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. 2002 Feb 16;324(7334):424.

Monitoring safety of over the counter drugs

Patients could do more than just treat themselves

Alan G Wade 1
PMCID: PMC1122344  PMID: 11850381

Editor—Clark et al raise an important issue related to the safety of drugs, both over the counter drugs and those provided by a pharmacy.1 As increasing numbers of drugs are licensed to be sold over the counter, there is a growing need for both the safety of the drugs and their interactions with prescribed drugs to be carefully monitored.

The solution proposed for pharmacy medicines seems to me to be dogged by the problems faced by current systems of surveillance of prescribed drugs—that is, under-reporting engendered by complicated systems, the time lag, and expense. Over the counter medicines present an even greater problem.

The philosophy of switching to pharmacy medicines or over the counter medicines is to empower the patient to participate more fully in his or her health care. Why not extend the same philosophy to safety monitoring? A card enclosed with the drug would invite all users to register as consumers—we already do this for consumer electrical products. Simple postal questionnaires supplemented if necessary by telephone follow up can provide good quality data not only on side effects but also on efficacy.2 My unit has conducted two successful pilot studies based on this model and is currently attempting to set up a full scale trial.

References

  • 1.Clark D, Layton D, Shakir S. Monitoring the safety of over the counter drugs. BMJ. 2001;323:706–707. doi: 10.1136/bmj.323.7315.706. . (29 September.) [DOI] [PMC free article] [PubMed] [Google Scholar]
  • 2.Fisher S, Bryant SG. Postmarketing surveillance: accuracy of patient drug attribution judgments. Clin Pharmacol Ther. 1990;48:102–107. doi: 10.1038/clpt.1990.123. [DOI] [PubMed] [Google Scholar]
BMJ. 2002 Feb 16;324(7334):424.

Over the counter medicines must be treated like all other medicines

James Walmsley 1,2, Graham Marshall 1,2

Editor—Many of those who read Clark et al's editorial on monitoring the safety of over the counter medicines must have gained the impression that no systems are in place.1-1 But all pharmaceutical companies already have a statutory compulsion to monitor and report adverse drug reactions as part of obtaining a marketing authorisation. In fact, all medicines (prescription, pharmacy, and general sales) are subject to exactly the same requirements in terms of pharmacovigilance.

Furthermore, over the counter medicines have always been included in the yellow card scheme, and healthcare professionals are encouraged to report adverse reactions on these products. The inclusion of community pharmacists in the yellow card scheme in November 1999 provided an extra level of vigilance for all medicines, including those sold over the counter.

Although the yellow card scheme has the limitations of any system that relies on spontaneous reports from healthcare professionals, these limitations are the same for both prescribed and over the counter medicines. Pharmacists are particularly well placed to report adverse reactions associated with over the counter medicines and are perhaps less likely to display the diffidence and complacency identified by Clark et al as reasons for under-reporting by doctors.

Clark et al call for a practical yet scientifically robust method of safety surveillance for medicines sold over the counter. Asking pharmacists to record details of over the counter purchases is anything but practical. Furthermore, no evidence is given to support the assertion that this would help ensure that products are not used inappropriately or would form part of a scientifically robust method of safety surveillance. Community pharmacists already supervise the sale of all pharmacy medicines, and, in our company, general sales medicines as well. It could be argued that this supervision is at least as good as that given for repeat prescriptions, when, often, the patient has not seen the prescribing doctor for some months.

Few would disagree that the safety of medicines is paramount and that current systems for monitoring that safety are imperfect. The real issue is how to improve postmarketing safety surveillance for all medicines; there is no need to make a separate case for medicines sold over the counter.

References

  • 1-1.Clark D, Layton D, Shakir S. Monitoring the safety of over the counter drugs. BMJ. 2001;323:706–707. doi: 10.1136/bmj.323.7315.706. . (29 September.) [DOI] [PMC free article] [PubMed] [Google Scholar]
BMJ. 2002 Feb 16;324(7334):424.

Authors' reply

Deborah Layton 1, Saad A W Shakir 1, David Clark 1

Editor—We support initiatives that provide better information to patients, but this does not negate the need for robust, proactive monitoring of the safety of non-prescription products. Reporting by patients, as suggested by Wade, is suitable for monitoring some adverse reactions that may occur with prescription and non-prescription products, but some events can only be identified and reported by health professionals.

We agree with Walmsley et al that the need to obtain and maintain a marketing authorisation for all medicines is laid down in British and European Union regulations. Extensive evidence of safety from premarketing clinical trials or from postmarketing use is required before products may be considered for reclassification. Limitations of such methods, however, include variable emphasis on reporting adverse events and poor prediction of outcomes in non-prescription settings.2-1

We agree with Walmsley et al that health professionals should be encouraged to submit spontaneous reports—especially pharmacists, who are well placed to report adverse events associated with non-prescription medicines. Increased use of non-prescription drugs proportionally increases the occurrence of adverse effects (in absolute numbers).2-2 Unfortunately, these adverse reactions are less likely to be reported by consumers or medical practitioners than are those associated with prescription products.2-3

Because under-reporting is likely, spontaneous reporting schemes are insufficient to monitor the safety of non-prescription drugs; complementary methods are required, if only for a limited period after reclassification. We disagree that pharmacists are less likely than general practitioners to suffer from constraints surrounding submitting reports. One need only read the Pharmaceutical Journal to understand the pressures that community pharmacists endure. In any case, community pharmacists' contribution to the yellow card scheme has not been fully evaluated.

We have repeatedly shown that prescription event monitoring provides a valuable addition to pharmacovigilance of prescription products in England. Although community pharmacists responded well to pilot pharmacovigilance projects,2-4 a more robust system is needed. Many community pharmacy companies, including Boots the Chemists, are investing greatly in computerised systems. Electronic linkage of computerised patient drug records and point of sale systems could allow systematic collection of data on the use of non-prescription medicines. The idea that pharmacists would need to personally log details is obsolete when such technology is abundant.

The withdrawal of products containing phenylpropanolamine highlights concerns that not all medicines are proved safe before reclassification. Our editorial merely added to debates on improving postmarketing surveillance to bring medicines sold without prescription in line with prescription products. This will increase confidence in the safety of non-prescription products and may facilitate future regulatory decisions.

Footnotes

saad.shakir@dsru.org Drug Safety Research Unit, Southampton SO31 1AA

References

  • 2-1.Schmid B. The safety assessment of over-the-counter products. Arch Toxicol. 1995;17:305–311. doi: 10.1007/978-3-642-79451-3_25. [DOI] [PubMed] [Google Scholar]
  • 2-2.Meyboom RHB, Egberts ACG, Gribnau FWJ, Hekster YA. Pharmacovigilance in perspective. Drug Safety. 1999;21:429–447. doi: 10.2165/00002018-199921060-00001. [DOI] [PubMed] [Google Scholar]
  • 2-3.Thomas DHV, Noyce PR. Over the counter drugs. The interface between self medication and the NHS. BMJ. 1996;312:688–691. doi: 10.1136/bmj.312.7032.688. [DOI] [PMC free article] [PubMed] [Google Scholar]
  • 2-4.Sinclair HK, Bond CM, Hannaford PC. Pharmacovigilance of over-the-counter products based in community pharmacy: a feasible option? Pharmacoepidemiol Drug Safety. 1999;8:479–491. doi: 10.1002/(SICI)1099-1557(199912)8:7<479::AID-PDS462>3.0.CO;2-B. [DOI] [PubMed] [Google Scholar]

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