Introduction
The purpose of this policy is to ensure the safe, effective, and legal management of medicines within Coast Medic Ambulance Ltd, including the handling of Controlled Drugs (CDs) and the use of Patient Group Directions (PGDs). This policy is in line with national legislation, guidelines and applies to all staff involved in the prescribing, dispensing, administration, and storage of medications.
Scope
This policy applies to all healthcare professionals (HCPs) employed or contracted by Coast Medic Ambulance Ltd, including paramedics, emergency medical technicians, and other staff authorised to handle medications within the organisation.
Objectives
- To ensure the safe and effective use of medicines.
- To comply with all legal and regulatory requirements.
- To provide clear guidance on the management of CDs.
- To outline procedures for the use of PGDs.
- To define responsibilities related to the handling of medicines.
Legal Framework and Standards
- Medicines Act 1968
- Misuse of Drugs Act 1971 and Regulations 2001
- Health and Social Care Act 2008
- Human Medicines Regulations 2012
- Care Quality Commission (CQC) Guidelines
Definitions
Controlled Drugs (CDs)
Medications that are subject to strict legal controls due to the risk of misuse, harm, and addiction.
Patient Group Directions (PGDs)
Written instructions that allow the supply and/or administration of specified medicines by named authorized health professionals to groups of patients who may not be individually identified before presentation.
Roles and Responsibilities
Chief Executive
Overall responsibility for the governance of medicines management.
Controlled Drugs Accountable Officer (CDAO)
Responsible for the secure management of CDs and ensuring compliance with legal requirements.
HCPs
Responsible for the safe administration, recording, and storage of all medicines, including adherence to PGDs and this policy.
Medicines Management
Procurement and Storage
All medicines must be sourced from licensed suppliers and stored according to manufacturer’s guidelines. Our preferred authorised supplier of medications is Royal Cornwall Hospital (RCHT) Pharmacy.
Medications Auditing*
Medicines should be checked regularly for expiration dates and stock levels.
Prescription and Administration
Medicines may only be prescribed and administered by authorised HCPs within their scope of practice. A clear record of all administered medicines, including the date, time, dosage, route, and signature of the administering HCP, must be maintained and recorded on both the Patient Clinical Record (PCR) and Medications Register.
Transport and Transfer of Medicines
Medicines, particularly CDs, must be transported in a secure and controlled manner, always ensuring safety and security.
Disposal of Medicines
Expired or unused medicines must be disposed of in accordance with legal requirements and environmental guidelines. Royal Cornwall Hospital Pharmacy is our primary site for secure disposal of medications.
Controlled Drugs (CDs)
Private Supply of CDs
Coast Medic Ambulance Ltd does not currently hold a home office licence to enable them to provide/supply CDs to authorised staff. Therefore, HCPs may carry a limited supply of their own privately sourced CDs.
CDs must always remain in the possession of the HCP and cannot left unattended or accessible at any time.
HCPs must not give or lend their CDs to any other clinician or person and must be administered by that clinician.
Record Keeping for CDs
Detailed records of CDs must be maintained. HCPs who have privately sourced CDs must have their own CD Register to record: receipt, administration, and disposal. These records should be accurate, complete, and retrievable for inspection.
Any CD administered to a patient must be recorded on their Patient Report Form (PRF).
Disposal of CDs
CDs require specific disposal methods to ensure compliance with regulations. Where HCPs have their own private supply of CDs, it is essential that they are disposed of appropriately and recorded.
8.4 Incident Reporting
Any incidents involving CDs, such as discrepancies or theft, must be reported immediately to the CDAO and investigated according to the organisation\\\’s incident management procedures. The incident should be reported using the Calus system on Salus3Cloud.
Patient Group Directions (PGDs)
Development and Authorisation
PGDs must be developed and authorized in accordance with national guidelines. Each PGD must be reviewed and signed off by the Medical Director and relevant clinical governance leads.
Use of PGDs
Only named and authorized HCPs may supply and/or administer medicines under PGDs. Staff must demonstrate appropriate competence and training in the specific PGD before being authorized.
Documentation and Review
A copy of the current PGD must be available at the point of care. Each PGD must be reviewed regularly, with a maximum review period of two years, or sooner if required by changes in practice or legislation.
Training and Competency
All staff involved in the handling of medicines must receive appropriate training and demonstrate competency in accordance with their role. This includes specific training on PGDs where applicable.
Audit and Monitoring
Regular audits of medicines management practices, including the use of CDs and adherence to PGDs, will be conducted. Findings will be reviewed by the Medical Director and used to improve practices and update this policy as necessary.
Clinician Drug Bags
Clinician Drug bags should be audited using the L10a form (found on our document library) and sealed. The bags should be replenished if any medications are used prior to the end of the shift, updating the store list and recording stock movement using Salus3Cloud.
All bags should be audited every month.
Frequently Used Drug Bags
Frequently Used Drug bags should be audited using the L10 form (found on our document library) and sealed. The bags should be replenished if any medications are used prior to the end of the shift, updating the store list and recording stock movement using Salus3Cloud.
All bags should be audited every month.
Medical Store Stock Audits
All medications stored in stock should be recorded in the Medications folder using the appropriate L11 form.
Medical Store Weekly Audits
All medications stores should be audited on a weekly basis using the L12 form.
Policy Review
This policy will be reviewed annually or in response to changes in legislation, guidelines, or organizational needs.