Over the counter medication
June 2005
Decision making about OTC medicines
It is required that sales of medicines in the Phramacy medicine (P) category are supervised by a pharmacist.
In practice, community pharmacies have a written protocol that sets out how staff will deal with OTC medicine sales. The acceptability of this concept with the public is debatable. Although most consumers in one UK study had a degree of awareness of why pharmacy staff might require information, almost two thirds had expected to make their most recent purchase without being questioned (Morris et al 1997). A Canadian study of consumers purchasing medicines in pharmacies without asking for advice found that over 90 per cent had used the product before or had received advice elsewhere about what to purchase (Taylor 1994). These findings indicate that many people buying medicines in a pharmacy may not consider it the legitimate business of pharmacy staff to ask what they may view as ‘personal’ questions about why the medicine was needed. This creates a potential conflict between the public health role of community pharmacy staff and the nature of consumer autonomy in purchasing a medicine. One way for pharmacists to deal with this potential dissonance is to differentiate between ‘novice’ and ‘expert’ users of OTC medicines.
This is an area that the Royal Pharmaceutical Society needs to consider, with the involvement of medicine users, not only in its work on future POM to P switches but also more widely in relation to OTC medicines.
There is some evidence from the UK (Bissell et al 2001) and the USA (Roumie and Griffin 2004) that members of the public regard OTC medicines as inherently ‘weaker’ than prescription medicines. OTC status in itself may lead to a perception that the medicine cannot be harmful, for example, 40 per cent of people in a US study believed that OTC medicines were ‘too weak to cause any real harm’ (Roumie and Griffin 2004). That doses of medicines switched from Precription only medicine (POM) to P may be lower than those used on prescription is likely to reinforce such beliefs, even though evidence on effectiveness of the lower dose for OTC medications will have been considered in the regulatory process.
User awareness of active ingredients in OTC medicines is an important safety issue and labelling is key, particularly for combination products. One US study found that more than 60 per cent of older people could not identify the active ingredient in their brand of pain relief, leading to a call for improved labelling of OTC analgesics and enhanced education for both healthcare providers and patients (Roumie and Griffin 2004).
The information accompanying the medicine and how that information is presented is a factor in how safely the medicine is used. Information leaflets inside medicine packages need further attention, in particular they need to describe in more detail the rationale for the medicine’s use, its benefits, and when to consult a doctor and pharmacist. Some of the current standard wording, for example, ‘If symptoms persist, consult your doctor’ is too non-specific to be helpful.
As medicines for longer term use are re-categorised as OTC there will need to be information to the effect that the medicine should be taken long-term and the need for medical and pharmaceutical input must be stressed in both leaflet and label. The MHRA is working on implementation of user testing for manufacturers’ Patient Information Leaflets (PILs) for both prescription and OTC medicines, incorporating evidence on the presentation of benefits and risks. Labelling is a critical factor in successful self-selection of General sales list (GSL) medicines as well as safe use of both GSLs and Ps. User testing of package labels is also needed.
The extent to which the use of OTC medicine either substitutes for, or simply delays, consultation with a health professional is difficult to determine. A US study following the POM to P switch of omeprazole found that 26 per cent of subjects who purchased OTC omeprazole had contact with a physician about their heartburn during the following three months (Fendrick et al 2004). These data are difficult to interpret without knowing the reasons why these patients chose to consult.