Pharmacy and Therapeutics Review Function

The drug usage review committee is charged with both formulating policy on drug utilization and ensuring compliance with those policies. (The use of antibiotics is the subject of a separate review function because of its relation to the spread of infectious disease in the hospital.) There are four components of the drug usage review function: (1) review of the hospital formulary, (2) review of adverse drug reaction, (3) review of controlled substance usage, and (4) review of investigational drug usage. The first three of these components are discussed in this section; the fourth is examined in the chapter on teaching hospitals.

Hospital Formulary. The hospital formulary establishes which drugs are available to practitioners in the hospital. The formulary may also place restrictions on the use of certain drugs, such as no "standing orders" for barbiturates. The enforcement of these restrictions is a hospital function. The nursing staff members, who administer almost all medications in the hospital setting, must be made aware of the restrictions on drug usage and the importance of not administering drugs without proper orders.

The main quality control value of the formulary is the prevention of the indiscriminate use of unproven or dangerous drugs in the hospital. Conversely, the risk of the formulary is that it will unreasonably limit the availability of valuable drugs. Because of this risk, there must be an explicit protocol for evaluating a request to add a new drug to the formulary. If the review committee decides not to add the drug, it should note this refusal in the committee minutes and record its reasons for turning down the request. The committee may choose to recommend that the requesting physician seek permission to use the drug under the investigational drug guidelines, but there should be explicit provisions in the hospital bylaws forbidding any physician from bringing unauthorized drugs into the hospital.

Adverse Drug Reactions. Adverse drug reactions may be due to the patient sensitivity, improper dosage or administration, improper formulation, or contamination. While the first two causes are important and must be investigated, possible drug misformulation or contamination is an emergency situation because of the threat to other patients. What ever committee structure the hospital or group practice adopts, there must be a mechanism for detecting reactions resulting from impure drugs. While the determination of the cause of any individual drug reaction requires careful medical investigation, the occurrence of two or more reactions to the same drug within a defined time frame should establish a presumption that the drug is impure. Further investigation may show the relationship to be coincidental; but until the investigation is complete, the hospital's supply of the drug must be withdrawn from use and an alternate supply located.

The prompt recognition of recurring drug reactions requires quick data collection and analysis. The simplest methods for achieving this is to handcarry to the pharmacy a copy of all incident reports dealing with drug reactions. The pharmacist must post the data in such a way that any trends can be identified quickly. This posting may be by computer or by a simple tabular method, such as maintaining a "reaction card" for all drugs in the formulary. By having a separate card for each drug, it will be immediately obvious if there has been another reaction to that drug recently. If there is a separate set of physician cards on which a tally of adverse reactions is kept by each physician's name, it will be possibly impure drug or a pattern of drug reactions in the patients of a given physician, the pharmacist should report this at once to the head of the review committee. In the case of an unpure drug, the pharmacist should also remove the drug from the pharmacy, recall any unused drug on the floors, and locate an alternate supply of the questionable drug.

Controlled Substance Usage. The management of controlled substances is one of the few areas where the hospital or group practice must deal with the criminal law system. The hospital pharmacy must first make sure that it has copies of all relevant state and federal laws governing the use of controlled substances. Also, the pharmacy review committee should contact the state drug enforcement agency and the federal drug enforcement agency to ensure that all of the committee's materials are up to date. The review committee must make sure that there are adequate inventory procedures and nursing guidelines to detect improper use of controlled substances by either physicians or hospital personnel. The committee should also establish a physician-indexed reporting system for all controlled substance prescriptions. This index must be carefully reviewed to detect excessive numbers of controlled substance prescriptions or sudden increases in such prescriptions.

Deviations from the expected rate of controlled substance use may indicate bad medical decisions, illegal diversion of drugs, or an addicted physician. While these problems have risk management significance for the hospital, they may also be violation involved, the responsible review committee becomes severely limited in its choice of actions. The hospital or group practice must act to stop any illegal activities at once. In some situations, there may be a duty to report known criminal violations; the committee members may become personally involved in a criminal violation if they tolerate criminal activities. The committee must also take action to review the continuation of staff privileges for a physician involved in controlled substance law violations, including an immediate limitation on the physician's right to write controlled substance prescriptions in the hospital.

The antibiotic usage review function is separate from the general pharmacy and therapeutics review because of the danger of nosocomial illness. While the choice of an antibiotic is a medical decision, it is also a public health decision affecting the general environment of the hospital. For this reason, the antibiotic usage review must be closely corelated with the general infection control program. Administratively, the hospital may want to maintain separate committees; but functionally, infection control and antibiotic usage review are inseparable.