The best way to best avoid inappropriate orders is to filter patients through exclusion inclusion criteria and formulate an individual risk profile for each patient using a combination of online prescribing risk matrixes and algorithmic risk formularies.

To reduce multiple orders of specific products, see below, we have coded a patient protection algorithm into our ordering system to ensure multiple high-risk medicines cannot be purchased within one order.

• Paracetamol / acetaminophen – a common medicine used in suicide.
• Pseudoephedrine – methamphetamine conversion risk.
• Dextromethorphan – opioid abuse potential.
• Pholcodine – opioid abuse potential.
• Promethazine – sedative abuse.
• Laxatives – weight loss.

Do you need a pharmacist consultant to help you with your governance to ensure you meet the regulations? Look no further, contact us here.

A key pharmacy regulator inspection point is for the healthcare organisation to address the potential issue of when something goes wrong there is a clear hierarchical structure to the business so that issues can be reported, analysed, corrected and reviewed. For this reason, it is good organisational practice to have an organisational chart, sometimes known as an organisational planogram. A simple version can be seen below.

A more complicated (regulator preferable) version would look something like this:

Using our proprietary “Team Builder” technology, an organisation can build a hierarchical team and establish clear lines of responsibility for different aspects in the workplace.

“already included in the PCT’s pharmaceutical list; or adjacent to or in close proximity to premises that are already included in the PCT’s pharmaceutical list“

The NHS is becoming more and more concerned with pharmacists who already have licenses requesting a second within the same premises. For instance, if you are a pharmacist and have an upstairs empty space, an entrepreneur may think there is an opportunity to add another license above the primary license and then sell the second license. So in this regard, you need to state that this is not the case nor that this is your intention.

If you would like to book time with one of our consultants please do so using this link.

In the UK, a business which can dispense Prescription Only Medicines (POMs) against a prescription is termed a ‘Pharmacy‘ and must be registered with the General Pharmaceutical Council (GPhC), the UK pharmacy regulator. “Pharmacy” is considered a protected title by the UK government, meaning using the title in regards to a business without registration can result in prosecution by the GPhC for “risk to public safety“. It is often prohibitively expensive to purchase an existing pharmacy as prices can range between £50,000 and £1,000,000+, entrepreneurs often find it easier to start one from scratch with the guidance of experienced veterans in the industry. This article has been created for business people looking to start an online pharmacy and acquire the ability to dispense POMs against a legal prescription.

How to set up an online pharmacy?

On average (we have dealt with over 1,000 applications), it takes 3 months to start an online pharmacy. The most important thing to understand is that there are two kinds of pharmacies in the UK, one which has been awarded a contract to serve the NHS and one which has not. Put simply:

An NHS-contracted pharmacy must abide by stipulations of both the Regulator, the GPhC (via the 5 principles) and the NHS via the Community Pharmacy Contractual Framework. Whereas a private online pharmacy, only needs to meet the requirements of the GPhC.

The next stage after deciding whether to pursue an NHS or Private Pharmacy is that you will then need to choose whether you want to have a presence on the high street or not. The following decision matrix can help you make this decision:

• NHS contracted pharmacy – this is the most common type of pharmacy you find in the UK. and includes the common high street pharmacies such as Boots, Llyods or Well. These pharmacies are contracted by the NHS to enable the UK public to hand the pharmacist a standard green FP10 prescription which was obtained from their NHS GP and receive the dispensed medicine at the standard NHS prescription charge which currently is £9.15.
• Private Pharmacy – are less common in the UK as the majority of healthcare provision is by an NHS-commissioned GP and Pharmacist. However, in recent years due to the lack of funding of the NHS, there has been an increase in the number of private prescribers and private pharmacies offering services to patients who are willing to pay for more convenient medicine.
• Easiest route – is to follow the right-hand path of the image to the left. i.e. dispense only private prescriptions via a distance-selling pharmacy.

Stage 1: Create or use an existing Companies House registered entity.

You do not need to be a pharmacist to start an online pharmacy (termed Distance Selling Pharmacy by the GPhC) in the UK. The essentials of the GPhC application process entail that you simply require to be a director of a Limited company / NHS trust / sole trader / partnership and be associated with a pharmacist who will represent your business as a “Superintendent“. By far the easiest mechanism to achieve this is to register a new limited company and contract the use of a remote Superintendent. A Superintendent is a special class of pharmacist who has at least 3 years of pharmacy experience and is not a superintendent of any other organisation.

Stage 2: Find a suitable location.

Once the fundamentals of the Companies House entity have been established, the next stage is finding a suitable location, this can be broken down into four distinct stages:

A great way to get a head start would be to open a pharmacy within a GPs centre, i.e. make a jeweller next to a gold mine, however, this has been explicitly excluded by GPhC stipulation. The site should not be next door or in the vicinity of any other Primary Care setting (GP Surgery, another pharmacy).

Stage 3: Making the GPhC application.

If you are making an application for an NHS Distance Selling Pharmacy this is initially done on a local level, you will need to find what local health authority your pharmacy will be under by consulting a list of local Clinical Commissioning Groups (CCG). Once you know which CCG you will be applying to you will need to contact NHS England to get their contact details via their website.

If you intend to register a private distance-selling pharmacy, you can bypass this first step and make an application directly to the GPhC using this form. Filling out this application form is simple up until section 5 where you have to give examples of how you intend to meet the GPhC’s five principles, we have created an automatic distance-selling pharmacy compliance tool you can use to check these points. Applicants often get stuck when they are asked for the following:

• Feedback and your complaints systems – the GPhC require all pharmacies to have a system in place which allows patients using the service to complain about the service.
• Standard Operating Procedures – this is usually required by the GPhC for submission ensuring that the pharmacy has sufficient clinical safeguards to ensure the safe dispensing of medicines.
• Online prescribing – this is a relatively new development in online pharmacy service provision. Because pharmacies in the UK are CQC-exempt, they may employ prescribers to prescribe medicines online. However, specific clinical governance requirements first must be met. These must include systems to ensure the safe management of:
  • Antimicrobial or antibiotic medicines
  • Medicines that are liable to abuse, overuse or misuse
  • Medicines that need to be monitored or managed

Stage 4: Making the MHRA Application

Due to Brexit in the UK, the Medicines and Healthcare products Regulatory Agency (MHRA) has temporarily decided to not make this step mandatory, you can read their full release here. We have included some information about what the requirements were previous to 2021 as it is likely that they will be reinstated at some point in a different form. Pre-2021 a new DSP would have had to pay the MHRA ≈£200 to ask them permission to use your GPhC license to offer medicines online. Once the application was complete the MHRA would have given the online pharmacy an additional logo with a hyperlink to their verified online pharmacy register.

Optional Stage 5: NHS Contract Application

Before a registered pharmacy can dispense prescriptions issued under the National Health Service, it must be included in the pharmaceutical list relating to a Health and Wellbeing Board Area, maintained by NHS England (administered by the local team). Applications to join this list can be submitted to NHS England via their Primary Care Support England (PSCE) website.

Within the NHS Distance Selling Application, you will be required to submit the following details:

• Opening hours – you will need to specify within what hours the service will be provided.
• What Advanced & Enhanced Services you will offer – will you offer smoking cessation? Needle exchange?
• Health and Wellbeing Board needs assessment – is there a need in the area?
• Pharmacist Declarations – you will need a pharmacist on board.

Online Pharmacy Issues

Once you have set up correctly and are up and running there are a few other attributes to your business you should consider. One is how does an online pharmacy check a patient’s identity will you do this in-house or use a third party, another is how to mitigate the medico-legal risks of online prescribing. For further information, we have made a list of the most common online pharmacy issues.

Conclusion

Overall, each application to the GPhC costs ≈£750. We provide a wide range of consultancy services to help you get online prescribing and dispensing to Best Practice in no time, get in contact with one of our consultants today.