The procedures for obtaining and dispensing investigational drugs for single-patient compassionate use are described, and roles for pharmacists in this process at a university medical center are identified. To obtain an investigational drug, a physician must contact a pharmaceutical-company study monitor to discuss the details of the case. Other responsibilities of the physician include obtaining institutional review board approval; completing FDA form 1572 or 1573, or both; and securing written informed consent from the patient. The responsibilities of the pharmacist are to ensure that informed consent has been obtained; inform nursing, pharmacy, and medical staffs about the use, admixture requirements, and administration of the investigational agent; provide a therapeutic drug monitoring plan; and store, handle, and prepare the medication. The pharmacist also keeps inventory of all shipped drugs and returns all unused drugs to the manufacturer. Pharmacists should be knowledgeable about the proper procedure for obtaining and dispensing investigational drugs on an emergency or treatment basis.

Drug Evaluation↗

PubMed1986

Cost analysis of substituting labetalol for nitroprusside.

Explore the source record for details and available documents.

Costs and Cost Analysis↗

PubMedDate not supplied

Forefoot pain involving the metatarsal region: differential diagnosis with MR imaging.

Many disorders produce discomfort in the metatarsal region of the forefoot. These disorders include traumatic lesions of the soft tissues and bones (eg, turf toe, plantar plate disruption, sesamoiditis, stress fracture, stress response), Freiberg infraction, infection, arthritis, tendon disorders (eg, tendinosis, tenosynovitis, tendon rupture), nonneoplastic soft-tissue masses (eg, ganglia, bursitis, granuloma, Morton neuroma), and, less frequently, soft-tissue and bone neoplasms. Prior to the advent of magnetic resonance (MR) imaging, many of these disorders were not diagnosed noninvasively, and radiologic involvement in the evaluation of affected patients was limited. However, MR imaging has proved useful in detecting the numerous soft-tissue and early bone and joint processes that occur in this portion of the foot but are not depicted or as well characterized with other imaging modalities. Frequently, MR imaging allows a specific diagnosis based on the location, signal intensity characteristics, and morphologic features of the abnormality. Consequently, MR imaging is increasingly being used to evaluate patients with forefoot complaints. Radiologists should be familiar with the differential diagnosis and MR imaging features of disorders that can produce discomfort in this region.

Diagnosis, Differential↗