​Standard Operating Procedure (SOP)

​

Prescription Requirement Prior to Purchase of Prescription Only Medicines (POMs)

REF-POM-PRES-001-SJ

Effective Date

01/01/2026

Review Date

01/01/2027

​

1. Purpose

The purpose of this SOP is to ensure that Prescription Only Medicines (POMs) are not sold, supplied, or made available to patients without a valid prescription issued following an appropriate clinical assessment by an authorised prescriber.

This SOP ensures compliance with:

• Human Medicines Regulations 2012

• Medicines and Healthcare products Regulatory Agency (MHRA) guidance

• Professional standards for safe prescribing and medicines management

2. Scope

This SOP applies to:

• All patients seeking access to POMs

• All clinical and non-clinical staff involved in patient onboarding, prescribing coordination, sales, dispensing, or supply

• All POMs provided by the organisation, including face-to-face and remote/online services

3. Definitions

• Prescription Only Medicine (POM): A medicinal product that may only be supplied in accordance with a valid prescription issued by an authorised prescriber.

• Authorised Prescriber: A healthcare professional legally permitted to prescribe medicines (e.g. GMC-registered doctor, NMC-registered independent prescriber).

• Clinical Assessment: A documented evaluation of a patient’s suitability for treatment, conducted in line with clinical guidance.

4. Responsibilities

4.1 Patients

• Must not attempt to purchase or obtain POMs without a valid prescription.

• Must provide accurate and complete medical information during clinical assessment.

4.2 Prescribers

• Must undertake and document an appropriate clinical assessment.

• Must prescribe only where clinically indicated and in the patient’s best interests.

• Are responsible for the accuracy, legality, and appropriateness of the prescription.

4.3 Organisation and Staff

• Must ensure that no POM is supplied or sold without a verified prescription.

• Must verify the authenticity and validity of prescriptions prior to supply.

• Must escalate and record any deviations from this SOP.

5. Procedure

5.1 Patient Information and Transparency

• Patients must be clearly informed that POMs cannot be purchased without a prescription.

• This information must be communicated:

  • On the organisation’s website

  • During patient onboarding

  • Prior to any payment being taken

This supports informed consent and prevents inducement to purchase medicines without clinical approval.

5.2 Clinical Assessment

• All patients must undergo a clinical assessment conducted by an authorised prescriber prior to prescribing.

• The assessment must be proportionate, evidence-based, and appropriate to the medicine requested.

• The assessment must include, where relevant:

  • Medical history and co-morbidities

  • Current medications and allergies

  • Contraindications and cautions

  • Relevant clinical parameters

The outcome of the assessment must be documented in the patient record.

5.3 Prescribing Decision and Issuance

• A prescription may only be issued where the prescriber is satisfied that treatment is clinically appropriate.

• All prescriptions must include:

  • Patient identifiers

  • Medication name, strength, dose, and quantity

  • Directions for use

  • Date of issue

  • Prescriber identification and signature (electronic or handwritten)

5.4 Prescription Verification

• Prior to supply or sale of any POM, staff must verify:

  • A valid prescription exists

  • The prescription has been issued by an authorised prescriber

  • The medicine supplied matches the prescription

  • The prescription is within its validity period

No POM may be supplied until verification is complete.

5.5 Supply and Sale

• Payment and supply may only occur after prescription verification.

• The medicine supplied must correspond exactly with the prescription issued.

• Patients must be provided with appropriate information on safe use.

6. Record Keeping and Governance

• Accurate records must be maintained for:

  • Clinical assessments

  • Prescriptions issued

  • Medicines supplied

• Records must be:

  • Secure

  • Legible

  • Auditable

  • Retained in line with data protection legislation (GDPR)

7. Non-Compliance and Escalation

• Where no valid prescription exists, no POM must be supplied under any circumstances.

• Any attempted or actual breach must be:

  • Documented

  • Escalated to the Clinical Lead or Responsible Person

  • Reviewed as part of governance and risk management processes

8. Training and Competency

• All relevant staff must receive training on this SOP.

• Training records must be maintained and reviewed regularly.

9. Audit and Review

• Compliance with this SOP will be audited periodically.

• Findings will be used to inform continuous improvement.

• This SOP will be reviewed annually or sooner in response to regulatory or legislative change.

10. Related Policies

• Medicines Management Policy

• Prescribing Policy

• Consent and Capacity Policy

• Data Protection and GDPR Policy

11. Approval

Approved by: Mrs Caroline Balazs
Role: Lead Clinical Prescriber
Date: 01/01/2026