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

Mechanism for the Management of Drug Samples in the HA________________________________________________________________________________Background1. Drug samples are offered freely by the pharmaceutical companies for doctors’ trial use inhospitals and clinics. This has always been the practice, and certainly not one that is uniqueto Hong Kong. Although there exists a well established and accountable system for thewhole administration process for all medications in HA institutions, drug samples are notsubjected to the same extent of control. Moreover, the number of drug samples kept in eachhospital is also substantial. A rough estimate of over 100 different drug samples are stockedin major acute hospitals in the HA, with approximately 11,000 to 12,000 dispensingtransactions for each major hospital in the year 2000-2001 alone.Advantages of using drug samples2. The provision of drug samples offers certain benefits for the HA. First, althoughpharmaceutical companies provide drug samples as a means of introducing new products todoctors and patients, and may try to change their utilization behaviour in due course, drugsamples provide doctors and patients with an opportunity to obtain first hand experiencewith newly released drugs which are otherwise available only on properly conductedclinical trials. Second, patients who have previously failed all other therapeutic choices onthe existing drug formulary or those who are suitable may benefit from the new drugtherapy. Third, by prescribing free drug samples, doctors may help to contain departmentaldrug budgets.Problem with using drug samples3. However, liberal distribution of free drug samples within the institutions is not withoutproblem. Being new drugs, information regarding these drug samples is often very limited.Doctors usually prescribe based on information supplied by pharmaceutical representatives,and not necessarily on the best scientific evidence available in the medical literature. Indeviating from clinical guidelines that are derived from best evidence, it is possible thatdrug samples may not be the most beneficial therapeutic choice for patients, bearing inmind the risk of undetermined efficacy (relative to established therapy) or unknown adverseeffects associated with their use. For the introduction of new pharmaceuticals, (andlikewise, for the introduction of new technologies), a well-founded system is alreadyavailable in the HA. The central Drug Advisory Committee has been serving this particularrole since 1996, by evaluation the cost-effectiveness of new pharmaceuticals based onscientific evidence, through a panel of experts from different medical disciplines with arotating membership. Free drug samples, being prescribed as non-formulary drugs,however, fall outside this system, and may not have been subjected to any formal evaluationbefore being widely used within the HA. HA normally provides coverage to all staff onliability arising from patients treatment including drug therapy and medical proceduresconducted within the organisation. However, since drug samples are used without a formalevaluation process, it is not certain whether HA would be able to provide the same extent ofprofessional indemnity coverage should any medication incidents or adverse effects that areassociated with the drug sample occur.1