In April, the GPhC published its guidance for registered pharmacies providing pharmacy services at a distance, particularly online.
The GPhC regards the online sale and supply of medicines as posing somewhat different risks to those within traditional pharmacy services. The guidance has included a number of measures that online pharmacies are required to comply with – elements of which have caused much consternation.
Nestled towards the end of the guidance lie some additional, onerous requirements imposed upon online pharmacy owners. Medicines such as antibiotics, sedatives, warfarin and asthma inhalers cannot be supplied online without the implementation of minimum, specified safeguards.
Patient identity checks
There must be robust processes in place for the checking of patient identity to ensure that the prescribed medication is going to the right individual [which could be done by abiding by NHS Digital's relevant standard].
Issues such as inappropriate requests for medicines, multiple orders to the same address or orders using the same payment details need to be safeguarded against by online pharmacies. Websites must be designed to ensure that patients cannot choose a prescription-only medicine and its quantity, until there has been an appropriate consultation with a prescriber.
Confirmation from GPs
The expectation is that online pharmacy prescribers contact a patient’s GP and proactively share with them all relevant information about a prescription. Medicines liable to abuse or posing a risk of addiction would need the prior approval of the patient’s GP. Essentially, these cannot be prescribed until the GP has confirmed that the prescription is appropriate for the patient and monitoring is in place.
Where a patient either does not have a GP or does not consent to the sharing of information, there needs to be robust processes in place to assess whether these types of prescription-only medicines are clinically appropriate for that patient. The prescriber needs to have made a clear, evidence-based record justifying their prescribing in such circumstances. Has the prescriber had access to the patient’s medical records, or other reliable information about the patient’s health and treatments they are receiving? Can they demonstrate that any 'off-label' prescribing is in accordance with national prescribing and best practice guidance?
Are these prescribing safeguards for high-risk medicines workable? Dr Andrew Green, the British Medical Association's GP committee clinical and prescribing lead, does not think so. He considers the measures inappropriate and would prefer that some drugs be "blacklisted" from online supply, rather than requiring GPs to "police the prescribing of others".
The GPhC has not indicated that it will blacklist high-risk drug supply by online pharmacies. However, for a multitude of practical and commercial reasons, the safeguards and required measures might render it too onerous for online pharmacies to be able to continue prescribing these, in circumstances other than when they have access to patient medical records.
Ignoring the guidance at one's own peril
The guidance, grouped under five principles, has now become a fundamental basis upon which online pharmacies will be assessed for their compliance with GPhC standards. The expectation is that GPhC inspections and investigations will become more prevalent. These will invariably require pharmacy owners to demonstrate compliance with the guidance and to provide evidence that prescribing risk assessments and audits are routinely conducted and reviewed.
The guidance is mandatory and any failure to follow it, or take appropriate steps, could amount to the GPhC identifying a failure to meet one or more of the standards for registered pharmacies, which could result in enforcement action. Depending upon the nature of any alleged breaches, these might entail the GPhC requiring: improvement action plans; serving improvement notices; seeking conditions to be attached to registration; or ultimately consideration of suspension, disqualification or removal by a fitness-to-practise committee.
It is therefore recommended that online pharmacy owners are fully familiar with the guidance and have implemented all of the required processes, to ensure that each part of their pharmacy service is compliant and being actively adhered to by all prescribers.
Andrew Andrews is a senior associate within the regulatory compliance team at the law firm VWV