Medication Safety

Medication is the most common intervention in healthcare. Errors can happen at any point from prescribing to administering. In 2021/22 the number of prescription items dispensed in the community in England was 1.14 billion costing the NHS £9.69 billion.

The CQC has information for practices on how to respond to patient safety. GP mythbuster 91: Patient safety alerts

The Medicines and Healthcare products Regulatory Agency (MHRA) regulates medicines, medical devices and blood components for transfusion in the UK. Please see here for the most recent drug safety updates. Practices should have procedures in place to action these updates.

Adverse Drug Reactions

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

Brand specific prescriptions

Central alerting system (CAS)

Drug interactions

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.

Drugs that require regular blood tests

Eclipse

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

Emergency Steroid Cards

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

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.

Medicines Safety Officer

MHRA

Potentially Addictive Medications

World Patient Safety Day 2024

Med Safety Week 4-10 November 2024

High risk in pregnancy MHRA Drug Safety Updates Isotretinoin Topiramate Valproate

High risk in pregnancy MHRA Drug Safety Updates

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

Topiramate (Topamax): introduction of new safety measures, including a Pregnancy Prevention Programme (20th June 2024)

Valproate: organisations to prepare for new regulatory measures for oversight of prescribing to new patients and existing female patients (28th November 2023)

Valproate use by women and girls (23rd March 2018, updated 30th January 2024)

MHRA advises men taking valproate and their partners to use effective contraception (5th September 2024)

Isotretinoin

Isotretinoin (Roaccutane▼): introduction of new safety measures, including additional oversight of the initiation of treatment for patients under 18 years of age

We have strengthened the safe use of isotretinoin through the introduction of additional oversight of the initiation of isotretinoin in patients under 18 years and through improved assessment and monitoring of mental health and sexual function issues. We ask healthcare professionals to review these new measures and supporting materials and integrate them into their clinical practice when referring patients and when prescribing or dispensing isotretinoin.

all patients must be counselled about the benefits and risks of treatment before isotretinoin is prescribed, including possible mental health and sexual function side effects; we also ask the referrer (usually the GP) to provide information about isotretinoin to the patient and provide counselling (where possible) regarding the benefits and risks of isotretinoin treatment
isotretinoin, as well as all of the oral retinoid medicines (including acitretin and alitretinoin), are teratogenic; all patients of childbearing potential must be entered into the Pregnancy Prevention Programme
prescribers should assess patients’ mental health before prescribing isotretinoin including the use of patient-reported outcome measures
ask patients about any sexual function concerns before prescribing isotretinoin
give the patient sufficient time to consider, reflect and ask questions before starting isotretinoin treatment
use the new regulatory risk minimisation materials with all patients: Acknowledgement of Risk Form, Patient Reminder Card, Pharmacist Checklist
the Lead Prescriber, who initiates isotretinoin treatment, must have expertise in the use of systemic retinoids for the treatment of severe acne and a full understanding of the risks of isotretinoin therapy and monitoring requirements
initiation of isotretinoin treatment in patients under 18 years of age now requires agreement by 2 independent healthcare professionals that there is no other appropriate effective treatment before it is prescribed. This means that isotretinoin should only be prescribed for severe acne that is resistant to adequate courses of standard therapy
review patients approximately 1 month after initiation of treatment in a face-to-face (in-person) appointment
monitor patients for side effects including mental health and sexual function side effects at each follow up appointment including objective mental health patient reported outcome measures
any healthcare professional involved in the treatment of patients with acne, particularly prescribers of isotretinoin, should review the full details of the new requirements in the Report of The Commission on Human Medicines Isotretinoin Implementation Advisory Expert Working Group
report suspected adverse drug reactions associated with isotretinoin on a Yellow Card

Topiramate

Topiramate (Topamax): introduction of new safety measures, including a Pregnancy Prevention Programme

Topiramate is now contraindicated in pregnancy and in women of childbearing potential unless the conditions of a Pregnancy Prevention Programme are fulfilled. This follows a review by the MHRA which concluded that the use of topiramate during pregnancy is associated with significant harm to the unborn child. Harms included a higher risk of congenital malformation, low birth weight and a potential increased risk of intellectual disability, autistic spectrum disorder and attention deficit hyperactivity disorder in children of mothers taking topiramate during pregnancy.

topiramate should not be used:
- in pregnancy for prophylaxis of migraine
- in pregnancy for epilepsy unless there is no other suitable treatment
topiramate should not be used in women of childbearing potential unless the conditions of the Pregnancy Prevention Programme are fulfilled. This aims to ensure that all women of childbearing potential:
- are using highly effective contraception
- have a pregnancy test to exclude pregnancy before starting topiramate
- are aware of the risks from use of topiramate
please see specific advice for prescribers and advice for dispensers
ensure women of childbearing potential sign the Risk Awareness Form, you will receive materials including the Risk Awareness Form by post in the coming weeks to use in the implementation of the Pregnancy Prevention Programme
report suspected adverse drug reactions associated with topiramate to the Yellow Card scheme

Patient Guide for Migraine and Epilepsy - to be provided to all girls and women of childbearing potential who are started on, or continue to use, topiramate-containing medicines

Guide for Healthcare Professionals for Migraine and Epilepsy

Risk Awareness Form for Migraine and Epilepsy - for the healthcare professional and the patient (or responsible person) to sign at initiation of treatment with topiramate and at annual treatment reviews. The patient should receive a copy of this form, a copy should be filed in the patient’s medical notes, and, if necessary, a copy sent to the patient’s GP

Patient Card - to be given by pharmacists to all female patients who are dispensed topiramate to inform them of the risks

Valproate

MHRA advises men taking valproate and their partners to use effective contraception (5th September 2024)

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

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

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?