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

Factors considered important by transplant pharmacists in decisions about g eneric product selection and in defining critical-dose drugs, as well as tr ansplant pharmacists' attitudes about bioequivalence testing, were studied. Surveys, completed by telephone and fax in 1997, were used to assess pharma cists' role at solid-organ transplant centers, factors the pharmacists cons idered important for generic product selection, and pharmacists' altitudes 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 safe ty (97% of respondents), clinical consequences (97%), efficacy (92%), and b ioequivalence (92%). Nearly all the pharmacists (95%) expressed a belief th at generic products of some critical-dose drugs should not be dispensed. On ly 12% of the respondents said they thought that the FDA guidelines on bioe quivalence testing were appropriate for critical-dose drugs, and 92% though t that bioequivalence testing for this category of drugs should be conducte d in actual patients. Efficacy, safety, the presence of a narrow therapeutic index, bioequivalenc e, and clinical consequences were identified by transplant pharmacists as i mportant factors in decisions about generic product selection; current FDA guidelines for establishing bioequivalence were viewed as possibly not appr opriate for critical-dose drugs.