The risk of opioids to UK pharmacy
Amidst the swell of litigation surrounding the opioid crisis in the US, the ripples of a court decision against the three largest pharmacy chains are being felt here in the UK. Andrew Andrews explains…
On 23 November 2021, CVS, Walmart and Walgreens were adjudged to have recklessly distributed vast quantities of prescription opioid pills, effectively holding the pharmacy chains accountable for playing a part in the opioid crisis and a failure to have adequate systems in place.
Following this decision, there is understandable concern amongst UK-based pharmacies that pharmacy owners, pharmacists and independent prescribers might too be held accountable and become subject to potential claims or regulatory action following incidents of patient opioid misuse.
Parallels have been drawn between the opioid crisis in the US and the substantial increase in opioid prescribing within the UK. Following the recommendations of The Opioid Expert Working Group of the Commission on Human Medicines, the Medicines and Healthcare products Regulatory Agency (MHRA) required stronger warnings about the risk of dependence and addiction to be added to patient information leaflets and for healthcare professionals to discuss these warnings with patients.
The General Pharmaceutical Council (GPhC) introduced additional safeguards for online pharmacies, within its guidance for pharmacist prescribers. It specifically referenced opioids as being a category of medicines not suitable to be prescribed or supplied at a distance, unless additional safeguards could be satisfied, which included the need:
· for robust processes for the verification of patient identity.
· to contact the patient's regular prescriber and for their consent to contact them about a prescription.
· for proactive sharing of all relevant information about the prescription with all individuals involved in the care of the patient.
· to contact the patient's GP to obtain their approval that the opioids are appropriate for that patient, and that there exists an appropriate system of monitoring in place.
· to have adequate systems in place where a patient does not have a regular prescriber or consent is not forthcoming, to ensure that there is a clear record for justifying the prescribing of opioids in these circumstances.
· for the prescribing of the opioids to be within national and local prescribing guidelines and best practice guidance.
Pharmacists and their teams play an important role in supporting patients and preventing harm arising from the misuse of opioids. As a result of the challenges presented by Covid-19, this has meant that patients are not always able or willing to have face to face contact with their pharmacist. This has its limitations in not being able to assess the patient's symptoms, their capacity to make decisions about their medicines and ensure that they fully understand how to take them safely.
Mitigating Opioid Misuse
Pharmacist prescribers remain accountable for their prescribing decisions and are required to always assess and manage any risks associated with their prescribing, particularly given the risks of abuse, misuse and the need for ongoing monitoring when prescribing opioids.
There is a very real risk of harm arising from opioid misuse. In the event of a serious incident, should a pharmacist not have prescribed or advised a patient appropriately, the individual and the pharmacy could both potentially be held liable by way of a claim and enforcement and regulatory action being taken by the GPhC. It is necessary that there is sufficient indemnity cover in place, which would cover legal expenses in the event of a future claim.
As part of its routine pharmacy inspections, the GPhC seeks to verify that high-risk medicines are always supplied with appropriate steps taken by the pharmacy owner, prescriber, responsible pharmacist and other members of the pharmacy team.
Pharmacies should ensure that there are clear communication pathways with other care providers to ensure prompt access to patient records and all relevant information about a patient, the supply of their medicines and any risks. Prescribed doses and durations must be appropriate and that any unusual doses or repeat prescriptions that might fall outside of the guidelines should be sufficiently scrutinised and discussed, where necessary, with the patient's GP.
All pharmacy professionals have a responsibility to adhere to those safeguards and evidence compliance aligned to the guidelines and best practice guidance and to potentially question decisions or raise concerns, where necessary, to enable them to be in a position to robustly defend any claims or concerns raised against them, should they ever need to.
It is important that pharmacy owners ensure that systems and measures are sufficiently robust and agile to enable their business to continue to deliver safe and effective care and services, regardless of a pandemic, demand pressures and staff illnesses.
The prescribing and supply of opioids presents as one of many risks that can be effectively controlled. Whilst the risk of harm or indeed litigation can never be entirely eliminated, pharmacy owners and professionals need to keep doing all that is reasonably practicable to protect their patients from harm.
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