Over the counter medication
June 2005
Government policy on OTC medication
In the blueprint for NHS modernisation the NHS Plan included a target relating to the public being able to ‘get the right medicine at the right time’ (NHS Plan 2000). This theme related to both prescribed and OTC medicines. In relation to OTC medicines there was a target of 10 switches (including both Prescription only medicine (POM) to Pharmacy medicines (P) and P to General sales list (GSL)) each year.
Table 4 shows the number of switches made since the introduction by the MHRA in 2002 of the new process for dealing with switch applications.
Table 4: Applications to reclassify a medicine (ARM consultations by the MHRA 2002-2004
| Year | POM to P | P to GSL |
| 2002 | Fluticasone nasal spray | Ketoconazole 2% shampoo |
 | Vivioptal capsules (multivitamin/multimineral) | Minoxidil2% lotion |
| | Pharmaton capsules (ginseng/multivitamin/multimineral) |
| | Topical hydrocortisone 1% (for bites and stings) |
| | Beclometasone nasal spray (adults, hayfever) |
| | |
| 2003 | Omeprazole 10mg | NiQuitin 4mg lozenge (2 products) (nicotine) |
| Topical dicofenac (new indication - non-serious arthritic pain) | Hyoscine butylbromide |
| Diclofenac spraygel | Dioralyte Relief (2 products) |
| Scopoderm patch (1.5mg hyoscine) | Clotrimazole cream = pesary |
| Zocor Heart Pro (simvastatin 10mg) | Cetirizine tablets; cetirizine syrup |
| | Nurofen Cold & Flu (200mg ibuprofen + pseudoephedrine 30mg)* |
| | Anbesol (lidoccine; chlorocresol; cetylpyridinium) |
| | Terbinafine cream, terbinafine spray |
| | |
| 2004 | Chloramphenical eye drops | Aciclovir cream 5% |
| | Wasp-eze (bezocaine 1%; mepyramine maleate 0.5%) |
| | Topical diclofenac 1.16% |
| | Germoloids HC spray (hydrocortisone 0.2%; lidocaine 1%) |
| | Calpol Infant Suspension; Calpol Sugar-Free Infant Suspension (packaging change) |
| | Calpol Six Plus Fastmelts (paracetamol 250mg) |
| | Acrivatine 8mg |
| | Bisacodyl 5mg (increased pack size) |
Source: OTC Bulletin no.228 September 2004 / MHRA
( http://medicines.mhra.gov.uk/inforesources/publications/arm.htm)
*application not approved
As the table shows, applications for P to GSL switches have greatly outnumbered those for POM to P (by three to one) since the new system to streamline the process was introduced.
The guiding principle of NHS modernisation was the aim of providing services that were best suited to the needs and convenience of patients. Other key aims were to increase self-care and to make better use of health professionals’ skills by breaking down traditional inter-professional boundaries. In this context, POM to P switching can be seen as increasing patient autonomy, as well as making more effective use of community pharmacists. Another issue for the NHS is the shortage of doctors and the increasing workload of GPs. POM to P switching could reduce the numbers of GP consultations for common ailments. Increasing the availability of medicines through switching also moves treatment from the NHS into the private sector, as the medicine must be purchased by the patient. It is inevitable that some will view this as privatisation of the NHS.
The cost of OTC medication has been recognised as a barrier to greater self-care, particularly in disadvantaged areas. In response, community pharmacy minor ailments schemes (MAS) have been developed as an NHS service to transfer workload from GPs, as well as to increase choice in England, Scotland and Wales. In Scotland the service is being rolled out across the country. In England the government urged PCTs to consider introducing such a scheme in areas where the cost of OTC medicines was a recognised barrier to their use (Building on the best DH 2003). Some MAS include certain POMs (supplied under Patient Group Direction), as well as OTCs. MAS are considered further in section 1.7: Access to OTC medicines.
POM to P switching can enable access to medicines for an indication that would not qualify for NHS treatment. Simvastatin is the first example, where the argument was made that people should be able to decide for themselves whether they wanted to initiate primary prevention below the level of CHD risk where the NHS would fund treatment. The drivers for POM to P switching and their effects in different countries are reviewed in greater detail elsewhere (Cohen et al 2005).
In its 2003 ‘Building on the best’ paper the government reiterated its commitment to POM to P switching and to the target of 10 switches each year (Building on the best DH 2003). The NHS emphasis on chronic disease management (now termed ‘long-term conditions’ in the NHS) highlights self-care and suggests that increasing attention will be paid to OTC medicines for long-term conditions. ‘Building on the best’ listed several therapeutic areas including asthma and migraine for future POM to P switches. In a 2004 conference speech Lord Warner reiterated this commitment (PAGB 2004). Future switches imply the need for education for both the public and for health professionals with the move towards greater self-management of long-term conditions. The extent of public and patient education required here should not be underestimated. The figure below sets out a model of POM to P switching that captures the relative complexity of different switches. The arrow denotes the likely future trend to more switches in new areas of self-care. Quadrant D represents the most complex and demanding switches in terms of education for the public and for professionals, and in relation to the need for effective links between self-care and the NHS.
Figure 1: Model of complexity of POM to P switching
Key:
A = Low complexity: medicine already available OTC and indication within existing area of self-care
B = Moderate: existing area of self-care but medicine previously POM (eg chloramphenicol eye drops)
C = Moderate: medicine already available OTC and indication for a new area of self-care
D = High: new area of self-care and medicine previously POM (eg simvastatin)
Source: Kilby S (2005), Royal Pharmaceutical Society of Great Britain
Future POM to P switches for long-term conditions will also need greater integration with the wider NHS, for example, management of referrals at the boundary between self-care and NHS care. There is evidence to suggest that a proportion of patients with long-term conditions would appreciate the opportunity for greater self-management with the help and advice of a community pharmacist. Some, however, would choose to continue to use the current medical model. Community pharmacy, under its new contract, is changing and it is anticipated that most premises will have a seated, confidential, consultation area over the next few years. It would be reasonable to measure, for example, PEFR and blood pressure in such a setting. Consequently, switching medicines for the treatment of conditions such as mild to moderate asthma and hypertension would become more feasible. The integration of such a service would require close liaison between community pharmacy and the rest of primary care. Forthcoming developments in NPfIT offer the opportunity to share information across different healthcare settings through the electronic patient record and it is important that OTC medicines for long-term conditions are included. Action is needed now if this is to happen. The agenda for medicines deregulation is largely driven by the pharmaceutical industry rather than by consideration of needs and priorities from a public health perspective. As the MHRA states: ‘Reclassification of a substance normally follows a request from the company which holds a marketing authorisation for it. Requests can however be made by any interested party, such as a professional body, or be initiated by the MHRA’ (MHRA 2005). This raises questions about the extent to which OTC medication is, or can be, integrated with wider health strategy. In addition, the short period of time between a consultation being issued for a proposed switch and the launch of the product will inevitably be more challenging for switches of higher complexity. Co-ordinating training for pharmacists and their staff, cascading of local communication at primary care organisation level, formulation of local referral policies and information for the public will be an even greater challenge for the new POM to Ps.
The Royal Pharmaceutical Society, which led a previous multi-stakeholder group on future POM to P switches, is currently planning to build on this work with stakeholders from 2005. Work on integration of OTC medication into the wider NHS is needed as part of these developments.