Andy Gray
A recent article in the British Medical Journal (BMJ 1998; 316: 184, also available on the Web at http://www.bmj.com/cgi/content/full/316/7148/1849/a ) raised the issue of control of clinical trials and the ethical standards applied in research. This issue was also raised in the report of the Review Panel on the Medicines Control Council, which stated that "there are insufficient guarantees for the maintenance of adequate ethical standards in clinical trials at the present time. The matter needs further examination." Many of these trials involve drugs, either new agents or older agents being tested for new indications. This raises the question: to what extent are the pharmacies and pharmacists in the hospitals or clinics concerned involved in the trials? As pharmacists we often trumpet our intention to be the custodians of drugs, the protectors of all patients who are exposed to the dangers of pharmacotherapy. That protection should extend to trial patients as well. Practically, what does that mean in a health facility? All trials should be presented, not only to an Ethics Committee (or Institutional Review Board), but also to the Pharmacy and Therapeutics Committee. The PTC can then decide who shall take responsibility for the storage of the drugs involved, for their issue to trial patients, for the collection of empty containers for accounting purposes, perhaps for the involvement of pharmacy personnel in holding the keys to blinding procedures. The PTC can also guard against tbe use of post-marketing or phase IV ‘trials’ to artificially create the demand for drugs which might not otherwise have been accepted onto the essential drugs list applicable at that level of facility. Involvement in trial design and execution can also develop the capacity of pharmacy staff to engage in their own research and therefore contribute to the knowledge base of our profession.
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