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J R Soc Med. 2004 July; 97(7): 316–317.
PMCID: PMC1079520

Direct reporting of suspected adverse drug reactions by patients

Adverse drug reactions (ADRs) are a serious cause for concern in both adults and children.1 Of child inpatients, nearly one in ten experiences an ADR—severe in 12%.2 For adults in hospital, ADRs are thought to be among the six major causes of death: in the USA, according to one estimate, over 100 000 hospital patients die each year as a result of such reactions.3 Within the UK at least ten suspected fatal ADRs are reported in children each year.4

How good are we at detecting harmful effects that escaped notice in the prelicensing phase of a drug? The ‘yellow card’ system, which depends largely on voluntary reporting by doctors, has long been seen as inadequate; and two leading critics, Charles Medawar and Andrew Herxheimer, have used their experience with patient reports on the antidepressant paroxetine5 to argue that patients in the UK should have the right to report ADRs directly. This campaign bore fruit in May this year when the Government, through the Health Minister Lord Warner, announced that patients will be given the right to report suspected ADRs, without the intervention of a health professional, to the Medicines and Healthcare products Regulatory Agency (MHRA).6 This is the first time within the UK that patients will have this right. Already patients are able to report their own ADRs to NHS Direct, but the final decision as to whether a yellow card is completed (i.e. the ADR is reported to the regulatory authorities) depends on the NHS Direct nurse, not the patient. The details of how patients will report suspected ADRs are not yet clear; pilot schemes will be run to determine the best system. A logical step forward would be to initiate a regional pilot of direct patient reporting; this has already proved a successful way to evaluate different surveillance schemes for paediatric ADRs.7

Many countries already accept direct reporting of ADRs by patients8 but no detailed national analysis has yet been conducted on the value of this innovation. Several studies do point to benefits. A Dutch investigation compared the reporting of ADRs to paroxetine by patients and health professionals.9 The authors identified nine new ADRs which were recorded by both patients and health professionals, and in each instance the ADR was reported earlier by the patients (mean difference in lag 273 days). A Scottish group looking at treatment with antidepressants, anticonvulsants and analgesics found that patients did not invariably tell their general practitioner about symptoms they suspected to be ADRs; moreover, general practitioners did not record all the symptoms that the patient had mentioned as possibly caused by an ADR.10

If the purpose of ADR surveillance is to detect new ADRs these findings suggest that patient reporting will be of benefit, but further work is required before a national patient ADR reporting scheme is introduced. We also need to consider paediatrics, where the reporter of a suspected ADR would probably be a parent. There have been no formal investigations of such reporting, but in one prospective study of midazolam withdrawal in critically ill children it was the parents who detected abnormal behaviour in two of the young patients.11

Medawar and Herxheimer will not see the UK Government's announcement as a complete triumph. In a paper last year they argued that the MHRA is an unsuitable body to exercise pharmacovigilance because, as the organization that licenses medicines, it has a conflict of interest.5 This is an important point, and to date neither the MHRA nor the Government has fully answered it. Nor are they the only commentators to express concern about the close links between the MHRA and the pharmaceutical industry, among them being Richard Brook, chief executive of the mental health charity Mind.6 Clearly there is much to be said for separation of licensing from pharmacovigilance, but the direct reporting of ADRs by patients must not await this reform; what we need now are some pilot schemes to see how it can best be done.

References

1. Choonara I, Rieder MJ. Drug toxicity and adverse drug reactions in children—a brief historical review. Paediatr Perinatal Drug Ther 2002;5: 12-18
2. Impicciatore P, Choonara I, Clarkson A, et al. Incidence of adverse drug reactions in paediatric in/out-patients: a systematic review and meta-analysis of prospective studies. Br J Clin Pharmacol 2001;52: 77-83 [PMC free article] [PubMed]
3. Lazarou J, Pomeranz B, Corey PN. Incidence of adverse drug reactions in hospitalized patients: a meta-analysis of prospective studies. JAMA 1998;279: 1200-5 [PubMed]
4. Clarkson A, Choonara I. Surveillance for fatal suspected adverse drug reactions in the UK. Arch Dis Child 2002;87: 462-7 [PMC free article] [PubMed]
5. Medawar C, Herxheimer A. A comparison of adverse drug reaction reports from professionals and users, relating to risk of dependence and suicidal behaviour with paroxetine. Int J Risk Safety Med 2003;16: 5-19
6. Boseley S. Patients get the right to report drug side-effects. Guardian, 5 May 2004: 7
7. Clarkson A, Conroy S, Burroughs K, Choonara I. Surveillance for adverse drug reactions in children: a paediatric regional monitoring centre. Paediatr Perinat Drug Ther (in press)
8. van Grootheest K, de Graaf L, de Jong van den Berg LTW. Consumer adverse drug reporting: a new step in pharmacovigilance? Drug Safety 2003;26: 211-17 [PubMed]
9. Egberts TCG, Smulders M, de Koning FHP, et al. Can adverse drug reactions be detected earlier? A comparison of reports by patients and professionals. BMJ 1996;313: 530-1 [PMC free article] [PubMed]
10. Jarernsiripornkul N, Krska J, Capps PAG, et al. Patient reporting of potential adverse drug reactions: a methodological study. Br J Clin Pharmacol 2002;53: 318-25 [PMC free article] [PubMed]
11. Hughes J, Gill A, Leach HJ, et al. A prospective study of the adverse effects of midazolam on withdrawal in critically ill children. Acta Paediatr 1994;83: 1194-9 [PubMed]

Articles from Journal of the Royal Society of Medicine are provided here courtesy of Royal Society of Medicine Press