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About this book
provides reference to the various systems of weights and measures that may be encountered by pharma­cists. Appendix 4 provides guidance on presentation skills; pharmacists throughout their professional careers require such skills. Key references and guid­ance to further reading for all the chapters are collated in Appendix 5.
For us as editors, it has been a daunting task to produce a textbook of a reasonable size that covers all the possible topics in pharmacy practice. We real­ize that it is possible only to provide an overview and supply key information. Any reader requiring more
information on the topic should initially consult Ap-
pendix 5 for suggested additional reading, then use
the information in Chapter 23 to practise their skills at information retrieval.
Finally, we acknowledge that changes will take place between writing and publishing that will mean that by the time this book appears in print some of it will almost certainly be out of date. This process of obsolescence will continue with time. Therefore it is suggested that readers keep up to date by reading current medical and pharmaceutical journals and literature.
xix
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Section One Section One Section One Section One Secti
o
Section One
Pharmacy Practice and Society
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Chapter One
The role of pharmacy in health care
Christine M. Bond
1
STUDY POINTS
*
The historical development of pharmacy
*
The position of pharmacy within the National Health Service in the UK
*
Recent developments in the services being provided by pharmacists
*
The need for lifelong learning
*
The publics attitudes to pharmacy

Introduction

Pharmacists are experts on the actions and uses of drugs, including their chemistry, their formulation in­to medicines and the ways in which they are used to manage diseases. The principal aim of the pharmacist is to use this expertise to improve patient care. Phar­macists are in close contact with patients and so have an important role both in assisting patients to make the best use of their prescribed medicines and in advising patients on the appropriate self-management of self-limiting and minor conditions. Increasingly this latter aspect includes over the counter (OTC) pre­scribing of effective and potent treatments. Pharma­cists are also in close working relationships with other members of the healthcare team – doctors, nurses, dentists and others – where they are able to give advice on a wide range of issues surrounding the use of medicines.
Pharmacists are employed in many different areas of practice. These include the traditional ones of hos­pital and community practice as well as newer advi­sory roles at health authority/health board level and working directly with general practitioners as part of the core, practice-based primary healthcare team.
Additionally, pharmacists are employed in the phar­maceutical industry and in academia.
Members of the general public are most likely to meet pharmacists in high street pharmacies or on a hospital ward. However, pharmacists also visit residen­tial homes, make visits to patients’ own homes and are now involved in running chronic disease clinics in primary and secondary care. In addition, pharmacists will also be contributing to the care of patients through their dealings with other members of the healthcare team in the hospital and community setting.

The changing role of pharmacy

Historically pharmacists and general practitioners have a common ancestry as apothecaries. Apothecaries both dispensed medicines prescribed by physicians and recommended medicines for those members of the public unable to afford physiciansfees. As the two professions of pharmacy and general practice emerged this remit split so that pharmacists became primarily responsible for the technical, dispensing aspects of this role. With the advent of the National Health Service (NHS) in the UK in 1948, and the philosophy of free medical care at the point of delivery, the advisory func­tion of the pharmacist further decreased. As a result pharmacists spent more of their time in the dispensing of medicines – and derived an increased proportion of their income from it. At the same time, radical changes in the nature of dispensing itself, as described in the following paragraphs, occurred.
In the early years, many prescriptions were for extemporaneously prepared medicines, either follow­ing standard recipesfrom formularies such as the
SECTION ONE Pharmacy practice and society
British Pharmacopoeia (BP) or British Pharmaceutical Codex (BPC), or following individual recipes written
by the prescriber. The situation was similar in hospital pharmacy, where most prescriptions were prepared on an individual basis. There was some small-scale manu­facture of a range of commonly used items. In both situations, pharmacists required manipulative and time-consuming skills to produce the medicines. Thus a wide range of preparations was made, including liquids for internal and external use, ointments, creams, poultices, plasters, eye drops and ointments, injections and solid dosage forms such as pills, capsules and moulded tablets.
Scientific advances have greatly increased the effec­tiveness of drugs but have also rendered them more complex, potentially more toxic and requiring more sophisticated use than their predecessors. The pharma­ceutical industry developed in tandem with these drug developments, contributing to further scientific advances and producing manufactured medical pro­ducts. This had a number of advantages. For one thing, there was an increased reliability in the product, which could be subjected to suitable quality assessment and assurance. This led to improved formulations, modifi­cations to drug availability and increased use of tablets whichhave agreater conveniencefor the patient.Some doctors did not agree with the loss of flexibility in prescribing which resulted from having to use prede­termined doses and combinations of materials. From the pharmacist’s point of view there was a reduction in the time spent in the routine extemporaneous pro­ductionof medicines, which manysaw as an advantage. Others saw it as a reduction in the mystique associated with the professional role of the pharmacist (see Ch. 2 for a more detailed discussion on the professional roles of pharmacists). There was also an erosion of the tech­nical skill baseof the pharmacist. A look throughcopies of the BPC in the 1950s, 1960s and 1970s will show the reduction in the number and diversity of formula­tions included in the Formulary section. That section has been omitted from the most recent editions.
Some extemporaneous dispensing is still required and pharmacists remain the only professionals trained in these skills. For this reason, Section 4 of this book deals with the types of medicine used, the ingredients employed in them and describes some of the practical skills required to make products suitable for use by patients.
The changing patterns of work of the pharmacist, in community pharmacy in particular, led to an uncer­tainty about the future role of the pharmacist and a general consensus that pharmacists were no longer
being utilized to their full potential. If the pharmacist was not required to compound medicines or to give general advice on diseases, what was the pharma­cist to do?

The extended role

The need to review the future for pharmacy was first formally recognized in 1979 in a report on the NHS which had the remit to consider the best use and management of its financial and manpower resources. This was followed by a succession of key reports and papers which repeatedly identified the need to exploit the pharmacists expertise and knowledge to better effect. Key among these reports was the Nuffield Report of 1986. This report, which included nearly 100 recommendations, led the wayto manynew initia­tives, both by the profession and by the government, and laid the foundation for the recent developments in the practice of pharmacy, which are reflected in this book.
Radical change, as recommended in the Nuffie ld Report, does not necessarily happen quickly, partic­ularly when regulations and statute are involved. In the23yearssinceNuffieldwaspublishedtherehave been several different agendas which have come together and between them facilitated the paradigm shift for pharmacy envisaged in the Nuffield Report. These agendas will be briefly described below. They have finally resulted in extensive professional change, most recently articulated in the definitive statements about the role of pharmacy in the NHS plans for pharmacy in England (2000), Scotland (2001) and Wales (2002) and the subsequent new contractual frameworks for community pharmacy. In addition other regulatory changes have occurred as part of government policy to increase convenient public access to a wider range of medicines on the NHS. These changes reflect general societal trends to deregulate the professions while having in place a framewo rk to ensure safe practice and a recognition that the public are increasingly well informed through widespread access to the Internet.
For pharmacy, therefore, two routes for the supply of prescription only medicines (POM) have opened up. Until recently POM medicines were only avail­able on the prescription of a doctor or dentist, but as a result of the Crown Review in 1999, two significant changes emerged. First, patient group directions (PGDs) were introduced in 2000. A PGD is a written direction for the supply, or supply and administration,
4
The role of pharmacy in health care CHAPTER 1
of a POM to persons generally by named groups of professionals. So, for example, under a PGD, com­munity pharmacists could supply a specific POM antibiotic to people with a confirmed diagnostic in­fection, e.g. azithromycin for Chlamydia.
Second, prescribing rights for pharmacists, along­side nurses and some other healthcare professionals, have been introduced, initially as supplementary pre­scribers and more recently as independent prescribers. To carry out these prescribing roles, pharmacists must have undertaken additional postgraduate training and be accredited by the Royal Pharmaceutical Society of Great Britain (RPSGB). It is anticipated that the train­ing will soon be routinely incorporated into undergrad­uate curricula.

The profession

The council of the RPSGB decided that it was necessary to allow all members to contribute to a radical appraisal of the profession, what it should be doing and how to achieve it. The ‘Pharmacy in a New Age’ consultation (familiarly referred to as PIANA) was launched in October 1995, with an invitation to all members to contribute their views to the council. These were combined into a subse­quent document produced by the council in September 1996 called Pharmacy in a New Age: The N ew Horizon. This indicated that there was overwhelming agreement from pharmacists that the profession could not stand still. Four main areas in which pharmacy should make a major contribu­tion to health outcomes were identified:
*
Management of prescribed medicines. This covers drug development, provision of medicines, information and support, and ensuring patient needs are met safely, efficiently and conveniently so that they can get maximum benefit from their medicines.
*
Management of chronic conditions. Here the need is to improve the quality of life and outcomes of treatment for the patient. Pharmacists may help by supplying medicines and advice, helping to develop local shared care protocols, ensuring that patients are taking or using their medicines properly and working as part of the healthcare team.
*
Management of common ailments. Patients require reassurance and advice, with or without the use of non-prescription medicines, and referral to other professionals if necessary.
*
Promotion and support of healthy lifestyles. Pharmacists can help people protect their own health through health screening, giving advice on healthy living and providing educational materials.
During the consultation process, pharmacists ex­pressed their views on the way the profession should change. These, too, may be summarized under four main headings:
*
The strengths of pharmacy. There was a high level of consensus that the knowledge base of pharmacy was very important. This is based on both the study of and experience with medicines and also in managing the medicines and handling relevant information. A second strength which was seen as important was pharmacistsavailability and accessibility in a wide range of different locations in the heart of the community, such as conventional high street premises, health centres, supermarkets, hospitals and in peoples homes. This accessibility is strengthened by easy communication with both patients and other professionals, giving pharmacists a pivotal position. The growth of information technology could be a potential threat to this, although pharmacists are noted for their adaptability.
*
Demonstrating the value of pharmacy. Pharmacy must claim its rights as a profession and accept the responsibilities which come with this. Thus high standards must be set and achieved. Additionally, evidence must be produced which demonstrates clearly the value of pharmacy in health care. This will require research and professional audit (see
Ch. 11). Further support for this development will
come from increased continuing education and recognition achieved by effective promotion of the profession.
*
Changes in practice. Three main areas where there could be an increase in services were identified. These are: the enhancement of services to patients (advice, counselling, domiciliary visits, health promotion and non­prescription medici ne sales); improved relationships with other healthcare professionals (closersupportforprescribers,medicine management, l iaison between hospital and community pharmacy and different communi ty pharmacists, training for other professionals and carers); and practice research and audit, continuing education and better use of information technology (all required to support the other developments). There was also a high
5
SECTION ONE Pharmacy practice and society
level of support for a reduction in the mechanical aspects of dispensing, sale of non-health-related products and routine paperwork associated with the NHS and business activities.
*
A sustainable future. These elements could make up a sustainable future for the profession. In particular, pharmacy would be concerned with advice and counselling, dispensing, health promotion, the sale of non-prescription medicines, medicines management and as a first port of call for health care. Some of these may require changes in the setting of pharmaceutical provision and others may require different types of employment for pharmacists. Other changes which would be required included changes to the system of payment under the NHS, a rationalization of pharmacy distribution and at least two pharmacists being employed per community pharmacy.
The main output of this professional review was a commitment to take forward a more proactive, patient centred clinical role for pharmacy using phar­macistsskills and knowledge to best effect.

The NHS drugs budget

Health services are expensive to run. Governments try to reduce expenditure as far as possible through a range of methods. In the UK some medicines have been identified as being ineligible for prescribing on the NHS. The so-called Black List was introduced in 1984 to reduce the size of the NHS bill. Furthermore the introduction of computer technology into pre­scription pricing has enabled far more data to be pro­duced than was previously possible. Doctors now receive a regular breakdown of the drugs they have prescribed and their prescribing costs. Chapter 18 considers the use of prescribing data (PACTor SPA) by pharmacists when advising doctors about reducing their prescribing costs.
However, despite these moves, and in common with other developed countries, UK drug costs are inexorably rising due to the greater availability of new effective treatments, patient demand and changes in patient demography (more older peo­ple). This has made many governments look at other ways of controlling this item of expenditure, and there are two ways in which pharmacists can have a role.
First, it is rec ognized that not all presc ribing follows the current best evidence for cost-effective practice. Pharmacists are seen as a profession with
the necessary knowledge to support quality in pre­scribing at a strategic and practice level. At a stra­tegic level they can appraise the evidence and make recommendations for the inclusion of a drug in a formulary. At a general practice level pharmacists can advise prescribers on the best drugs to pre­scribe for individual patients, and c ommunity phar­macists are well placed to monitor and review repeat prescriptions, which account for 80% of all prescriptions in primary care.
Second, in a move to promote self-care, pharma­cists can encourage patients to be r esponsible for their own health care and, by implication, remove the cost of treating what is known as minor illness from the NHS. Many drugs previously only av ail­able on prescription (POM) are now available over the counter from pharmacies (P) or from any retail outlet general sales list (GSL). All drugs are classi­fied into legal categories which restrict their supply in the interests of patient safety. The main catego­ries are: prescription only medicines (POM); phar­macy medicines (sale only under the supervision of a pharmacist; P); and general sales list (sale from any retail outlet including pharmacies; GSL; see Ch.
2). These changes have resulted in many potent
drugs now being available for sale from community pharmacies and the advisory r ole of the pharmacist has therefore been greatly enhanc ed. In 1983, ibu­profen and loperamide were the first of the many drugs to be deregulated in the following decades, and there is no obvious end to the process. Initially, deregulated drugs were for the management of con­ditions already diagnosed and treated by pharma­cists, such as dyspepsia, but where the choice of effective remedy was limited. Then deregulations became more focused on extending the licensed indications for P sale, such as the inclusion of eczema as an allowable indication for topical hydrocortisone. Most recently, deregulations have increasingly been for new drugs for newcondi­tions, such as emergency hormonal contraception and statins. Conversely, the two non-sedating anti­histamines terfenadine and astemizole are rare examples of the reclassification to POM because of the emergence of major safety concerns when these drugs were taken by increasing numbers of people. Terfenadine was subsequently removed to­tally from the UK market. Overall these moves have implications for the pharmacistsroleasafirstline provider of care for minor conditions, with a return to the traditional pre NHS advisory role including simple diagnosis and management.
6
The role of pharmacy in health care CHAPTER 1

The NHS workforce

As demand for health care grows, it is not only bud­gets that are stretched. Increasingly there are insuffi­cient trained professionals to deliver services, and innovative ways of working need to be introduced to maximize the skills of the different professionals in the healthcare team. This has resulted in a recognition that many of the tasks previously undertaken by the medical profession, in both primary and secondary care, can be undertaken by other professions such as pharmacists and nurses. Thus, some of the profession­al roles originally identified by the profession, such as the management of chronic disease and a greater role in responding to symptoms, are now supported by the wider healthcare community because they can con­tribute to more effective health care for the popula­tion. As a result a team approach to managing health care has emerged.

The current and future roles of pharmacists

There are currently around 46 000 registered UK member pharmacists, including those who are work­ing in different sectors of the profession as well as those who are in non-pharmacy-related posts or retired, both in Britain and overseas. The register is divided into practising and non-practising sections. There are 40 000 pharmacists on the practising register, of whom approximately 70% work in com­munity pharmacy, 20% in hospitals, 8% in primary care and 4% in the pharmaceutical industry. The next section will summarize the community, hospital and the other NHS roles as they are practised today, with indications of likely changes and challenges in the near future.
Community pharmacy
As a result of the final recognition of the pharmacists role beyond solely dispensing, new community pharmacy contractual frameworks were agreed for England and Wales, and for Scotland, in the early part of this century. In England and Wales, the contract is based on a list of essential services to be delivered from all NHS contracted pharmacies, and then an advanced service specification for specially accredited pharmacists operating from enhanced premises with
private consultation areas. At the time of writing the only advanced service is the medicines use review (MUR) and prescription intervention service. En­hanced services, which are negotiated locally with individual NHS primary care organizations, are also delivered. These are summarized in Box 1.1.In Scotland, the new contract is similar, but there is an emphasis on all pharmacists delivering all of the four core service areas: these are the acute medicines ser­vice (AMS), the chronic medicines service (CMS), the minor ailment service (MAS) and the public health service (PHS). More detail on these is provided in Box 1.2. In Northern Ireland, a new contract is proposed but is not yet delivered. However, which­ever contractual framework pharmacists are operating under,the following generic services will be delivered.
Dispensing, repeat dispensing and medication review
Despite the recent contractual recognition of new clinical roles, which are described later, dispensing remains a core role of community pharmacy and would still account for the majority of a pharmacists time. The preponderance of original pack dispensing means that, compared to even a decade ago, while the name may remain the same, the similarity ends there. The focus of dispensing now rests not only on accurate supply of medication but also on checking that the medication is appropriate for the patient and counsel­ling the patient on its appropriate use. All community pharmacists maintain computerized patient medica­tion records which are a record of previous prescrip­tions dispensed (see Chs 24 and 47). While not necessarily complete, since patients are not registered with an individual pharmacy, in practice the vast ma­jority of patients, particularly those on regular pre­scribed medication, do use one pharmacy for the majority of their supplies. Thus pharmacists have a database of information which will allow them to check on issues such as accuracy of the new prescrip­tion, compliance and potential drug interactions.
In the future the dispensing role will be further enhanced as connection of community pharmacy into the NHS net becomes a reality. Electronictransmission of prescriptions is currently being universally imple­mented in England and Scotland. Under this scheme, GPs will send prescriptions to a central cyberstore from which pharmacists can download the information using a unique identifier, and dispense the prescribed supplies or medications to the patient. Ultimately this electronic link shouldallow access by the pharmacist to
7
SECTION ONE Pharmacy practice and society
Box 1.1
Community pharmacy contractual framework (England & Wales), introduced 2005
Essential services Dispensing of prescribed medicine
Repeat dispensing Disposal of unwanted medicines/waste management
Public health Healthy lifestyle campaigns, prescription-linked healthy lifestyle interventions
Signposting Support for self-care E.g. advise on treatment of minor illness including OTC medicine sale, maintain records of
clinically significant products purchased
Clinical governance E.g. in relation to public and patient involvement, monitoring by NHS, participation in
clinical audit, undertaking risk management and supporting self and staff with education and professional development Appropriate use of information and compliance with statute such as the Data Protection Act 1998, the Human Right Act 1998, the NHS Code of Practice on Confidentiality, the Disability Discrimination Act 1995 and Health and Safety legislation Maintenance of patient medication records
Advanced services Medicines use review
A service initiated by either the pharmacist, the GP or the patient in which accredited pharmacists undertake structured concordance centred reviews with patients on multiple prescribed medicines. The aim is to help patients understand and comply with their treatment, identify problems if any, and provide a report to the patient and the GP
Enhanced services (locally negotiated) A wide range of services such as alcohol screening, anticoagulation monitoring, asthma,
care homes, care staff, controlled drugs, record cards, chronic obstructive pulmonary disease, databases, emergency hormonal contraception, gluten-free foods, Helicobacter pylori testing, minor ailments, needle and syringe exchange, needle collection, not dispensed scheme, out of hours, palliative care, Parkinsons disease, phlebotomy, point of care testing, prescription intervention, quality and outcomes framework, seasonal influenza, sexual health, smoking cessation, supervised administration (e.g. of methadone), vascular risk assessment, weight management and obesity
at least a selected portion of the patients medical record, further enhancing the pharmacist’s ability to assess the appropriateness of the prescription. It is hoped that there will also be a facility for pharmacists to write to the patient record, so that GPs will know whether or not prescriptions have been dispensed and what OTC drugs have been purchased.
A further enhanced dispensing role is in the man­agement of repeat prescriptions, which until recently have been issued from GP surgeries with little clinical review. Following research projects which demon­strated that when given this responsibility, communi­ty pharmacists could identify previously unrecognized side-effects, adverse drug reactions and drug interac­tions, as well as saving almost a fifth of the costs of the drugs prescribed, this repeat dispensing service is
8
now part of the new community pharmacy contract (see Boxes 1.1 and 1.2).
This opportunistic clinical input at the point of dispensing is also being developed in a more system­atic way, such that patients with targeted chronic conditions, such as coronary heart disease, have for­mal regular reviews with the community pharmacist about their medication and other disease-related behaviours. Again schemes like this, with research evidence of benefit in small studies, are currently undergoing national implementation through the new contractual frameworks. Such services, called medicines management (see Ch. 17), medicines use review (MUR) or chronic medicines services (CMS), are part of a more holistic approach often referred to as pharmaceutical care. Supplementary