Adverse Drugs Reaction
Adverse Drugs Reaction
DRUGS INEVITABLY PRODUCE UNWANTED EFFECTS. IF LEGAL CONSEQUENCES OF ADVERSE REACTIONS ARE TO BE AVOIDED, CONSISTENT CARE IS NEEDED AT EVERY STATE FROM DRUG
MANUFACTURE TO ADMINISTRATION. DRUGS THAT ARE LICENSED SHOULD BE PRODUCED TO THE HIGHEST STANDARDS OF CURRENT KNOWLEDGE. PRESCRIBERS SHOULD BE KNOWLEDGEABLE ABOUT THE DRUGS THEY PRESCRIBE, HAVING SELECTED THEM OBJECTIVELY FROM OTHER MEANS OF MANAGING THE CLINICAL SITUATION, SHOULD PROVIDE THE PATIENT WITH INFORMATION WHICH IS SUFFICIENT TO ENABLE AN INFORMED DECISION TO BE MADE ON WHETHER TO ACCEPT THE DRUG OR NOT, AND SHOULD SEEK ADVICE IF A PRESCRIPTION DOES NOT CONFORM WITH LOCAL LAWS, AND THEY CARRY THE SAME BURDEN OF RESPONSIBILITY AS A PRESCRIBER TO WARN ABOUT ADVERSE EFFECTS OF DRUGS THAT ARE SOLD DIRECT WITHOUT PRESCRIPTION. THOSE ADMINISTERING DRUGS MUST BE TRAINED PROPERLY TO CHECK THE DRUG AND ITS DOSE, AND SHOULD ENSURE THAT THE CORRECT ROUTE OF ADMINISTRATION IS BEING USED AND THAT INJECTIONS AVOID ANY VITAL STRUCTURE.
The tort [means a wrongful but not criminal activity ] of medical negligence is a breach of duty owed to a patient, with resulting harm. What is the 'duty of care' and who owes it? In legal terms we all owe a duty of care to our neighbour; in the medical field, for 'our neighbour' substitute 'our patient' and possibly the patient's dependants also, because harm to a patient may have repercussions on his dependants. In therapeutics the prescriber has a duty of care, but the chain of care stretches both backwards to the manufacturer and forwards to the pharmacist who dispenses and the nurse who administers the drug. Harm, then, may be caused at every stage of the therapeutic process from the development of the drug through to its clinical use. Where a direct connection between the drug and harm can be demonstrated on the balance of probabilities, the patient/plaintiff may be able to obtain compensation.
The question of causation is sometimes difficult to resolve, and it is often helpful t o apply the test: " if the drug had not been used in this particular way, would the harm have occurred?" This article considers medico legal aspects of therapeutics, particularly with regard to adverse drug reactions. The duties of the manufacturer Before a drug can be licensed for use in patients, it must be tested. Date about adverse effects in humans may be relatively sparse at this stage; thus research using human subjects should be conducted according to a protocol that has been approved by an independent ethics committee, in accordance with the Declaration of Helsinki.1 Tests using human volunteers may not be covered by laws regulating medicines; for example, in the United Kingdom (UK) the Medicines Act 19682 does not deal with studies in healthy volunteers.
However, they must be told of the risks they run in sufficient detail to enable them to give properly informed consent, particularly bearing in mind that there is no direct benefit, in health terms, to the subject
Reproduced from Adverse Drug Reaction Bulletin (UK): No. 172, pp651-654, June 1995 We are thankful to the publishers, M/S Chapman & Hall (UK) for the permission and also for waving the royalty on this account.