(2) The VA pharmaceutical prime vendor (PPV) must be used as the primary source of all contract pharmaceutical purchases. If the drugs are not available from the PPV, then they must be purchased following the VA Acquisition Regulations (VAAR).

(3) process. They have an ordering process specific to the manufacturer and are distributed through a specialty distribution company or a third-party distributor. NOTE: The PBM maintains a website with a list of specialty distribution drugs and the process for ordering und https://dvagov.sharepoint.com/sites/VHAPBM/Formulary/Special%20Handling%20Drug s/Forms/AllItems.aspx. This is an internal VA website not available to the public.

(4) There must be a clear separation of duties to minimize the risk of fraud or loss of property. Assignment of duties such as authorizing, approving, recording of all transactions, receiving orders, approving cardholder statements, making payments, certification of funding and reviewing or auditing need to be assigned to separate individuals to the greatest extent possible. NOTE: One person cannot be the cardholder and approving official for the same transaction. Additionally, the individual that places a purchase order cannot receive and check-in the same order.

(5) All received invoices must be uploaded into the drug accountability or inventory management software.

(6) For VA Fiscal Procurement invoice reconciliation requirements, see Appendix B.

b. Inventory Management.

(1) Medication inventory control is an integral part of VA inventory management. VA pharmacy supervisors, inventory managers and purchasing agents must comply with VHA Directive, 1761, VHA Supply Chain Management Operations, dated December 30, 2020, and must implement an inventory management system.

(2) Quarterly VA medical facility PPV inventory turn rate will be provided per VHA Directive 1761 VHA Supply Chain Management Operations and must be reviewed for performance improvement opportunities. Reports can be found at:

https://dvagov.sharepoint.com/sites/VHAPBM/AnnualPharmacyWallToWall/VPE_Invent ory_documents/Forms/AllItems.aspx. NOTE: End-of-year purchases make pharmaceutical inventories increasingly difficult to manage and are discouraged. This is an internal VA website that is not available to the public.

(3) An annual wall to wall inventory of all pharmacy items must be completed by February 28 of each calendar year and posted to the National Pharmacy Inventory SharePoint (NPIS) site, or current database by March 31.

(4) Units or clinic inventory:

(a) The VistA Automatic Replenishment system is utilized to record medication distribution to units or clinics as the record of inventory accountability for unit/clinic general stock.

(b) Facilities utilizing automated dispensing cabinets and associated inventory tracking software are not required to utilize VistA Automatic Replenishment and may

(c) Unit and clinic medication stock levels are determined by the pharmacy based on utilization and in collaboration with stake holders.

(2) A process must be established for reviewing medications available after hours and adjusting stock levels as needed.

(3) Five non-controlled drugs must be selected from a list developed annually by PBM. These items must be monitored and reported on a quarterly basis, beginning April 1 of each year.

(4) Expired or soon-to-expire medications in each VA medical facility and CMOP must be accounted for as follows:

(a) Drugs designated as return for credit or destruction must be stored in a secure locked area with limited access and separated from normal inventory.

(b) A current inventory must be maintained for non-controlled medications held for return for credit or destruction. At a minimum this list must contain drug name and quantity. NOTE: The contents of opened units or bottles may be estimated.

(c) If using a reverse distribution vendor, vendor-provided reports must be analyzed to ensure appropriate credits.

(d) Pharmacy inventory must be reconciled with any reverse distributor, tracked and documented.

(e) Destruction of expired or soon-to-be expired non-controlled medications must be witnessed and reconciled with the inventory list.

(5) Disposition of expired or soon-to-be-expired controlled medications must be accounted for as outlined in VHA Directive 1108.01(1).

(6) Discrepancies in expired or soon to expire drug inventories must be investigated and addressed.

(7) VA pharmacies must not restock into inventory, or reissue to another patient, any CMOP or locally dispensed prescription medication that has been returned as undeliverable.

12. INPATIENT PHARMACY

a. Medications stocked in patient care areas, including commercially available sterile product solutions, must be labeled with scannable barcodes and inventory quantities are based on utilization. Pharmacy must verify that all barcodes are scannable before distributing.

b. Unit dose bar coded medications are distributed to patient care areas for individual patients for a 24-hour period. Exceptions include Community Living Centers (CLC), long-term care units, Residential Rehabilitation Treatment Programs (RRTP) or domiciliary units which may be issued quantities in excess of a 24-hour supply. NOTE:

In the instance where unit dose medications may not be available, the Pharmacy will supply the smallest commercial or repackaged size available for patient safety.

c. In cartless medication systems, unit dose barcoded medications are distributed to patient care areas based on utilization needs.

d. Pharmacy technicians are authorized to deliver and restock barcoded non-controlled unit dose medications to automated dispensing units and medication carts without requiring a second check if all required product checks are completed. NOTE:

Job specific competencies related to unit dose stocking and replenishment must be part

e. Standardized administration and delivery times must be established to ensure the timely administration of medications. Response times for off-schedule dispensing of "STAT", "NOW" and change orders must be established through facility level standard operating procedures.

f. VA medical facility Logistics may stock non-drug containing solutions.

g. Medication orders.

(1) Authorized prescribers must enter all orders in the EHR. If EHR is unavailable, the schedule or desired flow rate, duration of therapy, and other information as established by local VA medical facility.

(2) A pharmacist must verify all inpatient medication orders and consider the current diagnosis and indication for each medication.

(3) Local SOP must define the requirements for indication for use on the medication orders.

(4) Medication order reviews may be performed by a pharmacist at a remote location. This review must be completed before the first dose is administered.

(5) All medication orders are reviewed by a licensed clinical pharmacist prior to the administration of the drug, except when required for emergent need or where all processes are controlled by a licensed independent practitioner (LIP). In those instances where a prior review is not possible, the clinical pharmacist must review the order as soon as possible, within 24 hours.

(6) End product evaluation and visual testing for all compounded sterile products (CSP) prepared in-house and any CSP procured from an outsourced vendor, for use in-house, must be checked by a clinical pharmacist prior to dispensing the product for patient administration. The end product testing shall include an evaluation for:

(a) Container leaks.

(b) Container integrity.

(c) Solution cloudiness or phase separation.

(d) Particulates in the solution.

(e) Appropriate solution color.

(f) Solution volume.

(g) Identity of the drug and additives (e.g., drugs, diluents, solutions) with the quantity of each additive evidenced by the empty vials or ampoules used. NOTE: This item pertains to those products compounded in-house.

h. When the onsite pharmacy is not open 24 hours a day and 7 days a week, a pharmacist must be available either on-call or at another location to answer questions or provide access to medications that are not available to non-pharmacy staff. NOTE:

Medications can be stored in an afterhours cabinet or automated dispensing cabinet.

i. Medication Brought into a VA Medical Facility by Patients.

(1) Patients are discouraged from bringing their medications when admitted to the hospital. If medications are brought in by the patient, the medications should be with patient belongings. For disposition of controlled substances brought into to the hospital, see VHA Directive 1114.

(2) In the unlikely event pharmacy service cannot obtain a medication or supply, a prescriber . A pharmacist must verify and relabel the medication prior to administration to the patient. Controlled and illicit substances are excluded.

13. OUTPATIENT PHARMACY

a. Prescriptions.

(1) VA medical facility authorized prescribers must enter all orders in the EHR.

Community Care Network (CCN) prescribers may prescribe electronically, via facsimile or with a hard copy prescription. NOTE: For requirements pertaining to CCN prescriptions, please refer to requirements outlined in appendix C.

(2) Outpatient prescription services must be provided to Veterans in a timely manner. Prescriptions must be ready for pick-up in 30 minutes on average. Facilities must monitor and address extended wait times.

(3) All prescriptions must be verified in the EHR by a pharmacist prior to filling, and all order checks must be addressed. NOTE: If a duplicate prescription order check is noted, see Appendix E for the process to cancel or hold prescription at the other VA medical facility.

(4) Renewed prescriptions must be evaluated by a clinical pharmacist to prevent dispensing if the patient has sufficient supply.

(5) Internal and external written prescriptions must contain the following:

(a) Patient's full name.

(b) Social Security Number (SSN) last four digits or p date of birth.

(c) .

(d) Generic name of medication is preferred.

(e) Dosage form.

(f) Strength (in metric).

(g) Quantity.

(h) Directions for use.

(i) Number of refills.

(j) DEA number. (For additional information, see VHA Directive 1108.01(1).)

(6) Non-controlled prescriptions are valid for one year from the date of issue, unless otherwise specified. Controlled substance CIII-V prescriptions are valid for six months from the date of issue, unless otherwise specified. CII prescriptions greater than 14 days from the date of issue should be verified for continued need prior to dispensing.

(7) The VA medical facility may have an SOP outlining extension of fills greater than 12 months in certain circumstances.

(8) On a limited basis, the VA medical facility medications prior to the normal dispensing date if a Veteran will be traveling.

(9) Prescriptions must generally be filled for no more than a maximum three-month (90-day) supply of medication. However, exceptions can be made for non-controlled medications and supplies to avoid breaking commercial package size, and for oral contraceptives if requested by the Veteran and their provider.

(10) Prescriptions for low-cost drugs to treat chronic conditions should be dispensed in greater than 30-day supplies if clinically appropriate and authorized by the prescriber.

(11) Prescriptions may be limited to a supply of 30 days or less based on patient safety, patient care needs or facility resources, including, for example, controlled substances (unless specified by VHA Directive 1108.01(1)), research medications or any medications with a restriction specified by the VA National Formulary (VANF).

(12) Routine prescription refills at the VA medical facility pharmacy window should be limited and mailout prescriptions encouraged.

(13) FDA Medication Guides and patient information associated with outpatient prescriptions must be provided as required by law, regulation, accreditation agencies or VHA policy.

(14) All filled prescriptions must be checked by a clinical pharmacist for accuracy, appropriate labeling (including auxiliary labels) and all necessary printed information prior to dispensing.

(15) Two forms…