Five hot topics - current issues of importance in pharmacy - were discussed on September 15. The parallel sessions examined emergency contraception, medicinal use of cannabis, clinical freedom, pharmacist prescribing and NHS fraud
One of the hot topics discussed during the British Pharmaceutical Conference was "Emergency contraception - should pharmacists get involved?". Even before the discussion had started, there was widespread consensus among the audience, which included Mr John D'Arcy (National Pharmaceutical Association director) and Mr Brian Hartley (ex-chief pharmacist at the Department of Health), that the answer was definitely "yes". A lively discussion emerged about how pharmacist involvement might be achieved in practice.
Mrs PAT HOARE (who was in the chair) asked for a show of hands in order to establish what the audience's opinion was, and to determine whether anybody had changed their view as a result of the discussion. Only four delegates voted against pharmacist involvement in prescribing the "morning after pill".
Mr ROGER ODD (head of professional and scientific support, Royal Pharmaceutical Society) told the audience a story of a young girl who had come to him when he was working in a community pharmacy. She was obviously distressed and did not know what to do, he said. After the girl had told him her story, his eye fell on the packs of emergency contraception behind him. Despite the fact that he knew exactly what the girl wanted and needed, he had no choice but to send her away. Mr Odd later found out that she had gone home and taken an overdose of paracetamol. "It has really hit me quite seriously that I had actually not done my duty to help this girl, despite the fact that I had done nothing wrong," he said.
Background
In his presentation, which was to provide a basis for the discussion, Mr Odd pointed out that it had not been the Society which had initiated the debate about pharmacist prescribing and selling of emergency contraception. The Society had been approached by the Royal College of Gynaecologists and patient groups as far back as 1985. The Society considered a POM to P switch to be the preferred option and protocols were drawn up accordingly. However, these had never been published because the debate was not taken any further, largely because of concerns by the product licence holders over litigation.
Mr Odd also tried to clarify a few myths and legends surrounding emergency contraception. He reminded the audience that this was not a new topic. He repeated the firm belief among the medical profession that Schering PC4 was not an abortifacient, because it acted before conception, ie, the point at which the ovum was embodied in the uterus wall. This point was later contested by a pharmacist from Belfast who said that "the ends do not justify the means" and urged delegates to agree with him in stating that conception was synonymous with fertilisation of the ovum.
Accessibility
Accessibility was an important issue in Mr Odd's opinion, since Schering PC4 had to be taken within 72 hours of unprotected sex and a World Health Organisation (WHO) report suggested an even shorter time period. The WHO-study showed an 80 per cent success rate when Schering PC4 was taken within 12 hours of unprotected sex. "The pharmacist is in the best position to react to requests since these problems tend to happen when everyone else is closed," Mr Odd said.
Mr Odd admitted that patients were taking a high dosage of hormones, but only over a very short period. And even after repeated use, no problems had been reported to date, making any side effects highly unlikely.
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Change of status
Mr Odd told delegates that a review of the legislation was currently taking place, looking at a number of ways to enable pharmacists to supply emergency contraception. The most appropriate way was not necessarily a POM to P switch. However, he could see pharmacists being allowed to supply Schering PC4 in emergencies and that seemed "only right for an emergency contraceptive", he said.
Mr Odd finished his presention by saying that, while Schering PC4 was currently the only emergency contraceptive available in this country and was licensed as a prescription only medicine, as far as new product were concerned (some were due to come on the market), the licence holders clearly favoured pharmacy only status.
Moving Schering PC4 to P status raised some concerns among the delegates and Mrs Hoare suggested that it should possibly be switched to a pharmacist-only sale product.
On the point of teenage pregnancies, Dr KEITH HOLDEN (Tyne and Wear) was worried that the debate was too focused on teenagers. In his experience, the under 19s were not the real problem, and pharmacists should not forget the other end of the scale, ie, women over 40. He added that by concentrating on the issues concerning teenagers, there was also a danger of getting drawn into child protection issues.
Role of the pharmacist
Mrs JOY WINGFIELD (Boots the Chemists) felt that a major point not yet discussed was the question of how pharmacists were going to manage the risk. Apart from determining what was good professional practice, what documentation was needed and what sort of questioning should be carried out, she asked. She felt that the Society needed to look at whether pharmacists could be prosecuted for supplying Schering PC4, liability issues and public relation problems. "The question of liability should be out in the open as it is not just the manufacturers who will be affected," she said.
Mr D'ARCY said that while liability was a real concern, he felt that sometimes pharmacists just had "to grit your teeth and say you cannot make an omelette without breaking eggs - to move forward, you have to take professional responsibility".
Mr D'Arcy added that as the biggest pharmacy insurer, the NPA would have to look at liability questions. However, "when it comes down to it, we are just going to have to foot the bill," he said.
Ms SARAH INSOLE (Isle of Wight) added that, in her opinion, pharmacists were often over anxious. With all due respect to their GP colleagues, she said, "how much of what we have been discussing here goes through their minds when they fill out an FP10? The opportunity for us is enormous."
Ms KAREN SMALLMAN (Kelso) said that emergency contraception was a subject pharmacists had to think carefully about. "I think we must not get the message across that all you need to do is go to your pharmacy," she said. A substantial education campaign had to accompany the change, she suggested.
There was a consensus among delegates that specialist training for pharmacists was required. Pharmacists could not work in isolation but must function as part of the care team. Other issues raised were cost, remuneration and anonymity.
Mr D'Arcy captured the spirit of the session when he said that as most pharmacists seemed to agree that emergency contraception was something they should get involved in, the profession should quickly move things forward. "What we are often guilty of, as a profession, is seeing an opportunity and then spending too much time talking ourselves out of it," the NPA director said.
A final show of hands showed that, while there was still opposition from a few pharmacists, there were some converts who were now supporting the idea of pharmacists becoming involved in the supply and sale of emergency contraception.
The main purpose of the Crown review had been to look at opportunities for health professionals to undertake new roles with regard to the prescribing and supply of medicines, said Mrs HELEN REMINGTON (a member of the Crown review of prescribing, supply and administration of medicines and lead speaker of the debate). The Medicines Act was now 30 years old, and practice had changed substantially in the intervening years. The Government needed to know how to use health professionals to best effect.
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Helen Remington: training and registration of new prescribers needed |
Types of prescribers
The Crown report had recommended two types of prescriber:
Mrs Remington accepted that pharmacists had little or no diagnostic skills, but this would not be a problem when acting as dependent prescribers.
With the extension of prescribing rights, it was essential that patients' medical records could be accessed by all relevant health care professionals. This might be accomplished by the appropriate use of information technology and development of electronic patient records, she said. The acceptability to patients of prescribing by any new practitioners was also an important issue.
It was generally accepted that separating prescribing and dispensing enhanced patient safety, and that this could present problems if community pharmacists were both to prescribe and to dispense. However, Mrs Remington felt that the risk involved in not separating prescribing and dispensing when continuing a course of treatment was much lower than when initiating therapy.
The report had recommended the establishment of a "new prescribers advisory committee" to assess applications from professional groups seeking prescriber status and also to consider the range of medicines appropriate to that group. The report had made clear that pharmacists should have a wide access to medicines (eg, for repeat prescribing), Mrs Remington said.
Mrs Remington explained that the Crown report had been published in March, 1999, and had been out for consultation until June. More than 100 responses had been received and the Department of Heath was now collating them. The British Medical Association had objected to pharmacists prescribing on the grounds of accountability, Mrs Remington said, although the report made clear that this would lie with the prescribing pharmacist not the doctor.
The group discussing this hot topic consisted of about one third hospital and two thirds community pharmacists. The majority indicated that they would welcome the opportunity to prescribe medicines. Reasons given for this included saving money for the NHS by prescribing for minor ailments, appropriate use of professional training and time, providing pharmaceutical care and being better at prescribing than receptionists. GPs were likely to remain the co-ordinators of patient care, although it was suggested that pharmacists might have their own patient load, following up therapy post-diagnosis.
Remuneration
It was clear that the current remuneration system, where fewer prescriptions meant less income, was a major obstacle for community pharmacists seeking a prescribing role. Alternative suggestions were that payment could be made for providing pharmaceutical care or that there could be some form of block contract for repeat prescribing.
Remuneration was not the only obstacle; the fact that prescribing by pharmacists would be a huge change for the profession should be recognised. The point was made that prescribing by pharmacists could cause the profession to break into separate factions. However, Mrs Remington said that there would be no compulsion on pharmacists to prescribe; individuals would be able to choose whether they wanted to pursue this course.
Clinical knowledge
Patient records were discussed, with lack of access to medical records being a another potential obstacle to prescribing by pharmacists. Mrs Remington felt that full access to a patient's medical records was essential, even when acting as a dependent prescriber. However, Mr ANDREW BURR (who was in the chair) said that records held by GPs were often incomplete and many patients did not take medicines that were prescribed. The accuracy of medical records was questionable and in certain circumstances (eg, house calls, deputising services) doctors acted without the patient's medical records. Solutions to these problems were to be found through utilisation of information technology and accurate history taking.
Mr Burr mentioned a system in America where specialist pharmacists prescribed under protocols for patients with AIDS. However, Mrs REMINGTON made clear that having a broad base of underpining knowledge (eg, a clinical diploma) was vital if pharmacists were to prescribe and that there could be dangers in specialisation. For example, what if a patient with AIDS also had a heart problem?
The point was made that community pharmacists already diagnosed minor ailments. Pharmacists could be accredited to prescribe for minor ailments for people who did not pay prescription charges, so a visit to the GP and the associated cost to the Health Service would be avoided. Pharmacists were already accountable for the advice they provided, so this aspect was not thought to be problematic.
Pharmacists needed to be bold and aim high if they were to move forward on prescribing. Nurses had been calling for prescribing rights more than five years ago, even before nursing had become an all graduate profession. The strength of the nurses political lobby was mentioned as one factor which might ensure that the report was acted on, even though the Crown review had not been set up by the present government.
The fact that the Crown report was about appropriate prescribing not nurse prescribing was stressed. The report opened new doors for pharmacy. However, the aspirations of different pharmacists were very different and this had to be recognised.
The National Health Service counter-fraud services directorate aims to investigate all prescriptions which have been dispensed free of charge but endorsed by community pharmacists to indicate that the patient's prescription charge exemption status should be checked.
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David McNeil: changing the culture to deter fraud |
Generally, he said, all such endorsements passed on by the Prescription Pricing Authority would be looked at.
Answering a question from Mrs DIANA MALLINSON (Glasgow), Mr McNeil reminded the session that if pharmacists wished to report particular cases of suspected fraud they could use the PPA "hotline" (telephone 0800 068 6161).
Mr PHILLIP ANSON (Eastbourne) asked whether, in cases of suspected fraudulent claims, the directorate was intending to send out fixed penalties by post or to visit the people concerned. If penalties were to be sent by post, he could see patients coming back to their pharmacist to complain.
Mr McNeil replied that currently the directorate was "knocking on doors" and interviewing people. In many cases their exemption certificate had expired. He thought that, in future, prescriptions forwarded by the PPA to the directorate for investigation would be matched against data held by other agencies. As he had said in his presentation, the directorate was trying to deter people from fraudulently claiming exemption by changing the culture: "You don't drink and drive, so you don't defraud the National Health Service," Mr McNeil declared. Getting that message across was the best approach, he went on, because once people saw the sanctions, there would be a change in perception - they would not want to be caught.
Answering a question from Mrs LINDA STONE, who was in the chair, Mr McNeil said that the directorate would help, rather than prosecute, people who had lost their exemption certificates. He welcomed Mrs Stone's suggestion that someone from the directorate should spend part of a day in a pharmacy to experience pharmacists' problems over explaining prescription exemption to patients, and later took up an offer from Mr ROBERT DARRACOTT (Moss Chemists) to arrange a visit to one of the company's pharmacies shortly.
Agreeing with a comment that the number of different prescription forms and the changing names for benefits were causing difficulties for pharmacists, Mr McNeil confirmed that the directorate's role included examining the overall complexity of prescriptions. He said that it was looking at simplifying both the prescription handling process and the names of benefits.
Mr McNeil agreed with a suggestion that reducing prescription charges to a flat rate of, for example, £1 or 50p for everyone, whether or not they were currently exempt from charges, seemed an obvious solution. It was a valid point, he said.
However, this was not the only kind of fraud the directorate was concerned with. In answer to a question about professional fraud, Mr McNeil confirmed that the directorate was looking at all types of NHS fraud. And in order to speed things up, it could use its own departmental solicitors rather than the Crown Prosecution Service.
Whether cannabis should be legally available for medicinal purposes was the subject of a hot topic session at this year's British Pharmaceutical Conference.
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Medicinal products containing cannabis needed |
Legal issues
Professor TONY MOFFAT (chief scientist, Royal Pharmaceutical Society), the lead speaker for the session, began by reviewing the law relating to cannabis and its supply. The Misuse of Drugs Act 1971 defined cannabis as the flowering or fruiting tops of any plant of the genus Cannabis from which the resin had not been extracted. The Criminal Law Act 1977 extended this definition so that any part of the cannabis plant was covered by legislation.
Professor Moffat went on to summarise the history of the medicinal use of cannabis from its use as early as 700BC in Assyrian tablets up until 1949 when the British Pharmaceutical Codex contained the last official monograph for a preparation of cannabis. The medicinal use of cannabis had come to an end following the introduction of the Misuse of Drugs Act 1971 when it was judged that, as cannabis had no therapeutic benefit, there was no reason to grant it any exemption. Hence cannabis and cannabis resin became Schedule 1 drugs (meaning they could not legally be prescribed or dispensed).
The World Health Organisation (WHO) believed that cannabis and many cannabinoids had no therapeutic benefit, a view shared by the United Nations (UN) Commission on Narcotic Drugs, which, through the UN Convention on Psycho-tropic Substances 1971, schedules drugs. Since the UK government was a signatory to the UN Convention on Psychotropic Substances 1971, it was unlikely to oppose the WHO/UN and reschedule cannabis as a Schedule 2 drug (although it did have the power to do so).
Constituents of cannabis
Professor Moffat explained that cannabis contained about 60 cannabinoids, the major ones being tetrahydrocannabinol (THC, thought to be responsible for the mind-altering effects of cannabis), cannabinol, cannabidiol, cannabigerol and cannabichromene. At present, it was not entirely clear which constituents were responsible for the therapeutic activity of cannabis, and standardising preparations of cannabis on the concentration of several constituents presented some difficulties. For these reasons, attention had, to some extent, focused on individual constituents, such as THC.
Recent developments had been the licensing of the synthetic cannabinoid nabilone for prescription-only, hospital-only use as an antiemetic in cancer chemotherapy-induced nausea and vomiting, and the licensing of drobabinol (THC; Marinol) in the US, also as an antiemetic in cancer chemotherapy and as an appetite stimulant in patients with AIDS. Both these drugs could be prescribed by doctors in the UK on a named-patient basis for any indication.
In April, 1995, the Council of the Royal Pharmaceutical Society had issued a statement saying that more clinical research was needed to investigate the potential therapeutic uses of cannabinoids in specific medical conditions, but that since it would be some considerable time before the results of such research were available, there was a case for allowing doctors to prescribe cannabinoids for serious named disorders, for example, multiple sclerosis, at least for a trial period. The Council had given evidence to the House of Lords select committee inquiry into the medicinal use of cannabis, and in November, 1998, the committee had recommended that the Government should allow doctors to prescribe cannabis for medicinal use. However, the Government response had been to reject immediately the recommendation on the grounds that cannabis should not be prescribable before its safety, quality and efficacy had been established scientifically.
Clinical trials
Prior to this, the Society had set up a working group to develop protocols for clinical trials of cannabis and cannabinoids. To date, two trial protocols had been agreed - one in collaboration with Dr John Zajicek (Derriford hospital, Plymouth) involving patients with multiple sclerosis, and another in collaboration with Dr Anita Holdcroft (Hammersmith hospital, London) involving patients with acute pain following tonsillectomy or abdominal surgery. Both trials would be conducted according to a randomised, double-blind design and would each involve three groups: placebo, a THC-standardised cannabis oil preparation, and THC only. "This design will allow us to determine whether tetrahydrocannabinol alone is responsible for the clinical effects of cannabis, or whether other constituents are also important," Professor Moffat explained. Other trials were being carried out by Dr Geoffrey Guy (chairman, GW Pharmaceuticals), whose company produced cannabis at a secret location in the south of England.
In summing up, Professor Moffat returned to the question "When will cannabis become a medicine?" His answer was that this depended on two factors - the law being changed and medicinal products being available for prescription and dispensing.
Oral formulations problematic
The session was then opened for discussion. A member of the audience asked why there was a focus on investigating oral formulations of cannabis and cannabinoids. In his view, there was a need for a non-oral formulation of THC (if shown to be the active constituent) such as a sublingual, an inhalation or even a rectal formulation. In response, Professor MOFFAT said that attention had focussed on oral formulations because there were already two licensed oral products available. Therefore it was known that these cannabinoids were bioavailable following oral administration. However, he agreed that the oral route was not the best method and that alternative routes, such as inhalation, needed to be investigated.
Adding to this, Dr GUY said that his initial reaction had been that the "smoked route is out", but that having compared all the various pyrolytic methods of delivering cannabis, cannabis "joints" had been shown to have the most favourable ratio of THC to particulate matter. In his view, the oral route was not optimal for delivering cannabis for two reasons - low bioavailability, and a relatively long time to peak effect (around 1.5 to two hours) making it difficult for patients to "autotitrate" doses.
Dr ELIZABETH WILLIAMSON (centre for pharmacognosy and phytotherapy, School of Pharmacy, University of London) agreed that the oral route was "fraught with problems". She went on to describe an "n of 1" study carried out in collaboration with colleagues from the departments of neurology at Charing Cross hospital and Atkinson Morley hospital, and from the medical toxicology laboratory at Guy's and St Thomas's hospital. In this study, a patient with acquired pendular nystagmus due to multiple sclerosis had experienced dramatic suppression of oscillopsia lasting for four to five hours after smoking cannabis resin, but had not experienced any therapeutic benefit after taking either nabilone tablets or capsules containing cannabis oil equivalent to around 5mg THC.
In response to a question from a member of the audience, Professor MOFFAT provided further details of the two trials mentioned earlier. The MS trial would involve a one-month pretreatment period during which patients would be required to self-titrate their dose using capsules equivalent to THC 2.5mg (or placebo) in order to achieve a balance between the desired therapeutic effect and any adverse effects. Following this, patients would undergo a three-month treatment period. It was planned to recruit around 330 patients into each of the three arms of the trial. Patients participating in the pain trial would receive a dose equivalent to THC 10mg (or placebo) pre-operatively; morphine consumption would then be monitored over the next six hours. Around 100 patients would be recruited into each of the three arms of the trial. According to Professor Moffat, applications for funding for both trials had been made to the Medical Research Council, which should reach a decision by December, 1999. If the applications were successful, the trials should start early in 2000 and were expected to take around 18 months to two years to complete.
Dr GUY told the audience that his company was carrying out "a whole clinical [research] programme involving around 2,000 patients". Phase I dose-response studies, which included psychometric and cognitive-function testing, were in progress; phase II studies would follow once the dosing regimen had been established. Dr Guy said that his group would be carrying out pilot studies (ie, feasibility studies) next year in patients with MS, spinal cord injury and phantom limb pain; each pilot trial would involve around 70 to 100 patients. They were, he said, working towards phase III trials investigating a product with an established dose range and using sensitive endpoints. Dr Guy emphasised that any patient who believed that they had gained benefit during a study and who wished to continue receiving material beyond the end of the trial would be entered into a long-term safety extension. "This is what politicians and ethics [committees] wanted," he explained. Similar clinical research programmes were being carried out in the US and Canada.
Dr Guy also described the flexibility in terms of producing cannabis extracts that his facility offered. Twelve different chemovars (species of the same plant characterised by their chemical composition) were grown in his greenhouses. It was possible to alter the ratios of the different constituents by breeding programmes, and also to grow plants each with a high concentration of one particular cannabinoid. By blending material from different chemovars, extracts with very precise amounts of cannabinoids could be produced.
At the start of the session, Mr DAJANI asked participants whether cannabis should be legalised for therapeutic use. Of approximately 75 people present, a quarter voted against legalisation. He asked the same question at the end of the session and a unanimous vote in favour of legalisation of cannabis, solely and specifically for medicinal use, was recorded.
Drawing the session to a close, Mr Dajani said: "The sort of initiative the Society has shown [in this area] is to be commended. . . .This is something we should be proud of and carry forward."
Clinical freedom is dead, Professor JAMES PETRIE (chairman, Scottish Intercollegiate Guidelines Network [SIGN]) told pharmacists attending a hot topic session titled "Clinical freedom versus clinical governance".
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Guidelines are "future of prescribing" |
Guidelines
Professor Petrie drew delegates' attention to the SIGN guidelines. They contained statements, the text of which was supported by evidence. The "level" of the evidence for a statement was indicated in the guidelines. Often that evidence had been derived from meta-analysis. SIGN guidelines were not mandatory; they invited doctors to consider a certain course of action rather than instructing them to take it.
SIGN was committed to patients being involved in guideline production and was working with patients' associations, which acted as advocates for the patient.
It was Professor Petrie's view that if patients could be persuaded of the value of guidelines, then it would be easier to persuade the Government that patients wanted what the guidelines offered. He felt that guidelines were most likely to be viewed as being scientific and valid if they had been developed by a national group. But there had to be local involvement and "ownership", he said.
Professor Petrie likened the concept of clinical freedom to being on an island alone. "It really is dead," he said. Doctors who caused concern by not prescribing according to guidelines might need to be retrained, he said.
A delegate pointed out that often health care professionals in hospitals were not prepared to challenge a consultant's prescription and this was a cause of difficulty.
Likewise, constraints on general practitioners meant that they were sometimes not able to carry on prescribing what consultants had recommended. Guidelines, therefore, were dead, unless there was multidisciplinary working.
Professor Petrie said that the British Medical Association was getting involved in this problem. He added that, in Scotland, doctors trusted the SIGN process of guideline development.
Another delegate wondered how clinical outcomes or adherence to guidelines could be audited in terms of "real validity" for the patient.
Professor Petrie said that he knew of no robust outcomes. However, readmission to hospital could be seen as a sign of failure. He suggested that if the process was right, then it should not be necessary to check what the outcomes were.