All prescribers should work within their scope of competence, governance framework, and the standards set out by their professional body, as well as the following:

Adverse drug reactions

Report suspected side effects to medicines, vaccines, e-cigarettes, medical device incidents, defective or falsified (fake) products to the Medicines and Healthcare products Regulatory Agency (MHRA) via the Yellow Card website.

Patient safety incidents

Patient safety incidents should be reported via the ‘Learning from Patient Safety Events’ (LFPSE) website at: https://record.learn-from-patient-safety-events.nhs.uk/. For more information, refer to the NHS England information about the rollout of the LFPSE service, and supporting local guidance about using LFPSE.

GP practices have a contractual obligation to register practice email(s) with the MHRA Central Alerting System (CAS) and to act on alerts received. Practices should separately register to receive the MHRA Drug Safety Update, which is not distributed via the CAS route.

Refer to GP mythbuster 91: Patient safety alerts (CQC, 2022).

There are also enduring standards that remain valid from previous patient safety alerts – content and actions from previous patient safety alerts from the NHSE, NHS Improvement or NPSA that have been identified as an ongoing enduring standard. These are standards that remain valid to a specific speciality or clinical issue beyond the initial alert’s ‘action completion date’. Does your organisation still comply with them all?

Anticoagulants

GP mythbuster 92: Anticoagulant monitoring in primary care (CQC, 2022)

DOACs (Direct Oral Anticoagulants) monitoring (SPS, 2022)

Understanding direct oral anticoagulant (DOAC) interactions (SPS, 2024)

Methotrexate

Refer to guidance on the Dorset Formulary regarding preferred pre-filled injection brands.

Methotrexate once weekly for autoimmune diseases: new measures to reduce risk of fatal overdose due to inadvertent daily instead of weekly dosing (MHRA, 2020)

The ‘Improving compliance with oral methotrexate’ patient safety alert and the associated patient booklet published by the National Patient Safety Agency (NPSA) in 2006 is available in the National Archives

Methotrexate patient card (2020)

Managing interactions with methotrexate (SPS, 2023)

Using folic acid with methotrexate in rheumatoid arthritis (SPS, 2023)

Methotrexate monitoring (SPS, 2022)

Administering Subcutaneous Methotrexate for Inflammatory Arthritis (RCN, 2021)

Lithium

Refer to guidance on the Dorset Formulary regarding safe dose conversions. The shared care guidance for lithium sets out baseline and ongoing monitoring requirements.

Recommendations for starting, stopping and monitoring lithium treatment is described in the NICE clinical guideline on Bipolar disorder: assessment and management.

‘Safer lithium therapy’ and the associated patient booklet/alert card published by the National Patient Safety Agency (NPSA) in 2010 is available in the National Archives.

Further paper supplies of the booklet and card can be ordered via the Primary Care Support England (PCSE) online ordering system for supplies.

Insulin

The ‘Safer administration of insulin’ Rapid Response report and the associated patient booklet/alert card published by the National Patient Safety Agency (NPSA) in 2010 is available in the National Archives.

‘The adult patient’s passport to safer use of insulin’ and the associated ‘insulin passport’ and alert information and patient booklet published by the National Patient Safety Agency (NPSA) in 2010 is available in the National Archives.

Further paper supplies of the insulin passport can be ordered via the Primary Care Support England (PCSE) online ordering system for supplies.

Valproate

Valproate (Epilim®, Depakote®, Episenta® and other generic brands) is associated with a significant risk of birth defects and developmental disorders in children born to women who take valproate during pregnancy. Since 2018 any use of valproate in patients of childbearing potential has to be within the terms of the Pregnancy Prevention Programme. This is designed to make sure patients are fully aware of the risks and the need to avoid becoming pregnant.

From January 2024, valproate must not be started in new patients (male or female) younger than 55 years, unless two specialists independently consider and document that there is no other effective or tolerated treatment, or unless there are compelling reasons that the reproductive risks do not apply.

Valproate use by women and girls (contains links to patient support material) (MHRA, 2024)

Full pack dispensing of valproate-containing medicines (MHRA, 2023)

Shared Care Guidelines for Valproate in The Treatment of Bipolar Disorder (2020)

If you work in primary care (including community pharmacy), specialist medicines advice can be obtained from SPS via 0300 7708564 or email asksps.nhs@sps.direct. (Staff in Dorset NHS Trusts should seek advice from their pharmacy teams. This service is also not intended for members of the public).

Medicines reconciliation guidance from the CQC (2023) includes information about who can reconcile medications, when reconciliation should be carried out, and information to reconcile

How to perform accurate medicines reconciliation (the Pharmaceutical Journal, 2023)

Medicines optimisation: the safe and effective use of medicines to enable the best possible outcomes (NICE NG5, 2015)

Keeping patients safe when they transfer between care providers – getting the medicines right (RPS, 2012)

The following templates are provided for adaptation by GP practices:

The Royal Pharmaceutical Society have developed ‘A Competency Framework for all Prescribers’. It is a generic framework that can be used by any prescriber at any point in their career, regardless of their professional background. However, it must be contextualised to reflect different areas of practice, levels of expertise and settings. The framework has been adopted by many professional bodies, including but not limited to the NMC and HCPC.

Also refer to GP mythbuster 95: Non-medical prescribing (CQC, 2024).

Instructions for prescription overprint layout can be found on the NHS BSA website.

How to avoid ‘unidentified’ prescribing (NHS BSA online)

The NHS Dorset Medicines Team has guidance about using and configuring prescriber codes in SystmOne – please email medicine.question@nhsdorset.nhs.uk if you would like a copy.

Also refer to guidance on the Dorset Formulary SystmOne Profile Setup 

If you have any suspicions or concerns about prescription forms being fraudulently used, you should report this to the NHSCFA. You can call the free, 24hour reporting line 0800 028 4060 or report online at https://cfa.nhs.uk/report-fraud.

Management and control of prescription forms: A guide for prescribers and health Organisations (NHS CFA, March 2018)

Management and control of prescription forms: Aide-mémoire for prescribers (NHS CFA)

GP mythbuster 23: Security of blank prescription forms (CQC, December 2022)

Spotting a forged or fraudulent prescription (NHS England)

The following templates are provided for adaptation by GP practices:

Controlled drugs and drug dependence (BNF online). Includes explanation of The Misuse of Drugs Act 1971, and list of drugs falling within schedule 1-5. Also sets out the prescription writing requirements applicable to schedule 2 and 3 CDs.

Controlled drugs (NHS England online). Includes information about the South West Controlled Drugs Team, reporting incidents, disposal of CDs and private prescribing.

Home Office approved wording for instalment prescriptions (www.gov.uk online)

Controlled drugs: safe use and management (NICE NG46, 2016)

Private controlled drugs

NHS Dorset factsheet on private CD prescribing/requisitions

Controlled drug incidents and concerns

Remember that ALL incidents or concerns involving CDs, including errors, excessive or inappropriate prescribing, loss, theft, diversion or misuse need to be reported to the local Controlled Drug Accountable Officer (CDAO) via the web-based CD reporting tool at: www.cdreporting.co.uk. Please remember to select the correct area team (South West). For the incident to be reviewed, it is also important that as much information as possible is included in the report.If you need urgent advice regarding a controlled drug concern, email: ENGLAND.southwestcontrolleddrugs@nhs.net.

There is national guidance available to support safe remote prescribing:

Remote prescribing high level principles (GMC)

High level principles for good practice in remote consultations and prescribing (co-authored and agreed by a range of healthcare regulators and organisations, including the following – GDC, GMC, GOC, GPhC, NMC, CQC)

Refer to the NHS Dorset Template SOP for repeat prescribing (coming soon)

Repeat prescribing and prescribing with repeats (GMC online)

Repeat prescribing in primary care (PrescQIPP, 2016. Requires a free account)

GP mythbuster 11: Electronic prescribing (CQC, 2022)

Refer to Professional guidance on the safe and secure handling of medicines (RPS, January 2024)

The Misuse of Drugs [Safe Custody] Regulations 1973 set out the rules for safe custody of controlled drugs (CDs). All Schedule 2 and those Schedule 3 CDs that are subject to safe custody requirements must be kept in a locked receptacle, which is so constructed and maintained as to prevent unauthorised access to drugs.

The following templates are suggested for adaptation by GP practices:

The supply of unlicensed medicinal products (“specials”). Medicines and Healthcare Products regulatory Agency Guidance Note 14. (MHRA, 2014)

Off-label or unlicensed use of medicines: prescribers’ responsibilities. Drug Safety Update (MHRA, 2014)

Nurse and midwife independent prescribing of unlicensed medicines. (NMC, 2010)

Governance principles for unlicensed medicines (SPS, 2023)

Using unlicensed medicines (SPS, 2023)

Understanding unlicensed medicines (SPS, 2023)

Explaining the licensed status of medicines (SPS, 2023)

Refer to the NHS Dorset Quick reference guide to pharmaceutical waste disposal

Managing pharmaceutical waste (SPS, 2023)

Identifying types of pharmaceutical waste and disposal containers (SPS, 2023)

Managing sharps contaminated with pharmaceutical waste (SPS, 2023)

Principles on the Disposal of Waste Pharmaceuticals used within Community Health Services (SPS, 2015)

Health Technical Memorandum 07-01: Safe and sustainable management of healthcare waste (NHS England, 2022)

Antineoplastic and Other Hazardous Drugs in Healthcare is an American resource from the Centers for Disease Control and Prevention (CDC) and has a useful list of medicines classified as cytotoxic and cytostatic (antineoplastic). The list previously included in the NHS England HTM 07-01 is no longer included in the current published document.

T28 exemption for controlled drug denaturing

Organisations must obtain an Environment Agency T28 exemption certificate in order to be able to store, sort and denature CDs. Each location where CD waste is produced and subsequently denatured should register for a T28 exemption. Organisations with more than one site will need multiple exemptions.

Also refer to: Managing Controlled Drugs (CD) waste (SPS, 2023)

If you need to request a witness for an authorised destruction of stock controlled drugs, please use the CD reporting portal at: www.cdreporting.co.uk. Please remember to select the correct area team (South West).

Refer to the NHS Dorset factsheet on working with the pharmaceutical industry (coming soon)

Also refer to the following documents:

NHS Dorset Standards of Business Conduct policy

The National Health Service (General Medical Services Contracts) Regulations (2004)

Code of Practice for the Pharmaceutical Industry (ABPI, 2019)