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Following the Health Services Safety Investigations Body releasing 3 reports relating to insulin safety we have gathered together some useful resources to support practitioners with quality improvement projects relating to insulin safety in a Primary Care setting.
The reports are available here:
Insulin: supporting safe self-administration for patients in the community with a disability
Insulin: supporting safe self-administration in vulnerable patient groups in the community
Some of the key strategies for improving insulin safety are professional collaboration – as Insulin is prescribed across the system within different care settings it is vital that communication between organisations is open and allows for interactive working.
The following page on the specialist pharmacy service website has some useful documents and short videos with hints & tips for developing insulin safety strategies:
Within the specialist pharmacy service there are a variety of topics and resources available to support your teams with improving insulin safety in practice – we have linked some of the main ones below:
Insulin safety is part of our workplan going forward as part of the Lincolnshire Medication Safety Network we are hoping to develop useful resources and information to support practices with all aspects relating to insulin.
To enable us to tailor the guidance and information we would value your input, if you have any common themes & trends relating to incidents around Insulin prescribing, administration or any safety concerns please could these be shared with us ensuring that any patient identifiable information is redacted – these can be emailed to licb.mso@nhs.net
We also promote the use of the Learning from Patient Safety Events (LFPSE) platform LFPSE Incident Recording - Home
Utilising this platform to record your incidents allows the ICB and National teams to review what is happening, where it is happening and what mitigations are being taken to reduce the risk of reoccurrence. It also allows us to locally implement guidance and SOPs to support practitioners with patient safety. The information shared on LFPSE does not include patient identifiable information and promotes enhanced learning over blame.
In autoimmune conditions and less commonly, in some cancer therapy regimens, methotrexate should be taken once a week; however, there continues to be reports of inadvertent overdose due to more frequent dosing.
The MHRA released a drug safety update in September 2020 which highlighted actions for healthcare professionals to take to reduce the risk of inadvertent overdose due to taking the wrong dose or due to more frequent dosing (including daily administration).
Between 1st January 2006 and up to 30th July 2020, there were eleven yellow card reports of serious toxicity associated with inadvertent daily dosing of once weekly methotrexate in the UK, with four of these reports being since January 2016.
Overdose of methotrexate can lead to serious adverse effects such as haematopoietic disorders (leukopenia, thrombocytopenia, anaemia, and pancytopenia) and gastrointestinal reactions (mucositis, stomatitis, oral ulceration, gastrointestinal ulceration, and gastrointestinal bleeding).
Some reports of overdose have been fatal. In the fatal cases, events such as sepsis or septic shock, renal failure and aplastic anaemia were reported.
A European review was completed and new recommendations made, which can be found here.
The prescribing of both 10mg and 2.5mg tablets increases the risk of overdose, the patient should just receive one strength, the 2.5mg tablets, with full information on what dose, including the total dose in milligrams and the number of tablets they need to take.
Following on from these recommendations Lincolnshire Integrated Care Board recommend:
- Methotrexate should only be prescribed by healthcare professionals who are fully aware of the benefits and risks of treatment and who have all necessary prescribing competence.
- All specialities, including haematology, should prescribe oral methotrexate doses in multiples of 2.5mg and the total dose in milligrams must also be included.
- Methotrexate 10mg tablets must not be prescribed or supplied.
- When oral methotrexate is prescribed as a once weekly dose, the prescription and the dispensing label must clearly show the dose in milligrams and the number of tablets to be taken with the frequency as “once a week on….” (The day of the week should be specified in full).
- Prescribing of methotrexate with co-trimoxazole or trimethoprim should be avoided and should not occur under any circumstances. This also applies to people who have recently taken methotrexate. *In exceptional circumstances, specialist paediatric services may use co-trimoxazole as prophylaxis, with watchful increased monitoring, for Pneumocystis pneumonia in children on immunosuppressive triple therapy that includes low dose methotrexate for inflammatory bowel disease or for leukaemia patients on maintenance methotrexate treatment. The specialist paediatric service will prescribe, supply, and monitor treatment.
- The patient/carer should be provided with full and clear dosing instructions on the once weekly dosing and decide together with the patient/carer on which day of the week they take the methotrexate. The day of the week should be noted in the patients record.
- All patients should be provided with full information about the methotrexate and know what the signs of methotrexate toxicity are.
- Monitoring requirements should be discussed with the patient/carer and follow up appointments booked. The importance of attending these appointments should be highlighted to the patient.
Further reading
MHRA Drug Safety Update - Here
BNF information - Here
Summary of Product Characteristics - Here
Lincolnshire Formulary - Here
Lincolnshire Prescribing & Clinical Effectiveness website - Here
Drug Safety Updates:
ACE-inhibitors: Be aware of the distinction between bradykinin- and histamine-mediated angioedema, as treatment strategies differ significantly.
Healthcare professionals should be aware of the potential for delayed onset of angioedema and the distinction between bradykinin- and histamine-mediated cases, as treatment strategies differ significantly and bradykinin-mediated angioedema does not respond to standard treatment.
Advice for Healthcare Professionals:
- Angioedema is a known uncommon or rare side-effect of ACE inhibitor treatment. This can either be allergic (histamine-mediated) or less commonly non-allergic (bradykinin-mediated). Healthcare professionals should consider bradykinin-mediated mechanisms as a cause when standard anaphylaxis treatment is ineffective
- Angioedema can occur at any time during treatment, including after weeks to years of use
- Swelling of the tongue, lip, face, or larynx which may cause difficulty in breathing or swallowing may progress and can lead to airway compromise. Other symptoms can include gastrointestinal pain and cramps
- Bradykinin-mediated angioedema is unlikely to respond to standard anaphylaxis treatments including adrenaline (epinephrine)
- Lack of response to standard anaphylaxis treatments should prompt consideration of bradykinin-mediated angioedema, with treatment informed by clinical protocols
- If angioedema is suspected in a patient taking an ACE inhibitor, discontinue the ACE inhibitor immediately and do not restart
For full information see - ACE-inhibitors: Be aware of the distinction between bradykinin- and histamine-mediated angioedema, as treatment strategies differ significantly - GOV.UK
Amiodarone: Reminder of risks of treatment and need for patient monitoring and supervision
Amiodarone has been associated with serious and potentially life-threatening side effects, particularly of the lung, liver, and thyroid gland. We remind healthcare professionals that patients should be supervised and reviewed regularly during treatment. Lung problems may have slow onset but then progress rapidly. Computerised tomography scans may help to confirm a suspected diagnosis of pulmonary toxicity.
Advice for healthcare professionals:
- Amiodarone can cause serious adverse reactions affecting the eyes, heart, lung, liver, thyroid gland, skin, and peripheral nervous system
- Review regularly patients on long-term amiodarone treatment – some of these reactions may be life-threatening but onset can be delayed
- Check liver and thyroid function before treatment, and at 6-monthly intervals; thyroid function should also be monitored for several months after discontinuation
- Although routine lung imaging is not necessary in patients taking amiodarone long-term, make patients aware of the need to seek advice if they have new or worsening respiratory symptoms and consider using computerised tomography (CT) scans if pulmonary toxicity is suspected
- Report suspected adverse drug reactions associated with amiodarone on a Yellow Card
For full information see - Amiodarone: reminder of risks of treatment and need for patient monitoring and supervision - GOV.UK
Finasteride and Dutasteride – Updated safety warnings for psychiatric side effects and sexual dysfunction
The MHRA has reviewed the evidence for finasteride and dutasteride and the risk of suicidal thoughts and behaviours and has recommended further measures to minimise this risk.
Advice for Healthcare Professionals:
- finasteride is associated with depression, suicidal ideation and sexual dysfunction which may persist after treatment is stopped
- inform patients of the risks at point of prescribing and advise patients to read the Finasteride patient cards and the patient leaflet for finasteride which are both supplied in the 1 mg and 5 mg packs
- the product information for finasteride 1 mg will be updated with a warning that sexual dysfunction may contribute to mood disorders, and that sexual dysfunction has also been reported without mood alterations
- when prescribing finasteride, review their medical record, ask patients if they have a history of depression or suicidal ideation and review patients regularly for psychiatric and/or sexual side effects
- patients prescribed finasteride 1 mg should stop taking the medicine if they develop suicidal thoughts or depression and contact their healthcare professional as soon as possible
- patients prescribed finasteride 5mg or dutasteride should consult their healthcare professional as soon as possible if they develop suicidal thoughts or depression
- dutasteride works in a similar way to finasteride – therefore, as a precaution, a warning will be added to the dutasteride product information that mood alterations have been reported with the same class of medicine (finasteride)
- patients prescribed finasteride or dutasteride should contact their healthcare professional if they experience sexual dysfunction
- report suspected adverse drug reactions associated with finasteride or dutasteride using the Yellow Card scheme
For full information see - Finasteride and Dutasteride – updated safety warnings for psychiatric side effects and sexual dysfunction - GOV.UK
MHRA and CAS Alerts:
Drug Recalls & National Patient Safety Alerts
This document explains the different levels of recall that the MHRA cascade out – MHRA recall information
All GP practices should have a nominated person to lead on MHRA alerts/Safety issues. They should be signed up to the alerts system and have a procedure to follow to manage them within the practice. This is a CQC requirement. If you require any support with this, you can email the MSO inbox below.
To sign up for the alerts click here.
Latest field safety notices can be found here.
New contact email for the Medication Safety Officer within the ICB – licb.mso@nhs.net
Medicine Safety Information:
The team are now encouraging practices to sign up to the Medicines Supply Tool via the Specialist Pharmacy Service (SPS) website. Sign up is free, but requires an nhs.net email.
The tool provides the latest information on supply issues, actions to take and alternatives to use.
For a summary of the latest MHRA alerts, please see the monthly MHRA newsletter.
For the latest Medicines and Healthcare products Regulatory Agency (MHRA) alerts, please use the link below:
Levothyroxine Dosing Highlight
Background
Levothyroxine is primarily used to treat hypothyroidism; the dosing will vary based on the individual patient’s blood results.
The patient's Thyroid Stimulating Hormone (TSH) level will usually be measured every three months until stabilised (two similar measurements within the reference range, three months apart), monitoring will be then continued on an annual basis unless the patient has any symptoms.
Levothyroxine Tablets are available in five different strengths, 12.5mcg, 25mcg, 50mcg, 75mcg & 100mcg. The tablets are manufactured by many different companies and come in various coloured boxes with tablet size varying between manufacturers.
Dosing issues & review
When reviewing a patient who takes Levothyroxine one of the most important questions to ask is what dose are you currently taking? If possible, ask them to show you the boxes.
Many people take numerous strengths of tablet to make up their dose, so confirming what they are actually taking can be a vital part of finding out why their bloods are fluctuating. It could be that the Pharmacy has changed brand but the patient is taking the tablets from the colour of the box, or that they are not aware they should be taking more than one strength at the same time to get the correct dose.
There have been numerous incidents where the patient’s TSH levels are fluctuating, the dose has been adjusted in line with the bloods for there then to be little to no effect on the next blood results. When reviewed by the practice pharmacist it has become apparent that the patient was not taking the correct dose; this has been either due to lack of patient counselling e.g., new strength given, and the patient hasn’t been informed they need to take both/all the strengths they have to make the correct dose, or the patient usually takes a tablet from the green box and one from the blue so if the manufacturer changes this could result in the wrong dose being taken.
Speaking with the patient before making any adjustment to medications to determine what dose they are taking can help with stabilising the patient on the medication, this results in better treatment outcomes.
Important counselling points
- Ensure the patient knows what dose they should be taking; confirm they understand the combination of strengths needed to make up the dose if needed.
- Inform the patient that they should take the levothyroxine 30-60 minutes before breakfast, caffeine-containing liquids, or other medication
- Check the patient is aware of the routine monitoring required when taking levothyroxine and how important it is to attend for scheduled blood tests
Medication Safety Matters:
Medication Safety Matters. If you require any further information or guidance around medication safety please contact: licb.mso@nhs.net
Keep Medicines Safe at Home
Protecting Your Family: Why Medication Safety Matters (Website)
Every year, thousands of people — both adults and children — are harmed or killed by taking medication that wasn’t prescribed to them. Whether by accident, curiosity, or misunderstanding, taking someone else’s medicine can be deadly. It’s a growing problem in homes across the country, and it’s one we all have the power to prevent.
The Risks of Taking Someone Else’s Medication
Prescription medications are carefully tailored to an individual’s health needs, age, weight, and medical history. What works for one person may be dangerous — even fatal — for another.
Taking someone else’s medicine can cause:
- Severe allergic reactions
- Dangerous interactions with other medications
- Overdose and poisoning
- Organ failure
- Death
This isn’t just a concern for children. Adults are increasingly affected, often misusing medications for pain, anxiety, or sleep without understanding the consequences.
Keep Medications Safe & Secure
Help prevent accidents and misuse by following these safety tips:
- Store medications out of reach and out of sight, ideally in a locked cabinet or box.
- Never leave tablets or medicines loose in purses, drawers, or countertops.
- Keep medication in original packaging with clear labels and instructions.
- Dispose of unused or expired medication safely — many pharmacies offer free disposal services.
- Talk openly with your family — especially teens and elderly relatives — about the dangers of sharing or taking medication that isn’t theirs.
What To Do If Someone Takes the Wrong Medication
If you suspect that someone has taken medication not prescribed to them:
- Stay calm but act quickly.
- Call 999 for an ambulance or go to your nearest A&E department if the person is unconscious, having trouble breathing, or acting erratically.
- Contact NHS 111 or visit www.111.nhs.uk for guidance if the person is conscious and stable.
- Give all available details — the medication taken, how much, and when.
Don’t wait for symptoms to show — some effects can be delayed but still dangerous.
Pharmacies
Your local pharmacist can help with safe medication storage, disposal, and advice.
Medication Safety Starts With You
You can save a life just by locking the medicine cabinet, talking to your children, or helping a friend get support.
The message is simple:
If it’s not prescribed for you, don’t take it. Ever.
Stay safe. Stay informed. Share the message.