We know that pharmacy owners and professionals have a number of questions about the new guidance .
Find out below, the answers to some of the most frequently asked questions:
How do pharmacies make sure that patients receive medicines that are clinically appropriate?
Our guidance puts in place extra safeguards to help make sure that patients only receive medicines that are clinically appropriate for them. This includes medicines liable to abuse, overuse or misuse, or when there is a risk of addiction and ongoing monitoring is important.
These safeguards include making sure the prescriber proactively shares all relevant information about the prescription with the patient’s regular prescriber after seeking the patient’s consent.
In the case of medicines liable to abuse, overuse or misuse, or where risk of addiction and ongoing monitoring is important, the pharmacy owner should assure themselves that the prescriber has contacted the regular prescriber (usually the GP) in advance of issuing a prescription, and asked for confirmation from them that the prescription is appropriate, and that monitoring is in place.
In cases where a patient does not have a GP, or a regular prescriber, or if there is no consent to share information and the prescriber has still issued a prescription, pharmacy owners should assure themselves that the prescriber has made a clear record setting out their justification for issuing the prescription.
What are online pharmacies now expected to do to check someone's identity?
We are expecting all online pharmacies to have systems in place to carry out appropriate identity checks.
During a risk assessment the pharmacy owner would gather evidence about the risks for each individual service, medicine and medical device that they provide at a distance, including on the internet, before providing that service. Through this careful and thorough look at the individual medicine, they should determine what level of identity checking will be appropriate.
We are not specifying a particular technical solution for checking identity but instead saying that online pharmacy owners should have a robust process in place to carry out checks appropriate to the medication they are supplying. They should be ready to explain to our inspectors how they are doing this.
For example, the identity checking system may be different for a high-risk medication and a medication with lower risk. Ways to check identity check could be to use an external credit reference database, a specific identity checking service or to carry out varying degrees of photo ID verification.
If pharmacy owners work with an online prescribing service or prescriber, they should also assure themselves that the prescriber has robust processes to check the identity of the person, and to make sure the medicines prescribed go to the right person.
For example, the pharmacy owner may check that the online prescribing service or prescriber is keeping to the Identity Verification and Authentication Standard for Digital Health and Care Services, which provides a consistent approach to identity checking across online digital health and care services.
Can patients still choose their medicine before a consultation online?
We know from our own regulatory tools and from external sources that this is a key risk for patients.
As set out in our guidance, we expect pharmacy owners to make sure that their website and the websites of companies they work with are arranged so that a person cannot choose a POM and its quantity before there has been an appropriate consultation with a prescriber.
Our guidance reflects what is set out by the MHRA’s Blue Guide on the advertising and promotion of medicines. But it sets an additional requirement for online pharmacies- that an appropriate consultation to be carried out before a POM and its quantity can be chosen. It also stipulates that online pharmacies should make clear that the decisions about treatment are for both the prescriber and the person to jointly consider during the consultation, in line with the MHRA’s guidance. However, the final decision will always be the prescriber's.
Will patients be able to get multiple orders to the same address?
We are clear in the guidance that owners must make sure that there are robust processes in place within the online pharmacy to:
- carry out identity checks on people obtaining medicines
- identify requests for medicines that are inappropriate, including multiple orders to the same address or orders using the same payment details.
Can online pharmacies work with prescribing services based outside the UK?
In the guidance we say that working with prescribers who are not appropriately registered with the relevant UK professional regulator, and with prescribing services not based in the UK, could create significant extra risks for patients and the public.
If pharmacy owners do decide to work with prescribers or prescribing services operating outside the UK, they need to make sure that they successfully manage the extra risks and that the prescriber is working within national prescribing guidelines for the UK.
Can online pharmacies send medicines to patients in other countries?
Pharmacy owners are expected to follow the guidance at all times, including when supplying to patients outside the UK.
We say in the guidance that if pharmacies sell or supply medicines to people in other countries they must keep to any other laws that apply. Countries have different restrictions and some do not allow the online supply of medicines at all.
Will you take enforcement action against pharmacies not following the guidance?
We are very clear that not following this guidance, or not taking the appropriate steps to achieve a desired outcome under our standards, could mean that the pharmacy fails to meet one or more of the standards for registered pharmacies.
This could result in our taking enforcement action.