Accord-UK Drug Safety

Focused on product safety

Accord-UK ltd is focused on product safety and conducts comprehensive safety monitoring and evaluations throughout all stages of our product lifecycle.

Patient safety is Accord’s primary concern and we encourage healthcare professionals and patients to report any adverse event which may occur in relation to an Accord product. An adverse event includes reports of any side effect, product misuse, abuse or overdose, including inappropriate use by children or women who are pregnant or breast-feeding. It also includes reports of a product that was used for something other than the intended purpose or was ineffective, or was given with another medicine. Complaints relating to the product can also be reported.

Adverse events should be reported either directly to The Medicines and Healthcare Products Regulatory Agency (MHRA) through its Yellow Card reporting system or you can contact Accord-UK Medical Information directly on 01271 385257.

If you have any medical queries or any feedback you would like to give us, please use the Medical Information email address below, and we will be pleased to get back to you.

[email protected]

Aspirin

In order to comply with MHRA guidelines¹ this product is required to be packed in a child resistant pack.

These can sometimes be difficult to open, so to help we have put together the following guide:

Aspirin how to guide

Aripiprazole

Aripiprazole FAQ and patient-caregiver Brochure

Please follow the links below to access the FAQ and patient-caregiver brochures

Aripiprazole FAQ Brochure Aripiprazole (Patient-Caregiver) Brochure

COMBINED ORAL CONTRACEPTIVES

Information for Alenvona, Alenini, Cleosensa, Juliperla and Sofiperla Tablets Below are links to MHRA additional safety information on combined oral contraceptives (Alenvona, Alenini, Cleosensa, Juliperla and Sofiperla Tablets)

Annex 1 - Combined oral contraceptives: Healthcare Professional communication Annex 2 - Combined oral contraceptives: Checklist for Prescribers Annex 3 - Combined oral contraceptives: Important information for women about the risk of blood clots Annex 4 - Combined oral contraceptives: Important information for women

Drug Driving Offence Information

New drug driving offence – information for healthcare professionals and patients

A new liability offence will come into effect in the summer of 2014 regarding the use of drugs whilst driving.

It is important that information is provided to healthcare professionals who prescribe these medicines and to patients who are prescribed or have purchased medicines affected by this new offence.

Pharmaceutical companies are requested to update the SmPC, the patient information leaflet and product labelling with the UK specific warnings.

Full details regarding the new driving offence concerning driving after drugs have been taken in the UK and may be found here:
https://www.gov.uk/drug-driving-law [External Link]

Section 4.7 ‘Effects on ability to drive and use machines’ of the SmPC will be updated with the following:

This medicine can impair cognitive function and can affect a patient’s ability to drive safely. This class of medicine is in the list of drugs included in regulations under 5a of the Road Traffic Act 1988. When prescribing this medicine, patients should be told:

The medicine is likely to affect your ability to driveDo not drive until you know how the medicine affects youIt is an offence to drive while under the influence of this medicineHowever, you would not be committing an offence (called ‘statutory defence’) if:

- The medicine has been prescribed to treat a medical or dental problem and

- You have taken it according to the instructions given by the prescriber and in the information provided with the medicine and

- It was not affecting your ability to drive safely"

Patient Information Leaflets will be updated with the following text under the heading:

Driving and using machines:

The medicine can affect your ability to drive as it may make you sleepy or dizzy.

Do not drive while taking this medicine until you know how it affects you.It is an offence to drive if this medicine affects your ability to drive.However, you would not be committing an offence if:

The medicine has been prescribed to treat a medical or dental problem and

You have taken it according to the instructions given by the prescriber or in the information provided with the medicine and

It was not affecting your ability to drive safely

Talk to your doctor or pharmacist if you are not sure whether it is safe for you to drive while taking this medicine.

Labelling will be updated as follows:

Flash (on front of pack) - New advice for drivers – see leaflet inside

Back of pack - This medicine can make you feel sleepy. Do not drive while taking this medicine until you know how it makes you feel. See the leaflet inside for more information.

FENTANYL TRANSDERMAL PATCHES

Fentanyl transdermal patches DHCP letter

DHCP letter reminder of the potential risk of like threatening harm from accidental exposure to Fentanyl transdermal patches.

Fentanyl transdermal patches letter

METHYLPHENIDATE

Actavis UK Ltd have agreement to join the Janssen-Cilag Ltd consortium website for Methylphenidate.

Please follow the links below to the risk minimisation materials for Methylphenidate.

Checklist 1: Methylphenidate checklist before prescribing Checklist 2: Methylphenidate checklist for monitoring of ongoing therapy Chart for ongoing monitoring during methylphenidate treatment

METOCLOPRAMIDE

Metoclopramide DHCP Letter

DHCP letter from UK marketing authorisation holders, the European Medicines Agency and the MHRA informing Healthcare professionals of updated advice on the benefits and risks of Metoclopramide.

Metoclopramide DHCP letter Annex 1 - Summary of Product Characteristics Commission Decision Annex 2 - Package Leaflet Commission Decision Annex 3 - Contact Details

Mycophenolate

Please access the Mycophenolate DHCP Letter, Patient Guide and Educational Guide on the risk of teratogenicity for Mycophenolate mofetil Guide via the links below.

Mycophenolate Patient Guide Health Care Provider Mycophenolate Guide Mycophenolate Letter

Paracetamol Solution for Infusion

Paracetamol Solution for Infusion training poster

Salbutamol DHCP Letter

DHCP letter provided by MHRA describing restrictions of use of short-acting beta agonists in obstetric indications following PRAC recommendations.

Salbutamol DHCP Letter

Information for Voriconazole

Please find below, links to the Voriconazole healthcare professional checklist, patient card and healthcare professional questions and answers brochure.

Please note that Voriconazole risk minimisation materials are same for the Film-coated tablets and the Powder for Solution for Infusion

Voriconazole healthcare professional checklist Voriconazole healthcare professional Q&A brochure Voriconazole patient checklist

Zerlinda

Zerlinda patient reminder card

Below is a link to the Zerlinda patient reminder card on the risk of osteonecrosis of the jaw (ONJ)

Zerlinda patient reminder card