Medicines alerts & safety issues

Drug Safety

Peanut Allergy

Through the Medicine Safety Group a peanut allergy bulletin has been developed following the recommendation from the MHRA that patients known to be allergic to peanuts should not use medicines containing arachis oil.

 

Oral retinoids

New prescriber checklists, patient reminder cards, and pharmacy checklists are available to support the Pregnancy Prevention Programme in women taking acitretin, alitretinoin, and isotretinoin.

Also, the advice about the risk of neuropsychiatric reactions has been made consistent for all oral retinoid medicines.

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

 

SAFE USE OF EMOLLIENT SKIN CREAMS TO TREAT DRY SKIN CONDITIONS

Take care when using creams to treat dry skin conditions as they can easily dry onto clothing, bedding and bandages making them more flammable.

Watch this video and share it with your family or carer:

Skin creams, sometimes known as emollients are used by many people every day to help manage different dry skin conditions such as eczema, psoriasis and ichthyosis.

The creams are easily transferred from skin onto clothing, bedding and bandages.  Tests and research have shown that the dried-on cream makes the fabric more flammable and the resulting fire burns quickly and intensely, resulting in serious injury or death.

It’s important for anyone using these creams to avoid any naked flame.

If you use an emollient or skin cream to treat a dry skin condition, please follow this advice.

Avoid smoking

Do not smoke, use naked flames or get near to anything which may cause a fire whilst wearing clothing or a bandage that has been in contact with skin creams.

If this is not possible, you must take steps to ensure you are safe when you smoke or use naked flames. For example, by using a flameless lighter or e-cigarette, and removing long sleeved or baggy clothing before using a gas hob.

Change and wash clothes and bedding

Change and wash your clothes and bedding frequently to reduce the build-up of skin cream. However, remember that whilst washing your clothing and bedding even at high temperatures might reduce the build-up, it does not remove it completely and the danger may remain.

Keep cream off furniture

Be careful to make sure the skin cream does not get onto the fabric of armchairs or other furniture, cushions and blankets. Be aware that the cream can transfer from your skin onto the fabric of furniture when you are sitting or lying on it.

Tell relatives and carers

Tell your relatives or carers about your treatment and ask how they can help you to reduce the risk. Download the leaflet  for them.

For HEALTHCARE PROFESSIONALS

Ensure patients and their carers understand the fire risk associated with the build-up of dried emollient residue on clothing and bedding and can take action to minimise the risk.

When prescribing, recommending, dispensing, selling, or applying an emollient, instruct patients not to smoke, cook or go near any naked flames or heat source (gas, halogen, electric bar or open fire) whilst wearing clothing or dressings that have been in contact with emollients. If the patient cannot do this advise on measures to do so safely (e.g use safety lighters or e-cigarettes; remove long sleeved or loose clothing before cooking; put on a thick uncontaminated shirt, overalls or apron, move chairs further away from the open fire or other heat source)

Be aware that washing clothing or bedding at a high temperature may reduce emollient build up but does not totally remove it – it is important to minimise risk in additional other ways (as above).

Watch the video above and share it with your patients or customers.

Report any fire incidents associated with the use of emollients to the Yellow Card Scheme

For complex cases contact the local fire and rescue service for advice and support.

Further information is available here.

 

Medicines and Healthcare products Regulatory Agency (MHRA)

The MHRA has also highlighted the risks in a press release.

It was previously thought the risk occurred with emollients which contain more than 50% paraffins.  However, evidence now points to a risk with emollients which contain lower levels of paraffin and with paraffin-free emollients. This advice therefore applies to all emollients whether they contain paraffin or not.

It is important people prescribing, dispensing or using any emollient, or caring for someone who uses an emollient, are aware of the potential fire risks and take appropriate action.

Further details are available here Press Release MHRA 181218

 

BBC News Health

BBC News Health has again highlighted the dangers of using skin preparations whilst smoking or using naked flames.

 

 

Local resources

We have updated our   poster for patients/carers and information sheet for both healthcare professionals and patients/public.

 

Further Resources

Drug safety update: paraffin based skin emollients on dressings or clothing: fire risk (includes information on where to report incidents)

https://www.gov.uk/drug-safety-update/paraffin-based-skin-emollients-on-dressings-or-clothing-fire-risk

National Patient Safety Agency (now NHS Improvement)

http://www.nrls.npsa.nhs.uk/resources/?entryid45=59876

Patient safety video

http://www.nrls.npsa.nhs.uk/patient-safety-videos/paraffin-based-skin-products/

West Sussex Coroner’s Report: lower strength paraffin-based products

https://www.judiciary.gov.uk/wp-content/uploads/2015/10/Hills-2015-0317.pdf

Risk assessment provided by Locala

Risk Assessment Template.pdf

BBC News Health

http://www.bbc.co.uk/news/uk-39308748

 

Resources to support safe use of valproate in women and girls

Valproate medicines must not be used in women of childbearing potential unless the Pregnancy Prevention Programme is in place. Actions for GPs, specialists and dispensers are available here. The link also includes how to order packs of information for patients/carers.

Further resources:

Valproate use by women and girls includes a video for healthcare professionals, patient cards/booklets, patient support networks etc.

Letter to pharmacists setting out urgent actions.

Valproate use for women and girls updated by MHRA May 2020

Drug safety update – Advice for Healthcare Professionals:

Valproate and developmental disorders: patient review and further consideration of risk minimisation measurements .

 

The Annual Risk Acknowldgement form which should be used during annual specialist review of all women and girls of childbearing potential on valproate medicines (irrespective of indication). Specialists should comply with guidance given on the form if they consider the patient is not at risk of pregnancy, including the need for regular review in case her risk status changes.

 

Reporting ADRs directly to MHRA

Healthcare professionals are to report suspected adverse drug reactions directly to the Medicines and Healthcare products Regulatory Agency. Further details are available from here.

Interactions with HIV medicines

Some commonly prescribed medicines interact with certain medicines used for HIV infection. These include corticosteroid inhalers, nasal sprays and intra-articular injections. If a corticosteroid is necessary, beclometasone is a safer option as it is less dependent on CYP3A metabolism.

Interactions can be checked using this website.

 

Insulins

A patient safety alert has been issued about the risk of severe harm and death resulting from withdrawing insulin from pen devices. This notes that

56 incidents have been reported which were associated with withdrawing insulin from insulin pens or refill cartridges:

• 12 described drawing up insulin directly from pens or cartridges

• 9 described a failure of safety needle

• 9 described incorrect technique with safety needles (healthcare professional)

• 6 described incorrect technique with safety needles (patients)

• 10 described other themes.

Extracting insulin from pen devices or cartridges is dangerous and should not happen.

A local newsletter about concern regarding high strength insulin and the dangers of taking insulin from pens or cartridges is available here:

UPDATED MARCH 2017 newsletter_concerns re high strengths insulins and withdrawing insulin

 

•The National Pharmacy Association have produced an Insulin Identification Checker to assist pharmacists and other relevant members of staff with selecting the correct insulin for dispensing against generic prescriptions.

• see key therapeutic topic from NICE on safer insulin prescribing. It includes actions to take to make insulin administration safer.

 

Advice from MHRA about medical device software including apps

Information on when software applications (apps) are considered to be a medical device and how they are regulated can be found here.  It includes information on making sure they comply with regulations and are acceptably safe. There is advice for the public in making sure apps are right for them.

 

CDs

Public Health England – Advice for prescribers on the risk of the misuse of pregabalin and gabapentin

Please see the link to guidance  published by Public Health England on the risk of misuse of pregabalin and gabapentin; this guidance explains when to avoid starting and how to reduce / stop use.

Advice on diamorphine and intrasite gel

The CD Accountable Officer is aware of the unlicensed use of Intrasite gel and diamorphine injection in certain settings.

The decision to use this would be a clinical judgement for the individual prescriber.

In all cases, if this is the chosen treatment, both the person administering the treatment, and the patient, must be  aware of its unlicensed status. There must also be a full audit trail for the use of the diamorphine (including destruction details of any part ampoules that may have been discarded)

 

Tackling Chronic Opioid Pain

The Medicines Optimisation Group East Anglia was supported by NIHR CLAHRC Eastern to develop an approach to opioid tapering. They combined research evidence with experiences of practitioners to identify seven key features that should be included in all opioid deprescribing interventions. See the  Toolkit .

 

Newsletters about CDs

• NHS England South West reported incident regarding methadone supplied to the patient’s brother in error.

NHS England South West April 2019  

• NHS England North Midlands reported incident when converting doses of opioids from oral to syringe driver

NHS England North Midlands February 2019

 

Other alerts and guidelines

 

Medicines Safety Sub-group – Nefopam bulletin

Please see the link to the Medicines Safety Bulletin that focuses on Nefopam; this bulletin also provides information on prescribing recommendations and an example of a Nefopam withdrawal regime.

 

Clozapine Patient Safety Alert: Clozapine

A reminder of the potentially fatal risk of intestinal obstruction, faecal impaction, and paralytic ileus as a result of constipation and reduced gastric motility.

 

Benzodiazepines and risk of suicide

Patient Safety Alert: Benzodiazepines and risk of suicide

A bulletin has been produced to highlight the potential risks of suicide associated with benzodiazepine prescribing and withdrawal.