Adverse drug reactions and medical and negligence

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?" My article considers medico legal aspects of therapeutics, particularly with regard to adverse drug reactions and some of the case studies discussed relevantly.

1) THE DUTIES OF 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.

CASE

A pharmaceutical company was convicted of issuing a false and misleading advertisement in the medical press, and their medical officer was convicted of consenting to and conniving with the issue of the advertisement.

Thirdly, there is the manufacturer's duty to warn of risk, 5,6 which may be achieved by the use of a patient information leaflet and/or a data sheet provided for prescribers, in which the manufacturer states what may be expected to be done with the product by a 'learned intermediary' (the prescriber), thus transferring a degree of responsibility to the prescriber.

2) THE DUTIES OF LICENCING AUTHORITY

• A licensing authority has the responsibility to ensure that testing procedures for a product have been satisfactorily devised, implemented, and completed, the result reaching an acceptable standard before a product Licence is issued. A manufacturer who markets a product in accordance with a licensing standard may defend a claim if the standard set was wrong.

CASE 

The Irish Supreme Court decided recently that it had not been enough for vaccine manufacturers merely to comply with mandatory of minimum requirements, and that they had been negligent in releasing a batch of diphtheria, tetanus, and pertussis vaccine which by their own tests was of too high a potency and which had led to brain damage in infants. An authority, which requires reporting of adverse effects, has a duty to act on the information contained in such reports, perhaps revoking the product licence.

3) THE DUTIES OF PRESCRIBER

• The potential prescriber should consider carefully whether a drug is needed for a particular patient. Is the benefit likely to outweigh the risk of possible adverse effects? Are there safer ways of achieving the same benefit? Are there reasons why this particular patient is more likely to suffer harm from adverse reactions of interactions?

CASE

A general practitioner was alleged to have prescribed a tranquillizer without warning the patient of possible side effects. The patient had taken two tablets and soon afterwards had driven a car and been involved in a road accident. The manufacturer's drug data sheet contained a warning against driving while under treatment with the drug. 'The patient was paid damages.

It may be necessary to obtain the agreement of the patient for routine monitoring of blood samples 

4) THE DUTIES OF PHARMACIST

• As a professional, the pharmacist has a duty of care to the patient both to supervise the sale of 'over-the-counter' (OTC) drugs which are available only in pharmacies and to dispense safely and correctly drugs which have been prescribed by a doctor. OTC drugs may be unsuitable for an individual patient for a number of reasons. If approached for advice, the same duty lies on the pharmacist to counsel, warn, and act reasonably as it does on any prescriber. In addition, there is a duty to contact the prescriber if any question about a prescription arises. 

CASE 

A Doctor prescribed an antibiotic for a patient, but the pharmacist misread the very badly written prescription and wrongly dispensed an antidiabetic drug. The patient suffered severe hypoglycaemia and brain damage. The doctor's legal representative claimed that the pharmacist should have contacted the doctor and queried the does of 3 tablets 3 times daily (which would have been most unusual for the antidiabetic drug), but it was finally agreed that both the doctor and the pharmacist had been negligent.

5) DUTIES IN ADMINISTERING DRUGS

• Just as care is needed in prescribing drugs, so is care needed in their administration. Knowledge of where to place an injection to order to avoid a nerve or other structure is expected of a practitioner, so that an error speaks for itself as a negligent act.

CASE

A patient was given a corticosteroid preparation by injection into the upper arm, although the manufacture's instructions stated clearly that the drug should only be given by deep intramuscular injection into the buttock, because of the danger of fat atrophy. The patient developed skin changes and loss of subcutaneous tissue, for which she successfully claimed compensation.

Errors in giving a drug by the wrong route can be catastrophic 

IMPORTANCE OF REPORTING ADVERSE DRUG REACTIONS

Adverse drug reactions very often produce symptoms of signs that may be difficult or impossible to distinguish from those of naturally occurring disorders. Consequently, doctors should never dismiss suspicions that a drug might have been responsible for a patient's illness merely because they think the evidence is flimsy. Instead, they should report their suspicions, however tenuous, to their national drug safety organization. They have a duty to make their observations known for they may be the first of their kind and may alert other doctors to the possibility of previously unrecognized adverse effects of treatment, and so protect patients against harm. The following are examples of reactions that should always be reported: anaphylaxis, blood dyscrasias, congenital abnormalities, endocrine disturbances, severe CNS effects, haemorrhage, jaundice, ophthalmic signs and symptoms, severe skin reactions. 

If my article is useful kindly share your comments and suggestions

by

Akshaya Srikanth, S.K.Jain*

Pharm.D Internee, *Chief Pharmacist-AIIMS

Hyderabad, India.