Drug Distribution and Control: Distribution–Technical Assistance Bulletins 177 ASHP Technical Assistance Bulletin on Hospital Drug Distribution and Control Drug control (of which drug distribution is an important control. Among the agencies and organizations affecting in- part) is among the pharmacist’s most important responsi- stitutional pharmacy practice are those described below. bilities. Therefore, adequate methods to assure that these re- sponsibilities are met must be developed and implemented. Regulatory Agencies and Organizations. The U.S. govern- These guidelines will assist the pharmacist in preparing drug ment, through its Food and Drug Administration (FDA), control procedures for all medication-related activities. The is responsible for implementing and enforcing the federal guidelines are based on the premise that the pharmacy is re- Food, Drug, and Cosmetic Act. The FDA is responsible for sponsible for the procurement, distribution, and control of the control and prevention of misbranding and of adultera- all drugs used within the institution. In a sense, the entire tion of food, drugs, and cosmetics moving in interstate com- hospital is the pharmacy, and the pharmacy service is simply merce. The FDA also sets label requirements for food, drugs, a functional service extending throughout the institution’s and cosmetics; sets standards for investigational drug stud- physical and organizational structures. ies and for marketing of new drug products; and compiles It should be noted that, although this document is di- data on adverse drug reactions. rected toward hospitals, much of it is relevant to other types The U.S. Department of the Treasury influences of health-care facilities. pharmacy operation by regulating the use of tax-free alco- hol through the Bureau of Alcohol, Tobacco and Firearms. Pharmacy Policies, Procedures, and The U.S. Department of Justice affects pharmacy practice Communications through its Drug Enforcement Agency (DEA) by enforcing the Controlled Substances Act of 1970 and other federal Policy and Procedure Manuals.1 The effectiveness of the laws and regulations for controlled drugs. drug control system depends on adherence to policies (broad, Another federal agency, the Health Care Financing general statements of philosophy) and procedures (detailed Administration, has established Conditions of Participation guidelines for implementing policy). The importance of an for hospitals and skilled nursing facilities to assist these in- up-to-date policy and procedure manual for drug control can- stitutions to qualify for reimbursement under the health in- not be overestimated. All pharmacy staff must be familiar with surance program for the aged (Medicare) and for Medicaid. the manual; it is an important part of orientation for new staff The state board of pharmacy is the agency of state gov- and crucial to the pharmacy’s internal communication mecha- ernment responsible for regulating pharmacy practice within nism. In addition, preparing written policies and procedures the state. Practitioners, institutions, and community pharma- requires a thorough analysis of control operations; this review cies must obtain licenses from the board to practice pharmacy might go undone otherwise. or provide pharmacy services in the state. State boards of Drug control begins with the setting of policy. The au- pharmacy promulgate numerous regulations pertaining to thority to enforce drug control policy and procedures must drug dispensing and control. (In some states, the state board come from the administration of the institution, with the en- of health licenses the hospital pharmacy separately or through dorsement of the medical staff, via the pharmacy and therapeu- a license that includes all departments of the hospital.) tics (P&T) committee and/or other appropriate committee(s). Standards and guidelines for pharmaceutical ser- Because the drug control system interfaces with numerous de- vices have been established by the Joint Commission on Accreditation of Hospitals (JCAH)2 and the American partments and professions, the P&T committee should be the 3 focal point for communications relating to drug control in the Society of Hospital Pharmacists (ASHP) . The United States institution. The pharmacist, with the cooperation of the P&T Pharmacopeial Convention also promulgates certain phar- committee, should develop media such as newsletters, bul- macy practice procedures as well as official standards for letins, and seminars to communicate with persons functioning drugs and drug testing. Professional practice guidelines and within the framework of the control system. standards generally do not have the force of law but rather are intended to assist pharmacists in achieving the highest Inservice Training and Education. Intra- and interdepartmental level of practice. They may, however, be employed in legal education and training programs are important to the effective proceedings as evidence of what constitutes acceptable prac- implementation of policies and procedures and the institution’s tice as determined by the profession itself. drug control system in general. They are part of effective com- In some instances, both federal and state laws may munication and help establish and maintain professional relation- deal with a specific activity; in such cases, the more strin- ships among the pharmacy staff and between it and other hospital gent law will apply. departments. Drug control policies and procedures should be in- cluded in the pharmacy’s educational programs. The Medication System Standards, Laws, and Regulations Procurement: Drug Selection, Purchasing Authority, Res­ ponsibility, and Control.4–6 The selection of pharmaceuticals The pharmacist must be aware of and comply with the laws, is a basic and extremely important professional function of regulations, and standards governing the profession. Many the hospital pharmacist who is charged with making decisions of these standards and regulations deal with aspects of drug regarding products, quantities, product specifications, and 178 Drug Distribution and Control: Distribution–Technical Assistance Bulletins sources of supply. It is the pharmacist’s obligation to establish Personnel involved in the purchase, receipt, and con- and maintain standards assuring the quality, proper storage, trol of drugs should be well trained in their responsibilities control, and safe use of all pharmaceuticals and related sup- and duties and must understand the serious nature of drugs. plies (e.g., fluid administration sets); this responsibility must All nonprofessional personnel employed by the pharmacy not be delegated to another individual. Although the actual should be selected and supervised by the pharmacist. purchasing of drugs and supplies may be performed by a non- Delivery of drugs directly to the pharmacy or other pharmacist, the setting of quality standards and specifications pharmacy receiving area is highly desirable; it should be requires professional knowledge and judgment and must be considered mandatory for controlled drugs. Orders for con- performed only by the pharmacist. trolled substances must be checked against the official order Economic and therapeutic considerations make it neces- blank (when applicable) and against hospital purchase order sary for hospitals to have a well-controlled, continuously updated forms. All drugs should be placed into stock promptly upon formulary. It is the pharmacist’s responsibility to develop and receipt, and controlled substances must be directly trans- maintain adequate product specifications to aid in the purchase ferred to safes or other secure areas. of drugs and related supplies under the formulary system. The USP–NF is a good base for drug product specifications; there Drug Storage and Inventory Control. Storage is an important also should be criteria to evaluate the acceptability of manufac- aspect of the total drug control system. Proper environmental turers and distributors. In establishing the formulary, the P&T control (i.e., proper temperature, light, humidity, conditions of committee recommends guidelines for drug selection. However, sanitation, ventilation, and segregation) must be maintained when his knowledge indicates, the pharmacist must have the au- wherever drugs and supplies are stored in the institution. thority to reject a particular drug product or supplier. Storage areas must be secure; fixtures and equipment used to Although the pharmacist has the authority to select a brand store drugs should be constructed so that drugs are accessible or source of supply, he must make economic considerations only to designated and authorized personnel. Such personnel subordinate to those of quality. Competitive bid purchasing is must be carefully selected and supervised. Safety also is an im- an important method for achieving a proper balance between portant factor, and proper consideration should be given to the quality and cost when two or more acceptable suppliers market safe storage of poisons and flammable compounds. Externals a particular product meeting the pharmacist’s specifications. In should be stored separately from internal medications. selecting a vendor, the pharmacist must consider price, terms, Medications stored in a refrigerator containing items other than shipping times, dependability, quality of service, returned goods drugs should be kept in a secured, separate compartment. policy, and packaging; however, prime importance always must Proper control is important wherever medications