Poor systems
Ania was detained under the Mental Health Act for her own safety, but a combination of poorly devised or implemented safety systems in the mental health unit where she lived and the online medicines providers she used, compromised that safety. Ania was able to easily purchase significant amounts of a potent medicine from five different online pharmacies which she was able to smuggle into the unit and ingest. Ania took a significant overdose the day after returning to the unit from home leave and by the time staff realised that she was seriously unwell, nothing could be done to save her despite prolonged efforts.
Coroner’s concerns
The coroner who presided over Ania’s inquest felt that several of the issues uncovered during witness testimony warranted the drafting of a Regulation 28 Report to prevent future deaths. This section regarding online prescribing is taken from the report:
The MATTERS OF CONCERN in relation to on-line prescribing are as follows:
(1) Whilst each individual pharmacy had in-house safety checks to safeguard against over prescribing by their own pharmacy, there is no integrated system in place which would alert a prescriber to prescriptions that have been dispensed by other online pharmacies. As a result, it is currently possible for a patient to obtain excessive quantities of medication by simply placing multiple orders with different online pharmacists.
(2) There is no requirement for the online pharmacies to share information with the patient’s GP. This means that, in the absence of the patient’s consent to share information, the online prescriber is reliant on the accuracy and truthfulness of the history provided by the patient.
(3) Lack of information sharing also creates a risk that a GP or Pharmacist Prescriber may unwittingly prescribe a medication that is contraindicated with a medication that has been dispensed through an online pharmacy.
Conclusion
The PDA has repeatedly warned its members about the risks of working as a prescriber in online pharmacies where there is no direct communication with the patient or their general practitioner. More than 30% of open Fitness to Practise cases at the GPhC relate to online pharmacy – a disproportionate amount compared to other pharmacy service providers. Fitness to Practice Committees considering these cases are taking a firm line, with pharmacists being suspended for significant periods of time from practice.
Following earlier cases where patients have died following overdoses of opiate medication, the GPhC issued In Practice: Guidance for Pharmacist Prescribers in November 2019. At that time, they included the following guidance:
Some categories of medicines are not suitable to be prescribed or supplied at a distance unless further safeguards have been put in place to make sure that they are clinically appropriate. The categories include:
Medicines liable to abuse, overuse or misuse, or when there is a risk of addiction, and ongoing monitoring is important. For example: opioids, sedatives, laxatives, and gabapentinoids.
The guidance goes on to require the following steps to reduce risk:
Safeguards to put in place if the above categories of medicines are to be supplied online:
If a pharmacist prescriber decides to prescribe at a distance or work with an online prescribing service, the above categories of medicines should not be prescribed unless the prescriber:
- Has robust processes in place to check the identity of the person, to make sure the medicines prescribed go to the right person
- Has asked the person for the contact details of their regular prescriber, such as their GP, and for their consent to contact them about the prescription
- Will proactively share all relevant information about the prescription with other health professionals involved in the care of the person (for example their GP)
- Has contacted the GP in advance of issuing a prescription for medicines which are liable to abuse, overuse or misuse (or where there is a risk of addiction and ongoing monitoring is important) and the GP has confirmed to the prescriber that the prescription is appropriate for the person and that appropriate monitoring is in place.
- Has systems in place for circumstances when the person does not have a regular prescriber such as a GP, or there is no consent to share information, and the pharmacist prescriber has decided, in exceptional circumstances, still to issue a prescription. They should make a clear record setting out their justification for prescribing (for example: how they have kept any risks as low as possible; the immediate need; how they have arrived at their decision to prescribe; and the exceptional circumstances)
Given the very sad outcome in this and other similar cases, the PDA urges the GPhC to extend the guidance above to include other medications including those which may not be considered ‘high-risk’ in normal usage, but which can be highly toxic in overdosage. It cannot be in patients’ best interests to allow almost unchecked access to prescription medicines which can cause fatalities when misused, with no requirement to alert GPs to the proposed supply. A common feature in these tragic events is that the pharmacist has no interaction whatsoever with the patient, instead relying solely on a questionnaire completed online.
Ania Sohail’s GPs had no idea that she was obtaining online supplies of a potentially harmful medication until they received the sad news of her death from the local hospital. Given her history of self-harm, they would most likely have been able to advise against supply, had they been contacted.
As part of the PDA’s ongoing work to minimise risk for patients and its members, the PDA strongly advises any pharmacist working in a private online setting to include the following considerations and steps when deciding whether or not to prescribe high-risk medicines including those which are toxic in overdosage:
- The prescriber should consider a refusal to consent to GP contact as a red flag
- Such a refusal must generate a clinical intervention by the prescriber via a phone/video call
- The patient should be gently probed to understand why they do not wish to consent
- The patient should be informed of the risks to their safe care and difficulties presented to other prescribers by a refusal to consent
- The patient should be encouraged to review their decision considering the above
- The information provided on the questionnaire can be explored to verify its accuracy at the same time
- After the discussion, the prescriber must fully document their thought process for deciding to prescribe or not.
If the risks of prescribing outweigh the risks of not prescribing, the patient should be informed and signposted to their own GP or other suitable healthcare provider.
The pharmacists called to give evidence at Ania’s inquest will have to live with the knowledge that she ended her life with medicines they prescribed for her.
The purpose of this article is to improve safety and alert pharmacists to the risks associated with prescribing for patients (some of whom may be vulnerable) within online systems which omit direct patient contact and communication with the GP, so that they can put in place appropriate mitigations which may prevent them from finding themselves in a similar distressing situation.
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