Dying for a pill: Regulation of online pharmaceutical sales
Zahra Ahmed considers how sales of online medicines are regulated to try and manage a growing modern-day risk to patient safety
The growth of online pharmacies and other forms of ‘distance selling’ pharmacies has surged exponentially in recent years. The covid-19 pandemic further accelerated the online pharmacy sector’s expansion to new levels, with increased demand for distance selling of medications.In December 2019, following an inquest into the death of 22-year-old Gemma MacDonald, who died of a mixed drug overdose after buying from two companies, a coroner raised concerns about the lack of rigorous checks and the availability of large amounts of drugs online.
These concerns are set out in the coroner’s Report to Prevent Future Deaths. The report questions whether online companies have appropriate checks of the welfare of customers in place. It also sheds light on an issue which has played a key theme in regulatory investigations at present: whether there are adequate systems in place to protect customers and monitor and control the size and frequency of customer orders.
The regulatory response
The relevant regulatory framework is codified through a mixture of statute, statutory instruments and ‘soft’ guidance which is updated periodically.
The General Pharmaceutical Company (GPhC) issued its ‘Guidance for registered pharmacies providing pharmacy services at a distance, including on the internet.’ The guidance was first issued in 2015, and last updated in April 2019.
The GPhC has developed enforcement powers. Pursuant to Article 8 of the Pharmacy Order 2010, the GPhC appoints inspectors. Enforcement powers include the option to impose conditions on a pharmacy, such as prohibiting supply prescriptions to companies not registered in the UK.
Improvement Notices, although comparatively rare to Conditions Notices, can also require pharmacies to improve in specific areas within a set time period. If an inspection does not pose an immediate risk, an action plan may be written by an inspector to improve the operation. In appropriate cases, section 80 Medicines Act 1968 allows for the powers of the relevant disciplinary committee to disqualify and direct removal from the register.
In 2017, the Care and Quality Commission (CQC), the independent regulator of all health and social care services, suspended the registration of ‘Dr Matt Ltd,’ a website selling prescription medications, and took action against three other online pharmacies: Frosts Pharmacy Ltd, White Pharmacy Ltd Ltd, i-GP Ltd, trading as i-gp.uk.
Issues highlighted following inspections included insufficient identity checks being carried out, poor recording of medical history, prescription of inappropriate medications and patients’ own GPs not being informed of the prescriptions.
The General Medical Council (GMC) has issued updated guidance on remote prescribing.
On a broader note, there is a clear need for ‘joined up thinking’ and consistency in approach across healthcare regulators. One example would be the GMC guidance being reflected through the Royal Pharmaceutical Society (RPS) Competency Framework. To support all prescribers in prescribing safely and effectively, a single prescribing competency framework was published by the National Prescribing Centre/National Institute for Health and Care Excellence (NICE) in 2012.
The RPS Competency Framework follows industry wide recognition that “a common set of competencies should underpin prescribing, regardless of professional background”. Work to be done going forward will necessitate the increased provision of information to professionals and the public on the applicability of the core competencies in the context of distance selling. No doubt, this will include further cross regulatory consultations and further updated guidance.
A multi-agency approach
The jurisdictional limitations of statutory regulatory bodies are exposed in cases where companies are set up by directors who are not registered practitioners. This is where a multi-agency approach can be effective. For instance, in April 2018, following a Medicines and Healthcare products Regulatory Agency (MHRA) raid, private individuals who operated a ‘fake’ online pharmacy were successfully prosecuted for the offence of possession with intent to supply unlicensed medicinal products and Class C controlled drugs, based on crucial evidence obtained as part of the raid.
Following a guilty plea, Mr Jakub WoÅºniak, 36, was sentenced to a total of 18 months immediate custody while Ms Izabela Wojceichowska, 37, received an eight-month sentence suspended for two years, in addition to 180 hours of unpaid work. The pair were also ordered to pay £3,000 in related costs.
The multi-agency approach is essential to ensure all key players are held accountable. In practical terms, bodies who commission inspections and/or raids of the premises of distance selling organisations can maintain prompt cross referrals for professionals involved and provide evidence to police.
Issues of evidence
The Fitness to Practise proceedings instituted by regulators has the overarching objective to protect and promote the safety and wellbeing of the public. Sanctions are intended to reflect the public interest in protecting the public and maintaining the public confidence in the profession and maintaining high standards in the profession. Unlike criminal proceedings, the sanction is not designed to serve as punishment in the punitive sense.
Professionals, such as doctors and pharmacists, who become implicated in organisations which fail to provide adequate patient safeguards, face investigations into their fitness to practise. The ultimate sanction would be the erasure from the relevant register. Effectively, this means the individual practitioners would lose their right to practise.
Experts may also need to be instructed to explain the clinical significance of decisions made by healthcare professionals involved in distance selling, such as the impact of repeat prescriptions of addictive drugs, such as opioids, in high quantities. Therefore, it is vital to monitor the dosages and frequency of supply.
The alleged pattern and nature of the failings may include the expert looking at a representative sample of the prescriptions. Findings from audits can also shed light on aspects of the operation which do not meet good practice standards set by regulatory bodies. The key issue will be whether or not the prescribing practice, operational model, management and reviewing procedures are designed to secure safe effective running of a business. Where an individual professional fails in their responsibilities is judged with reference to their position within the operational model, specialism, and the professional standards set by their respective regulators.
These are matters of evidence and in a contested case, it would be important for any regulator to produce such comprehensive evidence before a Fitness to Practise Committee. Fitness to Practise proceedings are civil proceedings and although allegations of misconduct relating to professional failings apply the lower standard of proof, namely the balance of probabilities, rather than the criminal standard, the regulatory bodies must still bear the legal burden of proving the case against the professional. It is not for the professional to prove anything during the fact-finding stage.
Similarly, the aim for defence practitioners would be to draw out a pattern of consistent, clinically justified decision making, where there is no physical interaction with patients and safety is dependent on robust reviewing and checking of the management, dispensing, and prescribing of medication, including regular contact with GPs.
The take-home point for prosecutors and defence practitioners is to canvass the appropriateness of commissioning an expert report at an early stage. Such evidence would help explain risks and dangers from a clinical perspective, explain significance of omissions, and even identify patterns of prescribing and/or wider systemic failings. A defence expert report could bolster credibility for a practitioner who seeks to demonstrate that he or she operated within the scope of their practice and give robust examples of good decision making. It is also essential that such experts give their opinion with reference to the relevant professional standards.
The key themes emerging from inspections involving distance selling companies include prescribing in a transactional manner, using generic template questionnaires where patients self-declare their conditions, with lack of consultation with patient GPs to assess that the prescriptions being issued were appropriate.
There appears to be a lack of checks on confirming diagnosis/presentation, no systems in place to confirm patient medical histories and/or prescribing histories, no effective risk assessments being undertaken, reviewed and/or incorporated (for instance on which medications would be considered as safe for remote prescribing). Whether prosecuting or defending, these themes will feature in professional disciplinary hearings in the future.
Zahra Ahmed is a barrister at 33 Bedford Row Chambers, London. She specialises in public and regulatory law 33bedfordrow.co.uk