This policy sets out the standards and procedures that must be followed by the GP Health Hub Limited staff to ensure that the medication process is safe and secure.
It is recognised that whilst individuals have a duty to ensure that medicines are handled safely and securely, the Group also has a statutory responsibility and a duty of care to staff and patients.
Dr Wewage Anthony Shanika Dep will define systems to ensure that:
However, it must be recognised that compliance with this policy does not override any individual responsibility of healthcare workers to ensure that the Group:
GMC: Raising and Acting on Concerns about patient Safety
The term ‘medicines’ is used throughout the document as a generic term that covers all products that are administered by mouth, applied to the body or introduced into the body for the purpose of treating or preventing disease, diagnosing or monitoring illness or contraception.
The generic term ‘patients’ is used throughout to refer to people receiving medicines.
Any paperwork such as requisition/order forms that can be used to obtain medicines is designated as ‘Controlled Stationery’. Any unauthorised use may lead to the fraudulent acquisition of medicines.
The use of medicines is underpinned by a series of legal, statutory and professional frameworks that include:
The Health and Social Care Act 2008 (Regulated Activities) Regulations 2014 (HSCA) set out the standards below which care must not fall, and this includes key aspects related to the management of medicines. Through this legislation the regulator, the Care Quality Commission, has powers and duties to regulate services health and social services, including around how they manage medicines.
This policy draws on the relevant aspects of each of these legal, statutory and professional frameworks to ensure that the management of medicines is conducted safely, securely and legally.
Prescribers must work within the limits of their competence and must keep their knowledge and skills up to date. This includes their knowledge of:
The Medicines and Healthcare products Regulatory Agency’s (MHRA) Drug Safety Update and Central Alerting System provide information and advice to support the safer use of medicines relevant to prescribing practice and alert prescribers to safety information about medicines they may prescribe.
The National Institute for Health and Care Excellence (NICE) brings together evidence on the safe, effective and efficient use of medicines from a range of organisations. It also publishes a range of products to help improve the safety, as well as the clinical and cost effectiveness of prescribing. The Electronic Medicines Compendium contains Summaries of Product Characteristics and Patient Information Leaflets (PILs).
If prescribers are unsure about interactions or other aspects of prescribing and managing medicines, they should seek advice from other experienced colleagues, including other clinic staff and pharmacists.
Staff should be familiar with the guidance in the British National Formulary (BNF) which contains essential information to help prescribe and monitor medicines.
All clinic prescribers must have adequate and appropriate insurance or indemnity arrangements in place that cover the full scope of their medical practice in the UK. The cover must be in place before the clinician begins to practise in the clinic. All clinic prescribers will need to provide annual evidence of their indemnity insurance details, including a copy of their insurance certificate.
For further advice clinic prescribers should speak to a medical defence organisation or another professional insurance or indemnity provider.
Clinic prescribers must consider the suitability of the consultation they are using, for example face-to-face or remote, depending on the patient’s individual needs or circumstances. Circumstances where a face-to-face consultation may be more appropriate include when:
All patients must have their identity, age and address checked directly by documentation via video consultation as GP health Hub Limited is a remote is a remote provider.
Before proposing, prescribing or providing medications, treatment or devices, clinic prescribers must consider whether the information they have is sufficient and reliable enough to enable them to provide safe care. If the clinic prescriber requires more information, or confirmation of the information they have, they should ask for the patient’s consent to contact their NHS GP or other treating doctors before proposing, prescribing or providing medications, treatment or devices without that information.
If the patient objects to information being shared with the clinic prescriber, or does not have a regular prescriber, clinic prescribers must be able to justify a decision to propose, prescribe or provide medications, treatment or devices without that information.
If failing to share information could pose a risk to patient safety, the clinic prescriber should explain to the patient that they cannot propose, prescribe or provide medications, treatment or devices. They should outline the patient’s options and signpost them to appropriate alternative services. They should clearly document the reasons for any decisions made.
Clinic prescribers must establish a dialogue with the patient to help them consider information about their options so they can decide whether or not to have care or treatment. They should take an adequate history that includes checking the patient’s allergy status, the recent use of other medicines including non-prescription and herbal medicines, illegal drugs and any medicines purchased online as well as any necessary clinical information.
Clinic prescribers should reach agreement with the patient on the treatment proposed explaining:
Clinic prescribers should be proportionate when obtaining a patient’s consent. For most prescribing decisions or proposals, clinic prescribers may rely on a patient’s verbal consent, as long as they are satisfied that they’ve had the opportunity to consider any relevant information and decided to go ahead. Sometimes a patient’s signature is required on a form, for example to comply with an MHRA drug safety alert about a medicine with serious side effect.
Clinic prescribers must begin with the presumption that every adult has capacity to make decisions about their care. The clinic prescriber should be able to draw reasonable conclusions about their patient’s capacity during their dialogue with them.
If the prescriber is unsure that the patient has capacity to make a decision, they should assess their capacity using the test under the relevant legislation. The General Medical Council have published detailed advice on assessing capacity and making decisions where a patient is known not to have capacity. Please see ‘Decision making and consent’. In general, where a patient is found to lack capacity, proceeding with treatment will beyond the scope of GP Health Hub Limited. The clinic prescriber should explain to the patient that they cannot propose, prescribe or provide medications, treatment or devices. They should outline the patient’s options and signpost them to appropriate alternative services. They should clearly document their reasons for any decisions made.
For some medicines it is necessary to carry out baseline tests before treatment can be initiated. Prescribers should follow what is stipulated in the medicine’s Summary of Product Characteristics, as well as the British National Formulary (BNF) and NICE guidance.
All prescriptions will be created using the Semble electronic prescribing system, with specific SOPs around the use of the system.
When writing a prescription the prescriber must ensure:
Prescriptions will normally be sent electronically, via the Semble system. CloudRX and Signature RX will be used for prescription fulfilment. The patient has the choice to either take the prescription to a local pharmacy for collection or opt to have the medication delivered to them.
Blank prescriptions will not be used in this clinic.
The Misuse of Drugs Regulations 2001 (and subsequent amendments) defines the classes of person who are authorised to supply and possess Controlled Drugs while acting in their professional capacities and lays down the conditions under which these activities may be carried out. Controlled Drugs are divided into five Schedules, each specifying the requirements governing such activities as import, export, production, supply, possession, prescribing, and record keeping which apply to them. Further information on these is set out below:
Clinical prescribers at the GP Health Hub Limited MAY NOT prescribe Schedule 1 , 2 or 3 medicines. If the clinician believes it is clinically necessary for a patient to be prescribed a Controlled Drug, they should refer the patient back to their GP to undertake this prescribing. Clinic prescribers are permitted to prescribe schedule 4 or 5 controlled drugs when it is clinically appropriate to do so and should follow what is set out in sections 6, 7, 9, 10 and 11 of this policy.
Licensed medicines are those that have a marketing authorisation or product license in the UK. These define the medicine’s terms of use, its Summary of Product Characteristics, the indication(s), recommended dose(s), contraindications and special warnings and precautions on which the medicine is based. Furthermore, a licensed medicine has been assessed for efficacy, safety, and quality; has been manufactured to appropriate quality standards; and when placed on the market is accompanied by appropriate product information and labelling.
However, there are clinical situations when the use of unlicensed medicines or use of licensed medicines outside the terms of the licence (i.e., ‘off-label’) may be judged by the prescriber to be in the best interest of the patient on the basis of available evidence.
The responsibility that falls on healthcare professionals when prescribing an unlicensed medicine or a medicine off-label may be greater than when prescribing a licensed medicine within the terms of its licence. Prescribers should pay particular attention to the risks associated with using unlicensed medicines or using a licensed medicine off-label. These risks may include: adverse reactions; product quality; or discrepant product information or labelling (e.g., absence of information for some unlicensed medicines, information in a foreign language for unlicensed imports, and potential confusion for patients or carers when the Patient Information Leaflet is inconsistent with a medicine’s off-label use).
Clinic prescribers may prescribe an unlicensed medicine, or prescribe a licensed medicine off-label if:
If a clinic prescriber chooses to prescribe an unlicensed medicine, or prescribe a medicine for an off-label indication, they must:
Where it is clinically appropriate to do so, repeat prescribing can be a useful utility that enables the repeated issue of medicines at agreed intervals, without the patient attending a consultation with the clinic prescriber.
A clinic prescriber can authorise the transfer of medication from an acute prescription to a repeat prescription. The decision to do so will take into consideration:
The clinic prescriber will only prescribe evidence-based medicines so long as they have adequate knowledge of the patient’s health and are satisfied that they meet the patient’s needs. The prescriber will also determine the number of repeat authorisations before a review is required; this may be every 3, 6 or 12 months.
Prior to transferring from acute to repeat prescriptions, the clinic prescriber must recall the patient and review the factors stated above, whilst informing the patient about the repeat prescribing process at the practice. Prescriptions will be created using the Semble electronic prescribing system and must follow the prescription writing requirements set out in section 7 of this policy. Prescriptions will then be electronically sent through to a registered pharmacy of the patient’s choosing.
Prescribers must make sure that suitable arrangements are in place for monitoring, follow up and review, taking account of the patients’ needs and any risks arising from the medicines. Specific monitoring requirements and frequencies for each medicine are stipulated in in the medicine’s Summary of Product Characteristics, as well as the British National Formulary (BNF) and NICE guidance.
When prescribing a new medicine, or re-authorising a repeat prescription following a medication review, the prescriber will set a date with the patient for a future medication review and/or necessary monitoring. This should be shared with the patient, recorded in the patient’s electronic medical notes and also recorded in the prescriber’s own diary.
A medication review with the patient should include:
If, after the medication review, the patient and clinic prescriber are happy to maintain the current prescription, then the prescription should be re-authorised for further repeat prescriptions and the next medication review booked with the patient and recorded in the patients’ medical notes and the clinician’s diary.
Due to the remote nature of GP Health Hub Ltd, No medicines will be kept at GP Health Hub, therefore no medicines will be transported or need to be stock managed.
If there is any risk or harm to an individual due to an incident involving medicines, priority must be given to the clinical care of that person or persons.
Any incident or near miss in which medicines are involved must be reported in accordance with the Clinic Incident Reporting policy.
Any drug may produce an adverse, unwanted, or unexpected reaction. Detection and reporting of these incidents is important.
Clinic staff should report serious adverse reactions to the Medicines and Healthcare products Regulatory Agency (MHRA) and all adverse drug reactions for medicines marked with a black triangle symbol. Reports can be made online at www.mhra.gov.uk/yellowcard or using yellow cards that are available in the BNF. Adverse drug reactions also need to be recorded in the patient’s medical record.
During manufacture or distribution of a medicine, an error or accident may occur whereby the finished product does not conform to its specification. Any suspected defect in a medicine should be reported to the MHRA.
Reports on the suspected defective medicine should include the brand or generic name – the name of the manufacturer or supplier, the strength and dosage form of the product, the product licence number, the batch number, and the nature of the defect.
All Drug Alerts are to be dealt with promptly on receipt and are to be returned to the Person Responsible Dr Wewage Anthony Shanika Dep for appropriate action.
Compliance with this policy will be monitored through a series of audits conducted by clinic staff as part of an annual audit programme. The audits will cover key areas of this policy that include the quality and safety of prescribing practice as well as ongoing monitoring compliance for patients prescribed long term medicines in addition to the safe and secure handling of medicines. The findings of these audits, and recommendations for action will be presented to the directors of the GP Health Hub Limited. The Person Responsible for the audit schedule will be– Dr Wewage Anthony Shanika Dep.
This Policy will be reviewed annually or earlier if there is any changes to relevant legislation, new evidence or change in organisational structure.
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