Part 3 - Professional Services
Chapter 7 - Pharmacy
3-7.1 INTRODUCTION
- General
This chapter establishes policies and procedures pertaining to the delivery of pharmaceutical care by Indian Health Service (IHS). Pharmaceutical care is the responsible provision of drug therapy for the purpose of achieving definite outcomes that improve patients' quality of life. Pharmaceutical care is the process through which pharmacists cooperate with patients and other health professionals in designing, implementing, and monitoring therapeutic plans that produce favorable patient care outcomes.
- Mission Statement
The mission of the IHS Pharmacy Program is to deliver the highest quality comprehensive pharmaceutical care possible within available resources.
In carrying out this mission, the IHS Pharmacy Program serves as an integral part of a comprehensive, community based health care delivery system. Pharmacy services are patient-centered and are directed toward optimal patient care outcomes, health promotion, and disease prevention. The principal purpose of IHS pharmacy services is to ensure efficacious, safe, and cost-effective drug therapy and appropriate outcomes in the use of drugs and medicines. Direct patient care activities are supported by managerial training, supply services, and drug distribution and control services.
The IHS pharmacy services require that all pharmacists consider and respect the cultural beliefs of the communities in which they serve. It is also important to realize that IHS pharmacists may serve as role models for persons within the communities who may wish to pursue careers in the health care field. Also, education and other programs to support rational drug therapy within the community are essential components of pharmacy services.
The expected outcomes of IHS pharmacy services are to:
- Ensure that medications are appropriately prescribed.
- Encourage the provision of cost effective health care.
- Prevent the inappropriate and overuse of medications.
- Increase the number of treatment successes and decrease the number of treatment failures.
- Decrease the frequency and severity of adverse reactions to prescribed medications.
- Decrease the number of unnecessary inpatient admissions and outpatient visits.
- Increase the appropriate use of medications to cure and prevent diseases, and to maintain good health.
Pharmacy services are fully integrated into the health care system. Therefore, pharmacists may be called upon to perform other extended functions such as primary patient care and program management.
3-7.2 PROGRAM ADMINISTRATION
- Functional Responsibilities
The IHS is organized into three major administrative levels: Headquarters, Area Offices, and service units. There is a line of authority from the IHS Director to the Area Directors and from the Area Directors to the Service Unit Directors.
Within a service unit, the Chief of Pharmacy Services reports to the Clinical Director who is directly responsible to the Service Unit Director.
A technical and consultative relationship exists between administrative levels, with the Area and Headquarters pharmacy staff responsible for, providing direction, guidance and evaluative services to the service unit and contracted program pharmacies. In addition, all levels of the IHS pharmacy staff shall provide consultation to contracted programs when requested.
- Headquarters Program
The IHS Chief of Pharmacy Services serves as the coordinator, consultant, and advisor for all matters relating to the provision of pharmacy services throughout the IHS. The IHS Chief of Pharmacy Services is responsible to the Director, Division of Clinical and Preventive Services (DCPS). The Director, DCPS, is responsible to the Associate Director, Office of Health Programs,. who is responsible to the Director, IHS.
The IHS Chief, Pharmacy Services, is responsible for the:
- Development of goals and objectives for improving the delivery of pharmacy services throughout the IHS.
- Development and implementation of IHS-wide. pharmacy policies, procedures, and standards.
- Identification and development of resources for the delivery of services. This includes coordination of the national recruitment program of pharmacists for the IHS and continuing staff development.
- Oversight, support, and evaluation of Area Pharmacy Programs, including the evaluation of Area quality improvement activities (see the IHS Area Pharmacy Program Review Document).
- Provision of consultation to tribal groups on delivery of pharmacy services and related matters.
- Maintenance of liaison with national pharmaceutical organizations to ensure the IHS Pharmacy Program remains current in the latest pharmaceutical knowledge, skills and methods to improve the health status of the American Indian/Alaska Native.
- Area Program
The primary function of the Area Pharmacy Officer (APO) is to ensure that the quality of pharmaceutical care delivered at each facility meets established standards and the needs of the population served. The APO is responsible for continually evaluating the quality of services delivered and providing recommendations for correcting deficiencies and improving care.
As Program Consultant on all matters relating to pharmaceuticals and the practice of pharmacy, the APO is responsible to the Area Director and serves the various Area program staff, service unit staff, and tribal groups.
The responsibilities of the APO include:
- Developing, interpreting and refining standards that promote effective pharmaceutical care.
- Developing an Area Pharmacy Program work plan containing goals and objectives that meet IHS Pharmacy Standards of Practice (see Appendix 3-7-A) and standards of national accrediting bodies.
- Conducting annual reviews of all service unit pharmacy programs (see the IHS Service Unit Pharmacy Program Review Document).
- Coordinating the development and operation of an Area Pharmacy and Therapeutics (P&T) Committee.
- Serving as Executive Secretary of the Area Pharmacy and Therapeutics Committee.
- Coordinating the development and maintenance of an Area formulary.
- Planning and introducing improvements in the delivery of pharmaceutical care and providing technical assistance as required.
- Evaluating the quality of services delivered by the service unit and contracted pharmacy programs.
- Coordinating the recruitment, retention, orientation, evaluation, training and career development of pharmacists.
- Coordinating pharmacy coverage of direct services during staffing shortages.
- Coordinating student extern and Commissioned Officer Student Training and Extern Program (COSTEP) activities.
- Serving as project officer for contracted pharmacy services.
- Analyzing, and reporting on overall pharmacy operations and costs the Area Director and the IHS Chief of Pharmacy Services.
- Providing quarterly and annual cumulative summary workload and narrative reports to the IHS Chief of Pharmacy Services.
- Maintaining liaison with national and local pharmaceutical organizations to ensure pharmacy practice within the Area remains current in the knowledge, skills, and methods of the profession.
- Developing an Area Pharmacy Quality Improvement (QI) Plan that assesses the quality of the Area Pharmacy Program and meets the requirements of national accrediting bodies.
- Assisting the IHS Chief of Pharmacy Services and facility staff in the design of new or remodeled pharmacy spaces in accordance with the space allocation standards for pharmacy practice as described in the IHS Health Facilities Planning Manual.
- Service Unit Program
The IHS Pharmacy Standards of Practice summarized in Section 3-7.3 of this Manual describe the elements of pharmaceutical care that are delivered at the service unit level.
The responsibilities of the Service Unit Chief of Pharmacy Services include:
- Providing leadership, guidance, and supervision to staff in achieving departmental goals and objectives.
- Conducting a pharmacy program that meets all standards of the IHS Pharmacy Program as well as those of national accrediting bodies.
- Developing short and long term goals and objectives for the department in conjunction with the pharmacy staff.
- Developing written policies and procedures for the provision of pharmacy services that are revised annually and approved by service unit management.
- Developing a departmental QI Plan based on the Area Pharmacy QI Plan.
- Serving on the Service Unit P&T Committee.
- Maintaining, revising, and printing (at least annually) a drug formulary based on the Area formulary.
- Managing departmental resources effectively and efficiently.
- Maintaining current knowledge of an compliance with all rules and regulations affecting the practice of pharmacy at the facility.
- Evaluating the overall performance of the pharmacy program as well as the performance of individual pharmacists in meeting the IHS Pharmacy Standards of Practice.
- Representing the pharmacy department in contacts with IHS administrators, tribal organizations, professional organizations, Colleges and Schools of Pharmacy, and other governmental organizations.
- Participating in the recruitment, retention and orientation of pharmacy staff.
- Participating as a preceptor for student externs, residents (when applicable), and other student training programs.
- Analyzing and preparing quarterly and annual cumulative summary workload reports and medication cost data for submission to the APO by the 15th day following the end of each quarter.
- Personnel
- Staffing
- Requirements.
The total number of positions required to manage and deliver pharmaceutical care is determined by the IHS Resource Requirements Methodology Needs Assessment (RRMNA) There are RRMNA criteria for both service unit and Area Office levels. The RRMNA criteria also suggest the ratio of professional to non-professional personnel. The supervisory, managerial, and clerical- positions required for each facility and the relative skill levels required for each position are determined by the civil service position classification and IHS Pharmacy Billet Standardization criteria.
The IHS Pharmacy Billet Standardization and RRMNA criteria use workload projections and other factors that affect staffing needs to determine the numbers and type of staff required to deliver pharmaceutical care that meets the IHS Pharmacy Standards of Practice (see IHS RRMNA and IHS Pharmacy Billet Standardization and Career Development Guidelines for further information).
When additional primary care providers are added to facility staffing, an assessment of pharmacy staffing shall be completed to determine the need for additional staff to meet the increased workload.
- Qualifications
All pharmacists delivering pharmaceutical care to American Indians/Alaska Natives shall be currently licensed by at least one of the fifty State boards of pharmacy in the United States. Exceptions to this rule are provided by both civil service regulations (see the Preston Case) and commissioned corps policies in accordance with applicable rules and regulations of the respective personnel systems.
Pharmacists hired directly by tribes or tribal organizations pursuant to Public Law 93-638 (P.L. 93-638) are subject to licensure requirements of the State in which their practice is located.
In addition to licensure requirements, pharmacists applying for employment under civil service or commissioned corps personnel systems must meet additional qualifications regarding academic achievement, physical and mental health, professional ethics, character, and United States citizenship as specified by each respective personnel system.
- Staff Development
The IHS Pharmacy Program encourages activities that enhance the professional growth of staff and the ability to accomplish the mission of the program.
- Career Development
Career development is an integral and beneficial component of personnel and program management within the IHS Pharmacy Program. To link individual career goals and potentials to comprehensive pharmacy program needs, the IHS Pharmacy Program has formulated and adopted formal career development guidelines. Incorporated into those guidelines is a standardization of the billet/position description systems.
These guidelines allow for a progression of duties/responsibilities, mobility, and career advancement in harmony with total program requirements (see IHS Pharmacy Billet Standardization and Career Development Guidelines). Mobility is further ensured by predetermined lengths of assignment to billets/locations (see IHS Circular 84-l).
Commissioned officers assigned to tribal P.L. 93-638 programs are covered by these guidelines.
- Training
- General
Training of pharmacy staff shall be provided for:
- The acquisition of new skills/techniques.
- The upgrading of knowledge and skills related to current trends in clinical and administrative pharmacy practice.
- Meeting identified personnel/program needs.
It shall be the responsibility of the Area Office and the-facility to identify resources for this training and to ensure its completion.
- IHS Clinical Pharmacy Orientation
All IHS pharmacists shall successfully complete the IHS Basic Clinical Pharmacy Orientation. This course provides an, orientation to the IHS philosophy of pharmaceutical care and provides training in skills needed to meet IHS Pharmacy Standards I and II.
- Extended Professional Training
- Residency
The IHS provides opportunities for one year post graduate specialty and residency programs. The residencies, approved by the appropriate accrediting bodies, are provided at various sites within IHS.
- Graduate Degree Programs
The IHS also provides opportunities for graduate training programs leading to advanced degrees. This training program has a limited number of positions for full time training. Funding primarily originates from the Area. In addition, graduate degrees can be pursued on a part time basis after normal working hours. Through Area or service unit support or through use of Veterans Administration benefits, IHS pharmacists can complete degree programs leading to Masters or Doctor of Pharmacy (Pharm. D.) degrees.
The APO should be contacted for specific information regarding these programs.
- Continuing Education
continuing education activities for pharmacy personnel are an important and integral part of the IHS pharmacy career development program. In addition to meeting license requirements, each pharmacist has an individual responsibility to enhance and expand his/her knowledge base through the use of resources such as professional text and journal reviews, attendance at professional conferences/meetings, individual instruction from local staff and practitioners, and other appropriate avenues. Program managers at all administrative levels shall support continuing education activities within available resources.
- Supportive Personnel
The IHS Pharmacy Program uses supportive personnel such as pharmacy technicians, pharmacy assistants, and clerical staff in the administration and provision of. pharmacy services. These personnel primarily receive on-the-job training in their pharmacy duties.
Supportive personnel must obtain annual certification of competency in designated skills. The annual certification shall be the responsibility of the Chief of Pharmacy Services at each facility. Use of available training guidelines and standards is encouraged [see American Society of Hospital Pharmacists (ASHP)
Statement on Supportive Personnel in Hospital Pharmacy ASHP Regulations on Accreditation of Hospital Pharmacy Technician Training Programs, and ASHP Accreditation Standards for Pharmacy Technician Training Programs). Program managers at all administrative levels shall support training activities for pharmacy supportive personnel within available resources.
- Professional Activities
All IHS pharmacists are encouraged to actively participate in the advancement of their profession.
Such activities may include but shall not be limited to:
- Serving as preceptors and role models for pharmacy interns, students, COSTEP appointees, and residents assigned to the program.
- Promoting interest and activities in the practice of pharmacy through participation, in national, State and local professional organizations.
- Promoting and participating in IHS residency programs.
- Supporting and participating in the recruitment and retention of pharmacy staff.
- Resource Management
- Facilities Planning And Construction
The IHS Health Facilities Planning Manual (HFPM) contains criteria for space allocation and construction of new health care facilities. Space for pharmacies is, allocated based on the projected number of inpatient days and/or the projected number of outpatient visits. The Pharmacy Standards of Practice dictate some construction criteria such as the provision of an adequate number of patient consultation rooms. A complete copy of the HFPM is available from the Area Office.
- Alternate Resources
The IHS remains the payor of last resort for services covered by other beneficiary programs (Medicare, Medicaid, State and local programs, and other third party payers). American Indian/Alaska Native patients covered under third party beneficiary programs may choose to receive care in IHS facilities. The IHS shall make every effort to bill and collect all allowable charges for these patients from the appropriate third party payor. The IHS automated pharmacy system, Resource Patient Management System (RPMS), contains computer software to facilitate third party billing for pharmacy services.
- Contracted Services
- Professional Review
Prior to contract award, the APO and a service unit pharmacist or pharmacy consultant shall review, for appropriateness and quality, all purchase agreements/contracts for pharmaceutical care or supplies obtained from contractors outside IHS. This shall include contracts and subcontracts with community pharmacies, P.L. 93-638 contracts, Urban programs, and contract health services.
The APO and the Service Unit Chief Pharmacist shall evaluate the performance of the contractor for scope, quality, and appropriateness of services to determine if the contractor is in compliance with the pharmaceutical care portion of the contract.
- Contract Community Pharmacies
The IHS may establish contracts with community pharmacies to provide pharmaceutical care for eligible patients. Community pharmacy contracts may be necessary in areas where there are no direct services available from the IHS. However, this practice should be minimized as it is more cost-effective to use IHS pharmacy services.
Contracts with community pharmacies must stipulate that patient medication profiles are to be maintained and used appropriately for all IHS patients. Also, all patients shall be individually counseled regarding the proper use of medications. A copy of the facility's current formulary shall be provided to all contract community pharmacies. Contractors must also adhere to the IHS Pharmacy Standards of Practice. The Service Unit Chief Pharmacist (or designee) shall review all contract prescriptions to ensure that all drugs dispensed are on the approved service unit formulary and the price charged by the community pharmacy does not exceed the maximum allowable costs for the area as determined by Medicaid, Health Care Financing Administration (HCFA). Health Resources and Services Administration Form HRSA-301, Contract Prescription Blank, shall be used for contract prescriptions.
The IHS will not pay for contract prescriptions for ineffective drugs in accordance with Department of Health and Human Services regulations (P.L. 97-35). All prescription information from contract pharmacies shall be readily available for reference and use by IHS patient care providers.
- P.L. 93-638 Contracts
Federally recognized American Indian Tribes and Alaska Native entities in the United States may contract to provide health care services through P.L. 93-638. The P.L. 93-638 contractor must maintain certain standards established by The Joint Commission on Accreditation of Healthcare Organizations (JCAHO) and HCFA in order to qualify for funds through Medicaid and from other third party payers (see the Joint Commission Accreditation Manual for Healthcare Organizations). Also, the P.L. 93-638 contractor must meet the requirements for periodic renewal of accreditation or certification in order to remain eligible for these funds.
In addition, all P.L. 93-638 contractors are strongly encouraged to adopt and comply with the IHS Pharmacy Standards of Practice.
- Computer Systems
- General
The IHS Pharmacy Program uses computer systems for prescription processing, clinical activities, and administrative pharmacy functions. The pharmacy system is linked to a larger IHS patient data base called the Patient Care Component (PCC).
All medications dispensed or administered to outpatients should be entered into the, computer system. All medications entered into the computer system must have a corresponding entry on a PCC encounter form with the same date and time. When the pharmacist refills medications or provides over the counter medications, he/she must complete a PCC form which corresponds to the computer entry. The PCC form must include patient identification, date, clinic code, provider code, diagnosis or symptom, and signature. All medications dispensed or issued from emergency room after-hours cabinets must also be entered into the computer system [see Section 3-7.3D(2b) of this Manual]. Discharge medications must be entered into the computer with patient status entered as "Inpatient."
- Professional Specialty Group
The IHS Pharmacy Branch Professional Specialty Group (PSG) serves as a liaison between IHS computer systems analysts and pharmacy computer system users. This IHS-wide committee was organized to develop short and long term goals and objectives for the development and enhancement of pharmacy software. The PSG consists of representatives from different Areas of the IHS and tribal programs. The PSG has responsibility for recommending, reviewing, implementing, and evaluating appropriate pharmacy software for use in all IHS facilities and those Tribal and Urban Health facilities using the IHS RPMS system.
- Software
The pharmacy computer system increases the accuracy and efficiency of prescription processing, provides increased accountability for drugs dispensed, and assists pharmacists in meeting the IHS Pharmacv Standards of Practice. The pharmacy computer system includes both inpatient and outpatient software packages; the respective User's Manual gives a complete description of each package.
IHS pharmacies are expected to use the most current version(s) of pharmacy software.
Tribal and Urban pharmacy programs are encouraged to use the system and current software if there are available resources for this activity. Tribal and Urban programs may receive training on the system and assistance in implementing and operating the program from the APO. The respective Area Information Systems Coordinator (ISC) and/or the APO are responsible for installing the most current version. The Area ISC is responsible for the prompt resolution of equipment or software problems in IHS facilities.
- Modification Of Software
Modifications or additions to the pharmacy software may be requested by pharmacy software users at any time. The procedure for requesting modifications or additions is as follows:
- A written request is prepared using the appropriate request form (see Appendix 3-7-B) with a description and justification of the modification desired.
- The request is submitted through the Service Unit Chief Pharmacist to the PSG member who represents the Area.
- The request is considered and evaluated at the next PSG meeting.
- If approved by the PSG, the request is submitted to IHS systems analysts and the desired changes -are implemented.
- The modification is included in the next scheduled software update release.
- Patient Care Component
The Patient Care Component (PCC) system is a computerized health information data base which is being implemented throughout the IHS. Using standardized patient encounter forms, patient care providers record health information which is- entered into the PCC computer system. The system generates a Health Summary Sheet at each, patient visit. The Health Summary Sheet includes the patient's immunization status, a summary of recent clinic visits, a summary of hospitalizations, a patient problem list, a list of patient drug allergies, selected laboratory results, and information on family planning and birth control. Medication profiles obtained from the pharmacy system are also included on the Health Summary Sheet.
Clinical information on the Health Summary Sheet must be updated at each patient visit in order to provide maximum benefit. The pharmacist is responsible for updating those items on the Health Summary Sheet which relate to pharmaceutical care.
PCC serves as a useful tool for health care providers in the clinical management of patients and in health promotion and disease prevention activities.
3-7.3 PROGRAM OPERATION
- General
This sub-chapter provides guidelines, policies, and procedures pertaining to the operation of the IHS Pharmacy Program based on the IHS Pharmacy Standards of Practice (see Appendix 3-7-A).
- Appropriateness Of Drugs Therapy
The goal of the pharmacy service is to ensure that drug therapy is safe, efficacious, and cost-effective. A pharmacist must review the complete health record of each ambulatory patient prior to the dispensing of medications. In contract community pharmacies, patient medication profiles shall be maintained and reviewed prior to the dispensing of medications. A complete drug history and review of the health record of each hospitalized patient shall be conducted prior to the administration of medications when possible, or as soon as a pharmacist is available. 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 shall be resolved with the prescriber prior to the dispensing or administration of any medication.
After initiation of drug therapy, a pharmacist shall monitor ongoing or intermittent therapy to evaluate effectiveness and to prevent or detect adverse outcomes. This is performed daily for hospitalized patients and at each pharmacy visit for ambulatory patients. Concerns or questions resulting from this process shall be resolved with the prescriber as soon as possible.
The following items shall be checked when screening health records and monitoring patients for appropriateness of drug therapy:
- Correct patient
- Legality of drug orders
- Completeness of medication orders
- Adverse drug reactions
- Appropriateness of drug therapy for stated indication
- Appropriateness of drug therapy for patient
- Drug-drug, drug-food, drug laboratory interactions
- Pathological conditions which might require alternative dose or drug
- Appropriateness of dosage form
- Appropriateness of dose and quantity of drug
- Completion of all treatment plan elements of current visit
- Current status of health maintenance and wellness parameters, e.g., PAP; immunizations, diet, lifestyle
- Appropriateness of follow up for current health problems
- Cost-effectiveness
A pharmacist shall attend physician rounds on a regular basis, if rounds are conducted at the facility, to provide recommendations regarding drug therapy. When possible, a pharmacist should also participate in nursing report on a daily basis and attend weekly discharge planning meetings.
Pharmacists shall document all appropriate record reviews, monitoring activities, interventions, consultations, and recommendations in the patient's health record.
When disagreements arise between the pharmacist and the prescriber regarding the appropriateness of a prescribed regimen, the pharmacist must exercise professional judgment in determining the most appropriate action to take. If the drug therapy seems rational though somewhat discrepant from approved usage or dosage, the pharmacist may note in the health record, "prescribed regimen verified with prescriber. If, on the other hand, the pharmacist is concerned that harm may come to the patient and the prescriber is not willing to change the order, the pharmacist may refer the matter to the Chief Medical Officer or the Clinical Director. The pharmacist must notify, the Chief Pharmacist of this matter. If resolution still cannot be reached, the pharmacist may exercise professional judgment and refuse to fill the prescription. All disagreements of this nature shall be reviewed as a risk management activity by the appropriate service unit committee and, depending upon the circumstances, the pharmacist may wish to complete an incident report utilizing Form HRSA-123, Incident Report.
No pharmacist shall be required to fill a prescription that he/she believes will endanger the health of the patient.
- Patient Consultation
The pharmacy service shall provide counseling to each patient receiving medication and shall verify the patient's understanding of the purpose of therapy. Information shall be presented in an appropriate manner to facilitate patient understanding of the medication regimen, how the regimen relates to treatment of the individual's condition, and the desired outcome of the drug therapy. When presenting information, the pharmacist shall incorporate respect for cultural values and traditions of the population served; a translator may be necessary when translation into a native language is required for effective communication.
- Initial Consultation
Counseling sessions for new medications shall include:
- The disease, symptom or complaint for which the patient is taking the medication.
- The name and strength of the medication.
- How the medication is to be used; for example, dose and dosage form; administration route, schedule, and technique; duration of therapy; preparation for use; proper storage; drug-drug and drug-food interactions; and ancillary instructions.
- Desired therapeutic outcome and what to do if it doesn't occur.
- Potential unwanted effects and what to do if they occur.
- How to minimize unwanted effects.
- Other treatment plan elements such as follow up appointments, laboratory tests, and medications administered at the facility, e.g., injections.
- Presentation of supplemental written information as required.
- Subsequent Consultations
Subsequent pharmacist-patient consultations on the same medication(s) shall verify that the patient is taking the medication(s) as directed, and may explore the patient's perception of the effect of the regimen on his/her well-being and quality of life. This may include:
- Exploring problems encountered with compliance.
- Providing supplemental information on coping with minor side effects.
- Providing an opportunity for the patient to relate any change in condition relevant to drug therapy.
Outpatients shall receive medication counseling in a private consultation room, if available. This room shall have the necessary arrangement of furnishings and instructional aids to provide an atmosphere conducive to effective communication.
Inpatients who are to receive discharge medications must receive medication counseling prior to discharge. This counseling shall be provided in the patient's hospital room, other inpatient area or the pharmacy consultation room and must be documented on the patient's discharge instruction sheet. Discharge medication counseling is to be performed by a pharmacist if one is available at the time of discharge.
- Medication Availability, Preparation, Control
The pharmacy service is responsible for ensuring that drug availability, distribution, and control are appropriate, safe, and meet the needs of patient care as defined by the Service Unit P&T Committee. Drug and dosage form, selection, purchasing, preparation and dispensing for both inpatients and outpatients shall meet contemporary, national standards.
- Pharmacy And Therapeutics Committee
Each Area shall have a Pharmacy and Therapeutics (P&T) Committee whose decisions shall be binding on all IHS facilities in the Area. Each service unit must also have a P&T Committee. The P&T Committee is an advisory group to the medical staff and serves as the organizational line of communication between the medical staff and the pharmacy department. The P&T Committee is composed of physicians, pharmacists, and other health professionals selected with the guidance of the medical staff. It recommends policy to the medical staff and administration on matters related to the therapeutic use of drugs.
- Area
- Purpose
The Area Pharmacy and Therapeutics Committee shall:
- Serve as an advisory committee to the Area and service unit staffs in formulating policies regarding the selection, use, and administration of pharmaceuticals and related products within the Area.
- Develop and maintain a formulary of accepted drug products for use in the Area. The formulary is to be revised at least yearly.
- Disseminate and ensure implementation of IHS policies concerning specific drug categories (see Appendix 3-7-C for IHS Policy On AIDS Drugs).
- Review the use of pharmaceuticals within the Area, including any significant variations from the Area formulary, and provide appropriate recommendations to the Area Director.
- Organization and Operation
While the composition, and operation of the Area, P&T Committee may vary from Area to Area, the following shall apply:
- Members shall be appointed by the Area Director and shall include service unit pharmacists and physicians. An example of an exemplary committee composition is as follows:
- Area Chief Medical Officer (Chairman) Casts deciding vote in case of a tie
- Area Pharmacy Officer (Executive Secretary) Non-voting
- Clinical Pharmacist or Drug Information Specialist
- Service Unit Representatives (Chairpersons of Service Unit P&T Committees or physician or pharmacist designee)
- Nursing Representative Non-voting
- The Committee shall meet at least annually.
- Subject matter experts may be invited to provide information on relevant subjects.
- An agenda and minutes shall be prepared for each meeting.
- Additions and deletions to the Area formulary may be submitted by any service unit only after approval by the Service Unit P&T Committee.
- Medical service representatives may not attend meetings.
- Service Unit
- Purpose
The primary purposes of the Service Unit P&T Committee are to:
- Recommend and assist in the formulation of broad policies regarding the evaluation, selection and therapeutic use of drugs in IHS facilities.
- Recommend and assist in the formulation of programs designed to meet the educational needs of the professional staff (physicians, nurses, pharmacists, and other health care practitioners) so that they remain current on matters related to drugs and drug use.
- Revise, at least annually, the service unit formulary.
- Review adverse drug reactions.
- Review medication errors and recommend corrective action.
- Organization and Operation
While the composition and operation of the P&T Committee might vary from facility to facility, the following shall apply:
- The P&T Committee shall be composed of at least one physician and one pharmacist.
- Committee members are appointed by a governing unit or elected official of the organized medical staff. The administrator or his/her designee shall be a non-voting member of the Committee.
- The chairman will be either a physician or pharmacist member. A pharmacist will serve as the executive secretary.
- The Committee shall meet regularly, at least once a quarter, and more often if required.
- The Committee may invite speakers/consultants to its meetings who can contribute specialized knowledge, skills, or judgment on issues relating to the Committee's functions.
- The Secretary will prepare an agenda and supplementary materials, including minutes of the previous meeting, and submit them to the Committee members in sufficient time before each meeting for members to review the material.
- The Secretary will prepare minutes of the Committee meetings and maintain them in the permanent records of the facility.
- Recommendations of the Committee are to be presented to the medical staff or its appropriate committee for adoption.
- The Committee shall liaison with facility committees on drug use and medical audit issues.
- Medical service representatives may not attend meetings.
- Functions
The basic organization of the facility and medical staff will determine some of the functions and scope of the P&T Committee. The service Unit P&T Committee shall:
- Advise the medical staff and administration in all matters pertaining to the use of drugs (including investigational drugs).
- Develop a formulary of drugs accepted for use in the facility based on the Area formulary.
- Review and revise the formulary at least annually. The selection of items to be included in the formulary shall be based on an objective evaluation of their therapeutic merits, safety and cost and shall include only items on the duplication of the same basic drug type, drug entity, or drug product.
- Establish programs and procedures that help ensure cost-effective drug therapy.
- Establish suitable educational programs for the facility's professional staff on matters related to drug use.
- Participate in quality improvement activities related to distribution, administration, and use of medications.
- Review and report adverse drug reactions and medication errors in the facility.
- Initiate and/or direct drug use evaluation programs and studies, and review the results of such activities to ensure compliance with JCAHO standards and guidelines.
- Formulary
A formulary is a continually revised list of pharmaceuticals and important ancillary information that reflects the current clinical judgment of the medical staff. The Area formulary includes all drugs approved by the Area P&T Committee. No drugs classified by the FDA as, ineffective are to be included in the Area formulary. Since generic or official names are used instead of trade names, an alphabetical cross reference of generic-trade and trade-generic names must be included. The metric system shall be used, and the inclusion of procurement costs is encouraged. Also, a pediatric dosage table and any necessary nomograms shall be included.
The service unit formulary contains only drugs in the Area formulary and must be kept current at each facility. A current copy of the service unit formulary is to be kept at each nursing station and at each field facility where drugs are prescribed. The ASHP Hospital Formulary Service index number or another index numbering system adopted for use by the IHS shall be included for each drug.
- Requests for Non-Formulary Drugs
Form HRSA-177, Request for Non-formulary Medication, or a similar form developed at the service unit, is used to request the procurement of a drug that has not been approved by the Area P&T Committee or the Service Unit P&T Committee. When a non-formulary drug is required in an emergency or is essential for a particular patient, an amount sufficient to meet the immediate need of the patient should be requisitioned. Form HRSA-177 or similar form must then be submitted to the P&T secretary within 24 hours. A non-formulary drug request may be initiated only by a person authorized to prescribe the medication.
- Criteria for Drug Use
The formulary may include drugs which are designated as restricted 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 all prescriptions written by IHS providers. Also, generic drugs may be used to dispense all prescriptions from non-IHS providers unless the non-IHS prescriber specifically requests the trade name product in writing. However, if the specific trade name product is not stocked in the facility, the prescriber shall be contacted about substituting an item in stock.
- Drug Samples
The use of drug samples within IHS facilities is discouraged. Drug samples shall be used for inpatients only if no other source of supply of the drug is available to the pharmacy. Any drug samples used must be maintained, controlled, and dispensed only by the pharmacy.
- Medical Service Representatives
Written policies and procedures governing the activities of medical service representatives (MSRs) within the institution shall be developed by the facility's pharmacy department. All MSRs must be provided with a copy of these rules, and their activities within the facility are to be strictly monitored by the pharmacy department.
- Prescribing/Dispensing
- Prescribing
- General
Prescriptions may be written only by properly credentialed members of the facility Medical/Dental Staff acting within the scope of their practice, and by physician extenders practicing in the facility under approved clinical protocols. All prescriptions shall be written in the patient's medical record. If a separate copy of a prescription is required, e.g., when a non-formulary drug is prescribed for purchase at the patient's own expense at a private pharmacy, Form HRSA 17-1, Prescription Blank, is used.
- Clinical Protocols
For physician extenders with prescriptive authority, the pharmacy department shall maintain current copies of all clinical protocols which have been reviewed and approved by the Clinical Director.
Drugs included in clinical protocols are selected on the basis of their relative safety when used according to the stated directions, established merit, and ability to fulfill patient needs. Controlled drugs and certain other dangerous prescription drugs shall not be included.
The clinical protocols must include an appendix containing a listing of the drugs with indication, dosage and interval, limitations by age, and any other pertinent information.
- Medication Order Content
A medication order must include the name of the patient, date, generic or trade name of the drug, strength of the drug, quantity of the drug or the duration of therapy, adequate directions for use, and the prescriber's health records approved signature (initials shall not be used according to medical records policies). The metric system is to be used for weights and measures. When multiple drug orders are entered in the health record, a separate line entry is used for each drug.
- Refill Orders
Refill orders must be written in their entirety in the patient's health record by the provider. Orders referencing previous orders by date or other abbreviated forms shall not be used, e.g., "refill drugs ordered 1/2/91.l Refill orders must also be in compliance with applicable Federal and State laws. The designation PRN on refill orders is not appropriate and shall not be used.
- Non-IHS Prescribers
Pharmaceutical care shall be provided by the IHS to eligible American Indian/Alaska Native beneficiaries (as defined by the IHS) when the prescriptionsare written by an IHS practitioner or a contract care provider to whom the patient has been referred by the IHS.
Prescriptions resulting from patient visits to a non-contract practitioner or to a contract provider without prior IHS referral may be filled by the IHS or at IHS expense only if the drug is included in the facility's formulary and is in stock. A more restrictive policy may be established by each Area Director and shall apply Area-wide. A current copy of the facility's formulary shall be provided to all contract providers and to other practitioners when appropriate. Contract community pharmacies will not be reimbursed for dispensing non-formulary drugs for non-referred patients.
Eligible American Indians/Alaska Natives presenting at an IHS facility with an outside prescription that may not be filled by the IHS, according to the above policy, have the option of being seen at an IHS facility by an IHS practitioner and obtaining formulary medications prescribed by the IHS provider.
If a drug prescribed by an IHS-referred provider is not on the formulary at the IHS facility, the pharmacist shall consult with the prescriber and recommend alternative drug therapy that is available. Upon prescriber approval the recommended alternative drug shall be dispensed. If formulary drug is procurement shall an alternative not available, be according to local non-formulary drug use policies and procedures.
When medications and pharmaceutical care are provided for contract physician or nursing home patients, the pharmacist must enter the complete prescription information into the patient's health record at the IHS facility.
At IHS facilities without a pharmacist, non-IHS prescriptions, including those written by contract providers or private providers for nursing home patients, shall not be filled. The eligible patient may elect to be seen, by the IHS provider and receive medication prescribed by that provider.
- Controlled Drugs
- General
Controlled substances may only be prescribed by a physician, dentist, or other Drug Enforcement Agency is: (DEA) registered prescriber 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.
- Writing for controlled substances only within the scope of his/her duties.
- Physician assistants, advanced practice nurses and clinical pharmacy specialists:
Prescribing privileges for controlled substances (Schedules II-V) shall be granted to physician assistants, advanced practice nurses and clinical pharmacy specialists in accordance with the following guidelines:
- The facility authorizes the physician assistant, advanced practice nurse or clinical pharmacy specialist to dispense or prescribe designated Schedules of controlled substances under its Drug Enforcement Administration registration; and
- The physician assistant, advanced practice nurse or clinical pharmacy specialist is registered, licensed or otherwise specifically recognized by a State as having authority to prescribe designated Schedules of controlled substances; and
- The physician assistant, advanced practice nurse or -clinical pharmacy specialist adheres to all local facility policies regarding the prescribing of controlled substances.
When controlled drugs are recommended for a patient by a physician assistant, advanced practice nurse or clinical pharmacy specialist not covered under Section 3-7,3D(2a)(vi), a supervising physician must review and sign the record before the controlled substances are dispensed or administered. When the physician assistant, advanced practice nurse or clinical pharmacy specialist not covered under Section 3-7.3D(2a)(vi) is on isolated duty., a phone call to the supervising physician prior to . administering or dispensing a controlled substance will suffice as a review by the supervising physician, if such practice is permitted in the jurisdiction under which the physician assistant, advanced practice nurse or clinical pharmacy specialist practices. The call shall be documented in the patient's health record and cosigned by 'the supervising physician within the legally prescribed time. In this instance, the amounts of controlled substances dispensed may not exceed a 72 hour supply except with seizure medications, in which case a larger quantity may be dispensed.
Providers may not prescribe controlled substances for their personal use, for members of their family, or for household members.
- Dispensing
- General
Prescriptions shall be filled by pharmacists who have obtained the necessary information from the patient's health record.
The pharmacist shall fill the prescription from the health 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. The title "pharmacist" (Pharm., R.Ph., Pharm. D.) shall follow the pharmacist's signature, If files are maintained for prescriptions from non-IHS prescribers, a separate file for Schedule II drugs must be maintained in compliance with DEA regulations.
- Non-Pharmacist Drug Distribution
In the absence of a pharmacist, medication may be provided directly to the patient by the attending prescriber, physician extender, or by a registered nurse. Any medication provided shall be limited to the amount necessary to meet immediate patient needs. A supply of pre-packaged and pre-labeled medications shall be available in a locked cabinet when there is no pharmacist on duty. These medications must be available in pre packaged containers in appropriate quantities and must be properly labeled as to name, strength, and quantity of drug dispensed; standard directions including length of therapy; pre-packaging control number; facility name, address, and phone number; appropriate auxiliary cautionary warning labels; and expiration date. The provider must enter the physician's name, patient health record number and name, and the date on, the label. A log of all items removed from the cabinet shall be maintained.
If it might be necessary to obtain drugs from the pharmacy when no pharmacist is available, written procedures covering this practice must be developed by the facility's pharmacy department.
Physician extenders and registered nurses may not transfer medication from one, container to another; nor label, count, package, or pour medications except under the direct visual supervision of a prescriber.
Prescriptions from non-IHS prescribers will not be filled in the absence of a pharmacist.
Prescriptions for chronic medications shall not be refilled by a non-pharmacist 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.
- Containers/Numbering/Labeling
- Containers
All pharmaceutical containers must be tight and, where required by the United States Pharmacopoeia (USP), light and moisture resistant. "Child-proof" containers shall be used for outpatients. Exceptions may be made when a request is made in writing by the prescriber or patient. not to use child proof containers for patients who would have difficulty opening safety-cap containers. A patient's request must be documented in the health record and signed by the patient or the patient's representative.
- Prescription Numbering
Each prescription must be assigned a unique number when filled. The simplest system for numbering prescriptions that is adequate for record keeping and billing purposes shall be used.
- Labeling
All containers must be properly labeled and must conform with Federal rules and regulations and to State laws, where applicable. Required accessory and cautionary labels shall be attached.
- Stock Containers
The labeling of all stock containers for drugs shall be performed by the pharmacist or under her/his direct supervision at all facilities. The label must be mechanically generated (typewriter, computer, or other); hand-written labels shall not be used. Generic names must be used; a trade name in parenthesis may be used in addition to the generic name ONLY IF that particular trade name product is used. To do otherwise would constitute mislabeling under the Food, Drug and Cosmetic Act.
- Prescription Labels
The prescription label is to be typewritten or computer generated and must include the name, address, and telephone number of the facility; the date; the pharmacy's identifying number for the prescription (patient's health record number may be used); the full name of the patient; the generic name, strength and quantity of the drug; the directions for use; the duration of therapy; the name and title of the prescriber; the initials of the dispensing pharmacist; the phrase "Keep Out of Reach of Children," the required DEA cautionary label on controlled substances; cautionary labels regarding alcohol consumption if applicable; and any other cautionary labels as required or indicated.
- Pre-packaged Items
Prepackaged items for use in the outpatient pharmacy shall be labeled with the required cautionary warning strip labels and a pre-printed label containing the generic name, strength, lot number, expiration date, and quantity of the medication. The label must be affixed to the container in such a manner as not to cover the label or directions on the container.
NOTE: The same labeling criteria shall apply for all IHS facilities whether or not a pharmacist is on staff.
- Mailed Prescriptions.
Prescriptions shall not be mailed to patients nor to their representatives. Exceptions to this policy shall be severely limited to rare instances in which, pharmacists can meet all aspects of the IHS Pharmacy Standards of Practice (Sections 3-7.3B and 3-7.3C); or on a one time only emergency basis where there is no other available option and not to do so might result in compromising patient care. Another exception to this policy is made for automated refill programs in the Alaska Area IHS when prescriptions are reviewed for appropriateness by IHS pharmacists and consultation is provided by trained community health aids.
- Abbreviations
All abbreviations shall conform to a list of accepted abbreviations that have been approved by the Service Unit P&T Committee and maintained on file in the medical records department.
- Bulk Compounding
Drug products may be bulk compounded; however, this activity should be kept to a minimum. Official bulk compounded preparations shall conform to official standards of potency, purity, and appearance as delineated in the USP/NF. Non-official bulk compounded preparations must be of the highest quality, have a pleasing appearance, and must be of the strength specified on the label. Adequate records and controls shall be maintained on each item which is bulk compounded. Forms HRSA-247 (Pharmaceutical Formulation Control Record) and HRSA-335 (Pharmacy Chronological Control Log), or computerized versions, shall be used for the formulation, control, and chronological records of products that are bulk compounded. Form HRSA-331, Pharmaceutical Bulk Compounding Work Sheet, or a computerized version, shall also be completed on each bulk compounded product. Manufacturer's Safety Data Sheets shall be maintained for all drugs/chemicals used in bulk compounding where required by Occupational Safety and Health Administration (OSHA) regulations.
- Prepackaging
Pharmacies may furnish pre-labeled, prepackaged drugs to small field activities that do not have pharmacies. Labels shall be computer generated or typewritten. The prepackaged drugs must be in appropriate stock containers having all the required labeling and in the sizes and units most commonly prescribed.
Original stock containers of legend drugs as supplied by the manufacturer (excluding unit-of-use packages) shall not be supplied to field activities or facilities not having a pharmacist on duty. Also, drugs may not be transferred from one container to another; counted; poured; packaged; nor labeled at field facilities that do not have either a pharmacist or a physician on duty.
Necessary controls shall be maintained for the safety of the patient. The computer generated prepack log must be printed out at least monthly. When the computer prepack program is not available, necessary controls shall be maintained manually on Form HRSA-335.
Drugs may be transferred from one stock container to another, counted, packaged, and labeled only by the pharmacist or under her/his direct supervision. Non-professional employees shall prepackage drugs except when under the direct supervision of a pharmacist.
Form HRSA-335 is the basic, control number record for bulk compounded and prepackaged items. The control number appearing in the first column is the control number that appears on the finished product's container and on Form HRSA-247. The count of these items from the appropriate column is then transferred to columns 4 and 5 of Form HRSA-168, Pharmacy Operations-Daily Record.
A uniform system for designating the control number shall be used. Each pharmacy shall 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.
- Inpatient Drug Distribution
- Unit Dose
The unit dose drug distribution system is a system which permits identification of the "drug up to the point of administration and shall be used for all IHS inpatient services.
- I.V. Admixtures
Hospitals shall have an intravenous admixture program. The compounding of I.V. admixtures shall be performed by a pharmacist or by a pharmacy technician who is trained in the preparation of I.V. admixtures. Pharmacists and pharmacy technicians shall be certified annually in the preparation of I.V. admixtures. The Chief Pharmacist is responsible for ensuring that all I.V. admixture products used in the institution are (1) therapeutically and pharmaceutically appropriate, that is, rational and free of incompatibilities or similar problems for the patient;. (2) free from microbial, viral, and pyrogenic contaminants; (3) free from unacceptable levels of particulate and other toxic contaminants; (4) correctly prepared, i.e., contain the correct amounts of the correct drugs; and (5) properly labeled, stored, and distributed. Training in the aseptic preparation of parenteral admixtures shall be provided by the pharmacy department to all nursing and medical personnel who may be required to prepare such products in the absence of the pharmacist.
- Automatic Stop Orders
There shall be automatic stop orders (ASOs) on drugs used within the hospitals. The purpose of ASOs is to provide the practitioner with an opportunity to review the patient's drug therapy and make any required changes or adjustments.
Intervals for ASOs shall be as follows:
- Schedule II Drugs: 72 hours
- Schedule III-V Drugs: 96 hours
- Antibiotics: 96 hours
- Anticoagulants: 24 hours
- All other Drugs: 30 days
All medications shall be discontinued prior to surgery and when patients are transferred to another ward.
The intended duration of therapy shall be included in each prescription order.
- Cytotoxic And Other Hazardous Drugs
The pharmacy department shall develop policies and procedures for the safe handling and disposal of cytotoxic agents and other hazardous drugs in accordance with Occupational Safety and Health Administration (OSHA) guidelines [see Work Practice Guidelines for Personnel Dealing with Cytotoxic Antineoplastic Drugs found as Appendix A of OSHA PUB 8-1.11 and other appropriate professional standards. Antineoplastics shall be requisitioned, stored, and prepared by the pharmacy department and administered only by trained, authorized personnel. Specific pharmacy and nursing department policies and procedures shall be developed and implemented in the following areas:
- Training, to include all staff involved in receiving, transporting, mixing, administering, and waste disposal
- Ordering
- Receiving
- Preparation and Delivery
- Administration
- Disposal
- Clean up, spills, and exposures
Contract oncologists shall provide copies of the patient's chemotherapy protocol to the pharmacy.
(See ASHP Technical Assistance Bulletin on Handling Cytoxic Drugs in Hospitals.
- Investigational Drugs
NOTE: This section may change based on new guidelines for Investigational Drugs being formulated by the Area Research Committees.
- Definition
For the IHS the term "investigational drug" is defined as either: (a) 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 (b) an already-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.
- Unapproved Indications
The above definition does not preclude a physician from legally prescribing a marketed drug for individual patients which are not a part of a study under conditions not approved in the package insert, i.e., a variation in dosage or indication for use. The pharmacy will monitor such uses as required under the IHS Pharmacy Standards of Practice and will report any trends to the Service Unit P&T Committee for review. The patient shall be informed by the prescriber that the drug is being used for an unapproved indication and it must be noted in the patient's health record that the patient has been so informed. Any drug used in this manner does not meet the definition of an "investigational drug."
- Required Clearances
For any investigational drug to be used in an IHS facility, clearance is required as outlined in either (i) or (ii) below:
- Single Patients Prescribed
Investigational Drugs Approved for Clinical Investigators Located at a Non-IHS Institution:
At times, it may be prudent to place a. patient on an investigational drug for which a non-IHS provider has received FDA approval to conduct studies. Or, in some cases, a patient may have entered an investigational drug study at another institution and is admitted to an IHS facility for inpatient care or requests treatment on an outpatient basis. For individuals placed on an investigational drug 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 of the drug. However, before a patient may receive an investigational drug at an IHS facility, the following requirements shall be met:
- The IHS physician accepting responsibility for care of the patient shall 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 shall provide the Service Unit 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 shall contain information specific to the investigational drug and shall be approved by the Service Unit P&T Committee and Area Research Committee before signed permission is obtained from the patient.
The form, shall 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 (see Appendix 3-7-D for sample informed consent form).
- The Service Unit P&T Committee shall review the proposed use of the investigational drug, evaluating the indications, toxicity, and risks; the informed consent form; the potential benefits of the drug; and the lack of a suitable approved drug or the failure, contra-indications, or adverse effects of other usual treatment methods. The Committee shall forward its recommendations, a copy of the signed informed consent, and other relevant information regarding the investigational protocol and/or drug to the Area Medical Officer for approval or denial.
- The Area Medical Officer shall decide whether to accept the review of the IRH from the research institution or refer the review to the Area Research Committee.
- If use of an investigational drug is approved, the IND shall be used under the supervision of the FDA-approved Clinical Investigator. The Clinical Investigator shall 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 Medical Officer to use the investigational drug for a limited time, not to exceed 30 days, during which the formal process outlined above shall be completed.
- Multiple Patients Enrolled in an Investigational Drug Study:
The following requirements shall 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 shall be included on FDA Form 1572 by the principal investigator.
- The proposed study must be approved by the institution's P&T Committee, the Service Unit Director, the Tribal authorizing body, the Area Research Committee, the 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 shall 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 followup, 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 shall be furnished for review to the various required committees and individuals indicated in item (ii):
- 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 shall 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
- contraindications
- blood dyscrasias
- degree of supervision needed
- synopses of previous published studies
- Manufacturer's information and published reports describing side effects, toxicity and indications
- 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 shall be used:
- The voluntary signed written consent must be obtained from each subject or his/her legal guardian, and maintained on file.
- A physical examination shall be completed on each subject.
- The Chief Investigator who is using the investigational drug shall 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 this 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 P&T Committee.
- Investigational drugs shall be clearly labeled as such by the pharmacy.
- The sponsor or principal investigator shall 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/Dispensing
Investigational drugs shall be stored, packaged, labeled and dispensed by the pharmacy following ASHP guidelines (see ASHP Guidelines for the Use of Investigational Drugs in Institutions).
- Controlled Substances
- General
The service unit director is responsible for the overall safeguarding and handling of controlled substances (including alcohol and spirituous liquors) within the service unit and for ensuring compliance with all applicable State and Federal regulations pertaining to controlled substances.
- Any hospital or other facility that dispenses controlled substances must be registered with the Drug Enforcement Agency (DEA). Registration is obtained utilizing Form DEA-224, Application for Registration, or DEA-224a, Reregistration Application. Pharmacists and physicians who are employed by facilities that are registered to dispense controlled substances need not be registered individually (See ASHP Technical Assistance Bulletin on Institutional Use of Controlled Substances and Code of Federal Regulations, Title 21, Chapter 11, Part 1301 for further information on registration requirements and procedures). In addition, applicable State laws must be followed.
Tax-free alcohol may be purchased from the PHS Supply Service Center in Perry Point. Each individual facility need not be registered with the Bureau of Alcohol, Tobacco, and Firearms.
- Facilities With Pharmacies
The authority and responsibility for the procurement, receipt, security, storage, accountability, and proper dispensing of controlled substances in the pharmacy and pharmacy storeroom shall be delegated to the Chief Pharmacist. If Schedule 111, IV, and V drugs are stored in the general storeroom, the Administrative Services Department shall be delegated the authority and responsibility for the proper security, storage, and accountability of those items in accordance with IHS Manual, Part 5, Management Services, Chapter 6, Supply Management. The pharmacist shall perform monthly inspections of security and records in the storeroom and make appropriate recommendations.
- Facilities Without Pharmacies
The authority and responsibility for security of controlled substances and maintenance of proper records may be delegated, in writing, to a physician, dentist, or registered nurse and appropriate records shall be maintained by that individual at this location.
- Nursing Locations
The charge nurse shall be delegated the authority and responsibility for the security, storage, and maintenance of appropriate records of controlled substances at the nursing location.- A pharmacist shall audit these activities on a monthly basis. A daily audit of controlled substances by the nursing staff at outpatient clinics is required. At hospitals, an audit of all controlled substances must be conducted at each change of custody (shift change). Form HRSA-191, Consolidated Eight Hour Controlled Substances Audit, shall be used for this audit.
- Transfer of Custody
A written transfer of custody is required whenever there are changes involving personnel having custody of central and pharmacy stocks of controlled substances. Also, a joint inventory must be taken before the transfer is effected. Form HRSA-245, Transfer of Custody of Controlled Substances and Spirituous Liquors, is used to effect the transfer of custody. When practical, combinations to safes and locks should be changed upon departure of personnel who have had access to controlled substances.
- Records
- General
An inventory of all controlled substances located within the pharmacy and bulk storage area shall be done every two years on or about May 1 of the odd-numbered years. The inventory of Schedule II substances is to be maintained separately from all other records.
The record of issues and receipts of stored bulk controlled substances is to be maintained on Form HRSA-176, Perpetual Inventory of Narcotics and Other Controlled Substances, Pharmacy, and/or on the visible record inventory control card.
At facilities using the automated supply program, a pre-printed storeroom issue book may be used to issue controlled substances from bulk stores. The transaction register and balance runs or special pharmacy runs may be used as control documents. Alternatively, it may be desirable to submit Form HRSA-248, Pharmacy Requisition, or HRSA-413, Off Schedule Storeroom Issue Report, so that a separate file of issues on all controlled substances can be maintained.
All records pertaining to the distribution of controlled substances shall be maintained on file in the pharmacy according to Federal rules and regulations. Records pertaining to the acquisition and receipt of controlled substances must be maintained on file in the pharmacy and in Administrative Services. Personnel authorized to receive controlled substances must be designated in writing.
- Pharmacy Stocks
- Receipt
An ongoing and retrievable record must be maintained on the receipt of all Schedule II-V drugs. The completed third copy of Form DEA-222, Controlled Substances Order Form, shall constitute the receiving records for Schedule II drugs. Invoices for Schedules III, IV, and V drugs may be considered complete receiving records if the actual date of receipt is clearly recorded on the invoices by the pharmacist or other responsible individual.
- Issue
Two dispensing logs shall be maintained on controlled substances: one log for Schedule II items and a separate log for items in Schedules III-V. These logs may be computer generated or may be maintained on HRSA-176 or HHS-46, Stock Record Card. Dispensing logs shall be maintained so that the information can be readily coordinated with the appropriate health record (see ASHP Technical Assistance Bulletin on Institutional Use of Controlled Substances and Code of Federal Regulations).
If files are maintained for prescriptions written on traditional prescription blanks, e.g., from non-IHS prescribers, a separate file for Schedule II drugs must be maintained to comply with DEA regulations.
A perpetual inventory shall be maintained on all Schedule II drugs. Form HRSA-176 or HHS-46 shall be used. A separate Form HRSA-176 or HHS-46 shall be maintained for each unit of a controlled drug for which a perpetual inventory is maintained.
For example, meperidine HC1 tablets 50mg., 20's and meperidine HCl tablets 50mg., 100's, would each require a separate form.
- Inventory
The biennial inventory of all Schedule II-V drugs shall be maintained on file in the pharmacy department. In addition to the perpetual inventory of Schedule II drugs, Form HRSA-174, Monthly Report for Narcotics and Other Controlled Substances (Pharmacy), must be completed monthly for all Schedule II-drugs. This-report is sent to the Service Unit Director with a copy sent to the APO monthly.
- Schedule II Audit
The APO or his/her designee shall conduct an annual physical audit of all schedule II controlled substances at each facility in the Area. The designee must be a senior level pharmacist from outside the service unit. Form HRSA-173, Audit Report for Narcotics and Other Controlled Substances, shall be used.
All Schedule II controlled substances shall be audited and the count verified against the inventory records. This shall include stocks in the pharmacy storeroom and the pharmacy. Every location in the facility 'where controlled substances are maintained shall be randomly audited for accuracy, discrepancies,. and for compliance with controlled drug procedures.
At the time the physical audit is performed, a visual inspection for quality control shall 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 shall be verified for entry on the inventory record at each location where Schedule II drugs are stocked within the facility. DEA Form 222 shall be randomly audited to ensure that receipts of controlled substances are properly recorded.
Procurement records for Schedule II drugs shall be audited for and verified with pharmacy records.
- Nursing Locations
Perpetual inventory records shall be maintained on all controlled substances available at nursing units. At the discretion of the service unit director, perpetual inventory records may also be required on ethyl alcohol.
Nursing units at facilities with pharmacists shall use Form HRSA-248 or other suitable locally authorized form for requisitioning controlled substances. The perpetual inventory and administration records must be maintained on Form HRSA-219, Inventory and Disposition Record: Nursing Unit Narcotics, or on a similar form suitable for use in a small "visual Kardex."
Nursing units at facilities without pharmacists shall use Form HRSA-219 or a similar form as described above for recording the administration, dispensing (including outpatient), and inventory of controlled substances. A separate Form HRSA-248 or a similar approved form must be signed by an authorized individual and used to requisition controlled substances from the pharmacy department.
Emergency transfer of controlled drugs between nursing units shall be accomplished with proper documentation.
- Storage
- Pharmacy Stocks
- Schedule II
Schedule II controlled substances, alcohol, and spirituous liquors shall be stored in a substantially constructed locked cabinet, safe, or drawer.
- Other Scheduled Drugs
Although Federal law allows for the dispersion of Schedule III, IV, and V controlled substances among the regular stock, it is strongly suggested that only a small working stock be dispersed among regular stock with the remainder securely stored under lock and key. Schedule III, IV and V controlled substances stored in Drug-0-Matic cassettes or Baker cells shall be secured under lock and key after pharmacy hours unless access to the pharmacy is solely restricted to pharmacy staff.
A duplicate key or copy of the safe combination shall be kept in a sealed envelope in the service unit director's safe or other secure place for use in emergency situations.
- Nursing Locations
All controlled substances, alcohol, and spirituous liquors shall be stored in a safe or separate locked cabinet or locked drawer. The charge nurse at the unit shall have responsibility for the combination or key. Controlled items shall be issued to wards and clinics in reverse-numbered units of 25 doses or less when possible and in packaging that facilitates security and control. The charge nurse shall return excess controlled items to the pharmacy.
- General Storeroom
There shall be no Schedule II drugs stored in the general storeroom. All other controlled substances, alcohol, and spirituous liquors shall be stored in a properly secured safe, cabinet, or separate room.
- Expired Controlled Substances
Expired controlled substances shall be isolated from active and stores stock and labeled "Expired Drugs: Do not use." A separate inventory shall be maintained on these items. Complete Form DEA-41, Registrants Inventory of Drugs Surrendered, for the destruction of outdated or otherwise unusable controlled drugs in compliance with DEA regulations. Inventory and disposal records shall be maintained for two years as required by Federal law.
- Inventory Discrepancies
Discrepancies in audits involving small amounts of controlled drugs on the nursing unit shall be reported to the Director of Nurses or Head Nurse and to the Chief of Pharmacy Services. Subsequently, an investigation must be performed to determine the cause of the discrepancy. A copy of the report of the investigation, signed by the Director of Nurses or Head Nurse, shall be filed with the Chief Pharmacist.
Any inventory discrepancies deemed to be a significant or recurring problem shall be thoroughly investigated in a timely manner. A written report of this investigation shall be provided to the service unit director and a copy sent to the APO.
The Regional Office of the Drug Enforcement Administration must be notified of the theft or significant loss of any controlled substance. DEA Form 106, Notification of Theft or Loss of Controlled Substances, (obtainable from the DEA) shall be completed and forwarded to that office.
- Adverse Drug Reactions
All adverse drug reactions shall be reported to, and reviewed by, the Service Unit P&T Committee in accordance with JCAHO requirements. 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 shall be reported directly to the FDA utilizing Form FDA-1639, Adverse Reaction Report. Adverse reactions to vaccines shall be reported using Form VAERS-1, Vaccine Adverse Event Reporting System. A copy of each report shall be filed in the pharmacy with a copy sent to the P&T Committee.
- Product Defects
Drug product quality concerns shall be reported directly to the FDA and to the supply source or vendor using the Drug Quality Reporting System.
The report may be filed utilizing Form FDA-3318, Drug Quality Reporting System, or may be reported by phone by calling l-800-FDA-1088.
Medical device product problems are to be reported to the United States Pharmacopeia (USP) using Form FDA-2519f, Medical Device and Laboratory Problem Reporting Program, or by calling l-800-638-6725.
- Product Recalls
There shall be a written drug recall procedure at all facilities. A file of all drug recall reports, notices, and actions taken shall be kept in the pharmacy.
- Inventory Control System
- Procurement
- General
The Chief Pharmacist is responsible for the quality of drugs used in the service unit. Reliable vendor sources must be used to procure all drugs. The pharmacist shall determine the product specifications required for each drug purchased including the strength, dosage form, packaging, preservative, flavor, shape, color, configuration, and labeling. The purchasing agent or contracting officer shall purchase drugs meeting these product specifications at the lowest price possible following Federal guidelines (see Federal Acquisitions Regulations).
- Ineffective Drugs (DESI List)
IHS funds, including grant and contract funds, shall not be used to procure drugs that are classified as ineffective by the FDA according to departmental regulations (DES1 list). Exception to this will be made only if the prescribing physician states in writing that no other suitable drug is available. The Area and service unit formularies shall not contain ineffective drugs. Prescriptions from contract pharmacies and non-formulary drug requests shall be reviewed by the Chief Pharmacist or his/her designated representative to ensure conformance with this policy.
- Selection of Generic Drugs
The current edition of FDA publication Approved Drug Products with Therapeutic Equivalence Evaluations (known as the Orange Book) shall be used for reference when changing vendors of drug products. There are two-basic classifications of therapeutic equivalence as defined by the FDA:
- - Drug products that the FDA considers to be therapeutically equivalent to other pharmaceutically equivalent products
- - Drug products that the FDA does not consider to be therapeutically equivalent to other pharmaceutically equivalent products
Drug products rated "A" by the FDA shall be purchased when changing vendors of a particular drug. If a drug is one for which all manufacturers' products receive a "B" code, the drug shall be purchased from the manufacturer that has accumulated data substantiating the efficacy of the drug (usually the manufacturer that conducted the initial research and introduced the drug to the market) or from sources that provide the specified manufacturer's product. If it should become necessary to purchase a "B" coded drug from a different manufacturer, the medical staff shall be informed of the change.
All mandatory Federal and agency sources shall be used to the fullest extent possible. Pharmacists may restrict the distribution of any drug materials which are felt to be sub-standard until such time as analytical laboratory analysis confirms acceptability of the product for human consumption.
- Supply Sources
All purchases of drugs and supplies for the IHS must be in accordance with Federal Acquisitions Regulations 8.001, Priorities For Use of Government Supply Sources.
The primary supply source for the IHS shall be the IHS Regional and Area Supply Service Centers. Secondary supply sources shall include other governmental supply depots such as the PHS Supply Service Center at Perry Point, Maryland, the Veterans Administration (VA) depot, and the Department of Defense (DOD) depot. The next source of supplies is the Federal Supply Schedule contracts. The final source would be open market purchase from individual vendors or from wholesalers.
Facilities operating under P.L. 93-638 may use supplies and drugs purchased from Federal sources only for the benefit of those persons entitled to receive services under the P.L. 93-638 contract or for persons eligible to receive services of the IHS on a fee basis, according to Section 713 of the Indian Health Care Amendments of 1988, P.L. 100-713.
Emergency requisitioning of supplies should be kept to a minimum. Responsible personnel should anticipate, through past experience or present usage rate, the needs for drug items on regular issue or requisitioning days. In cases where drugs are needed urgently and patient care is dependent upon the immediate availability of the drug, small quantities of the drug may be purchased through open market or obtained through any other source.
- Requisitioning
- Nursing Locations
The nurse in charge is responsible for maintaining the stock of drugs at the proper level. Special or emergency orders for drugs shall be kept to a minimum. For requisitioning drugs within the hospital, HRSA-248 or an order book listing the drug items may be used.
- After Hours
A locked emergency drug cabinet may be used to hold drugs for after hours use. The Nursing Supervisor would have possession of the only key(s). A key to the pharmacy may also be issued to the Duty Medical Officer or Nursing Supervisor, but ' this is not encouraged. There shall be a written policy to establish local procedures.
- Installations Without a Pharmacist
Facilities without a pharmacist on staff shall receive drugs from an IHS pharmacy, except when the Area Director and the APO determine that it would be more expeditious and economical to have an item shipped directly to the facility, e.g., bulky items such as intravenous solutions.
- Storage
The following shall apply in all drug storage locations:
- Drugs for external use and disinfectants shall be stored separately from internal and injectable medications.
- Flammables shall be stored in a safety cabinet in compliance with OSHA guidelines.
- All drug items shall be stored under proper environmental conditions as defined by the USP/NF and/or the drug manufacturer.
All drug storage shall be inspected monthly by pharmacy services to assure proper quality control practices. in IHS Areas with a Supply Service Center (SSC), the SSC pharmacist shall be responsible for ensuring proper security and quality control practices at the SSC and for coordinating acceptable drug quality with pharmacists throughout the Area.
- Nursing Locations
Drugs at each nursing location shall be stored in a separate locked cabinet or closet. Such cabinets or closets are to be kept locked at all times except when authorized personnel are preparing medications or are in constant attendance. Unit dose packaging shall be used for these drugs.
Nursing personnel shall return excess, outdated, and deteriorated drugs to the pharmacy.
- Drugs Requiring Special Security
Controlled drugs, alcohol, and spirituous liquors shall be stored as specified in Section 3-7.3D(8c).
- Drugs Requiring Special Storage
Drugs requiring special storage conditions to ensure stability shall be stored in accordance with current established standards (USP/NF). In instances where drugs are not included in official compendia, storage conditions shall ensure that the integrity, stability, and effectiveness of the drug are maintained.
- Disposal
Surplus drugs that cannot be returned to the supply source for credit and unusable drugs and chemicals shall be disposed of in accordance with Indian Health Manual, Part 5, Chapter 6, Sections 5-6.3AB and,5-6.3R (see Appendix 3-7-E). Controlled drugs shall be disposed of by the pharmacy according to DEA regulations [see Section 3-7.3D(8c) of this Manual].
Discontinued and outdated drugs that cannot be returned to the supply source for credit and deteriorated or unusable products shall be stored in a separate and clearly labeled location in the pharmacy until disposal.
- Drug Information Services
It is the responsibility of the pharmacy service to ensure that the facility's health care providers have access to current drug information that is adequate to support safe, cost-effective rational drug therapy.
Drug information and education programs shall include:
- Pharmacist-initiated, patient-specific interventions with appropriate documentation.
- Drug therapy consultation on request from other professional staff.
- Inservice education to other professionals and health workers.
- The phone number of the nearest regional drug information center.
Drug education services shall incorporate but are mot limited to:
- Publishing drug therapy bulletins.
- Participating in patient rounds.
- Providing drug information handouts to patients
- Presenting relevant drug information to community health resources such as community health representatives and health aids.
Pharmaceutical reference materials shall be available to provide professional staff with current, authoritative, and reliable information concerning drugs. The pharmacy service shall maintain information resources and an information retrieval system that is commensurate with the size and scope of ' services at the facility and has the capability to readily retrieve drug information prior to the initiation of therapy. This information may be in hard copy; in microfiche format, on a CD-ROM disk, or in electronic format.
A pharmacy library shall consist of appropriate and readily retrievable reference material to include:
- Pharmaceutical compendia.
- Reference texts and periodicals covering the practice of pharmacy, including chemistry, toxicology, pharmacology, therapeutics, bacteriology, sterilization and disinfection, compatibility, and drug interactions.
- Authoritative, current antidote information.
- Current Federal and applicable State laws governing the practice of pharmacy.
(See Appendix 3-7-F for recommended core references)
- Health Promotion And Disease Prevention
The IHS Pharmacy Program promotes the Health Promotion and Disease Prevention (HP/DP) component of the IHS program priorities. IHS pharmacists promote primary disease prevention through preventive drug therapy and drug use education. Activities include health record review and screening, comprehensive consultative activities (targeting high-risk patients), participation in community based education programs, and. others.
HP/DP priorities shall be based upon guidelines provided by the appropriate IHS administrative level, with sensitivity to local needs and capabilities.
The number and types of HP/DP activities initiated are based on the local requirements and the available resources.
- Primary Care Programs
IHS pharmacists have historically been directly involved as primary or ,intermittent providers of care for selected patients whose principle form of therapy is medication.
- Types/Levels
There are three levels of pharmacist therapeutic provider roles. All activities are guided by clinical protocols developed in conjunction with and approved by the medical staff.
- Basic
- General Refill Protocol
The pharmacist may refill prescriptions without physician authorization for chronic medications (not to include controlled substances) in quantities sufficient to last until the next scheduled provider visit for patients who miss appointments, lose medication, or receive insufficient amounts to last until the next appointment.
- Pharmacist Dosage Adjustment
After the physician selects the drug, the pharmacist selects the initial dose and may adjust subsequent dosage based on patient parameters.
- Intermediate
- Acute Care/OTC Programs
When patients present or are referred to the pharmacy for assessment and treatment of minor acute illnesses, an assessment is performed almost exclusively through interview of the patient and by chart review, with limited physical assessment. Patients assessed as more seriously ill are referred to a medical provider.
- Chronic Care
Pharmacists manage the drug therapy of patients with uncomplicated, stable, chronic disease states between their physician visits. Pharmacists may adjust drug therapy within defined limits. Controlled substances are refilled according to Federal rules and regulations. Patient assessment is similar to that in intermediate level acute programs, with problems referred to the physician.
- Advanced
Specially trained pharmacist practitioners (PPs) assume the same level of diagnostic and therapeutic responsibilities as medical personnel, similar to nurse practitioners and physician assistants. PPs utilize comprehensive interviewing, physical assessment, and diagnostic skills to manage patients who present with common, high volume acute and chronic illnesses. Complex problems are referred to the physician.
- Implementation
- Basic
General refill protocols and pharmacist dosage adjustment programs are an essential part of all IHS Pharmaceutical Care Programs with all IHS pharmacists performing these functions.
- Intermediate/Advanced
These programs are optional and can be implemented at the service unit level. The following conditions must be met before these programs are initiated:
- Program Need
A needs assessment must be performed to clearly identify a need for these programs as a matter of improving clinic efficiency and/or improve the quality of patient care.
- Adequate staffing
There shall be adequate staffing levels of pharmacists to carry out the basic IHS Pharmaceutical Care Program as outlined in the IHS Pharmacy Standards of Practice and the additional workload entailed with the implementation of intermediate or advanced programs. Higher levels of pharmacist therapeutic provider programs shall not be implemented at the expense of basic clinical pharmacy programs, such as patient consultation, drug information, drug use control, and quality improvement.
- Pharmacy Based
Primary care programs shall be conducted only in the pharmacy consultation rooms attached to the outpatient pharmacy.
- Quality Improvement
All programs involving pharmacist prescriptive authority shall contain the following components:
- Clinical Protocols
The protocols shall contain all the following components adjusted to the specific nature of the program:
- Scope
- The type(s) of program(s), e.g., OTC, refill, pharmacist-managed care, the specific disease state or symptom complex, and the severity of disease to be managed by pharmacists.
- Criteria for inclusion in pharmacy based care, e.g., stable disease, blood pressure < 180/100, temperature <100 degrees F., complete hypertensive workup, etc.
- Procedures
- Mechanism for patient referral to pharmacy for care, such as physician or nurse referral
- Frequency of visits to the pharmacist and physician
- Procedures, with limitations, for patient self referral to the pharmacist for care
- Professional Responsibilities
Specific definitions of roles and responsibilities of the referring physician or nurse and the pharmacist who provides the care
- Quality Improvement
- Criteria for periodic physician visits to review patient status and quality of care delivered by the pharmacist
- Frequency and mechanism of additional evaluation of the care provided by the pharmacist
- Criteria for Collecting Subjective and Objective Data at Each Visit to Evaluate:
- Patient disease status
- Presence of disease complications
- Need for referral to the physician
- Side effects of chronic medication
- Disease-specific and drug-specific questions
- Physical assessment
- Diagnostic laboratory and/or radiologic procedures
- Assessment
- Criteria for referral to the physician
- Criteria for consultation with the physician
- Criteria for management by the pharmacist
- Patient Care Plan
- Drug Therapy
- Non-drug therapy
- Future visits and treatment
- Patient Education
- Other diagnostic procedures
The protocols shall be developed jointly with the medical staff and shall be approved by the medical staff.
- Pharmacist Training/Certification
All pharmacists participating in these programs shall be certified as competent to perform these functions by the pharmacy and the medical staff.
- Additional Quality Improvement Measures
The performance of each pharmacist with prescriptive authority shall be evaluated annually for quality and effectiveness. For basic level programs, the Chief, Pharmacy Services, is responsible for the evaluation of individual pharmacists. For intermediate level programs, the medical staff is responsible but may delegate all or part of the responsibility to the Chief, Pharmacy Services. The medical staff is responsible for advanced programs.
3-7.4 PROGRAM EVALUATION
- General
The IHS Pharmacy Branch shall make every effort to ensure the quality of pharmacy services provided in IHS facilities. Pharmacy standards of the IHS Pharmacy Program, JCAHO, HCFA, and ASHP shall be used as applicable, to evaluate pharmacy programs. Evaluations of pharmacy programs shall be undertaken at each level within the IHS Pharmacy Branch.
- Headquarters
The responsibility of Headquarters Pharmacy Branch is to provide the Area Office and service units with the support and guidance needed to achieve Area program management and quality improvement goals. These responsibilities include policy setting, establishment of standards, oversight of and support to Area Pharmacy Officers, and monitoring of quality care issues through Area program reviews.
Area pharmacy program reviews are conducted periodically in each IHS Area by the Chief or Deputy Chief, Pharmacy Services, IHS. A standardized Area Pharmacy Program Review Document shall be used to assist the Chief, Pharmacy Services in conducting these reviews. During the Area program reviews, the Chief or Deputy Chief,- Pharmacy Services shall visit representative pharmacy programs within the Area to aid in assessing the quality of pharmacy services provided in the Area.
- Area
The Area Pharmacy Officer shall assist service units in achieving program management and quality improvement goals. The APO will work with pharmacy programs in the Area to ensure that IHS Pharmacy Standards of Practice and the standards of national accrediting bodies are maintained.
An important benchmark in the measurement of quality health care programs is accreditation by JCAHO or HCFA. The APO shall assist service unit pharmacy programs in meeting all JCAHO standards. This is accomplished through the development and implementation of an Area-wide pharmacy quality improvement program for hospitals and ambulatory care clinics. This program shall be developed in conjunction with Service Unit Chief Pharmacists. It must include standard indicators developed to evaluate the pharmacy programs at the service unit level by measuring compliance with the IHS Pharmacy Standards of Practice. The APO may conduct pre-JCAHO survey evaluations to identify and correct deficiencies and shall perform follow up reviews as necessary.
A standard Service Unit Pharmacy Program Review Document shall be used to assist the APO in conducting annual program reviews. This review document assesses program compliance with all applicable pharmacy standards of practice (IHS, JCAHO, ASHP, HCFA) and shall include an assessment of the facility's quality improvement programs and drug use evaluation activities.
- Service Unit
The service unit is the point of service delivery to the patient. Quality improvement is of utmost importance at this level of the organization. The Chief Pharmacist of the service unit is responsible for assuring compliance with applicable standards of the IHS, JCAHO, ASHP, and HCFA. The Chief Pharmacist is responsible for the quality of pharmacy services provided and for the development and implementation of a departmental quality improvement program.
To continuously monitor and evaluate pharmacy services provided, each service unit pharmacy shall develop a written departmental Quality Improvement Plan approved by the Clinical Director and the service unit director. The Quality Improvement Plan shall include:
- Provision for monitoring and evaluating of the pharmacy quality improvement program.
- Provision for written annual evaluation of the pharmacy quality improvement program.
- Provision indicators which cover all important aspects of care for the pharmacy service. These pharmacy indicators should include those which measure compliance with each of the six (6) standards of the IHS Pharmacy Standards of Practice.
- Provision for appropriate reporting of the monitoring and evaluation of pharmacy services to other departments, the facility QI committee, and, where applicable, to the Governing Body.
- REPORTS/FORMS
The following table summarizes the reporting requirements for IHS Pharmacy Branch:
REPORT - DESCRIPTION - REPORTED BY
Annual Area Pharmacy Branch Report - Annual Narrative by APO, annual narrative by stations, annual HRSA-91 spreadsheet, data on drug budget with analysis. - APO
Quarterly Area Pharmacy Workload Report - Quarterly station HRSA-91 spreadsheets, Area cumulative spreadsheet, brief narrative. - APO
Annual Service Unit Narrative Report - Description of station programs, objectives, accomplishments, personnel changes, problems encountered, etc. - Chief, Service Unit Pharmacist
Quarterly Station Workload Report - HRSA-91 for station workload data, brief narrative. - Chief, Service Unit Pharmacist
Monthly Report for Narcotics and Other Controlled Substances - HRSA-174 - Chief, Service Unit Pharmacist
Drug Quality Report - FDA-3318 - Chief, Service Unit Pharmacist
Adverse Drug Reaction Report - FDA-1639 - Chief, Service Unit Pharmacist
Vaccine Adverse Event Report - VAERS-1 - Chief, Service Unit Pharmacist
3-7.5 PROGRAM REFERENCES
ASHP Accreditation Standard for Pharmacy Technician Training Programs
ASHP Guidelines for the Use of Investigational Drugs in Institutions
ASHP Regulations on Accreditation of Hospital Pharmacy Technician Training Programs
ASHP Statement on Supportive Personnel in Hospital Pharmacy
ASHP Technical Assistance Bulletin on Handling Cytotoxic Drugs in Hospitals
ASHP Technical Assistance Bulletin on Institutional Use of Controlled Substances
Code of Federal Regulations, Title 21, Chapter II - Drug Enforcement Administration
Federal Acquisitions Regulations
IHS Area Pharmacy Program Review Document
IHS Circular 84-1
IHS Health Facilities Planning Manual
IHS Pharmacy Billet Standardization and Career Development Guidelines
IHS Pharmacy Standards of Practice
IHS Resource Requirements Methodology Needs Assessment
IHS Service Unit Pharmacy Program Review Document
The Joint Commission Accreditation Manual for Healthcare Organizations
Practice Standards of ASHP
United States Pharmacopeia
Work Practice Guidelines for Personnel Dealing with Cytotoxic (Antineoplastic) Drugs - OSHA Instruction PUB 8-1.1, Appendix A
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