STANDARD OPERATING PROCEDURE

GLP-1 Receptor Agonist Prescribing for Weight & Metabolic Management

REF:GLP-1-PRES-001-SJ

Version1.0

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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

• 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

• Manufacturer SPC

Requirements:

• Store at 2–8°C before first use

• Maintain temperature logs

• Document fridge monitoring daily

• Secure storage

• Controlled access

Cold chain breach must trigger incident reporting.

11. Monitoring & Review

2–4 Week Review

• Tolerability

• Side effects

• Weight trend

• Dose decision

• Weight change

• 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

• 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