Transplant pharmacists' opinions on generic product selection of critical-dose drugs

Factors considered important by transplant pharmacists in decisions about generic product selection and in defining critical-dose drugs, as well as transplant pharmacists' attitudes about bioequivalence testing, were studied. Surveys, completed by telephone and fax in 1997, were used to assess pharmacists' role at solid-organ transplant centers, factors the pharmacists considered important for generic product selection, and pharmacists' attitudes about the FDA guidelines on bioequivalence testing. Surveys were completed by 59 pharmacists. The factors considered important by pharmacists for inclusion of generic products on the formulary were safety (97% of respondents), clinical consequences (97%), efficacy (92%), and bioequivalence (92%). Nearly all the pharmacists (95%) expressed a belief that generic products of some critical-dose drugs should not be dispensed. Only 12% of the respondents said they thought that the FDA guidelines on bioequivalence testing were appropriate for critical-dose drugs, and 92% thought that bioequivalence testing for this category of drugs should be conducted in actual patients. Efficacy, safety, the presence of a narrow therapeutic index, bioequivalence, and clinical consequences were identified by transplant pharmacists as important factors in decisions about generic product selection; current FDA guidelines for establishing bioequivalence were viewed as possibly not appropriate for critical-dose drugs.