Over the counter medication
June 2005
Availability versus control
Previous paragraphs have considered the potential risks associated with OTC medication against the background of the regulatory framework that allows their use. It has also illustrated the ill-defined nature of these regulations and the need for their careful interpretation to achieve the responsible use of medicines. The Prescription only medicine (POM) legislation imposes controls on the supply of medicines such that the risks can be monitored by a professional to the benefit of the patient taking the drug. There is ongoing debate about the extent to which control should be relinquished completely at the point of deregulation. In the UK there are three categories of medicines classification (see earlier). The first tier after the POM is the Pharmacy medicine (P). In this category, the pharmacist and his/her staff have a professional responsibility to ensure the safe and effective supply and use of medicines (Royal Pharmaceutical Society of Great Britain 2004), which requires a degree of intervention, and may result in refusal to supply a requested product. Slow initial sales of the then newly deregulated H2 blockers were attributed to the reluctance of pharmacists to promote their sale. It has been suggested that if pharmacists take on this gatekeeper role, it is merely replacing the traditional paternalistic medical prescriber with a pharmacist and is not widening access to medicines or empowering the public (Prayle and Brazier 1998). This negative attitude however ignores the increased accessibility and convenience of accessing medicines directly from a retail outlet, or the supportive, rather than prescriptive role of the pharmacist in self-care. Thus, the key principle of wider access to medicines is maintained, while including an element of risk management.
In contrast, in the USA there is no intermediate category of drug classification and the range of OTC products is generally more limited than in the UK, although there are some anomalies (for example, topical antibiotics are available OTC in the USA). Conversely, in Australia and New Zealand there is a fourth category of pharmacist-only medicines, which requires the personal involvement of the pharmacist in every sale. This has empowered the pharmacist to ask more searching questions at the point of sale.
An alternative to amendments to the actual classification of a medicine is a change to the specific details of the OTC licence. When there were widespread concerns about the numbers of fatalities attributed to paracetamol overdose for example, the response was not to revert to POM status, but to limit the OTC pack size, and total quantity which could be sold OTC. There were initial concerns that this move would not be sufficient to address the problem. Since the change, the number of paracetamol associated fatalities appears to have been reduced, although a recent paper reminds us that without a control group the true cause of this trend is unknown (Morgan et al 2005). An alternative approach adopted in the USA was to add methionine to the paracetamol (ie the antidote which is harmless) but that ‘admits’ there is a problem with its toxicity.
Conversely, as confidence in the safe and appropriate use of deregulated products is acquired, then the OTC indications can become extended, for example the prophylactic use of H2 blockers to protect against ‘over indulgence’. The dosage available might also be increased. For example, the first nicotine replacement product to be deregulated was the 2mg chewing gum, but since then there has been subsequent availability of a 4mg strength, as well as other formulations such as patches and inhalators. Further, in the UK, complete deregulation from P to GSL status is the ultimate natural progression when there is confidence in the drug’s safety in wider use. While truly achieving maximum public accessibility and convenience, this further reduces the chance of any health professional input. Some of the disadvantages of this are discussed in the next section.