Is old medicines law holding back new pharmacy practice?
Pharmacy practice has moved on in the more than 40 years since the Medicines Act 1968 came into being. Some issues are being addressed but, in the meantime, says Alan Nathan, pharmacists need professional guidance
Over the past quarter of a century daily life and society have been transformed by information and other technologies. But in many respects the practice of pharmacy, which is still governed by legislation that was enacted more than a generation ago, seems to be languishing in the era of the mortar and pestle.
So is pharmacy law holding back pharmacy practice? Is it inhibiting innovations such as dispensing machines, remote prescription collection and other developments that would increase convenience to the public? And is the current law unfair to pharmacists?
The main relevant current legislation is the Medicines Act 1968. It has been partially updated since its enactment and further changes are imminent, but the parts that govern current practice might still be regarded as antiquated and not serving current needs.
Guidance provided by bodies such as the Medicines and Health care Regulatory Agency, the Pharmaceutical Services Negotiating Committee and the Royal Pharmaceutical Society is necessarily also based on the same elderly legislation.
A good example of where it could be argued that legislation and professional guidance has not kept pace with progress is that of remote collection points such as the Asteres ScriptCenter machine, currently being piloted by Sainsburys.
In essence, patients register on the machine with a unique ID and PIN code. Prescriptions are placed in the machine, they are collected, dispensed at a pharmacy, the medicines replaced in the machine and retrieved by the patient using their ID and PIN. The machines increase convenience because they can be used at any time of day or night, and they can be situated outside pharmacies or in locations remote from them.
Strictly, this method of supply contravenes section 52 of the Medicines Act as well as NHS terms of service, because the medicines are not supplied from registered pharmacy premises or under the supervision of a pharmacist.
The Medicines (Collection and Delivery Arrangements) Order 1978 grants an exemption to the law so that people in areas distant from a pharmacy can collect their medicines from a convenient local point such as a post office or village shop, but guidance on this issue from the Royal Pharmaceutical Society of Great Britain was that such arrangements should only be used in exceptional circumstances, and the General Pharmaceutical Council, which replaced the Society as the profession’s regulator, has, to date, issued no advice.
Similar issues of legitimacy are raised by remote robotic dispensing machines, such as the Pharmatrust MedCentre, which is being trialled in some UK hospitals.
In this system patients insert their prescriptions into the machine, pick up a telephone receiver and are linked to a pharmacist via a video conferencing system. The pharmacist examines a scanned image of the prescription and can also interview the patient before authorising it for dispensing.
Once the prescription has been authorised, medicines are automatically dispensed and labelled by the machine and video images of them are checked by the pharmacist before the machine releases them to the patient.
The same legal and NHS issues apply here as to remote collection points, but there is no collection point exemption because the medicines are dispensed remotely. In addition, under the Medicines Act the application of a label to a medicine becomes “assembly”, requiring an assembly licence from the MHRA. Conventional dispensing by a pharmacist in a registered pharmacy is exempt from this requirement.
Hub and spoke dispensing is becoming an increasingly popular method of reducing dispensing costs, but it is another legal grey area. Here, prescriptions are taken in from patients at pharmacies, sent to a central facility for dispensing and then delivered direct to patients or returned to the pharmacies for issue.
Under the Medicines Act, an assembly licence would appear to be required if the hub is a separate commercial entity from the spoke, although one is not necessary if they are within the same company and both premises are registered as pharmacies. There also appear to be NHS terms of service issues if medicines are delivered direct to patients from hubs that are not registered as pharmacies.
Not fit for purpose
There are other better-known examples of current legislation apparently not being fit for purpose for a society that has moved on in the more than 40 years since the Medicines Act was enacted. The responsible pharmacist Regulations, which came into effect in late 2008, allow a pharmacist to be absent from a pharmacy for up to two hours a day. However, this would appear to conflict with NHS terms of service, which require a pharmacist to be on the premises at all times during contracted opening hours.
Another issue that has caused concern is section 64 of the Medicines Act, which effectively makes a dispensing error, even one which has caused no harm, a criminal offence.
Some of the above issues are currently being addressed. The MHRA is carrying out a review on the decriminilisation of dispensing errors and a consultation on the reinterpretation of supervision is due to take place this year. In the meantime, until these issues are resolved, pharmacists may feel unsupported as far as professional guidance is concerned.
ACKNOWLEDGEMENT This article is based on a presentation by Noel Wardle, solicitor, Associate at Charles Russell Solicitors, given at a legal and regulatory pharmacy conference in London on 2 February 2011.
Citation: The Pharmaceutical Journal URI: 11073392
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