Chapter 7 - Pharmacy

3-7.1   INTRODUCTION

1. Purpose.   This chapter establishes the requirements for the development of local policies and procedures of pharmacy services operated by the Indian Health Service (IHS).
2. Background.   The IHS Pharmacy Services are essential components of the IHS health care system. The safe, appropriate, and cost-effective use of medications is the overarching goal of the IHS Pharmacy Program. The IHS is a recognized leader in the provision of professional pharmacy practice. Pharmacy management continues to increase in complexity and includes formulary management and pharmaceutical supply chain integrity; drug safety; risk reduction; adverse drug event reporting; drug cost avoidance; electronic prescribing (eRx); and Consolidated Mail Outpatient Pharmacy. The IHS Clinical Pharmacy Services have also increased in complexity to include integrating clinical pharmacy services into team-based models of care, pharmacist prescriptive authority; order interpretation; and laboratory result interpretation. This policy is intended to identify the basic requirements for IHS pharmacies to ensure both consistency of care and safety and efficiency of IHS pharmacies throughout the IHS and the continued advancement of the IHS pharmacy as an industry leader.
3. Policy.   It is the policy of the IHS Pharmacy Program to:
   1. Ensure efficacious, safe, and cost-effective drug therapy, and appropriate outcomes in medication therapy;
   2. Provide high quality comprehensive pharmacy services in accordance with professionally determined standards of pharmacy practice in all settings, emphasizing the promotion of health, prevention of disease, and health maintenance;
   3. Ensure quality by reviewing and evaluating pharmacy practice in accordance with standards developed by the IHS and other nationally recognized organizations, such as the American Pharmacists Association, American Society of Health System Pharmacists (ASHP), the Centers for Medicare & Medicaid Services (CMS), The Joint Commission, the Accreditation Association for Ambulatory Health Care, etc.; and
   4. Ensure medication safety by reviewing and evaluating best-practice guidelines such as those established by the Institute for Safe Medication Practices, the National Coordinating Council for Medication Error Reporting and Prevention and the United States Pharmacopeia (USP).
4. Definitions.  
   1. Adverse Drug Event.   An unwanted effect or harm that occurs after using a medication where the medication is suspected as the cause of the unwanted effect or harm.
   2. Clinical Investigator.   An individual involved in a clinical trial who is responsible for ensuring that an investigation is conducted according to the signed investigator statement, the investigational plan, and applicable regulations; for protecting the rights, safety, and welfare of subjects under the investigator's care; and for the control of drugs under investigation.
   3. Clinical Pharmacy.   A health science discipline in which pharmacists provide patient care that optimizes medication therapy and promotes health, wellness, and disease prevention. The practice of clinical pharmacy blends a caring orientation with specialized therapeutic knowledge, experience, and judgment for the purpose of ensuring optimal patient outcomes. As a discipline, clinical pharmacy also has an obligation to contribute to the generation of new knowledge that advances health and quality of life.
   4. Clinical Privileges.   The listing of the specific services and procedures an organization’s staff member is permitted to perform in the facility, e.g., diagnostic services, procedures, prescribing medications. Clinical privileges are based on the review of an individual pharmacist's professional training, licensure, experience, and expertise.
   5. Collaborative Practice Agreement (CPA).   Agreements used to create formal relationships between pharmacists and physicians or other providers that allow for expanded services the pharmacist can provide to patients and the healthcare team within the scope of a defined clinical protocol. The CPA defines certain patient care functions that a pharmacist can autonomously provide under specified situations and conditions. Of important note, CPA is not required for pharmacists to perform many patient care services (e.g., medication reviews, patient education and counseling, disease screening, referral).
   6. Competency.   Having sufficient aptitude, knowledge, skill, and abilities to fulfill the duties and responsibilities of the assigned position.
   7. Credentialing.   An ongoing process whereby a facility’s medical staff obtains, verifies, and assesses an individual’s professional credentials. This information is used by the medical staff and governing body to evaluate competency and appropriately grant medical staff membership and/or clinical privileges.
   8. Credentials.   The attestation of qualification, competence, or authority issued to an individual by a third party with the authority or assumed competence to do so. Examples of credentials include the documents that constitute evidence of pharmacist training, licensure, experience, and expertise.
   9. Drug Diversion.   The illegal distribution or use of prescription drugs.
   10. Emergency Use Authorization (EUA).   Section 564 of the Federal Food, Drug, and Cosmetic Act (FD&C Act) permits the Food and Drug Administration (FDA) Commissioner to authorize the emergency use of an unapproved medical product or an unapproved use of an approved medical product for certain emergency circumstances after the Secretary of Health and Human Services has made a declaration of emergency or threat justifying authorization of emergency use. The EUA authority under section 564 allows the FDA to facilitate availability and unapproved uses of medical countermeasures (i.e., drugs, antivirals, antidotes) needed to prepare for and respond to chemical, biological, radiological and nuclear emergencies. The FDA Commissioner may issue an EUA to allow a medical countermeasure to be used in an emergency to diagnose, treat, or prevent serious or life-threatening diseases or conditions caused by a chemical, biological, radiological and nuclear agent when there are no adequate, approved, and available alternatives.
   11. Focused Professional Practice Evaluation (FPPE).   A process used to validate the privilege specific competency of a clinical pharmacist in the following time limited situations: all new clinical privilege requests, as needed for a currently privileged practitioner in circumstances where privileges or clinic processes change, and as needed for a currently privileged practitioner to determine the validity of patient care issues or concerns of poor care trends revealed through peer reviews.
   12. Formulary.   An approved list of prescription medications that may be used at a particular hospital, in a particular health system, or under a particular health insurance policy. The development of medication formularies is based on evaluations of efficacy, safety, and cost-effectiveness of drugs.
   13. Investigational Drug.   Either:
       1. A new drug or new dosage formulation (i.e., Investigational New Drug (IND)), which has not been approved for any medical indication by the FDA; or
       2. A FDA approved and marketed drug used in a group of patients for study or research purposes for a non-FDA approved indication.
   14. Legend Drug.   A medication dispensed only pursuant to a valid prescription from a health care provider.
   15. Medication Error.   Any preventable event that may cause or lead to inappropriate medication use or patient harm while the medication is in the control of the health care professional, patient, or consumer.
   16. Medication Dispensing.   The preparation, packaging, labeling, record keeping, and issuing of a prescription medication to a patient or their representative.
       1. The pharmacist provides and documents the final verification for the accuracy, validity, completeness, and appropriateness of the patient's prescription or medication order prior to the delivery of the medication to the patient or the patient's representative.
       2. Only a pharmacist may provide counseling to each patient or patient representative receiving new medication and/or medication therapy changes.
   17. Medication Distribution.   The delivery of a drug or drug device other than by administration or dispensing to a patient. This would include the distribution of medication refills to patients.
   18. The National Core Formulary (NCF).   A core set of drugs, maintained by the National Pharmacy and Therapeutic Committee, available to IHS beneficiaries. The NCF ensures parity, portability, quality, convenience, safety, and promotes cost-effective use of medications.
   19. Ongoing Professional Practice Evaluation (OPPE).   An ongoing monitoring process for oversight of the clinical pharmacist to confirm the quality of care delivered and ensure patient safety. The OPPE is used as a screening tool to systematically assess and summarize multiple performance elements of individual clinical pharmacists for privileges granted. The OPPE process allows the clinical leadership to identify professional practice trends that affect quality of care and patient safety, some of which may require intervention.
   20. Outside prescription.   A prescription written by a non-IHS provider presented to an IHS pharmacy from outside the facility or a prescription provided by an IHS prescriber to be filled at a non-IHS pharmacy.
   21. Peer Review.   A process in which individual patient care visits are regularly reviewed by other privileged pharmacists or providers. Individual visit practices, documentation, and processes are evaluated against existing department standards.
   22. Pharmaceutical care.   The direct responsible provision of medication-related care for the purpose of achieving definite outcomes that improve a patient’s quality of life.
   23. The Pharmacy Professional Specialty Group (PSG).   A subcommittee of the National Pharmacy Council that works to identify and prioritize the resource management and technology needs of pharmacists in IHS, Tribal, and Urban facilities.
   24. Privileging.   The act of a healthcare organization granting a permission to a healthcare practitioner to provide health care services.
   25. Professional Practice Evaluations.   A component of the credentialing and privileging process where quality patient care is ensured through the ongoing monitoring, evaluation, and improvement of clinical pharmacist performance. This process includes, but is not limited to, FPPE, peer reviews, and OPPE.
   26. Protocols.   A clinical practice guideline used to assist the practitioner about appropriate healthcare for specific clinical circumstances.
   27. Re-credentialing.   The process whereby credentials are reviewed every two years, or after the one-year provisional period.
   28. Reverse Distributor.   A Drug Enforcement Agency (DEA) registrant who receives controlled substances acquired from another DEA registrant for the purpose of:
       1. Returning unwanted, unusable, or outdated controlled substances to the manufacturer or the manufacturer's agent; or
       2. Processing such substances or arranging for processing such substances for disposal.
   29. Schedule II Controlled Substances.   Drugs that have a high potential for abuse which may lead to severe psychological or physical dependence, as defined under the Controlled Substances Act.
   30. Schedule III Controlled Substances.   Drugs that have a potential for abuse less than substances in Schedule II and abuse may lead to moderate or low physical dependence or high psychological dependence, as defined under the Controlled Substances Act.
   31. Schedule IV Controlled Substances.   Drugs that have a low potential for abuse relative to substances in Schedule III, as defined under the Controlled Substances Act.
   32. Schedule V Controlled Substances.   Drugs that have a low potential for abuse relative to substances listed in Schedule IV, as defined under the Controlled Substances Act, and consist primarily of preparations containing limited quantities of certain narcotics.
   33. Serious Adverse Drug Events.   Drug events that result in death, require hospital admission or prolongation of existing hospital stay, result in persistent or significant disability/incapacity, are life threatening, or cause congenital anomaly or birth defect.
   34. Suspect Product.   A product for which there is reason to believe it is potentially:
       1. Counterfeit, diverted, or stolen;
       2. Intentionally adulterated such that the product would result in serious adverse health consequences or death to humans;
       3. The subject of a fraudulent transaction; or
       4. Appearing unfit for distribution such that the product would result in serious adverse health consequences or death to humans.
   35. Visit Note.   A record containing a detailed account of the patient’s visit, which may include the history, exam, relevant lab or study findings, and the clinician’s assessment and plan of care.

3-7.2   RESPONSIBILITIES

1. Chief Medical Officer, IHS.   The IHS Chief Medical Officer (CMO) is administratively responsible for the issuance of this policy.
2. Principal Pharmacy Consultant.   The Principal Pharmacy Consultant (PPC) serves as the coordinator, consultant, and advisor for all matters relating to the provision of pharmacy services throughout the IHS. The PPC performs pharmacy quality improvement efforts, including overseeing implementation of the pharmacy policy to ensure safe, efficient, and effective pharmacy services and pharmacy-related activities are conducted within IHS facilities.
3. Area Director.   The Area Director is responsible for:
   1. Ensuring that administrative support and necessary resources are available at IHS pharmacies in their respective Areas to implement this policy; and
   2. Ensuring that this policy is fully implemented.
4. Area CMO.   The Area CMO is responsible for monitoring IHS facilities for compliance with this policy.
5. Area Pharmacy Consultant.   The Area Pharmacy Consultant (APC) serves as the coordinator, consultant, and advisor to the PPC, Area Director, Area program staff, and Service Unit (SU) staff on all matters relating to provision of pharmacy services. Also serves as a consultant and technical advisor to Tribal health programs and Urban Indian Organizations (UIO), as requested by those programs, on matters relating to the provision of pharmacy services.
6. Chief Executive Officer.   The SU Chief Executive Officer (CEO) is responsible for approving the facility's pharmacy policy and ensuring the policy is fully implemented, reviewed, and updated per Area Governing Board procedures.
7. Chief Pharmacist.   The SU Chief Pharmacist is responsible for developing policies and procedures for the provision of pharmacy services, assuring the establishment of competencies and evaluating the competency and performance of pharmacy personnel, and assuring all pharmacy policies are reviewed at least annually. Each SU must have a policy which specifies procedures and safeguards to prevent prescription drug diversion.

3-7.3   PHARMACY AND THERAPEUTICS COMMITTEES

1. National Pharmacy and Therapeutics Committee.   See Indian Health Manual Circular 23-09, “National Pharmacy and Therapeutic Committee – Charter.”
2. Local Pharmacy and Therapeutics Committee.   Each SU with a federally operated pharmacy will develop a local Pharmacy and Therapeutics (P&T) Committee.
   1. Local P&T Committee membership will include at least one physician and one pharmacist.
   2. Local P&T Committees will develop procedures to cover the following functions:
      1. Review and/or revise local SU formulary at a minimum of annually to account for changes to the NCF;
      2. Review and/or revise emergency medications and other medications stocked in patient care areas at a minimum of annually;
      3. Develop and approve written medication substitution protocols to be used in the event of a medication shortage or outage;
      4. Review adverse drug reactions; and
      5. Review and analyze medication errors and pharmacy interventions.
3. Formulary.  
   1. IHS pharmacies.   Are required to adhere to the IHS NCF.
   2. Non-Formulary Medications.   Every effort must be made to use NCF- and SU-approved formulary drugs. A Non-Formulary Medication Request will be utilized to request consideration for the procurement of a drug that has not been approved by the SU P&T Committee. Pharmacies must have expedited processes for providing access to non-formulary drugs when the formulary drug is contraindicated secondary to ineffectiveness or adverse effect.
   3. Utilization of non-IHS pharmacies.   In certain instances, the IHS may contract with private sector pharmacies to fill prescriptions written by authorized IHS prescribers.
      
      When appropriate, arrangements can be made for emergency prescription services through a community pharmacy or non-IHS program. These arrangements are to be made on a selective, individual patient basis, after careful determination of the type and recurring nature of the prescription.
   4. Criteria for Drug Use.   The formulary may include drugs which are restricted by Federal law or policy for specific uses. It is the responsibility of the P&T Committee to identify these drugs and to provide objective criteria for their use.
   5. Generic Substitution.   The pharmacy may dispense therapeutically equivalent generic drugs on prescriptions written by IHS providers and non-IHS providers unless dispensed as written is specified. However, if the specific trade name product is not stocked in the facility, the prescriber will be contacted.
   6. Sample Medications.   The use of drug samples within IHS facilities is prohibited.
   7. Medical Pharmaceutical Service Representatives (MPSR).   Written policies and procedures governing the activities of MPSR within the institution will be developed by the facility's pharmacy department. All MPSRs must be provided with a copy of these rules, and their activities within the facility are to be strictly monitored by the pharmacy department.

3-7.4   STAFFING REQUIREMENTS

1. Staffing Standards.  
   1. Pharmacy staffing will be maintained at levels necessary to carry out basic IHS pharmacy services, additional workload entailed with the implementation of any expanded primary care and specialty pharmacist services (programs involving prescriptive authority).
   2. The total number of positions required to manage and deliver pharmaceutical care is determined by the IHS Resource Requirements Methodology (RRM).
   3. The RRM pharmacy staffing module estimates the requirements for pharmacists and pharmacy technicians to deliver appropriate pharmaceutical care.
   4. The SU Chief Pharmacist or designee at IHS facilities will calculate the RRM and report to the APC and facility leadership:
      1. On an annual basis;
      2. When new primary care providers are added to facility staffing, or
      3. When expansion of new or existing services are proposed.
   5. All pharmacy positions, both professional and non-professional, must be assigned to and under the general supervision of the Chief Pharmacist. This individual must be a licensed pharmacist. In the Chief's absence, another licensed pharmacist will be designated as Acting Chief Pharmacist, as appropriate.
   6. Primary care pharmacist services will not be implemented at the expense of patient consultation, drug information, drug utilization, and quality improvement.

3-7.5   MEDICATION PROCUREMENT

1. Pharmaceutical Prime Vendor.   The primary supply source for the purchase of medications is the Department of Veterans Affairs’ (VA) pharmaceutical prime vendor program with the IHS National Supply Service Center (NSSC) serving as the Ombudsman. Alternative drug procurement sources shall include Gallup Regional Supply Service Center and the NSSC (Federal Supply Schedules managed by the VA). The final source would be open market purchase from the pharmaceutical prime vendor or other trading partners, including from individual vendors/wholesalers. The IHS pharmacies will only procure open market medications from entities that are authorized trading partners, as defined by the FDA Drug Supply Chain Security Act (DSCSA).
2. FDA-Approved Medications.   Only medications that are FDA-approved as safe and effective may be procured. The IHS funds, including grant and contract funds, will not be used to procure drugs that are classified as ineffective by the FDA.
3. Drug Supply Chain Security Act.   All pharmacies will have a local policy that complies with the requirements of the DSCSA.
4. Ordering Controlled Substances.  
   1. Personnel authorized to order controlled substances must be designated in writing in the SU pharmacy policies and procedures.
   2. Online electronic ordering of controlled substances will be used in accordance with DEA Regulation.
   3. The primary method for ordering Schedule II drugs will be via the DEA Controlled Substance Ordering System (CSOS). In instances when CSOS is not available, facilities may temporarily revert to using the paper DEA 222 form (see Manual Exhibit 3-7-A).
   4. Unless otherwise registered with the DEA, personnel authorized to order Schedule II controlled substances must be designated in writing, via completion of a DEA Power of Attorney form, kept on file in the pharmacy, and a copy provided to the CEO of the facility.
   5. Electronic records must be readily retrievable and organized by date order was received.
   6. When available, pharmacies will stock all controlled substances in 100-count bottles, or smaller, to simplify the counts, and prevent large thefts.
5. Receiving Controlled Substances.  
   1. Personnel authorized to receive controlled substances must be designated in writing in the SU pharmacy policies and procedures.
   2. Receiving controlled substances will not be performed by the same individual who placed the order for those controlled substances. An exception would be when there is only one pharmacy staff at the facility. In this situation, the pharmacy staff member would receive the medication stock with another facility employee. Both individuals would sign and date the invoice, documenting the receipt of the medication stock.
   3. All orders for controlled substances must be delivered directly to the pharmacy in unopened shipping containers or boxes.
   4. Two facility employees (one being a pharmacist) must acknowledge and sign for receipt of the order on the appropriate forms. The receiving pharmacist will finalize the receipt of all controlled substances, CII – CV, in the pharmaceutical prime vendor ordering system and ensure that they are documented correctly in the perpetual inventory.
   5. Order discrepancies must be reconciled before controlled substances are accepted into the pharmacy inventory.
6. Records Maintenance.  
   1. All records pertaining to the acquisition, receipt, and distribution of medications and controlled substances will be maintained, filed, or stored electronically according to IHS records management policy.
   2. All medication stock invoices will be maintained for no less than three years.
   3. An ongoing and retrievable record must be maintained on the receipt of all Schedule II-V drugs. Schedule II invoices must be maintained separately from Schedule III-V invoices. Invoices must be maintained for a period of three years.
   4. All DEA 222 Forms, both executed and unexecuted, will be maintained for a period of three years. Alternatively, these forms may be maintained electronically, as long as they are stored in a secure system with appropriate data storage backup.
   5. The records of all medication inventories and disposals will be kept a minimum of three years.
   6. Records involving losses of controlled and non-controlled substances must be maintained on site for three years.

3-7.6   INVENTORY MANAGEMENT

1. Required Inventories.  
   1. Perpetual Inventory. A perpetual inventory will be maintained on all Schedule II-V drugs. The Perpetual Inventory of Controlled Substances Form (see Manual Exhibit 3-7-B) may be used. In lieu of this form, perpetual inventories of controlled drug substances may be maintained by automated dispensing cabinet software with hard copies maintained as a back-up e.g., transaction by drug and strength, quantity, date, patient, cabinet user, prescriber, controlled substance schedule, etc.
   2. Monthly Inventory. An inventory of Schedule II – V drugs will be completed monthly using the Monthly Report for Narcotics and Other Controlled Substances (MRNOCS) (see Manual Exhibit 3-7-C) Pharmacy form or equivalent. This report will be stored electronically for review by the Pharmacy Policy Alignment Committee, the APC and the PPC. The report will be sent to the facility CEO with a copy to the Area CMO and Area Director (if required).
   3. Biennial Inventory. An inventory of all controlled substances located within the pharmacy will be done every two years. This biennial inventory may be taken on any date which is within two years of the previous inventory date. The inventory of Schedule II substances is to be maintained separately from all other records. The biennial inventory must include whether the inventory was taken at the beginning or close of business.
   4. Annual Inventory. An inventory of all pharmaceuticals (controlled and non-controlled) will be conducted at a minimum of annually. Non-controlled medications may be counted using the “halves” method. An opened bottle or container may be counted as ½ bottle or ½ container.
      
      The annual inventory may be completed either with a vendor or in-house using the Pharmaceutical Prime Vendor’s software program.
   5. Enhanced Surveillance Inventory.
      1. All pharmacies must conduct Enhanced Surveillance Inventory (ESI). The SU pharmacies will review at minimum five medications (one strength of each medication) from the ESI list on a monthly basis.
      2. Medications selected for ESI are updated and maintained by the IHS National Pharmacy Council (NPC) Inventory Management Subcommittee annually. Medications selected are based upon the medication’s high cost or high potential for diversion.
      3. The ESI drugs list and policy are available on the NPC Inventory Management webpage.
2. Medication Storage.  
   1. Proper Medication Storage. The following will apply for all medication storage locations:
      1. Medications for external use and disinfectants will be stored separately from internal and injectable medications.
      2. Bulk stocks of flammable products must be stored in a flammable storage cabinet that meets or exceeds guidelines from the Occupational Safety and Health Administration. Properly labeled individual containers may be maintained within the work area as needed for immediate use.
      3. All drugs will be stored at appropriate temperatures and under appropriate conditions in accordance with requirements, if any, in the labeling of such drugs, or with requirements in the current edition of the United States Pharmacopeia/National Formulary.
      4. Appropriate manual, electromechanical, or electronic temperature recording equipment, devices, and/or logs will be utilized to document proper storage of medications.
      5. All medication storage locations will be inspected monthly by pharmacy staff to ensure proper quality control practices and to remove expired drugs.
   2. Medication Storage Outside of Pharmacy (Secure Storage Outside of Pharmacy).
      1. Medications stored outside of the pharmacy will be stored in a separate secure medication storage cabinet, closet, or automated dispensing cabinet (ADC). Such cabinets or closets are to be kept secured at all times except when authorized personnel are preparing medications or are in constant attendance.
      2. Mobile nursing carts, anesthesia carts, epidural carts, and other medication carts containing Schedule II-V medications must be locked within a secure area.
      3. Perpetual Inventory records will be maintained on all controlled substances stored outside of the pharmacy.
      4. Whenever controlled substance medications are stored outside of the pharmacy department, if an ADC is utilized, an audit of all accessed controlled substance pockets must be conducted at each shift change of custody. If there is no ADC, a manual audit must be performed on all controlled substances at each shift change of custody. The Consolidated Eight Hour Controlled Substance Audit form (see Manual Exhibit 3-7-D), or equivalent, will be used when performing manual audits.
      5. An ADC can produce controlled substance reports on demand, when needed. The ADC transaction reports which include the date, patient, employee name, drug and quantity will be stored electronically; or printed and kept on file for a period of at least three years.
      6. A discrepancy report will be reviewed at least weekly to identify unresolved discrepancies and identify trends.
      7. A pharmacist will audit these activities at least on a monthly basis.
3. Disposal of Medication.  
   1. Disposal of Returned or Expired Medications.
      1. Inventory shall be checked on a monthly basis for expired medications.
      2. Expired non-controlled medications will be removed and maintained separately from active inventory and labeled “Expired Drugs: Do not use.” Return of expired medications may be disposed of per facility policy or through a registered Reverse Distributor.
      3. Expired controlled substances will be isolated from active inventory and labeled "Expired Drugs: Do not use" and kept in a locked medication storage cabinet, safe, or drawer. These items will be deducted from the perpetual inventory and a separate perpetual inventory will be maintained on these expired items.
      4. Expired controlled drug stocks will be inventoried monthly and reported with monthly controlled substance inventory.
      5. Return of expired controlled substance medications will be arranged with a registered DEA Reverse Distributor for pickup and removal. The registered DEA Reverse Distributor will furnish a completed DEA form 222 to the pharmacy when accepting expired medications in compliance with DEA regulations.
   2. Disposal of Unused Patient Medications. All IHS Federal pharmacies will provide assistance with the disposal of unused patient medications. Provided assistance will be compliant with applicable Federal regulations. Assistance provided may include:
      1. Assisting with healthcare facility hazardous waste segregation, storage, and disposal specifically in compliance with the Resource Conservation and Recovery Act;
      2. Educational materials on the self-disposal of medications based on Federal guidelines. For example, the FDA guidance on the disposal of unused medicines;
      3. Information on local drug take-back programs;
      4. Pharmacies may accept all non-controlled drugs for disposal through hazardous waste program or pharmaceutical reverse distributor program; and
      5. The IHS hospitals and clinics with an onsite pharmacy may wish to register with the DEA as a controlled substance collector site, in compliance with DEA regulations.
         1. The IHS pharmacies may not collect unused controlled substance prescriptions from patients unless the pharmacy is registered with the DEA as a collector site and a DEA approved method of collection is in place.
         2. The IHS facilities may not host or participate in any take back day unless the event is in cooperation with law enforcement officers as required by the DEA.
4. Loss or Theft of Controlled and Non-Controlled Medications.  
   1. Procedure in Case of Suspicious Loss or Theft of Controlled Substances. Any suspected theft, diversion, or suspicious loss of controlled substances must be immediately reported to the Chief Pharmacist, CEO, and APC. The Chief Pharmacist and APC will review and implement a corrective action plan necessary to prevent reoccurrence.
      1. A written report must be made within one day to the APC, CEO, and the DEA Field Division Office in the area.
      2. The DEA Form 106, Report of Theft or Loss of Controlled Substances, must be completed in accordance with Title 21 Code of Federal Regulations Section 1301.76(b).
      3. The CEO will forward information to the Area CMO and Area Director.
      4. The CEO or designee must, in turn, notify concurrently the HHS Office of Inspector General (OIG) and the HHS Office of General Counsel (OGC).
      5. The appropriate controlled substances record must be reconciled and a brief explanation of the circumstances, including submission of any DEA Form 106, entered onto the MRNOCS or equivalent form (see Manual Exhibit 3-7-C).
      6. The use of a two-person (facilitator and witness) signature system for documentation must be strictly enforced on all adjustments or discrepancies. Balance adjustments must be done on paper and have two signatures, by individuals authorized in local policy, documenting the adjustment. Facilities may make these adjustments with two electronic signatures in their inventory management software.
      7. All balance adjustments must be reviewed by the Chief Pharmacist, Clinical Director, or designee, and reported to the CEO and APC as part of the monthly inspection process.
      8. Records of balance adjustments must be readily retrievable, on paper or electronically, for a minimum of three years.
   2. Procedure for accidental loss, breakage, or destruction of insignificant quantities of Schedule II through V controlled substances.
      1. At the earliest opportunity, entries and explanations must be signed by the person responsible for the loss or breakage and must be called to the attention of the immediate supervisor.
      2. If the explanation is not considered satisfactory by the immediate supervisor, the incident must be reported to the Chief Pharmacist, CEO, and APC for further investigation.
      3. The appropriate controlled substances record must be balanced, and a brief explanation of the circumstances entered onto the MRNOCS or equivalent form (see Manual Exhibit 3-7-C).
      4. The use of a two-person (facilitator and witness) signature system for documentation must be strictly enforced on all adjustments or discrepancies. Balance adjustments must be done on paper and have two signatures, by individuals authorized in local policy, documenting the adjustment.
         
         NOTE: Facilities may make these adjustments with two electronic signatures in their inventory management software.
   3. Procedure in Case of Loss of Non-Controlled Substances
      1. Any suspected theft, diversion, or suspicious loss of non-controlled substances must be immediately reported to the Chief Pharmacist, CEO, and APC for investigation and to implement the action needed to prevent reoccurrence.
      2. The CEO will forward the information to the Area CMO and Area Director.
      3. The CEO or designee must, in turn, notify concurrently HHS OIG and HHS OGC.
5. Transfer of Custody for Controlled Substances.  
   1. When there is a transition in the Chief Pharmacist position, a controlled substance inventory must be taken with the outgoing and incoming Chief Pharmacist.
      1. If the incoming Chief is not yet present, an Acting Chief will be designated to avoid a gap in custody.
      2. A joint inventory must be completed before the transfer is effected.
      3. A memorandum is used to document the transfer from the outgoing pharmacist to the incoming pharmacist. The memorandum will include the inventory date and attestation that the inventory is correct.
   2. Unless otherwise registered with the DEA, the personnel authorized to order Schedule II controlled substances must be designated in writing, via completion of a DEA Power of Attorney form, kept on file in the pharmacy, and a copy provided to the CEO of the facility. See DEA Power of Attorney form.

3-7.7   PHARMACY SECURITY

1. Controlled Substances.   All controlled substances must be physically secured and under the control of pharmacy services.
2. Controlled Substance Stock.   Controlled substance stock will not be dispersed with general pharmacy inventory.
3. Schedule II - V Drugs.   Schedule II - V Drugs must be secured in strongly constructed metal cabinet(s) or safe(s) as per DEA regulations.
4. Schedule II - V Drugs.   Schedule II - V Drugs may be securely stored in automated systems (ex. BD - Pyxis C2 Safe, Omnicell Controlled Substance Manager or similar products/systems). The automated system shall be locked at all times when not in use for dispensing or restocking. It shall be located in a manner that a pharmacist can easily observe when the controlled substances cells are being accessed.
5. Access to Controlled Substances.   Access to controlled substances within the pharmacy is controlled and limited.
   1. The Chief Pharmacist will maintain a list of pharmacy staff with access to controlled substances and this list will be readily retrievable.
   2. Local policy and procedures must ensure that there is a controlled, limited number of pharmacy employees that have access to stocks of scheduled drugs, including the safe, working stock, and automated dispensing systems.
   3. Access will be limited to pharmacists. Technicians may have access if the controlled substances are stored in an automated system that monitors access and maintains an automated perpetual log of medications (ex. BD - Pyxis C2 Safe, Omnicell Controlled Substance Manager or similar products/systems).
   4. All controlled substance prescriptions ready for pick-up must be kept in a securely locked storage area to decrease the risk of diversion by staff. Access will be limited to pharmacists. Technicians may have access if stored in a secure will call system that requires individualized access and automatically tracks the addition and removal of medications to the system (ex. GSL Intellicab Will-Call System or equivalent).
   5. Closed Circuit Television Cameras.
      1. Closed-circuit television (CCTV) cameras will be installed inside the pharmacy and at remote medication storage areas to document and prevent diversion of scheduled controlled substances.
      2. The recorded footage must be securely stored with restricted access.
      3. Signage clearly indicating the use of CCTV shall be visible within the pharmacy area, with the goal of putting patients and guests on notice that they may be recorded
      4. Cameras will provide adequate coverage of the following areas:
         1. Medication filling/handling location(s)
         2. Pharmacy Counseling room(s)
         3. Controlled substance safe(s)
         4. Pharmacy patient reception
         5. Automated dispensing unit(s)/robot(s)
         6. Prescription shelving/storage
         7. Pharmacy entrance(s)/exit(s)
      5. Cameras must:
         1. Be protected against tampering/disabling;
         2. Have a video quality of high resolution, with motion activation to trigger recording; and
         3. Have a personal identity masking capability.
      6. Video Storage:
         1. Video footage must be transmitted and secured in accordance with applicable Federal authorities, including but not limited to the Health Insurance Portability and Accountability Act (HIPAA) Security Rule, at 45 CFR Part 160, 45 CFR Part 164 Subparts A and C, and 45 CFR 164.312.
         2. Video Storage must be capable of securely saving up to 45 days of security footage for each camera, and easily upgradeable to accommodate future expansion, increased storage capacity, or increased security measures as needed.
         3. Local policy must establish a request and approval process for viewing of and access to pharmacy video and storage. The hierarchy of approval must include individuals from outside of the pharmacy department to ensure proper separation of duties.
   6. After Hours Pharmacy Access to Medications. a. A secured emergency medication storage cabinet or ADC must be used to store medications that are approved by the local P&T Committee for after-hours use. A system of recording, review and reconciliation of all after-hours access by pharmacy is required. b. Only appropriate providers, within scope of practice, may access the ADCs. Access to the pharmacy after hours is limited to pharmacists. c. A local policy must be in place to accept medication deliveries outside of pharmacy hours to include identification of individuals authorized to sign for the delivery, and designation of a secure storage location.
   7. Electronic Access Control.
      1. Any door leading into the pharmacy, or other medication storage areas, will have security-enhanced or Cipher-type locks in order to prevent unauthorized access into the pharmacy.
         1. Examples of security-enhanced locks include electronic access control using a Personal Identity Verification (PIV) Card or Biometrics i.e., fingerprint or retina scan.
         2. Cipher-type locks may only be used if they have individual access codes; group codes shall not be used.
            Both security-enhanced and Cipher-type door locks must provide a centralized, readily retrievable history of entrance into the pharmacy.
         3. Only pharmacists may have physical keys that can override security-enhanced or Cipher-type locks. Physical key use will be restricted to times when security-enhanced or Cipher-type locks are not functioning e.g., power outage. A log of key issuance and return, with signatures, shall be maintained.
      2. The combination of the Cipher lock must be changed every 90-days and as soon as possible after an employee leaves the employment of the IHS facility.
   8. All visitors and non-pharmacy personnel entering the pharmacy must be escorted by the pharmacy personnel at all times and sign a log book recording, at a minimum, the following information: printed name, signature, reason for entry, time of entry, and time of exit.
   9. An alarm system with motion detectors and an auto-dialer must be installed to alert local security or law enforcement to unauthorized after-hours access to the pharmacy.
      1. Alarm system(s) will be tested and documented at least quarterly.
      2. Alarm system(s) must have at least a 24-hour battery or other standby power source(s) in the event of commercial power failure.
   10. Automated Dispensing Robots and Cabinets.
       1. All automated dispensing robots and cabinets in the facility must possess biometric authentication to identify the end user, if available.
       2. When biometric authentication is not available, user passwords may be used and must be changed every 90-days in compliance with government standards for password security.
6. Pharmacy Windows.   Pharmacy windows located on the exterior of the facility will have bars or bullet-resistant glass, which is sufficient to deter/prevent forcible entry into the pharmacy. Windows on the exterior of the pharmacy, but interior of the facility, will have barriers sufficient to prevent unauthorized access to the pharmacy. Barriers may include bars, bullet-resistant glass, or security shutters. If security shutters are used, pharmacy personnel must be physically present at all times while the shutters are open.

3-7.8   PHARMACY SERVICES

1. Patient Care Activities.  
   
   The role of each clinical pharmacist may differ and must be delineated in their clinical privileges, as appropriate.
   
   The pharmacy service will provide counseling to each patient receiving new medication and/or medication therapy changes. If the patient refuses medication counseling for these prescriptions, the pharmacy staff must document the refusal per local procedure. The goal of medication counseling will be to optimize patient and/or caregiver understanding of the therapy and improve clinical outcomes.
2. Roles for Pharmacy Technicians.  
   
   Under the supervision of a clinical pharmacist, the pharmacy technician may serve the pharmacy team in the following activities including, but not limited to:
   1. Obtaining medication histories to assist with medication reconciliation;
   2. Patient education related to IHS formulary status of medications;
   3. Documenting medication adherence;
   4. Documenting patient allergies and adverse drug reactions;
   5. Patient education on navigating the IHS pharmacy (including patient management of refills and renewals, important telephone numbers for pharmacy issues, etc.); and
   6. Distribution of medication refills to patients.
      
      If the patient requests counseling on a medication refill, the prescription must be referred to a pharmacist to provide the counseling.
3. Pharmacy-Managed Clinics.  
   1. Clear and standardized processes for referral of patients to pharmacy-managed clinics must be established at the IHS SU. The method of referral may differ based on the role of the clinical pharmacist within the specific practice area. The referral method may include, but is not limited to, standardized templates e.g., formal chart consults, referral of patients from providers or team members through clinical chart consults. The referral method ensures that the appropriate patient is referred to the pharmacy for management.
   2. Infrastructure must exist for a clinical pharmacist to refer patients to higher levels of care, when appropriate. Policy must outline types of appropriate referrals that can be made by the clinical pharmacist and the process that such referrals are to be carried out. Some examples include, but are not limited to, referrals for routine care or assessment to clinical nutrition professionals, social workers, integrated mental health professionals, or other specialty areas. The clinical pharmacist must communicate with the collaborating provider(s), or referring provider as appropriate, in cases when patient assessment requires a referral to higher levels of care.
4. Automated Pharmacy Systems.  
   1. Automated pharmacy systems should be used to improve safety, efficiency, and accuracy.
   2. The Chief Pharmacist, or designee, must:
      1. Establish local SU policy and procedures to assess workflow, establish training programs, and standardize the use of the equipment to include minimum competency requirements for all personnel who have access to and operate the equipment. The use of automated pharmacy systems requires written policy and procedures to be in place prior to their installation to ensure safety, accuracy, security, and patient confidentiality. This policy must define access limits to the equipment and medications.
      2. Develop a plan for ensuring the safe and efficacious use of the system(s) with a focus on patient safety. The plan needs to identify the minimum standards for routine assessment through an established monitoring and quality assurance program. The plan needs to address high-risk and hazardous drugs, look-alike sound-alike medications, and any potential for medication errors or controlled substance discrepancies. The plan must address the removal, security, re-stock of pharmacy inventory, and accountability of medications when a system is removed from a patient care area.
      3. Establish a contingency plan in the event of a power, system or process failure; including who is to be notified and how the system’s medications are to be secured and processed.
         
         NOTE: It is recommended that a routine be established to determine: if a system failure is imminent, how to identify when a system failure occurs, how to compensate in order to protect patient safety when failures occur, and how failures are to be corrected expeditiously.
      4. Ensure that patient confidentiality is maintained in accordance with applicable privacy authorities, including the Privacy Act; the HIPAA Safeguards consistent with these authorities must be established to prevent unauthorized access to patient data.
      5. Assign all activities associated with equipment assessment, routine maintenance, and oversight to appropriately trained pharmacy technicians when possible. Job-specific competencies related to the care and operation of the automated pharmacy system(s) must be part of the pharmacy technician’s performance plan and review.
5. Drug Information Services.   It is the responsibility of the SU Chief Pharmacist to ensure that the facility's health care providers have access to current drug information.
   1. Drug information and education will include:
      1. Pharmacist-initiated, patient-specific interventions with appropriate documentation;
      2. Drug therapy consultation on request from other professional staff; and
      3. In-service education to other professionals and healthcare workers.
   2. Drug information services will incorporate, but are not limited to:
      1. Providing drug therapy bulletins;
      2. Participating in patient clinical rounds;
      3. Providing drug information handouts to patients; and
      4. Presenting drug information to community health representatives and health aids.
   3. The pharmacy library will have access to readily retrievable reference material to include:
      1. Pharmaceutical compendia;
      2. Current references covering the practice of pharmacy, including chemistry, toxicology, pharmacology, therapeutics, bacteriology, sterilization and disinfection, compatibility, and drug interactions;
      3. Authoritative, current antidote information; and
      4. Current Federal and applicable State laws governing the practice of pharmacy.
6. Medication/Drug Recalls.  
   1. There will be a written drug recall procedure at all facilities. A file of drug recall reports, notices, and actions taken will be kept in the pharmacy.
   2. Recalls will be acted on in accordance with FDA regulations. Drug recalls fall into three different categories under the FDA’s regulation:
      1. Class I recalls are for dangerous or defective products that predictably could cause serious health problems or death.
      2. Class II recalls are for products that might cause a temporary health problem or pose only a slight threat of a serious nature.
      3. Class III recalls are for products that are unlikely to cause any adverse health reaction, but that violate FDA labeling or manufacturing regulations.
7. Participation in State Prescription Drug Monitoring Programs.  
   
   All IHS pharmacies must query and report to State Prescription Drug Monitoring Programs as outlined in Part 3, Chapter 32, “State Prescription Drug Monitoring Programs,” of the Indian Health Manual.

3-7.9   MEDICATION ORDERING/PRESCRIBING

1. General Requirements.  
   1. Within IHS facilities, prescriptions shall be written by members of the facility medical staff acting within the scope of their privileges, or by non-physician providers practicing in the facility under approved clinical protocols or agreements. All prescriptions will be documented in the patient's Electronic Health Record (EHR).
   2. The IHS SU policy must specify the required elements of any of the following types of inpatient orders that are deemed acceptable for use: as needed, or pro re nata (PRN) orders; standing orders; hold orders; automatic stop orders; resume orders; titrating orders; taper orders; range orders; and compounded medication orders.
   3. The generic drug name is the preferred nomenclature for medication prescribing and labeling. Providers are encouraged to use the generic name, whenever possible, during the prescribing process.
   4. Each IHS SU must define, in local policy, the requirements for indication-for-use on the medication order.
   5. Look-alike or sound-alike drug names require special precautions and therefore, IHS SU policy must communicate procedures for ordering, storing, prescribing, and administering these medications.
   6. Pharmacists are to take appropriate actions, as established by IHS SU policy, for medication orders that are incomplete, illegible, or unclear.
   7. A listing of non-approved abbreviations to be avoided during the act of prescribing must be established in local SU policy and reviewed by the P&T Committee.
   8. 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, documentation must include an allergy assessment. Medications are only to be dispensed if an allergy assessment has been completed.
      
      NOTE: In emergent situations, when no allergy assessment can be made, the patient’s provider can exercise authority to override this practice on an order-by-order basis.
   9. When the EHR is not available, a facility-approved contingency plan for implementation must exist in local SU policy in the event of a computer system failure.
   10. Verbal or telephone medication orders are discouraged, but may be accepted in an emergency, when urgency is a factor and it clearly is in the best interest of the patient. The clinical pharmacist or nurse receiving the verbal or telephone order must immediately commit it to writing and read it back to the provider to verify the accuracy in accordance with SU policy.
       
       NOTE: The verbal order must then be recorded electronically in the patient’s file.
   11. Locally established “Telehealth Service Agreements” must identify, in SU policy, the procedure for contacting the telehealth provider when medication order clarification is required.
2. Controlled Substance Prescribing.  
   1. Authorized Prescribers - Controlled substances may only be prescribed by a physician, dentist, podiatrist, or other provider eligible for DEA registration who is:
      1. Authorized to prescribe controlled substances by applicable rules and regulations;
      2. Registered under the Controlled Substances Act or exempted from registration, e.g., certain military and Public Health Service practitioners in accordance with 21 C.F.R. § 1301.23; and
      3. Prescribing controlled substances only within the scope of his or her official duties.
   2. Any provider employed by the facility that will be prescribing controlled substances must register with the DEA and obtain an individual registration number.
3. Prescribers without an Individual DEA Registration.  
   
   Providers pending applications to the DEA, but otherwise meeting the requirements of 3-7.9(B) above, who are credentialed to prescribe controlled substances may prescribe under the facility’s DEA number followed by a hyphen and a unique identifier for the prescriber, pursuant to 21 CFR § 1301.22.
   
   Provider-specific identifiers will be maintained in an area designated by the facility and will be readily retrievable. Provider-specific identifiers can only be used within the confines of the SU and are not permitted for prescribing of controlled substances outside of the SU.
4. Contract Prescribers Not Licensed in the State Where Delivering Services.  
   
   Contract Providers must maintain a DEA Registration in at least one state. In accordance with DEA-approved protocols, a facility DEA number may be assigned followed by a hyphen and a unique identifier for the prescriber, including locum tenens practitioners. This provider-specific identifier will be maintained in an area designated by the facility and will be readily retrievable. This provider-specific identifier can only be used within the confines of the SU and is not permitted for prescribing of controlled substances outside of the SU.
5. Issuing Controlled Substance Prescriptions.  
   
   Prescriptions for controlled substances (Schedule II – V) from within the IHS facility will be issued in accordance with Federal law including DEA regulations. Sites should maximize the use of Electronic Prescription of Controlled Substances (EPCS) and only use the print function in the event the EPCS function is not available for a prolonged period of time.
6. Clinical Protocols.  
   
   For non-physician providers, all prescribing must be under approved clinical protocols, agreements, or within the scope of their practice. The pharmacy department will maintain readily retrievable access to all clinical protocols and agreements, which have been reviewed and approved by the Clinical Director.
7. Required Prescription Content.  
   
   A prescription must include the name of the patient, date, generic or trade name of the medication, strength of the medication, quantity or the duration of therapy, adequate directions for use, and the prescriber's electronic signature. If the signature is written, it must be accompanied by the prescriber’s printed or stamped name. The metric system is to be used for weights and measures.
8. Refill Orders.  
   
   The prescriber may authorize refills at the time of generation of an original prescription.
   
   NOTE: Medical provider’s orders referencing previous orders by date or other abbreviated forms will not be used, e.g., "refill drugs ordered 1/2/2005.”
9. Non-IHS Prescribers.  
   1. Pharmacy services will be made available to eligible American Indian/ Alaska Native beneficiaries whether an IHS practitioner or a purchased/referred care (PRC) provider writes the prescriptions.
   2. If a drug prescribed by an IHS PRC provider is not on the formulary at the IHS facility, the pharmacist will consult with the prescriber and recommend alternative drug therapy that is available. Upon prescriber approval, the recommended alternative drug will be dispensed.
   3. When medications or other pharmacy services are provided pursuant to PRC providers’ or nursing home patient private providers’ orders, the pharmacist must enter the complete prescription information into the patient's health record at the IHS facility.
   4. Facilities may develop additional policies and procedures for handling prescriptions received from PRC prescribers and other non-IHS prescribers consistent with this section.
   5. Local Policy will determine how facilities handle non-IHS prescriptions.
   6. IHS facilities may not accept outside controlled substance prescriptions utilizing a facility DEA number. Facilities have two options when receiving a prescription using a facility DEA number with a unique identifier:
      1. Contact the facility where the prescription originated to obtain the applicable DEA registration number that IHS can document, (this may require a new prescription) or
      2. Have a local provider review the prescription and rewrite if appropriate.
10. Issuing Outside Prescriptions.  
    1. All outside prescriptions issued by IHS prescribers, to fill at non-IHS pharmacies, will be issued electronically via Outside Pharmacy – eRx to a non-IHS pharmacy or via the Outside Pharmacy – print option to provide a hard copy for the patient to physically take to an outside pharmacy or for a prescriber to fax to an outside pharmacy.
       1. Outside print must use tamper-evident process or technology. Tamper-evident paper is tracked (inventoried) and stored securely in the pharmacy prior to issuance to the prescriber. After issuance, the prescriber is responsible for ensuring that prescription paper is properly secured to prevent unauthorized access and diversion.
       2. The pharmacy will no longer stock and/or issue prescription paper/pads.
11. Appropriateness of Medication Therapy.  
    1. A pharmacist must review the IHS health record of each patient prior to the dispensing of medications. This review will occur for all prescriptions, including outside prescriptions. The standards of care developed or adopted by the professional staff of the facility and relevant literature are the criteria for determining the appropriateness of drug therapy. Any concerns or questions identified by the review will be resolved with the prescriber prior to the dispensing or administration of any medication. As a patient safety measure, IHS pharmacies will not process prescriptions to be dispensed to a patient or designated proxy, that are written by IHS providers, prior to the completion of the visit note in the EHR.
    2. After initiation of drug therapy, a pharmacist will monitor ongoing or intermittent therapy to evaluate effectiveness and to prevent or detect adverse outcomes. This is performed daily for hospitalized patients, at each pharmacy visit for ambulatory patients, or as part of an outpatient care team. Concerns or questions resulting from this process will be resolved with the prescriber as soon as possible.
    3. The following items will be checked when screening health records and monitoring patients for appropriateness of drug therapy:
       1. Correct patient;
       2. Legality and completeness of medication orders;
       3. Current and complete visit note and pertinent historic encounters;
       4. Medication-related adverse events;
       5. Appropriateness of medication therapy for the stated indication;
       6. Appropriateness of the medication, dose, frequency, route and method of administration:
       7. Therapeutic duplications:
       8. Real or potential drug interactions;
       9. Medical condition interactions;
       10. Gender or age conflicts;
       11. Compliance with local patient agreements e.g., chronic opioid therapy agreements;
       12. Compliance with SU and IHS policies (e.g. P&T policies); and
       13. Excessive duration, inappropriate use or overuse of certain medications, and/or early refill.
    4. Pharmacists will document all appropriate record reviews, monitoring activities, interventions, consultations, and recommendations in the patient's health record. All interventions will be entered into the facility’s quality assurance performance improvement tracking program.

3-7.10   PREPARING AND DISPENSING MEDICATION

1. Prepackaging.   Pharmacies may furnish pre-labeled, prepackaged drugs to small field clinics that do not have pharmacies.
   1. Labels must be computer generated.
   2. The prepackaged drugs must be in appropriate stock containers having required labeling and available in the sizes and units most commonly prescribed.
   3. Original stock containers of legend drugs as supplied by the manufacturer (excluding unit-of-use packages) will not be supplied to field clinics or facilities not having a pharmacist on duty.
   4. Drugs may not be transferred from one container to another; counted; poured; packaged; or labeled at field facilities that do not have either a pharmacist or a licensed independent practitioner, performing within his or her scope of practice, on duty.
   5. The computer generated pre-pack log can be digitally archived or must be printed out at least monthly if digital archiving is not available. When the computer pre-pack program is not available, necessary controls will be maintained manually on a Pharmacy Chronological Control Log.
   6. The Pharmacy Chronological Control Log is the basic control number record for bulk compounded and prepackaged items
   .
   7. Drugs may be transferred from one stock container to another, counted, packaged, and labeled only by a pharmacist or licensed independent practitioner or under the direct supervision of a pharmacist or licensed independent practitioner. Non-professional employees will not prepackage drugs, except when under the direct supervision of a pharmacist.
   8. A uniform system for designating the control number will be used. Each pharmacy will use the following system, which consists of seven numbers. The first two numbers represent the month, the second two numbers represent the year, and the last three numbers represent the order in which the drugs are listed on the form; e.g., 0792007 would be the seventh product bulk compounded or prepackaged in July 1992; 1192117 would be the 117th product bulk compounded or prepackaged in November 1992.
2. Containers/Labeling.  
   1. Containers. All pharmaceutical containers must be tight and, where required by the USP, light and moisture resistant. "Child-proof" containers will be used for outpatient and discharge medications, unless a patient requests non child-proof caps, which shall be documented in the electronic health record.
   2. Labeling.
      1. Each prescription must be assigned a unique prescription number when filled.
      2. Prescription labels must include the name, address, and telephone number of the facility, the date, the patient’s name and health record number, the prescription number, the generic name, strength and quantity of the drug, the directions for use, the name and title of the prescriber, the initials of the pharmacist, the phrase "Keep Out of Reach of Children," and other cautionary labels as appropriate.
      3. Prepack labeled items for use in the outpatient pharmacy will be labeled with the required cautionary warning strip labels and a pre-printed label containing the generic name, strength, lot number, pre-packaging control number, expiration date, and quantity of the medication. The expiration date is one year from the date of repackaging unless the expiration date on the stock bottle is less than 1 year. The label must be affixed to the container in such a manner as not to cover the label or directions on the container.
         
         NOTE: The same labeling criteria will apply for all IHS facilities whether or not a pharmacist is on staff.
3. Dispensing.   The pharmacist will fill the prescription from the health care record. If the medication order is on a separate prescription form, such as those written by non-IHS prescribers, the complete prescription information must be entered into the patient's health record before the medication is dispensed. Medications that the FDA indicates can be dispensed behind the counter from a pharmacy without a prescription or a provider visit must be dispensed according to DEA and/or FDA labeling and/or guidelines.
   1. Controlled Substances.
      1. Patients or designated proxies, are required to present valid photo identification (ID) to pick up controlled substances. Examples of valid ID include: Tribal ID, state driver’s license, state ID, passport or military ID.
      2. Two prescription processing logs will be maintained on controlled substances: one log for Schedule II items and a separate log for Schedules III-V items. These logs may be computer generated or may be maintained manually.
      3. An automated dispensing system may be used for counting controlled substances if the system is locked with only pharmacist access to cells or is located within a narcotic vault room.
   2. Non-pharmacist Medication Dispensing.
      1. In the absence of a pharmacist, medication may be provided directly to the patient by a licensed practitioner authorized to prescribe medication. Any medication provided will be limited to the amount necessary to meet immediate patient needs and must be within the practitioner`s authorized scope of duties. The medications must be available in pre-packaged containers in appropriate quantities and must be properly labeled in accordance with section 3-7.10B. Prior to dispensing, the prepack label must contain the ordering provider's name, patient health record number, patient name, and the date. A log of all items removed from the cabinet or medication automated storage cabinets will be maintained.
      2. The following safeguards must be applied:
         1. Access is limited to a pre-determined set of medications that has been approved by the facility. These medications can be stored in a night cabinet or automated storage cabinet.
         2. Only trained, designated prescribers and nurses are permitted access to medications.
         3. Quality control procedures (such as an independent second check by another individual or a secondary verification built into the system, such as bar coding) are in place to prevent medication retrieval errors.
         4. The facility arranges for a qualified pharmacist to be available either on-call or at another location (for example, at another organization that has 24-hour pharmacy service) to answer questions or provide medications beyond those accessible to non-pharmacy staff.
         5. This process is evaluated on an ongoing basis to audit the medications accessed routinely.
         6. Non-physician providers and registered nurses may not transfer medication or labels from one container to another. Non-physician providers may not count, package, or pour medications, except under the direct visual supervision of a prescriber.
         7. A non-pharmacist will not refill prescriptions for chronic conditions after pharmacy hours. If necessary, a small quantity of medication may be provided to meet immediate patient needs. However, the patient must be instructed to return to the outpatient pharmacy during pharmacy working hours for a complete refill.
   3. Mailing Prescriptions.
      1. Certain prescriptions may be mailed to patients. The facility’s policy will define patients eligible to receive prescription refill mail-out service, including restrictions on medications mailed.
      2. A pharmacy may elect to fill and mail from their local facility or use a central fill pharmacy.
      3. Schedule II controlled substances will not be mailed. Facilities can determine locally if Schedule III through V controlled substances will be mailed, taking into consideration clinical necessity and potential for diversion. Process will be detailed in the SU Controlled Substance policy and procedure.
      4. New or first-time prescriptions will be filled and dispensed locally.
   4. Returning Medications to Stock.
      1. All prescriptions that are not picked up by the patient or proxy will be returned to stock within 10 days in the pharmacy software program (i.e. Resource and Patient Management System) and all other pharmacy automation. The medication will not be returned to the original stock bottle.
      2. All controlled substances not picked up and returned to stock must be processed in pharmacy software program, checked into inventory and returned to stock all on the same day. The process of returning controlled substance prescriptions to physical stock must be completed by a pharmacist and witnessed by another pharmacist, pharmacy technician, or by another licensed healthcare professional.
4. Billing.   When billing for oral tablets, dispensed quantities and days’ supplies will match the actual quantity dispensed. Sites will not alter the days’ supply for cost avoidance or reimbursement purposes; for example, sites will not dispense a 90-days’ supply of medication and bill for a 30-days’ supply.

3-7.11   CLINICAL PHARMACY SERVICES

1. Primary Care Providers.  
   
   To the extent consistent with the scope of practice permitted by their state license, IHS pharmacists may serve as primary care or intermittent providers for selected patients whose principal form of therapy is medication. All primary care programs involving pharmacist prescriptive authority will require either an approved CPA and/or credentialing and privileging through the local medical staff in accordance with medical staff bylaws and within the scope of their licensure. See Section 3-7.11E below for more information regarding CPAs.
2. Basic Pharmacotherapy Assessment Skills.  
   
   Pharmacists must be able to demonstrate and perform basic pharmacotherapy assessments including, but not limited to, patient interview, chart review, ordering of laboratory tests, administering immunizations, laboratory test interpretation, and limited physical assessment, e.g., blood pressure, pulse, height, weight, finger stick glucose, patient observation, etc., and providing patient counseling and education.
3. General Refills.  
   
   Pharmacists may refill prescriptions without prescriber authorization for chronic medications (not to include controlled substances) in quantities sufficient to last until the next scheduled provider visit for patients who missed an appointment, lost medication, or received insufficient amounts, to last until the next appointment.
4. Clinical Pharmacy Privileges.  
   
   Clinical privileges are required for any position in which the clinical pharmacist has patient care activities and serves as a non-physician provider to initiate, modify, renew, or discontinue medication therapy. Clinical privileges are facility specific. Pharmacists shall only practice clinically within facilities where they have been granted privileges. Clinical pharmacists shall only practice within the specific clinical privileges granted.
   1. The clinical privileges allow the clinical pharmacist to function with a high level of autonomy in collaboration with the health care team for the overall care of the patient. Prescriptive authority will be limited to practice areas for which the clinical pharmacist has experience and expertise, to include:
      1. Addressing medication management needs of patients with defined diagnoses;
      2. Management of medication-related adverse events;
      3. Ongoing and acute medication monitoring; and
      4. Collaboration with other health care providers for management of new diagnoses for patients.
   2. The SU must have a policy that addresses all required elements of pharmacist clinical privileging including, but not limited to:
      1. A process for granting clinical privileges including the local credentialing and privileging process and/or initiating a collaborative practice agreement within the scope of individual licensure;
      2. Processes for renewal of clinical privileges;
      3. Professional practice evaluations (focused and ongoing);
      4. All required competency assessments, education, training, and experience requirements; and
      5. A renewal process for each clinical pharmacist at least every two years, but prior to the expiration of clinical privileges.
   3. Procedures for Initial Clinical Privileges. Initial clinical privileges are approved with a mandatory one-year provisional period. During this time, the pharmacists’ qualifications and clinical skills shall be assessed. All clinical pharmacists applying for clinical privileges must have appropriate competency assessment of the critical duties. The Medical Staff, Chief Pharmacist, and if appropriate, collaborating physician, will outline any mentorship and assessment requirements to be completed prior to granting the requested clinical privileges.
   4. Mentorship. A clinical pharmacist mentorship is an optional period of training and observation in which a currently employed clinical pharmacist is assigned a “mentor” to provide additional training to obtain necessary competencies for new or expanded clinical functions. A mentorship is not a requirement for all pharmacists to obtain clinical privileges but is an option that may occur prior to approval of initial or revised clinical privileges.
      1. A mentorship may be warranted if there is insufficient evidence that the clinical pharmacist is ready to take on duties outlined in their proposed clinical privileges based on the individual clinical pharmacist’s competency assessments, education, training, and experience in the practice area.
      2. A mentorship is required for:
         1. Any currently-employed clinical pharmacist with less than one year of post-graduate experience e.g., graduated within the last year, who requests privileges; or
         2. Any clinical pharmacist requesting initial or expanded privileges in a specialized practice area in which there is not sufficient evidence of their readiness to perform these activities based on the individual clinical pharmacist’s education, training, and experience.
   5. Each clinical pharmacist seeking clinical privileges must prepare an application including mentorship results (as applicable), which have been reviewed and endorsed by the Chief Pharmacist and Clinical Director, prior to submission to the Medical Staff for review and recommendation.
   6. Supplemental Privileges are privilege requests that are not included in initial or renewal privileges and can be submitted as needed, according to medical staff bylaws, after initial privileges are approved.
   7. All clinical pharmacists with clinical privileges must participate in an OPPE evaluation. The cumulative results will be used for assessing the appropriateness of renewal of clinical privileges.
5. Collaborative Practice Agreement.  
   1. The CPA will be developed jointly with the medical staff and will be approved by the medical staff. The CPA will contain all the following elements:
      1. Statement of need, rationale, and purpose for agreement;
      2. Agreement information, including, but not limited to:
         1. Process for obtaining referrals and eligibility documentation;
         2. Patient care procedures;
         3. Process regarding referral and/or discharge back to referring primary care provider; and
         4. Clear statements of tasks that the pharmacist is authorized to perform such as:
            1. Order and interpret laboratory tests;
            2. Perform limited physical assessment;
            3. Provide patient education;
            4. Provide follow-up care; and
            5. Prescribe (initiate, modify, and discontinue) medications.
      3. Document outcomes:
         1. Identify clinical and administrative outcomes/measures to be collected.
         2. Annually obtain, document, and report outcomes to the Medical Staff.
      4. Quality Assurance/Performance Improvement:
         1. Describe continuous performance improvement process for clinical services provided.
         2. Report performance improvement annually to Medical Staff.
         3. Implement, describe, and document a peer review process.
      5. Training and Local Certification:
         1. Define pharmacist training requirements and practice qualifications.
         2. Describe the process for annual evaluation and documentation of competencies.
      6. Treatment Guidelines: Identify and adhere to current national clinical practice guidelines.
      7. Clinical Protocol Approval:
         1. Agreement will be signed with appropriate signatures, position titles, and dates of approval.
         2. All revision and review dates will be documented.
6. Professional Practice Evaluations.  
   
   All pharmacists with clinical privileges must participate in a professional practice evaluation program which includes peer reviews, OPPE and FPPE. The criteria for both the OPPE and FPPE processes are to be defined in advance, using objective criteria, accepted by the practitioner, and recommended by the Clinical Director and Medical Staff as part of the privileging process. The process may include, prospective, concurrent, or retrospective activities and include periodic chart review, direct observation, or discussion with other individuals involved in the care of patients. An evaluation of the patient care provided by the clinical pharmacist, or clinical care review, is a required component of the professional practice evaluation.
   
   The professional practice evaluation forms and processes shall be reviewed with each pharmacist prior to the start of the first professional practice evaluation period, and any time the indicators are changed.
   
   The Chief of Pharmacy must review, on an ongoing basis, all professional practice evaluation activities, including completion of focused and ongoing professional practice evaluations, and must provide reports to the Medical Staff Executive Committee, as appropriate.

3-7.12   INPATIENT PHARMACY

1. Inpatient Medication Distribution.  
   
   Unit dose drug distribution systems permit identification of drugs up to the point of administration and will be used for all IHS inpatient services.
2. Medications Brought Into a SU by Patients.  
   1. In those instances when the pharmacy service cannot obtain a medication or supply in a timely manner through the routine procurement methods, a pharmacist can authorize the use of a patient’s own medication when ordered by the provider.
   2. A process must be established to safely control i.e., approve for use, or manage, outpatient medications/supplies e.g., IHS or non-IHS dispensed medications/supplies brought into the IHS SU by the patient or family member. The IHS SU policy must provide guidance as to the use, disposition, storage, or return of these medications/supplies.
   3. For those IHS SUs that allow patients to bring outpatient medications/supplies into the medical center, these products must not be administered, unless the treating provider makes the determination that their use is appropriate and required. The provider must enter specific orders into the patient’s medical record authorizing the use or administration.
   4. When the required approvals have been processed and the medication/supply is deemed necessary, a clinical pharmacist must identify and validate the correctness of the medication prior to dispensing or administration to the patient.
   5. When an outpatient medication is authorized for inpatient use, the pharmacy service must relabel the medication in accordance with the provider’s instructions. This must be done using standard labeling as required for inpatient dispensing, prior to reissue.
3. Inpatient Medication Orders.  
   1. All medication orders must be re-evaluated by a provider with any change in patient status or relocation to another ward or service.
      
      NOTE: In instances when the same treatment team follows the patient after relocation to another ward or unit, IHS SU policy may define requirements for stop orders or the reinstatement of prior orders for medications.
   2. To ensure that only medications needed to treat the patient’s condition(s) are ordered, a clinical pharmacist must verify all inpatient orders, taking into consideration the current diagnosis and indication for each medication.
   3. When electronic order entry is unavailable, all medications, including parenteral fluids, must be ordered on a locally approved form. The medication order must have the medication name, dosage, dosage schedule or desired flow rate, duration of therapy, and other information as established by local SU policy.
      
      NOTE: The notations, “keep vein open” or to “keep open” must be accompanied by the appropriate flow rate, as determined by the ordering provider.
   4. Automatic Stop Orders. Orders may be written specifying a finite duration, and if appropriate, prescribers are encouraged to specify the desired length of therapy with each order. Orders that do not specify a finite duration will not be subject to automatic stop, discontinuation or expiration dates with the following exceptions:
      1. All medication orders are automatically cancelled when a patient undergoes surgery or is admitted or discharged from the Intensive Care Unit (ICU).
      2. New orders must be written post-operatively or upon ICU admission or discharge.
      3. Post-operative and ICU transfer orders written as "renew all previous orders" are not recognized.
   5. Upon discharge, the remaining portions of partially-used bulk medications e.g., inhalers, eye drops, creams, or ointments, identified to specific patients will be relabeled to meet outpatient prescription requirements and dispensed to those patients, when appropriate.
      
      NOTE: The relabeling of these products is to be in compliance with all applicable laws and regulations.
   6. Before administering a new medication, the patient or patient’s representative is to be informed about any potential for clinically significant ADR or other concerns regarding administration of a new medication. Authorized medical facility personnel e.g., providers, nurses, etc., must support this communication effort in the absence of the clinical pharmacist.
4. Intravenous Admixtures.  
   
   See Indian Health Manual Part 3, Chapter 41, “Pharmaceutically Compounded Sterile Products” forthcoming as of date of this publication and Indian Health Manual Part 3, Chapter 27, “Handling Hazardous Drugs in the Health Care Setting.”
5. Pharmacy Staffing During Off-Hours.  
   1. When the onsite pharmacy is not open 24 hours-a-day and 7 days-a-week, a contingency plan must exist to ensure a review of the medication orders prior to administration.
      1. This review of the medication orders may be performed by a clinical pharmacist at a remote location, or a licensed independent practitioner in emergent situations.
      2. This review must be performed by an individual who is not the prescriber and completed before the first dose is administered.
      3. When an order is reviewed by a licensed independent practitioner, a clinical pharmacist must conduct a retrospective review of the order as soon as possible, or when the pharmacy opens, whichever is sooner.
   2. Those medications deemed to be emergent can be stored in a night cabinet, automated storage and distribution device, or a section of the pharmacy with controlled access and separate from the main pharmacy area.
   3. A qualified clinical pharmacist must be available either on-call or at another location to answer questions and/or provide access to medications that are not available in the night cabinet, automated storage and distribution device, or the controlled access section of the pharmacy in emergent situations.

3-7.13   INVESTIGATIONAL DRUGS

1. Unapproved Indications.  
   
   Physicians may legally prescribe a marketed drug for an unlabeled indication or at an unlabeled dose as deemed appropriate on an individual patient basis. The pharmacy will monitor such uses and will report any trends to the SU P&T Committee for review.
2. Required Clearances.  
   
   For any IND to be used in an IHS facility, clearance is required as outlined:
   1. Single Patient in Investigational Drug Study. For individuals placed on an IND that has been approved for use by a Clinical Investigator located at a non-IHS institution, the IHS, at its option, may rely upon the review of the Institutional Review Board (IRB) from the research institution in making a decision to continue the patient on the drug. The Area CMO will decide whether to accept the review of the IRB from the research institution or to refer the review to an IHS IRB.
      
      Before a patient may receive an investigational drug at an IHS facility, the following requirements will be met:
      1. The IHS physician accepting responsibility for care of the patient will make personal contact with the FDA-approved clinical investigator to determine the feasibility of initiating or continuing therapy with an investigational drug. If it is agreed to admit a new patient to the investigational drug study, the Clinical Investigator will provide the SU P&T Committee with the pertinent protocol and other information necessary to monitor the patient. If it is agreed to continue investigational drug therapy for a patient already enrolled in a study, the clinical investigator need only provide the necessary information to monitor the patient and a copy of the patient's signed consent. In either case, the clinical investigator must indicate each institution's responsibilities.
      2. For patients started on an investigational drug by an IHS physician, an informed consent form specific to the project must be used. This form will contain information specific to the investigational drug and will be approved by the SU P&T Committee and Area IRB before signed permission is obtained from the patient.
      3. The informed consent form will include the specific reason the investigational drug is to be administered; e.g., no other effective drug therapy or other methods are available, other FDA-approved drugs have failed, or the patient could not tolerate other FDA-approved drugs because of toxicity or adverse effects. The form must meet all the requirements of informed consent, including the nature of the treatment and its possible consequences.
      4. The SU P&T Committee will review the proposed use of the investigational drug, evaluating the indication, toxicity, and risks; the informed consent form; the potential benefits of the drug; and the lack of a suitable approved drug or the failure, contraindications, or adverse effects of other usual treatment methods. The SU P&T Committee will forward its recommendations, a copy of the signed informed consent, and other relevant information regarding the investigational protocol and/or drug to the Area CMO for approval or denial.
      5. If use of an IND is approved, the IND will be used under the supervision of the FDA approved Clinical Investigator. The Clinical Investigator will be responsible for including the IHS physician's name on FDA Form 1572, Statement of Investigator, as a sub-investigator.
      6. In instances where time is a critical factor because of serious or potentially fatal illness, the IHS physician accepting responsibility for use of the IND may request verbal approval from the Area CMO to use the IND for a limited time, not to exceed 30 days, during which the formal process outlined above will be completed.
   2. Multiple Patients in Investigational Drug Study. The following requirements will be met for enrolling multiple IHS patients in an IND study whether initiated by an IHS provider or included in a study conducted by another institution or investigator holding an approved IND application:
      1. Prior to requesting approval to use an IND drug in an IHS facility, the investigator must submit a completed FDA Form 1572, Statement of Investigator, and FDA Form 1571, Investigational New Drug Application, to the FDA and receive approval from them. If an IHS provider is acting as a sub-investigator, his/her name will be included on FDA Form 1572 by the principal investigator.
      2. The proposed study must be approved by the institution's P&T Committee, the SU CEO, Tribal authorizing body, Area IRB, IHS Research Director, and the Director of the IHS or designee.
      3. It is recommended that the committees and approving officials consider such proposals in the light of current knowledge of the drug and other drugs in the same therapeutic class.
      4. Research protocols will set forth the laboratory and the clinical aspects of the study, make provisions for control, confirm the availability of adequate laboratory and other diagnostic and testing resources for the particular study or follow-up, and indicate the basis of comparison with accepted pharmacological agents.
      5. In presenting a request for approval of an IND study, the following information will be furnished for review to the various required committees and individuals:
         1. Name of principal investigator and his/her training and experience.
         2. Purpose of the study.
         3. Names of the drug: trade, generic, chemical, and any other.
         4. Information on the drug as supplied by the manufacturer and from other sources, including toxicities and undesirable side reactions as well as the desirable actions of the drug.
         5. Benefits the patient may derive from such a study.
         6. The informed consent form used for obtaining signed permission from participants which will include the reason the IND is to be administered. The investigator and the medical officer responsible for the patient's care are reminded that even though treatment is proper they may be held liable for the consequences of treatment, if they fail to advise the patient in advance of the nature of the treatment and its possible consequences.
         7. A statement as to whether or not the proposed study has been explained (preferably in writing) to the appropriate Tribal Council or other Tribal authority and whether or not the Tribe concurs.
         8. A short statement of the study methodology including a description of the location and subjects (age, sex, ambulatory, or hospitalized).
         9. The degree of risk involved and related factors including:
            1. Withholding of a recognized and accepted treatment;
            2. Adverse effects on quality of life issues;
            3. Contraindications;
            4. Blood dyscrasias;
            5. Degree of supervision needed;
            6. Synopses of previous published studies;
            7. Manufacturer's information and published reports describing side effects, toxicity and indications; and
            8. Additional staffing, costs, and/or workload projections.
   3. When final approval for the use of an investigational drug has been obtained from the IHS Director, or his/her designee, the following procedures will be used:
      1. The signed written consent will be obtained from each subject or his/her legal guardian and maintained on file.
      2. A physical examination will be completed on each subject.
      3. The Chief Investigator who is using the investigational drug will be responsible for providing the pharmacy service with pertinent information on the drug.
      4. The pharmacy service will be responsible for preparing and making available to the nursing service summaries of the basic information on INDs.
      5. The administration of INDs by any route by members of the nursing staff will be prohibited, until adequate information concerning the administration, actions, uses, dosage, toxicity, and precautions of such drugs is available on the nursing unit in a form approved by the SU P&T Committee.
      6. The INDs will be clearly labeled as such by the pharmacy.
      7. The sponsor or principal investigator will abide by all applicable FDA regulations, including the reporting of adverse experiences associated with the use of the drug and the filing of an annual report.
   4. Storage, Labeling, and Dispensing of INDs. Investigational drugs will be stored, packaged, labeled and dispensed by the pharmacy, following ASHP guidelines.

3-7.14   EMERGENCY USE AUTHORIZATION

Emergency Use Authorization - Drugs and/or vaccines receiving FDA Emergency Use Authorization shall not require IRB review or approval, provided that use conforms to all of the stipulations of the EUA and that appropriate patient consent is obtained and documented.

3-7.15   QUALITY ASSURANCE AND IMPROVEMENT

The IHS Pharmacy Program will make every effort to ensure the quality and oversight of pharmacy services provided in IHS facilities. The IHS Pharmacy Program, CMS and other recognized accreditation bodies, as well as national professional pharmacy organizations will be used as applicable to evaluate pharmacy programs. Evaluations of pharmacy programs will be undertaken at each level within the IHS Pharmacy Program. The IHS Pharmacy Program will ensure compliance with regulatory agencies, accrediting bodies, and current practice standards.
1. Quality Assurance and Performance Improvement Plan.  
   1. A Quality Assurance and Performance Improvement (QAPI) plan must be approved by the SU Clinical Director and the CEO per CMS or other accrediting body standards. The QAPI plan may be a stand-alone program or part of a broader facility wide QAPI plan.
   2. The QAPI activities for pharmacy will include, but not be limited to:
      1. Establishing and monitoring the medication management system to ensure medications are safely stored, dispensed, and/or administered. This includes, but is not limited to, ensuring appropriate safety measures are in place for look-alike and sound-alike drugs, high-alert medications, and hazardous medications;
      2. Monitoring and evaluating the pharmacy QAPI plan. Monitoring will include at a minimum: adverse drug events, medication errors, medication recalls and other pharmacy indicators;
      3. Written annual evaluation of the pharmacy QAPI; and
      4. Appropriate reporting of the monitoring and evaluation of pharmacy services to other departments, the facility QAPI committee, and, where applicable, to the Governing Body.
2. Program Evaluation.  
   1. Annual Controlled Substance Review.
      
      The APC or his/her designee will conduct an annual unannounced physical audit of all Schedule II-V controlled substances at each facility in the Area, using the Pharmacy Controlled Substances Audit Tool (see Manual Exhibit 3-7-E), to ensure accuracy, identify discrepancies, and monitor for compliance with controlled substance procedures. The designee must be a senior level pharmacist from outside the SU.
   2. Annual Program Review.
      
      The APC or his/her designee will conduct an annual onsite program review at each facility in the Area using the Pharmacy Program Review Tool (see Manual Exhibit 3-7-F). The designee must be a senior level pharmacist from outside the SU.
   3. Compliance Review.
      
      The Pharmacy Policy Alignment Committee is a subcommittee of the National Pharmacy Council. The Pharmacy Policy Alignment Committee is tasked with assisting local pharmacy leadership in completing a self-guided review of their program. These reviews include:
      1. An annual review, using the Pharmacy Policy Alignment Review Tool (see Manual Exhibit 3-7-G), to ensure all required local policies are in place, meet the national requirements, and are updated annually; and
      2. A monthly review to ensure that all MRNOCS (see Manual Exhibit 3-7-C) forms are submitted, complete and any controlled substance loss is reported as required in section 3-7.6D(1) of this chapter.
   4. PPC Review.
      
      All program evaluations will be stored electronically and available for review by the PPC.
3. Reporting Adverse Drug Events and Medication Errors.  
   
   Adverse drug events will be reported to and reviewed by the SU P&T Committee, quality assurance, and/or medication safety committee(s).
   1. This includes, but is not limited to, all allergic responses to drugs, all serious adverse drug events, and any other unexpected response to a drug that results in actual or potential risk to the patient.
   2. In addition, all serious and unexpected adverse drug events will be reported directly to the FDA MedWatch program, using the form FDA 3500 or online reporting portal.
   3. Adverse reactions to vaccines will be reported online, using Form FDA VAERS 2.0, Vaccine Adverse Event Reporting System. A copy of each report will be filed in the pharmacy with a copy sent to the P&T Committee.
   4. Medication errors will be entered into an IHS approved medication error reporting database and reviewed by the SU P&T Committee, quality assurance, and/or medication safety committee(s). Reporting will utilize the Medication Error Index as put forth by the National Coordinating Council for Medication Error Reporting and Prevention for categorization of adverse drug events and medication errors (see Manual Exhibit 3-7-H).

3-7.16   IHS INFORMATION SYSTEMS TECHNOLOGY MAINTENANCE

1. Pharmacy Software Enhancements.  
   1. Local or regional modifications to the IHS pharmacy software is discouraged. Any modifications to the software should be done at the national level to prevent unexpected problems with the software and ensure proper support of system changes.
   2. IHS pharmacy software users may request national modifications or additions to the pharmacy software at any time. The procedure for requesting modifications or additions is as follows:
      1. A written request with a description and justification for the modification desired is generated at the local facility.
      2. The request is entered by the requestor at the local facility, via the Feedback page, and then routed to the appropriate package leads.
      3. Requests for changes or enhancements to the pharmacy package are entered in tracking software and are systematically reviewed, discussed, and voted on by the Pharmacy PSG.
      4. If approved by the PSG, the request is prioritized and submitted to the IHS Office of Information Technology for possible inclusion in the pharmacy package. Issues of patient safety are prioritized first and may not fall into the normal progression of change requests.
      5. The recommended modification will be reviewed by systems analysts for inclusion in software update releases. The degree of difficulty of the programming request, availability of funding, and whether the modification coincides with overall program priorities are determining factors on how soon or if the modification is released as a software update.

3-7.17   PROGRAM REFERENCES

ASHP Guidelines for the Use of Investigational Drugs in Institutions

Code of Federal Regulations, Title 21, Chapter II - Drug Enforcement Administration

Code of Federal Regulations, Title 21, Part 1317 Disposal (of Controlled Substances by Registrants)

Institute for Safe Medication Practices

National Coordinating Council for Medication Error Reporting and Prevention

United States Food & Drug Administration Disposal of Unused Medicines: What You Should Know

United States Food & Drug Administration Drug Supply Chain Security Act

United States Pharmacopeia-National Formulary Good Storage and Distribution Practices for Drug Products