Table 3 Knowledge of community pharmacists in Palestine on generic medicine (n = 302)
Knowledge item | Correct response N (%) | Incorrect response N (%) | I don’t know N (%) |
|---|---|---|---|
1. The term generic medicine is a drug product marketed under the drugs non-proprietary approved name or a product marketed under a different brand name (proprietary) name. (T) | 192 (63.6) | 93 (30.8) | 17 (5.6) |
2. Generic products must be bioequivalent to the innovator brand before they can be approved to be marketed in many developed and some developing countries. (T) | 280 (92.7) | 9 (3.0) | 13 (4.3) |
3. Product quality data are NOT required before a generic product can be registered in such countries that require bioequivalent data. (F) | 21 (7.0) | 239 (79.1) | 42 (13.9) |
4. Provided that a generic product conforms to bioequivalence and product quality requirements, it is assumed that its efficacy, quality and safety are similar to the original branded product. (T) | 286 (94.7) | 13 (4.3) | 3 (1.0) |
5. Two pharmaceutical products are bioequivalent if they are pharmaceutically equivalent and their bioavailabilities are similar to such a degree that their effects, with respect to both efficacy and safety, can be expected to be essentially the same. (T) | 251 (83.1) | 23 (7.6) | 28 (9.3) |
6. For generic drug to be bioequivalent to its innovator brand or other generics, the 90% confidence intervals for the ratio of each pharmacokinetics parameters (i.e. Cmax and AUC), must lie within the range of 90–110%. (F) | 156 (51.7) | 38 (12.6) | 108 (35.8) |
7. A generic medicine is usually manufactured without a license from the innovator company, but marketed after expiry of patent or other exclusivity rights. (T) | 179 (59.3) | 87(28.8) | 36 (11.9) |
8. When two pharmaceutical products are bioequivalent, it means that the Cmax and AUC ratios estimated for each formulation can vary by −20 to +25%. (T) | 68 (22.5) | 94(31.1) | 140 (46.4) |
9. Where there is a generic substitution policy, the community pharmacists is allowed to dispense a different brand of the drug, but may or may not refer back to the prescriber depending on the jurisdiction/law. (F) | 263 (87.1) | 23 (7.6) | 16 (5.3) |
10. If a generic medicine is bioequivalent to a branded medicine, it means that it is also therapeutically equivalent. (T) | 231 (76.5) | 56(18.5) | 15 (5.0) |