Over the Counter Drugs: The future for self medicationBMJ 1996; 312 doi: https://doi.org/10.1136/bmj.312.7034.835 (Published 30 March 1996) Cite this as: BMJ 1996;312:835
- Colin Bradley, senior lecturer in general practicea,
- Alison Blenkinsopp, director of education and researchb
- a Medical School, University of Birmingham, Birmingham B15 2TT
- b Department of Pharmacy Policy and Practice, University of Keele, Keele, Staffordshire ST5 5BG
- Correspondence to: Dr Bradley.
The increasing trend towards deregulation of more medicines to over the counter status has implications for the primary health care team as well as for consumers and patients. Better information for patients could improve the safety of over the counter medicines, but better systems need to be devised for reporting adverse reactions. “Collaborative care” could bring financial benefits. Doctors, nurses, and pharmacists need to discuss how they will respond to self medication practices, and ways of rewarding pharmacists for advising patients need to be found. Improved communication between doctors and pharmacists and the involvement of nurses could bring health care professionals into a new and more constructive interaction with each other and with the patient—or the changes required could split the professions as they each try to keep control of medicines.
Predicting the future is always risky, but current trends and the stated intentions of policy makers and stakeholders are often helpful. As we argued in the first article in this series, the factors promoting greater availability and use of over the counter medicines far outweigh the inhibitors.1 The uncertainty is therefore how far this trend will go and how health care professionals and consumers will respond.
More drugs were changed from prescription only medicines (POM) to pharmacy (P) medicines in the past two years than over the previous decade.1 Furthermore, the range now encompasses drugs which have, on prescription, been used for potentially more serious and longer term conditions.2 Some of the more recently deregulated medicines (H2 antagonists, for example) may not seem to doctors to be natural choices for over the counter use. However, formulations, dosages, and licensed indications for drugs that become available over the counter are not necessarily the same as those which pertain to its use as a prescription only preparation.
The explicit policy in medicines licensing and relicensing in Britain and throughout the developed world is that a drug should be made freely available to patients unless a case can be made for its availability being restricted.3 The main ground for restrictions is safety. But safety is not simply an intrinsic feature of the drug—it can arguably be achieved by providing better information to the patient. In Australia it was thought that β agonists could safely be supplied over the counter if pharmacists were required to provide additional information.4 Similarly, those arguing for oral contraceptives and emergency contraception being available over the counter predicate their argument on the provision of better information to the patient.5 6 The Medicines Control Agency now puts great emphasis on the provision of information for patients in its assessment of applications for drugs to be switched from prescription only to pharmacy status.3
If safety concerns can generally be met by providing adequate information, this opens the way to an even wider range of drugs becoming available over the counter. And there are pressures to extend the range considerably. One influential force for change has been the Royal Pharmaceutical Society, whose list of drugs suggested in 1991 for switching to pharmacy status has clearly influenced which drugs have been switched so far.7 Still included on the society's “hit list” are antibiotic eye drops and topical creams and oral antifungal agents. Since many of these drugs are reasonably safe in normal use (and some, such as antibiotic creams, have been sold over the counter in the United States for years), and if patient safety is being assured by means of good patient information, it becomes difficult to argue against the trend.
Further deregulation could sweep away many of the current restrictions on over the counter medicines for use only in easily diagnosed self limiting conditions of short duration. Once a doctor has made a diagnosis for which long term or recurrent treatment is required, this treatment could be available over the counter at the patient's request. This concept, in which part of the continuing treatment of patients with chronic conditions is delegated by doctors to others, particularly pharmacists, has been termed “collaborative care.” At its most elaborate the concept could include all aspects of care and all health carers, including informal carers, and be jointly managed to an agreed plan. Patients would need to take a greater share of the responsibility for their care and would have to pay for their drugs, which would be purchased over the counter. Many of the benefits of collaborative care could be achieved more simply by introducing “repeat dispensing” by pharmacists: provision for the doctor to specify on a prescription how often it is to be repeated before medical review (this currently exists only for private prescriptions) and by better communication between general practitioners and pharmacists.
The appeal of “collaborative care” to those who fund health care is obvious. It would allow some of the costs of repeat prescriptions to be shifted at least partially to patients—perhaps a more politically acceptable approach than a copayment system or a further hike in prescription charges.
Implications for doctors
If the scope of self medication widens as predicted, doctors, pharmacists, and other health professionals will need to respond in a more active and constructive way than they have to date. Greater vigilance for adverse reactions is needed, and the reporting system should be widened to include pharmacists. Doctors must improve on their current record of reporting adverse drug reactions using the yellow card system. Doctors and pharmacists need to clarify their attitudes towards deregulation and try to reach a consensus about how their shared goal of the safe and effective use of medicines can be achieved. This will require more communication between them; electronic forms of communications should help, but difficulties regarding confidentiality of patient data and incompatibility of computer systems will need to be ironed out.
Because of their continuous and regular contact with much of the population, general practitioners have a particularly vital role in ensuring that medicines continue to be used safely even when they are more widely available without a consultation taking place. To fulfil this role they must become more acceptable to patients as advisers on self medication. At present, consumers of over the counter medicines find pharmacists a more acceptable source of advice. Some patients see a recommendation by a general practitioner to use an over the counter medicine as an attempt to fob them off.8 Patients also recognise that many general practitioners are less than enthusiastic about self medication; hence they are reluctant to discuss their self medication practices with their general practitioner. These attitudes will have to be changed. Doctors cannot ignore or discourage prior self medication, and knowledge of such medication is essential, if only to check that the patient has not already tried the medicine that is about to be prescribed. It is also obviously important to guard against drug interaction between over the counter and prescribed medicines.
The patient empowerment that flows from deregulation can be seen as a good thing. Doctors who encourage and support responsible self medication will be seen by their patients as a more acceptable source of independent advice. The role of the doctor will then evolve to one of a collaborator with patients in the management of their health problems rather than an exclusive controller of access to medicines. The alternative approach of fighting to retain control over access to medicines will mean that, as patients gain more and more access to the means to treat their own illnesses, doctors will be rejected as a source of help and advice. Patients will, naturally, continue to need access to special information to deal with health problems that are often complex, but they may turn to other sources such as other health professionals who have more “liberal” attitudes, or, increasingly, to written and electronic sources of information.
Implications for pharmacists
For pharmacists the widening scope for self medication brings different challenges. It might seem to create the possibility of greater profits through increased sales, but in the longer term it could reduce income through the loss of dispensing fees and the associated professional allowance and could even threaten the viability of some pharmacies. More importantly, however, the professional input into the patient's choice of medicine could be lost unless a mechanism can be found for rewarding professional advice rather than just the dispensing of medicines. If doctors do not rise to the challenges of greater self medication, patients may turn to pharmacists instead. If pharmacists were to exploit this opportunity to extend their role in direct opposition to doctors the already wary relations between the two professions could deteriorate further. This is unlikely to benefit patients.
A more optimistic scenario envisages greater cooperation between doctors and pharmacists to ensure that patients get the best possible advice, both on diagnosis from doctors and on medication from pharmacists. Evidence that this is happening comes from the increasing number of initiatives in which doctors and pharmacists are forging links to improve patients' use of medicines. These positive developments need to be strongly encouraged and developed. Current obstacles to greater cooperation include the separate locations of doctors and pharmacists (in most cases) and the regulations which tie the pharmacist to the shop during opening hours. Freeing pharmacists to participate in more joint activities in undergraduate medical teaching, vocational training for general practitioners, and continuing professional development would help both professions.
Better communication is also vital—not just about individual prescriptions for individual patients but about policy making in both practices and pharmacies. Practice prescribing policies should take account of pharmacies' policies on the recommendation of over the counter products, and vice versa, so that patients receive consistent messages. Mechanisms similar to those used in the development of general practice formularies9 should be applied to formularies of over the counter drugs, with the proviso that pharmacy customers have the right to choose drugs other than those in the formulary.
Nurses and over the counter medicines
The extension of the nursing role and, in particular, the development of specialist nursing functions (for example, in health promotion and management of chronic diseases) also have potential to influence consumer choice of over the counter drugs. Nurse prescribing is now being piloted in various locations. The potential upward effect of nurse prescribing on practices' prescribing costs might be decreased by nurses becoming more involved in recommending medicines available over the counter. Many practice nurses are already advising patients about over the counter solutions to minor health problems, and as the range of products increases, nurses are likely to become involved in recommending them sooner and across a wider range of drugs than they are going to be allowed to prescribe for. Training is needed for nurses to fulfil this new role, which is as likely to be thrust on them as to be sought by them; ideally, they ought to be brought into the joint training proposed above for doctors and pharmacists. Nurses also need to establish lines of communication with community pharmacists, meeting with them to exchange ideas and problems and develop policies. They should be brought into new, broader mechanisms for reporting adverse drug reactions and into practice and pharmacy policy making.
The future: dream or nightmare?
The increasing scope for self medication and its likely consequences can be seen as a shift from “primary care” of both minor and stable health care problems to “self care.” Whether this transition occurs smoothly or not depends to a large extent on the attitudes and responses of the primary health care professionals involved, and whether they view this as a positive or negative development. It will also depend on how well informed and equipped the consumers are to take on the burden of self care.
These changes could bring together the health care professionals involved (doctors, nurses, and pharmacists) into a new and more constructive interaction with each other and with the patient—or they could split the professions as they squabble with the patient and with each other for the last vestige of control of medicines, leaving the patient baffled, confused, and vulnerable to the dangers inherent in all medicine taking. Will health professionals rise to the challenge?