IMPORTANT: Patient safety update for owners / superintendent pharmacists providing online pharmacy services including those linked to online prescribing services
30 Sep 2019
Patient safety update for owners / superintendent pharmacists that are providing online pharmacy services including those linked to online prescribing service
Please note that this update is intended for pharmacies regulated and inspected by the GPhC in England, Scotland and Wales. Pharmacies in Northern Ireland are included in this update for information purposes – you are advised to review your pharmacy service models in line with the Pharmaceutical Society of Northern Ireland’s (PSNI) standards and guidance.
During the last two weeks, pharmacies providing online pharmacy services, including those linked to online prescribing services have come under increased scrutiny from both the General Pharmaceutical Council (GPhC) and the media, especially due to concerns about inappropriate prescribing and supply of opioids.
You may also be aware that “The Times” newspaper published three articles on Saturday 28 September 2019 on online prescribing and supply of opioids from online pharmacies. The articles also covered the recent action taken by the GPhC against online pharmacies who have been identified as supplying high-risk medicines without proper checks.
In April 2019, the GPhC published its updated guidance for pharmacy owners providing pharmacy services at a distance, including on the internet. The guidance made it clear that some categories of medicines, including opioids, are not suitable to be supplied online unless further safeguards have been put in place to ensure they are clinically appropriate for patients. GPhC inspectors have been looking for evidence that the guidance is being followed during their pharmacy inspections.
The NPA strongly supports the safeguards introduced for online pharmacies by the GPhC in this updated guidance in April 2019 and the proactive steps it is taking to check compliance, especially around supply of high-risk medicines. This is in the interests of patient safety, which must be the first concern of every pharmacist and every pharmacy owner.
The NPA has produced a factsheet, “Providing online pharmacy services safely” to help pharmacy owners/superintendent pharmacists to safely provide online pharmacy services in line with the GPhC’s updated guidance. The factsheet provides guidance and information on the following:
- Key areas of concern regarding online pharmacies/prescribing services
- Key action points for owners / superintendent pharmacists
- Conducting a pharmacy-specific risk-assessment
- High-risk categories of medicines
- Safeguards when incorporating online prescribing services/prescribers
Whilst the vast majority of registered internet and ‘bricks & mortar’ pharmacies provide safe pharmacy services which meet the GPhC’s professional standards, evidenced by the recent publication of inspection reports by the GPhC, a small number of pharmacies have been identified as operating in a manner which poses significant risk to patient safety.
On 17 September 2019, the GPhC announced the launch of their new site publishing inspection reports in the public domain. The reports, which are available publicly, show that the majority of pharmacies inspected are meeting professional standards. The GPhC’s knowledge hub shows examples of good, and poor, practices identified during the inspections. The published reports included those from online pharmacies inspected since the updated GPhC guidance was published in April 2019.
On 18 September 2019, the GPhC announced that it is taking action against online pharmacies who have been identified as supplying high-risk medicines without proper checks.
The chief executive of the GPhC, Duncan Rudkin, has written to the owners of online pharmacies and asked them to provide information on the actions they have taken to follow the new guidance and make sure patients access online pharmacy services safely. Owners are required to respond to the GPhC via email to firstname.lastname@example.org by 16 October 2019 with the requested information.
If you are operating a pharmacy service model that provides pharmacy services to patients at a distance, and you have received this letter from the GPhC, we recommend that you respond to the GPhC by the deadline of 16 October 2019.
Joint statement from regulators of online primary care services
On 26 September 2019, the GPhC and other primary care regulators of healthcare services, medicines and health professionals throughout the UK, issued a joint statement. The regulators recognise that while the majority of medicines are prescribed and dispensed appropriately online, there are instances when patients are able to access medicines inappropriately, and/or in quantities that they would not usually be prescribed by their regular GP or through other NHS services. The regulators are concerned that certain pharmacy/prescribing service models may be operating in ways that may take them out of the scope of UK regulators and thus prevent them from being liable to the same degree of inspections and safety checks as those who fall within the scope of the UK regulators.
- The Care Quality Commission (CQC) has requested changes to the law to bring online providers into regulation that have so far been out of scope due to their pharmacy/prescribing service model which means they must be registered with the CQC by law.
- The Medicines and Healthcare products Regulatory Agency (MHRA) is working with the Department of Health and Social Care (DHSC) and others to review opioid addiction, including online sales.
If you are an owner/superintendent pharmacist of a pharmacy that provides pharmacy/ prescribing services at a distance, you must read and understand the GPhC’s updated guidance for pharmacy owners providing pharmacy services at a distance, including on the internet. In addition, you may find it helpful to familiarise yourself with the GPhC’s Inspection Decision-making Framework which provides examples that may show when GPhC standards have/have not been met.
DISCLAIMER: The information included in this update is a very brief summary and for information purposes only. You must read the full GPhC guidance and take all necessary actions to meet the requirements of the guidance as well as professional standards for registered pharmacy premises, and pharmacy professionals. The NPA does not accept any responsibility for any consequences of actions taken or decisions made as a result of the information presented in this update. It remains the responsibility of the pharmacy owner/superintendent pharmacist, in all cases, to ensure that they do their own due diligence in all matters involving their pharmacy business.
For further advice and support from the Pharmacy Services team:
- Call us on 01727 891800 between 9am and 6pm Monday – Friday, and 9am to 1pm on Saturdays
- Email us anytime at email@example.com
To check your professional indemnity arrangements, contact the Member Services team:
- Tel: 01727 795914 between 9am and 5pm Monday – Friday