Agrippal suspension for injection in pre-filled syringe

Class 2 Drug Alert (Action Required Within 48 Hours): Novartis Vaccines and Diagnostics S.r.l.  - Agrippal suspension for injection in pre-filled syringe - Influenza Vaccine - EL (12) A/34

Novartis Vaccines and Diagnostics S.r.l.

Agrippal suspension for injection in pre-filled syringe(Influenza Vaccine)PL 13767/0004


Summary:
At the request of MHRA, Novartis Vaccines and Diagnostics S.r.l. is executing a precautionary recall of Agrippal suspension for injection in pre-filled syringes. Recipients of this Drug Alert should bring it to the attention of relevant contacts by copy of this letter. Primary care trusts are asked to forward this to relevant clinics and to general practitioners and community pharmacists for information.

Batch Number	Expiry Date	Pack Size	First Distributed
126201A	31 May 2013	10 x pre-filled syringes	9 Oct 2012
126102	31 May 2013	10 x pre-filled syringes	17 Oct 2012

Based on the information available, there is no evidence of any new safety concerns or of any impact on efficacy. No adverse reactions which may be associated with this issue have been reported to Novartis in connection with these batches. Those who have had a flu vaccine from these batches should have no cause for concern and there is no need for revaccination.

Remaining stocks of the affected batches should be quarantined and returned to the original supplier for credit. For enquiries relating to stock returns please contact Novartis Vaccines Customer Services on 08457 451 500

For medical information enquiries, please telephone Novartis Vaccines Medical Information on 01748 828 816.

Risks of Liver Problems With Black Cohash

The MHRA have again reminded public about the risk of liver problems with the herbal remedy Black Cohosh – a product commonly used to relieve menopausal symptoms.

The reminder follows a serious case of liver failure resulting in a liver transplant suspected to have been caused by a herbal product containing Black Cohosh. The investigation of this case and of the product involved is ongoing.To date, the MHRA has received 53 reports of adverse reactions suspected to be associated with the use of Black Cohosh products through its medicines safety monitoring reporting system, the Yellow Card Scheme. The majority of these reports (36) have involved liver problems including abnormal liver function, jaundice and hepatitis.

Black Cohosh products are available for general sale in pharmacies, supermarkets and health food shops. Currently, there are both authorised (registered under the Traditional Herbal Registration (THR) scheme) and unlicensed products legally on the market.

Since 2006, the MHRA has asked all manufacturers of Black Cohosh products to ensure that an appropriate warning about possible liver problems is included on the label. The MHRA recently became aware that some unlicensed products containing Black Cohosh may not have this warning and we are issuing a reminder to the sector of the need to carry appropriate warnings on their product labelling.

The MHRA always recommends that registered herbal products are used. Registered products can be identified by the Traditional Herbal Registration (THR) registration number or logo on their packaging. These products have been assessed and quality checked to ensure that they are acceptably safe to use and are accompanied by a leaflet with information on how to use the product with possible side effects listed.

The unlicensed products do not have the THR registration or logo number and have not been assessed for quality.  

Richard Woodfield, the MHRA’s Head of Herbal Policy, said: “It is important that people with a history of liver problems do not use Black Cohosh herbal products

“Other people who wish to use Black Cohosh herbal products should check for the traditional herbal registration (THR) number on the packaging indicating that it has been made to assured standards. If the product does not have a THR registration number there would have been no assessment as to the safety or quality of the product.

“Reading the patient information leaflet ensures that you are aware of the correct way to take a medicine, the potential side effects as well as any possible interactions with other medication you may be taking. Unlicensed herbal products may have incomplete, inaccurate or no safety information and can mean you are gambling with your health, especially if you take these products without consulting a GP or qualified healthcare professional.”

http://www.mhra.gov.uk/home/groups/es-herbal/documents/websiteresources/con2024279.pdf

MHRA wins High Court case on wholesaler dealing

The case, relating to Blackbay Ventures Ltd, concerned whether or not regulations allowed for those that operate both as registered pharmacies and licensed wholesale dealers to obtain medicinal products from pharmacies which do not hold a licence.

The judge ruled that it is unlawful for the holder of a wholesale dealer’s licence to obtain supplies from a person who does not have a licence to distribute medicinal products. He also said that it is no defence for the holder of the wholesale dealer’s licence to claim he was acting as a pharmacy when he obtained the products from a person who does not have a licence to distribute.

The core of the judgment is that in order to comply with legislation holders of wholesale dealer’s licences (even if they also operate as a pharmacy) must only obtain medicines from another wholesale dealer licence holder or from a licensed manufacturer. 

http://www.mhra.gov.uk/home/groups/comms-po/documents/news/con197923.pdf

New rules on importing active pharmaceutical ingredients into the European Union

The European Commission has published an information leaflet on the new rules on
importing active pharmaceutical ingredients into the European Union.

http://ec.europa.eu/health/files/documents/active_pharmaceutical_ingredients_leaflet_en.pdf

Typhoid Vaccine

Class 2 Drug Alert (Action Within 48 hours): Sanofi Pasteur MSD Limited - Typhim Vi - Typhoid Polysaccharide Vaccine - EL (12)A/33

The MHRA today issued a drug alert to healthcare professionals advising them that
the manufacturer Sanofi Pasteur MSD has recalled 16 batches of their typhoid
vaccine, Typhim Vi.

he Medicines and Healthcare products Regulatory Agency (MHRA) today issued a drug alert to healthcare professionals advising them that the manufacturer Sanofi Pasteur MSD has recalled 16 batches of their typhoid vaccine, Typhim Vi.

This recall is due to concerns about the effectiveness of the vaccine in some syringes distributed from 7 January 2011 following filling problems in the manufacturing process. Therefore some patients who have been vaccinated with Typhim Vi may not be fully protected against the disease.

If you received this vaccine and have recently returned from abroad, and are unwell, you should contact your doctor.

Vaccine is still available and the Department of Health is working with manufacturers to help ensure that current supply problems are resolved as soon as possible.

MHRA Head of Defective Medicines Report Centre, Ian Holloway said: “There are no concerns over the safety of this vaccine but the recall has taken place because the vaccine may not be as effective as it should be.

“Anyone who has been to a typhoid region of the world and has a fever, abdominal pain and vomiting should contact a healthcare professional. They can also give them information and advice about minimising the risk of getting typhoid.”

Typhim Vi batches being recalled are in this document:
http://www.mhra.gov.uk/home/groups/is-md/documents/websiteresources/con192144.pdf

For medical information enquiries, please telephone  0800 7311654 or fax to 01628 635072.

Counterfeit And Unlicensed Drugs

MHRA played a vital role in $6.5 million drugs bust and stopping spam emails.

More than $6.5 million worth of counterfeit and unlicensed medicines have been seized across the globe as part of a week-long international crackdown on the illicit internet trade in pharmaceuticals.

http://www.mhra.gov.uk/NewsCentre/Pressreleases/CON189211

Pharmaceutical Wholesaler In UK Sept 2012

Register of Licensed Wholesale Dealer Sites (Human Veterinary and Combined Sites) 
September 2012

http://www.mhra.gov.uk/home/groups/is-lic/documents/publication/con2025604.pdf

Risks Of Antipsychotic Drugs

Learning package on Antipsychotic drugs launched

The MHRA have today launched a learning module on antipsychotic drugs for clinical practitioners. The self-directed learning package outlines the key risks of this widely prescribed class of medicines.

Antipsychotics learning module

About this learning module

Antipsychotics are prescribed very widely, mainly for psychosis, but also for other indications. This module identifies the most important hazards of antipsychotics and informs on actions that health professionals can take in order to anticipate, minimise and manage the risks.

Who should complete this module

This training module is for medical, nursing and pharmaceutical professions. It is especially suitable for pharmacists, general practitioners and those starting out in psychiatry. Health professionals who are established in practice will also find the module a helpful refresher.

Learning objectives

Used with summaries of product characteristics and authoritative guidelines on the clinical use of antipsychotics, this module will help to maximise the benefits of antipsychotics.

On completion of the module you will be able to:
• recognise any antipsychotic drugs you encounter and how the drugs are classified
• list important risks of antipsychotic drugs in general
• outline factors that contribute to the risks of antipsychotics and how the risks can be reduced
• identify important drug interactions of antipsychotics
• outline the risks of special uses of antipsychotics (eg in the elderly with dementia, use of immediate-acting and prolonged-action parenteral antipsychotics and of clozapine) and how these risks can be minimised

Time required

It will take you about 3.5 hours to complete the module. It doesn’t have to be done in one sitting. You will need about 30 minutes to answer the multiple-choice questions and to check your answers against the question feedback we have provided.

Learn it all here:
http://www.mhra.gov.uk/ConferencesLearningCentre/LearningCentre/Medicineslearningmodules/Antipsychoticslearningmodule/CON155606

Fake Prescription Medicine

Press Release: Three Essex men sentenced for sale and manufacture of controlled drugs and fake prescription medicines.

Following an investigation into the website www.staymassive.com and a number of other websites by the Medicines and Healthcare products Regulatory Agency (MHRA), three Southend-on-Sea men were sentenced yesterday at Southend Crown Court on a number of counts in relation to the possession and supply of controlled drugs and prescription only medicines online.