OTCs - Safety comes first

All medicines, whether they are OTC or prescription only (POM) products, are subject to the same strict licensing procedures laid down by the Medicines Act 1968 and EU legislation. These are enforced by the Medicines Control Agency (MCA) and the Committee on Safety of Medicines (CSM).

A product can only be sold if it has a marketing authorisation and this is only issued once a medicine has been evaluated and proven to meet strict criteria in terms of safety, efficacy and quality.

In considering a product for a move from prescription only (POM) to pharmacy status (P), the CSM considers the clinical issues first and then the criteria for legal status, as set out in the legislation (see criteria for Legal Status).

Evidence of efficacy and safety needs to be demonstrated from randomised, controlled clinical trials and the CSM also looks for evidence that the product has been shown to be safe in wider use as a prescription only medicine.

A risk/benefit consideration is also part of this approval process and for a medicine to receive approval, any benefits must far outweigh any associated risks. This includes an assessment of the consequences of any side effects or misuse of the product.

If the product passes...

Medicines which pass this stringent scrutiny are then granted an OTC marketing authorisation. This stipulates the ailments and/or symptoms that can be treated with the medicine, the circumstances in which the medicine should not be used, how to take it and at what dosage.

Should the product's manufacturer wish to change any part of the medicine or its information then they must first have the marketing authorisation altered by going through the approval channels of the MCA.

The CSM also considers a product's label and/or information leaflet to be an integral part of the safety of the medicine, as it acts as a substitute for medical supervision and protects the consumer from accidental misuse. The information on the medicine's label and leaflet is also assessed by the MCA as part of the marketing authorisation process.

The work of the MCA in safeguarding the public does not stop with the issuing of the marketing authorisation. It continues to monitor medicines when they are in use, keeping records of any reported side effects.

Manufacturers also have a legal obligation to report any new information on the safety profiles of their products to the MCA. The monitoring of OTCs has been extended to community and hospital pharmacists.

Support for self-medication

Evidence indicates that growing numbers of both GPs and consumers are in favour of increased self-medication. Positive support by GPs for self-medication is growing and research shows that more than half of GPs expect to increase their levels of OTC recommendation over the next 12 months - the reason most frequently given being the availability of more products OTC (1).

83% of GPs say they are comfortable about referring patients to the pharmacist (1), and the Department of Health supports this by promoting the pharmacist as the first port of call for people suffering from minor ailments. More than half of consumers (56%) agree that it is useful to be able to buy some of the stronger medicines without having to go to the doctor (2).

However, when problems arise with OTC products and the media pick up the story, the public's confidence in self-medication is seriously undermined, for example, when the MCA addressed safety issues relating to the pack sizes of OTC analgesics such as paracetamol and aspirin, and when they questioned the availability of the hayfever treatment terfenadine. The proposal in each case was to restrict access to the products in question, to help avoid the consequences of inappropriate use by a small number of people, compared with the millions who use these products safely.

The reality is that many millions of people have used, and still use, these medicines safely. Even though very few people are at risk, this can lead to people losing confidence and naturally questioning the safety of other OTC medicines.

The industry, health professionals, consumer representatives and the regulatory bodies ail wish to ensure that medicines are used safely. When there is new information about side effects and contra-indications, everyone wants to ensure that it is acted upon. The challenge is to achieve the necessary high level of consumer safety for the few at risk, while not restricting access to the product for the many who continue to use it without problems.

More targeted consumer information must be the way forward. Professor Richard Eiser, of the University of Exeter, maintains that for people to make sensible decisions about their health they need to be helped to acquire the necessary knowledge, confidence and competence to make such decisions more independently (3).

Both GPs and pharmacists have a role to play in helping people assess the risk of using medicines, and appropriate labelling information on the medicine also allows the individual to take steps to ensure his or her own safety.

Every day, people use household products such as flammable liquids, bleaches and appliances which have safety instructions - people are expected to take sensible steps to look after themselves. Is the risk/benefit decision process for medicines really all that different?

References

1. BMRB Everyday Healthcare Study, 1997.
2. PMSI poll, commissioned by the PAGB, 1997.
3. Bradley C.R. et al, Family Practice 1998; 15: 44-50

Criteria for Legal Status Following the requirements of the Medicines Act 1968, the natural status of a medicine is Pharmacy only (P). If the product falls into one or more of the following categories, it will be designated a prescription only medicine (POM). Could present danger, directly or indirectly, even if used correctly, without medical supervision Are frequently used incorrectly and could present a danger to human health directly or indirectly Contain substances, the activity or side effects of which require further investigation Are normally given by injection. The other issues taken into account when considering legal status are: The presence of narcotic or psychotropic substances in non-exempt quantities The risk of medicinal abuse, possibility of addiction or illegal misuse Novel substances with properties requiring full investigation Where the usage is confined to hospitals or for conditions diagnosed in hospitals Where the use is intended for outpatients but requires specialist/special supervision.