House of Commons - Health

Select Committee on Health Fourth Report

6 Control of access to medicines

135. Doctors are the principal gatekeepers of access to prescribed medicines but nurses and pharmacists have been given an increasingly important role. Greater prescribing powers has meant that these groups are now particularly involved in the management of minor ailments and chronic conditions.

136. The NHS is the pharmaceutical industry's primary client in this country. In 2002-3, the NHS spent £7.5 billion on drugs in England.[90] Most of this is spent on branded medicines, which account for around 80% of the NHS drugs bill.

137. The issuing of a prescription is the most common intervention of the health service, after the consultation itself.[91] 650 million prescription items were dispensed in 2003 in England alone.[92] The BNF gives information to healthcare professionals about medicines that may be prescribed on the NHS.

Drug classification

138. Medicines are divided into three categories: those that are obtainable only through the issue of a prescription, which have the status of prescription-only medicines (POMs), those available over the counter from a pharmacist, which have pharmacy (P) status, and medicines available in outlets other than pharmacies, such as supermarkets (including many painkillers or anti-indigestion tablets), which have General Sales List (GSL) status. Medicines with both P and GSL status are also known as OTC drugs.

139. At the time of licensing, the great majority of drugs are POMs. Reclassification may take place after a medicine has been available on prescription for some time, when the regulator deems that the drug is safe enough for OTC availability. OTC drugs are often supplied in lower doses than the same medicine that is available on prescription. In 2004, following on from PICTF recommendations, the Government increased the number of drugs to be reclassified annually from five to ten.

140. Applications by pharmaceutical companies to reclassify drugs are evaluated by the MHRA, and the CSM advises as necessary. Public consultation follows, via the MHRA website. Evaluation of responses received, again by the MHRA, is conducted before approval is granted, which occurs provided no additional safety issues are raised. Other companies with similar drugs are prevented from carrying out 'switches' on the basis of the same data for 12 months. Agreement between stakeholders, such as the RPSGB and NPA, on the drug protocol is not mandatory before reclassification may take place. The MHRA is not required to take into account the clinical effectiveness of a product by itself in a public sales setting.

141. Broad controls on who may prescribe what are determined by the regulator. Below we look at doctor, nurse and pharmacist prescribing powers.

Prescribing

DOCTORS

142. Basic training in drug prescribing is included in medical teaching. Thereafter, prescribers are kept up-to-date about drug selection and prescribing developments mainly through the BNF, which they receive regularly; the work of the National Prescribing Centre, which publishes information and organises events; the Drug and Therapeutics Bulletin (DTB), which provides independent reviews of medical treatments; the work of NICE and through occasional circulars from the Chief Medical Officer and the MHRA/CSM. Doctors also receive extensive and targeted information from the pharmaceutical industry, in the form of various publications, promotional literature and sponsored events. The Department of Health spends around £4.5 million each year on providing independent medicines information to prescribers.[93] In contrast, the ABPI told us that around 14% of the industry's expenditure is on promotion and marketing.[94] Spend on information from the Department therefore represents about 0.3% of the approximately £1.65 billion a year that the pharmaceutical industry spends on marketing and promotional efforts.

143. Most prescriptions are issued by GPs. Between April 2002 and April 2003, 650 million prescriptions were dispensed to general practice patients in England. This represents an increase of 5.3% compared to the previous year.[95] Prescribing by doctors is subject to varying types of guidance and control. In some hospitals, Drug and Therapeutics Committees (or similar) demand high standards of benefit versus risk before allowing drugs on to the Hospital Formulary. They may be more stringent than NICE guidelines. In other hospitals, if clinical pharmacologists, specialist pharmacists or physicians with a special interest are not available, controls may be weaker. There are also Area Prescribing Committees, described by the Department as addressing prescribing and medicines use across primary and secondary care and comprising "a multi-disciplinary team, with contributions from PCTs and local NHS Trusts".[96] These Committees vary widely across the country. Remarkably, GPs, who issue the majority of prescriptions, have greater freedom than specialist hospital doctors in the range of medicines that they prescribe. Most PCTs do not have tightly controlled, evidence-based formulary systems, managed by Drug and Therapeutics Committees (or similar) and enforced by pharmacists.

NURSES

144. There are currently about 25,500 nurse prescribers in the UK.[97] Nurses are able to prescribe once they have successfully completed the extended/supplementary prescribing programme, which includes sections designed to equip nurses with the knowledge to assess evidence that may be provided by drug company representatives.

145. There are three types of independent nurse prescriber. The first is district nurses and health visitors, who may prescribe appliances, dressings and some POMs. Secondly, Extended Formulary Nurse Prescribers may, in addition to prescribing all drugs with P and GSL status, prescribe almost 180 POMs, including some specified controlled drugs. Approximately 2,400 nurses are currently qualified and registered to prescribe from the Extended Formulary and around 1,000 more are in training. This process implies that there will be much greater contact between nurses and the pharmaceutical industry:

The RCN is working increasingly closely with the pharmaceutical industry as nurse prescribing powers expand, and greatly values the support the pharmaceutical industry offers in terms of the sponsorship of professional events and the provision of education programmes.[98]

146. Thirdly, from April 2003, amendments to NHS regulations also allowed the introduction of supplementary prescribing for first level nurses and midwives. Supplementary prescribing is defined as a voluntary partnership between an independent prescriber (a doctor or dentist) and a supplementary prescriber, to implement an agreed patient-specific Clinical Management Plan with the patient's consent.

147. Approximately 1,700 nurses and 100 pharmacists are currently qualified to act as supplementary prescribers. There is no restriction on the conditions that may be treated by supplementary prescribing, but chronic conditions are most likely to be treated in this way. There is no specific formulary for supplementary prescribers.

PHARMACISTS

148. In 2000, the NHS Plan set an objective of making better use of pharmacists. Changes to pharmacy opening hours and the increasing array of services offered to customers form part of a larger programme that aims to increase the use of pharmacies by the general public.

149. Following negotiations with the NHS Confederation and the Pharmaceutical Services Negotiating Committee, which represents community pharmacy contractors providing NHS services in England and Wales, a new contract for high street pharmacists will be implemented (subject to a ballot by pharmacists) in April 2005. The new contract has been designed to encourage pharmacists to increase the range of services they offer. Such services may include, for example, blood pressure testing or smoking cessation programmes in addition to the supplementary prescribing role described above.

150. Supplementary prescribing for pharmacists was also introduced in 2003. In addition, there is currently a public consultation on options for independent prescribing by pharmacists.[99]

151. According to the PAGB, the British public prefer not to take medicines unless it is absolutely necessary.[100] Half of all symptoms experienced in any two-week period are not treated or are managed with a home remedy. The first port of call for treatment is therefore likely to be a pharmacist rather than a GP.

Control of medicines use at University College London Hospitals Trust (UCLH)
Drug and Therapeutics Committees are an important source of independent medicines information and prescribing guidance and control. Such Committees include representatives from all groups involved in prescribing, including representatives from local PCTs and at UCLH there is also a lay member.
The Committee evaluates applications submitted by consultants or other prescribers to include new drugs on the local formulary by examining clinical trials and other evidence relating to the medicines. Information on efficacy, safety, cost and ease of use are considered, according to a hierarchy of evidence. A decision is made to accept the application, decline it or request further information. Guidance on dose and duration of treatment is given. This information is invaluable, particularly because doctors are usually unaware that the licensing process does not consider the comparative efficacy of drugs.
At UCLH - where the Drug and Therapeutics Committee is known as the Use of Medicines Committee (UMC) - approximately 50% of applications are accepted. The onus is on the applicant to provide information, although the pharmacist will check that a comprehensive data set has been provided. The Hospital Management Board ratifies decisions.
Advice given by the UMC may be more stringent than NICE guidance. The line taken by UCLH on the prescribing of COX-2 inhibitors, for example, was much more restrictive than that of NICE, and preceded the NICE advice by several months. The Committee produced a leaflet on COX-2 inhibitors, explaining the decision on recommended prescribing limitations. As a result, prescribing levels, particularly in the local PCTs (primary care being a strong driver for the use of COX-2 inhibitors), was lower than the national average.
Unusual prescribing patterns, or sudden changes in prescribing rates of particular medicines, may not be immediately identified and addressed by UMCs, however. It seemed anomalous that the electronic production of prescriptions that is in place in most PCTs is not present in hospitals and that there is no centralised record of drugs prescribed and dispensed in hospitals.
Although all NHS trusts are required to have a Drug and Therapeutics Committee (or equivalent), there is no standard structure, membership, processes, powers or terms of reference. The UCLH UMC counts clinical pharmacologists and specialist pharmacists among its members. However, this is not true for many such committees, particularly in small trusts with limited clinical pharmacology and pharmacy support. Furthermore, many PCTs do not have medicines management committees with the scope and influence of secondary care trusts' Drug and Therapeutics Committees.[101]