Standard Operating Procedure (SOP)

Standard Operating Procedure

GLP-1 Receptor Agonist Prescribing for Weight & Metabolic Management

REF: GLP-1-PRES-001-SJ
Version: 1.0

1. Purpose

To ensure safe, effective, and legally compliant prescribing of GLP-1 receptor agonists for weight and metabolic management in accordance with:

• Health and Social Care Act 2008 (Regulated Activities) Regulations 2014
• CQC Fundamental Standards
• MHRA safety guidance
• NICE guidance (where applicable)
• GMC / NMC prescribing standards
• Human Medicines Regulations 2012

2. Scope

Applies to:

• Independent Prescribers
• Clinical assessment staff
• Medicines management team
• Administrative staff involved in onboarding and follow-up

3. Regulatory Framework

This SOP supports compliance with Key Lines of Enquiry (KLOEs):

• Safe (S): S1 (Systems to assess, monitor and manage risk); S4 (Safe and proper use of medicines)
• Effective (E): E1 (Evidence-based practice); E2 (Monitoring outcomes)
• Well-led (W): W1 (Governance and oversight); W3 (Continuous improvement and audit)

4. Clinical Governance Responsibilities

Medical Lead / Clinical Director

• Oversight of prescribing protocols
• Annual audit of prescribing outcomes
• Incident review and learning

Prescriber

• Full clinical assessment
• Documentation of rationale
• Ensuring eligibility
• Obtaining informed consent
• Monitoring and review

Medicines Lead

• Cold chain management
• Stock reconciliation
• Expiry date monitoring

5. Patient Eligibility Criteria

Patients must meet licensed criteria OR documented clinical justification for off-label use.

Licensed Indication (example – semaglutide weight management):

• BMI ≥30 kg/m² OR
• BMI ≥27 kg/m² with at least one weight-related comorbidity

Clinical justification must be recorded clearly if prescribing outside strict NICE criteria in private practice.

6. Contraindications

Absolute contraindications:

• Personal/family history of medullary thyroid carcinoma
• MEN2 syndrome
• Pregnancy or breastfeeding
• Active pancreatitis
• Hypersensitivity to active substance
• Gallbladder disease
• History of pancreatitis
• Severe renal impairment
• Severe gastrointestinal disease

7. Baseline Assessment Requirements

A full consultation must include:

• Medical History
• Weight history
• Comorbidities
• Medication review
• Mental health screening
• Alcohol intake
• Height, Weight, and BMI
• Blood monitoring if clinically indicated

Document refusal if patient declines to give this information.

8. Informed Consent

Consent must include discussion of:

• Mechanism of action
• Common side effects (nausea, vomiting, constipation)
• Serious risks (pancreatitis, gallbladder disease)
• Unknown long-term data
• Off-label status (if applicable)
• Treatment duration expectations
• Discontinuation risk and relapse potential

Consent must be:

• Voluntary
• Documented
• Capacity confirmed
• Written and signed consent form

9. Prescribing Protocol

Example titration schedule (adjust per product SPC):

• Week 1–4: 0.25mg weekly
• Week 5–8: 0.5mg weekly
• Escalate as tolerated

Do not escalate if significant GI intolerance.

Prescriber must:

• Prescribe within competence
• Check interactions
• Record dose and quantity

10. Medicines Storage & Handling

In accordance with MHRA Good Distribution Practice and Manufacturer SPC.

Requirements:

• Store at 2–8°C before first use
• Maintain temperature logs
• Document fridge monitoring daily
• Secure storage and controlled access

Cold chain breach must trigger incident reporting.

11. Monitoring & Review

2–4 Week Review:

• Tolerability and Side effects
• Weight trend and Dose decision
• Weight change and Waist circumference
• Blood pressure
• Repeat bloods if indicated

Minimum review frequency: every month.

Failure to give review information → prescribing paused.

12. Adverse Event Reporting

All serious adverse events must:

• Be documented in patient record
• Be reported via MHRA Yellow Card Scheme
• Be reviewed internally as clinical incident

Symptoms requiring urgent review:

• Severe abdominal pain
• Persistent vomiting
• Signs of pancreatitis
• Pregnancy

13. Safeguarding & Eating Disorder Screening

Due to increased prescribing risk in weight-focused services:

• Screen for active eating disorders
• Refer if suspected
• Avoid treatment in active anorexia/bulimia
• Document mental health considerations

14. Discontinuation Criteria

Stop immediately if:

• Pregnancy
• Suspected pancreatitis
• Severe adverse effects
• No meaningful clinical response after adequate trial

Structured exit plan required to minimise rebound weight gain.

15. Record Keeping

Each consultation must include:

• Clinical rationale
• Dose prescribed
• Weight
• Side effects
• Advice given
• Consent confirmation
• Follow-up date

Records must be contemporaneous, secure, and GDPR compliant.

16. Audit & Quality Assurance

Annual audit must assess:

• % patients meeting eligibility
• Average % weight loss at 12 weeks
• Adverse event rate
• Discontinuation rate
• Compliance with blood monitoring

Findings reviewed in governance meeting.

17. Training Requirements

Prescribers must:

• Be registered with GMC/NMC/HCPC
• Hold prescribing qualification
• Undertake annual CPD in obesity/metabolic medicine
• Remain updated with MHRA safety alerts

18. Review Schedule

This SOP must be reviewed:

• Annually
• Following MHRA safety updates
• After serious incident
• If NICE guidance changes

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Effective Date: 01/01/2026
Review Date: 01/01/2027
Approved By: Caroline Balazs [Clinical Director / Medical Lead]
Location: Clinical Governance Folder
Related Policies: Consent Policy, Safeguarding Policy, Medicines Management Policy, Cold Chain Policy, Incident Reporting Policy

Medicines Management Protocol

REF: MED-MAN-001-SJ
Type: Standard Operating Procedure

1. Purpose

To ensure the safe, effective, and legal management of medicines, minimising risk to patients, staff, and the organisation.

2. Scope

This SOP applies to all staff involved in prescribing, ordering, receiving, storing, administering, monitoring, and disposing of medicines.

3. Responsibilities

• Clinical Lead / Prescriber: Prescribing medicines appropriately and reviewing treatment.
• Medicines Manager / Practice Manager: Oversight of medicines management, audits, and compliance.
• Clinical Staff: Safe administration, documentation, and patient monitoring.
• All Staff: Reporting errors, near misses, or concerns.

4. Prescribing

• Medicines must be prescribed only by authorised, competent practitioners.
• Prescribing must follow current clinical guidelines and local formularies.
• Patient allergies, contraindications, and interactions must be checked.
• Clear documentation of medicine name, dose, route, frequency, and duration is required.

5. Ordering and Receipt of Medicines

• Medicines must be ordered from approved suppliers only.
• Deliveries must be checked against the order for accuracy, damage, and expiry dates.
• Controlled drugs (if applicable) must be checked and signed for by two authorised staff members.

6. Storage

• Medicines must be stored according to manufacturer instructions.
• Refrigerated medicines must be kept between 2–8°C, with temperatures recorded daily.
• Controlled drugs must be stored in a locked cabinet compliant with legal requirements.
• Access to medicines must be restricted to authorised staff only.

7. Administration

• The 5 Rights must always be followed: right patient, right medicine, right dose, right route, right time.
• Patient identity must be confirmed prior to administration.
• Medicines must be administered in accordance with the prescription and SOP.
• Any refusal, omission, or error must be documented and escalated.

8. Documentation

• All medicines administered must be recorded accurately and contemporaneously.
• Records must include date, time, dose, batch number (where required), and staff signature.
• Errors and adverse events must be reported using the incident reporting system.

9. Monitoring and Review

• Patients must be monitored for effectiveness, side effects, and adherence.
• Medicines should be reviewed regularly and discontinued when no longer required.
• High-risk medicines require enhanced monitoring.

10. Controlled Drugs (if applicable)

• Managed in line with national legislation and regulations.
• Accurate registers must be maintained and reconciled regularly.
• Any discrepancies must be reported immediately.

11. Disposal of Medicines

• Expired or unused medicines must be disposed of safely via approved routes.
• Controlled drugs require witnessed disposal and documentation.
• Medicines must never be disposed of in general waste or wastewater systems.

12. Training and Competency

• Staff must receive appropriate training before handling medicines.
• Competency must be assessed and refreshed regularly.
• Training records must be maintained.

13. Audit and Review

• Regular audits of medicines management must be undertaken.
• This SOP must be reviewed at least annually or following significant change or incident.

14. Incident Management

• All medication errors and near misses must be reported.
• Incidents will be investigated, and learning shared to prevent recurrence.

15. References

• National medicines legislation and professional guidance
• Local clinical governance policies

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Approved by: Caroline Balazs
Date: 01/01/2026
Review Date: 01/01/2027

Website Compliance Checklist – Online Sale of Medicines

REF: WEB-CHECK-MED-001-SJ

This checklist must be used by marketing, web, and clinical teams before publishing or updating any website content relating to medicines. Its purpose is to prevent regulatory breaches and ensure ongoing compliance.

1. Regulatory Visibility (Distance Selling)

• ☐ Business name and registered address clearly displayed
• ☐ Contact details (email and telephone) clearly visible
• ☐ Details of responsible clinician / pharmacist available

2. Product Classification Check

For each product listed:

• ☐ Confirm product is legally classified as non‑prescription (OTC)
• ☐ Product appears on the approved medicines list
• ☐ No prescription‑only medicines (POMs) accessible without clinical pathway
• ☐ No implied prescription‑level claims made

3. Product Information (Mandatory)

Each medicine page must include:

• ☐ Medicine name and active ingredient(s)
• ☐ Clear indication / intended use
• ☐ Who the medicine is suitable for
• ☐ Who should not use the medicine (contraindications)
• ☐ Clear dosing instructions
• ☐ Duration of use and when to stop
• ☐ Side effects and warnings
• ☐ Advice on when to seek medical help
• ☐ Statement: “Not suitable for everyone” or equivalent

4. Advertising & Marketing Claims (ASA / MHRA Critical Area)

Marketing content must:

• ☐ Be factual, balanced, and evidence‑based
• ☐ Not exaggerate benefits or outcomes
• ☐ Not minimise risks or side effects
• ☐ Avoid absolute claims (e.g. “guaranteed”, “risk‑free”)
• ☐ Avoid before‑and‑after imagery where inappropriate
• ☐ Avoid testimonials that imply medical cures
• ☐ Clearly separate editorial content from advertising

5. Weight‑Management & Sensitivity Safeguards (if applicable)

• ☐ Language avoids shame, pressure, or unrealistic expectations
• ☐ No claims of rapid or effortless weight loss
• ☐ No implication that medication replaces lifestyle or medical care
• ☐ Vulnerable groups are not targeted

6. Suitability & Safeguarding Controls

• ☐ Online suitability questionnaire in place before purchase
• ☐ Mandatory completion before checkout
• ☐ Red‑flag answers trigger block or escalation
• ☐ Age‑verification system active
• ☐ Clear statement that supply may be refused on safety grounds

7. Consent & Transparency

• ☐ Clear explanation of private service model
• ☐ Pricing transparent and upfront
• ☐ Consent wording present where required
• ☐ Privacy notice and data use explained

8. Ordering, Delivery & Returns Information

• ☐ Secure checkout and payment systems
• ☐ Clear delivery timescales
• ☐ Packaging described as discreet and secure
• ☐ Medicines returns policy visible (no re‑supply of returned meds)

9. Data Protection & Cookies

• ☐ GDPR‑compliant privacy policy
• ☐ Cookie consent banner active
• ☐ Health data handled via secure systems

10. Governance & Sign‑Off

Before publication, confirm:

• ☐ Clinical lead approval obtained
• ☐ Content reviewed against SOPs
• ☐ Version control recorded
• ☐ Review date scheduled

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Final Declaration (Internal Use)

Reviewed by: Caroline Balazs
Role: Advanced Practitioner Clinical Lead
Date: 01/01/2026
Review Date: 01/01/2027

Consent & Mental Capacity Policy

REF: MEN-CAP-001-SJ

Consent and Mental Capacity Policy – Private Services & GLP-1 Prescribing

1. Purpose

To ensure that consent is obtained lawfully, ethically, and consistently for private healthcare services, including GLP-1 weight‑management prescribing, and that individuals are supported to make informed decisions in line with the Mental Capacity Act 2005, professional standards, and regulatory expectations.

2. Scope

This policy applies to all staff involved in providing assessment, prescribing, treatment, monitoring, or advice within the private service, including face‑to‑face and remote consultations.

3. Legal and Professional Framework

• Mental Capacity Act (MCA) 2005 and Code of Practice
• Common law principles of consent
• GMC, NMC, HCPC professional standards

4. Key Principles of Consent (Private & GLP‑1 Context)

• Consent must be voluntary, informed, and given by a person with capacity
• Individuals must understand that treatment is private, including costs and prescribing arrangements
• Consent is an ongoing process, particularly for long‑term medicines such as GLP‑1 agonists
• Consent may be verbal or written, but must always be documented
• Individuals may withdraw consent at any time without prejudice

5. Mental Capacity Act – Five Statutory Principles

All staff must apply the following principles:

• A person is assumed to have capacity unless proven otherwise
• A person is not to be treated as unable to make a decision unless all practicable support has been given
• A person is not to be treated as unable to make a decision merely because they make an unwise decision
• Any act done for a person lacking capacity must be in their best interests
• Any action must be the least restrictive option

6. Assessing Capacity

Capacity is decision‑specific and time‑specific.

A person lacks capacity if they cannot:

• Understand relevant information
• Retain that information long enough to make a decision
• Use or weigh that information as part of the decision‑making process
• Communicate their decision (by any means)

Capacity assessments are particularly important where:

• Treatment is elective or privately funded
• Medicines carry significant side effects (e.g. GLP‑1 therapies)
• There is concern about coercion, unrealistic expectations, or vulnerability

All capacity assessments must be clearly documented.

7. Informed Consent for GLP‑1 Prescribing

Before initiating GLP‑1 treatment, the prescriber must ensure the individual understands:

• The licensed and/or off‑label status of the medicine (where applicable)
• Expected benefits and realistic outcomes
• Common and serious side effects (e.g. nausea, vomiting, GI symptoms)
• Potential risks and contraindications
• The importance of adherence and follow‑up monitoring
• That medication is part of a wider clinical approach, not a standalone cure
• Financial implications, including ongoing private costs

Written consent is required for:

• Initiation of GLP‑1 medication
• Off‑label use
• Any treatment with significant or ongoing risk

8. Remote Consultations and Digital Consent

Where consultations are conducted remotely:

• Identity must be verified
• Capacity must still be assessed
• Information must be provided in an accessible format
• Consent must be explicitly recorded

Digital or electronic consent is acceptable provided it is auditable and secure.

9. Lack of Capacity and Best Interests Decisions

If a person lacks capacity:

• GLP‑1 prescribing must not proceed unless clinically justified and lawful
• A best interests decision must be made and documented
• Family, carers, or advocates should be involved where appropriate
• Any legal authority (LPA, Court of Protection) must be respected

10. Refusal or Withdrawal of Consent

• A person with capacity may refuse or discontinue treatment at any time
• This must be respected and documented
• Risks of stopping treatment should be explained clearly
• Supportive follow‑up should be offered

11. Documentation and Record Keeping

Records must include:

• Capacity assessment (where applicable)
• Information provided about GLP‑1 treatment
• Consent obtained (verbal or written)
• Any refusal or withdrawal of consent
• Best interests decisions and rationale

Documentation must be clear, contemporaneous, and suitable for inspection.

12. Training and Competency

• All clinical staff must receive training on consent, capacity, and private prescribing
• GLP‑1‑specific consent training must be completed before prescribing
• Training records must be maintained

13. Audit and Review

• Consent documentation will be audited regularly
• This policy will be reviewed annually or following regulatory, legal, or clinical guidance changes

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Document Control

Approved by: Caroline Balazs
Role: Lead Clinical Prescriber
Date: 01/01/2026
Review Date: 01/01/2027
Version: 1.1

Cold Chain Management Protocol

REF: COLD-CHAIN-MAN-001-SJ

1. Purpose

To ensure the safe storage, handling, and monitoring of temperature-sensitive medicines, maintaining their quality, efficacy, and safety at all times.

2. Scope

This policy applies to all staff involved in the receipt, storage, monitoring, and management of refrigerated medicines within the service.

3. Definitions

• Cold Chain: The system of transporting and storing medicines within the recommended temperature range of 2–8°C from manufacture to administration.
• Temperature Excursion: Any deviation outside the recommended temperature range.

4. Responsibilities

• Clinical Lead: Overall accountability for cold-chain compliance.
• Practice / Service Manager: Ensuring systems, equipment, and audits are in place.
• Clinical Staff: Daily monitoring, documentation, and escalation of issues.
• All Staff: Reporting incidents or concerns immediately.

5. Equipment Requirements

• Dedicated medicines refrigerator (not used for food or specimens)
• Lockable or located in a restricted-access area
• Calibrated digital minimum/maximum thermometer or data logger
• Clear labelling: “Medicines Only”

6. Storage Requirements

• Refrigerated medicines must be stored between 2–8°C at all times
• Medicines must be stored in original packaging where possible
• Do not overcrowd the refrigerator; allow air circulation
• Medicines must not be stored in fridge doors or directly against cooling elements

7. Receipt of Refrigerated Medicines

• Deliveries must be checked immediately on arrival
• Confirm medicines are cool to touch and packaging intact
• Record delivery date and place medicines into the refrigerator without delay
• Any concerns must be escalated before medicines are used

8. Temperature Monitoring

• Refrigerator temperatures must be checked and recorded daily (including weekends if applicable)
• Record current, minimum, and maximum temperatures
• Reset min/max thermometer after recording
• Records must be retained for audit purposes

9. Temperature Excursions

If the temperature falls outside 2–8°C:

• Quarantine affected medicines immediately (label “Do Not Use”)
• Do not discard unless advised
• Record details of the excursion (temperature, duration, medicines affected)
• Seek advice from pharmacy/manufacturer
• Document outcome and actions taken
• Complete an incident report if required

10. Power Failure or Equipment Failure

• Escalate immediately to the manager or clinical lead
• Keep refrigerator door closed if safe to do so
• Transfer medicines to contingency storage if available
• Document the incident and actions taken
• Arrange urgent repair or replacement of equipment

11. Cleaning and Maintenance

• Refrigerator cleaned regularly according to local cleaning schedules
• Cleaning must be documented
• Annual calibration and servicing of temperature monitoring equipment

12. Training and Competency

• Staff handling refrigerated medicines must receive cold-chain training
• Competency must be assessed and refreshed regularly
• Training records must be maintained

13. Audit and Review

• Regular audits of temperature records and compliance
• Policy reviewed annually or following incidents or regulatory change

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Document Control

Approved by: Caroline Balazs
Role: Lead Clinical Prescriber
Date: 01/01/2026
Review Date: 01/01/2027
Version: 1.0

Associated Documents:

• Medicines Management SOP
• Incident Reporting Policy
• Prescribing Policy

Prescription Requirement Prior To Purchase of Prescription Only Medication

Purpose of this Summary

This document provides inspectors with a concise overview of how the organisation ensures that no Prescription Only Medicine (POM) is sold, supplied, or paid for without a valid prescription, and how this process operates safely in practice across general prescribing, GLP-1 services, weight management, and online/remote care.

How the SOP Works in Practice

1. Clear Separation of Prescribing and Purchase

• Patients are informed at multiple points (website, onboarding, consultation journey) that POMs cannot be purchased without a prescription.
• No payment is taken and no medicine is made available until a prescribing decision has been completed.
• This prevents inducement and ensures prescribing decisions are clinically led, not commercially driven.

2. Clinical Assessment First

• Every patient requesting a POM undergoes an appropriate clinical assessment by an authorised prescriber.
• Assessments are proportionate to the medicine requested and aligned with recognised clinical guidance.
• For remote and online services, assessments include structured questionnaires, review of medical history, and clinical oversight by a prescriber.

3. Independent Prescribing Decision

• Prescribers issue prescriptions only where clinically appropriate and in the patient’s best interests.
• Prescribers are responsible for:
  • Assessing suitability
  • Identifying contraindications
  • Determining dose and duration
• Prescribing decisions are documented within the patient record.

4. Prescription Verification Prior to Supply

• Before any POM is supplied or sold, staff verify:
  • That a valid prescription exists
  • That it has been issued by an authorised prescriber
  • That the medicine and quantity match the prescription
• Supply cannot proceed unless verification is complete.

5. Safe Supply and Patient Information

• Medicines are supplied strictly in line with the prescription.
• Patients receive appropriate information on safe use, storage, and follow-up.
• Ongoing monitoring arrangements are in place where clinically required.

Governance, Oversight, and Compliance

• All clinical assessments, prescriptions, and supplies are fully documented and auditable.
• Any deviation from the SOP is escalated to the Clinical Lead and reviewed through governance processes.
• Staff receive training on medicines governance and prescription verification.
• Compliance is monitored through audit and regular SOP review.

Cross-Referenced SOPs and Policies

This SOP operates alongside and is supported by the following documents:

• Medicines Management Policy – overarching governance of medicines use and supply
• Prescribing Policy – standards for safe, ethical, and evidence-based prescribing
• Online and Remote Prescribing SOP – safeguards for digital and remote consultations
• GLP-1 Prescribing SOP – specific clinical criteria, monitoring, and follow-up for GLP-1 medications
• Weight Management Service SOP – integrated approach to prescribing, lifestyle support, and ongoing review
• Consent and Capacity Policy – ensuring informed consent prior to treatment
• Data Protection and GDPR Policy – secure handling of patient information

These documents collectively demonstrate compliance with:

• Human Medicines Regulations 2012
• MHRA guidance on online and distance selling of medicines

Key Assurance Statement for Inspectors

The organisation maintains a robust system that ensures:

• Prescribing decisions are clinically led and independent of payment
• No POM is supplied without a valid prescription
• Patients are safeguarded through assessment, verification, and governance controls

This approach supports safe, effective, and compliant prescribing across all services, including GLP-1 and weight management pathways.

Protocol for Selling Non‑Prescription (OTC) Medicines Online

REF: NON-PRES-001-SJ

1. Purpose

To ensure the safe, legal, and ethical sale of non‑prescription (over‑the‑counter, OTC) medicines via online platforms, protecting patient safety and ensuring regulatory compliance.

2. Scope

This protocol applies to all staff and systems involved in the advertising, sale, supply, dispatch, and follow‑up of non‑prescription medicines sold online by the service.

It applies to:

• Website and e‑commerce platforms
• Remote consultations or questionnaires
• Order processing and fulfilment
• Customer support and aftercare

3. Regulatory and Legal Framework

• Human Medicines Regulations 2012
• MHRA guidance on distance selling of medicines
• Consumer Protection Regulations
• Advertising Standards Authority (ASA) guidance
• General Data Protection Regulation (GDPR)

4. Definitions

• Non‑Prescription / OTC Medicines: Medicines that can be sold without a prescription but may still require professional oversight.
• Distance Selling: Sale of medicines without face‑to‑face contact, including online platforms.

5. Governance and Accountability

• A Responsible Pharmacist / Clinical Lead must oversee online medicine sales
• Clear lines of accountability must be documented
• Systems must be auditable and inspection‑ready

6. Approved Medicines List

• Only medicines legally classified as non‑prescription may be sold
• Medicines must be sourced from licensed and approved suppliers
• A current approved product list must be maintained and reviewed regularly

7. Online Information and Advertising

The website must clearly display:

• Medicine name and active ingredients
• Intended use and limitations
• Clear dosing instructions
• Warnings, contraindications, and side effects
• Advice on when not to use and when to seek medical advice
• Statement that medicines may not be suitable for everyone

Advertising must:

• Be factual, balanced, and not misleading
• Avoid exaggerating benefits or minimising risks
• Comply with ASA and MHRA advertising guidance

8. Customer Assessment and Safeguards

Before supply:

• Customers must complete an online questionnaire where appropriate
• Screening must include age, pregnancy/breastfeeding status, allergies, and relevant medical conditions
• High‑risk responses must trigger escalation to a healthcare professional

Medicines must not be supplied if:

• There is uncertainty about safety or suitability
• The customer provides incomplete or concerning information

9. Age Verification

• Robust age‑verification measures must be in place
• Medicines must not be supplied to individuals below the legal age where restrictions apply

10. Professional Oversight

• A healthcare professional must be available for advice and escalation
• Clear contact details must be provided to customers
• Decisions to refuse supply must be documented

11. Ordering, Packing, and Dispatch

• Orders must be checked for accuracy before dispatch
• Medicines must be packaged securely and discreetly
• Temperature‑sensitive medicines must follow cold‑chain requirements (if applicable)
• Dispatch records must be maintained

12. Information Supplied with Medicines

Each order must include:

• Patient information leaflet (PIL)
• Clear usage instructions
• Safety warnings and advice
• Contact details for queries or concerns

13. Refusal, Cancellation, and Returns

• The service reserves the right to refuse supply on clinical or safety grounds
• Reasons for refusal must be documented
• Medicines returned must not be re‑sold
• Refunds must follow consumer law and internal policy

14. Incident Reporting and Complaints

• Adverse reactions, errors, or near misses must be reported
• Incidents must be investigated and learning shared
• A clear complaints process must be available to customers

15. Data Protection and Confidentiality

• Customer data must be handled in accordance with GDPR
• Secure systems must be used for storage and transmission of data
• Confidentiality must be maintained at all times

16. Training and Competency

• Staff involved in online medicine sales must be trained and competent
• Training must include OTC medicines, safeguarding, and escalation procedures
• Training records must be maintained

17. Audit and Review

• Regular audits of online sales, refusals, and incidents
• This protocol must be reviewed annually or following regulatory change

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Document Control

Approved by: Caroline Balazs
Role: Advanced Practitioner Clinical Lead
Date: 01/01/2026
Review Date: 01/01/2027
Version: 1.0