- Indication
- Managing Medicines in a GP Practice
- RAG rating
- n/a
- Document type
- Prescribing guideline
- Place
- Hertfordshire and West Essex ICB
- Output type
- Pharmacy / Prescribing
Inspection - CQC
Care Quality Commission Inspections -
Managing Medicines in a GP Practice Resource
Support for practices to comply with medicines management priorities in Health & Social Care Act 2008 (regulation 12g - the proper and safe management of medicines)
This document is a resource to help you prepare for medicines management aspects of a Care Quality Commission (CQC) inspection.
How CQC monitors, inspects and regulates GP PRACTICES August 21 - Please always refer to the CQC website for the most up to date guidance.
The information in the document is intended to be used to inform a wider practice protocol for prescribing and managing medicines. Practices should have Standard Operating Procedures (SOPs) covering all of the aspects of prescribing and medicines handling, including Controlled Drugs (CDs). All SOPs relating to medicines should have a review date. They should be reviewed annually (by a designated member of staff) or more often if changes in legislation, evidence, national or local guidance or best practice occur. Template SOPs are available from many sources, but these must be amended to reflect what happens in your practice and should specify the role responsible (including deputies in case of absence) for any actions they may contain. It is advisable to have these SOPs (including CD documentation) easily available for staff and inspectors, either paper or electronically.
CQC inspectors focus on use of information within the practice, including:
- dissemination to relevant staff
- opportunities for reflection
- actions to be carried out
CQC has published their guidance for GPs and GP out of hours services, on care standards and information on inspections and monitoring accessible on their website: GPs: information for providers | Care Quality Commission (cqc.org.uk)
Additionally, for specific information and support under the 5 key pillars (Safe, Effective, Caring, Responsive to peoples’ needs, and Well-led), GP Mythbusters are available: GP mythbusters | Care Quality Commission (cqc.org.uk). Majority of the medicines related information will be under "SAFE” and "EFFECTIVE”.
Your practice should have the following (please refer to the additional resources for links for further information on each point):
- A repeat prescribing policy that covers conducting medication reviews; management of high risk medications; controlled drugs and shared care requests. Your repeat prescribing policy should be specifically designed for your practice (See Appendix A).
- A standard operating procedure (SOP) for disseminating and acting on local/national clinical guidance, Medicines and Healthcare products Regulatory Agency (MHRA) alerts, national and local formularies and patient safety alerts to staff (see Appendix B). Medicines handling SOP that cover the following that are appropriate for your practice: obtaining, storing, prescribing, dispensing, preparation, administration and disposing of medicines, which includes medical gases and emergency drugs. A controlled drugs SOP at your practice. This procedure should cover sharing concerns about mishandling and investigations of adverse events, incidents, errors, storage, security and prescription management.
- A SOP for overall prescription management and security.
- Evidence of regular medicines management audit which encompasses the adherence to the above SOPs and policies.
- Evidence of an up-to-date training matrix/log for non-medical prescribers including competencies in progress and to achieve and how the provider has assured themselves that staff are capable, supported and provided with appropriate training for the role.
- Evidence that practices have systems or processes to assess, monitor and mitigate risks relating to the health, safety and welfare of patients. Practices should have systems to make sure non-medical prescribers are working within the limits of their competency and must also provide staff with appropriate supervision and allocate an appropriate senior member of the primary care team to provide day-to-day supervision of all clinical staff.
- Evidence of audits and demonstrable activities to support antibiotic stewardship.
Additional Resources
1. Many of the CQC standards support the National Institute of Health and Care Excellence (NICE) Guideline NG5 on Medicines Optimisation: the safe and effective use of medicines to enable the best possible outcome. The guideline and supporting information can be found at: https://www.nice.org.uk/guidance/ng5.
2. The CQC provider information to explain what inspectors look for when they visit GP practices. See below for the relevant handbook:
https://www.cqc.org.uk/guidance-providers/gps/how-we-monitor-inspect-regulate-gp-practices.
3. CD governance self- assessment tool for primary care organisations, a useful tool to complete prior to the inspection and add to the CD folder: http://www.cqc.org.uk/content/controlled-drugs.
4. Advice on storage of medication in fridges can be obtained from Public Health England:
5. CQC Practice GP mythbuster 99: Infection Control and Clinical Waste Management in General: https://www.cqc.org.uk/guidance-providers/gps/gp-mythbuster-99-infection-prevention-control-general-practice.
6. CQC GP mythbuster 23: Secure storage and control of prescriptions: https://www.cqc.org.uk/guidance-providers/gps/gp-mythbuster-23-security-blank-prescription-forms.
7. BMA How to Prepare for a CQC inspection:
https://www.bma.org.uk/advice-and-support/gp-practices/the-cqc/how-to-prepare-for-a-cqc-inspection.
8. Oxygen use in the workplace Fire and explosion hazards: Fire and explosion hazards (hse.gov.uk).
9. CQC GP mythbuster 12: Accessing medical records during inspection–GP mythbuster 12: Accessing medical records during inspections - Care Quality Commission (cqc.org.uk).
10. CQC GP mythbuster 95: Non Medical Prescribing: GP mythbuster 95: Non-medical prescribing - Care Quality Commission (cqc.org.uk).
11. CQC GP mythbuster 81: Pharmacy Professionals in General Practicehttps://www.cqc.org.uk/guidance-providers/gps/gp-mythbuster-81-pharmacy-professionals-general-practice.
For further information or support please contact a member of the relevant place ICB Pharmacy and Medicines Optimisation Team (PMOT).
Appendix A
The practice must have a comprehensive repeat prescribing policy that covers conducting medication reviews. The repeat prescribing policy should be specifically designed for the practice taking into account available resource and wider practice policies.
A significant component of the policy is the requirement to ensure that a systematic audited procedure is in place that identifies all patients prescribed drugs requiring monitoring and ensuring testing as recommended such that the prescriber can be confident when issuing prescriptions.
A monitoring procedure must include both checking correct monitoring at the correct frequencies and also regular searches to ensure all patients prescribed drugs requiring monitoring are identified.
Regular audit must be done to ensure the procedure is identifying all patients prescribed drugs needing regular monitoring and that it is ensuring all patients have the correct tests at the recommended frequencies.
Included in this section
- A1 Outline of standard repeat prescribing policy
- A2 Drug monitoring guidance
Appendix A1 – Repeat Prescribing Policy
An up to date and accurate Repeat Prescribing Policy should be available to all users in the practice.
The policy should include at least the following and be tailored to the practices specific processes:
- Ordering Prescriptions
- Prescription Generation, Recording and Computer Security
- Prescription authorisation
- Prescription Collection
- Managing Patients Using Monitored Dosage Systems (Dossettes)
- Repeats Dispensing/eRD
- Care Homes
- Hospital and Other Correspondence Letters Issued by Health Care Professionals
- Recording Specialist Drugs
- Arrangements for prescribing and reviewing drugs with a potential to be abused or cause addiction e.g. CDs, benzodiazepines
- Management of High Risk Medication
- Drug Monitoring
- Medication Review
- Prescription Security
- Learning from near miss/significant and adverse medication incidents
- Audit (refer to additional resources for list of audits)
- Updating the Repeat Prescribing Policy
- Shared care agreements
Appendix A2 – Drug Monitoring Guidance
Therapeutic drug monitoring is used to optimise individual dosage regimens. It is unnecessary for the majority of medications and is used mainly for monitoring drugs with narrow therapeutic ranges, drugs with marked pharmacokinetic variability, medications for which target concentrations are difficult to monitor and drugs known to cause therapeutic and adverse effects. GP systems include a flag to highlight these. Clinicians and relevant practice staff should additionally refer to local shared care protocols for guidance on monitoring requirements.
Examples of suggested monitoring regimes can be found at: https://www.sps.nhs.uk/home/guidance/drug-monitoring/
Ardens reports are available for a significant number of searches for central alerting system (CAS) and MHRA alerts, prescribing safety, and CQC inspection searches. See the Ardens CQC website for more information about how to access these searches in collaboration with the CQC - GP mythbuster 12: Accessing medical records during inspections - Care Quality Commission (cqc.org.uk). Ardens searches can be scheduled can be scheduled for to be run automatically at specific times. Further information on this can be found on the Ardens support page for the relevant clinical system. Support : Ardens EMIS Web
NHS Pathways (Eclipse Live) is an additional tool that can be used to for drug safety monitoring.
Appendix B
A procedure for disseminating and acting on local/national clinical guidance, Medicines and Healthcare products Regulatory Agency (MHRA) alerts, national and local formularies and patient safety alerts to staff.
There should be a system in place for cascading alerts to appropriate staff and checking that alerts are actioned and, where necessary, for collating information about practice rationale for not following the recommendation in the alert. There should be a Standard Operating Procedure (SOP) detailing the action to take in the event of a medication safety alert.
Please refer to GP mythbuster 91: Patient safety alerts - Care Quality Commission (cqc.org.uk) for further details.
The Care Quality Commission (CQC) has issued guidance for providers about compliance with the Health and Social Care Act 2008 and meeting the regulations relating to complying with relevant Patient Safety Alerts, recalls and rapid response reports issued from the Medicines and Healthcare products Regulation Agency (MHRA) and through the Central Alerting System (CAS).
1. MHRA Drug Safety Updates and Drug and Device Alerts
MHRA Drug Safety Updates and Drug and Device Alerts include information about defective medicines/devices, side effects associated with medicines and information sent to healthcare professionals from product manufacturers which all require to be acted upon and actioned within required timescales by GP practices.
There is also a drug safety update monthly newsletter available for healthcare professionals, bringing information and clinical advice on the safe use of medicines.
These can be accessed from the following links below and you can also subscribe to email alerts.
- Drug Safety Updates and Drugs and Medical Devices
Some of these can also be accessed from the Central Alerting System (CAS).
It is the practice’s responsibility to monitor these updates and take appropriate action in a timely manner. Current updates relevant to Primary Care will also be highlighted at locality prescribing meetings. The practice should have a well-defined audit trail in place to evidence the review and updating of search results on a regular basis.
As all practices receive MHRA Drug Safety Updates the Medicines Optimisation Team will only inform prescribers when there is additional local information relevant to an alert. For example this may take the form of a suggested search strategy to identify patients potentially affected by the alert.
2. Central Alerting System (CAS)
The Central Alerting System (CAS) is a web-based cascading system for issuing patient safety alerts, important public health messages and other safety critical information and guidance to the NHS and others, including independent providers of health and social care.
Alerts available on the CAS website include safety alerts, chief medical officer (CMO) messages, drug alerts and Medical Device Alerts, as well as feedback from the National Reporting and Learning Service that enables healthcare professionals to learn from incidents.
All GP practices in England are required to register to receive CAS alerts directly and
- register a practice email address with the CAS and monitor the email account to act on CAS alerts where appropriate;
- notify the MHRA if the email address changes to ensure MHRA distribution list is updated;
- register a mobile phone number (or several numbers) with the MHRA CAS which will only be used as an emergency back up to email for text alerts when e-mail systems are down.
Registration link: https://www.cas.mhra.gov.uk/Register.aspx
To access the website, please see the link below:
Note: please add it to your email safe list now to avoid alerts being caught in your spam or junk filters. This address should be used to email the helpdesk
It is important to ensure that the email address used for the CAS alerts is one that can be accessed via a number of staff members e.g. GP practice generic email address. However, information governance and data protection requirements must be adhered to.
The CAS website has an interactive help tool which will guide new users round the website – it can be found under the "help” button.
Once a GP practice has signed up for the CAS alert system it would be advisable to set up a system within whereby:
- Someone is responsible for checking for CAS alerts at least daily and alerts are logged (evidence required for CQC)
- They are then screened for relevance to the GP practice – if the alert is not relevant this should be documented in the log
- An action plan is developed where necessary information is disseminated to all staff
- Actions completed (if any) are documented
This will enable practices to demonstrate to CQC whether they have acted on a CAS alert and what action was taken. The implementation of CAS alerts is vital to ensure that patient safety is maintained to national standards, and this will be useful evidence if required for CQC.
- Version number
- 2.0
- Developed by
- Adapted by Anushka Uppal, Senior Pharmaceutical Advisor; Hazel Angus, Senior Pharmacist and Radhika Kotecha, Pharmaceutical Advisor HWE ICB PMOT
- Approved by
- HWE MODIG
- Date approved / updated
- November 2022
- Review date
- The recommendation is based upon the evidence available at the time of publication. This recommendation will be reviewed upon request in the light of new evidence becoming available.
- Superseded version
- PCMMG East and North Hertfordshire CCG. (v1.0 April 2018)