Monitoring safety of over the counter drugs

BMJ 2002; 324 doi: https://doi.org/10.1136/bmj.324.7334.424 (Published 16 February 2002) Cite this as: BMJ 2002;324:424

Patients could do more than just treat themselves

  1. Alan G Wade (alan@edgehill.demon.co.uk), medical director
  1. CPS Clinical Research Centre, Riverside MediPark, Clydebank G81 4SA
  2. Boots the Chemists, Nottingham NG90 1BS
  3. Department of Pharmacology, University of Otago, Dunedin, New Zealand Drug Safety Research Unit, Southampton SO31 1AA

    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 …

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