Pharmacy - a one-stop resource for pharmacists

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Class 3 Drug Alert (Action within five days): Teva UK Limited - Glibenclamide 5 mg Tablets in Teva UK Limited and Generics (UK) Limited Livery - EL (10)A/06 Rev 1 - added 17 March 2010

Our monthly electronic newsletter aims to give the latest advice for all medicines users to ensure the safe use of medicines:
 12 Aug 2009 | Drug Safety Update: Volume 3 Issue 1, August 2009
 5 May 2009 | Drug Safety Update: Volume 2 Issue 10, May 2009

Medical Device Alerts
Medical devices and equipment are items used for the diagnosis and/or treatment of disease, for monitoring patients, and as assistive technology. Medical Device Alerts (MDAs) are the MHRA's prime means of communicating safety information to medical device users in health and social care. Each MDA is designated either for Immediate action or Action. MDAs may also be used to provide updated information.
MDA/2009/069 - Prostate screening home test kits manufactured by Biomerica Inc USA
MDA/2009/045 - First Steps medicine feeder manufactured by RSW International Ltd
MDA/2009/027 - Ambulatory insulin infusion pump. Accu-Chek Spirit manufactured by Roche

Drug Alerts
If a defective medicine is thought to be a risk to public health, the product is withdrawn from the market and information from the MHRA issued. The Drug Alerts issued in 2009 are below:
 
Class 2 Drug Alert (Action within 48 hours): Teva UK Ltd - Epirubicin Hydrochloride 2 mg/ml solution for injection or infusion in vials - EL (10)A/05 - 5 March 2010
Class 2 Drug Alert (Action within 48 hours): Winthrop Pharmaceuticals UK Ltd Alimemazine Tartrate 7.5 mg/5 ml Syrup - EL (10)A/04 - 5 March 2010
Class 3 Drug Alert (Action within 5 days): Schering-Plough Ltd - IntronA 18, 30 and 60 million IU solution for injection (Recombinant interferon alfa-2b) - EL (10)A/02 - added 1 February 2010
Class 3 Drug Alert (Action within 5 days): Aurum Pharmaceuticals - Amiodarone Hydrochloride 50 mg/ml Concentrate - EL (10)A/01 - added 5 January 2010
Class 4 Drug Alert (Caution in use): Teva UK Limited - Ondansetron IV Injection 2mg/ml (2ml) and 2mg/ml (4ml) (All supplied in Pliva livery) - EL (09)A/35
Class 2 Drug Alert (Action within 48 hours): DDD Limited - Dentinox Teething Gel - EL (09)A/34
Class 2 Drug Alert (Action within 48 hours): Chefaro UK Limited - Metatone - EL (09)A/33
Class 4 Drug Alert (Caution in use): Aurum Pharmaceuticals Limited - Acetylcysteine 200mg/ml Injection - EL (09)A/32
Class 2 Drug Alert (Action within 48 hours): Procter & Gamble (Health & Beauty Care) Ltd - Vicks Sinex Micromist - EL (09)A/31
Class 2 Drug Alert (Action within 48 hours): Pinewood Laboratories Limited - Boots Heartburn Relief Peppermint Flavour, Peptac Peppermint Liquid, Peptac Liquid Aniseed Flavour - EL (09)A/30
Class 2 Drug Alert (Action within 48 hours): Reckitt Benckiser Healthcare (UK) Ltd - Gaviscon Advance Peppermint Flavour - EL (09)A/29
Class 2 Drug Alert (Action within 48 hours): Abraxis BioScience Ltd - Abraxane 5mg/ml powder for suspension for infusion - EL (09)A/28Rev 1
Class 4 Drug Alert (caution in use): Focus Pharmaceuticals Limited - Fluconazole 2mg/ml Solution for Infusion – EL (09)A/27
Class 2 Drug Alert (Action within 48 hours): GlaxoSmithKline Biologicals sa - Cervarix (human papillomavirus vaccine) - EL (09)A/26
Drug safety information: Phenergan Elixir, PL 04425/0630, 100ml packs - EL (09)A/25
Class 2 Drug Alert (Action within 48 hours): Chemidex Pharma Ltd - Dexamethasone 500 microgram Tablets - EL (09)A/24
Class 2 Drug Alert (Action within 48 hours): Karib Kemi Pharm Ltd - Multiple product Drug Alert - EL (09)A/23
Class 4 Drug Alert (Caution in use): Solvay Healthcare Limited - Creon Micro Pancreatin 60.36mg Gastro-resistant Granules - EL (09)A/22
Class 2 Drug Alert (Action within 48 hours): Strandhaven Limited - Amlodipine 5mg and 10mg Tablets - EL (09)A/21 Rev 1 
Class 2 Drug Alert (Action within 48 hours) : Sandoz Limited - Multiple Product Drug Alert - Baclofen 10mg Tablets; Fluoxetine 20mg Capsules and Metformin 500mg and 850mg Tablets - EL (09)A/20 
Class 2 Drug Alert (Action within 48 hours): LPC Medical (UK) Limited - Multiple Product Drug Alert - Co-Amilozide 5/50 Tablets; Metformin 500mg and 850mg Tablets; Naproxen 250mg and 500mg Tablets - EL (09)A/19 
Class 2 Drug Alert (Action within 48 hours): Karib Kemi Pharm Limited - Multiple Product Drug Alert - Doxazosin 2mg and 4mg Tablets; Fluoxetine 20mg Capsules - EL (09)A/18
Class 2 Drug Alert (Action within 48 Hours): Milpharm Limited - Fluoxetine 20mg Capsules - EL (09)A/17 
Class 2 Drug Alert (Action within 48 hours): Greystone Ltd - Amlodipine 5mg and 10mg Tablets - EL (09)A/16 
Class 2 Drug Alert (Action within 48 hours): Jubilant Pharmaceuticals NV and Wockhardt UK Ltd - Amlodipine 5mg and 10mg Tablets - EL (09)A/15
Class 4 Drug Alert (Caution in use): Sanofi-aventis - Priadel Liquid (Lithium Citrate Liquid) - EL(09)A/14
Class 1 Drug Alert (Action now – including out of hours): Niche Generics Ltd and Actavis UK Ltd - Oxybutynin Hydrochloride Tablets 5mg - EL(09)A/13

Regulation explained
There is a brief introduction to medicines regulation at the following links:
How it works

The MHRA role

• Medicines and Medical Device Regulations: What you need to know
• Making Regulatory Decisions about medicines and medical devices
• My medicine - the life cycle of a medicine

The pharmacist’s role

• The Medicines Act 1968, together with the Misuse of Drugs Act 1971 and the Veterinary Medicines Regulations 2007, regulate all retail and wholesale dealings in medicines. A summary of the provisions of these Acts as they relate to pharmacists is published by the Royal Pharmaceutical Society of Great Britain in the publication ‘Medicines, Ethics & Practice’. This document also includes an alphabetical list of medicines (both by brand and non-proprietary name) with their legal status. Downloadable versions are available from the RPSGB website (external link).
  

Dealing with patients
Most common patient questions (87Kb)
Reporting Adverse Drug Reactions with the Yellow Card Scheme - A Guide for Pharmacists (214Kb)
How to stay ahead of the media stories – hints and tips (96Kb)

Dispensing prescriptions/medicines information
How to find the latest regulatory status of a medicine:

• The MHRA’s Information Centre can help with questions about specific medicines. Our database is too large to make available online, but our information scientists will carry out searches for you without charge. To find out if a particular substance or product is licensed in the UK, please send an email to info@mhra.gsi.gov.uk. If your requirement is very urgent you can also phone (020 7084 2000).  Monthly lists of new medicines are published on the website, however you should check availability with the licence holder and your wholesaler.
  

Recent MHRA guidance and publications
These guidance documents/posters all relate to areas of practice that cardiology care practitioners may be involved in and so may be of help:

Consultations

Responses to MLX 363: MHRA regulatory fees for medicines - proposals for 1 April 2010 - added 16 February 2010
Public consultation (MLX 367): Proposals for amendments to the Prescription Only Medicines (Human Use) Order 1997 (the POM Order) - added 11 February 2010
Public consultation (MLX 366): Intention to amend the Medicines for Human Use (Prescribing by EEA Practitioners) Regulations 2008 (SI 2008/1692) - added 2 February 2010
Public consultation (MLX 365): Measures to strengthen the medicines’ supply chain and reduce the risk from counterfeit medicines - added 18 December 2009
Public consultation ARM 64: Request to reclassify Galpharm Non-drowsy Hayfever and Allergy Relief Tablets from pharmacy (P) to general sale list (GSL)

Publications

Guidance helping pharmaceutical manufacturers and distributors to meet their obligations regarding the supply of medicines
New swine flu vaccines section launched
Letter to healthcare professionals: Swine flu - Reporting suspected adverse reactions to Tamiflu, Relenza and future Swine flu H1N1 vaccines
Updated advice on non-prescription medicines containing codeine or dihydrocodeine (DHC)
Counterfeit medicines - Guidance for pharmacists (328Kb)
External defibrillators used for cardiac arrest - top tips
Measuring blood pressure - top 10 tips
Point of Care Testing - Urine Dipsticks
Point of Care Testing - Cholesterol testing
Point of Care Testing - Blood glucose meters
Point of care testing - top 10 tips
Medical devices - reporting adverse incidents
Pharmacy leaflet - With your help we can make medical equipment safe!
Devices in Practice - a guide for health and social care professionals
Practice guidance: Medical devices - a guide for pharmacists

Press releases

Press release: Warning over internet sales of counterfeit weight loss medication - added 1 February 2010

Journals and online literature resources
Pharmaceutical Journal (external link)
International Journal of Pharmacy (external link)
Electronic Medicines Compendium (external link)
MEDLINE PLUS (US National Library of Medicine) (external link)

Other MHRA publications/resources
Safety warnings
Safety guidance
Reporting faulty medical equipment
Taking medicines: questions and answers about side effects
Pregnancy testing top tips leaflet 
Consultations
Annual report
Posters and leaflets
Latest news and press releases

One Liners
All medical devices can fail, but many incidents that result in significant morbidity or mortality arise out of user/deviceinterface problems or because of poor practices. The aim of one liners is to outline these problems to make users more aware of what can go wrong – it is all too easy to take equipment for granted.

One Liners

Other resources:
Reclassification and details of latest ARMs (Applications to reclassify medicines)
Pharmacist Independent prescribing and Supplementary prescribing
Suspect a counterfeit? What to do
Counterfeit medicines - Guidance for pharmacists (328Kb)
Assuring the medicines supply chain - please refer to our list of currently approved wholesale dealers i.e. those with granted licences from us): Department of Health and MHRA Register of Licensed Wholesale Dealer Sites (Human Veterinary and Combined Sites) 2008 (4680Kb)

Interactive education modules
This section provides educational programmes about medical devices, for all levels of healthcare professional, on topics related to our work.

Devices in practice
Anaesthetic machines
Electrosurgery
The operating table

Other training organisations
Centre for Pharmacy Postgraduate Education (CPPE) (external link)
National Pharmcy Association (NPA) (external link)
Royal Pharmaceutical Society of Great Britain (RPSGB) (external link)

Have you thought about?

Herbal medicines
Pharmacists will often be in a position to advise members of public who are considering taking an over-the-counter (OTC) herbal medicine. A key development is the growing availability of regulated herbal medicines, made to assured standards. Increasingly, products with a traditional herbal registration (THR) are now coming onto the market. These products, which can be identified by the THR number on the packaging, meet assured standards of safety, quality and patient information. The products include minor indications based on evidence of traditional use. Alongside these products there will continue to be herbal medicines with a product licence (PL), which also meet assured standards.

During a transitional period unlicensed OTC herbal medicines will continue to be available. However, it is important to remember that these products have not been assessed by MHRA With unlicensed herbal medicines manufacturing standards can be variable, patient information may not be accurate or comprehensive and by law such products must not be accompanied by written indications.

For further information please visit:
Traditional Herbal Medicines Registration Scheme
Herbal safety news - safety issues associated with herbal medicines
Advice to consumers: Safe use of herbal medicines

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