Taking action on unsafe supply of high-risk medicines online
We are taking regulatory and enforcement action after identifying significant patient safety concerns in relation to the supply of high-risk habit-forming medicines online.
These patient safety concerns were identified during recent pharmacy inspections which looked at whether online pharmacy owners were meeting the standards for registered pharmacies [PDF 986 KB] and following updated guidance published in April this year [PDF 575 KB].
In light of the very real patient safety risks identified, we have now written to online pharmacy owners to emphasise that they should not operate a pharmacy model where prescribing and supply decisions for habit-forming medicines are primarily informed by online questionnaires with no access to a patient’s medical history or consent to contact a patient’s GP, and without appropriate risk management and safeguards in place.
Managing risks of supplying medicines online
The updated guidance on providing pharmacy services at a distance [PDF 575 KB] states clearly that selling and supplying medicines at a distance brings different risks which need to be appropriately managed to protect patient safety. Medicines are not ordinary items of commerce and must not be treated as such.
The guidance makes clear that some categories of medicines are not suitable to be supplied online unless further safeguards have been put in place to make sure they are clinically appropriate for patients. This includes medicines liable to abuse, overuse or misuse, or when there is a risk of addiction and ongoing monitoring is important, such as opiates and sedatives.
We have identified cases where some online pharmacies have supplied these high-risk medicines to patients without appropriate steps being taken by the pharmacy owner, prescriber, responsible pharmacist or other members of the team to check that the medicine being prescribed and dispensed was clinically appropriate for the patient.
In response, we are taking enforcement and regulatory action where appropriate against the owners of these registered pharmacies, as well as individual pharmacy professionals involved in both the prescribing and supply of medicines where their conduct may have fallen short of professional standards. In particular, we are taking enforcement action where we see high-risk habit-forming medicines being supplied where the prescriber is relying primarily on an online questionnaire completed by the patient to inform their decision to prescribe, and without other appropriate steps being taken to check that the medicine being prescribed and dispensed is clinically appropriate for the patient.
Examples of enforcement action taken:
Enforcement action against an online pharmacy owner: conditions on registration
An online pharmacy had conditions imposed on its registration after patient safety concerns were identified in relation to a private dispensing service provided to overseas patients. These safety concerns included the prescriber working for the service relying predominantly on online questionnaires completed by the patient to inform the prescriber’s decision on whether to prescribe habit-forming medicines, with no access to patient’s medical records and/or contact with the patient’s GP. The online pharmacy has had to stop providing this service until the pharmacy can demonstrate that there are adequate systems in place to:
- manage the associated risks of this service to protect the safety and wellbeing of patients;
- meet GPhC standards for registered pharmacies and GPhC guidance for registered pharmacies providing pharmacy services at a distance, including on the internet; and
- meet record-keeping requirements for dispensed medicines, labelling of dispensed medicines, and supply of prescription-only medicines against lawful prescriptions.
Enforcement action against an online pharmacy owner: improvement notice and conditions on registration
An online pharmacy was given an improvement notice setting out improvements it had to make after not meeting a number of standards during an inspection. The safety concerns again included the prescriber working for the service relying predominantly on online questionnaires completed by the patient to inform the prescriber’s decision on whether to prescribe habit-forming medicines, with no access to patient’s medical records and/or contact with the patient’s GP.
The improvements the pharmacy had to make included making sure:
- the pharmacy effectively monitors and reviews all prescriptions to prevent over-ordering or misuse
- the prescribers the pharmacy works with are operating within their spheres of competence and working within UK national prescribing guidelines and good practice guidance.
The inspector monitored the pharmacy’s compliance with the improvement notice. After identifying that sufficient improvements had not been made to protect patient safety, a condition was imposed on the pharmacy that it must not dispense any controlled drugs from schedule 1 to 5.
Fitness to Practise investigation: responsible pharmacists
We are investigating a number of concerns about responsible pharmacists working for online healthcare services who dispensed medicines when appropriate safeguards were not in place to make sure that the prescriptions were clinically appropriate for patients. In some of these cases, the responsible pharmacists were dispensing medicines liable to abuse, overuse or misuse, or when there was a risk of addiction, and so which may have been sought online by vulnerable people.
Fitness to Practise investigation: pharmacist independent prescriber
A pharmacist independent prescriber working for an online pharmacy was referred by a GPhC inspector for a fitness to practise investigation after concerns were identified about their practice during an inspection. We are now investigating the concerns that the pharmacist independent prescriber prescribed high-risk medicines to patients without having the information they needed about the patient to provide appropriate care or to enable them to use their judgement to make clinical and professional decisions. The pharmacist independent prescriber is alleged to have based their prescribing decisions on information provided by patients in online questionnaires and was not consulting with the patient, reviewing medical records or contacting the patient’s GP. An interim order has been imposed on the pharmacist’s practice while the investigation is ongoing so the pharmacist cannot prescribe or work in an online pharmacy while the interim order remains in place.
Required action from all online pharmacies
Our chief executive Duncan Rudkin has now written to the owners of online pharmacies [PDF 210 KB] and asked them to provide information on the actions they have taken to follow the new guidance and make sure patients access pharmacy services online safely. This information will be used to proactively prioritise our inspection programme.
Online pharmacy owners have been asked to consider the implications of two recent determinations from the Medical Practitioners’ Tribunal Service. Two doctors working for an online pharmacy had their GMC registration suspended after they were found to have inappropriately issued a number of online prescriptions of opioid medication. The Tribunal also found that the operating model was inappropriate in that the doctors based their prescribing decisions primarily on information provided by patients in online questionnaires. The operating model did not allow the opportunity for face to face consultations and the doctors did not have access to the patients’ GP records. The first determination is available here and the second determination is available here.
Key points to note:
- Online pharmacy owners have to provide information to the GPhC on the actions they have taken to follow the updated guidance and make sure patients access pharmacy services online safely by 16 October.
- Online pharmacy owners have to make sure they are not operating or working within a pharmacy model where prescribing and supply decisions for habit-forming medicines are primarily informed by online questionnaires with no access to a patient’s medical history or consent to contact a patient’s GP and without appropriate risk management and safeguards in place.
- Prescribers working for online pharmacies who are prescribing remotely need to take appropriate steps to make sure a medicine is clinically appropriate for a patient, as outlined in regulatory standards and guidance.
- Pharmacists and pharmacy technicians working for online pharmacies also have an important responsibility to use their professional judgement to make clinical and professional decisions. This would include considering whether appropriate safeguards are in place at each stage within the system in which they are working to identify if a medicine is clinically appropriate for a patient, even if they are not responsible for the decisions made at earlier stages. They should challenge poor practice and behaviours that could potentially put patients at risk.
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