Medicines & Prescription Management Policy

Prescribing is a high-risk clinical activity and requires clear governance, robust systems and consistent professional judgement. This policy sets out how Psych2Gether Ltd manages medicines and prescription processes so that prescribing remains safe, legal, evidence-based, auditable and person-centred.

The policy has been structured to support safe practice, reduce avoidable error, strengthen accountability and provide a clear evidence base for regulatory inspection, audit and internal assurance.

The policy is informed by relevant legal and professional requirements, including the Human Medicines Regulations 2012, the Misuse of Drugs Act 1971, the Misuse of Drugs Regulations 2001, GMC prescribing guidance, NICE prescribing guidance, NHS Counter Fraud guidance, STOMP principles and applicable CQC expectations.

Psych2Gether Ltd is committed to ensuring that all prescribing activity is undertaken safely, competently and within the law. The organisation will maintain systems that support safe prescribing, appropriate monitoring, prompt incident reporting, effective learning and demonstrate governance oversight.

The organisation will provide a safe system of work in a safe environment, not only for patients, but also for any third parties who may be associated with it.

All prescribers must work within their scope of practice, maintain appropriate professional registration, follow the prescribing competence framework expected of their profession, and seek senior support when a clinical decision falls outside their competence or when the information available to them is insufficient.

The organisation will promote a culture of safety, openness and learning where concerns, incidents and near misses are reported promptly, reviewed proportionately and used to improve practice.

All prescribers for Psych2Gether Ltd, including independent prescribers, will be expected to meet and follow the prescribing competency framework (source: Prescribing Competency Framework (rpharms.com)). This framework sets out the competencies expected of all prescribers to support safe prescribing, as set out by the Royal Pharmaceutical Society.

The policy applies to all clinicians, prescribers and staff involved in medicines management, prescription generation, prescription security, monitoring, audit, incident reporting or governance within Psych2Gether Limited.

The policy covers private and electronic prescribing, remote prescribing, repeat prescribing, written prescriptions, controlled drugs, high-risk medicines, audit and risk management. It does not prescribe individual clinical treatment pathways, but it sets the minimum governance and safety requirements for all prescribing activity.

When prescribing any medication(s), prescribers at Psych2Gether Ltd will adhere to the following guidelines (Good Practice in Prescribing and Administering Medication, 2013):

• Keep up to date with and follow the law, General Medical Practice guidance and other regulations relevant to their work.
• Recognise and work within the limits of their competence.
• Prescribe drugs or treatment, including repeat prescriptions, only when they have adequate knowledge of the patient’s health and are satisfied that the drugs or treatment serve the patient’s needs.
• Provide effective treatments based on the best available evidence.
• Check that any care or treatment provided is compatible with any other treatments the patient may be receiving, including (where possible) self-prescribed over-the-counter medications.
• Make good use of the resources available.
• Ensure that any records taken are clear, accurate, legible and contemporaneous.

For medicines requiring enhanced monitoring, including ADHD medications, antipsychotics, lithium, valproate, and other high-risk psychotropic medicines, monitoring will be undertaken in accordance with the relevant SPC, national guidance, and shared-care arrangements where applicable.

5.1  Where a Psych2Gether Ltd Prescriber Is Not the Primary Prescriber

Prescribers at Psych2Gether Ltd will adhere to the following when prescribing to a patient whose GP or main prescriber is someone else:

• Inform the patient of the prescriber’s full name, role and, if online, GMC registration number.
• Explain how the consultation will work and what they should do if they have any concerns or questions.

Prescribers should follow the GMC Good Prescribing and Managing Medical Devices Guidance on sharing information with the relevant people; this will be used in conjunction with the Information Governance Policy.

5.2  Electronic Prescribing

Psych2Gether Ltd will utilise a SignatureRx® electronic prescription (EPS) and Semble® Patient Medication Records (PMR) platform for the generation, transmission and storage of prescriptions. These systems are demonstrably compliant with all applicable UK regulatory and statutory frameworks governing digital health services, including NHS Digital / Digital Social Care assurance standards, the Data Protection Act 2018 and UK GDPR. This allows prescribing clinicians to send prescriptions electronically to a pharmacy of the patient’s choice.

All patient and prescription data are encrypted both in transit and at rest, with security controls aligned to recognised national standards. User access will be governed through role-based permissions, multifactor authentication where supported, and comprehensive audit logs. All prescribing activity—initiation, amendments and discontinuation—is recorded, timestamped and fully auditable.

Psych2Gether Ltd will maintain a formal contractual agreement with the system provider incorporating robust expectations for regulatory compliance, cyber security, infrastructure resilience, and service continuity. The contractor is required to evidence regular updates, penetration testing, incident reporting, and business continuity capability.

Staff involved in prescribing processes will receive structured training, competency assessment and ongoing support in using the EPS platform. As part of our governance framework, scheduled audits, data quality reviews, and compliance checks will be carried out to ensure the safe, effective, and legal operation of the system.

5.3  Remote Prescribing

Psych2Gether Ltd recognises that remote consultations and prescribing online carry potential risks to patient safety. As such, online consultation prescribing will be conducted in accordance with the key principles for remote prescribing, as set out by the GMC and other recognised bodies — Good practice in prescribing and managing medicines and devices (gmc-uk.org).

Remote prescribing is permitted only when it is clinically appropriate, legally valid and safe. The prescriber must confirm the patient’s identity, explain their role, set out how the consultation will work and ensure the patient understands the limits of remote care.

• Remote prescribing must not be used where the assessment is incomplete or where physical examination, tests or direct observation are required for safe decision-making. If at any time a prescriber feels that prescribing to a patient remotely is not safe or in their best interests, the prescriber will ensure that if a patient requires a physical examination, diagnostic test, or any assessment that cannot be completed safely through a virtual consultation e.g. an ECG requirement in keeping with national guidance for monitoring patients on specific medications, the prescriber will advise that an in-person review is essential. To protect patient safety and ensure accurate clinical decision-making, the patient will be directed to their registered GP or, if they prefer, a suitably regulated private healthcare provider capable of carrying out the required checks. This approach ensures that all physical health needs are managed in the safest and most clinically appropriate setting.
• The prescriber must obtain informed consent and consider mental capacity and safeguarding issues where relevant.
• The patient must be offered information about realistic treatment options, including non-treatment or signposting to another service where prescribing is not appropriate.
• Relevant information should be shared with other professionals involved in the patient’s care unless the patient objects and there is no overriding safety reason to do so.
• The prescriber must maintain clear notes explaining the assessment, the rationale for the decision and any follow-up actions.

5.4  Repeat Prescribing

Psych2Gether Ltd will follow guidance from the GMC (Repeat prescribing and prescribing with repeats — GMC) regarding issuing repeat prescriptions.

Staff members are responsible for any prescription they sign, including repeat prescriptions for medicines initiated by colleagues, so staff members must make sure that any repeat prescription they sign is safe and appropriate. They should consider the benefits of prescribing with repeats, and where possible, reduce repeat prescribing.

Staff members must agree with the patient which medicines are appropriate and how their condition will be managed, including a date for review. Staff members should make clear why regular reviews are important and explain to the patient what they should do if they:

• Suffer side effects or adverse reactions.
• Stop taking the medicines before the agreed review date, or before a set number of repeats have been issued.

Repeat prescribing must only occur where the medicine remains indicated, the patient has been reviewed appropriately, and the prescriber is satisfied that the repeat is safe and necessary.

• The treatment plan, review date and monitoring expectations must be agreed with the patient.
• Repeat prescriptions must be based on current clinical information and any changes following hospital admission, specialist review or recent assessment must be reconciled promptly.
• Prescribers must check that the patient is taking the medicine as intended and that the medicine remains effective, tolerated and appropriate.
• Early, late or frequent repeat requests may indicate poor adherence, adverse effects, inadequate control or misuse and must be reviewed clinically.
• Only staff who are competent and authorised may prepare repeat prescriptions for authorisation.

At each review, staff members should confirm that the patient is taking their medicines as directed and check that the medicines are still needed, effective and tolerated. This may be particularly important following a hospital stay or changes to medicines following a hospital or home visit. Staff members should also consider whether requests for repeat prescriptions received earlier or later than expected may indicate poor adherence, leading to inadequate therapy or adverse effects.

When staff members issue repeat prescriptions or prescribe with repeats, they should make sure that procedures are in place to monitor whether the medicine is still safe and necessary for the patient.

6.1  Prescribing for Controlled Drugs — FP10PCD Prescriptions

Psych2Gether Ltd will keep a record of the serial numbers of all prescriptions issued to maintain clear, unambiguous records of the prescription forms received, used or securely destroyed. The first and last serial numbers of the prescription pads will be recorded (Appendix I). Psych2Gether Ltd will ensure the use of a tamper-evident, hard-backed notebook for this purpose, which will be kept securely with the prescription forms. Prescription forms will be ordered from the NHS Area Team by the Registered Manager, via the PCSE website, and will be collected in person by the Registered Manager, an appropriately appointed individual or will be delivered by courier. A pre-determined date of arrival will be ascertained where possible, so a missed delivery can be followed up quickly within 6 working days from the date of the order being placed. The register (Appendix I) will be completed on receipt of new prescriptions and witnessed.

Prescriptions are processed by the patient’s preferred community pharmacy. Any clinicians registered with the local NHS Area Team must hold a PIN to prescribe controlled drugs. Psych2Gether Ltd will assist clinicians in obtaining this PIN. Once registered, clinicians will be issued their personal FP10PCD prescription forms.

• Prescribers must hold the appropriate prescriber identification and must only prescribe CDs in accordance with law, professional guidance and organisational policy.
• CD prescriptions must be complete, dated, signed, legible and include all legally required particulars, including the total quantity in words and figures.
• The quantity prescribed must normally not exceed 30 days’ supply unless a clearly documented justifiable clinical reason supports a longer period.
• Instalment prescriptions must specify the amount and interval clearly.
• Where a CD prescription is issued, an auditable record must be retained in the Semble® patient record and in the SignatureRx® prescription management system.

6.2  Prescriptions Posted in the Mail

6.2.1 Non-Controlled Drug Prescriptions

The preferred and safest options for patients to obtain a signed prescription form from their prescriber are either face-to-face from prescribers at Psych2Gether Ltd or via its SignatureRx® EPS portal, which sends the prescription to the patient’s preferred pharmacy for collection by the patient or a named representative using a code sent directly to the patient. Using either of these options reduces the opportunity for fraudulent activity to occur involving a genuine prescription form. However, sometimes this option is not suitable, and it may be necessary to post signed prescription forms to patients at their home address. The decision to send prescriptions to the patient’s home directly needs to be discussed with the Registered Manager in every instance. In this instance, Psych2Gether Ltd will undertake several precautions to ensure that the prescription is delivered and dispensed to the legitimate patient.

These may include, but are not limited to:

• Checking that the patient’s address is current and correct.
• Considering if there are known individuals at the patient’s address with substance misuse issues.
• Checking whether someone will be in to accept the delivery (use next day delivery).
• Recording the date the prescription form was posted, name and address of the recipient, expected delivery date and items prescribed/dosages/amounts.
• Discreet information on the external envelope/packing so that the item is not easily identified.
• Return address if the item cannot be delivered.
• Using a postal service with tracking information.
• Getting the item signed for at the point of delivery to ensure it can be traced in the event it has not been received by the intended recipient.
• Reconciliation checks to ensure that the patient received the prescription form.

6.2.2 Controlled Drug Prescriptions

Before transferring an FP10CD prescription to Signature Pharmacy, the patient’s consent to (a) use Signature Pharmacy, and (b) transfer the prescription by post, must be obtained and documented in the patient’s clinical record.

The patient must be informed of: the prescription transfer process; the use of tracked postal services; medication delivery arrangements; the requirement for a signature upon delivery; and the process for managing failed deliveries.

Patients who do not consent to the use of Signature Pharmacy must not be disadvantaged and will be offered an alternative lawful and clinically appropriate arrangement for obtaining their prescribed medication. Where consent is declined: the patient’s decision must be recorded in the clinical record; alternative arrangements will be discussed and agreed; and the agreed plan must be documented in the clinical record.

6.2.2.1 Transfer of the FP10CD Prescription

The completed FP10CD prescription will be sent securely to Signature Pharmacy using a Signature Pharmacy prepaid envelope. A copy of the completed FP10CD will also be uploaded to the secure SignatureRx portal in accordance with local Information Governance requirements. The original FP10CD will be posted at a Post Office using a tracked postal service. The following information must be recorded in the patient’s clinical record: date of posting; name of staff member posting the prescription; and postal tracking/reference number. This record will provide an auditable trail of the prescription transfer process.

6.2.2.2 Confirmation of Receipt

Upon receipt of the original FP10CD prescription, Signature Pharmacy will acknowledge receipt via the secure SignatureRx portal against the patient’s record. The electronic acknowledgement together with the postal tracking information will provide an end-to-end audit trail from prescription generation to receipt by the dispensing pharmacy. Any delay, discrepancy or failure of receipt must be investigated promptly and the outcome documented in the patient’s clinical record.

6.2.2.3 Dispensing and Patient Notification

Following receipt of the FP10CD prescription, Signature Pharmacy will undertake the appropriate clinical and legal checks prior to dispensing. Once the prescription has been clinically checked and dispensed, the patient will be informed of the anticipated dispatch date of their medication.

6.2.2.4 Delivery of Controlled Drug Medication

Controlled Drug medication will be dispatched by Signature Pharmacy using Royal Mail Signed For® or an equivalent tracked and signed-for delivery service. The delivery service will provide: package tracking; proof of delivery; and confirmation of receipt by signature. Delivery information must be retained and be available for audit, investigation of incidents, or governance review purposes.

6.2.2.5 Failed Deliveries

In the event of a failed delivery, Royal Mail will follow its secure redelivery procedures. Where delivery cannot be completed: the package will be held securely pending redelivery; or the package will be returned to Signature Pharmacy. Returned Controlled Drug medication will be managed by Signature Pharmacy in accordance with its Controlled Drugs Standard Operating Procedures. Any significant incidents, losses, delays, or concerns relating to Controlled Drug deliveries must be escalated and documented in accordance with local incident reporting procedures.

6.2.2.6 Record Keeping

The following records must be maintained: patient consent; copy of the FP10CD uploaded to SignatureRx; date of prescription posting; tracking/reference number; Signature Pharmacy acknowledgement of receipt; patient notification of medication dispatch; delivery confirmation or failed delivery actions; and any incidents, discrepancies, investigations, or escalations. These records must be retained in accordance with local record retention and Information Governance policies.

6.3  Security and Control of Prescription Stationery

Prescribers have sole responsibility for any prescription forms in their possession, and such forms are for the sole use of that prescriber. Prescribers will:

• Ensure a record is kept of all prescriptions that they issue (e.g., as per Appendix II).
• Not pre-sign blank prescription forms.
• Store all prescription forms and prescriptions in the designated locked cupboard in a locked room. Authorised individuals will only have access to the prescriptions, and a log of authorised individuals will be kept.
• Retain spoiled or cancelled prescriptions for audit purposes and ensure this is recorded.

6.4  Duplicates and Spoiled Prescriptions

If a duplicate prescription is accidentally written or printed, or if an error is made in a prescription, prescribers will do one of the following:

• Put a line through the script and write ‘spoiled’ on the form, sign and date it.
• For written prescriptions, cross out the error, sign and date the error, then write the correct information.
• For printed prescriptions, handwritten alterations should only be made in exceptional circumstances; it is preferable to print a new prescription. Any alterations must be made in the doctor’s own handwriting and countersigned, and computer records should be updated to fully reflect any alteration.
• Prescription forms that are issued as a duplicate should be labelled clearly as such.

6.5  Destroying Void Prescriptions

Destroying void prescriptions will be done by two healthcare professionals (i.e., nurse, doctor, pharmacist). Two lines and the words void or cancelled will be written on the prescription by either healthcare professional. The staff member must also sign the destroyed section of the Prescription Management Record (Appendix I), and a second registered professional will witness the process and countersign the register. The void prescription(s) will be destroyed using an approved crosscut shredder. This should be done at the earliest possible convenience.

The prescription form remains the responsibility of the person to whom it was issued until two signatures are entered onto the Prescription Management Register documenting their destruction. Records of forms destroyed should be kept for audit purposes.

6.6  Security of Prescription Forms

The Clinic shall maintain robust governance arrangements for the management, prescribing, monitoring and auditing of controlled drug prescriptions. Systems shall be in place to ensure prescription forms are secure, prescribing activity is monitored, discrepancies are promptly identified, and lessons are learned from incidents to reduce the risk of patient harm, fraud, diversion and misuse. The Clinic shall maintain an auditable trail for all controlled drug prescriptions and demonstrate appropriate oversight through its clinical governance framework.

A register shall be maintained for all controlled drug prescription forms issued to authorised prescribers and shall include: prescriber name; professional registration number; prescriber identification number (where applicable); serial number or serial number range allocated; date issued; signature of recipient; and date returned, cancelled or destroyed, where relevant.

6.7  Missing, Fraudulent and Lost Prescriptions

Any member of staff who becomes aware of a lost, missing, stolen, altered, fraudulently obtained or otherwise unaccounted-for prescription form shall immediately notify the Medicines Management Lead, Clinical Lead and Registered Manager.

The following actions shall be undertaken without undue delay:

• Immediate confirmation of the prescription serial number or serial number range affected.
• Verification that the prescription has not been legitimately used, cancelled, filed or destroyed.
• Assessment of any actual or potential risk to patients.
• Assessment of any actual or potential risk of unauthorised access to medicines, including controlled drugs.
• Documentation of the incident on the Clinic’s incident reporting system.
• Consideration of whether external reporting is required.
• Review of any associated security weaknesses.
• Implementation of immediate measures to reduce the risk of further losses.

The investigation shall seek to establish: the circumstances surrounding the loss; whether fraud, theft or diversion may have occurred; whether any patients may be at risk; whether there have been similar previous incidents, trends or contributory factors; and any corrective and preventive actions required.

Where a lost prescription is subsequently recovered, the circumstances shall still be reviewed to identify learning and determine whether further action is required. If a missing prescription form cannot be accounted for, the Clinic shall consider notifying relevant external organisations, including regulators, law enforcement agencies, controlled drug governance bodies, dispensing pharmacies or other stakeholders, as appropriate to the circumstances.

Any confirmed or suspected fraudulent use of prescription forms shall be treated as a serious incident and escalated through the Clinic’s governance and risk management processes.

Details of all lost, missing or stolen prescriptions shall be reviewed as part of the monthly Controlled Drug Prescribing Assurance Report and included within quarterly and annual governance reviews to identify recurring themes, trends and opportunities for improvement.

In addition to routine audits, the Clinic shall undertake ongoing surveillance of prescribing activity to identify unusual patterns or emerging risks.

Monitoring may include:

• Significant increases in prescribing volume.
• Prescribing outside normal clinical practice.
• High quantities of controlled drugs prescribed.
• Frequent requests for replacement prescriptions.
• Early repeat requests.
• Multiple prescriptions issued to the same patient within a short period.
• Prescribing activity outside expected working hours.
• Variations in prescribing practice between prescribers.
• Patients obtaining prescriptions from multiple prescribers within the service.
• Prescribing trends that differ significantly from those of peers or established clinic practice.

Where unusual patterns are identified, a documented review shall be undertaken and appropriate action implemented.

Within the designated EPS system, SignatureRx, access shall be restricted to authorised users with unique credentials. Usernames, passwords and authentication methods shall not be shared. The Clinic shall maintain a complete audit trail of electronic prescribing activity.

Monthly monitoring shall include review of:

• User access permissions.
• New account creation and account deletion.
• Prescribing activity by user.
• Cancelled prescriptions.
• Amended prescriptions.
• Duplicate prescriptions.
• Failed login attempts.
• Unauthorised access attempts.
• Prescribing activity outside expected working patterns.

User access rights shall be reviewed at least annually and immediately following any change in employment status or role. Any concerns regarding system misuse, inappropriate prescribing or unauthorised access shall be investigated promptly.

9.1  Monthly Prescription Form Reconciliation

The Medicines Management Lead shall undertake and document a monthly reconciliation of controlled drug prescription forms. The reconciliation shall include:

• Verification of all prescription serial numbers issued.
• Review of any gaps in serial number sequences.
• Confirmation of the location and accountability of unused prescription forms.
• Review of cancelled, voided or spoilt prescriptions.
• Identification of any missing or unexplained serial numbers.
• Confirmation that actions arising from previous reconciliations have been completed.

Records of reconciliations shall be retained as part of the Clinic’s governance records and made available for inspection upon request. Any unexplained discrepancy shall be investigated immediately and recorded through the Clinic’s incident management process. Repeated discrepancies shall trigger an enhanced review and escalation through the Clinic’s governance and risk management processes.

9.2  Monthly Controlled Drug Prescribing Audit

A monthly audit of controlled drug prescribing shall be undertaken by the Medicines Management Lead or delegated clinician with appropriate competence. The audit shall include review of:

• Total number of controlled drug prescriptions issued.
• Prescribing activity by individual prescriber.
• Compliance with legal prescription requirements.
• Clinical indication for prescribing.
• Quantity prescribed.
• Duration of treatment.
• Frequency of repeat prescribing.
• Requests for early supplies.
• Prescriptions issued outside established treatment plans.
• Prescriptions subsequently amended, cancelled or replaced.
• Complaints, incidents or safeguarding concerns associated with prescribing activity.
• Compliance with relevant national guidance and internal prescribing standards.

Where prescribing volumes are low, all controlled drug prescriptions issued during the audit period shall be reviewed. Where prescribing volumes are higher, a risk-based sample shall be reviewed, including all high-risk cases and a representative sample from each authorised prescriber. Audit findings shall be documented, reviewed and retained within the Clinic’s governance records. Any identified concerns shall result in an action plan, with timescales for completion and review.

9.3  Governance and Assurance

The Medicines Management Lead shall prepare a monthly Controlled Drug Prescribing Assurance Report for review through the clinic’s clinical governance framework. The report should include:

• Number of controlled drug prescriptions issued.
• Audit findings.
• Prescription form reconciliation outcomes.
• Incidents, near misses and investigations.
• Trends and themes identified.
• Corrective and preventive actions.
• Outstanding risks.
• Training and competency issues.
• Recommendations for service improvement.

A quarterly governance review shall be undertaken by the Clinical Lead and Registered Manager to assess overall compliance with this policy.

An annual Controlled Drug Governance Review shall be completed and shall include: review of prescribing trends; review of all incidents and investigations; review of audit outcomes; review of policy compliance; identification of emerging risks; effectiveness of implemented actions; training and competency compliance; and recommendations for continuous improvement.

9.4  Additional Governance Controls

To assure safe and effective controlled drug prescribing, the Clinic shall maintain:

• A controlled drug prescriber authorisation register.
• Evidence of professional registration and revalidation checks for prescribers.
• Records of controlled drug prescribing training and competency assessments.
• Annual controlled drug competency declarations by authorised prescribers.
• A controlled drug incident log.
• A controlled drug audit programme and audit schedule.
• A governance action tracker.
• A controlled drug risk register where significant risks have been identified.
• Records of monthly assurance reports, quarterly governance reviews and annual governance reviews.

These records shall be retained in accordance with the Clinic’s records management procedures and made available for governance review, regulatory inspection and audit purposes.

High-risk medicines require enhanced vigilance because of their potential for serious adverse effects or the need for laboratory, physical or physiological monitoring. Psych2Gether Ltd will identify all patients on high-risk medicines, ensure the required monitoring is scheduled and confirm that actions are taken when results fall outside agreed parameters.

• Monitoring requirements must follow national guidance, the product literature and any relevant local protocol or shared-care arrangement.
• Patients requiring physical examinations, ECGs, blood tests or other investigations must be directed to the appropriate provider where those checks cannot be completed safely through remote care.
• Results must be reviewed promptly and acted on in line with the organisation’s investigation and results management arrangements.
• Prescribers must confirm that monitoring is current before issuing ongoing prescriptions for medicines where safety depends on regular review.
• Any abnormal findings, missed tests or non-attendance must trigger review, follow-up and documented clinical decision-making.

Psych2Gether Ltd will operate a continuous cycle of audit, review and improvement to support safe prescribing and demonstrable governance.

• Regular audits will assess whether policy requirements are being followed, including prescribing quality, documentation, monitoring, consent, prescription security, remote prescribing safeguards and controlled drug controls.
• Findings will be documented together with actions, owners and completion dates.
• Audit results, incident learning and trend analysis will inform policy updates, training plans and service improvements.
• Prescribing activity will be monitored for unusual patterns, including high volumes, off-pattern prescribing, frequent replacement requests, early repeats, multiple prescribers and activity outside expected working practice.
• The organisation will use governance reporting to identify recurring themes, emerging risks and opportunities for improvement.

Any incident involving controlled drug prescribing, prescription stationery or electronic prescribing systems shall be reported via the Clinic’s incident reporting process. Examples include:

• Missing prescription forms.
• Unexplained serial number discrepancies.
• Prescribing errors.
• Incorrect quantities prescribed.
• Suspected fraudulent prescriptions.
• Forged prescriptions.
• Unauthorised access to prescribing systems.
• Suspected diversion or misuse of controlled drugs.
• Breaches of prescription security arrangements.

All incidents shall undergo a proportionate review to determine contributory factors, actual or potential harm, and opportunities for organisational learning. The Clinic shall adopt the principles of the Patient Safety Incident Response Framework (PSIRF) as a recognised best-practice methodology for incident management.

Investigations shall:

• Focus on learning rather than blame.
• Take a systems-based approach.
• Be proportionate to the level of risk and harm.
• Consider human, organisational and environmental factors.
• Identify opportunities for improvement.
• Promote a just and learning culture.
• Include dissemination of learning where appropriate.

Where concerns indicate possible criminal activity, fraud, theft, diversion of controlled drugs or professional misconduct, the Clinic shall escalate matters to the appropriate external agencies, regulators or law enforcement bodies as required.

12.1  Risk Management and Escalation

Any loss, theft, unexplained discrepancy, suspected fraudulent prescription, prescription stationery security breach, unauthorised prescribing activity, or recurring prescribing concern shall be subject to a documented risk assessment and recorded on the Clinic’s Risk Register where appropriate.

The risk remains under active review until:

• The investigation has been completed.
• All identified actions have been implemented.
• Assurance has been obtained that the risk has been adequately mitigated.

High-risk incidents, repeated discrepancies, significant audit findings, or concerns relating to controlled drug prescribing shall be escalated to the Clinical Lead and Registered Manager and reviewed through the Clinic’s governance framework. Progress against agreed actions shall be monitored and recorded through an action tracker to ensure timely completion, ongoing oversight and organisational learning.

The Clinic shall maintain evidence of:

• Risk assessments relating to controlled drug prescribing and prescription security.
• Investigations and outcomes.
• Corrective and preventive actions.
• Lessons learned and service improvements.
• Completion and effective review of actions implemented.

Where incidents identify wider system weaknesses, processes shall be reviewed and amended as necessary to reduce the likelihood of recurrence and support continuous quality improvement in line with the principles of a just culture and the Patient Safety Incident Response Framework (PSIRF).

Compliance with this policy will be monitored through audit, incident review, governance reporting, training compliance, user access review, patient feedback and staff feedback.

The policy will be reviewed at least annually or sooner if there are changes in legislation, national guidance, operational practice, system design, significant incidents or regulatory expectations.

• Confidentiality Policy and Procedure
• Dealing with Enquiries Policy
• Incident Management Policy and Procedure
• Information Governance Policy and Procedures
• Lone Worker Policy
• Making Reasonable Adjustments for Face-to-Face Policy
• Quality, Governance and Risk Policy and Procedures
• Safety Alert Policy and Procedure

• CQC, 2019, GP mythbuster 28: Management of controlled drugs — Care Quality Commission
• CQC, 2020, GP mythbuster 23: Security of blank prescription forms — Care Quality Commission
• GMC, 2013, Good practice in prescribing and managing medicines and devices (gmc-uk.org)
• GMC, Remote prescribing high-level principles — GMC (gmc-uk.org)
• NHS Counter Fraud Authority, 2025, Management and control of prescription forms
• NHS Business Service Authority, Controlled_drug_prescribing.pdf (nhsbsa.nhs.uk)
• NICE, Guidance on Prescribing, Guidance on prescribing | Medicines guidance | BNF
• NICE guidelines on Prescription Writing, Prescription writing | Medicines guidance | BNF
• Health and Social Care Act 2008 (Regulated Activities) Regulations 2014
• Human Medicines Regulations 2012
• Safer prescribing and monitoring of high-risk medicines — Wood — 2020 — Prescriber — Wiley Online Library