Pharmacy-coordinated investigational drug services.

ABSTRACT

The concept of a pharmacy-coordinated investigational drug service (IDS) is proposed as an approach to better control of investigational drugs. The IDS should be considered as set of service functions aimed to ensure that investigational drug studies in the hospital are executed in a safe, effective, and efficient manner. These functions are the distribution and control of study drugs, clinical services, research activities, and management of clinical studies. The IDS will vary from hospital to hospital, and should reflect the extent to which the institution is involved with research, available resources, and the needs of the hospital. Successful development and operation of an IDS depend on proper planning and continued effective management. The IDS will require resources of personnel, money, and facilities, space, and equipment. The primary expense of the IDS (probably about 80%) will be personnel. Job descriptions for each staff position should be prepared, and a complete set of standard operating policies and procedures is required. Periodic reports summarizing the activities of the IDS and an ongoing quality assurance program are needed. To create an IDS, the pharmacy must acquire the necessary approvals, authority, and resources. The IDS will benefit patients, nursing staff, clinical investigators, hospital risk management, and sponsors of clinical research. These benefits can be used to gain support for the IDS concept. Once the IDS is established, the best promotion will be a successful track of accomplishing the IDS objectives.