Clinical policy

All Treated prescriptions are written by UK clinicians who are either:

• GMC registered doctors;
• GPhC registered pharmacist prescribers;
• Specialist non-medical prescribers; or:
• Nurse specialists.

Clinicians base their prescribing decisions on information provided by patients in their medical profile and condition-specific questionnaire, and in product-specific questionnaires in cases where a certain preference is indicated by the patient. In some instances, additional information may be requested from the patient by the clinician, which is also taken into consideration.

For certain conditions, clinicians may also base their prescribing decision on images uploaded by the patient, evidence of previous prescription history, evidence of test results, or Summary Care Record or GP Health Record information.

Decisions on prescriptions are made taking the Summary of Product Characteristics (SMPC), evidence-based knowledge, national guidelines, established clinical practice and reliable research into consideration.

A clinician may refuse to prescribe in cases where they:

• think that prescribing treatment may present an unacceptable risk to the patient
• do not have sufficient information to prescribe safely
• have reason to believe that information provided by the patient is either inaccurate or incomplete
• believe that the patient requires treatment beyond the scope of an online healthcare provider
  believe that treatment may be more safely prescribed following an in-person appointment or physical examination
• thinks that treatment would be more safely prescribed by another clinician with access to a patient’s full medical record
• believe that information about a prescription should be shared with a patients usual healthcare provider (GP) and a patient refuses consent to share this information
• do not think a prescription for the requested treatment would be appropriate for one or more other reasons.

If a clinician refuses a prescription, they will signpost the patient to appropriate alternative services wherever possible.

When taking a consultation, patients will complete:

• a condition-specific questionnaire
• a general health profile

and in some cases be asked to:

• complete a product specific questionnaire
• provide additional information for reference (such as pictures of an area of the body affected by symptoms or a test result)
• grant us permission to view additional health records (such as SCR).

Collectively, these elements are referred to as a medical questionnaire.

All medical questionnaires are developed by a member of the Clinical Team (who is either a GMC-registered doctor or GPhC-registered pharmacist prescriber), before being peer-reviewed by another member of the clinical team, prior to being published and treatments for the condition associated with the questionnaire being made available on the site.

These questionnaires are developed taking national guidelines, accepted clinical practice, medicine product licenses and reliable research into account. Medical questionnaires will also follow guidance set out by regulatory bodies such as the GPhC, MHRA, and CQC, where applicable.

Medical questionnaires are configured on the website before being rigorously tested.

The medical questionnaire is a screening aid, not a medical device. When a patient completes a medical questionnaire, it is always reviewed by a member of the clinical team who has experience and relevant competence. Automated, algorithmic triage is not utilised for any part of the medical questionnaire review process. Specific prompts for patients and clinicians may be set up on the questionnaire system and triggered by patients selecting certain answers, but these are purely informational, and do not determine the pathway the patient follows.

If a patient provides information that indicates a ‘red flag’ – such a strict contraindication or safeguarding concern – this may automatically generate an alert to the patient or a clinician indicating that an online service might not be suitable for them, or signpost them to more appropriate services. Review and the final decision on prescribing is always made by a human.

3a. Aftercare

Aftercare frameworks are developed by the clinical team, and applied on a product-specific basis.

‘Aftercare’ consists of:

• system triggered messaging, prompting the patient to answer questions relevant to their treatment. This can be ‘non-mandatory’ (useful information for clinicians, but not requiring a response in order for the supply of treatment to be continued) or, in rare cases, ‘mandatory’ (where a response is required for the clinician to approve further supply of treatment); and:
• patient-initiated direct messaging, with the facility to ask the clinician questions or for guidance on any aspect of their treatment.

The extent and frequency of system-triggered messaging within aftercare may vary, depending on:

• the treatment being taken;
• the dose of treatment being taken;
• the quantity of treatment supply; or:
• the frequency of treatment supply.

The content of system-triggered messaging may include, but not be limited to:

• information about the patient’s specific treatment;
• information about off-label prescribing or unlicensed use, where applicable; or:
• questions related to treatment efficacy, side effects, health metric requests (such as weight, peak flow, or blood pressure), test result requests, or image requests to illustrate progress.

Aftercare helps the clinicians to ensure treatment compliance, that a patient’s treatment is performing effectively, pre-empt any potential issues, and gather information that may be useful in optimising treatment outcomes.

It also facilitates side effect reporting, so that clinicians can offer support and guidance to patients where required, recommended treatment adjustments if necessary, and promptly report information through the MHRA Yellow Card Scheme.

Aftercare responses are reviewed manually by a clinician (i.e. a GMC-registered doctor or GPhC-registered pharmacist prescriber). No algorithmic process is used to ascertain continued treatment suitability or initiate intervention.

3b. Medical review

At certain intervals, patients on repeat treatment plans (subscriptions) will be asked to complete a follow-up called a ‘Medical review’ in order to receive a continued supply of treatment.

The intervals at which a medical review is initiated varies by treatment.

This is handled separately to ‘aftercare’ (but information from aftercare responses may inform a medical review).

For the patient, the medical review involves:

• completing a follow-up questionnaire that relates specifically to the condition being treated, or the treatment being taken;
• reviewing and updating their medical profile;
• reviewing and confirming their treatment preference, including the dose and quantity prescribed, in addition to the frequency of supply.

Patients are prompted to complete a medical review approximately one month before the validity of their existing prescription expires. No further supply of their existing treatment can be provided until this medical review has been completed.

The process for reviewing information provided by patients as part of the medical review closely follows that of the initial medical questionnaire. A clinician reviews the information provided by the patient in the follow-up questionnaire and medical profile, in addition to any requested changes to treatment preference, before making a decision to prescribe. They may also consider information provided by the patient through aftercare to help them make this decision.

A clinician may refuse to continue a prescription if they:

• perceive that continuing to prescribe treatment may be unsafe or unsuitable for the patient
• do not feel as though they have sufficient information to continue to prescribe safely
• have reason to believe that information provided by the patient is either inaccurate or incomplete
• believe that continued treatment is not likely to be effective for the patient
• believe a different treatment would be more beneficial
• do not think continuing to prescribe treatment would be appropriate for one or more other reasons.

If not completed by the patient, the medical review period expires three months after the expiry of their previous prescription. After this time, the patient is required to complete the same medical questionnaire they would if they were beginning treatment, which is assessed by a member of the clinical team in the manner described above (see Section 2).

In cases where treating a patient online isn’t suitable, a clinician will signpost that patient to their GP for further guidance. This may be for one or more of the reasons for refusing a prescription outlined in Sections 1 & 3, or if they feel:

• the patient requires urgent treatment
• the treatment required falls outside of the scope offered by Treated

If the clinician deems that the patient may need emergency care, they’ll advise the patient to contact emergency services as soon as possible.

If the clinician suspects that emergency care has not been sought, they are encouraged to follow Treated’s safeguarding procedures.

Safeguarding procedures are in place to alert authorities and refer patients to applicable services where appropriate.

Because of the online nature of contact between clinician and patient, clinicians are trained to act upon information received through:

• medical questionnaire or medical profile submission
• aftercare responses
• medical review
• direct messaging
• telephone conversations
• GP communication

If the clinician believes the information they’ve received indicates a risk to the patient or someone else, they may notify one or more of the following:

• local health services, including the patient’s GP
• social services
• Public Health England
• police
• regulators, such as the GMC or MHRA

More information on the data clinicians may share in such cases can be found in our Privacy Policy.

Treated provides ‘off-label’ prescriptions for certain conditions and treatments.

The decision to offer a specific treatment off-label is reached collectively by the clinical team, through:

• evidence-based research
• risk assessment
• the availability of licensed treatments
• the comparative effectiveness or safety profile of licensed treatments

This process ensures that a treatment will only be offered off-label if it is deemed to be safe, and likely to be effective.

Off-label prescriptions are not provided without prior consultation between the clinical team.

When a treatment is offered off-label, an individualised clinical framework will be produced for that treatment, which may include:

• specific instructions for off-label use
• additional questions on the medical and review questionnaires
• specific guidance delivered via aftercare

Patients are notified prior to and after a prescription is created if it is off-label, via the medical questionnaire and/or aftercare messaging, and signposted to our off-label prescribing policy.

In some cases, there may be medical factors that preclude the issue of a prescription. The specific factors may vary depending on the treatment being requested, or the condition being treated.

These factors may include (but not be limited to):

• a patient’s age
• a patient’s biological gender
• alcohol intake
• tobacco use
• recreational drug use
• the presence of existing medical conditions or co-morbidities
• the current, planned or previous use of prescription or non-prescription medication
• the presence of allergies
• any previous, recent or planned surgical procedures
• a family history of medical conditions
• being pregnant, planning to become pregnant, or breastfeeding
• side effects during previous use of a specific medication or medication category

In cases where these factors do not preclude the issue of a prescription, they may impact the nature of the treatment prescribed (such as medication, dose, quantity or frequency) or require closer monitoring.

Patients are provided with information regarding their treatment via several means, including:

• the medical questionnaire. For example, in cases where a patient is required to acknowledge and confirm understanding of a piece of information relating to a treatment prior to their consultation being reviewed by a clinician.
• direct messaging from the clinician. For example, in cases where information provided by the patient in the medical questionnaire indicates that they may benefit from more specific guidance on a treatment before it is prescribed for them.
• a phone call from the clinician. For example, in cases where the clinician may need to confirm information and issue specific guidance before prescribing a treatment.
• pharmacy instructions. For example, the label adhered to the patient’s medication. Clinicians have the capacity to amend these instructions with more specific guidance on an individual basis.
• aftercare messaging. If additional, post-prescription information needs to be communicated to the patient about their treatment, such as how to take or use it, side effects, performance expectations, and what to do if they require further support.

Clinicians receive in-house training on the use of plain language, to ensure the clear and accessible communication of information in any direct contact with patients. Clinicians collaborate with an in-house content team to produce and review other patient-facing content, such as that used in the medical questionnaire, aftercare messaging, and website content, to ensure that it’s accessible, easy to understand and that plain language is used.

Consent given during completion of the medical questionnaire, alongside direct message history and aftercare messaging is stored in the patient’s record. A summary of any phone conversations may also be noted in the patient’s record.

The Treated Clinical Board comprises of one or more each of the following:

• GMC-registered doctors
• GPhC-registered pharmacists and pharmacist prescribers
• NMC-registered nurse practitioners
  operations director specialising in clinical governance

Dr Daniel Atkinson is the Treated Clinical Lead, and is supported by the wider team of practitioners to ensure the safe and effective provision of care.

Pharmacist prescribers, responsible for assessing patient consultations and prescribing treatments, are also involved in the development of clinical frameworks, medical questionnaires, and aftercare.

Sanjeda Chowdhury is the Superintendent Pharmacist for our pharmacy, HR Healthcare. She oversees the safe dispensing of medicines in the pharmacy.

Inayat Omarji is Operations Director for HR Healthcare, and a member of the Treated Clinical Board. His role involves ensuring that Treated policies and procedures are compliant with regulatory requirements.

Treated and HR Healthcare are routinely inspected by:

• The General Pharmaceutical Council (GPhC).
• The Medicines and Healthcare Products Regulatory Agency (MHRA)
• The Care Quality Commission (CQC).

Our most recent inspection outcomes were:

• GPhC: Standards met (in all categories)
• CQC: Good (in all categories)

The clinical team conducts continuous audits on clinical frameworks and prescribing processes. This encompasses our formulary offering, questionnaires, aftercare framework, medical review and website content. These are discussed during periodic clinical meetings which take place every two months, where findings are shared, any opportunities for improvements are identified, and recommendations are discussed before being implemented.

When new guidance or evidence relating to a treatment is published, such as in the BMJ, or by the MHRA or NICE, the clinical team will review this and conduct an impact assessment to determine whether it necessitates any new considerations or changes in practice. Any changes are logged in the relevant clinical framework.

All website content is reviewed periodically by the content team and clinical team every three years. Additional changes to website content are made as required throughout this time, upon the release of new guidance or evidence.

Patient feedback is regularly reviewed by the clinical team, and formally discussed at periodic clinical meetings. In cases where this feedback highlights an opportunity for improvement, the clinical team will discuss possible solutions and come to an agreement on a solution. This may be a change to one or more processes that requires input from the technical team, operations team, or digital team. In other cases, it may be a change to a clinical framework or prescribing process which is addressed within the clinical team.

All significant events, where a patient’s safety or privacy may have been put at risk, are recorded, and discussed at clinical meetings. If an urgent change in process is required, this is discussed by the wider clinical team immediately, with an agreed solution implemented as soon as possible.

We have developed our data handling and privacy standards in alignment with:

• EU General Data Protection Regulation (GDPR)
• UK law
• NHS practice

All staff receive training on the safe and proper handling of patient data.

We store and transmit patient information using secure, encrypted systems, which are only accessible with multifactor authentication.

Patient records are only routinely accessed by members of the clinical team and operations team, but health information contained within these is only routinely accessed by members of the clinical team.

Our system also uses role-based permissions to ensure that medical information is only accessible to staff who require it.

In accordance with GDPR, in the event that we learn of a potential data breach, these are reported by our Data Protection Officer to the Information Commissioner’s Office (ICO) and any affected individuals within 72 hours.

In cases where a patient accesses the service but care or medication is not provided, that patient’s data will be retained for a period of no longer than three years.

In accordance with NHS practice, in cases where a patient accesses the service and receives care or medication, that patient’s data will be trained for a period of 13 years (or 25 years if the patient was pregnant at the time of care or medication being provided).

During clinical audits, we conduct Data Protection Impact Assessments to ensure that any current or new processes sufficiently protect patient data, and to help us identify and mitigate risk. Our systems and processes are audited during regulatory inspections to ensure patient safety and privacy.

All triage is reviewed by humans, and not conducted by machines.

Certain questionnaire selections may trigger an informational prompt, created and configured through collaboration between the clinical and digital teams, that aids a prescriber to identify a suitable treatment and facilitate more efficiency, but these are treated as considerations and not directives. Prescribing decisions are always made by humans, taking clinical frameworks, guidance and evidence into account, in addition to these informational prompts.

Informational prompts are reviewed regularly as part of the clinical audit, and updated in line with new evidence or guidance as and when required.