Quality assurance program for a hospital investigational-drug service.

The development and implementation of a quality-assurance (QA) program for a pharmacy-based investigational-drug service are described. The objective of the QA program was to assess the quality of the activities in the areas of drug acquisition, inventory control, availability of drug data sheets and dispensing guidelines, provision of a quarterly drug accountability report, and documentation of drug dispensing to patients and decentralized pharmacy areas. The audit criteria were based on hospital policies and procedures and federal regulations for the handling of investigational drugs. Audits of four randomly selected protocols are conducted quarterly by a pharmacist who is not affiliated with the investigational drug service. The results of the first two audits have identified several areas for improvement, including the need for additional pharmacy staff education regarding study protocols, the importance of maintaining complete and accurate drug accountability records by decentralized pharmacists, and the need to provide a centralized source of study protocol information. The QA program has enabled the investigational-drug service to establish and enforce the policies and procedures for the appropriate handling of investigational drugs in this institution.

Costs associated with the inappropriate route of administration of parenteral histamine2-receptor antagonists.

The objectives were to assess the parenteral route for cimetidine and ranitidine and to determine excess medication costs associated with inappropriate use. Criteria were based on clinical situations that do not permit oral therapy, result in questionable dry absorption, or require a more rapid onset of action. The parenteral route was assessed as appropriate, inappropriate, or questionable. During two months, parenteral therapy was prescribed for 199 adult inpatients. Initially, 63 percent received the parenteral form appropriately; only 16 percent continued to receive the parenteral form appropriately throughout therapy. Less than half of the parenteral doses were determined to be appropriate. A major reason appears to be that orders are not changed as patients' conditions improve. Excess medication costs attributed to inappropriate parenteral therapy for the study period amounted to $6796 or $8002, depending on whether questionable doses were considered appropriate or inappropriate, respectively. An annual projected savings of $40,776 or $48,012 could be achieved if oral doses had been administered in place of inappropriate parenteral therapy.

Maintenance therapy for prevention of recurrent peptic ulcers.

Peptic ulcer disease is a chronic, relapsing disease. Successful healing of duodenal and gastric ulcers with antacids, cimetidine, ranitidine, famotidine, or sucralfate is frequently followed by ulcer recurrence. The need for long-term, low-dose maintenance therapy is based on disease severity, ulcer history, complications, therapeutic intervention, response to treatment, and potential risk factors. Comparison of ulcer maintenance trials requires consideration of important factors such as frequency of endoscopy, duration of follow-up period, and the method used to calculate ulcer recurrence rates. Clinical trials indicate that chronic treatment with low-dose cimetidine, ranitidine, famotidine, and probably sucralfate decreases the frequency of duodenal ulcer recurrence and that ranitidine may be superior to cimetidine. Preliminary studies indicate that higher doses of these same medications may be required to prevent gastric ulcer recurrence. Long-term maintenance therapy with these agents must be continuous in order to prevent relapses, but treatment should be limited to one year because of unknown consequences beyond this period.