Ibuprofen and the fertile imagination

There is an astounding variety of painkillers available for purchase both in supermarkets, chemists, and corner shops. Just take a look at the shelf of your nearest Tesco or Sainsbury. You have various types of paracetamol, both made by pharmaceutical companies as well as in house versions of the supermarkets.

What is the difference between them and why are there so many varieties?

When pharmaceutical companies take on the decision to manufacture a new drug, they are given a twenty-year patent which covers the research into the product, testing and manufacturing, and sales. The period of twenty years, a monopoly as such, is to reward them for the time invested into the research. In the course of the research into the product, pharmaceutical companies must publish various forms of medical evidence and put it into public domain, so that if there is any medical evidence that points to the contrary, these can be debated both by the medical community and the pharmaceutical world.

The problem, if we can call it that, is that business is a very competitive world, and if research is put out in the open without any form of intellectual protection, any manufacturer can pounce on the research undertaken by someone else who has taken the effort and trouble to do it, and produce their product off the back of it. They would have saved the time and cost investment.

Imagine if a writer has taken the time to research a topic, organise his thoughts succinctly, and find a publisher. And when his book is published, someone else photocopies it, binds the copied pages and subsequently peddles it as their own.

Within the period of twenty years, a pharmaceutical company has to research, market and sell enough of the product to recoup the investment costs and profit. It is after the twenty period has expired that the other sharks enter the fray. This is where you get the supermarket brands of the product, which are cheaper because they don’t need to pay for research.

What is the difference between brand names and generics? They essentially do the same thing. But if the original company has done a good job in making the product synonymous with its own brand, then you might think they are better. If you take Neurofen for headaches, then you might think it better than Tesco ibuprofen, even though they both contain the same active ingredient.

But pharmaceutical companies have to reinvent themselves, to make varieties of the same product, otherwise they will lose their market share and eventually die out. If you realise that Neurofen is matched in ability by the cheaper Tesco ibuprofen, you would buy the latter, unless you are persuaded that Neurofen for Flus and Colds, or Neurofen Muscle Pain has something clinically formulated for that specific purpose.

So the shelves of supermarkets are stacked with different priced products with the same active ingredient, as well as different varieties of the same product.

Painkillers are a common medicine because there will always be a demand for pain management.

The availability of pain relief medicine means it is easy for the average individual to obtain them. There is the possibility of overdose, and while this may be a rarity, there is a higher likelihood that the greater availability may mean individuals are taking more doses than they should.

What are the long term health impacts of taking ibuprofen for prolonged periods?

One problem is that the body adapts and so the long-term resistance is affected. In certain groups such as the elderly, aspirin also increased the risks of stomach bleeding.

A clinical trial seemed to suggest it may impact on testosterone production and hence affect fertility.

Test subjects were administered 2 x 600mg doses of ibuprofen daily for six weeks, much higher than the average dose. The sample size was only a small group of 30, and half received ibuprofen, while the others received a placebo. It would have been better if the subject group had been greater, so that there could be more confidence in the test results, but because a test of such nature is to examine human resistance to what is essentially toxicity, it would have been unethical to involve a large group of participants. The research findings found that there was no impact on testosterone already in the body, but the pain relieving nature of ibuprofen, as a relaxant of sorts, had impact on the production of testosterone and appeared to slow down production.

How did these reports end up in the media? The tabloids had a field day, and you would undoubtedly have found one with the usual wisecracks about balls and other man-related genitalia, along the lines of “Ibuprofen shrinks your balls” or “Ibuprofen smalls your balls”.

Maybe instead of Ibuprofen for colds or fast relief, we need Ibuprofen for Dummies.

A short history of non-medical prescribing

It had long been recognised that nurses spent a significant amount of time visiting general practitioner (GP) surgeries and/ or waiting to see the doctor in order to get a prescription for their patients. Although this practice produced the desired result of a prescription being written, it was not an efficient use of either the nurses’or the GPs’time. Furthermore, it was an equally inefficient use of their skills, exacerbated by the fact that the nurse had usually themselves assessed and diagnosed the patient and decided on an appropriate treatment plan.

The situation was formally acknowledged in the Cumberlege Report (Department of Health and Social Security 1986), which initiated the call for nurse prescribing and recommended that community nurses should be able to prescribe from a limited list, or formulary. Progress was somewhat measured, but The Crown Report of 1989 (Department of Health (DH) 1989) considered the implications of nurse prescribing and recommended suitably qualified registered nurses (district nurses (DN) or health visitors (HV)) should be authorised to prescribe from a limited list, namely, the nurse prescribers’formulary (NPF). Although a case for nurse prescribing had been established, progress relied on legislative changes to permit nurses to prescribe.

Progress continued to be cautious with the decision made to pilot nurse prescribing in eight demonstration sites in eight NHS regions. In 1999, The Crown Report II (DH 1999) reviewed more widely the prescribing, supply and administration of medicines and, in recognition of the success of the nurse prescribing pilots, recommended that prescribing rights be extended to include other groups of nurses and health professionals. By 2001, DNs and HVs had completed education programmes through which they gained V100 prescribing status, enabling them to prescribe from the NPF. The progress being made in prescribing reflected the reforms highlighted in The NHS Plan (DH 2000), which called for changes in the delivery of healthcare throughout the NHS, with nurses, pharmacists and allied health professionals being among those professionals vital to its success.

The publication of Investment and Reform for NHS Staff –Taking Forward the NHS Plan (DH 2001) stated clearly that working in new ways was essential to the successful delivery of the changes. One of these new ways of working was to give specified health professionals the authority to prescribe, building on the original proposals of The Crown Report (DH 1999). Indeed, The NHS Plan (DH 2000) endorsed this recommendation and envisaged that, by 2004, most nurses should be able to prescribe medicines (either independently or supplementary) or supply medicines under patient group directions (PGDs) (DH 2004). After consultation in 2000, on the potential to extend nurse prescribing, changes were made to the Health and Social Care Act 2001.

The then Health Minister, Lord Philip Hunt, provided detail when he announced that nurse prescribing was to include further groups of nurses. He also detailed that the NPF was to be extended to enable independent nurse prescribers to prescribe all general sales list and pharmacy medicines prescribable by doctors under the NHS. This was together with a list of prescription-only medicines (POMs) for specified medical conditions within the areas of minor illness, minor injury, health promotion and palliative care. In November 2002, proposals were announced by Lord Hunt, concerning ‘supplementary’prescribing (DH 2002).

The proposals were to enable nurses and pharmacists to prescribe for chronic illness management using clinical management plans. The success of these developments prompted further regulation changes, enabling specified allied health professionals to train and qualify as supplementary prescribers (DH 2005). From May 2006, the nurse prescribers’extended formulary was discontinued, and qualified nurse independent prescribers (formerly known as extended formulary nurse prescribers) were able to prescribe any licensed medicine for any medical condition within their competence, including some controlled drugs.

Further legislative changes allowed pharmacists to train as independent prescribers (DH 2006) with optometrists gaining independent prescribing rights in 2007. The momentum of non-medical prescribing continued, with 2009 seeing a scoping project of allied health professional prescribing, recommending the extension of prescribing to other professional groups within the allied health professions and the introduction of independent prescribing for existing allied health professional supplementary prescribing groups, particularly physiotherapists and podiatrists (DH 2009).

In 2013, legislative changes enabled independent prescribing for physiotherapists and podiatrists. As the benefits of non-medical prescribing are demonstrated in the everyday practice of different professional groups, the potential to expand this continues, with consultation currently under way to consider the potential for enabling other disciplines to prescribe.

The financial considerations of investing in medicine and medical research

BBC News reports that a drug that would reduce the risk of HIV infection would result in cost savings of over £1bn over 80 years. Pre-exposure prophylaxis, or Prep, would reduce infection and hence lower the treatment costs for patients in the long term.

The catch? There is one. It’s the long term.

The cost of the treatment and prevention is such that its provision for the first twenty years – bundling together the cost of medical research and production of medicine – would result in a financial loss, and parity would only be achieved after a period of about thirty to forty years; this period is hard to define because it is dependent on what the drug would cost in the future.

Prep combines two anti-HIV drugs, emtricitabine and tenofovir. The medical trials behind it have concluded it has an effective rate of over one in five when it comes to protecting men who have unprotected sex with men from HIV infection. The exact figure is close to 86%.

Prep can be used either on a daily basis, or on what has been termed a sexual event basis – using it for two days before, during and after periods of unprotected sex.

The research model analysed the potential impact of Prep and found that it could reduce infection rates by over a quarter. The cost of the treatment itself, comparative to the cost of treating infection, would result in a saving over one billion pounds over eight years.

However, it does raise a few ethical questions. If the National Health Service is aiming to be a sustainable one – and one of the aims of sustainability is to empower citizens to take responsibility for their own health –  shouldn’t it be considering less about how it will balance the books, but spend more on education for prevention in the first place? The cost of producing Prep on the NHS would be £19.6 billion over 80 years; while the estimated savings from treatment would be £20.6 billion over the same period. Educating people not to have unprotected sex with those at the risk of HIV arguably would result in a higher saving over a lower time period. Perhaps the NHS should consider ways of reducing cost more significantly, rather than latching on to a cheaper prevention drug immediately. If consumer behaviour is not going to change, symptoms are still going to surface, and the provision of Prep on the NHS may only encourage less self-regulation and awareness.

Media’s Marvellous Medicine

When it comes to our health, the media wields enormous influence over what we think. They tell us what’s good, what’s bad, what’s right and wrong, what we should and shouldn’t eat. When you think about it, that’s quite some responsibility. But do you really think that a sense of philanthropic duty is the driving force behind most of the health ‘news’ stories that you read? Who are we kidding? It’s all about sales, of course, and all too often that means the science plays second fiddle. Who wants boring old science getting in the way of a sensation-making headline?

When it comes to research – especially the parts we’re interested in, namely food, diet and nutrients – there’s a snag. The thing is, these matters are rarely, if ever, clear-cut. Let’s say there are findings from some new research that suggest a component of our diet is good for our health. Now academics and scientists are generally a pretty cautious bunch – they respect the limitations of their work and don’t stretch their conclusions beyond their actual findings. Not that you’ll think this when you hear about it in the media. News headlines are in your face and hard hitting. Fluffy uncertainties just won’t cut it. An attention-grabbing headline is mandatory; relevance to the research is optional. Throw in a few random quotes from experts – as the author Peter McWilliams stated, the problem with ‘experts’ is you can always find one ‘who will say something hopelessly hopeless about anything’ – and boom! You’ve got the formula for some seriously media-friendly scientific sex appeal, or as we prefer to call it, ‘textual garbage’. The reality is that a lot of the very good research into diet and health ends up lost in translation. Somewhere between its publication in a respected scientific journal and the moment it enters our brains via the media, the message gets a tweak here, a twist there and a dash of sensationalism thrown in for good measure, which leaves us floundering in a sea of half-truths and misinformation. Most of it should come with the warning: ‘does nothing like it says in the print’. Don’t get us wrong: we’re not just talking about newspapers and magazines here, the problem runs much deeper. Even the so-called nutrition ‘experts’, the health gurus who sell books by the millions, are implicated. We’re saturated in health misinformation.

Quite frankly, many of us are sick of this contagion of nutritional nonsense. So, before launching headlong into the rest of the book, take a step back and see how research is actually conducted, what it all means and what to watch out for when the media deliver their less-than-perfect messages. Get your head around these and you’ll probably be able to make more sense of nutritional research than most of our cherished health ‘gurus’.

Rule #1: Humans are different from cells in a test tube
At the very basic level, researchers use in-vitro testing, in which they isolate cells or tissues of interest and study them outside a living organism in a kind of ‘chemical soup’. This allows substances of interest (for example, a vitamin or a component of food) to be added to the soup to see what happens. So they might, for example, add vitamin C to some cancer cells and observe its effect. We’re stating the obvious now when we say that what happens here is NOT the same as what happens inside human beings. First, the substance is added directly to the cells, so they are often exposed to concentrations far higher than would normally be seen in the body. Second, humans are highly complex organisms, with intricately interwoven systems of almost infinite processes and reactions. What goes on within a few cells in a test tube or Petri dish is a far cry from what would happen in the body. This type of research is an important part of science, but scientists know its place in the pecking order – as an indispensable starting point of scientific research. It can give us valuable clues about how stuff works deep inside us, what we might call the mechanisms, before going on to be more rigorously tested in animals, and ultimately, humans. But that’s all it is, a starting point.

Rule #2: Humans are different from animals
The next logical step usually involves animal testing. Studying the effects of a dietary component in a living organism, not just a bunch of cells, is a big step closer to what might happen in humans. Mice are often used, due to convenience, consistency, a short lifespan, fast reproduction rates and a closely shared genome and biology to humans. In fact, some pretty amazing stuff has been shown in mice. We can manipulate a hormone and extend life by as much as 30%1. We can increase muscle mass by 60% in two weeks. And we have shown that certain mice can even regrow damaged tissues and organs.

So, can we achieve all of that in humans? The answer is a big ‘no’ (unless you happen to believe the X-Men are real). Animal testing might be a move up from test tubes in the credibility ratings, but it’s still a long stretch from what happens in humans. You’d be pretty foolish to make a lot of wild claims based on animal studies alone.

To prove that, all we need to do is take a look at pharmaceutical drugs. Vast sums of money (we’re talking hundreds of millions) are spent trying to get a single drug to market. But the success rate is low. Of all the drugs that pass in-vitro and animal testing to make it into human testing, only 11% will prove to be safe and effective enough to hit the shelves5. For cancer drugs the rate of success is only 5%5. In 2003, the President of Research and Development at pharmaceutical giant Pfizer, John La Mattina, stated that ‘only one in 25 early candidates survives to become a prescribed medicine’. You don’t need to be a betting person to see these are seriously slim odds.

Strip it down and we can say that this sort of pre-clinical testing never, ever, constitutes evidence that a substance is safe and effective. These are research tools to try and find the best candidates to improve our health, which can then be rigorously tested for efficacy in humans. Alas, the media and our nutrition gurus don’t appear to care too much for this. Taking research carried out in labs and extrapolating the results to humans sounds like a lot more fun. In fact, it’s the very stuff of many a hard-hitting newspaper headline and bestselling health book. To put all of this into context, let’s take just one example of a classic media misinterpretation, and you’ll see what we mean.

Rule #3: Treat headlines with scepticism
Haven’t you heard? The humble curry is right up there in the oncology arsenal – a culinary delight capable of curing the big ‘C’. At least that’s what the papers have been telling us. ‘The Spice Of Life! Curry Fights Cancer’ decreed the New York Daily News. ‘How curry can help keep cancer at bay’ and ‘Curry is a “cure for cancer”’ reported the Daily Mail and The Sun in the UK. Could we be witnessing the medical breakthrough of the decade? Best we take a closer look at the actual science behind the headlines.

The spice turmeric, which gives some Indian dishes a distinctive yellow colour, contains relatively large quantities of curcumin, which has purported benefit in Alzheimer’s disease, infections, liver disease, inflammatory conditions and cancer. Impressive stuff. But there’s a hitch when it comes to curcumin. It has what is known as ‘poor bioavailability’. What that means is, even if you take large doses of curcumin, only tiny amounts of it get into your body, and what does get in is got rid of quickly. From a curry, the amount absorbed is so miniscule that it is not even detectable in the body.

So what were those sensational headlines all about? If you had the time to track down the academic papers being referred to, you would see it was all early stage research. Two of the articles were actually referring to in-vitro studies (basically, tipping some curcumin onto cancer cells in a dish and seeing what effect it had).

Suffice to say, this is hardly the same as what happens when you eat a curry. The other article referred to an animal study, where mice with breast cancer were given a diet containing curcumin. Even allowing for the obvious differences between mice and humans, surely that was better evidence? The mice ate curcumin-containing food and absorbed enough for it to have a beneficial effect on their cancer. Sounds promising, until we see the mice had a diet that was 2% curcumin by weight. With the average person eating just over 2kg of food a day, 2% is a hefty 40g of curcumin. Then there’s the issue that the curcumin content of the average curry/turmeric powder used in curry is a mere 2%. Now, whoever’s out there conjuring up a curry containing 2kg of curry powder, please don’t invite us over for dinner anytime soon.

This isn’t a criticism of the science. Curcumin is a highly bio-active plant compound that could possibly be formulated into an effective medical treatment one day. This is exactly why these initial stages of research are being conducted. But take this basic stage science and start translating it into public health advice and you can easily come up with some far-fetched conclusions. Let us proffer our own equally absurd headline: ‘Curry is a Cause of Cancer’. Abiding by the same rules of reporting used by the media, we’ve taken the same type of in-vitro and animal-testing evidence and conjured up a completely different headline. We can do this because some studies of curcumin have found that it actually causes damage to our DNA, and in so doing could potentially induce cancer.

As well as this, concerns about diarrhoea, anaemia and interactions with drug-metabolizing enzymes have also been raised. You see how easy it is to pick the bits you want in order to make your headline? Unfortunately, the problem is much bigger than just curcumin. It could just as easily be resveratrol from red wine, omega-3 from flaxseeds, or any number of other components of foods you care to mention that make headline news.

It’s rare to pick up a newspaper or nutrition book without seeing some new ‘superfood’ or nutritional supplement being promoted on the basis of less than rigorous evidence. The net result of this shambles is that the real science gets sucked into the media vortex and spat out in a mishmash of dumbed-down soundbites, while the nutritional messages we really should be taking more seriously get lost in a kaleidoscope of pseudoscientific claptrap, peddled by a media with about as much authority to advise on health as the owner of the local pâtisserie.

Rule #4: Know the difference between association and causation
If nothing else, we hope we have shown that jumping to conclusions based on laboratory experiments is unscientific, and probably won’t benefit your long-term health. To acquire proof, we need to carry out research that involves actual humans, and this is where one of the greatest crimes against scientific research is committed in the name of a good story, or to sell a product.

A lot of nutritional research comes in the form of epidemiological studies. These involve looking at populations of people and observing how much disease they get and seeing if it can be linked to a risk factor (for example, smoking) or some protective factor (for example, eating fruit and veggies). And one of the most spectacular ways to manipulate the scientific literature is to blur the boundary between ‘association’ and ‘causation’. This might all sound very academic, but it’s actually pretty simple.

Confusing association with causation means you can easily arrive at the wrong conclusion. For example, a far higher percentage of visually impaired people have Labradors compared to the rest of the population, so you might jump to the conclusion that Labradors cause sight problems. Of course we know better, that if you are visually impaired then you will probably have a Labrador as a guide dog. To think otherwise is ridiculous.

But apply the same scenario to the complex human body and it is not always so transparent. Consequently, much of the debate about diet and nutrition is of the ‘chicken versus egg’ variety. Is a low or high amount of a nutrient a cause of a disease, a consequence of the disease, or simply irrelevant?

To try and limit this confusion, researchers often use what’s known as a cohort study. Say you’re interested in studying the effects of diet on cancer risk. You’d begin by taking a large population that are free of the disease at the outset and collect detailed data on their diet. You’d then follow this population over time, let’s say ten years, and see how many people were diagnosed with cancer during this period. You could then start to analyse the relationship between people’s diet and their risk of cancer, and ask a whole lot of interesting questions. Did people who ate a lot of fruit and veggies have less cancer? Did eating a lot of red meat increase cancer? What effect did drinking alcohol have on cancer risk? And so on.

The European Prospective Investigation into Cancer and Nutrition (EPIC), which we refer to often in this book, is an example of a powerfully designed cohort study, involving more than half a million people in ten countries. These studies are a gold mine of useful information because they help us piece together dietary factors that could influence our risk of disease.

But, however big and impressive these studies are, they’re still observational. As such they can only show us associations, they cannot prove causality. So if we’re not careful about the way we interpret this kind of research, we run the risk of drawing some whacky conclusions, just like we did with the Labradors. Let’s get back to some more news headlines, like this one we spotted: ‘Every hour per day watching TV increases risk of heart disease death by a fifth’.

When it comes to observational studies, you have to ask whether the association makes sense. Does it have ‘biological plausibility’? Are there harmful rays coming from the TV that damage our arteries or is it that the more time we spend on the couch watching TV, the less time we spend being active and improving our heart health. The latter is true, of course, and there’s an ‘association’ between TV watching and heart disease, not ‘causation’.

So even with cohorts, the champions of the epidemiological studies, we can’t prove causation, and that’s all down to what’s called ‘confounding’. This means there could be another variable at play that causes the disease being studied, at the same time as being associated with the risk factor being investigated. In our example, it’s the lack of physical activity that increases heart disease and is also linked to watching more TV.

This issue of confounding variables is just about the biggest banana skin of the lot. Time and time again you’ll find nutritional advice promoted on the basis of the findings of observational studies, as though this type of research gives us stone cold facts. It doesn’t. Any scientist will tell you that. This type of research is extremely useful for generating hypotheses, but it can’t prove them.

Rule #5: Be on the lookout for RCTs (randomized controlled trials)
An epidemiological study can only form a hypothesis, and when it offers up some encouraging findings, these then need to be tested in what’s known as an intervention, or clinical, trial before we can talk about causality. Intervention trials aim to test the hypothesis by taking a population that are as similar to each other as possible, testing an intervention on a proportion of them over a period of time and observing how it influences your measured outcome.

The role of pharmacy in healthcare

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 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 more recently introduced 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 (see Ch. 49), 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.

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 physicians’fees. 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 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 ‘recipes’from formularies such as the British Pharmacopoeia (BP) or British Pharmaceutical Codex (BPC), or following individual recipes written by the prescriber (see Ch. 30). 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 (see Chs 32–39). 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 which have a greater convenience for 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 production of medicines, which many saw as an advantage. Others saw it as a reduction in the mystique associated with the professional role of the pharmacist. There was also an erosion of the technical skill base of the pharmacist. A look through copies 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. However, some extemporaneous dispensing is still required and pharmacists remain the only professionals trained in these skills.

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 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 pharmacist’s 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 way to many new 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 Nuffield Report, does not necessarily happen quickly, particularly when regulations and statute are involved. In the 28 years since Nuffield was published, there have 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, 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 (see Ch. 4). These changes reflect general societal trends to deregulate the professions while having in place a framework 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, 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.

The council of the Royal Pharmaceutical Society of Great Britain (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 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 New Horizon. This indicated that there was overwhelming agreement from pharmacists that the profession could not stand still.

The main output of this professional review was a commitment to take forward a more proactive, patient-centred clinical role for pharmacy using pharmacists’ skills and knowledge to best effect.