Category Archives: Other

Class 2 Medicines Recall: Teva UK Limited and Mylan – recall of some Valsartan containing products

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Some valsartan containing products including certain batches supplied by Teva UK Limited and all unexpired batches supplied by Mylan are being recalled.

Class 2 Medicines Recall: Teva UK Limited and Mylan – recall of some Valsartan containing products – GOV.UK

Company name

Teva UK Limited

Valsartan 320mg Film-coated Tablets, PL 00289/1238

BATCH NUMBER EXPIRY DATE PACK SIZE DATE OF FIRST DISTRIBUTION
100433 28/02/2019 1 x 28 21/06/2017
101777 31/07/2019 1 x 28 15/01/2018

Valsartan 40mg Film-coated Tablets, PL 00289/1235

BATCH NUMBER EXPIRY DATE PACK SIZE DATE OF FIRST DISTRIBUTION
100350 28/02/2019 1 x 7 01/06/2017
100938 30/04/2019 1 x 7 03/01/2018
101776 31/08/2019 1 x 7 13/09/2018

Valsartan / Hydrochlorothiazide 80 / 12.5mg Film-coated Tablets, PL 00289/1233

BATCH NUMBER EXPIRY DATE PACK SIZE DATE OF FIRST DISTRIBUTION
6P601163 31/01/2019 1 x 28 23/06/2016
6P606333 30/06/2019 1 x 28 07/10/2016
0001584 31/12/2019 1 x 28 26/04/2017
0002626 31/03/2020 1 x 28 25/08/2017
0002627 31/03/2020 1 x 28 05/07/2017
0003214 30/04/2020 1 x 28 30/10/2017
0004744 31/08/2020 1 x 28 27/12/2017

Valsartan / Hydrochlorothiazide 160 / 12.5mg Film-coated Tablets, PL 00289/1215

BATCH NUMBER EXPIRY DATE PACK SIZE DATE OF FIRST DISTRIBUTION
6P607166 31/07/2019 1 x 28 07/10/2016
0000426 30/09/2019 1 x 28 13/02/2017
0001520 31/12/2019 1 x 28 04/05/2017
0001521 31/12/2019 1 x 28 25/05/2017
0002298 29/02/2020 1 x 28 16/08/2017
0003663 31/05/2020 1 x 28 27/09/2017
0004670 31/08/2020 1 x 28 11/12/2017

Valsartan / Hydrochlorothiazide 160 / 25mg Film-coated Tablets, PL 00289/1234

BATCH NUMBER EXPIRY DATE PACK SIZE DATE OF FIRST DISTRIBUTION
6P601084 31/01/2019 1 x 28 19/05/2016
6P606270 30/06/2019 1 x 28 13/09/2016
0000350 30/09/2019 1 x 28 23/01/2017
0000352 30/09/2019 1 x 28 12/04/2017
0001997 31/01/2020 1 x 28 12/06/2017
0002338 29/02/2020 1 x 28 16/08/2017
0003615 31/05/2020 1 x 28 27/09/2017

Mylan

MEDLINE PRODUCT PL NUMBER
Valsartan 40mg Capsules PL 04569/1000
Valsartan 80mg Capsules PL 04569/1001
Valsartan 160mg Capsules PL 04569/1002
Valsartan 40mg Film-coated Tablets PL 04569/1175
Valsartan 320mg Film-coated Tablets PL 04569/1178

Further to Drug Alert number EL (18) A/11, issued in July 2018 in connection with Valsartan containing products contaminated with N-nitrosodimethylamine (NDMA), we have become aware of another nitrosamine contaminant in batches of Valsartan active substance.

This contaminant is N‑nitrosodiethylamine (NDEA), which also has genotoxic and carcinogenic potential. Valsartan containing products from UK suppliers Teva UK Limited and Mylan are affected.

Teva is recalling the listed batches and Mylan is recalling all unexpired batches of the above products from pharmacies as a precautionary measure at a European level due to possible contamination with NDEA.

Healthcare Professionals and wholesalers

  • Stop supplying the above products / batches listed above immediately. Quarantine all remaining stock and return it to your supplier using your supplier’s approved process.
  • If you receive queries about this issue from patients, advise them not to stop taking their medication as the health risk of discontinuing the medicine is higher than the potential risk presented by the contaminant. A treatment review is not necessary until the next routine appointment.
  • We do not anticipate any shortages of Valsartan containing products. It is possible, however, that there may be some local supply issues, in which case patients should be advised to speak to their doctor to discuss alternative treatments.

This is a developing issue and the MHRA is actively involved with the European Medicines Agency and with other medicines regulators to determine any possible impact. An investigation into other potentially impacted products is continuing and further updates will be provided as the investigation progresses.

Company contacts for further information

Teva UK Limited

For stock control:general.enquiries@tevauk.com

For medical information enquiries: medinfo@tevauk.com

Mylan

For stock control: mguk_customer.services@mylan.co.uk, 01707 853100

For medical information enquiries:info@mylan.co.uk, 01707 853 000, Option 1

Recipients of this Drug Alert should bring it to the attention of relevant contacts by copy of this letter. Local area teams are asked to forward this to relevant clinics, general practitioners and community pharmacists.

MHRA recalls Valsartan blood pressure and heart medication from pharmacies

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UK pharmacies are assisting with the precautionary recall of Valsartan medication.

Valsartan recall image

The Medicines and Healthcare products Regulatory Agency (MHRA) are undertaking a pharmacy level recall of all affected batches of Valsartan containing medicines made by Mylan and Teva as a precautionary measure.

This follows an earlier pharmacy level recall in July, when MHRA recalled affected batches of valsartan containing medicines from Dexcel and Actavis (now Accord), also to pharmacy level.

That recall occurred across Europe, following information that an impurity, N-nitrosodimethylamine (NDMA) was identified as part of the manufacturing process in a valsartan active substance manufactured at one facility based in China.

During the course of the investigation into NDMA, another impurity, N-nitrosodiethylamine (NDEA), was discovered in valsartan drug substance. MHRA, together with other EU regulators, are continuing to investigate other sartan products which share a similar chemical structure to valsartan.

At present there is no evidence that this impurity has caused any harm to patients. This recall is being undertaken as a precautionary measure to prevent further exposure to this impurity in the affected medicines whilst the investigation is ongoing. Due to the risk associated with suddenly stopping high blood pressure medication, people are therefore advised not to stop any treatments without consulting their doctor or pharmacist.

We are working closely with other EU member states, the European Medicines Agency (EMA) and the European Directorate for the Quality of Medicines (EDQM) to ensure a thorough investigation and we will consider the impact in the UK and what actions may be necessary.

(SOURCE – MHRA)

Aquilon Medical Nebulisers: people urged to stop use immediately

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People and healthcare organisations are being urged to check if they have the affected Aquilon series of nebulisers.

Following withdrawal of CE certification for the Aquilon series of nebulisers, the manufacturer has continued to place the nebulisers on the market. We have issued a Medical Device Alert today to all relevant healthcare professionals.

The affected nebulisers and packaging do have a CE mark placed on them, however this has not been obtained through appropriate regulatory oversight and therefore, their safety cannot be assured.

A medical device cannot be marketed in Europe without carrying a CE mark. It is applied by the manufacturer and means that the device meets the relevant regulatory requirements and, when used as intended, works properly and is acceptably safe.

This issue affects Aquilon2, Aquilon, Aquilon+ and Aquilon Pro series medical nebulisers manufactured since 01 April 2015. MHRA believes that more than 8,000 Aquilon nebulisers, which have been on the market since 2015 are affected in the UK.

If there is suspicion that a nebuliser is affected, people are advised to stop using immediately, dispose of the device and to use an alternative nebuliser where available. It is advisable that you speak to your healthcare professional or GP who can help you find out if your device is affected, give you advice on how to dispose of it and provide a replacement.

John Wilkinson, MHRA’s Director of Medical Devices said:

We have been made aware that the manufacturer has continued to sell nebulisers even after their CE certification was withdrawn. We cannot guarantee they have been manufactured to an appropriate standard.

These devices deliver potential life-saving treatment and it is vital they operate correctly when needed.

We are taking action, as a matter of priority, to make sure people are aware the CE mark has been withdrawn and that these devices should not be used and should be disposed of.

Patient safety is our highest priority and we urge anyone with questions to speak to a healthcare professional as soon as possible.

Class 4 Medicines Defect Information: Bleo-Kyowa, powder for solution for injection, 15,000 IU

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Caution in Use – Distribute to Hospital Pharmacy, Ward, Chemotherapy Unit and Clinic Level. (EL (18) A/05)

Product information
MDR number
MDR 147-09/17

Company name
Kyowa Kirin

Product description
Bleo-Kyowa®, Powder for Solution for Injection (Bleomycin sulfate), 15,000 IU

PL number
PL 16508/0046

Batch number/expiry
Batch Number Expiry Date Pack Size First Distributed
X7B240 September 2020 10 February 2018
Brief description of the problem
In April 2017, glass particles were detected in a batch of Bleo-Medac (bleomycin sulfate) from the same manufacturer.

Actions for healthcare professionals
While investigations are ongoing, additional measures should be adopted, as follows:

Follow all the recommended steps for the preparation of Bleo-Kyowa in accordance with the Summary of Product Characteristics.

Carefully inspect the reconstituted product under a bright light.

If particulate or glass matter is visible after reconstitution, do not administer the product to patients. Please retain the vial, quarantined safely away from other stock and notify the marketing authorisation holder (details overleaf).

If there is no visible particulate matter after reconstitution, the use of a standard 5-micron (5 µm) filter needle to withdraw the reconstituted product from the vial prior to administration is recommended as glass particles may be difficult to see.

Background
In April 2017, reports of glass particles in a batch of Bleo-Medac Powder for Solution for Injection, 15,000 IU, resulted in recall in some European countries. No recall action was necessary in the UK as the affected batch had not been distributed in the UK.

The marketing authorisation holder continues to investigate the root cause of this quality defect. To maintain continuity of supply in the UK, the marketing authorisation holder will distribute new batches of Bleo-Kyowa that meet current specifications.

Company contact information
If you have any questions about this letter or any other enquiry, please contact Kyowa Kirin Medical Information:

Tel: +44 (0)1896 664000

Email: medinfo@kyowakirin.com

Recipients of this Drug Alert should bring it to the attention of all relevant contacts involved with the supply and administration of chemotherapy, including: hospital pharmacists; hospital clinicians; ward staff; chemotherapy unit staff; nursing staff and clinic staff by copy of this letter.

In addition, the relevant Healthcare Professionals should be informed where the product is being used in a domiciliary setting. Local area teams are asked to forward this to relevant clinics and hospital pharmacy departments.

Published 22 February 2018

Batches of Ventolin Accuhaler and Seretide Accuhaler asthma inhalers recalled

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Three specific lots of asthma inhalers are being recalled, including preventer and emergency relief inhalers.

People with asthma are being asked to replace specific batches of their Ventolin Accuhaler inhalers, used for the emergency relief of asthmatic symptoms. This is due to a manufacturing issue that results in a small number of the devices not delivering the full number of doses.

The Medicines and Healthcare products Regulatory Agency (MHRA) has today issued a patient level drug alert recalling two specific affected lots manufactured by Glaxo Wellcome UK Limited.

Patients who have used the affected batches of Ventolin may find that their symptoms are not relieved as normal by their Ventolin Accuhaler. If this happens, they should seek medical advice. Affected Accuhalers should be returned to their pharmacist for a replacement.

Additionally, one lot of Seretide Accuhaler, used for the maintenance of preventative treatment of asthma, is being recalled from hospitals, pharmacies, dispensing practices, retailers and wholesalers in the UK.

The recall of Seretide Accuhaler is pharmacy level because this is used for maintenance treatment as opposed to a reliever treatment.

The two affected batches of Ventolin Accuhaler and the one affected batch of Seretide were distributed to the UK market.

Only a small proportion of the units are defective (images below). Other asthma inhalers, including the more commonly used Ventolin Evohaler, are not affected.

Bernadette Sinclair Jenkins, MHRA’s Regulatory Assessment Unit Manager of the Inspections, Enforcement and Standards unit said:

It is important people check whether they have an affected inhaler. We want patients and their families to be confident treatment will be safe and effective when required.”

People with a Ventolin Accuhaler from the affected lots should take them to their pharmacy or their dispensing practice and speak to a pharmacist who will provide a replacement.

We strongly encourage anyone to report any issues with their inhalers or other medicines or medical devices to MHRA via our Yellow Card Scheme.

Information is also available to patients and healthcare professionals by contacting GSK’s Customer Support Team via customercontactuk@gsk.com or calling on 0800 221 441 (option 4).

Product Description Lot details Final market Expiry Date
Ventolin 200mcg – Accuhaler 1x60D 786G UK 05/2019
Ventolin 200mcg – Accuhaler 1x60D 754P UK 05/2019
Seretide 50/250mcg – Accuhaler 1x60D 5K8W UK 04/2019

 

AstraZeneca’s $1B Imfinzi

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Backed by convincing survival data, AstraZeneca’s Imfinzi is breaking out on its own. Friday, the drug snagged an FDA green light in previously treated, stage 3 lung cancer patients whose tumors can’t be removed, a market without a single competitor in sight.

That’s an entirely new experience for Imfinzi, the fifth-to-market PD-1/L1 immunotherapy, which faces four other contenders in its only other approved indication, bladder cancer.

With those rivals years away from gaining a similar nod in lung cancer, Imfinzi could hit $1 billion in worldwide sales from that indication alone, Leerink Partners analyst Seamus Fernandez has predicted. Bernstein’s Tim Anderson has estimated that the opportunity in the world’s top seven markets tallies about 47,000 patients.

The FDA approved the new use based on phase 3 data showing Imfinzi could stave off disease progression for a whopping 11.2 months longer than chemo achieved, good for a 48% reduction in the risk of disease progression and death. But even before AZ rolled out those numbers at September’s European Society for Medical Oncology (ESMO) annual meeting, its top-line data from that trial, dubbed Pacific, were generating plenty of buzz.

The trial “is the kind of breakthrough that promises to pull upward on the I-O market size,” he wrote to clients in July.

AstraZeneca certainly hopes so. The company is counting on Imfinzi to help it come out of what CEO Pascal Soriot earlier this month called a “really difficult period,” and he ensured investors that there was just one more year to go before “fast growth” sets in.

 

Source- FiercePharma

EU recommendations for 2017/2018 seasonal flu vaccine composition

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The European Medicines Agency has delivered the European Union (EU) commendations for the influenza virus strains that vaccine companies should include in vaccines for the inhibition of seasonal influenza from autumn 2017.

Every year, EMA’s ad hoc Influenza Working Group issues EU recommendations for the composition of seasonal influenza vaccines on the basis of interpretations by the World Health Organization (WHO). The recommendations for the influenza season 2017/2018 were endorsed by the Agency’s Committee for Medicinal Products for Human Use (CHMP) on 23 March 2017.

Trivalent vaccines for the 2017/2018 season should comprise these three virus strains:

  • an A/Michigan/45/2015 (H1N1)pdm09-like virus;
  • an A/Hong Kong/4801/2014 (H3N2)-like virus;
  • a B/Brisbane/60/2008-like virus.

For quadrivalent vaccines with two influenza B viruses, a B/Phuket/3073/2013-like virus in addition to the strains mentioned above is considered appropriate.

These recommendations also relate to the manufacturing of live mitigated influenza vaccines.

Dated: 24th March 2017

http://www.ema.europa.eu/ema/index.jsp?curl=pages/news_and_events/news/2017/03/news_detail_002720.jsp&mid=WC0b01ac058004d5c1

Use of big data to improve human and animal health

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The term big data refers to tremendously large sets of information which involve specific computational tools to enable their examination and exploitation. These data might come from electronic health records from millions of patients, genomics, social media, clinical trials or impulsive adverse reaction reports, to name just a few. The massive volume of data has the potential to contribute suggestively to the way the assistances and risks of medicines are evaluated over their entire lifecycle.

Together with the heads of the national competent authorities in the European Economic Area (EEA), known as Heads of Medicines Agencies (HMA), the European Medicines Agency (EMA) has established a new task force to explore how medicines regulators in the EEA can use big data to provision research, innovation and robust medicines development in order to benefit human and animal health.

The task force, chaired by the Danish Medicines Agency and EMA, is composed of experienced staff from medicines regulatory agencies in the EEA. Their efforts will be complemented on an ad hoc basis by external experts in big data collection analysis.

The group has agreed a number of actions for the next 18 months. These include:

  • planning foundations and features of big data;
  • exploring the potential applicability and influence of big data on medicines regulation and emerging endorsements on necessary changes to regulation, regulatory guidelines or data security requirements;
  • formation of a roadmap for the growth of big data aptitudes for the assessment of applications for marketing authorizations or clinical trials in the national proficient specialists;
  • Teamwork with other regulatory authorities and partners outside the EEA to consider their understandings on big data enterprises.

Dated: 23rd March 2017

http://www.ema.europa.eu/ema/index.jsp?curl=pages/news_and_events/news/2017/03/news_detail_002718.jsp&mid=WC0b01ac058004d5c1

Quality Payments: Calculate your SCR usage

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NHS Digital has circulated the Summary Care Record (SCR) usage calculator tool to support community pharmacy contractors in checking and aggregate their SCR usage.

The Quality Payments scheme, which measures each appropriate pharmacy against quality standards and awards points for each one fulfilled will be a key factor in incapacitating the pharmacy cuts.

Use of the Summary Care Record accounts for 10% of Quality Payments points over the year, meaning it could be worth up to £1,280 per pharmacy.

According to NHS England’s quality criteria regulation, pharmacists will need to meet the SCR quality criterion, which entails contractors to be able to validate on the day of the review, a total increase in access to SCR from period one to two.

For the 28 April 2017 review point, period one is from Monday 27 June 2016 to Sunday 27th November 2016; and period two is from Monday 28 November 2016 to Sunday 30 April 2017.

The calculator will show the number of times a pharmacy has viewed the SCR in period 1 and period 2. And will be updated every Thursday to show the latest figures.

Dated: 10th March 2017

http://www.thepharmacist.co.uk/news/latest-news/quality-payments-calculate-your-scr-usage/

 

European and US regulators agree on mutual acknowledgment of inspections of medicines manufacturers

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Officials in the European Union (EU) and the United States (US) have decided to start assessments of manufacturing sites for human medicines directed in their particular areas on both sides of the Atlantic.

The contract will enable both the EU authorities and the FDA to make better use of their assessment funds to help them to concentrate on other parts of the world where active pharmaceutical ingredients (APIs) and medicines for the EU or US markets are manufactured. This will ensure that patients can rely on the quality, safety and efficacy of all medicines, no matter where they have been produced. Around 40% of finished medicines marketed in the EU come from overseas and 80% of the manufacturers of APIs for medicines available in the EU are located outside the Union.

Each year, national proficient authorities from the EU and the US Food and Drug Administration (FDA) inspect many production sites of medicinal products in the EU, the US and elsewhere in the world, to certify that these sites operate in compliance with good manufacturing practice (GMP). Under the new agreement, EU and US regulators will rely on each other’s assessments in their own areas. In future, the need for an EU authority to inspect a site located in the US, or vice versa, will be partial to remarkable conditions.

In the EU, inspections of manufacturing sites are carried out by national proficient authorities from EU Member States. The European Medicines Agency plays an important role in directing these activities in association with Member States.

The contract is reinforced by strong evidence on both sides of the Atlantic that the EU and the US have comparable regulatory and procedural frameworks for inspections of manufacturers of human medicines. Teams from the European Commission, EU national competent authorities, EMA and the US FDA have been auditing and evaluating the respective managerial systems since May 2014, and have worked closely together to reach this agreement.

The agreement is an extension to the EU-US MRA which was signed in 1998 but is not yet executed. Many provisions of the agreement have already entered into force and others will enter into force on November 1, 2017. By that date, the EU will have completed its valuation of the FDA and the FDA is likely to have accomplished its valuation of at least eight EU Member States, and will be progressively prolonged to all Member States.

Dated:2nd March 2017