2005 Edition Report on Drug Administration Procedure & Practices ...

Action7.4.2 types of patients to be treated7.4.3 estimated number of patients to be treated7.4.4 duration of treatment for each patient7.4.5 total trial period7.5 Patients should be fully informed that the drug samples prescribed for them are fortrial use over a definite period only. The efficacy and safety of the drug sampleswould require further evaluation. HA could not commit to provide these drugsamples on a long-term basis. An information pamphlet for patients receiving drugsamples will be designed by HAHO and issued to hospitals for future distribution.7.6 Hospital DTC will inform HAHO (via CPO) of the use of drug sample in itsinstitutions. This will enable HAHO to keep an updated record of all the drugsample used in the HA, and facilitate appropriate action to be taken promptly if anyurgent situation such as recall or medication incidents should occur.7.7 Hospital DTC is responsible for the monitoring of the progress of the use of drugsamples in its institutions. If hospital DTC and the CPO have been notified of theuse of the drug sample, and that it is prescribed according to hospital guidelines, HAshould be able to cover liability associated with its use as with other formularydrugs.7.8 All drug samples must be stored by the pharmacy according to the manufacturer’sspecifications and prevailing law and regulation.7.9 Drug samples should be labeled and dispensed according to the same standardisedmethod that the hospital uses for non-sample medications i.e. dispensed throughhospital pharmacy.7.10 Documentation requirements for drug samples should be the same as for other nonsamplemedications ordered and dispensed by the hospital i.e. written records forordering and administering in hospitals should be kept on the MAR, and on MOE orprescriptions for out-patients. Computerised records should be kept on the CDDH(Corporate Drug Dispensing History) system and should be easily retrieved whenrequired.7.11 The recall mechanism for drug samples should be efficient and effective, and shouldfollow the same procedure that exists for other formulary drugs in the HA. Inaddition to the computerized records, a manual record may be kept by the hospitalpharmacy if such record keeping facilitates the recall procedures and is convenientto update.7.12 As with other medications, it is expected that significant medication errors andsignificant adverse drug reactions that occur with sample drugs are identified,reported and reviewed according to the same procedures for other drugs listed in theHA i.e. using the same MIRP and ADR reporting systems and indicating that thedrugs implicated are drug samples.8. All hospitals are advised to observe the recommendations outlined above in para 7 and todevise a hospital drug sample policy accordingly. These should be forwarded to HAHO forrecord.HAHO Feb 023