Prescribing Guide and SOP for Controlled Drugs

Read alongside

Practice Privileges Policy

Incident Reporting and Investigation Policy

Duty of Candour Policy

Consent to Treatment Policy

Clinical Partners' Formulary

Patient Terms and Conditions

1.0 Introduction

1.1 This document provides details of the prescribing requirements under which Prescribers, working for or on behalf of Clinical Partners, must operate.

1.2 The Clinical Partners Registered Manager has operational and regulatory responsibility for all activities within the service. They are registered for this purpose with the Care Quality Commission.

1.3 Whilst prescribers with practice privileges and nurses who work for Clinical Partners are independent self-employed contractors, the Registered Manager, is required to demonstrate that all those engaged under such arrangements or are directly employed follow best practice guidance issued by professional bodies when prescribing.

1.4 Good clinical practice says that prescribers must recognise and work within the limits of their competence and that they must keep their knowledge and skills up to date. They must maintain and develop the knowledge and skills in pharmacology and therapeutics, as well as prescribing and medicines management, relevant to their role and prescribing practice.

2.0 Organisational structure within Clinical Partners for the oversight of prescribing

2.1 Chief Executive Officer. The Clinical Partners CEO has operational responsibility for all activities within the service including prescribing.

2.2 Registered Manager. The Registered Manager is responsible for the operational and regulatory activity of treatment for disease disorder or injury for Clinical Partners and is registered for this purpose with the Care Quality Commission.

2.3 Chief Medical Officer. The Chief Medical Officer for Clinical Partners is the medical representative on the organisation's Board and is responsible for the oversight of clinical governance of prescribers reporting directly to the board. Their responsibilities include but are not limited to:

• providing clinical advice to the Board

• providing professional leadership

• overseeing clinical governance, quality and safety.

2.4 Controlled Drug Accountable Officer (CDAO) NHS England has a statutory duty to ensure that safe systems are in place for the management and use of controlled drugs. This is to prevent harm to patients and staff from any misuse of controlled drugs. Clinical Partners' Chief Medical Officer is the CDAO. Amendments to the Misuse of Drugs Regulations 2001 require private prescriptions or requisitions for medicines containing schedule 2 and 3 controlled drugs to be issued on 3 controlled stationery bearing a unique prescriber identification number (PIN) obtained from an NHS Accountable Officer. These will be obtained by Clinical Partners for prescribers from their local area NHS Accountable Officer. (See Appendix 2 SOP Controlled Drugs).

2.5 Designated Body All Clinical Partners are GMC-licensed doctors who have a connection with one organisation which supports them with annual appraisal and revalidation. This organisation is referred to as their ‘designated body’. Most doctors’ designated body is the organisation where the majority of their clinical work takes place. Clinical Partners is also a designated body for our directly employed or contracted clinicians who work solely or mainly for us. The Chief Medical Officer is Clinical Partners' Responsible Officer (AO).

2.6 Clinical Governance Group The Clinical Governance Group will assess, monitor and analyse data and audits. The Committee will report to the Board reviews of quality, effectiveness, safety and patient experience. This Committee reports to the Board on its findings.

2.7 Medical Practitioners Medical practitioners’ responsibilities:

• To practice in accordance with the requirements of the GMC in line with Good Medical Practice 2013 (updated 2019)

• To follow the GMC's Good practice in prescribing and managing medicines and devices 2013

• To be personally accountable for their professional and ethical practice and to be prepared to justify their clinical decisions and actions to Clinical Partners

• To report prescribing errors, incidents, complaints or concerns to Clinical Partners and to take an active part in investigations and share learning.

2.8 Independent Prescribers (IP) For Clinical Partners these are nurses who are Independent Prescribers. These nurses have successfully completed an Independent Nurse Prescribing Course and are registered with the NMC as an IP. They are able to prescribe any medicine provided it is in their competency to do so. This includes medicines and products listed in the BNF, unlicensed medicines and all controlled drugs in schedules two - five.

3.0 Prescribing process

3.1 Clinical Partners will keep a full list of all of the prescribers working under practice privileges, contract arrangements or employed by them. This will include ensuring that their practice remains up to date in accordance with Clinical Partners’ Practice Privileges Policy or contract renewal arrangements.

3.2 Prescribing will be in accordance with the relevant NICE Guidelines and Clinical Partners prescribing formulary (Appendix 1 Prescribing Formulary).

3.3 Prescribers should prescribe medicines on behalf of Clinical Partners only if they have:

• verified and recorded they have done so, who the patient is by review of a piece of photo ID (in the case of a child without photo ID the birth certificate) and proof of address

• adequate knowledge of the patient’s health and

• are satisfied that they serve the patient’s needs.

3.4 Together with the patient and their pre-assessment questionnaire information, an assessment of their condition must be made before deciding to prescribe a medicine. Prescribers must take an adequate history, including:

• any previous adverse reactions to medicines

• recent use of other medicines, including non-prescription and herbal medicines, illegal drugs and medicines purchased online

• other medical conditions.

3.5 If a patient has not been referred by their general practitioner, prescribers should also:

• consider whether the information they have is sufficient and reliable enough to enable them to prescribe safely; for example, whether:

  • they have access to their medical records or other reliable information about the patient’s health and other treatments they are receiving

  • they can verify other important information by examination or testing.

3.6 Prescribers must ask for the patient’s consent to contact their general practitioner if they need more information, or they require confirmation of the information they have before prescribing. If the patient objects to Clinical Partners contacting their GP and the prescriber feels that it would be detrimental to positive healthcare outcomes and patient safety not to do so it should be explained that Clinical Partners cannot prescribe for them and what their options are. This is outlined in the patient’s Terms and Conditions. Clinical Partners' strongly advise patients to allow Clinical Partners to inform their GP of any medication prescribed by Clinical Partners. The information that we might share with a patient’s general practitioner may include:

• changes to the patient’s medicines (existing medicines changed or stopped and new medicines started, with reasons)

• length of intended treatment

• monitoring requirements

• any new allergies or adverse reactions identified.

3.7 Every patient is assessed in respect of Mental Capacity and specifically of capacity to consent to treatment and contact with their GP. If a patient is assessed as lacking capacity, such as a young person under the age of 18, consent can be given on their behalf by any one person with parental responsibility (if the matter is within the ‘zone of parental control’) or by the court as appropriate. The power to consent must be exercised according to the ‘welfare principle’: that the child’s ‘welfare’ or ‘best interests’ must be paramount. Even where a child lacks capacity to consent on their own behalf, it is good practice to involve the child as much as possible in the decision-making process. In the case of an adult lacking capacity, consent can be given by someone authorised to do so under a Lasting Power of Attorney (LPA) or someone who has the authority to make treatment decisions as a court appointed deputy). Every effort must be made to involve the patient. Prescribers must report any concerns regarding safeguarding to the Registered Manager.

3.8 In a shared care arrangement, our prescribers may advise the patient’s general practitioner which medicine to prescribe. Both the general practitioner and the patient must be provided with sufficient information to permit the safe management of the patient’s condition.

3.9 Prescribers should encourage patients to be open about their use of alternative remedies, illegal substances and medicines obtained online, as well as whether in the past they have taken prescribed medicines as directed.

3.10 The consultation assessment should include the general physical health of the patient, identify the likely cause of the patient’s presenting condition and which treatments are likely to be of overall benefit to them. The treatment proposed, should be discussed with an explanation of:

• the likely benefits, risks and burdens, including serious and common side effects

• what to do in the event of a side effect or recurrence of the condition

• how and when to take the medicine and how to adjust the dose if necessary, or how to use a medical device

• the likely duration of treatment

• arrangements for health monitoring, follow-up and review, including further consultation, blood tests or other investigations, processes for adjusting the type or dose of medicine, and for issuing repeat prescriptions. This should be clearly documented in the patient’s notes and report.

3.11 The amount of information given to each patient will vary according to the nature of their condition, the potential risks and side effects and the patient’s needs and wishes. Prescribers are required to check that the patient has understood the information, and encourage them to ask questions to clarify any concerns or uncertainty. They should consider the benefits of written information, information in other languages and other aids for patients with disabilities to help them understand and consider information at their own speed and to retain the information you give them.

3.12 Patients’ carers should be provided with information about the medicines prescribed, either with the patient’s consent or, if the patient lacks capacity to consent, if it is in their best interests. The prescribed medication will be logged on the web prescribing platform for audit purposes.

4.0 Prescriptions - non-controlled drugs

4.1 For face to face consultations the patient can be offered the prescription for dispensing and supply at their chosen pharmacy. In line with GMC advice the clinician must keep a clear record of any drugs prescribed.

4.2 For virtual consultations or where the patient consents to use an online service, prescribing through Pharmacierge or CloudRx, is the preferred method, both are national providers of pharmaceutical services to private sector doctors.

This service will provide a safe and effective service for Clinical Partners prescribers and partners. If the patient does not consent to using the Pharmacierge or CloudRx service prescriptions will need to be sent using the prescriptions team. The prescribed medication will be logged on web prescribing for audit purposes.

4.3 All prescribers working for Clinical Partners must register with both the Pharmacierge service and CloudRx (unless alternative arrangements are in place under contractual arrangements with third parties such as the NHS). The registration process includes:

• an identity verification process using passport facial recognition technology

• one to one training and information provided by both Pharmacierge and CloudRx regarding the service and the process

• checking GMC registration

• allocation of a personal PIN. A security code is issued to the prescriber each day when logging in for added security.

4.4 Once set up on the system prescribers will be able to send prescriptions directly from their desktop to the dispensary. These prescriptions must include:

 4.5 Patients will receive their medication via a courier usually within 3-5 days (for Pharmacierge) and next day delivery (CloudRx) following receipt of the prescription, For patients utilising the Pharmacierge service a same day delivery is possible if they reside in London.

4.6 Clinical Partners’ practitioner Terms and Conditions require prescribers to allow Clinical Partners access to their prescribing data for clinical governance, audit and quality improvement purposes. Clinical Partners’ Chief Medical Officer will be the “colleague prescriber” on the Pharmacierge or CloudRx platform for monitoring and audit processes.

5.0 Prescription requests

5.1 Clinicians will receive prescription requests from triage team prescription co-ordinator individually so as not to erroneously confuse patients. Clinical Partners require that clinicians respond with the tracking number(s) for each patient, so we can inform them of this and track the prescription if there are any queries.

5.2 FP10s must be posted using the Royal Mail’s Special Delivery guaranteed by 1pm next day service. FP10 prescriptions should be sent to either Pharmacierge, or CloudRx, not the patient’s home address). Clinicians can put multiple prescriptions into a single envelope to Pharmacierge/CloudRx. There is a quick and easy way to manage this from home by buying the postage online, printing the label at home, and dropping it off at a post office: Step 2 - Service - Royal Mail Click & Drop | Send an item - Buy, Print, Drop. Clinicians must use prescriptions@clinical-partners.co.uk as the tracking address.

5.3 Repeat prescriptions will be issued in line with Clinical Partners packages of care only if the patient continues to be a Clinical Partners patient and is being monitored. Prescription fees will only be paid if Clinical partners are informed of the tracking reference.

6.0 Controlled Drug prescribing

6.1 For the prescribing of controlled drugs. (See Appendix 1. SOP Controlled Drugs).

6.2 The position of Clinical Partners is that initiation of Controlled Drug medication is not to take place during an ADHD assessment appointment. Once the patient has been assessed, diagnosed, and issued with a report, should they wish to proceed with medication the private outpatient (triage) team will ensure that the required results are received and documented prior to the patient having their first follow up appointment with you. For all subsequent follow up appointments we would like you to request the most recent vital signs and include this in your report/letter.

6.3 Even for ultra-low risk patients we require as a minimum a Blood Pressure and Heart Rate reading prior to every prescription and at each follow up appointment.

7.0 Prescribing unlicensed medicines

7.1 The term ‘unlicensed medicine’ is used to describe medicines that are used outside the terms of their UK licence or which have no licence for use in the UK. Unlicensed medicines are commonly used in some areas of medicine such as in paediatrics, psychiatry and palliative care. They are also used, less frequently, in other areas of medicine. Clinical Partners does not prescribe unlicensed medication unless listed for specific indication/s on the formulary. (See Appendix 1 Clinical Partners Formulary)

7.2 If any prescriber considers prescribing an unlicensed medicine not on the Clinical Partners’ formulary they must submit an unlicensed medication application which must be discussed and agreed by the Chief Medical Officer before a prescription is issued. Any changes to the formulary will be considered by the Chief Medical Officer upon request using the Amendment to the Formulary request form.

7.3 In order for an unlicensed medicine to be prescribed the prescriber must:

• complete the Unlicensed Medicines request form.

• be satisfied that there is sufficient evidence or experience of using the medicine to demonstrate its safety and efficacy

• take responsibility for prescribing the medicine and for overseeing the patient’s care, monitoring, and any follow up treatment, or ensure that arrangements are made for another suitable doctor to do so

• make a clear, accurate and legible record of all medicines prescribed and, where not following common practice, their reasons for prescribing an unlicensed medicine

7.4 If a medicine, in or not in the formulary, is being used for an off license clinical indication there must be specific note as to why this has been done.

7.5 Patients (or their parents or carers) must receive sufficient written information about the medicines prescribed to allow them to make an informed decision.

8.0 Adverse reactions

8.1 If any serious suspected adverse reactions are reported to the medical practitioner the Registered Manager must be informed immediately.

8.2 Clinical Partners will then inform the MHRA within 48 hours about:

• serious suspected adverse reactions to all medicines and all reactions to products marked with a Black Triangle in the BNF and elsewhere using the Yellow Card Scheme.

8.3 Clinical Partners will provide patients with information about how they can report suspected side effects directly to the MHRA.

9.0 Security of prescription pads

9.1 Prescriptions will be written on an FP10 form obtained from the local NHS Accountable Officer and are personalised to the clinician and clinic that they will consult from. While an NHS prescription must be written or printed on an FP10 form, there is no mandatory form for a private prescription. In the case of CDs however the FP10PCD form should be used (see appendix 2 for further details). Private prescriptions should be written on a sheet of Clinical Partners headed notepaper. However, a pharmacist can dispense medicines (not including schedule 2 or 3 CDs) on a private prescription written on any paper, provided that s/he is satisfied that the document is genuine, the signatory is entitled to prescribe and the technical requirements are satisfied. These written prescriptions should be treated with the same security measures as NHS forms, as the same risks apply.

9.2 To reduce the risk of misuse, blank prescriptions should never be pre-signed.

9.3 Prescription stationery must be securely stored to prevent fraudulent use. It is the responsibility of the prescriber to ensure adequate arrangements are in place to maintain the security of their prescription pads.

• When working at Clinical Partners satellite locations prescribers must take suitable precautions to prevent the loss or theft of forms, such as ensuring prescription pads are carried in a lockable carrying case and kept out of sight until they are needed.

• Before leaving the satellite premises, prescribers should record the serial numbers of any FP10PCD prescription forms they are carrying. Only a small number of prescription forms should be taken to sessions depending on the number of patients to be seen.

• Storing prescription forms in vehicles is not without risk, as there have been reported incidents of vehicles being broken into and prescription pads being stolen. Prescribers should take precautions to keep their prescription forms out of sight when not in use. This includes not leaving prescription forms on view in a vehicle. If they have to be left in a vehicle, they should be stored in a locked compartment such as a car boot and the vehicle should be fitted with an alarm.

• Prescriptions should never be left in a vehicle overnight.

• Patients, temporary staff and visitors should never be left alone with prescription forms or allowed into secure areas where forms are stored.

10.0 Audit and monitoring

10.1 Any untoward drug incidents must be reported to the Registered Manager. All incidents will be investigated in accordance with our incident reporting policy or under our Duty of Candour policy. Clinical Partners will report incidents as required to CQC.

10.2 Managing compliance

• The RM and the Chief Medical Officer are responsible for the prescribing and medicines management systems and processes in place.

• Audits will be carried out in accordance with the requirements of the service and the improvement programme but at least annually. Audits will follow the appropriate Prescribing Observatory Mental Health Audit Cycles.

• Incident reporting systems.

• An annual review of the Prescribing Guide and SOPs in place.

11.0 Appendix 1 - Standard Operating Procedure Controlled Drugs

1. Introduction

Clinical Partners Limited (the Company) must comply with The Health and Social Care Act 2008 (Regulated Activities) Regulations 2014 the proper and safe management of medicines.

2. Principles of safe controlled drugs management

2.1 Where controlled drugs are prescribed organisations should have:

• clear, written standard operating procedures (SOPs) covering all aspects of CD management that are known, understood and followed by all relevant staff.

• SOPs that cover the organisations ordering, storing, administering, recording, and destruction of CDs as relevant to that organisation

• staff with the relevant knowledge and skills to undertake the CD related tasks required of them

• staff that know what to do and who to contact if they have a concern about an incident or the performance or practice of other healthcare professionals / staff

• staff who know how to contact the NHS England lead controlled drugs accountable officer (CDAO) for the area.

3. Scope

3.1 This SOP covers any activity undertaken in the prescribing of a controlled drug for a Clinical Partners’ patient or under contract arrangements with another provider.

4. Procedure

4.1 Ordering - Clinical Partners does not order controlled drugs for any location or satellite.

4.2 Receiving - Clinical Partners does not receive any controlled drugs at any location or satellite.

4.3 Storage - Clinical Partners does not store controlled drugs at any location or satellite.

4.4 Prescribing - All Clinical Partners prescribing is private unless part of an NHS contract.

• Once the patient has been assessed, diagnosed, and issued with a report, should they wish to proceed with controlled medication the private outpatient (triage) team will ensure that the required vital sign results (minimum blood pressure and heart rate) are received and documented prior to the patient receiving medication. For all subsequent follow up appointments the clinician must request and have seen the most recent vital signs and include this in their report/letter before repeat prescribing.

• The private prescription form FP10PCD (single sheet and personalised padded form) in England has been introduced for schedule 2 and 3 CDs and is available to all private prescribers of CDs for prescriptions which are to be dispensed by a community pharmacy only. The private CD prescription form can be dispensed by a registered community pharmacy and must contain the prescriber’s identification number.

• Clinical Partners prescribers of CDs, Schedule 2, and 3 will order their prescription forms from their local area CDAO who will be responsible for the onward secure delivery of the forms to Clinical Partner's office.

• Prescribers who issue private prescriptions will be allocated a unique six-digit prescriber code which is different from their NHS prescriber code. Therefore, prescribers who operate in the NHS as well as privately will have at least two separate codes (one for private prescribing and one or more for NHS).

For Schedules 2 and 3 CDs must be:

• Written on standard forms (FP10(PCD)) designed to be similar to, but distinguishable from, the NHS prescription form.

• To meet legal requirements, the following details must be present on the prescription and legible.

  • The name and address of the patient.

  • The form and strength of the preparation.

  • The total quantity or the number of dose units, in words and figures.

  • The dose.

  • The name, prescriber reference, address and signature of the prescriber.

  • Particulars to indicate the class of prescriber, e.g. doctor, dentist, nurse supplementary prescriber.

  • The date.

• Prescribers on behalf of Clinical Partners must limit the quantity of Schedule 2, 3 and 4 CDs prescribed to amounts that meet the patient’s clinical need for up to 30 days’ supply.

• In exceptional circumstances, where the prescriber considers more than 30 days is clinically indicated and would not pose an unacceptable risk to patient safety, a record of the reasons for deviating from the guidance should be made in the patient’s record and the prescriber should be able to justify the decision, if challenged.

4.5 Delivery/collection of prescriptions

• Tracked postal service

  • FP10PCDs must be posted using the Royal Mail’s Special Delivery guaranteed by 1pm next day service. FP10PCDs prescriptions should be sent to Pharmacierge or CloudRx not the patient’s home address). There is a quick and easy way to manage this from home by buying the postage online, printing the label at home, and dropping it off at a post office: Step 2 - Service - Royal Mail Click & Drop | Send an item - Buy, Print, Drop.

  • Clinicians must use prescriptions@clinical-partners.co.uk as the tracking address. Prescription fees will only be paid if Clinical partners are informed of the tracking reference.

• Pharmacierge/CloudRx

  • Clinicians can put multiple prescriptions into a single envelope to Pharmacierge or CloudRx using the Step 2 - Service - Royal Mail Click & Drop | Send an item - Click. Save. We Collect.(The prescription will be logged on the web prescribing system for record and audit purposes only).

  • Clinicians must use prescriptions@clinical-partners.co.uk as the tracking address. Prescription fees will only be paid if Clinical partners are informed of the tracking reference.

  • No controlled drugs will be dispensed until Pharmacierge or CloudRx has received a paper copy of the prescription in accordance with The Controlled Drugs (Supervision of Management and Use) Regulations 2013 (“the 2013 Regulations”) came into force in England and Scotland on 1 April 2013. (Appendix 2. SOP Controlled Drugs).

4.6 Before sending a prescription prescribers should:

• Check that the patient details are up to date.

• Keep records of the date the prescription form was posted, expected delivery date and items prescribed/dosages/amounts.

• Return address if the item cannot be delivered.

• Understand escalation and reporting actions in the event the patient reports non receipt of the prescription form.

4.7 Repeat prescriptions will be issued in line with Clinical Partners packages of care only if the patient continues to be a Clinical Partners patient.

4.8 Prescribers must consider:

• the frequency of review for further repeat prescriptions taking the controlled drug and the person's individual circumstances into account.

• the potential risk for misuse. Could a patient continue to request a prescription, even when they no longer need the controlled drug? They could make a request directly or via a friend or family member.

• how the patient should be managed once we are aware that the patient no longer needs the controlled drug.

4.9 Prescription stationery must be securely stored to prevent fraudulent use. It is the responsibility of the prescriber to ensure adequate arrangements are in place to maintain the security of their prescription pads.

• Prescription pads are stored at head office in a locked ,restricted access cupboard. The serial numbers will be logged on allocation to the clinician prior to being sent tracked delivery.

• When working at Clinical Partners satellite locations prescribers must take suitable precautions to prevent the loss or theft of forms, such as ensuring prescription pads are carried in a lockable carrying case and kept out of sight until they are needed.

• Only a small number of prescription forms should be taken to sessions depending on the number of patients to be seen.

• Prescribers should record the serial numbers of any prescription forms/pads they have , especially those they carry with them to clinics.

• Storing prescription forms in vehicles is not without risk, as there have been reported incidents of vehicles being broken into and prescription pads being stolen. Prescribers should take precautions to keep their prescription forms out of sight when not in use. This includes not leaving prescription forms on view in a vehicle. If they have to be left in a vehicle, they should be stored in a locked compartment such as a car boot and the vehicle should be fitted with an alarm.

• Prescriptions should never be left in a vehicle overnight.

4.10 Duplicate and spoiled prescriptions

If a duplicate prescription is accidentally sent to the pharmacy it should be securely destroyed or returned to the prescriber as soon as possible. If an error is made in a prescription, best practice is for the prescriber to do one of the following:

• put a line through the script and write ‘spoiled’ on the form

• cross out the error, initial and date the error, then write the correct information

• to retain them securely for local auditing purposes for a short period before destruction.

4.11 Lost Prescriptions

If a patient reports that they have lost a prescription form this will be recorded in the organisation’s incident reporting system. Before a replacement prescription is provided, a risk assessment will be undertaken to ensure, that the reported loss is genuine and not an attempt to commit prescription fraud. As this prescription will contain significant data, the loss should be treated like all other prescription/data losses. If the lost prescription form was for CDs, the CQC and the local NHS CDAO (england.pharmacyandoptometry@nhs.net) will be informed and extra precautions taken to ensure the medication is dispensed to the intended recipient without incident.

5. Incident Reporting and Action

• Any controlled drug incident must be reported and will be investigated via the clinical governance group.

• Clinical Partners has a CDAO, the Chief Medical Officer. Clinical Partners will register and report CD incidents to NHS England and NHS Improvement (NHSE&I) via the online reporting system CD Reporting

• If prescription forms are stolen the police will be informed.

• If it is suspected that prescription forms are being misused Clinical Partners will inform the CDAO, the police, the Clinicians responsible officer and CQC. If the clinician works in the NHS, the NHS Fraud & Corruption Reporting Line 0800 028 40 60 or online at Report NHS fraud may be informed.

• For all incidents Clinical Partners will review the need for a statutory notification and it's Duty of Candour.

6. Duties and Responsibilities

Registered Manager

The Registered Manager has ultimate responsibility for all elements of governance, including medicines management within the Company. The Registered Manager will work with the Chief Medical Officer to ensure that Clinical Partners takes all reasonable steps to ensure that medicines are safely managed by Clinical Partners.

7. Processes for Monitoring Compliance with this SOP

• The RM and the Chief Medical Officer are responsible for the prescribing and medicines management systems and processes in place.

• Audits will be carried out in accordance with the requirements of the service and the improvement programme but at least annually. Audits will follow the appropriate Prescribing Observatory Mental Health Audit Cycles.

• Incident reporting systems.

• The Chief Medical Officer will review all medicines management incidents and report to the Clinical Governance Group and the Board.

• As required, Clinical Partners may report to CQC, Responsible Officers or professional bodies.

• An annual review of the Prescribing Guide and SOPs in place.

12.0 Appendix 2 - Clinical Partners Formulary

13.0 References

The Health and Social Care Act 2008 (Regulated Activities) Regulations 2014

The Care Quality Commission (Registration) Regulations 2009

The National Health Service (Amendments to Primary Care Terms of Service relating to the Electronic Prescription Service) Regulations 2015

Medical regulation: responsible officer guidance

The Misuse of Drugs (Amendment) (No. 2) (England, Wales and Scotland) Regulations 2015

The Human Medicines (Amendment) (No. 2) Regulations 2015

Prescribing Competency Framework | RPS

Counter fraud guidance

Safer management of controlled drugs (CD) | NHSBSA

https://www.gmc-uk.org/ethical-guidance/ethical-guidance-for-doctors/good-practice-in-prescribing-and-managing-medicines-and-devices

https://www.gmc-uk.org/ethical-guidance/ethical-guidance-for-doctors/good-medical-practice