Formulary Manual
Table of Contents
Pharmacy and Therapeutics Committee Guidelines
The Pharmacy and Therapeutics Committee is a committee of the Medical Staff. The Committee is comprised of at least five members including three members of the Medical Staff, one of whom serves as chairperson; The Director of Pharmacy Services, who serves as secretary; and the Director of Nursing or designee. The Committee is advisory to the medical staff and pharmacists in the evaluation, selection, distribution and administration of drugs and supplies issued by the Pharmacy. The Committee recommends policies which provide for the safe, effective use and monitoring of drugs in the hospital, including investigational and hazardous drugs. The Committee is also responsible for the preparation and revision of the hospital's Formulary.
The Formulary provides a list of those drugs which, according to the current judgement of the Committee and the Medical Staff, meet the highest quality standards for treatment of the usual clinical problems without duplication of therapeutic effect.
Drug Categories
A. Formulary Drug
Considered essential for patient care. Its therapeutic efficacy is well established and it is not duplicated by other agents in the Formulary.
1. Restricted Formulary Drug: Optimum efficacy/risk ratio has not been established or the drug has limited use. A physician of a specified subspecialty may order; other physicians may order with prior approval and/or continued direction of specified subspecialties.
2. Supervised Formulary Drug-Physcian must confer with specified subspecialty to continue use in a patient.
Therapeutic Evaluation Drug
A drug which is being considered for admission to the Formulary for which there is insufficient information as to its usefulness and/or safety in this hospital. This classification permits availability of a drug to specified physician for a period during which time data and experience with it is collected. At the end of the evaluation period, the requesting physician(s) will be contacted for written evaluation and the committee will determine whether the drug is to be admitted to the Formulary, continued on an evaluation status to acquire more data, or discontinued.
C. Non-Formulary Drug
Any commerically available drug other than those classified as a Formualry Drug or Therapeutic Evaluation Drug; or a specified brand of any Formulary Drug that is not stocked by the Pharmacy. Non-Formulary drugs will be obtained for use in a specified patient only at the request of an Attending Physician, Chief Medical or Surgical Resident.
D. Investigational Drug
A drug which has not yet been approved by the Federal Food and Drug Administration for general use. All protocols concerned with the use of investigational or experimental drugs in the hospital will be submitted to the Pharmacy and Therapeutics Committee and the Human Research Committee for evaluation and approval. An investigational drug must be used under the close supervision of the chief investigator. The ultimate responsibility for the use of an investigational drug rests with the Medical Board.
All Investigational drugs used on inpatients in this hospital are to be distributed through the Department of Pharmacy Services.
Addition of Drugs to Formulary
A request to have a drug included in the Formulary may be made by an Attending Physician who submits a
completed Formulary Addition Request Form to the Secretary of the Pharmacy and Therapeutics Committee. The Drug Information Center will prepare a monograph on the drug, which will be distributed to all members of the Committee and the requesting physician prior to the next meeting. The requesting physician may be asked to attend the Committee meeting or meet with a Committee representative to discuss his request.
If the majority of the Committee members present at the meeting approve the request, the drug will be listed in the Formulary and the Medical Board will be notified.
Drugs are added to the Formulary under generic name. The Department of Pharmacy Services will determine which proprietary brands will be stocked based on product evaluation.
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