Liability for drug-induced injuries did not become an issue of general concern until quite recently. However, a number of drug-induced problems, from thalidomide in the 1960s to antipsychotics and tardive dyskinesia in the 1970s and Opren in the 1980s, have caused widespread public disquiet and led to increasing awareness of issues to do with liability. 29 In psychiatry, the first big concern in the UK focused on the question of benzodiazepine prescribing, while in the USA the paramount issue was tardive dyskinesia in individuals taking antipsychotics. In both cases the arguments became highly emotive, with some commentators referring to the appalling frequency of drug-induced injury, while others commented on its astonishing rarity.
Drug-induced problems may stem from the toxic effects of a drug, from toxic effects caused by an impure additive, or from allergic reactions to the drug or its additives. Problems may also stem from overprescribing. For instance, in the case of someone who dies from a resistant bacterial infection, a relative could claim that the subject’s death arose in part from the excessive prescription of antibiotics that contributes to the production of resistant infections. In the case of the antipsychotics, problems may be brought about by the overuse of these drugs, promoted by drug companies on the one hand but also stemming in part from the current politics of mental health, which can lead to deaths from rapid tranquillisation delivered by harassed staff in undermanned psychiatric units.
The question of liability is something of a rolling log on which companies, prescribers and drug takers try to maintain a footing. In addition to attempting to produce increasingly safe compounds, companies try to restrict liability by hedging their data sheets with warnings and lists of side effects, so that if something goes wrong either the prescriber or the consumer will be to blame, on the basis that they were warned beforehand if they chose to notice. The other side of this coin is that, in the pursuit of markets, rather than make novel compounds, drug companies often manufacture drugs that are closely related to other compounds on the market in an attempt to gain a share of what is obviously selling well. This minor manipulation of a molecule may confer no additional therapeutic benefit but may produce unsuspected side effects.
When it comes to determining whether a particular drug has been responsible for a particular injury, it can be extremely difficult to decide with confidence what has actually happened. Questions that arise are, for example, whether it is known that the individual actually did take the drug that supposedly caused the problem. Did they take anything else? Did the individual have any pre-existing disorder that made an unfortunate reaction to a compound more likely? The problems have been made worse in recent years because of company efforts to deny problems, which have led to terming suicidal acts ‘emotional lability’ and withdrawal syndromes ‘symptoms on stopping’.
The majority of drug-induced disorders resemble disorders that happen naturally anyway. For example, benzodiazepine withdrawal produces anxiety. Anxiety is common. One can question whether all that is happening in the case of withdrawal is a re-emergence of the anxiety that led to the individual being put on treatment in the first instance. In the case of tardive dyskinesia, dyskinesias that are indistinguishable from those caused by the drugs occur in individuals who have never had antipsychotics. Even the limb deformities produced by thalidomide occur naturally. Drug-induced injury often involves a change in the frequency of something rather than an entirely novel development. For reasons such as these, some prescribers can have reasonable grounds to resist a linkage between treatment and an adverse event.
Even if it is agreed that the drug has caused the problem, questions arise as to whether the prescriber should have prescribed for the problem in the first instance. If not, then they share a part of the blame. Did the taker implicitly or explicitly agree to run the risk that is involved in all drug-taking? Did they contribute to their own injury in any way – by altering the amount of salt in their diet, perhaps, while taking lithium?
In the case of a possible suicide consequent on antidepressant or antipsychotic-induced akathisia, for example, it is not clear exactly where blame might lie in individual cases. It may not be possible, given our current state of knowledge, to produce antidepressants or antipsychotics that will never produce akathisia or dysphoria, and hence the drug induction of suicidal behaviour is at present an inherent risk of drug-taking. This puts an onus on prescribers to warn patients of this possible side effect and what to do should it develop. The particular interest in the cases of selective serotonin-reuptake inhibitor (SSRI)-induced akathisia is explicit company denials that their drug could lead to akathisia or suicide. What do these company denials do to liability?
There are three principles that can be applied to all drug-taking, as outlined in Box 26.1.30 and 31
Box 26.1
Principles of drug-taking
First principle
No drug or drug treatment can be guaranteed in advance to be entirely safe. Risks are inevitable and justifiable provided they are not disproportionate to the purpose that the treatment is supposed to serve.
At present, society as a whole deems that risks such as tardive dyskinesia may be justifiable against the backdrop of an otherwise irremediable illness such as schizophrenia. But what of tardive dyskinesia consequent on the prescription of an antipsychotic for anxiety or a sedative antipsychotic as a hypnotic, or given to a child for a vague behaviour problem?
Second principle
No party can reasonably be blamed for doing their best, even if injury is one of the consequences.
The issue here, of course, may depend on being able to show that one has done one’s best; herein lies the importance of documenting advice given.
Third principle
Responsibility is carried by anyone on whom one is entitled to rely.
This includes the nurses who hand out medication, who have a responsibility to get the drug and dose right, the pharmacist to dispense the right medication, and potentially anyone who acts as an authoritative source of advice regarding the benefits or hazards of medication, including mothers, and these days anyone who accesses the Internet and the pharmaceutical companies who engineer what appears on the Net.
RISKS AND BENEFITS
The idea that one of the cardinal principles of medical practice is that a healer should ‘first of all do no harm’ is appealing, but it is a very poor description of medical practice. In the case of drug treatment, no treatment is possible unless risks are taken. No drug is safe. Treatment is a matter of weighing risks and benefits. The discovery of anaesthesia crystallised this dilemma. When first introduced, it was known that some people would die from the anaesthetic. Many had problems with the idea that some lives would intentionally be put at risk to benefit others, but this in fact is the situation with practically all treatments today. There is therefore a need to ensure that the person being treated is going to derive a clear benefit from treatment such that it is justifiable to take certain risks. For example, in the case of someone with cancer, it may be justifiable to take the very considerable risks associated with chemotherapy, but it would not be reasonable to give chemotherapeutic agents to someone with a cold or depression.
The antihypertensives provide a good case. There are very few people who absolutely need antihypertensives to lower malignant increases in blood pressure caused by hypertensive disease. However, there are legions of people who have some increase in blood pressure, and increased blood pressure is associated with an increased risk of heart attacks or strokes as a consequence. Some individuals may have raised blood pressure only as a result of the anxiety of attending their doctor. Increases in blood pressure are, furthermore, only an indication that a disease process may be operative. One option in such cases is repeated monitoring with a recourse to treatment only if the situation worsens. For those with minimal increases in blood pressure, the risk of likely problems is so small that one can legitimately ask whether the cost in side effects (impaired sexual functioning for instance and the hypochondriasis that goes with being on treatment) is worth it.
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