Medication Safety

Primary Care Valproate Recommendations Jan 24

Valproate Pregnancy Prevention Programme Jan 24

National Patient Safety Alert: Valproate Nov 23

Somerset Valproate Action and Improvement Plan

November 28th 2023- National Patient Safety Alert: Valproate: organisations to prepare for new regulatory measures for oversight of prescribing to new patients and existing female patients (NatPSA/2023/013/MHRA) 

National Patient Safety Alert- Valproate: organisations to prepare for new regulatory measures for oversight of prescribing to new patients and existing female patients

Update on MHRA review into safe use of valproate – Update on MHRA review into safe use of valproate 12/12/22:

The CHM has advised that no one under the age of 55 should be initiated on valproate unless two specialists independently consider and document that there is no other effective or tolerated treatment. Where possible, existing patients should be switched to another treatment unless two specialists independently consider and document that there is no other effective or tolerated treatment or the risks do not apply.

Valproate use by women and girls MHRA guidance updated 30/01/24 – Information about the risks of taking valproate medicines during pregnancy.

Report suspected side effects to medicines, vaccines, e-cigarettes, medical device incidents, defective or falsified products to the MHRA via the Yellow Card scheme to ensure safe and effective use. You should report all suspected adverse drug reactions (ADRs), whether self-medicated or prescribed.

You can also report ADRs to the Yellow Card scheme easily through EMIS Web

EMIS Web - Submitting a Yellow Card

The Specialist Pharmacy Service have produced a Q&A sheet on the potential adverse effects of Cannabidiol oil

BNF Interactions A to Z Browse drugs by A to Z to check for interactions, including information on the severity of an interaction and the type of evidence to support it.

The BNF includes a complete section on grapefruit juice which totals 97 interactions.

Do other fruit juices affect the drug absorption of the medication you’re prescribing? Apple, orange and grapefruit may also affect absorption by inhibiting OATP transporters in the digestive system, a 4 hour delay between taking affected medication and those fruit juices is advisable.

Some drugs require regular monitoring. High risk drugs should be prioritised. PrescQIPP has a useful guide of the type of tests needed and the frequency.

The SPS Drug Monitoring Tool has recommendations and guidance for medicines that require monitoring.

SPS also has more in depth guidance for DOACs monitoring.

NHS Pathways is a means of risk stratifying patients which allows medicines optimisation to reduce risk and improve patient outcomes.

For practice level data Eclipse is the best risk reduction tool available.

Patient safety – Preventing harm and avoidable hospital admissions.

Quality improvement tool – Identify trends and focus on prevention.

Audit tool – Provides assurance that safety alerts are being reviewed regularly during an investigation if serious incident has occurred.

New user requests can be made via the Helpdesk. For Practice level access, the Practice Manager is the only person authorised to request for new user profiles. They will need to email support@prescribingservices.org

PrescQIPP has created some guidelines for the new NHS Steroid Emergency Card. For EMIS Web searches and protocols please contact your sessional pharmacist or locality manager.

Implementing the steroid card safety advice

Patients guide to NHS Steroid Emergency Card

Steroid Emergency Card guidance on using the searches

Neonatal & Paediatric Pharmacists Group Position Statement- Use of Steroid Medication Warning Cards for Children and Young People

Medication errors are any Patient Safety Incidents where there has been an error in the process of prescribing, preparing, dispensing, and administering, monitoring or providing advice on medicines.

Somerset uses the Datix system to report incidents. We encourage the reporting of all errors and near misses so we can help with learning across the county. It will help us to analyse trends and provide needed support.

For more information on Datix please contact somicb.riskteam@nhs.net

Please see the Medication errors: short life working group for The Report of the Short Life Working Group on reducing medication-related harm.

Please see the Did you know? General Practice Medication Errors from NHS Resolutions and Learning from medication errors for information leaflets.

The Medicines Safety Officer for NHS Somerset is Esther Kubiak esther.kubiak@nhs.net

Medication Safety – SPS – Specialist Pharmacy Service – The first stop for professional medicines advice

This Medicine Safety bulletin from PrescQIPP offers guidance and background information on medicines safety.

Please see here for the most recent drug safety updates from the MHRA. Practices should have procedures in place to action these updates.

Emollients

Nitrofurantoin

Testogel

Unfortunately no complete list exists of all medications which pose a safety issue to pregnancy, however we do have emerging data coming through with safety reviews happening. Medication risk can also vary depending on stage of pregnancy or time before conception. All patients taking medications, particularly those on long term treatment should be supported to make informed decisions about their contraceptive needs and pregnancy planning. MHRA Drug Safety Updates in pregnancy share all pregnancy related alerts. Also see below for more information on teratogenic drugs and safe prescribing including drugs subject to a Pregnancy Prevention Programme.

Please see the Pain Management page for extensive resources on reducing opioid use.

There are resources on the Hypnotics and Anxiolytics page for reducing the use of benzodiazepines and Z-drugs for insomnia.

Valproate Safety

November 28th 2023- National Patient Safety Alert: Valproate: organisations to prepare for new regulatory measures for oversight of prescribing to new patients and existing female patients (NatPSA/2023/013/MHRA) 

National Patient Safety Alert- Valproate: organisations to prepare for new regulatory measures for oversight of prescribing to new patients and existing female patients

Update on MHRA review into safe use of valproate – Update on MHRA review into safe use of valproate 12/12/22:

The CHM has advised that no one under the age of 55 should be initiated on valproate unless two specialists independently consider and document that there is no other effective or tolerated treatment. Where possible, existing patients should be switched to another treatment unless two specialists independently consider and document that there is no other effective or tolerated treatment or the risks do not apply.

Valproate use by women and girls MHRA updated guidance 11/02/2021 – Information about the risks of taking valproate medicines during pregnancy.

2022/23 Community Pharmacy Contractual Framework National Clinical Audit – Reducing the potential for harm from valproate prescribing in patients of childbearing age who are biologically able to be pregnant.

Specialist Pharmacy Service- SPS – Epilepsy: treatment during pregnancy

Access the electronic medicines compendium for risk materials for healthcare professionals to access information on the pregnancy prevention programme for valproate products.

NHS England Decision support tools page links to bipolar disorder – is valproate the right treatment for me and is valproate the right epilepsy treatment for me?

Isotretinoin

31 October 2023- MHRA Drug Safety Update- Isotretinoin (Roaccutane▼): introduction of new safety measures, including additional oversight of the initiation of treatment for patients under 18 years of age

Oral retinoid medicines▼: revised and simplified pregnancy prevention educational materials for healthcare professionals and women

Access the electronic medicines compendium for risk materials for healthcare professionals to access information on the pregnancy prevention programme for isotretinoin.

Isotretinoin remains RED in Somerset see the Traffic Light System for latest guidance.

Resources

NHS Somerset Medicines in pregnancy, children and lactation formulary page.

The Safer Use of Medicines in Pregnancy Poster- Planning Ahead is now available. If you would like copies to display in a practice or pharmacy please contact:

somicb.medicinesmanagementteam@nhs.net

NHS Somerset formulary page contraception for patients taking medication with teratogenic potential

World Patient Safety Day 2023 is on 17 September under the theme “Engaging patients for patient safety” to recognise the role patients, families and caregivers play in the safety of health care.