Health start-ups: Online prescribing is no panacea – the pitfalls and perils of prescribing medication online
This is a particularly complex area so it’s as well to know what is what. Interfaces (such as Amazon, E-bay and Uber) which utilise the internet, SMS and Apps to deliver goods and services, are popular because they save time – and savvy healthcare businesses realise that patients are no different.
They view time taken to make doctors’ appointments and queuing at the surgery as wasted time. Such business are capitalising on this perception by creating interfaces which allow patients to obtain prescriptions remotely (on-line, by SMS or App).
However, while this may seem a natural and logical next step in health service provision – and it is potentially profitable – it is not without its legal hurdles, as prescribing medications is heavily regulated.
This article reviews the following key issues that any healthcare business will need to consider if they wish to develop a remote prescribing interface (RPI):
- The remote prescribing model;
- Patient review and assessment;
- Who can prescribe; and
- Can an App do it all?
Remote prescribing model
RPIs typically offer a narrow range of prescription medications comprised of first-line medications for commonly diagnosed conditions. For example, there are multiple on-line prescription services for cholesterol lowering and diabetes’ medications. The reason for this is that RPI’s must comply with the same legislation and guidance governing traditional (face-to-face) prescribing. The most important of these is the requirement for a full clinical review and assessment.
Whilst RPIs can theoretically be used to prescribe any medication (except controlled drugs), by narrowing the medications and conditions for which prescriptions will be provided it is easier to ensure that a comprehensive patient assessment has taken place. Simply put, the patient assessment can be tailor-made to a particular condition and the specific contraindications associated with the particular medication being requested. It is quite possible for such assessments to be administered remotely via a questionnaire containing closed-questions designed to highlight contraindications before being reviewed by an appropriate clinician.
Patient review and clinical assessment
The questionnaire containing the patient assessment must comply with the General Medical Council’s (GMC) Guidance outlined in ‘Good Medical Practice in Prescribing and Managing Medicines 2013’, The Human Medicines Act Regulations 2012 and the British National Formulary.
In particular, it must elicit enough information about a patient’s medical history to enable the clinician reviewing the questionnaire to determine whether or not the medicine being requested is appropriate for a particular patient and whether the patient requires further examination or medical assessment via a face-to-face appointment before it is prescribed.
If the relevant clinician determines that the questionnaire provides enough information to prescribe the medication, the RPI must have a mechanism for conveying information about the drug, its possible side-effects and what the patient should do if he/she experiences side-effects.
Conversely, if the clinician does not feel that they can prescribe medication as a result of issues flagged up by the questionnaire, the RPI should have a procedure for notifying a patient of this and signposting them to an appropriate local clinic for a face-to-face consultation.
Importantly, even if the questionnaire and the clinical review are comprehensive, there is one risk that is difficult to mitigate: lying. If a patient suffers an adverse effect from the relevant medication a claim could be brought against both the RPI operator and the prescribing doctor. However, such a claim would likely be defensible if it can be demonstrated the patient has lied on the questionnaire and that the lie relates to something that would not have been picked up in a face-to-face appointment.
Who can prescribe?
New legislation has recently come into effect that allows nurses, physiotherapists and pharmacists to prescribe medication if they have received the appropriate training. However, as only the GMC currently provides guidance that allows for remote prescribing in the context outlined in this article, any business that is considering using an RPI will need to hire a doctor to conduct a clinical review of patient assessments. That doctor in turn, will need to ensure that their assessment complies with the GMC’s guidance: “Good Practice in Prescribing and Managing Medicines and Devices 2013”.
Can an App do it all?
The applicability and use of specifically-tailored questionnaires, set against a background of increasing interest in medical devices that comprise standalone software, raises the question of the point at which an App could complete the prescribing process without the need for a medical practitioner to intervene at all.
In some cases, technological and medical considerations may not (in theory) be a barrier to an App completing the process. The reality is that the regulatory regime requires that a regulated medical practitioner is responsible and accountable for the issuing of a prescription. On this basis, that practitioner would be ill-advised to attempt to delegate his decision-making to an App.
As in every case, the practitioners involved in these developments will require professional indemnity insurance (in addition to insuring the business itself). However, as this is a relatively new area to the market, there is no clearly established regime for this and it will be necessary to discuss the cover (and cost) on a case by case basis.
The need to overcome the issues described above may delay progress towards fully automated prescribing, but the ‘direction of travel’ towards meeting patient needs using more streamlined and convenient solutions will certainly continue.
RPIs can provide patients with a fast and safe way to access prescriptions for medications for common medical problems. The remote prescribing model is dependent on a robust patient assessment in the form of a questionnaire and subsequent clinical review by a doctor. The content of each questionnaire depends on the particular condition and medication(s) that the questionnaire has been designed to address. This inevitably means that any health business intending to utilise RPIs cannot use a “one size fits all” patient assessment. Rather, the assessment is dependent on the medication being prescribed and on the legislation and regulations that govern that particular medication. On this basis, it is advisable for healthcare businesses wishing to undertake such an enterprise to seek legal advice to ensure that their patient assessment and clinical review is compliant.