Safety Alerts

 

The Medicines and Healthcare products Regulatory Agency (MHRA) regulates medicines, medical devices and blood components fr tranfusion in the UK. A key role of the MHRA is helping to educate the public and healthcare professionals about the risks and benefits of medicines, medical devices and blood components, leading to safer and more effective use. 

Forum Health Centre will place key safety alerts on this page for patients to note with links to further information:

Epipen Shortage - October 2018

EpiPen and EpiPen Junior will be subject to limited availability until the end of 2018. This supply alert is specifically for the Mylan brand of adrenaline auto-injector devices and alternative auto-injector devices are available.

Please note:

  • Do not dispose of expired devices until you have replaced them.
  • The product expires on the last day of the month that is indicated on the device e.g. a device labelled 'April 2019' does not expire until the end of April 2019.
  • If you need to use an alternative adrenaline auto-injector please seek advice on how to use it from your pharmacist. Additional training materials are available below.
  • Certain batches of the adult EpiPen can be safely used for 4 months after the expiry date. Check the table below for EpiPens that can be used past their expiry date.

EpiPen 300mcg auto-injectors that can be used beyond expiry date:

           LOT                         

Labelled Expiry Date (end of the month)

Extended Use by Date (end of the month)

6FA794J

07.2018

11.2018

6FA795Y

07.2018

11.2018

7FA112F

09.2018

01.2019

7FA106B

09.2018

01.2019

7FA283B

10.2018

02.2019

7FA251D

10.2018

02.2019

7FA250B

10.2018

02.2019

7FA265C

11.2018

03.2019

7FA265B

11.2018

03.2019

Please remember the extended use only applies to the lots of EpiPen 300mcg listed above and not to EpiPen 150mcg auto-injectors or any 300mcg lot number not specified.

Auto-Injector Training

It is important to remember if you are prescribed an alternative auto-injector device that it may differ slightly in the way it is used and specific training is required for each device. You can ask your pharmacist for guidance on using auto-injector devices. The following links provide additonal training materials for different devices:

EpiPen devices: http://www.epipen.co.uk/patients/epipenr-user-guide
EpiPen Training video: https://www.medicines.org.uk/emc/product/4289/rmms
EpiPen Junior Training Video: https://www.medicines.org.uk/emc/product/4290/rmms
Jext devices: https://jext.co.uk/
Jext 150 Training Video: https://www.medicines.org.uk/emc/product/5747/rmms
Jext 300 Training Video: https://www.medicines.org.uk/emc/product/5748/rmms
Emerade devices: https://www.emerade-bausch.co.uk/patient/how-to-use-emerade
Emerade 150 Training Video: https://www.medicines.org.uk/emc/product/5278/rmms
Emerade 300: https://www.medicines.org.uk/emc/product/5280/rmms
Emerade 500: https://www.medicines.org.uk/emc/product/5279/rmms

Fentanyl Patches: Life-threatening and fatal opioid toxicity from accidental exposure - September 2018

Regulatory authorities have received reports of life-threatening reactions and fatalities from fentanyl overdose occurring as a result of:

  • inappropriate strength of fentanyl patches prescribed in opioid naive patients
  • failure to remove an old patch before applying a new fentanyl patch
  • exposure of the patch application site to a heat source (e.g. hot bath, hot water bottle, electric blanket, heating pad etc.) or increased body temperature (e.g. fever)
  • inadvertent ingestion of fentanyl patches
  • poorly affixed fentanyl patches transferring to another person
  • children applying improperly disposed patches to their body believing the patches to be stickers or plasters

The following advice has been given to reduce the risk or accidental exposure to fentanyl:

  • Follow the prescribed dose.
  • Follow the correct frequency of patch application.
  • Ensure old patches are removed before applying a new one.
  • Do not apply patches to broken skin.
  • Do not shave the area before applying a patch.
  • Do not apply patches to the same area within a seven day period.
  • Never cut patches prior to application or use damaged patches.
  • Avoid touching the adhesive side of patches and wash hands after application.
  • Check the adhesion of patches, especially the edges.
  • Regularly check, by sight or touch, that the patch is still adhered to the skin properly.
  • Do not expose patch application site to external heat e.g. hot bath, sauna, hot water bottle, electric blanket, heat pad or excessive sun exposure.
  • Seek medical advice if the patient develops a fever.
  • Fentanyl patches can cause drowsiness. If affected the patient should be advised not to drive or operate any tools or machinery. It is an offence to drive if their ability is impaired by the use of fentanyl patches.
  • Alcohol can potentiate the side-effects of fentanyl, increasing the risk of drowsiness.
  • Store patches securely and out of the sight and reach of children.
  • To dispose of the patch, the used patch should be folded as soon as it is removed so that the adhesive side of the patch sticks firmly to itself. The folded patch should be placed in the original outer pouch and discarded safely in the bin with your household waste or disposing in a yellow sharps container.
  • If a fentanyl patch is inadvertently transferred to another person, it should be removed immediately and medical help sought. If a patch is swallowed e.g. by a child, medical help should be sought immediately.
  • Patients should make all healthcare professionals aware that they use fentanyl patches so that any treatment given is safe and does not interact with fentanyl and if necessary patches are removed before procedures, scans etc.
  • Patients should seek the advice of a community pharmacist when purchasing medicines for common ailments so that the pharmacist can recommend medicines that are safe to use with fentanyl patches.
  • Trouble breathing, shallow breathing; tiredness or extreme sleepiness or sedation; inability to think, walk or talk normally; feeling faint, dizzy or confused, are signs and symptoms of fentanyl overdose. Seek urgent medical attention if any of these signs or symptoms are noted.

Click here for a patient information sheet on Fentanyl patches.

Sodium Valproate and risk to babies in Pregnancy - February 2016

Sodium Valproate Guidelines

New regulations have been introduced by the Medicines and Healthcare products Regulatory Agency (MHRA) around the way in which the drug, sodium valproate is prescribed to women and girls of childbearing age. Sodium valproate is associated with risks for babies exposed to the drug during pregnancy. The new measures are designed to ensure that all women who have to take the drug for their epilepsy, are fully informed of the risks, are advised on the importance of using effective contraception and are invited for a yearly review of their treatment.

What is sodium valproate?

Sodium valproate is an epilepsy drug prescribed for all seizure types including absence, myoclonus and tonic clonic seizures. It is also prescribed to a lesser degree for bipolar disorders. It is known under different brand names including Epilim, Epival, Episenta and Convulex.

How effective is sodium valproate in the treatment of epilepsy?

For many people sodium valproate is effective in controlling epileptic seizures and for some women with epilepsy may be the only medication that works.

What are the risks around sodium valproate?

If a baby is exposed to the drug during pregnancy, there is a risk of it being born with physical disabilities and developmental issues. This applies whether valproate is taken alone or in combination with other medicines.

The risk of disabilities such as spina bifida is approximately 10 per cent while studies show that up to 30-40 per cent of babies exposed to the drug in the womb experience delays in their early development such as talking, and/or walking, have low intellectual abilities, poor language skills and memory problems.

Should you stop taking sodium valproate straight away?

You should never stop taking your epilepsy medication without first consulting your doctor. This also applies if you are pregnant. In some circumstances seizures can cause miscarriage, trauma related to falls and may harm your baby. Even if you are not pregnant, seizures can pose a risk to your well being. It is important to seek the advice of your doctor and look at changing slowly to a different medication.

What are the new measures around sodium valproate?

The MHRA have changed their regulations to introduce a number of safety measures, including the recommendation that sodium valproate must no longer be prescribed to women and girls of childbearing age, unless they are on a pregnancy prevention programme. This is because of the risk of birth defects and developmental disorders for an unborn baby.

What does this mean for you?

This means that if your doctor decides, in collaboration with you and/or your parent or legal guardian, that sodium valproate is the only medication that will effectively control your seizures, they must also discuss the need to use effective contraception to prevent you from getting pregnant.

Depending on the type of contraception that you and your doctor consider to be best, regular pregnancy tests might be needed to make sure you are not pregnant.

Your epilepsy specialist or GP must also invite you for a review of your epilepsy and medication at least once a year. This is an important opportunity to review your treatment and discuss the risks around the medication. You and your doctor will both need to sign a form acknowledging that you have discussed and understand the risks.

Make an appointment to talk to your doctor or specialist and arrange to have a review if you haven't already been invited for one.

What should you do if you are not planning to start a family?

It is still important to take effective contraception to ensure that you do not become pregnant. As above, you must have an annual review with your specialist. Depending on the type of contraception you use you may also need to take a regular pregnancy test and sign a risk acknowledgement form.

What should you do if you are planning to start a family?

Make an appointment to see your doctor as early as possible and discuss your treatment options. Never stop taking your sodium valproate or contraception but discuss with your doctor the safest options to ensure your safety and that of any future babies.

What should you do if you are pregnant?

Do not stop taking your medication but make an appointment to see your doctor immediately. You will be able to discuss together the best form of treatment to safeguard the well being of both you and your baby. In some circumstances you may not be able to switch to another medication and your doctor will provide you with more information. You will be closely monitored to ensure you have the best seizure control and to check how your baby is developing.

What should happen if you are prescribed sodium valproate?

  • your doctor should talk to you about the risks to babies during pregnancy and the importance of using an effective contraception
  • they should ensure you have seen a specialist in the last year
  • they should offer you an updated patient information booklet for more information
  • both you and your doctor should sign a risk acknowledgement form showing that you have been informed of and understand risks associated with valproate.

When you receive your medication, your pharmacist should:

  • show you the warning on the packaging that contains your medication
  • make sure you have the patient card and leaflet  about sodium valproate
  • check that you have seen your doctor to discuss risks and measures for women and girls.

If you have any questions around sodium valproate, epilepsy, pregnancy and contraception, please contact our helpline on 01494 601 400 or helpline@epilepsysociety.org.uk

Click here for the MHRA page with the latest medicines and healthcare products alerts.