Non-Prescription Medicines: Prescribing Legislation
By Nathan, Alan
Summary
This article discusses developments in prescribing legislation in relation to non-prescription medicines. The three supply categories are outlined: prescription only, general sale list, and pharmacy medicines. Changes in legislation towards increased availability of medicines that do not require prescription are covered and the implications for at-risk groups are discussed. A table of minor ailments and their principal treatments is provided.
Keywords
Adverse reactions; Drug administration; Drugs; Law; Non- prescription medicines
These keywords are based on the subject headings from the British Nursing Index. This article has been subject to double-blind review. For related articles and author guidelines visit our online archive at www.nursing-standard.co.uk and search using the keywords.
RECOGNITION AND ENCOURAGEMENT of patient autonomy in respect of their health care, and extension of the roles and clinical responsibility of non-medical health professionals, are two relatively recent developments in primary health care. These changes have coincided with an increase in the range of medicines supplied without prescription. Professional responsibility has increased for community pharmacists, and patients have benefited by being able to treat themselves with medicines for minor ailments without needing to see the GP and obtain a prescription.
Many nurses have a direct interest in non-prescription (over-the- counter) medicines, which include all medicines that are not prescription only – both pharmacy and general sale list (GSL) medicines – as prescribers and in recommending medicines to patients for selftreatment of minor ailments. This article discusses the range of medicines available without prescription and the legal requirements for their supply.
Legal classification and supply conditions
The supply of all medicines is regulated by the Medicines Act 1968 (sections 51 and 58). There are three supply categories:
* Prescription-only medicines (POMs) are listed in a statutory instrument appended to the act. They can only be supplied by prescription from ‘an appropriate practitioner’. An appropriate practitioner is a doctor, a dentist, a supplementary prescriber (pharmacist or nurse), an extended formulary nurse prescriber, or a nurse prescriber (district nurse or health visitor): only two POMs may be prescribed by district nurses and health visitors: nystatin in the form of pastilles or suspension and co-danthramer suspensions.
* GSL medicines are listed in a statutory instrument appended to the Medicines Act 1968 and are sold without the supervision of a pharmacist. They may be sold from any retail premises (excluding market stalls), and are available for self-selection by purchasers.
* Pharmacy medicines have no corresponding list. Therefore, any licensed medicine not listed as either POM or GSL is considered to be pharmacy medicine. Pharmacy medicines may only be sold from registered pharmacies under the supervision of a pharmacist; they are not made available for self-selection by purchasers. Some medicines classified as GSL in small quantities, for example, aspirin, paracetamol and ibuprofen, are classified as pharmacy medicines in larger quantities. Non-effervescent aspirin and paracetamol tablets and capsules are POMs in quantities greater than 100.
Sale of medicines from pharmacies is additionally regulated through the Royal Pharmaceutical Society’s (2005) Code of Ethics and Standards. The same conditions for sale from conventional pharmacy premises apply to sale over the internet or by mail order: internet pharmacies must be registered with the Royal Pharmaceutical Society (2005), and all sales must be supervised by a pharmacist.
Non-prescription medicines may not be sold from a GP practice unless the practice has a registered pharmacy with a pharmacist in attendance. They may be supplied under protocol from NHS walk-in centres (Department of Health (DH) 2004a).
Nurse prescribers can prescribe a limited number of non- prescription medicines listed in the Nurse Prescribers’ Formulary (British National Formulary (BNF) 2005). Extended formulary nurse prescribers can prescribe any GSL or pharmacy medicine allowable for prescription on the NHS, as may supplementary prescribers who are prescribing in accordance with an agreed clinical management plan.
Many non-prescription medicines are not allowable for NHS prescription (commonly known as ‘blacklisted’ medications) and should not be prescribed. They are indicated in the BNF (2005) by the letters ‘NHS’ diagonally crossed through in a rectangular box beside the drug name. A list of ‘blacklisted’ medicines is published monthly in Part XVIIIA of the Drug Tariff (DH2005a).
Herbal remedies and homeopathic medicines
Many herbal, vitamin and other preparations are marketed and promoted but not all are licensed medicines. A medicines licence indicates that a product has been reviewed by the national medicines licensing authority, the Medicines and Healthcare products Regulatory Agency (MHRA), and has met its criteria for safety, quality, efficacy and manufacturing practice. Licensed medicines can be recognised by a product licence number: the initials PL followed by an eight or nine digit number, for example PL12345/6789, on the package. If a product is not a licensed medicine no medicinal claims may be made for it. However, this prohibition is sometimes circumvented by careful wording in advertising and product information material. The Homeopathic Registration Scheme confirms the safety and quality, but not the efficacy, of homeopathic medicines (MHRA 2003). Homeopathic products approved under the scheme carry a registration number, prefixed HR.
Self-care and the role of pharmacies
Self-care has been defined as: ‘.. .a life-long habit and culture. It is the action individuals take for themselves and their families to stay healthy and manage minor and chronic conditions, based on their knowledge and the information available and working in collaboration with healthcare professionals where necessary’ (Proprietary Association of Great Britain (PAGB) 2003a).
In the UK the change from a ‘dependency culture’ in health care, that developed following the inception of the NHS in 1948, towards a self-care culture, began in the early 19 8 Os (clayton 1998 (,encouraging people to take greater responsibility for their own health (Allsop 1995).
More medicines are now available without prescription, so that people can treat themselves effectively for minor ailments without needing to go to the doctor for a prescription. This increases convenience to patients, reducing the workload of GPs and is intended to reduce the costs to the NHS. The DH embarked on a programme of reclassification of POMs to pharmacy status in 1983 (Bond 2001 ) and since then more than 50 substances have been reclassified. Many of these, including ibuprofen, the antifungal azoles and H^sub 2^-antagomsts for treatment of dyspepsia, have since been further deregulated to GSL status.
The movement towards self-care in health featured in The NHS Plan (DH 2000a). Pharmacy in the Future (DH 2000b), the document that set out the specific role of pharmacies in relation to The NHS Plan, indicated that pharmacists were particularly well placed to help people cope with everyday health problems. In The NHS Plan the government encouraged medicine manufacturers to apply for non- prescription status for their products to ensure that pharmacies have a growing range of medicines to offer. In A Vision for Pharmacy in the New NHS (DH 2003), the government further promoted pharmacies as a readily accessible source of advice and medicines. In this document the government also reiterated that it intended to continue to expand the range of medicines that pharmacies can supply without a prescription (DH 2003). The government has recently relaxed restrictions on advertising of non-prescription medicines to allow them to be advertised for the prevention and treatment of more serious and long-term illnesses, which was previously prohibited (DH 2004b).
Community pharmacies have been participating in primary care trust-based minor ailment treatment schemes for some years (Whittingtoneia/2001, Bellingham 2004), meaning that patients are treated in pharmacies for minor conditions and supplied with nonprescription medicines at NHS cost, instead of going to the GP. This pharmacy role has now been confirmed as a service in the new NHS contract for community pharmacy in England and Wales that has recently been negotiated (Pharmaceutical Services Negotiating Committee (PSNC) 2004). However, no central funding has been reserved and it will be up to individual primary care trusts to set up and run their own schemes.
In Scotland, minor ailment treatment is a core NHS service that will be provided by all community pharmacies. Self-care, including the treatment of minor ailments, has recently been promoted in a document from the DH aimed at primary care trusts, NHS trusts, strategic health authority and social care management teams, as well as health and social care professionals and practitioners (DH 2005b).
Non-prescription medicines for treatment of minor ailments
There are nearly 40 conditions for which non-prescription medicines are licensed and available (Nathan2002) (Table 1 (.These include medicines licensed for non-prescription sale, for example, nicotine replacement the\rapy treatments, the emergency hormonal contraceptive, and simvastatin: a cholesterollowering drug to reduce the risk of major coronary events. Simvastatin is the first medicine for a serious long-term condition to receive a licence for non- prescription sale.
Packages or package inserts of all medicines contain full information about indications, cautions, contraindications, side effects and dosage, and special precautions for particular groups or in particular situations. These can be consulted on e-MIMS.net (Haymarket Publishing 2005). More detailed information can be found in the summary of product characteristics of a medicine in the ABPI Medicines Compendium (Association of the British Pharmaceutical Industry (ABPI) 2005a), available free of charge to GPs on request or online (ABPI 2005b).
At-risk groups and interactions
Children A wide range of medicines formulated and marketed specifically for children is available, and many other medicines have specific dosage schedules. If a medicine is contraindicated for children it will be clearly stared in the product information.
Pregnant and breastfeeding women Particular care is necessary in considering non-prescription medicines for pregnant and breastfeeding women. Some medicines are contraindicated and others should be used with caution. Contraindications are specified in the product information. Some non-prescription medicines are generally safe to use during pregnancy, for example, topical azoic antifungals for vaginal candidiasis, but the conditions of their licensing for sale without prescription prohibit sale without medical advice.
Older people Declining renal and hepatic function in some older people may mean that certain medicines, for example ibuprofen, need to be avoided. Because many older people are taking prescribed drugs, often several, they are at increased risk of experiencing interactions between prescribed and non-prescription medicines. Older people are also more susceptible to the side effects of some drugs, such as those of sedative antihistamines, which include drying up of salivary and ocular secretions, urinary retention, constipation and blurred vision, as well as drowsiness. It is important that older people wishing to buy non-prescription medicine inform the pharmacist about all the medicines they take and that pharmacists request this information. A pharmacist will often refer an older person wishing to buy a non-prescription medicine to the doctor.
Long-term conditions Certain non-prescription medicines are contraindicated or should be used with extreme caution in people with some longterm conditions (Nathan 2002). For example, sympathomimetic decongestants, such as pseudoephedrine used in upper respiratory tract infections can raise blood pressure and increase heart rate; these should be avoided by patients with hypertension or any kind of cardiovascular condition. Sympathomimetic decongestants may also interfere with glucose metabolism and should be avoided in patients with diabetes or thyroid problems. The sedative effects of drugs prescribed for anxiety, depression and psychosis may be enhanced by antihistamines.
Interactions Interactions are possible between some prescribed drugs and non-prescription medicines (Randall and Neil 2003), which is another reason why nurses and pharmacists need to ask about other medicines that patients may be taking. A chart detailing non- prescription and prescribed-drug interactions can be found in the PAGB OTC Directory (PAGE 2003b).
Selection of non-prescription medicines
There are few sources of evaluated information on non- prescription medicines. One publication of this type covers medicines licensed and marketed in the UK (Nathan 2002); a third edition is due for publication in 2006. There are few quality clinical publications available on non-prescription medicines; manufacturers often say that they have such evidence on file but do not publish it for reasons of commercial sensitivity. Conclusions about the effectiveness of non-prescription medicines are sometimes extrapolated from clinical research on prescription versions of the same drug substance. However, this is not sufficient because it usually relates to different indications and dosages. The best current source of information for nurses on non-prescription medicines is the local pharmacist who has direct experience and knowledge of products and also receives reports on effectiveness from patients who use them.
TABLE 1
Minor ailments and their principal non-prescription treatments
Conclusion
The government is reclassifying an increasing number of prescription medicines for sale without prescription. Some proposed reclassifications are trimethoprim for the treatment of cystitis, and sumatriptan and zolmitriptan for patients with migraine. The recent relaxation on advertising restrictions of non-prescription medicines and the reclassification to pharmacy status of simvastatin for cholesterol reduction may indicate that the government is intending to extend self-treatment to other serious long-term conditions. Pharmacists and, increasingly, nurses are key professionals in advising the public on non-prescription medicines
Useful websites
Department of Health
www.dh.gov.uk
Medicines and Healthcare products Regulatory Agency
www.mhra.co.uk
National Prescribing Centre
www.npc.co.uk
Nathan A (2005) Non-prescription medicines: prescribing legislation. Nursing Standard. 19, 52, 41-45. Date of acceptance: April 29 2005.
References
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Association of the British Pharmaceutical Industry (2005a) ABPI Medicines Compendium 2005. Datapharm Communications, Surrey.
Association of the British Pharmaceutical Industry (2005b) Electronic Medicines Compendium (eMC) www.medicines.org.uk/ home.aspx (Last accessed: August 25 2005.)
Bellingham C (2004) How the minor ailments service works. Pharmaceutical Journal. 272, 7283,115-116.
Bond C (2001) POM to P: Implications for practice pharmacists. Primary Care Pharmacy. March, 2, 5-7
British National Formulary (2005) British National Formulary No. 49. British Medical Association and the Royal Pharmaceutical Society of Great Britain, London, 778-779.
Clayton J (1998) The changing shape of the NHS. In Birchenali M, Birchenall P (Eds) Sociology as Applied to Nursing and Health Care. Baillire Tindall, Edinburgh, 205-209.
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Department of Health (2000b) Pharmacy in the Future: Implementing the NHS Plan. The Stationery Office, London.
Department of Health (2003) A Vision for Pharmacy in the New NHS. The Stationery Office, London.
Department of Health (2004a) A Practical Guide to Setting up an NHS Walk-in Centre. The Stationery Office, London.
Department of Health (2004b) The Medicines (Advertising) Amendment Regulations 2004. Statutory Instrument 2004 No. 1480. The Stationery Office, London.
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Medicines and Healthcare products Regulatory Agency (2003) The Homeopathic Registration Scheme. Guidance for Manufacturers and Suppliers. MHRA Guidance Note No. 17 MHRA, London.
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Proprietary Association of Great Britain (2003a) Advancing self- care: helping people to take care of their own health. PXlGB Self- Care Review 2003. PAGB, London.
Proprietary Association of Great Britain (2003b) PAGB OTC Directory 2003/2004. Communications International, London, xvi- xvii.
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Royal Pharmaceutical Society (2005) Code of Ethics and Standards. In Medicines, Ethics and Practice: A Guide for Pharmacists. No 29. The Royal Pharmaceutical Society of Great Britain, London, 85.
Whittington Z, Cantrill J, Hassell K, Bates F, Noyce P (2001) Community pharmacy management of minor conditions: the ‘Care at the chemist’ scheme. Pharmaceutical Journal. 266, 7141, 425-428.
Author
Alan Nathan is a pharmacist and adviser on non-prescription medicines to the Proprietary Association of Great Britain. Email: alannathan@onetel.com
Copyright RCN Publishing Company Ltd. Sep 7-Sep 13, 2005