Part 3, Chapter 7: Manual Appendix A
IHS Pharmacy Standards of Practice
UNITED STATES PUBLIC HEALTH SERVICE
INDIAN HEALTH SERVICE
STANDARDS OF PRACTICE
Pharmacy Services in the Indian Health Service (IHS) are an integral part of a comprehensive, community-based health care delivery system. Pharmacy services are patient-oriented and are directed toward optimal patient care outcomes, health promotion and disease prevention. The principal purpose of IHS pharmacy services is to assure efficacious, safe and cost effective drug therapy and appropriate outcomes in the use of drugs and medications in the communities served. Direct patient care activities are supported by managerial, training, supply, drug distribution and control services.
Pharmacy services within the IHS require that pharmacists consider and respect the cultural beliefs of the communities they serve. Pharmacists in the IHS serve as role models for persons within the communities who may wish to pursue careers in the health field. Education and other programs to support rational drug therapy and appropriate use of drugs within the community are essential parts of pharmacy services.
Pharmacy services are fully integrated into the health are system. Therefore pharmacists maybe called upon to perform other extended functions such as primary patient care and program management.
PHARMACY SERVICES WITHIN THE IHS SHALL CONFORM TO THE INDIAN HEALTH MANUAL AND SHALL MEET OR EXCEED APPLICABLE NATIONAL STANDARDS E.G., THOSE OF THE JOINT COMMISSION ON ACCREDITATION OF HEALTH CARE ORGANIZATIONS, VIZ. THE PHARMACEUTICAL SERVICE STANDARDS PLUS OTHER APPLICABLE STANDARDS IN THE CURRENT EDITION OF THE ACCREDITATION MANUAL FOR HOSPITALS, THE CURRENT EDITION OF THE AMBULATORY HEALTH CARE STANDARDS MANUAL, AND CURRENT EDITION OF STANDARDS FOR THE ACCREDITATION OF HOME CARE (APPENDIX 1).
ASSURE APPROPRIATENESS OF DRUG THERAPY
The pharmacy shall assure that drug therapy is safe, efficacious, and cost Effective. Toward that end, a pharmacist shall review the complete medical record of each ambulatory and hospitalized patient who is to receive medications prior to the dispensing or administering of the medications, or, if a pharmacist is not immediately available, as soon as a pharmacist becomes available. Standards of care developed or adopted by the professional staff of the facility shall be the criteria for appropriateness of drug therapy. Any concerns or questions about the drug therapy which has been ordered which result from this review shall be resolved with the prescriber prior to dispensing.
After drug therapy has been initiated, a pharmacist shall monitor patient's ongoing or intermittent therapy to evaluate its effectiveness and to prevent and detect undesired drug reactions early in the course of therapy. Any concerns or questions which result from this monitoring shall be resolved with the prescriber as soon as possible.
Pharmacists shall screen patient health records and monitor patients for the appropriateness of therapy with attention to the following:
- correct patient
- legality of drug orders
- completeness of medication orders
- drug-induced or drug-related problems
- appropriateness of drug therapy for the stated indication
- appropriateness of drug therapy for the patient
- drug-drug, drug-diet, drug-laboratory test interactions
- pathological conditions that might require alternative dose or drug
- appropriateness of the dosage form
- appropriateness of the dosage and quality of drug ordered
- completion of all treatment plan elements of current visit
- current status of health maintenance and wellness parameters, e.g., immunizations, diet, lifestyle
- appropriateness of follow up for current health problems
Pharmacists shall document their record reviews and monitoring activities in the patients’ health records according to IHS documentation criteria.
Compliance with this standard shall be assessed by a review of patients’ medical records for conformance to prescribed drug therapy with local and nationally accepted standards of care and evidence of documentation of pharmacists’ review and monitoring activities and any outcomes of that monitoring and review.
VERIFY THAT PATIENTS UNDERSTAND THEIR MEDICATIONS AND
APPROPRIATE OUTCOMES OF THEIR DRUG.
All outpatients who present to the pharmacy shall receive medication counseling in a private consultation room. This room shall have necessary furnishings and instructional aids and shall be arranged in a manner conducive to effective communication.
All inpatients who are to receive discharge medications shall receive medication counseling prior to discharge. This counseling shall be provided in the patient’s hospital room, other appropriate inpatient area or the pharmacy consultation room.
During counseling the pharmacist shall verify that patients understand the purpose, proper use and expected outcomes of the drug therapy. The pharmacist shall determine patient understanding through patient feedback. Supplemental written information shall be provided when indicated. Counseling shall include the following:
- The indication for which the patient is taking the medication
- disease, symptom or complaint
- The name and strength of the medication
- How the medication is to be used
- dose and dosage form
- administration schedule and technique
- duration of therapy
- preparation for use
- storage of the medication
- ancillary instructions
What changes to expect
- desired therapeutic outcome
- what to do if it doesn’t occur
- potential unwanted effects
- what to do if they occur
- how to minimize unwanted effects
- Other treatment plan elements
Other treatment plan elements
- follow up appointment
- medication issues relating to radiology and laboratory procedures
- medications administered at the facility e.g., injections
Compliance with this standard shall be assessed by review of documentation of pharmacist counseling in the patients’ medical records and periodic exit interviews to determine effectiveness.
ASSURE AVAILABILITY, PREPARATION AND CONTROL
The pharmacy service is responsible for assuring that drug availability, distribution and control are safe and appropriate and meet the needs of patient care. Drug and dosage form selection, purchasing, preparation and dispensing for both inpatients and outpatients shall meet contemporary, national standards.
A major drug use control activity is the Pharmacy and Therapeutics function as defined in the Medical Staff Standard of the Joint Commission of Health Care Organizations (Appendix A, Standard MS.6.1.6, pages 120-121). This function supports national therapeutics and, as such, the mission of IHS pharmacy services. Therefore, support of the Pharmacy and Therapeutics function is an essential pharmacy service. To provide this function, the Pharmacy Service shall assure that a Pharmacy and Therapeutics Committee and Formulary System are in effect as defined in the current practice standards of the American Society of Hospital Pharmacists, viz, ASHP Statement on the Pharmacy and Therapeutics Committee (Appendix 3B), ASHP Statement on the Formulary System (Appendix 3C).
Outpatient drug distribution and control is essential for ambulatory and home patient care. The pharmacy service shall assure that medications are available to outpatients at all times and pharmacists shall distribute and control outpatient medications according to applicable laws and regulations.
Inpatient medications shall be distributed through a contemporary unit dose drug distribution system.
Controlled substances for both inpatient and outpatient use shall be distributed and controlled according to current federal law and regulations and the Indian Health Manual
, Section 3-7.23, pages 34-39 (Appendix 3D).
The pharmacy service shall maintain an appropriate inventory of drugs and chemicals for the extemporaneous formulation of needed drugs. Provision shall be made for determining the need for medications not routinely available at the facility and for obtaining needed medications that are not routinely available. The pharmacy service shall assure that quality medications are available at reasonable cost according to the current supply management sections of the Indian Health Manual
(Appendix 3E) and the current practice standards of the American Society of Hospital Pharmacists, viz, ASHP Guidelines for Selecting Pharmaceutical Manufacturers and Distributors (Appendix 3F), ASHP Technical Assistance Bulletin on the Scientific and Therapeutic Evaluation of Drugs for Hospital Formularies (Appendix 3G).
The pharmacy service shall prepare and extemporaneously compound needed medication which are not commercially available in finished dosage forms.
The pharmacy service shall provide intravenous admixture and other parenteral dosage form preparation and distribution for inpatients and for ambulatory care patients requiring parenteral therapy. Cytotoxic drugs shall be handled according to the current practice standards of the American Society of Hospital Pharmacists, viz, ASHP Technical Assistance Bulletin on Handing of Cytotoxic Drugs in Hospital (Appendix 3H) and in the current guidelines of the Occupational Safety and Health Administration (OSHA).
In any facility in which investigational drugs are used, the pharmacy service shall assure that such drugs are reviewed, packaged, labeled, distributed and controlled according to the current practice standards of the American Society of Hospital Pharmacists, viz, ASHP Guidelines for the Use of Investigational Drugs in Institutions (Appendix 31, and current IHS policy (Appendix 3J).
Compliance with this standard shall be assured by comparing current services with the listed standards of other professional organizations and current applicable IHS policy.
PROVIDE DRUG INFORMATION DRUG THERAPY CONSULTATION
AND STAFF EDUCATION RELATING TO DRUG THERAPY.
The pharmacy service shall provide drug information and education by a variety of methods which shall include: (1) pharmacist-initiated, patient-specific interventions (2) drug therapy consultation on request from other professional staff and (3) inservice education to other professionals and health workers such as community health representatives and health aides. Other methods by which pharmacists might provide drug information and education may include but not limited to publishing drug therapy bulletins, attending patient rounds, and providing drug information handouts to patients.
The pharmacy service shall maintain information resources and an information retrieval system which provide the capability to disseminate needed drug information prior to the initiation of therapy. This information may be in hard copy, microfiche format, on-line or other appropriate format. Core references which should be available are listed in Appendix 4.
Pharmacists shall serve as role models and shall serve as preceptors for pharmacy interns, students on externships and clerkships, COSTEPS and residents assigned to the service.
Compliance with this standard shall be assessed by review of records of interventions and consultations and documentation of inservice education and preceptor activities.
PROVIDE HEALTH PROMOTION AND DISEASE PREVENTION
ACTIVITIES RELATING TO DRUG USE AND PREVENTIVE DRUG THERAPY
Pharmacies shall promote primary disease prevention through preventive drug therapy and drug use education. Such activities shall include, but not limited to: (1) reviewing the patient's complete medical record as a part of routine screening for documentation of needed health maintenance activities e.g., Pap test, immunizations, dental fluoridation, and assuring the initiation of needed health maintenance activities; (2) discussing safe and appropriate drug use and storage as an integral part of all patient education and consultation activities (3) routinely counseling prenatal patients on safe drug use during pregnancy and (4) participating in community-based drug education, poison prevention and substance abuse avoidance programs and activities. Examples of settings in which pharmacists might provide these programs and activities are schools, elderly care centers and health fairs.
To prevent complications from previously diagnosed disease, pharmacists shall provide secondary disease prevention services through routine screening for appropriate drug therapy and providing patent consultation on prescribed therapy.
Compliance with this standard shall be assessed by review of documentation in patients' medical records and documentation of follow-up on needed health promotion and disease prevention measure's.
MANAGE THERAPY FOR SELECTED PATIENTS IN WHOM DRUGS ARE THE
PRINCIPAL METHOD OF TREATMENT
Pharmacists shall manage care for selected patients in whom drugs are the principal form of therapy. The types of patients to receive these services and the ways in which the pharmacists provide these services shall be defined by the medical staff of the facility which the services are provided.
A pharmacist shall make necessary changes and adjustments in the therapy of ambulatory patients who have chronic or recurrent diseases such as diabetes mellitus, hypertension, and seizure disorders; and inpatients requiring continuous, short term therapy such as total parenteral nutrition and drugs requiring pharmacokinetically based monitoring and dosage adjustment.
Pharmacists also shall assume principal responsibility for managing the care of ambulatory patients with selected acute illnesses such as upper respiratory tract infections and rashes.
Diseases and indications for which pharmacists shall provide these services and the standing orders and treatment protocols which define these services shall be developed in conjunction with the local medical staff.
For each patient encounter, the pharmacist shall make clinical assessments based on subjective and objective data, prescribe appropriate therapy, determine needed follow up care and document the services in the patient’s health record.
Compliance with this standard shall be assessed by review of documentation in the patients' heath records.