Healthy Skepticism Library item: 20535

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Publication type: Journal Article

Aders HP
Legal Liabilty and Drug Prescribing
Current Therapeutics 1991 Jun; 32:(6):17-21

Abstract:

The potential for harm by drug therapy has become an increasing problem as the number of drugs and their complexity has grown in recent decades. Litigation resulting from foreseeable and unexpected effects of drugs has been brought against government health authorities, pharmaceutical manufacturers, medical practitioners, hospitals, nursing staff and pharmacists. Overseas class actions against manufacturers arise like the phoenix from the ashes of drug-related catastrophes. The potential for multimillion dollar liabilities is now well recognised: thalidomide, diethylstilboestrol, tetracycline, practolol, benoxaprofen, and pertussis vaccine are notable examples alleged to have caused serious problems on a wide scale [1]. A deluge of claims against the manufacturers of benzodiazepines has been lodged in UK courts in the last 9 months. Federal legislation passed on 17 April 1991 will provide an avenue for class actions to be brought in Australia.

The increased requirements for adequate pre-market evaluation of drugs and the development of centralised reporting schemes for the notification of drug adverse reactions seek to reduce some of these risks or to shorten the time for their recognition. It seems likely, however, that some new drugs with delayed adverse reactions will continue to slip through the nets [2]. This assumes that, henceforth, drug manufacturers and suppliers will have the courage and financial resources to market new drugs.

A review of the Medical Defence Union’s Australasian statistics suggests that about one in a hundred of its GP members will write to the Union about a drug-or prescription-related medico-legal problem each year. Given the enormous number of prescriptions written by medical practitioners in general, and general practitioners in particular, it is surprising that the incidence is not higher. Approximately 20% of the drug-related cases reported are associated with the prescription of dangerous drugs of addiction. An inquest into the death of a drug addict is frequently the stimulus for a doctor to seek the Union’s assistance.

Serious injury from administration of drugs or serious unexpected adverse reaction will often lead to litigation. Injection injuries to the sciatic or radical nerves and complications due to dosage errors feature regularly in incident reports.

Health professionals involved in prescribing and administering drugs are expected to know the correct dosage range for the drugs they use. Excessive dosage or inappropriate use of anticoagulants is one of the most common problems of this type in the hospital setting. The results of heparin and warfarin overdose can be catastrophic when they lead to cerebral injury or spinal cord compression. When patients on oral anticoagulants are discharged from a hospital, the hospital has a duty to ensure adequate provision for follow up and dosage monitoring. All too often the referring practitioner will be unaware of a patient’s discharge on anticoagulants or may wrongly assume that dosage monitoring is being performed elsewhere. The doctor may become partly liable for problems that arise out of failure to obtain an adequate drug history at each consultation.

Apart from anticoagulants, opioids and insulin have provided many dramatic examples of excess dose leading to serious injury or death. Nursing staff are expected to be familiar with the doses of the commonly prescribed drugs in hospitals. If there is doubt about the correct dosage, then nursing staff have a duty to check with the prescribing doctor.

Case Report

The mother of a newborn child was prescribed ‘Phenergan’ for a very itchy rash. On the second day she received a further dose at 6am. At 4pm she was given pethidine 50mg by injection and 2 ‘Digesic’ tablets. At 10pm she had 2 more ‘Digesic’ and ‘Phenergan’ 25mg by injection.

At 11pm ‘Serepax’ 30mg was given. Two hours later the normal male child was brought in for breast feeding. The mother, woken from a deep sleep, complained of being tired and preferred to feed her infant lying down. An hour and a half later the mother was found deeply asleep with the child asphyxiated beneath the breast.

The Coroner found that death was due to asphyxia. He observed that close supervision was called for but that the mother has been overlooked for 90 minutes. He was critical of the shortage of staff cover of the ward at the time. Experts gave evidence that the prescription of the drugs in the circumstances was not outside the bounds of normal accepted practice. Civil proceedings followed and the claim by the mother was settled for $45,000 to which the defence organisation for the doctors contributed 10%. The hospital paid the remaining 90% on behalf of the nursing staff.

Indefensible claims

Drugs may be contraindicated for a variety of reasons including known allergic reactions following previous exposure. Severe allergic reactions such as anaphylaxis or Stevens-Johnson syndrome will almost invariably result in litigation when previous allergy is overlooked. There can be no adequate defence for a failure to note or enquire of previous allergic reaction.

Severe and life-threatening bronchospasm due to the administration of ß-adrenergic receptor blockers in known asthmatics will also give rise to indefensible claims. Vigilance by pharmacists and nursing staff will often prevent such potentially serious reactions.

Illegible Prescriptions

Illegible prescriptions give rise to some well known mix-ups: chlorpropamide and chlorpromazine; ‘Marevan’ and ‘Marplan’; ‘Eugulucon’ and ‘Erythrocin’; ‘Daonil’ for ‘Amoxil’; ‘Tagamet’ and ‘Tegretol’; ‘Merital’ and ‘Mexitil’; ‘Indocid’ and ‘Inderal’; ‘Teldane’ and ‘Feldene’; ‘Maxolon’; and ‘Moxacin’; and ‘Daonil’ and ‘Clinoril’ are some notable examples. Pharmacists have a duty to check with the prescribing doctor if there can be any doubt about what is intended on a prescription. Failure to make such a check may render a pharmacist liable for a substantial proportion of the claim resulting.

In the more serious cases, irreversible brain damage due to hypoglycaemia or hypoxaemia gives rise to large awards. A claim for several hundred thousand dollars was settled when a teacher suffered irreversible hypoglycaemic injury following her taking several doses of ‘Euglucon’ instead of ‘Erythrocin’ which had been intended. In this case, not only did the pharmacist dispense the wrong drug, he interpreted the patient’s name incorrectly and there was an obvious inconsistency in the dose prescribed. The pharmacist’s defence organisation contributed 60% toward the settlement, the doctor’s defence organisation 40%.

Administration Errors

Administration errors can, in rare instances, give rise to criminal proceedings. Recently in New Zealand an anaesthetist was found guilty of manslaughter following the death of his patient under anaesthesia when a 20ml ampoule of dopamine (800mg) was administered intravenously where a 20ml ampoule of ‘Dopram’ (doxapram), a respiratory stimulant, had been intended. The court held that the anaesthetist’s failure to properly check the contents of the syringe amounted to disregard for the patient’s safety of a criminal magnitude.

The decision of the court was upheld despite appeals to the High Court and Privy Council. It is unlikely that such a severe finding would have resulted in an Australian court where it is arguably more difficult to establish the requisite degree of criminal negligence. The New Zealand anaesthetist involved was unable to continue practice in that country and left of his own accord to practice elsewhere.

Tragic fatalities have occurred following the inadvertent intrathecal injection of vincristine during treatment of leukaemia. Ten such cases have been reported to the Union in recent years. In one English case recently, the doctor involved faced a manslaughter charge.

In a recent Australian example a 12-year-old girl with a CNS relapse of acute lymphoblastic leukaemia had an ‘Ommaya’ reservoir implanted to facilitate intrathecal methotrexate therapy. Cytarabine was substituted when methotrexate toxicity of the brain developed. Two days before the next 3-days course of cytarabine was due, a registrar had written up orders for cytarabine and the monthly dose of intravenous vincristine which was also due. That evening on a ward round the consultant oncologist, in company with the registrar and RMO, decided to withhold the planned intravenous vincristine. Unfortunately, the written order was not cancelled. Two days later, when the intrathecal treatment was due, a syringe with vincristine 1.8mg labelled ‘not for intrathecal injection’ was lying in the pharmacy refrigerator to which the staff had after hours access. A nurse took one of 2 packages prepared for the patient believing it to be the drug required for the intrathecal injection. She removed the outer envelope and placed the syringe on a tray ready for the RMO’s use. The RMO, without further checking the name of the drug on the syringe label injected the vincrisitine intrathecally via the reservoir. The error was realised within a few minutes but despite the exchange of 300ml of CSF with saline, the patient died 12 days later.

The Coroner found death due to accident and was critical of the nurse and RMO in particular. He commented that elementary steps appropriate to the giving of any medication were omitted. Fortunately, a criminal charge did not follow. The hospital subsequently revised its protocol for precautions to prevent intrathecal injection of vincristine.

A Medical Board enquiry into alleged misconduct by the registrar and resident followed. A reprimand was the penalty against the resident who, the Board acknowledge, was relatively junior and had worked only 10 days in the unit prior to the incident. The Board did not find evidence of misconduct by the registrar.

This was not the end of the saga. A claim by the parents followed seeking compensation for the psychological effects of the tragic death. Liability was apportioned 50% hospital, 34% by the defence organisation for the resident and registrar, and 16% for the consultant in charge.

Duty to inform

Finally, I refer to informed consent and drug prescribing. It is generally accepted that patients need to be informed of the material risks of any proposed course of treatment. It is no longer sufficient for a doctor to rely on what his peers may be doing and Australian courts reserve the right to accept or reject the practice a reputable body of medical practitioners. The material risks of surgery are perhaps easier to define than those of drug treatment. The small print in prescribing literature might include a number of potentially serious complications which are so rare as to be almost esoteric.

Few doctors would quibble with the need to advise a patient of the possibility of deafness with gentamicin therapy, or of neutropenia when carbimazole is prescribed. Few doctors would disagree with the need to warn patients of the possibility of peptic ulcers and gastrointestinal bleeding when prescribing non-steriodal anti-inflammatory drugs. A failure to warn of the possibility of sedation with antihistamines, tranquillisers and other psychotropic drugs would in all probability be a negligent omission if the patient so sedated runs his car into a solid object or person! But the esoteric complications of drug therapy present difficulties. The Union has had a number of claims for compensation for hepatic failure associated with ketoconazole therapy. These usually allege failure to warn of the risk of hepatic failure, failure to institute appropriate liver function testing and failure to cease therapy when the reduction first appears. Although the incidence of serious hepatic dysfunction may be of the order of 1 in 15,000 [3], such a complication is occasionally fatal and it could be difficult to convince a judge and jury that this was not a material risk. Even so, one would not have to go far to find medical practitioners who would consider that an unnecessary warning. Equally few, if any, doctors would warn their hypertensive patients of the possibility of acquired haemolytic anaemia or chronic hepatitis associated with methyldopa therapy. Few doctors would know, and perhaps none would warn, of reports of amnesia associated with ‘Indocid’.

In defending a case based on alleged lack of consent a very important consideration is the availability of alternative less toxic treatments. A patient is unlikely to be able to convince a court that he or she, told of the possibility of hearing loss, would not have undergone a course of gentamicin therapy when faced with the prospect of a life-threatening pseudomonas infection. Few, if any, more effective alternatives exist. On the other hand, it is hard to justify the prescription of a drug with rare but potentially serious side effects for a diagnosis or condition whose existence and threat to well being may be in doubt. This is the problem with the prescription of a drug with rare but potentially serious side effects for a diagnosis or condition whose existence and threat to well-being may be in doubt. This is the problem with the prescription of a drug like ketoconazole for an asymptomatic and non-threatening fungal infection.

In a recent NSW judgement [4], a woman was awarded over $700,000 in damages when she developed a rare but known side effect of sympathetic opthalmia when she underwent a corneal operation. The complication rendered her virtually blind in both eyes. The court accepted that she would not undergone the procedure if she had known of the possibility of this complication which was assessed by experts as having a frequency of between 1 in 10,000 and 1 in 20,000 eye operations. It was not so much the magnitude of the risk as the patient’s peculiar insistence on being told of absolutely every conceivable complication, that determined the adverse finding against the surgeon. The elective nature of the procedure and the reasonable alternative of no surgery added to the doctor’s duty to include rare, but in this instance material, complications in his warnings. The decision has been appealed and the verdict is still being awaited. The verdict seems likely to be upheld. The implications for the average doctor will be a still greater duty of disclosure and discussion of risks.

Conclusion

A doctor’s risks can be reduced by careful attention to documentation, careful and legible prescribing and adequate enquiry of patients’ previous adverse reactions, current drug therapy and adequate discussion with patients of the pros and cons of treatment. The duty to inform of possible risk increases where the risks are serious and less toxic treatments are available or no treatment is a reasonable option. Judges (and prudent practice) require the correct drug in the correct dose by the correct route in the correct site using safe equipment and given after discussion of the material risks.

References:

1. Gerber P. Mass product-liability litigation. Medical Journal of Australia 148: 485, 1988
2. Editorial. Benoxaprofen. Britsh Medical Journal. 285: 459, 1982
3. Lewis JH, et al. Hepatic injury associated with ketoconazole therapy. Analysis of 33 cases. Gastroenterology 86: 503, 1984
4. Whittaker and Rogers. New South Wales, 1990 (unreported)

Notes:

Salient Points

Approximately 20% of drug-related requests for medico-legal assistance are associated with the prescription of dangerous drugs of addiction.

Injection injuries to the sciatic or radial nerve feature regularly in litigation.

Heparin and warfarin overdoses and deficient dosage monitoring can cause catastrophic injury.

There can be no adequate defence for a failure to note or enquire of a patient’s previous allergic drug reactions.

Pharmacists and nursing staff may become partly liable for failing to contact the prescribing doctor to clarify what is intended where there is any doubt about the prescribed drugs or its dosage.

Serious prescribing errors may give rise to criminal proceedings.

Patients need to be informed of the material risks of any proposed treatment.