This article was first published in the Irish Pharmacy News, December 2011 edition.
The pharmacy sector has undergone considerable change in recent years, starting with the enactment of the Pharmacy Act in 2007. A common complaint is that pharmacists have come under increased pressure as a result of these regulatory changes and that greater administrative burdens have been imposed, for example in processing their claims under the various community drugs schemes operated by the State. With reductions in staff forced on them as a result of cuts in their remuneration, many pharmacists are also finding it difficult to find the time to devote to their patients and to the development of new services.
The noticeable increase in regulation is partly due to the fact that, as a profession, pharmacy had been grossly under-regulated for so long and is now in catch-up. However, it would appear that what some pharmacists perceive as a "regulatory overload" may just be the groundwork for the Government's plan to expand the role of primary care in this country.
Pharmacists have for many years called for greater recognition and utilisation of their knowledge and skills in the delivery of an accessible, efficient and cost-effective healthcare system for this country. The Pharmacy Ireland 2020 Working Group, in its interim report published in April 2008, identified several ways in which community pharmacists could enhance the services they provide to patients and deliver cost-effective solutions to problems within the health system. Among the measures envisaged are –
- The involvement of pharmacists in the carrying out of regular medication reviews for all patients.
- A greater role for pharmacists – including the power to prescribe – in the management and treatment of minor ailments.
- The provision of health screening.
- The administration of vaccination programmes.
In October 2011 the Medicinal Products (Prescription and Control of Supply) Regulations 2011 were introduced, permitting suitably trained pharmacists to supply and administer the flu vaccine for the first time in Ireland. Other jurisdictions where pharmacists are involved in the delivery of immunisation programmes have seen increased uptake rates due to the greater accessibility of the service and it will be interesting to see whether this trend is replicated here.
Pharmacist-prescribing and the introduction of a Minor Ailments Scheme are other proposals on the agenda with a view to achieving a more rational use of healthcare resources, by keeping minor ailments away from busy GP surgeries, thereby allowing them to treat more serious conditions requiring medical intervention. Central to these proposals is the proposal to provide wider access to medicines which have a proven safety record by switching them from prescription-only status (POM) to medicines which can be sold without prescription in pharmacies (P). The Pharmacy Ireland 2020 Report, already referred to, identifies several medicines as being suitable for switching in this way, including –
- Analgesics for migraine;
- Malaria prophylaxis;
- Antifungal treatments;
- Inhaled bronchodilators.
The Report notes that in the UK these and many other medicines are available in pharmacies without prescription, including emergency contraception, and recommends the development of a national policy in this country with regard to POM to P switching.
Earlier this year one of the country's larger pharmacy chains took matters into its own hands by rolling out a service providing the emergency contraceptive pill and the flu vaccine without the need for a doctor's prescription. It did so on the basis of what it described as a "Patient Group Directive" or PGD issued by the pharmacy's own medical director which, it was claimed, allowed it to supply prescription-only medicines without a prescription. PGD's are a feature of the English system but do not exist under Irish law. The service was discontinued after intervention from the IMB. Whether this was the catalyst for change, or whether change would have happened in any event, is not entirely clear but, not long after, the status of Norlevo was changed from POM to P.
It is interesting to note that the 2020 Report calls for a new category of "pharmacist prescribed" medicines – OTC medicines which could be supplied only after the pharmacist had carried out a number of clinical checks, with the pharmacist having to record details of the consultation. The Report identifies Codeine as one such medicine that should come within this new category. This would appear to explain the rationale behind the PSI's Guidance issued to pharmacists in August 2010 requiring codeine-based OTC medicines to be stored in the dispensary or in a location where they would not be visible to the public. And in November 2011 pharmacists will have received further guidance from the PSI advising that, due to new safety issues concerning non-prescription domperidone medicines (Motillium and Domerid Relief 10mg), these should be stored in the dispensary. If indeed new information has come to light which casts doubt as to the safety of a medicinal product that is available without prescription, one wonders whether it would not be more appropriate that its OTC status be changed to prescription-only rather than create a new class of product which is not recognised in Irish law. As regards the particular safety issue relating to domperidone, one pharmacist client of mine commented that, short of hooking patients up for a quick ECG at the counter, it is anyone's guess as to whether there is a risk in supplying it! In short, if there is a safety issue with this medicine, then its sales status may need to be reviewed (or the product withdrawn) rather than issuing a guidance which requires pharmacists to verify whether it is safe to supply.
Moreover, it would appear that the Pharmacy Regulator is – not for the first time – acting beyond its powers as the classification of medicinal products is a function of the Irish Medicines Board and not the Pharmacy Regulator. In addition, the legal status of this Guidance is, at best, uncertain. By all means, if it is considered appropriate that a class of "pharmacy prescribed" medicine be introduced, then this should done on a proper statutory basis with clear rules surrounding such matters as storage, supply and advertising. The Guidance just issued in relation to domperidone states that, as regards the promotion of such products, "any material which is not consistent with the new safety situation should be removed." Because "pharmacist prescribed" medicines are not yet a legally recognised classification, the law permits the advertisement of OTC medicines, subject to compliance with the requirements of the Medicinal Products (Advertising) Regulations 2007. No Guidance issued by the PSI can alter that or introduce restrictions, as the Pharmacy Regulator does not have power to legislate.
Whilst on the subject of medicines advertising and promotion, in October 2011 the PSI issued new Guidance relating to the advertising, promotion and sale of medicinal products, and related matters. In an email to all pharmacists the PSI explains that this new Guidance is intended to replace Practice Notice 5 on the Advertising and Promotion of Medicinal Products on the basis of price or quantity discounts issued in 2009. However, the PSI did not give any explanation as to the reasons for revising its guidance, which was issued without any consultation. Without an explanation, the significance of the new guidance is likely to be lost on pharmacists.
Practice Notice 5 stated that the promotion of OTC medicinal products on the basis of price or quantity discounts was both unlawful and in breach of the Statutory Code of Conduct for Pharmacists. The truth is that it was neither! In fact there is no mention whatsoever of price promotions or quantity discounts either in pharmacy legislation or in the Code. Whilst the new Guidance does not make a similar claim, it does not inform pharmacists that the law permits the advertising and promotion of medicinal products on the basis of price or quantity discounts and the tenor of it is such that pharmacists will continue to be under the misapprehension that price promotions are unlawful. Contrast this with the equivalent Guidance of the UK's Medicines and Healthcare products Regulatory Agency in its Blue Guide. This makes clear that such promotions are lawful but encourages good practice and responsible behaviour, whilst discouraging volume-based price promotions of analgesics which could result in unnecessary purchases and put consumer safety at risk.
Once again, there is an issue with regard to the legal status of the PSI's Guidance on price promotions which is questionable. It is claimed that it is issued pursuant to section 7(2)(b)(vii) of the Pharmacy Act 2007, however that particular section empowers the Society to "make public statements about any aspect of pharmacy to which its functions relate." The Guidance (non-compliance with which would presumably result in a disciplinary process under Part 6 of the Act) would not amount to a public statement. Whether or not that view is correct, it is unsatisfactory for such an important issue to be dealt with by way of Guidance.
If the role of pharmacists is to be developed in the manner envisaged by the Pharmaceutical Society in the 2020 Report, it is critical that a rigorous regulatory framework and fitness to practise regime is put in place. The Pharmacy Act 2007 was just the start of the process. Unfortunately, the "regulatory overload" that has followed appears to be the price pharmacists will have to pay for the expansion of their role in the delivery of primary care services. But it is important that this is done on a proper statutory basis – and not by means of the issue of one "guidance" after another.
There is one practical issue causing difficulty for pharmacists in their every-day practise in relation to which they would welcome a change in the legislation. Under the Medicinal Products (Prescription and Control of Supply) Regulations one of the requirements for a valid prescription is that it be in ink. This presupposes that there is always someone to walk into the pharmacy and present an original prescription.
Very often, the reality is quite different. Take, for example, the supply of medicines to patients in residential homes (which includes prisons). Significant numbers of patients in these settings are seen by their doctor on any given day resulting in substantial numbers of prescriptions being issued at all times of the day. In many of these cases fax is the only means of transmitting the prescription to the pharmacist if the medication is to be dispensed and delivered to the patient in a timely manner. However, the Pharmacy Regulator insists that these patients be treated in the same way as patients who attend personally at the pharmacy and has stated that faxed prescriptions will not be tolerated. Surely, in this digital age some practical solution can be found to deal with what is a daily problem, so that pharmacists can practise within the law?
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