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Freedom to Prescribe v The Formulary

Published on 24/10/06 at 12:12pm

The modern concept of a formulary embraces three basic principles: first, it is a limited list of treatments chosen from those theoretically available; second, the choices are made with a view to clinical effectiveness and value for money, and finally, the establishment, review and implementation of a formulary usually operate as a function of the management structures of the organisation to which it relates. However, it hasn't always been so and there has been a long evolution along the road to establishing this pattern.

The birth of formularies

For hundreds of years, drugs were dispensed by individual doctors or pharmacies (and apothecaries), but the quality of these early pharmaceutical items was highly questionable since there was no systematic way of ensuring purity or constancy of dosage. At the same time, there was no formal separation of quackery from legitimate prescribing, which made taking medicines a very risky business for patients.

Even laudanum (an opium-derived preparation), widely available over the counter in the late 19th century, could vary in strength. One of its common uses was to calm babies, especially those who were starving, and no doubt many died if not from malnutrition, then from inadvertent overdose.

In the early 20th century, new pharmacopoeias were developed. These specified the chemical content of drugs and often offered advice on use. This provided prescribers with reliable information on the drugs they might use and the effects these drugs might have, but there was one problem with these tomes - their weight. They were heavy volumes with a content no one could ever absorb, and in any case, most doctors would find the detailed content completely unintelligible.

At the same time as hospital services became more organized and newer therapeutic agents created a compelling case for use, there was a need to have some logic around stock control, and thus formularies were born. The first formularies were little more than stock lists, and while doctors could choose to prescribe what they wanted, if it wasn't on the shelf, the patient could not get it.

Immediately, there was a potential tension between what doctors might want and what was being stocked. In those pre-NHS times, there was often an uncontested deference to the views of doctors, so in practice, they would often get their own way. Pharmacy as a profession was still rudimentary in terms of looking at therapeutics, rather than simply the acquisition and dispensing of medicines. Public health took little interest in the immediate patient focus of clinical medicine and managers, such as there were (often a group of local worthies sitting on the board of management), were ill-equipped and hardly motivated to confront the wishes of their honorary consultants.

The BNF  an anachronism?

During the 1930s, companies providing private insurance developed their own preferred list of products, based, perhaps, on cost more than anything, and with the outbreak of World War II, these were amalgamated into the National (War) Formulary. It was hardly surprising the post-war Labour government built upon the idea to produce the British National Formulary to coincide with the inception of the NHS.

That could have been the end of formularies and prescribing decision-making. A centralised state collectivist health service had a centralised state collectivist prescribing formulary. All NHS prescribing would be solely from the BNF, and some proto-NICE body would decide what was in and what was not as new products came on line but, in fact, it didn't come about.

Had this happened, pharma would look very different today (some of us might say better). The whole marketing and sales side would be much smaller and focused on national negotiations - drug acquisition would probably have taken on many of the features of defence procurement, with decisions on available drugs being reached in much the same way as those made by the government for whichever fighter aircraft, warships or rifles it chooses to order.

There were three factors that prevented this. As part of the negotiations with the BMA, doctors were promised freedom to prescribe without having to adhere to the BNF - a freedom still enjoyed by NHS GPs today. New drugs and products continued to become available, and these were taken up by clinicians based on marketing by pharma and on dissemination of information through the scientific literature. Finally, during its first 30 years, the BNF atrophied, becoming so out of date as to be almost anachronistic, with prescribing developing as though the BNF hardly existed. In 1981, the BNF was updated to include all licensed medicines (and a few that weren't). It showed little selectivity in the advice it offered on choice of therapy so, on the two key criteria for a useful formulary, identifying the best treatments and advising on cost-effective choices, an obsolete publication had been replaced by one which was both up-to-date yet completely irrelevant.

The cost of chaos

By the time the new BNF appeared, there were already major issues around prescribing quality and prescribing costs. Especially in GI and cardiac medicine, there were many newer, more expensive agents and a pressure-to-use based not only on patient benefit, but also on reduced risk of more expensive consequences.

The first example was probably H2 antagonists to reduce life-threatening complications and the need for surgery in peptic ulcer disease. There was an increasing case for identifying and treating hypertension, and the inhaled steroids revolutionised asthma care, but with associated costs.

With no effective cost controls in either hospital or GP prescribing, there was a frightening increase in prescribing costs. The only sanction against GPs was visits from the divisional medical officer of the Department of Health who might flag up particular items of extreme cost, but could do little more. Hospitals retained the stock list effect and were becoming far less compliant with doctors' orders, not least because the pharmacy profession in hospital (at least) was acquiring a well-deserved reputation as a repository of best prescribing advice.

Increasingly in hospital medicine, doctors would have to argue their case if they wanted a drug not currently stocked, usually through a drugs and therapeutics committee, which became keeper of a de facto formulary.

Primary care prescribing had no such constraints and there was scant motivation for change until the 1990 GP contract and the advent of fundholding. All practices were given Indicative Prescribing Budgets and for the fundholders, these were real as savings made could be reinvested in other aspects of patient care and potentially (though not admitted at the time), could boost GPs' incomes, too.

At the same time, prescribing information derived from the Prescription Pricing Authority (PACT) offered extremely detailed analysis of prescribing, so potential changes could be easily identified. Practices and larger healthcare groupings rushed to develop local formularies based chiefly on cost-effectiveness.

What goes up . . .

The early 1990s were happy times. A new structure of prescribing advisers (Independent Medical Advisers) was established within the FHSAs (Family Health Service Authorities), while new cash-limited budgets for hospitals drove similar internal reforms in secondary care. The results, in cost terms, had the potential to be dazzling.

The softest target was generic substitution. Merely spelling a name differently could save millions. New, naive and over-inflated by the results, fundholding practices expanded their premises and set on acquiring new staff on the back of massive savings on their prescribing budget. For the first time, proper doctors (later it would usually be proper pharmacists) visited practices to review their prescribing and offer advice.

Besides the soft options of generic prescribing, there were also many older (usually) products of dubious efficacy and with little up-to-date evidence base, which practitioners were encouraged to drop. Vasodilators for peripheral vascular disease were probably the biggest victims of this policy.

These changes required internal discipline to ensure prescribing policies were followed, especially by new prescribers, so hospitals and practices developed their own formularies or adapted off the peg versions widely available from elsewhere.

. . . must come down

After the quick wins came the losses. Once the quick wins were done, they were done  with typical prescribing patterns, leaving scant fat from which any more could be trimmed. At the same time, there were greater pressures to increase prescribing costs as a result of evidence-based medicine, inevitably with much support from pharma. Sometimes, this involved new classes of drugs, such as the ACE inhibitors in heart failure, but often it simply identified unmet need and optimised care with higher prescribing volume, higher dosing and greater polypharmacy.

This all occurred against a background of a central government which was refusing to acknowledge the reality of some form of rationing and was answering any questions of funding by saying local health authorities had the resources and the responsibility to provide local health services. The inevitable result was that local health managers struggled as best they could, but often struggled in different ways  hence postcode prescribing.

Despite the cost-pressures, this was a good time for pharma in many ways. It could engage with general practices and the wider local health communities to provide services which the NHS could not directly afford but which ultimately reaped benefits in sales through case-finding and optimised care. Examples included providing echocardiography to identify heart failure and hoardes (or so it seemed) of pharma-funded nurses who would carry out clinical audit and sometimes patient reviews, almost always with a great net increase in sales being the main outcome. Ironically perhaps, given the intuitive antagonism to formularies, pharma might feel these initiatives often kick-started practice-based formulary development.

Meanwhile, national negotiations on pricing and profits (the PPRS) prevented too much grief for the industry, but left local commissioners of health services most vulnerable. Headline cases, such as policies on funding beta interferon for multiple sclerosis, gave much grief to local NHS managers and embarrassed central government. It was obvious local managers could not consistently decide which drugs were in the local formulary and which weren't.

The third hurdle

There was now a growing consensus within the NHS that a third hurdle was needed beyond the criteria for licensing, which would both encompass cost-effectiveness and acknowledge how new treatments would fit in with overall NHS funding and NHS costs, and, in addition, could assess how they would compare with other competitive areas also demanding funding.

By the turn of the century, most of these arguments had become secondary care questions around high-cost, low-volume drugs, which did not cure. Primary care went relatively quiet, although new drugs for obesity and the management of the metabolic syndrome will no doubt rekindle issues about primary care formularies in the future.

This third hurdle, which New Labour offered to the NHS, was NICE. This was certainly not what most NHS managers, prescribing advisers, public health doctors or probably pharma wanted, given its slow quasi-judicial means of working. A contracted-out advisory body, perhaps based on a consortia of universities which bids to take on the job, would have suited most NHS managers better, and ironically, would have been more in the spirit of New Labours  approach to commissioning services.

Having said that, at least NICE guidance has reduced the most glaring discrepancies in decisions on what to include in formularies. Hospitals still have the stock list as the bottom line for formulary adherence and will often impose conditions on new drugs being approved, only to be later initiated by certain consultants.

This can lead to some bizarre results. In the early days of long-acting beta-2s for asthma, many local GPs started prescribing (clearly a decision vindicated by national guidelines), but none was available on the hospital formulary - apparently because no one had thought to ask and the key committee members didn't talk to local industry reps, who could have prevented this nonsense.

Freedom to prescribe

The right of GPs to prescribe freely has acted as a major driver for innovation and a central skill is to recognise and manage the exceptional case where standard advice - as in the formulary - should not be followed. With a greater proportion of GPs being salaried, they may be forced, or may simply choose, to do what it says in the formulary. Increasing talk of co-payments within the NHS, and patients funding their own drugs when their PCO won't, could lead to a new two-tier prescribing system as applies in much insurance-funded healthcare overseas.

Formularies have helped make prescribing more efficient with more effective treatments becoming available to more people. They have also made prescribing safer by ensuring greater familiarity with the items included. The pharmaceutical industry has made a significant contribution to this process, not only through local influence, but also through supporting the large trials which have formed the basis of so much current evidence-based practice.

Have formularies been good for the industry? By ensuring more independent assessment of the value of drugs and supporting the greater use of better drugs, the answer is a qualified yes. But if formularies upset you, maybe you need a different product portfolio.

 

Dr Stephen Head is a GP practising in Derbyshire and medical editor of Pharmafocus.

 

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