MEDICINES


Engagement (PACE) meetings. At these, patients, patient organisations and clinicians discuss aspects of a new medicine’s value beyond the health economics, such as the severity of the condition, unmet need, the potential value to patients and carers, and how the medicine might fit into the patient pathway.


The SMC then hears summaries of any patient group submissions before discussion is opened to the whole group. Like the paperwork, this conversation is guarded, members often referring to sections in papers that the public do not have when talking about costs.


Only on rare occasions – the SMC says eleven times across 148 medicines so far – does the SMC go in to closed session:


‘We are occasionally unable to be fully open about the information contained in submissions for new


NEW MEDICINES IN SCOTLAND’S NHS THE ROLE OF PHARMACISTS


The pharmacy profession is involved throughout the chain of decision making processes around every new medicine considered for use in NHS Scotland. Scottish Pharmacist asked the Chairman of the Scottish Medicines Consortium, Professor Jonathan Fox, to explain the profession’s input at the different stages.


JM: What role do pharmacists play, working alongside other professionals, in the SMC process (up to and including SMC publishing its advice)?


PJF: Pharmacists are vital to our work. Since the inception of SMC in 2001, pharmacists have been central to the work of SMC and are very actively involved in both the New Drugs Committee (NDC) and SMC.


We have thirteen pharmacists on the core SMC staff, who are involved in all SMC activities, including the critical appraisal of the submissions, horizon scanning and the PACE process. The head of the SMC staff team, Anne Lee, is a pharmacist. We currently have eleven pharmacist members sitting on NDC/SMC and SMC’s most recent past chair, Professor Angela Timoney, is a pharmacist. We have also had a pharmacist chair of NDC,


medicines because companies state that some of the information in their submission is commercial or academic in confidence,’ says the SMC’s spokesman. ‘This often relates to medicine prices or discounts and consequently this may mean that the cost-effectiveness data that informs some SMC decisions cannot be disclosed to the public.


‘As we would like our meetings to be as transparent as possible we are engaging with pharmaceutical industry colleagues involved in SMC to explore how confidential information can be kept to a minimum.’


When the discussions are over the chairman summarises whether the medicine concerned can have some of the SMC’s ‘modifiers’ applied to allow more leeway, for instance if it is for an end of life or very rare condition. Then members vote.


One impact of the move to holding


Dr Jan Jones, who is now one of our Principal Pharmacists, and of course there are our vice chairs, Gail Caldwell and Caroline Hind. Across the whole range of our work, from submission assessment to senior decision making, pharmacists play an essential role – SMC couldn’t function without them.


JM: How is community pharmacy represented on SMC and in its decision-making processes?


PJF: We currently have two senior pharmacists with community pharmacy responsibilities who are full members of SMC and are also vice chairs for the Committee chairs, myself and Dr Alan Macdonald. They are Gail Caldwell, Director of Pharmacy at NHS Forth Valley and Caroline Hind, Deputy Director of Pharmacy and Medicines Management at NHS Grampian. Both Gail and Caroline have health board responsibilities for the operational management and development of Primary Care Pharmacy Services, including community pharmacy services, so they provide valuable expertise to SMC, ensuring that decisions are made with full understanding of key community pharmacy issues.


We also have several NDC and SMC members who have primary care roles in health boards and a large pool of clinical experts who advise on our submissions including pharmacists working in a primary


meetings in public is that the vote is now done by secret ballot where, previously, there was discussion until agreement was reached.


The medicines trade body, ABPI Scotland, has questioned whether this is helpful, telling the recent Montgomery Review of access to new medicines:


‘We have concerns that voting in public has made decisions less predictable than before, based on the discussion, and that anonymous voting is less transparent with regards the reason for a decision being reached, particularly from a manufacturer perspective. There may be advantages in moving back to consensus decision making which is not anonymous but having this part of the discussion in private.’


The ABPI said the secret vote sometimes did not seem to reflect the discussion that went before it,


care setting.


JM: What do you see as the role of area drug and therapeutic committees and formulary pharmacists at board level in taking forward the advice of the SMC?


PJF: SMC was set up as a consortium of the Area and Drug Therapeutic Committees (ADTCs) across Scotland – to create efficiencies and avoid duplication by taking a ‘once for Scotland’ approach in the assessment of all new medicines. This has been very effective and allows ADTCs to concentrate on other medicines governance activities focusing on the safe and effective use of all medicines, not just new ones.


All ADTCs have well established processes in place to review the advice from SMC, which is issued to them confidentially on the first Friday of each month, four weeks before it is published on the SMC website.


Health board pharmacists play a pivotal role in these processes, as a key part of the multidisciplinary team who support the implementation of SMC advice within a local context. This may be in relation to the development of shared care arrangements, guidelines or local pathways of care. Pharmacists across the range of clinical settings work closely with other healthcare professionals to ensure their patients have early access to clinically and cost-effective new medicines.


and has made it more difficult for the companies whose medicines were rejected to find out why.


When I was witnessing proceedings, it took over three hours to consider and decide on seven medicines. The meeting then went in to closed session to discuss four medicines where there had been no submission to SMC from the companies.


A little over a month after the meeting, SMC published advice on twelve medicines. The four that had not been submitted for consideration automatically received a ‘not recommended’. Of the remainder, two were accepted, four accepted with restrictions on how they might be used within their license, and two were not recommended.


What was interesting was, despite the restriction on information, the general discussion the chairman’s summary had allowed me to predict SMC’s decision correctly for six out of the seven medicines.


The central question for me is whether holding the SMC meeting in public helps Scotland’s medicines decision makers make the best decisions.


Group decision making benefits, I feel, from discussion to allow people to listen to the arguments of others and perhaps to be swayed by them. A secret ballot is simply a poll of thirty individuals, albeit better informed by attending the meeting than they were from the paperwork alone.


The public, meanwhile, is invited to watch a process rather than to understand fully the complex argument for and against a new medicine. When the very presence of the public may be constraining the discussion, it is difficult to be sure that making decisions in public has improved the process.


At the same time, it is essential that patient groups and clinicians can make their views known directly to the SMC. Even armed with health economics and research data, the SMC is still a group of people making decisions about people. •


John Macgill is Director of Ettrickburn, a communications and government relations consultancy specialising in Scottish healthcare and lifesciences. www.ettrickburn.com


SCOTTISH PHARMACIST - 9


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