Chapter 7 - Pharmacy
|Manual Exhibit 3-7-A [PDF - 886 KB]||Sample DEA Form - 222|
|Manual Exhibit 3-7-B [PDF - 48 KB]||Perpetual Inventory of Controlled Substances Form|
|Manual Exhibit 3-7-C [PDF - 33 KB]||Consolidated Eight Hour Controlled Substance Audit|
|Manual Exhibit 3-7-D [PDF - 17 KB]||Monthly Report for Narcotics and Other Controlled Substances|
|Manual Exhibit 3-7-E [PDF - 84 KB]||NCC MERP Index for Categorizing Medication Errors|
- Purpose. This chapter establishes the requirements for the development of local policies and procedures of pharmacy services operated by the Indian Health Service (IHS).
- Policy. It is the policy of the IHS Pharmacy Program to:
- Ensure efficacious, safe, and cost-effective drug therapy and appropriate outcomes in the use of drugs and medicines.
- 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.
- Assure 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 Pharmacist (ASHP), The Centers for Medicare & Medicaid Services (CMS), The Joint Commission, The Accreditation Association for Ambulatory Health Care, etc.
- Assure medication safety by reviewing and evaluating best-practice guidelines such as those established by the Institute for Safe Medication Practices (ISMP), the National Coordinating Council for Medication Error Reporting and Prevention (NCCMERP) and the United States Pharmacopeia (USP).
- Clinical Investigator - 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.
- Clinical Pharmacy - 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.
- 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.
- 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 health care team. 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).
- Competency - having sufficient aptitude, knowledge, skill, and abilities to fulfill the duties and responsibilities of the assigned position.
- Credentialing - an ongoing process whereby a facility’s medical staff obtains, verifies, and assesses an individual’s professional credentials. This information is utilized by the medical staff and governing body to evaluate competency and appropriately grant medical staff membership and/or clinical privileges.
- 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.
- Drug Diversion - the illegal distribution or use of prescription drugs.
- Focused Professional Practice Evaluation (FPPE) - process used to validate the privilege-specific competency of a clinical pharmacist in the following time-limited situations: required for 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.
- Formulary - list of prescription medications that are approved to be prescribed at a particular hospital, in a particular health system, or under a particular health insurance policy. The development of prescription formularies is based on evaluations of efficacy, safety, and cost-effectiveness of drugs.
- Investigational Drug - Either:
- A new drug or new dosage formulation (i.e., Investigational New Drug (IND)), which has not been approved for any medical indication by the Food and Drug Administration (FDA); or
- An FDA approved and marketed drug which is to be administered to a group of patients for study or research purposes for a non-FDA approved indication.
- Legend Drug - a medication that cannot be obtained legally without a prescription from a licensed health care provider.
- The National Core Formulary (NCF) - core set of drugs, maintained by the National Pharmacy and Therapeutic Committee, available to IHS beneficiaries. The NCF assures parity, portability, quality, convenience, safety, and promotes cost-effective use of medications.
- Ongoing Professional Practice Evaluation (OPPE) - 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 all privileges. 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.
- Peer Review - process in which individual patient care visits are assigned and regularly reviewed by other privileged pharmacists or providers. Individual visit practices, documentation, and processes are evaluated against existing department standards.
- Privileging - the act of a health care organization granting a privilege to an individual.
- 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.
- Re-credentialing - the process whereby credentials are reviewed every two years, or after the one year provisional period.
- Schedule II Controlled Substances - drugs that have a high potential for abuse which may lead to severe psychological or physical dependence.
- 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.
- Schedule IV Controlled Substances - drugs that have a low potential for abuse relative to substances in Schedule III.
- Schedule V Controlled Substances - drugs that have a low potential for abuse relative to substances listed in Schedule IV and consist primarily of preparations containing limited quantities of certain narcotics.
- Suspect Product - a product for which there is reason to believe it is
- counterfeit, diverted, or stolen;
- intentionally adulterated such that the product would result in serious adverse health consequences or death to humans;
- the subject of a fraudulent transaction; or
- appearing unfit for distribution such that the product would result in serious adverse health consequences or death to humans.
- Visit Note - 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.
- Chief Medical Officer, IHS. The IHS Chief Medical Officer (CMO) is administratively responsible for the issuance of this policy.
- 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.
- Area Director. The Area Director is responsible for:
- ensuring that administrative support and necessary resources are available at IHS pharmacies in their respective Areas to implement this policy; and
- ensuring that this policy is fully implemented.
- Area CMO. The Area CMO is responsible for monitoring IHS facilities for compliance with this policy.
- Area Pharmacy Consultant. The Area Pharmacy Consultant (APC) serves as the coordinator, consultant, and advisor to the PPC, Area Director, Area program staff, Service Unit (SU) staff, and Tribes on all matters relating to provision of pharmacy services.
- 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.
- Chief Pharmacist. The SU Chief Pharmacist is responsible for developing policies and procedures for the provision of pharmacy services 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;
- National Pharmacy and Therapeutic Committee. Circular 17-02, – Charter https://www.ihs.gov/ihm/index.cfm?module=dsp_ihm_circ_main&circ=ihm_circ_1702
- Local Pharmacy and Therapeutics Committee. Each SU with a
federally-operated pharmacy will develop a local Pharmacy and Therapeutics
Committee (P&T) Committee.
- Local P&T Committee membership will include at least one physician and one pharmacist.
- Local P&T Committees will develop procedures to cover the following
- review and/or revise local SU formulary at a minimum of annually to include medications added to the NCF;
- review and/or revise emergency medications and other medications stocked in patient care areas at a minimum of annually;
- develop and approve written medication substitution protocols to be used in the event of a medication shortage or outage;
- review adverse drug reactions; and
- review and analyze medication errors and pharmacy interventions.
- IHS pharmacies are required to adhere to the IHS NCF.
- Non-Formulary Medications. Every effort must be made to utilize NCF and SU approved formulary drugs. A Non-Formulary Medication Request can be utilized to request the procurement of a drug that has not been approved by the SU P&T Committee. Pharmacies should have expedited processes for providing access to non-formulary drugs when the formulary drug is contraindicated by reason of ineffectiveness or adverse effect.
- Utilization of non-IHS Pharmacies. In certain instances, 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.
- 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.
- 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.
- Sample Medications. The use of drug samples within IHS facilities is prohibited.
- 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.
- Staffing Standards.
- Pharmacy staffing will be maintained at levels necessary to carry out basic IHS Pharmacy Services and the additional workload entailed with the implementation of any expanded primary care and specialty pharmacist services (programs involving prescriptive authority).
- The total number of positions required to manage and deliver pharmaceutical care is determined by the IHS Resource Requirements Methodology (RRM).
- The RRM Pharmacy staffing module estimates the requirements for
pharmacists and pharmacy technicians to deliver appropriate pharmaceutical
- The workload parameters that are the key variables in the staffing estimation are the number of pharmacy practice locations, actual workload data and average daily patient load.
- When new primary care providers are added to facility staffing, an assessment of pharmacy staffing will be completed to determine the need for additional staff to meet the increased workload.
- 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 should be designated as Acting Chief Pharmacist, as appropriate.
- Primary care pharmacist services will not be implemented at the expense of patient consultation, drug information, drug utilization, and quality improvement.
- 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. 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).
- FDA-Approved Medications. Only medications which are FDA-approved as safe and effective may be procured. IHS funds, including grant and contract funds, will not be used to procure drugs that are classified as ineffective by the FDA.
- Drug Supply Chain Security Act. All pharmacies will have a local policy that complies with the requirements of the DSCSA.
- Ordering Controlled Substances.
- Personnel authorized to order controlled substances must be designated in writing in the SU pharmacy policies and procedures.
- Online electronic ordering of controlled substances will be used in accordance with Drug Enforcement Agency (DEA) Regulation.
- The primary method for ordering Schedule II drugs will be via the DEA Controlled Substance Ordering System (CSOS). A record of these orders may be maintained in a secure electronic system with appropriate data storage backup. In instances when CSOS is not available, facilities may temporarily revert to using the paper DEA 222 form (see Manual Exhibit 3-7-A).
- 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.
- Electronic records must be readily retrievable and organized by date order was received.
- When available, pharmacies will stock all controlled substances in 100-count bottles, or smaller, to simplify the counts and prevent large thefts.
- Receiving Controlled Substances.
- Personnel authorized to receive controlled substances must be designated in writing in the SU pharmacy policies and procedures.
- 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.
- All orders for controlled substances must be delivered directly to the pharmacy in unopened shipping containers or boxes.
- Two facility employees (one being a pharmacist) must acknowledge and sign for receipt of the order on the appropriate forms. The receiving pharmacist must verify that the receipt of the controlled substances has been finalized in the pharmaceutical prime vendor ordering system and are logged correctly into the inventory.
- Order discrepancies must be reconciled before controlled substances are accepted into the pharmacy inventory.
- Records Maintenance.
- All records pertaining to the acquisition, receipt, and distribution of medications and controlled substances will be maintained on file or stored electronically according to IHS records management policy.
- All medication stock invoices will be maintained for no less than three years.
- 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.
- For Schedule II controlled substances, executed and unexecuted DEA Form 222 or the electronic equivalent will be maintained. Order forms must be kept for a period of three years.
- The records of all medication inventories and disposals will be kept a minimum of three years.
- Records involving losses of controlled and non-controlled substances must be maintained on site for three years.
- Required Inventories.
- Perpetual Inventory. A perpetual inventory will be maintained on all Schedule II-V drugs. The Perpetual Inventory of Controlled Substances Pharmacy 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 & Strength, Quantity, Date, Patient, Cabinet User, Prescriber, Controlled Substance Schedule, etc.).
- Monthly Inventory. An inventory of Schedule II – V drugs will be completed monthly using the Monthly Report for Narcotics and Other Controlled Substances Pharmacy form or equivalent. This report is sent to the CEO with a copy to the APC and Area CMO, if required by the Area Director.
- 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.
- Annual Inventory. An inventory of all pharmaceuticals (controlled and
non-controlled) will be conducted at a minimum of annually. 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 utilizing the Pharmaceutical Prime Vendor’s software program.
- Twenty-five random medications will be an exact count to validate accuracy of the annual inventory.
- Enhanced Surveillance Inventory.
- All pharmacies must conduct Enhanced Surveillance Inventory (ESI). The SU pharmacies shall review at a minimum five medications (one strength of each medication) from the ESI list on a monthly basis.
- 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.
- The ESI drugs list and policy are available on the NPC Inventory Management webpage. https://home.pharmacy.ihs.gov/index.cfm?module=gen_one&id=70
- Medication Storage.
- Proper Medication Storage. The following will apply for all medication
- Medications for external use and disinfectants will be stored separately from internal and injectable medications.
- All flammable products will be stored in a safety cabinet in compliance with Occupational Safety and Health Administration guidelines.
- All prescription 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.
- Appropriate manual, electromechanical, or electronic temperature recording equipment, devices, and/or logs will be utilized to document proper storage of prescription drugs.
- All medication storage locations will be inspected monthly by pharmacy staff to assure proper quality control practices and to remove expired drugs.
- Medication Storage Outside of Pharmacy (Secure Storage Outside of
- Medications at each nursing location 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.
- Mobile nursing carts, anesthesia carts, epidural carts and other medication carts containing Schedule II-V medications must be locked within a secure area.
- The charge nurse and pharmacy will assure that medication stocks are maintained at operational levels. The charge nurse will assure the security, storage, and maintenance of appropriate records of controlled substances at the nursing location.
- Perpetual Inventory records will be maintained on all controlled substances available at nursing units.
- 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, an audit must be performed on all controlled substances at each shift change of custody.
- 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.
- A discrepancy report will be reviewed at least weekly to identify unresolved discrepancies and identify trends.
- A pharmacist will audit these activities on at least a monthly basis.
- For nursing units without an ADC, the Consolidated Eight Hour Controlled Substances Audit form (see Manual Exhibit 3-7-C), or equivalent, will be used when performing manual audits.
- Disposal of Medication.
- Disposal of Returned or Expired Medications
- Inventory shall be checked on a monthly basis for expired medications.
- Expired non-controlled medications will be removed and maintained separately from active inventory and labeled "Expired Drugs: Do not use." Return of expired medications should be arranged with the Reverse Distributor.
- 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. A separate perpetual inventory will be maintained on these items.
- Expired drug stocks will be inventoried monthly and reported with monthly controlled substance inventory.
- A contract must be maintained with a registered DEA Reverse Distributor for pickup and removal of expired controlled substance medications. The registered DEA Reverse Distributor will furnish a completed DEA form 222 to the pharmacy when accepting expired medications in compliance with DEA regulations.
- 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, State and
Tribal regulations. Assistance provided may include:
- educational materials on the self-disposal of medications based on Federal guidelines, for example the FDA guidance on the disposal of unused medicines;
- information on local drug take-back programs;
- pharmacies may accept all non-controlled drugs for disposal through hazardous waste program or pharmaceutical reverse distributor program; and
- 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.
- Loss or Theft of Controlled and Non-Controlled Medications.
- 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.
- A written report must be made within one day to the APC, CEO, and the DEA Field Division Office in the area.
- The DEA Form 106, Report of Theft or Loss of Controlled Substances, must be completed in accordance with 21 Code of Federal Regulations 1301.76(b) https://www.deadiversion.usdoj.gov/21cfr/cfr/1301/1301_76.htm.
- The CEO will forward information to the Area CMO and Area Director.
- The CEO or designee must, in turn, notify concurrently the Office of the Inspector General and the Office of General Counsel.
- The appropriate controlled substances record must be balanced, and a brief explanation of the circumstances entered onto the Monthly Report for Narcotics and Other Controlled Substances Pharmacy form or equivalent form (see Manual Exhibit 3-7-D).
- 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.
- 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.
- Records of balance adjustments must be readily retrievable, on paper or electronically, for a minimum of three years.
- Procedure for accidental loss, breakage, or destruction of
insignificant quantities of Schedule II through V controlled substances.
- 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.
- 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.
- The appropriate controlled substances record must be balanced, and a brief explanation of the circumstances entered onto the Monthly Report for Narcotics and Other Controlled Substances equivalent form (see Manual Exhibit 3-7-D).
- 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
NOTE: Facilities may make these adjustments with two electronic signatures in their inventory management software.
- Transfer of Custody for Controlled Substances.
- When there is a transition in the Chief Pharmacist position, a
controlled substance inventory must be taken with the outgoing and incoming
- If the incoming Chief is not yet present, an Acting Chief will be designated to avoid a gap in custody.
- A joint inventory must be taken before the transfer is affected.
- 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.
- 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.
DEA Power of Attorney form:https://www.deadiversion.usdoj.gov/21cfr/cfr/1305/1305_05.htm
- When there is a transition in the Chief Pharmacist position, a controlled substance inventory must be taken with the outgoing and incoming Chief Pharmacist.
- Procedure in Case of Suspicious Loss or Theft of Controlled Substances.
- Disposal of Returned or Expired Medications
- Proper Medication Storage. The following will apply for all medication storage locations:
- All Controlled Substances must be secured and under the control of pharmacy services.
- Controlled substance stock shall not be dispersed with general pharmacy inventory.
- Schedule II - V Drugs should be secured in strongly constructed metal cabinet(s) or safe(s) as per DEA regulations.
- 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.
- Access to controlled substances within the pharmacy is controlled and
- The Chief Pharmacist will maintain a list of pharmacy staff with access to controlled substances and this list will be readily retrievable.
- 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.
- Only pharmacists should have access to controlled substances if there is not an electronic monitoring system in place.
- All controlled substance prescriptions waiting 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.
- Closed Circuit Television Cameras.
- Closed-circuit TV Cameras will be installed inside the pharmacy and at remote medication storage areas to document and prevent diversion of scheduled controlled substances.
- The recorded footage must be securely stored with restricted access.
- Cameras should provide adequate coverage of the following areas:
- medication filling/handling location(s),
- counseling room(s),
- controlled substance safe(s),
- pharmacy patient reception,
- automated dispensing unit(s)/robot(s),
- prescription shelving/storage, and
- pharmacy entrance(s)/exit(s)
- Cameras must:
- be protected against tampering/disabling;
- have a video quality of high resolution, with motion activation to trigger recording; and
- have storage hardware for recorded footage, capable of saving up to 30 days of security footage for each camera, and should be easily upgradeable to accommodate future expansion/increased storage capacity as needed.
- After Hours Pharmacy Access to Medications.
- A secured emergency medication storage cabinet or ADC must be used to store medications that are approved by the local P&T Committee for afterhours use.
- Only appropriate providers, within scope of practice, may access the ADCs. Access to the pharmacy after hours is limited to pharmacists.
- 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.
- Electronic Access Control.
- Any door leading into the pharmacy will have security-enhanced or
Cipher-type locks in order to prevent unauthorized access into the
- Examples of security-enhanced locks include electronic access control using a Personal Identity Verification Card or Biometrics (i.e. fingerprint or retina scan).
- 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.
- 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).
- The combination of the Cipher lock should be changed every 90 days and as soon as possible after an employee leaves the IHS facility employment.
- Any door leading into the pharmacy will have security-enhanced or Cipher-type locks in order to prevent unauthorized access into the pharmacy.
- 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: name, reason for entry, time of entry, time of exit.
- An alarm system with motion detectors and an auto-dialer must be
installed to alert law enforcement and health center management to
unauthorized after-hour access to the pharmacy.
- Alarm system(s) will be routinely tested.
- Alarm system(s) must have at least a 24-hour battery or other standby power source(s) in the event of commercial power failure.
- Automated Dispensing Robots and Cabinets.
- All automated dispensing robots and cabinets in the facility should possess biometric authentication to identify the end user.
- 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.
- 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-proof glass, or security shutters. If security shutters are used, pharmacy personnel must be physically present at all times while shutters are open.
3-7.8 PHARMACY SERVICES
- 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. Medication refill counseling will be offered to the patient. If the patient refuses medication refill counseling, the pharmacy staff must document the refusal per local procedure. When counseling a patient, the pharmacist will verify the patient understands the purpose of therapy.
- 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:
- obtaining medication histories to assist with medication reconciliation,
- patient education related to IHS formulary status of medications,
- documenting medication adherence,
- documenting patient allergies and adverse drug reactions, and
- patient education on navigating the IHS Pharmacy (including patient management of refills and renewals, important telephone numbers for pharmacy issues, etc.).
- Pharmacy-Managed Clinics.
- 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 e-mail communications, team or interdisciplinary meetings, clinical chart consults, and population management databases. The referral method ensures that the appropriate patient is referred to the pharmacy for management.
- Infrastructure must exist for a clinical pharmacist to refer patients to higher levels of care when appropriate. Policy must outline which referrals are appropriate to be made by the clinical pharmacist. 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.
- Automated Pharmacy Systems.
- Automated pharmacy systems should be utilized to improve safety, efficiency, and accuracy.
- The Chief Pharmacist, or designee, must:
- 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.
- 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 be established to address the removal, security, re-stock of pharmacy inventory, and accountability of medications when a system is removed from a patient care area.
- 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.
- Ensure that patient confidentiality is maintained in accordance with Health Insurance Portability and Accountability Act Standards (see Health Information Privacy at: http://www.hhs.gov/ocr/privacy/index.html). Safeguards must be established to prevent "outside" access to patient data.
- 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.
- Drug Information Services.
It is the responsibility of the Chief Pharmacist to ensure that the facility's health care providers have access to current drug information.
- Drug information and education will include:
- pharmacist-initiated, patient-specific interventions with appropriate documentation;
- drug therapy consultation on request from other professional staff; and
- in-service education to other professionals and health care workers.
- Drug information services will incorporate but are not limited to:
- providing drug therapy bulletins;
- participating in patient clinical rounds;
- providing drug information handouts to patients; and
- presenting drug information to community health representatives and health aids.
- The pharmacy library will have access to readily retrievable reference material to include at a minimum:
- pharmaceutical compendia;
- current references covering the practice of pharmacy, including chemistry, toxicology, pharmacology, therapeutics, bacteriology, sterilization and disinfection, compatibility, and drug interactions;
- authoritative, current antidote information; and
- current Federal and applicable State laws governing the practice of pharmacy.
- Drug information and education will include:
- Medication/Drug Recalls.
- 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.
- Recalls will be acted on in accordance with FDA regulations. Drug
recalls fall into three different categories under the FDA’s regulation:
- Class I recalls are for dangerous or defective products that predictably could cause serious health problems or death.
- Class II recalls are for products that might cause a temporary health problem or pose only a slight threat of a serious nature.
- Class III recalls are for products that are unlikely to cause any adverse health reaction, but that violate FDA labeling or manufacturing regulations.
- Participation in State Prescription Drug Monitoring Programs.
All IHS Pharmacies must report to State Prescription Drug Monitoring Programs as outlined in Part 3, Chapter 32 of the Indian Health Manual https://www.ihs.gov/ihm/pc/part-3/p3c32/.
- General Requirements.
- Within IHS facilities, prescriptions shall be written by members of the facility medical staff acting within the scope of their privileges, and/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.
- 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 orders; standing orders; hold orders; automatic stop orders; resume orders; titrating orders; taper orders; range orders; compounded medication orders.
- 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.
- Each IHS SU must define, in local policy, the requirements for indication-for-use on the medication order.
- 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.
- Pharmacists are to take appropriate actions, as established by IHS SU policy, for medication orders that are incomplete, illegible, or unclear.
- 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. The Joint Commission Official “Do Not Use” List is found at https://www.hnfs.com/content/dam/hnfs/tn/prov/news/pdf/Prov_News_10_2010_V6_I10.pdf.
- Allergy and adverse drug reaction (ADR) information must be recorded in
the Electronic Health Record (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.
- When 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.
- 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
NOTE: The verbal order must then be recorded electronically in the patient’s file.
- Locally established “Telehealth Service Agreements” must identify, in SU policy, the procedure for contacting the telehealth provider when medication order clarification is required.
- Controlled Substance Prescribing.
- Authorized Prescribers - Controlled substances may only be prescribed
by a physician, dentist, podiatrist, or other provider eligible for DEA
registration who is:
- Authorized to prescribe controlled substances by applicable rules and regulations;
- Registered under the Controlled Substances Act or exempted from registration (e.g., military and Public Health Service practitioners);
- Prescribing controlled substances only within the scope of his or her duties.
- Any provider employed by the facility that will be prescribing controlled substances must register with the DEA and obtain an individual registration number.
- Authorized Prescribers - Controlled substances may only be prescribed by a physician, dentist, podiatrist, or other provider eligible for DEA registration who is:
- Prescribers Without an Individual DEA Registration.
Providers pending applications to the DEA that 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. 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.
- Contract Prescribers Not Licensed in the State Where Delivering Services.
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.
- Issuing Controlled Substance Prescriptions.
- Scheduled II Prescriptions. Schedule II prescriptions provided to a patient for filling outside of an IHS facility must be prescribed utilizing tamper-evident process or technology and will be issued in accordance with Federal law including DEA regulations.
- Scheduled III-V Prescriptions. Prescriptions for controlled substances (Schedule III – V) from within the IHS facility will be issued in accordance with Federal law including DEA regulations.
- Secured Prescription Paper. Prescription paper, including prescription pads, 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.
- 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.
- 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.
- Refill Orders.
The prescriber may authorize refills at the time of generation of an
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."
- Non-IHS Prescribers.
- Pharmacy services will be made available to eligible American Indian/ Alaska Native beneficiaries whether an IHS practitioner or a purchased and referred care (PRC) provider writes the prescriptions.
- 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.
- 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.
- Facilities may develop additional policies and procedures for handling prescriptions received from PRC prescribers and non-PRC prescribers consistent with this section.
- Appropriateness of Medication Therapy.
- A pharmacist must review the health record of each patient prior to the dispensing of medications. 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, providers will complete the visit note prior to or along with current prescriptions in the EHR system.
- 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.
- The following items will be checked when screening health records and
monitoring patients for appropriateness of drug therapy:
- correct patient,
- legality and completeness of medication orders,
- current and complete visit note and pertinent historic encounters,
- medication-related adverse events,
- appropriateness of medication therapy for the stated indication,
- appropriateness of the medication, dose, frequency, route and method of administration,
- therapeutic duplications,
- real or potential drug interactions,
- medical condition interactions,
- gender or age conflicts,
- compliance with SU and IHS policies (i.e. P&T policies), and
- excessive duration, inappropriate use or overuse of certain medications, and/or early refill.
- 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.
- patient's health record. All interventions will be entered into the facility’s quality assurance performance improvement tracking program.
- Prepackaging. Pharmacies may furnish pre-labeled, prepackaged
drugs to small field clinics that do not have pharmacies.
- Labels must be computer generated.
- The prepackaged drugs must be in appropriate stock containers having required labeling and available in the sizes and units most commonly prescribed.
- 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.
- 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.
- 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.
- The Pharmacy Chronological Control Log is the basic control number record for bulk compounded and prepackaged items.
- 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.
- 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.
- 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.
- Each prescription must be assigned a unique prescription number when filled.
- 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.
- 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
NOTE: The same labeling criteria will apply for all IHS facilities whether or not a pharmacist is on staff.
- 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 should be dispensed according to DEA and/or FDA labeling
- Controlled Substances.
- Patients are required to present valid photo identification to pick up controlled substances. Examples of valid ID: tribal ID, state driver’s license, or military ID.
- 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.
- An automated robot may be used for counting controlled substances if the robot is locked with only pharmacist access to cells or is located within a narcotic vault room.
- Non-pharmacist Medication Dispensing.
- 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.
- The following safeguards must be applied:
- 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.
- Only trained, designated prescribers and nurses are permitted access to medications.
- 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.
- 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.
- This process is evaluated on an ongoing basis to audit the medications accessed routinely.
- 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.
- 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.
- Mailing Prescriptions.
- 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.
- A pharmacy may elect to fill and mail from their local facility or use a central fill pharmacy.
- 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. Facilities must report mail delivery practices conducted under this section to the IHS Principal Pharmacy Consultant, who will maintain a list of such facilities.
- New or first-time prescriptions will be filled and dispensed locally.
- Returning Medications to Stock.
- All prescriptions that are not picked up by the patient or proxy should be returned to stock within 10 days in the Resource and Patient Management System (RPMS) and all other pharmacy automation. The medication will not be returned to the original stock bottle.
- All controlled substances not picked up and are returned to stock must be processed in RPMS, 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 health care professional.
- Controlled Substances.
- 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 as this is not an appropriate billing procedure.
- Primary Care Providers.
To the extent consistent with their licensure scope of practice, IHS pharmacists are permitted to 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.
- Basic Pharmacotherapy Assessment Skills.
Pharmacists may perform basic pharmacotherapy assessments including, but not limited to, patient interview, chart review, ordering of laboratory tests, administering immunizations, laboratory test interpretation, limited physical assessment (e.g., blood pressure, pulse, height, weight, finger stick glucose, patient observation, etc.), and providing patient counseling and education.
- 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.
- 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.
- 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:
- addressing medication management needs of patients with defined diagnoses,
- management of medication-related adverse events,
- ongoing and acute medication monitoring, and
- collaboration with other health care providers for management of new diagnoses for patients.
- The SU must have a policy that addresses all required elements of
pharmacist clinical privileging including, but not limited to:
- 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,
- processes for renewal of clinical privileges.
- professional practice evaluations (focused and ongoing),
- all required competency assessments, education, training, and experience requirements. and
- a renewal process for each clinical pharmacist at least every two years, but prior to the expiration of clinical privileges.
- Procedures for Initial Clinical Privileges. Initial clinical privileges are approved with a mandatory 1-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 requirements to be completed prior to granting the requested clinical privileges.
- 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
- 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.
- A mentorship is required for:
- 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
- Any clinical pharmacist requesting an 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.
- 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.
- 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.
- 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.
- 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:
- Collaborative Practice Agreement.
- 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
- statement of need, rationale, and purpose for agreement;
- agreement information, including but not limited to the following:
- process for obtaining referrals and eligibility documentation;
- patient care procedures;
- process regarding referral and/or discharge back to referring primary care provider;
- clear statements of tasks that the pharmacist is authorized to perform
- order and interpret laboratory tests;
- perform limited physical assessment;
- provide patient education;
- provide follow-up care;
- prescribe (initiate, modify, and discontinue) medications.
- Document outcomes:
- identify clinical and administrative outcomes/measures to be collected;
- annually obtain, document, and report outcomes to the Medical Staff.
- Quality Assurance/Performance Improvement
- describe continuous performance improvement process for clinical services provided;
- report performance improvement annually to Medical Staff;
- implement, describe, and document a peer review process;
- Training and Local Certification.
- define pharmacist training requirements and practice qualifications;
- describe the process for annual evaluation and documentation of competencies.
- Treatment Guidelines. Identify and adhere to current national clinical practice guidelines.
- Clinical Protocol Approval.
- agreement will be signed with appropriate signatures, position titles and dates of approval; and
- all revision and review dates will be documented.
- 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:
- 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, 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.
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.
- 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.
- Medications Brought Into a SU by Patients.
- 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.
- 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) brought into the IHS SU by the patient or family member. IHS SU policy must provide guidance as to the use, disposition, storage, or return of these medications/supplies.
- 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.
- 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.
- 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.
- Inpatient Medication Orders.
- 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.
- 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.
- 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 notation, keep vein open or, to keep open, must be accompanied by the appropriate flow rate, as determined by the ordering provider.
- 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:
- All medication orders are automatically cancelled when a patient undergoes surgery or is admitted or discharged from the Intensive Care Unit.
- New orders must be written post-operatively or upon Intensive Care Unit (ICU) admission or discharge.
- Post-operative and ICU transfer orders written as "renew all previous orders" are not recognized.
- 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.
- 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.
- All medication orders must be re-evaluated by a provider with any change in patient status or relocation to another ward or service.
- Intravenous Admixtures.
- Hospitals will have an intravenous (IV) admixture program that meets
current USP standards. The compounding of IV admixtures will be performed
by a pharmacist or by a pharmacy technician who is trained in the
preparation of IV admixtures. Pharmacists and pharmacy technicians will be
certified annually in the preparation of IV admixtures. The pharmacist is
responsible for ensuring that all IV admixture products prepared by
pharmacy personnel are:
- therapeutically and pharmaceutically appropriate, that is, rational and free of incompatibilities or similar problems for the patient;
- free from microbial, viral, and pyrogenic contaminants;
- free from unacceptable levels of particulate and other toxic contaminants;
- correctly prepared, i.e., contain the correct amounts of the correct drugs;
- properly labeled, stored, and distributed.
- The pharmacy department will ensure training in the aseptic preparation
of parenteral admixtures is provided to all nursing and medical personnel
who may be required to prepare such products in the absence of the
Cytotoxic and Other Hazardous Drugs. See Indian Health Manual Part 3, Chapter 27 - Controlling Occupational Exposure to Hazardous Drugs https://www.ihs.gov/ihm/pc/part-3/p3c27/.
- Hospitals will have an intravenous (IV) admixture program that meets current USP standards. The compounding of IV admixtures will be performed by a pharmacist or by a pharmacy technician who is trained in the preparation of IV admixtures. Pharmacists and pharmacy technicians will be certified annually in the preparation of IV admixtures. The pharmacist is responsible for ensuring that all IV admixture products prepared by pharmacy personnel are:
- Pharmacy Staffing During Off-Hours.
- When the onsite pharmacy is not open 24 hours-a-day and 7 days-a-week, a contingency plan must exist to assure a review of the medication orders prior to administration.
- 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.
- This review must be performed by an individual who is not the prescriber and completed before the first dose is administered.
- 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.
- 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.
- 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.
- When the onsite pharmacy is not open 24 hours-a-day and 7 days-a-week, a contingency plan must exist to assure a review of the medication orders prior to administration.
- 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.
- Required Clearances.
For any investigational drug to be used in an IHS facility, clearance is required as outlined:
- 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 another IRB.
Before a patient may receive an investigational drug at an IHS facility, the following requirements will be met:
- 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.
- 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.
- 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.
- 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 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.
- If use of an investigational drug 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.
- In instances where time is a critical factor because of serious or potentially fatal illness, the IHS physician accepting responsibility for use of the investigational drug may request verbal approval from the Area CMO to use the investigational drug for a limited time, not to exceed 30 days, during which the formal process outlined above will be completed.
- Multiple Patients in Investigational Drug Study. The following
requirements will be met for enrolling multiple IHS patients in an
investigational drug study whether initiated by an IHS provider or included
in a study conducted by another institution or investigator holding an
approved IND application:
- Prior to requesting approval to use an investigational 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.
- The proposed study must be approved by the institution's P&T Committee, the SU Director, Tribal authorizing body, Area IRB, IHS Research Director, and the Director of the IHS or designee.
- 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.
- 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.
- In presenting a request for approval of an investigational new drug
study, the following information will be furnished for review to the
various required committees and individuals:
- Name of principal investigator and his/her training and experience.
- Purpose of the study.
- Names of the drug: trade, generic, chemical, and any other.
- 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.
- Benefits the patient may derive from such a study.
- The informed consent form used for obtaining signed permission from participants which will include the reason the investigational drug 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.
- 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.
- A short statement of the study methodology including a description of the location and subjects (age, sex, ambulatory, or hospitalized).
- The degree of risk involved and related factors including:
- withholding of a recognized and accepted treatment;
- adverse effects on quality of life issues;
- blood dyscrasias;
- degree of supervision needed;
- synopses of previous published studies;
- manufacturer's information and published reports describing side effects, toxicity and indications; and
- additional staffing, costs, and/or workload projections.
- When final approval for the use of an investigational drug has been
obtained from the Director of IHS, or his/her designee, the following
procedures will be used:
- The signed written consent must be obtained from each subject or his/her legal guardian and maintained on file.
- A physical examination will be completed on each subject.
- The Chief Investigator who is using the investigational drug will be responsible for providing the pharmacy service with pertinent information on the drug.
- It is the responsibility of the pharmacy service to prepare and make available to the nursing service summaries of the basic information on investigational drugs.
- The administration of investigational drugs by any route by members of the nursing staff is 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.
- Investigational drugs will be clearly labeled as such by the pharmacy.
- 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.
- Storage, Labeling, and Dispensing of Investigational Drugs. Investigational drugs will be stored, packaged, labeled and dispensed by the pharmacy, following ASHP guidelines.
- 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 another IRB.
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 Branch. The Pharmacy Branch will assure compliance with regulatory agencies and accrediting bodies (i.e. Drug Enforcement Agency, The Joint Commission, etc.) and current practice standards such as 1) The ASHP Statement on the Pharmacy and Therapeutics Committee and the Formulary System and 2) The ASHP’s Technical Assistance Bulletin on the Evaluation of Drugs for Formularies.
- Quality Assurance and Performance Improvement Plan (QAPI).
- A QAPI plan must be approved by the SU Clinical Director and the CEO per CMS or other accrediting body standards.
- The QAPI activities for pharmacy will include but not be limited to:
- 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 sound-alike drugs, high-alert medications, and hazardous medications;
- Monitoring and evaluating the pharmacy QAPI plan. Monitoring will include at a minimum: adverse drug events, medication errors, medication recalls and other pharmacy indicators;
- Written annual evaluation of the pharmacy QAPI; and
- Appropriate reporting of the monitoring and evaluation of pharmacy services to other departments, the facility QAPI committee, and, where applicable, to the Governing Body.
- Program Evaluation.
- Annual Controlled Substance Audit.
- The APC or his/her designee will conduct an annual physical audit of all Schedule II-V controlled substances at each facility in the Area 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.
- The count will be verified against the inventory records.
- An exact count must be completed (versus an estimate).
- This will include stocks in the pharmacy and all locations in the facility where controlled substances are maintained.
- During the physical audit, a visual inspection for quality control will be performed to determine the integrity of the containers and the condition of the contents, including any deterioration, substitution, or tampering.
- Records of stocks received will be verified for entry on the inventory record at each location where Schedule II medications are stocked within the facility.
- DEA Form 222 and electronic generated scheduled substance orders will be randomly audited to ensure that receipts of controlled substances are properly recorded.
- Procurement records for Schedule II medications will be audited and verified with pharmacy records.
- Annual Controlled Substance Audit.
- Reporting Adverse Drug Events and Medication Errors.
- All adverse drug events will be reported to and reviewed by the SU
P&T, quality assurance and/or medication safety committee(s).
- This includes all allergic responses to drugs, any overextension of therapeutic effects or side effects, and any other unexpected response to a drug that results in actual or potential risk to the patient.
- In addition, all serious, unusual, or previously unreported adverse effects will be reported directly to the FDA MedWatch program.
- Adverse reactions to vaccines will be reported online using Form VAERS-1, Vaccine Adverse Event Reporting System https://vaers.hhs.gov/. A copy of each report will be filed in the pharmacy with a copy sent to the P&T Committee.
- Medication errors will be entered into an IHS approved medication error reporting database and reviewed by the SU P&T, 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-E)
- All adverse drug events will be reported to and reviewed by the SU P&T, quality assurance and/or medication safety committee(s).
- Pharmacy Software Enhancements.
- 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 assure proper support of system changes.
- 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:
- A written request with a description and justification for the modification desired is generated at the local facility.
- The request is entered by the requestor at the local facility via the RPMS Feedback page on the IHS website where it then gets routed to the appropriate package leads.
- 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 Professional Services Group (PSG).
- If approved by the PSG, the request is prioritized and submitted to 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.
- 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.
ASHP Guidelines for the Use of Investigational Drugs in Institutions https://www.ashp.org/-/media/assets/policy-guidelines/docs/guidelines/management-investigational-drug-products.ashx?la=en&hash=51D88DFB7BF0F706667BE563295F9E5A6FAE8C85
Code of Federal Regulations, Title 21, Chapter II - Drug Enforcement Administration https://www.deadiversion.usdoj.gov/21cfr/cfr/index.html
Code of Federal Regulations, Title 21, Part 1317 Disposal of Controlled Substances by Registrants https://www.deadiversion.usdoj.gov/21cfr/cfr/2117cfrt.htm
Institute for Safe Medication Practices https://www.ismp.org/
National Coordinating Council for Medication Error Reporting and Prevention http://www.nccmerp.org/
United States Food & Drug Administration Drug Supply Chain Security Act https://www.fda.gov/Drugs/DrugSafety/DrugIntegrityandSupplyChainSecurity/DrugSupplyChainSecurityAct/
United States Food & Drug Administration Disposal of Unused Medicines: What You Should Know
United States Pharmacopeia-National Formulary Good Storage and Distribution Practices for Drug Products.