As more people turn to the internet to find out more about their health conditions, it is not unexpected for people to want to buy their medications online too, especially prescription-only medications.
With technological advancement that increases accessibility and convenience, how can you make sure that any risks associated with buying a medication online are reduced?
When you carry out a search online, the results are not always from UK websites only. The same is applicable to websites that sell medications. A lot of the search results are likely to be from websites outside of the UK and outside of UK regulation.
What are the risks of buying medications online?
When you buy any medication, especially prescription only medicines (POMs), from unregistered or unauthorised sources, you run the risk of receiving substandard or fake medicines.
If you buy the medicine without first speaking with a duly registered and qualified health care professional, you run the risk of being supplied with a medication that isn’t suitable for you as an individual or is not safe for you to take, based on your own medical history. These medicines may not meet UK regulatory and quality standards.
Furthermore, if you buy any medicine from an unregulated website, you don’t know what you are taking. Is the medication you received what you are meant to receive? There’s no way for you to know what effect these drugs could have on your health.
What is Professional Regulation?
Professional regulation is a way to ensure that certain professionals, especially healthcare professionals, carry out their practices safely and continue to do so throughout the course of their career. This is done to reduce the risk of harm occurring when people receive treatment or care.
The General Pharmaceutical Council (GPhC) is the organisation that regulates pharmacists, pharmacy technicians and pharmacies in Great Britain. They work to assure and improve standards of care for people using pharmacy services by setting important safeguards.
The Medicines & Healthcare products Regulatory Agency (MHRA) is an executive agency, sponsored by the Department of Health and Social Care that regulates medicines, medical devices and blood components for transfusion in the UK. It plays a leading role in protecting and improving public health. It does this by ensuring that medicines, medical devices and blood components for transfusion in the UK meet applicable standards of safety, quality and efficacy and the supply chain is safe and secure.
The Care Quality Commission (CQC) monitor, inspect and regulate services to ensure they meet fundamental standards of quality and safety. They set out what good and outstanding care looks like and ensure services meet fundamental standards. The CQC inspects hospitals, GPs and doctors and care homes.
The General Medical Council (GMC) help to protect patients and improve medical education and practice in the UK by setting standards for students and doctors. The GMC supports students and doctors in achieving and exceeding those standards, and take action when they are not met.
Why are these safeguards important?
The GPhC published on their blog about being aware of situations where patients have been put at risk due to inappropriate prescribing, sale and supply of medicines over the internet. This is because some primary care service providers undermine important safeguards put in place to protect patients from accessing medications that are not clinically suitable for them.
With some online primary care providers, anyone can obtain a prescription only medication with just a few clicks on their computer screen, where they answer a short online questionnaire and submit their credit or debit card details.
However, medicines are not ordinary items of commerce and thus, must not be treated as such.
What are prescription only medicines?
Prescription only medicines (POMs) are a legal category of medicines. This means that medications in this category can only be supplied according to the instructions in a legal prescription written by a duly qualified and registered doctor or independent prescriber, for instance, a Nurse Independent Prescriber or a Pharmacist Prescriber.
How does the GPhC protect patients going online for their medicines?
According to the GPhC, regulating healthcare services and/or providers online, especially online pharmacies is a very complex process. This is because different organisations and agencies are responsible for different parts of the service.
The GPhC has been working hand in hand with other regulators in Great Britain that is involved in regulating online prescribing services to ensure that patients receive safe and effective care at every stage from when they initially visit an online primary care service provider to when they receive their medications from a pharmacy.
What are the GPhC proposed safeguards?
As of June 2018, the GPhC is proposing to add the following points to their updated guidance:
- Transparency and patient choice – this governs what information a pharmacy should provide to the general public about the primary care services being offered online and who is providing them. This would help people make informed decisions about where to obtain their medicines and other services
- Making sure medicines are clinically appropriate for patients – Is it appropriate for online pharmacies to allow patients to choose a prescription only medicine, and its quantity, before having a consultation with a prescriber. The GPhC is still open to receiving views about this including the potential benefits and risks of patients being able to do this
- Further safeguards for certain categories of prescription-only medicines – The GPhC is proposing that certain categories of medicines including antibiotics and sedatives, may not be suitable to be prescribed online unless further steps are undertaken to ensure that these categories of medicines are clinically appropriate for the patient. Further steps that could be taken include contacting the patient’s GP. The GPhC wants to make it clear that it is not appropriate for pharmacy owners to work with prescribing services unless they are assured that the safeguards they have identified are in place
- Regulatory oversight – It is not appropriate for pharmacy owners to with prescribing providers online who may intentionally try to bypass the regulatory oversight that aims to ensure patient safety throughout the healthcare system. These potential additional risks to patients can occur if pharmacy owners choose to work with prescribers or prescribing services that operate outside the UK. Should a pharmacy owner choose to do this, then the pharmacy owner is expected to manage these additional risks it creates.
GPhC Guidance for registered pharmacies providing pharmacy services at a distance, including on the internet
The GPhC guidance for registered pharmacies providing pharmacy services online recommends that if the online pharmacy also sells Pharmacy Only Medicines (P medicines) or works with an online prescribing service to supply POMs, the pharmacy owners needs to ensure that these categories of medicines are only displayed for sale on a website that is associated with a registered pharmacy.
This could be under a service level agreement or some other arrangement. The public may be able to access the site directly or through a third-party site. People who use pharmacy services should be able to select a P medicine for purchase only on a website associated with a registered pharmacy.
The pharmacy owner makes sure that their website works effectively and looks professional. The website must be secure and follow information security management guidelines and the law on data protection. This is particularly important when the website asks patients for their personal details.
The pharmacy owner must make sure that their website has secure facilities for collecting, using and storing patient details and a secure link for processing card payments. All information must be clear, accurate and updated regularly, and it must not be misleading in any way. The website may include information about medicines, health advice and links to other information sources such as relevant healthcare services and other regulators.
The site must not mislead pharmacy service users about the identity or location of the pharmacies involved in providing your pharmacy services. Links from the pharmacy website to an online prescribing service or another registered pharmacy website must be clearly shown as such. Some pharmacy businesses and online prescribing services are owned by the same company and operate together using the same website.
If a pharmacy owner allows a link from their website to another business (either hosted on your website or reached by an external link) the pharmacy owner is responsible for making sure that the business is legitimate. And, if relevant, it must be registered with the appropriate regulator such as the Care Quality Commission, Healthcare Improvement Scotland or the Health Inspectorate Wales
How does the MHRA protect patients going online for their medicines?
In 2015, the MHRA released a press release stating that “from 1 July anybody in the UK selling medicines online to the general public needs to be registered with the MHRA and to be on the MHRA’s list of UK registered online retail sellers.”
How does the CQC protect patients going online for the medicines?
Before a care provider can undertake any of the activities regulated by the CQC, they must register with them and satisfy that they meet several requirements including the fundamental standards of quality and safety.
The CQC uses data, evidence and information throughout their work and inspections carried out by experts. After an inspection, the CQC publishes an inspection report with ratings on how the service provider performed overall as well as rate different areas. The ratings range from Outstanding to Inadequate. Care providers legally need to display the ratings given to them by the CQC including on their website.
The CQC shares information about services and people’s experience of them with some of their national partners like the MHRA and the GPhC.
The CQC regulates providers of online primary care services in England where they provide regulated activities including:
- treatment of disease, disorder or injury
- transport services, triage and medical advice provided remotely
- diagnostic and screening procedures.
‘Providers of online primary care’ refers to healthcare services that provide a regulated activity by an online means. This involves transmitting information by text, sound, images or other digital forms for the prevention, diagnosis or treatment of disease and to follow up patients’ treatment.
When a new provider of online primary care registers with CQC, the CQC aims to inspect them within three months of registration. If they do not identify any breaches of regulations in that comprehensive inspection, they will inspect again after approximately two years. If they find any breaches of a regulation, they will base the frequency of their inspections on the level of risk and the significance of their concerns, and any enforcement action they have taken.
To direct the focus of their inspection, CQC inspection teams use a set of key lines of enquiry (KLOEs) that directly relate to the five key questions – are services safe, effective, caring, responsive and well-led? For online primary health care inspections, they use the standard KLOEs for healthcare services.
The CQC does not currently have the legal powers to rate providers of online primary care, although they expect to be granted these powers in the future.
What are the CQC fundamental standards?
Everyone has the right to expect the following standards of care:
- Person-centred care – The care or treatment you received should be tailored to you and should meet your health needs and preferences
- Dignity and respect – Whilst receiving care and treatment, you should be treated with dignity and respect and be given any support you need to remain independent
- Consent – You (or anyone legally acting on your behalf) must give your consent before any care or treatment is given to you
- Safety – You must not be given unsafe care or treatment or be put at risk of harm that could be avoided. Providers must assess the risks of harm to your health and safety during any care or treatment
- Safeguarding from abuse – You must not suffer from any form of abuse or improper treatment whilst receiving care
- Complaints – You must be able to complain about the care or treatment you receive
You can find out more about the CQC Fundamental Standards on their website.
How does the GMC protect patients going online for their medicines?
The GMC has set strict guidelines that doctors need to follow before prescribing medications, especially POMs, to patients remotely:
Before you prescribe for a patient via telephone, video-link or online, you must satisfy yourself that you can make an adequate assessment, establish a dialogue and obtain the patient’s consent in accordance with the guidance at paragraphs 20 – 29.
You may prescribe only when you have adequate knowledge of the patient’s health and are satisfied that the medicines serve the patient’s needs. You must consider:
the limitations of the medium through which you are communicating with the patient
the need for physical examination or other assessments
whether you have access to the patient’s medical records.
You must undertake a physical examination of patients before prescribing non-surgical cosmetic medicinal products such as Botox, Dysport or Vistabel or other injectable cosmetic medicines. You must not, therefore, prescribe these medicines by telephone, video-link, or online.
If you are prescribing for a patient in a care or nursing home or hospice, you should communicate with the patient (or, if that is not practicable, the person caring for them) to make your assessment and to provide the necessary information and advice. You should make sure that any instructions, for example for administration or monitoring the patient’s condition, are understood and send written confirmation as soon as possible.
If the patient has not been referred to you by their general practitioner, you do not have access to their medical records, and you have not previously provided them with face-to-face care, you must also:
give your name and, if you are prescribing online, your GMC number
explain how the remote consultation will work and what to do if they have any concerns or questions
follow the advice in paragraphs 30 – 34 on Sharing information with colleagues.
You should not collude in the unlawful advertising of prescription-only or unlicensed medicines to the public by prescribing via websites that breach advertising regulations.
If you prescribe for patients who are overseas, you should consider how you or local healthcare professionals will monitor their condition. You should also have regard to differences in a product’s licensed name, indications and recommended dosage regimen. You may also need to consider:
MHRA guidance on import/export requirements and safety of delivery,
whether you will need additional indemnity cover
whether you will need to be registered with a regulatory body in the country in which the prescribed medicines are to be dispensed.
How can you verify that an online pharmacy is legitimate?
As pharmacy is a regulated profession, all pharmacists, pharmacy technicians and pharmacy premises need to be registered with the GPhC. All pharmacies, including online pharmacies, need to have a responsible pharmacist.
As a member of the public, before using the services of an online pharmacy to buy or request the supply of a medication, the first step to confirming if an online pharmacy is legitimate, you need to ask yourself: “has the details of the responsible pharmacist been published on their website as well as the address of the pharmacy premises?”
If these details are not published on the website, then there is a great chance that the online pharmacy is not a legitimate one. Even if these details have been published, you can verify the published details on the GPhC website. The GPhC keeps a register of pharmacists, pharmacy technicians and pharmacy premises that are registered with them. The register is available online for the public to search for pharmacists, pharmacy technicians and pharmacy premises.
If the name of the responsible pharmacist published on the website of an online pharmacy does not show up on the GPhC register when you search for that person, then that person is not a registered pharmacist with the GPhC. The same thing applies with the pharmacy premises, if it does not show up in your search result on the GPhC website when you search their online register, then it means that online pharmacy is not registered with the GPhC.
You can search for a pharmacist, pharmacy technician, or pharmacy here https://www.pharmacyregulation.org/registers
Anyone who is not registered with the GPhC but practises as a pharmacist or pharmacy technician, or refers to themselves as such, is breaking the law and can be prosecuted.
As a minimum, the GPhC recommends that the following information is published on an online pharmacy website:
- the GPhC pharmacy registration number
- the name of the owner of the registered pharmacy
- the name of the superintendent pharmacist, if there is one
- the name and address of the registered pharmacy that supplies the medicines
- details of the registered pharmacy where medicines are prepared, assembled, dispensed and labelled for individual patients against prescriptions (if any of these
- happen at a different pharmacy from that supplying the medicines)
- information about how to check the registration status of the pharmacy and the superintendent pharmacist (if there is one)
- the email address and phone number of the pharmacy
- details of how patients and users of pharmacy services can give feedback and raise concerns
- the MHRA EU internet logo
- voluntary GPhC internet logo
Either logo should link to that pharmacy’s entry in the appropriate register.
Anyone in the UK selling medicines online “needs to display on every page of their website offering medicines for sale, the new European common logo which is registered to the seller.
The registered EU common logo will contain a hyperlink to their entry in the MHRA’s list of registered online sellers.
Anybody buying medicines online can check if the website is legitimately registered and will be able to click on the logo which will take them through to a list of approved sellers.
If the registered person retails a medicine through a third-party marketplace website, then the third-party marketplace service provider must display that registered person’s EU Common Logo on every page of their website that offers the registered person’s medicine for sale to the public from that service provider’s site.
This is a different scheme to the voluntary logo run by the General Pharmaceutical Council (GPhC) or Pharmaceutical Society Northern Ireland (PSNI). The EU common logo is a legal requirement across Europe whilst the GPhC/ PSNI run a voluntary logo scheme which is applicable only to registered pharmacies.
Under the rules of the new scheme, the medicine being offered online must be licensed in the member state where the member of the public who buys the medicine is based.
The person selling the medicine must be legally entitled to sell medicine to the public in accordance with UK medicines legislation.
Registered pharmacies can sell general sales list medicine, pharmacy medicine or supply prescription-only medicine that they have dispensed against a prescription. All other general retailers can only sell general sales list products.
The penalty for selling medicines online without being registered and not displaying the logo is up to 2 years in prison or a fine or both.”
If an online pharmacy has its own in-house online doctor service, you can check that the service is registered with the CQC via the search box on their website or by calling 03000 616161.
All fully approved and regulated websites should have a clickable link that will take you to the CQC register to show that they are compliant.
If an online pharmacy has its own in-house online doctor service, the name of the doctor should be displayed on the website. You can check if the doctor is registered with the GMC by using the search facility on their website to search their register.
Mens Pharmacy is not liable for the currency or accuracy of the information contained in this blog post. For specific information about your personal medical condition, please contact our doctors or pharmacists for advice on [email protected].