Drug control (of which drug distribution is an important part) is among the pharmacist’s most important responsibilities. Therefore, adequate methods to assure that these responsibilities are met must be developed and implemented. These guidelines will assist the pharmacist in preparing drug control procedures for all medication-related activities. The guidelines are based on the premise that the pharmacy is responsible for the procurement, distribution, and control of all drugs used within the institution. In a sense, the entire hospital is the pharmacy, and the pharmacy service is simply a functional service extending throughout the institution’s physical and organizational structures.
It should be noted that, although this document is directed toward hospitals, much of it is relevant to other types of health-care facilities.
Pharmacy Policies, Procedures, and Communications
Policy and Procedure Manuals.1 The effectiveness of the drug control system depends on adherence to policies (broad, general statements of philosophy) and procedures (detailed guidelines for implementing policy). The importance of an up-to-date policy and procedure manual for drug control cannot be overestimated. All pharmacy staff must be familiar with the manual; it is an important part of orientation for new staff and crucial to the pharmacy’s internal communication mechanism. In addition, preparing written policies and procedures requires a thorough analysis of control operations; this review might go undone otherwise.
Drug control begins with the setting of policy. The authority to enforce drug control policy and procedures must come from the administration of the institution, with the endorsement of the medical staff, via the pharmacy and therapeutics (P&T) committee and/or other appropriate committee(s). Because the drug control system interfaces with numerous departments and professions, the P&T committee should be the focal point for communications relating to drug control in the institution. The pharmacist, with the cooperation of the P&T committee, should develop media such as newsletters, bulletins, and seminars to communicate with persons functioning within the framework of the control system.
Inservice Training and Education. Intra- and interdepartmental education and training programs are important to the effective implementation of policies and procedures and the institution’s drug control system in general. They are part of effective communication and help establish and maintain professional relationships among the pharmacy staff and between it and other hospital departments. Drug control policies and procedures should be included in the pharmacy’s educational programs.
Standards, Laws, and Regulations
The pharmacist must be aware of and comply with the laws, regulations, and standards governing the profession. Many of these standards and regulations deal with aspects of drug control. Among the agencies and organizations affecting institutional pharmacy practice are those described below.
Regulatory Agencies and Organizations. The U.S. government, through its Food and Drug Administration (FDA), is responsible for implementing and enforcing the federal Food, Drug, and Cosmetic Act. The FDA is responsible for the control and prevention of misbranding and of adulteration of food, drugs, and cosmetics moving in interstate commerce. The FDA also sets label requirements for food, drugs, and cosmetics; sets standards for investigational drug studies and for marketing of new drug products; and compiles data on adverse drug reactions.
The U.S. Department of the Treasury influences pharmacy operation by regulating the use of tax-free alcohol through the Bureau of Alcohol, Tobacco and Firearms. The U.S. Department of Justice affects pharmacy practice through its Drug Enforcement Agency (DEA) by enforcing the Controlled Substances Act of 1970 and other federal laws and regulations for controlled drugs.
Another federal agency, the Health Care Financing Administration, has established Conditions of Participation for hospitals and skilled nursing facilities to assist these institutions to qualify for reimbursement under the health insurance program for the aged (Medicare) and for Medicaid.
The state board of pharmacy is the agency of state government responsible for regulating pharmacy practice within the state. Practitioners, institutions, and community pharmacies must obtain licenses from the board to practice pharmacy or provide pharmacy services in the state. State boards of pharmacy promulgate numerous regulations pertaining to drug dispensing and control. (In some states, the state board of health licenses the hospital pharmacy separately or through a license that includes all departments of the hospital.)
Standards and guidelines for pharmaceutical services have been established by the Joint Commission on Accreditation of Hospitals (JCAH)2 and the American Society of Hospital Pharmacists (ASHP)3. The United States Pharmacopeial Convention also promulgates certain pharmacy practice procedures as well as official standards for drugs and drug testing. Professional practice guidelines and standards generally do not have the force of law but rather are intended to assist pharmacists in achieving the highest level of practice. They may, however, be employed in legal proceedings as evidence of what constitutes acceptable practice as determined by the profession itself.
In some instances, both federal and state laws may deal with a specific activity; in such cases, the more stringent law will apply.
The Medication System
Procurement: Drug Selection, Purchasing Authority, Responsibility, and Control.4–6 The selection of pharmaceuticals is a basic and extremely important professional function of the hospital pharmacist who is charged with making decisions regarding products, quantities, product specifications, and sources of supply. It is the pharmacist’s obligation to establish and maintain standards assuring the quality, proper storage, control, and safe use of all pharmaceuticals and related supplies (e.g., fluid administration sets); this responsibility must not be delegated to another individual. Although the actual purchasing of drugs and supplies may be performed by a nonpharmacist, the setting of quality standards and specifications requires professional knowledge and judgment and must be performed only by the pharmacist.
Economic and therapeutic considerations make it necessary for hospitals to have a well-controlled, continuously updated formulary. It is the pharmacist’s responsibility to develop and maintain adequate product specifications to aid in the purchase of drugs and related supplies under the formulary system. The USP–NF is a good base for drug product specifications; there also should be criteria to evaluate the acceptability of manufacturers and distributors. In establishing the formulary, the P&T committee recommends guidelines for drug selection. However, when his knowledge indicates, the pharmacist must have the authority to reject a particular drug product or supplier.
Although the pharmacist has the authority to select a brand or source of supply, he must make economic considerations subordinate to those of quality. Competitive bid purchasing is an important method for achieving a proper balance between quality and cost when two or more acceptable suppliers market a particular product meeting the pharmacist’s specifications. In selecting a vendor, the pharmacist must consider price, terms, shipping times, dependability, quality of service, returned goods policy, and packaging; however, prime importance always must be placed on drug quality and the manufacturer’s reputation. It should be noted that the pharmacist is responsible for the quality of all drugs dispensed by the pharmacy.
Records. The pharmacist must establish and maintain adequate recordkeeping systems. Various records must be retained (and be retrievable) by the pharmacy because of governmental regulations; some are advisable for legal protection, others are needed for JCAH accreditation, and still others are necessary for sound management (evaluation of productivity, workloads, and expenses and assessment of departmental growth and progress) of the pharmacy department. Records must be retained for at least the length of time prescribed by law (where such requirements apply).
It is important that the pharmacist study federal, state, and local laws to become familiar with their requirements for permits, tax stamps, storage of alcohol and controlled substances, records, and reports.
Among the records needed in the drug distribution and control system are
- Controlled substances inventory and dispensing records.
- Records of medication orders and their processing.
- Manufacturing and packaging production records.
- Pharmacy workload records.
- Purchase and inventory records.
- Records of equipment maintenance.
- Records of results and actions taken in quality-assurance and drug audit programs.
Receiving Drugs. Receiving control should be under the auspices of a responsible individual, and the pharmacist must ensure that records and forms provide proper control upon receipt of drugs. Complete accountability from purchase order initiation to drug administration must be provided.
Personnel involved in the purchase, receipt, and control of drugs should be well trained in their responsibilities and duties and must understand the serious nature of drugs. All nonprofessional personnel employed by the pharmacy should be selected and supervised by the pharmacist.
Delivery of drugs directly to the pharmacy or other pharmacy receiving area is highly desirable; it should be considered mandatory for controlled drugs. Orders for controlled substances must be checked against the official order blank (when applicable) and against hospital purchase order forms. All drugs should be placed into stock promptly upon receipt, and controlled substances must be directly transferred to safes or other secure areas.
Drug Storage and Inventory Control. Storage is an important aspect of the total drug control system. Proper environmental control (i.e., proper temperature, light, humidity, conditions of sanitation, ventilation, and segregation) must be maintained wherever drugs and supplies are stored in the institution. Storage areas must be secure; fixtures and equipment used to store drugs should be constructed so that drugs are accessible only to designated and authorized personnel. Such personnel must be carefully selected and supervised. Safety also is an important factor, and proper consideration should be given to the safe storage of poisons and flammable compounds. Externals should be stored separately from internal medications. Medications stored in a refrigerator containing items other than drugs should be kept in a secured, separate compartment.
Proper control is important wherever medications are kept, whether in general storage in the institution or the pharmacy or patient-care areas (including satellite pharmacies, nursing units, clinics, emergency rooms, operating rooms, recovery rooms, and treatment rooms). Expiration dates of perishable drugs must be considered in all of these locations, and stock must be rotated as required. A method to detect and properly dispose of outdated, deteriorated, recalled, or obsolete drugs and supplies should be established. This should include monthly audits of all medication storage areas in the institution. (The results of these audits should be documented in writing.)
Since the pharmacist must justify and account for the expenditure of pharmacy funds, he must maintain an adequate inventory management system. Such a system should enable the pharmacist to analyze and interpret prescribing trends and their economic impacts and appropriately minimize inventory levels. It is essential that a system to indicate subminimum inventory levels be developed to avoid “outages,” along with procedures to procure emergency supplies of drugs when necessary.
In-House Manufacturing, Bulk Compounding, Packaging, and Labeling.7,8 As with commercially marketed drug products, those produced by the pharmacy must be accurate in identity, strength, purity, and quality. Therefore, there must be adequate process and finished product controls for all manufacturing/bulk compounding and packaging operations. Written master formulas and batch records (including product test results) must be maintained. All technical personnel must be adequately trained and supervised.
Packaging and labeling operations must have controls sufficient to prevent product/package/label mixups. A lot number to identify each finished product with its production and control history must be assigned to each batch.
The pharmacist is encouraged to prepare those drug dosage forms, strengths, and packagings that are needed for optimal drug therapy but that are commercially unavailable. Adequate attention must be given to the stability, palatability, packaging, and labeling requirements of these products.
Medication Distribution (Unit Dose System).9–11 Medication distribution is the responsibility of the pharmacy. The pharmacist, with the assistance of the P&T committee and the department of nursing, must develop comprehensive policies and procedures that provide for the safe distribution of all medications and related supplies to inpatients and outpatients.
For reasons of safety and economy, the preferred method to distribute drugs in institutions is the unit dose system. Although the unit dose system may differ in form depending on the specific needs, resources, and characteristics of each institution, four elements are common to all: (1) medications are contained in, and administered from, single unit or unit dose packages; (2) medications are dispensed in ready-to-administer form to the extent possible; (3) for most medications, not more than a 24-hour supply of doses is provided to or available at the patient-care area at any time; and (4) a patient medication profile is concurrently maintained in the pharmacy for each patient. Floor stocks of drugs are minimized and limited to drugs for emergency use and routinely used “safe” items such as mouthwash and antiseptic solutions.
(1) Physician’s drug order: writing the order. Medications should be given (with certain specified exceptions) only on the written order of a qualified physician or other authorized prescriber. Allowable exceptions to this rule (i.e., telephone or verbal orders) should be put in written form immediately and the prescriber should countersign the nurse’s or pharmacist’s signed record of these orders within 48 (preferably 24) hours. Only a pharmacist or registered nurse should accept such orders. Provision should be made to place physician’s orders in the patient’s chart, and a method for sending this information to the pharmacy should be developed.
Prescribers should specify the date and time medication orders are written.
Medication orders should be written legibly in ink and should include
- Patient’s name and location (unless clearly indicated on the order sheet).
- Name (generic) of medication.
- Dosage expressed in the metric system, except in instances where dosage must be expressed otherwise (i.e., units, etc.).
- Frequency of administration.
- Route of administration.
- Signature of the physician.
- Date and hour the order was written.
Any abbreviations used in medication orders should be agreed to and jointly adopted by the medical, nursing, pharmacy, and medical records staff of the institution.
Any questions arising from a medication order, including the interpretation of an illegible order, should be referred to the ordering physician by the pharmacist. It is desirable for the pharmacist to make (appropriate) entries in the patient’s medical chart pertinent to the patient’s drug therapy. (Proper authorization for this must be obtained.12) Also, a duplicate record of the entry can be maintained in the pharmacy profile.
In computerized patient data systems, each prescriber should be assigned a unique identifier; this number should be included in all medication orders. Unauthorized personnel should not be able to gain access to the system.
(2) Physician’s drug order: medication order sheets. The pharmacist (except in emergency situations) must receive the physician’s original order or a direct copy of the order before the drug is dispensed. This permits the pharmacist to resolve questions or problems with drug orders before the drug is dispensed and administered. It also eliminates errors which may arise when drug orders are transcribed onto another form for use by the pharmacy. Several methods by which the pharmacy may receive physicians’ original orders or direct copies are
1. Self-copying order forms. The physician’s order form is designed to make a direct copy (carbon or NCR) which is sent to the pharmacy. This method provides the pharmacist with a duplicate copy of the order and does not require special equipment. There are two basic formats:
a. Orders for medications included among treatment orders. Use of this form allows the physician to continue writing his orders on the chart as he has been accustomed in the past, leaving all other details to hospital personnel.
b. Medication orders separated from other treatment orders on the order form. The separation of drug orders makes it easier for the pharmacist to review the order sheet.
2. Electromechanical. Copying machines or similar devices may be used to produce an exact copy of the physician’s order. Provision should be made to transmit physicians’ orders to the pharmacy in the event of mechanical failure.
3. Computerized. Computer systems, in which the physician enters orders into a computer which then stores and prints out the orders in the pharmacy or elsewhere, are used in some institutions. Any such system should provide for the pharmacist’s verification of any drug orders entered into the system by anyone other than an authorized prescriber.
(3) Physician’s drug order: time limits and changes. Medication orders should be reviewed automatically when the patient goes to the delivery room, operating room, or a different service. In addition, a method to protect patients from indefinite, open-ended drug orders must be provided. This may be accomplished through one or more of the following: (1) routine monitoring of patients’ drug therapy by a pharmacist; (2) drug class-specific, automatic stop-order policies covering those drug orders not specifying a number of doses or duration of therapy; and (3) automatic cancellation of all drug orders after a predetermined (by the P&T committee) time interval unless rewritten by the prescriber. Whatever the method used, it must protect the patient, as well as provide for a timely notification to the prescriber that the order will be stopped before such action takes place.
(4) Physician’s drug order: receipt of order and drug profiles. A pharmacist must review and interpret every medication order and resolve any problems or uncertainties with it before the drug is entered into