- Skin preparation electrode gel: recall of all lots of LemonPrep, PediaPrep, Wave Prep and Cardio Prep due to risk of contamination and transmission of infection.
- Company led drug alert: Iohexol solution for injection (350mg/ml and 300 mgI/ml)
- Class 2 Medicines recall: Medreich PLC, Ranitidine 150mg and 300mg Tablets.
- t:slim X2 insulin pump: discard or destroy defective mains (A/C) power adapters.
- Appeal panel rules that NICE needs to request evidence for erenumab effectiveness in subgroup of people with chronic migraine.
- FreeStyle Libre Supply further update.
- College calls for action due to ongoing shortages of HRT and contraceptives.
- PHE reaches crucial step in fully sequencing novel coronavirus.
- EMA supports development of vaccines and treatments for novel coronavirus.
MEDICINES AND HEALTHCARE PRODUCTS REGULATORY AGENCY
SKIN PREPARATION ELECTRODE GEL: RECALL OF ALL LOTS OF LEMONPREP, PEDIAPREP, WAVE PREP AND CARDIO PREP DUE TO RISK OF CONTAMINATION AND TRANSMISSION OF INFECTION
The manufacturer – Mavidon - has identified an issue at their manufacturing facility which means products are potentially contaminated with Burkholderia cepacia, a drug-resistant microorganism. They are now recalling all products made at this site that use the affected production method.
COMPANY LED DRUG ALERT – IOHEXOL SOLUTION FOR INJECTION (350MG/ML AND 300 MGI/ML)
As a precautionary measure, Glenmark Pharmaceuticals is recalling specific batches of Iohexol solution for injection (350mg/ml and 300 mgI/ml) due to an out of specification result from the ongoing stability studies. The out of specification result for all batches of Iohexol distributed in United Kingdom are up to 4% over the upper specifications limits for content.
CLASS 2 MEDICINES RECALL: MEDREICH PLC, RANITIDINE 150MG AND 300MG TABLETS
Medreich Plc is recalling all unexpired stock of Rantidine 150mg and 300mg tablets from pharmacies and wholesalers as a precautionary measure due to possible contamination with an impurity N-nitrosodimethylamine (NDMA) which has genotoxic and carcinogenic potential.
A full list of the batches affected are available in the attachment here.
T:SLIM X2 INSULIN PUMP – DISCARD OR DESTROY DEFECTIVE MAINS (A/C) POWER ADAPTERS
A potential safety issue has been identified with the A/C power adapter that was originally supplied along with the t:slim X2 insulin pump. This issue involves the A/C power adapter breaking apart, thus exposing the metal prongs contained within the adapter, which could cause injury if the exposed metal prongs were touched when the adapter was plugged into an electrical wall outlet. The manufacturer has recommended discarding or destroying defective mains power adapters.
NATIONAL INSTITUTE FOR HEALTH AND CARE EXCELLENCE
APPEAL PANEL RULES THAT NICE NEEDS TO REQUEST EVIDENCE FOR ERENUMAB EFFECTIVENESS IN SUBGROUP OF PEOPLE WITH CHRONIC MIGRAINE
NICE has published the outcome of the appeal against its final draft guidance on erenumab (Aimovig) for preventing chronic migraine.
The independent appeal panel upheld one appeal point: the committee unreasonably failed to consider the cost-effectiveness of erenumab versus best supportive care in people with chronic migraine who had failed to benefit from the comparator drug (botulinum toxin) or when it is contra-indicated.
The appraisal committee has now been asked to request any available data to enable it to consider the role of erenumab when it is used at this point in the treatment pathway.
Whether in the light of such data (if any) the recommendation should be amended will be a matter for the committee to decide at a later date.
PHARMACEUTICAL SERVICES NEGOTIATING COMMITTEE
FREESTYLE LIBRE SUPPLY FURTHER UPDATE
The Pharmaceutical Services Negotiating Committee has reported that Abbott has advised they are currently experiencing some temporary supply problems with FreeStyle Libre sensors. Community pharmacy teams unable to obtain supplies of the sensors are advised to refer any affected patients back to their prescriber for consideration of alternative monitoring methods in the interim period.
ROYAL COLLEGE OF OBSTETRICIANS AND GYNAECOLOGISTS
COLLEGE CALLS FOR ACTION DUE TO ONGOING SHORTAGES OF HRT AND CONTRACEPTIVES
The Royal College of Obstetricians and Gynaecologists (RCOG) has announced it has joined forces with the British Menopause Society and the Faculty of Sexual and Reproductive Healthcare following ongoing manufacturing and supply issues with hormone replacement therapy (HRT) and most recently, contraceptives.
They have written to the secretary of state for health and social care, Matt Hancock, calling for a working group to be set up to address ongoing supply constraints.
As well as this affecting the physical and mental wellbeing of women and girls, RCOG are concerned this situation may lead to a rise in unplanned pregnancies and abortions, whilst inadvertently affecting the most vulnerable in our society.
PUBLIC HEALTH ENGLAND
PHE REACHES CRUCIAL STEP IN FULLY SEQUENCING NOVEL CORONAVIRUS
Scientists at Public Health England (PHE) has fully sequenced the novel coronavirus (2019-nCoV) viral genome. As one of the first countries outside China to have testing capability for the novel coronavirus, PHE has since developed further specific tests in partnership with the World Health Organisation (WHO) and a global network of laboratories.
The publication of the sequence by PHE provides information on any mutations in the virus over time and allows an improved understanding of how the virus spreads.
The new sequencing in the UK cases illustrates that so far the virus has not evolved to better infect humans since the sequence was first published by China.
EUROPEAN MEDICINES AGENCY
EMA SUPPORTS DEVELOPMENT OF VACCINES AND TREATMENTS FOR NOVEL CORONAVIRUS
To contribute to the global response to the outbreak of the novel coronavirus (2019-nCoV) infections, the European Medicines Agency (EMA) is taking actions to accelerate the development and availability of medicinal products for the treatment and prevention of the new coronavirus.
The Agency is actively searching for potential antivirals or vaccines to treat or prevent novel coronavirus infections. EMA is also analysing all available information on developers’ drug pipelines.
There are currently no commercially available medicinal products that are authorised to detect, treat or prevent infections with the novel coronavirus. EMA is therefore ready to support medicine developers with all available regulatory tools to advance and expedite the development of effective measures to fight and prevent the spread of this virus.