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🚨 New CQC Safety Alert Indicators

Identifies patients on higher-risk medicines who may need safety advice, monitoring, or a medication review to prevent potential harm.

Updated over 3 weeks ago

We’ve added a suite of new CQC Safety Alert indicators to help practices identify patients who may be at risk due to high-risk medicines, drug interactions, or missing monitoring.

These indicators help practices identify patients who may need safety advice, medication reviews, or checks at the right time, supporting safer prescribing in line with CQC and MHRA guidance.


🔍 What’s new

These indicators highlight:

  • Patients on higher-risk medicines

  • Patients with important drug interactions

  • Patients who need safety education

  • Patients who require urgent medication reviews

  • Patients who may be on contraindicated combinations

Each indicator follows the same structure:

  • Denominator = patients at risk

  • Numerator / complete = patients who’ve had the required review or safety advice

  • Not complete = patients needing action

Below is a breakdown of each safety alert.


1️⃣ CQCSAFETYALERT001 — Hydrochlorothiazide & Skin Cancer Risk

Identifies patients who need skin cancer risk information after starting hydrochlorothiazide.

What it checks

  • Prescribed hydrochlorothiazide in the last 6 months

  • Whether the patient has received written skin cancer risk information

What counts as complete

  • Patient has been given written advice about skin cancer risk since starting hydrochlorothiazide

Why this matters

Hydrochlorothiazide increases photosensitivity and is linked to higher rates of non-melanoma skin cancer. Patients should be informed about sun protection and monitoring for skin changes.


2️⃣ CQCSAFETYALERT002 — High-Dose SSRIs in Patients Aged 65+

Identifies elderly patients on high-dose SSRIs who need a medication review.

What it checks

  • Patients aged 65+

  • Taking citalopram 40mg or escitalopram 20mg

  • Whether a medication review has occurred in the last 3 months

What counts as complete

  • Medication review completed in the last 3 months

Why this matters

Higher SSRI doses increase risks of QT prolongation, falls, hyponatraemia, and bleeding in older adults. A dose adjustment may need to be considered.


3️⃣ CQCSAFETYALERT003 — Clopidogrel with Omeprazole / Esomeprazole

Identifies patients at risk due to reduced clopidogrel effectiveness.

What it checks

  • Patients taking clopidogrel

  • AND taking omeprazole or esomeprazole

  • Medication review completed in the last 3 months

What counts as complete

  • A medication review that documents consideration of the drug interaction

Why this matters

Omeprazole and esomeprazole reduce clopidogrel activation, risking treatment failure and cardiovascular events. Switching to an alternative PPI may be considered.


4️⃣ CQCSAFETYALERT004 — Febuxostat in Patients with Cardiovascular Disease

Identifies patients with cardiovascular disease who are prescribed febuxostat and need a risk–benefit review.

What it checks

  • Patients with CHD, stroke, TIA, or PVD

  • Currently prescribed febuxostat

  • Medication review in the last 3 months

What counts as complete

  • Medication review completed within the last 3 months

Why this matters

Febuxostat is associated with increased cardiovascular mortality in patients with pre-existing cardiovascular disease. Reviews help ensure safe gout management.


5️⃣ CQCSAFETYALERT005 — Fentanyl Patches Started Without Prior Opioid Use

Identifies patients who may be at risk of respiratory depression.

What it checks

  • Fentanyl patch started within the last year

  • No opioid prescriptions in the 3 months before initiation

  • Medication review completed

What counts as complete

  • Medication review completed since starting the fentanyl patch

Why this matters

Fentanyl patches are only appropriate for opioid-tolerant patients. Starting them without prior opioid exposure is a serious safety risk.


6️⃣ CQCSAFETYALERT006 — Mirabegron & Blood Pressure Monitoring

Identifies patients on mirabegron who need up-to-date blood pressure readings.

What it checks

  • Patients prescribed mirabegron

  • Blood pressure recorded in the last 12 months

What counts as complete

  • Blood pressure reading within the last 12 months

Why this matters

Mirabegron can raise blood pressure and requires regular monitoring, particularly in patients with cardiovascular disease.


7️⃣ CQCSAFETYALERT007 — Dual RAS Blockade (Not Yet Implemented)

Identifies patients on two or more RAS blockers who need urgent medication review.

What it checks

  • Concurrent use of multiple RAS blockers (ACE inhibitors, ARBs, aliskiren)

  • Medication review in the last 3 months

What counts as complete

  • Medication review completed in the last 3 months

Why this matters

Dual RAS blockade significantly increases the risk of hyperkalaemia, renal impairment, and hypotension. This is a high-risk, contraindicated combination.


8️⃣ CQCSAFETYALERT008 — SGLT-2 Inhibitors: Safety Education

Identifies patients who need safety information after starting SGLT-2 inhibitors.

What it checks

  • Prescribed SGLT-2 inhibitors in the last 6 months

  • Whether both types of education were provided:

    • Ketoacidosis symptoms

    • Fournier’s gangrene symptoms

What counts as complete

  • Both ketoacidosis education

  • AND Fournier’s gangrene education

  • Recorded after SGLT-2 inhibitor initiation

Why this matters

SGLT-2 inhibitors carry rare but serious risks that require early patient recognition and prompt action.


9️⃣ CQCSAFETYALERT009 — High-Dose Simvastatin with CYP3A4 Inhibitors

Identifies patients at risk of myopathy due to drug interactions.

What it checks

  • Patients on simvastatin 40mg or 80mg

  • Also prescribed amlodipine, diltiazem, or verapamil

  • Medication review in the last 3 months

What counts as complete

  • Medication review completed within the last 3 months

Why this matters

These combinations increase simvastatin levels and the risk of serious muscle toxicity. Dose adjustment may be required.


🔟 CQCSAFETYALERT010 — Teratogenic Medications in Women of Childbearing Age

Identifies women who need pregnancy-prevention counselling and review.

What it checks

  • Women aged 8–55

  • Prescribed valproate, carbimazole, modafinil, topiramate, or pregabalin

  • No pregnancy-preventing procedures recorded

  • Medication review in the last 3 months

What counts as complete

  • Medication review including contraception or pregnancy-prevention discussion

Why this matters

Teratogenic drugs carry significant fetal risk. MHRA requires pregnancy-prevention measures, particularly for valproate.


💡 Why this matters

These safety alerts help practices:

  • Identify high-risk prescribing quickly

  • Prevent medication-related harm

  • Provide timely safety advice

  • Ensure drug interactions are addressed

  • Align with MHRA safety updates and CQC expectations


✅ These indicators are now live

You can add them to your Recall Campaigns to support safer prescribing and timely medication reviews.

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