Medicines and Healthcare products Regulatory Agency (MHRA) has urged the healthcare professionals to share their views on the consultation on 'how MHRA
communicate with healthcare professionals to improve medicines and medical devices' safety'.
Through this consultation the agency wants to review its approach to engagement with healthcare professionals to improve the safety of medicines and medical devices.
"We want to ensure that healthcare professionals are receiving actionable information and guidance on safe use of medicines and medical devices that they can take
into their working practice, providing timely advice to patients," said MHRA.
"We need to improve the way we communicate with healthcare professionals. We want to hear from you to enable us to transform how we communicate with you and how we
work together on our common goal of greater patient safety."
The Medicines and Healthcare products Regulatory Agency (MHRA) has appointed Dekra to certify medical devices in the UK.
Dekra Certification UK has joined the three current UK approved bodies, increasing the UK's capacity to process conformity assessments for medical devices to ensure
safe and effective devices reach the UK public.
An approved body is an organisation that has been designated by the MHRA to assess whether manufacturers and their medical devices meet the requirements set out in
the UK Medical Devices Regulations 2002.
Following an appropriate assessment, the new approved body will issue relevant certification allowing manufacturers to place a UKCA marking on their products before
putting them on the market.
Dr Laura Squire, chief healthcare quality and access officer at the MHRA, said: "This is a major milestone in our mission to ensure patients across the UK have access
to the high-quality medical devices they need to protect their health.
The Medicines and Healthcare products Regulatory Agency (MHRA) has been accepted as a full member of three international work-sharing partnerships.
Through these partnerships the agency said it will play vital international role in making sure medicines and medical devices are regulated safely and efficiently
worldwide,
Two of these, the International Medical Device Regulatory Forum (IMDRF) and the International Council for Harmonisation of Technical Requirements for Pharmaceuticals
for Human Use (ICH) are focused on improving the harmonisation and convergence of medicines and medical devices regulation globally.
The partnerships will also help the MHRA to share expertise with other leading organisations, support the development of regulatory guidelines and drive greater
harmonisation of regulation around the world. This will help deliver timely access to innovative medical products not just in the UK but globally.
People are advised to be mindful of medications that may cause sun reactions, and to watch out for dodgy hay fever treatments and fake weight loss pens.
For those traveling abroad, the MHRA advises considering the suitability of medicines available to reduce the risk of contracting tropical diseases.
Dr Alison Cave, Chief Safety Officer at the MHRA, said: "The summer is an exciting time for many of us, as we take time off to travel and enjoy the warmer weather.
"But it is important to understand what this time of year means for our medicines and medical devices, and take the precautions necessary to use products safely
and protect ourselves."
Watch out for dodgy hay fever treatments
Millions of Britons suffer from hay fever symptoms in the summer. The MHRA advises consulting a healthcare professional to find the best treatment for your symptoms.
People are also warned to be cautious of medicines advertised as hay fever treatments but not approved for use in the UK, such as Kenalog. This is a
prescription-only steroid injection licensed as a medicine for other conditions, but not for the treatment of hay fever.
The Medicines and Healthcare products Regulatory (MHRA) and Genomics England to launch a brand-new genetic research resource, known as a 'biobank' on Thursday
(June 01) to tackle the issue of Adverse Drug Reactions (ADRs).
Biobank will help to better understand how a patient's genetic makeup can impact the safety of their medicines.
"The Yellow Card biobank, which will contain genetic data and patient samples, will operate alongside the MHRA's Yellow Card reporting site for suspected side
effects and adverse incidents involving medicines and medical devices," said MHRA.
The biobank pilot will officially begin on 1 June 2023 with participant recruitment commencing later this year, on 1 September. The sequencing of participants'
genetic material will begin in Spring 2024, with initial research findings from the pilot due to be published in 2025. Genomics England will be supporting the
MHRA with sequencing and storage of genetic material through use of their well-established and secure infrastructure.
The Medicines and Healthcare products Regulatory Agency (MHRA) is doubling down on its efforts to combat online pharmacy frauds, emphasising innovation,
eradication of legacy systems, and cybersecurity in its updated technology roadmap.
The online sale of medicines and medical devices is a "growing phenomenon offering convenience, anonymity, and lower prices " for the public.
However the lack of robust cyber monitoring also "poses significant risks", as many online pharmacies are "unregulated, illegal, or fraudulent."
According to the MHRA's recent report highlighting the impact of artificial intelligence on the regulation of medical products, the strategic themes
of "fundamental to the successful deployment of AI" are essential for protecting consumers from fraudulent medical products.
Reacting to recommendations from a UK-first independent review, the Department of Health and Social Care (DHSC) has outlined action to tackle potential
bias in the design and use of medical devices.
Professor Dame Margaret Whitehead, professor of public health at the University of Liverpool, was appointed to lead the review, which focused on three
areas - optical devices such as pulse oximeters, AI-enabled devices, and polygenic risk scores (PRS) in genomics.
The DHSC commissioned the medical devices review after concerns were raised that pulse oximeters - widely used during the COVID-19 pandemic to monitor blood
oxygen levels - were not as accurate for patients with darker skin tones. There were worries that this could cause delays in treatment if dangerously low oxygen
levels in such patients were missed.
However, no evidence was found from NHS studies indicating that this differing performance had an impact on patient care.
Accepting the report's conclusions, the DHSC has committed to several actions, such as ensuring the safe use of pulse oximeter devices across a range of skin
tones within the NHS and eliminating racial bias from data sets employed in clinical studies.
Proprietary Association of Great Britain, PAGB - which represents manufacturers of branded over-the-counter (OTC) medicines, self-care medical devices
and food supplements - on Tuesday (12 December) celebrated 40 years of reclassification of medicines.
Expanding self-care for common ailments and minor injuries will not only help ease pressure on primary care services, but also provides significant potential
savings for the NHS, the consumer healthcare association highlighted during the event.
Nurofen (ibuprofen) and Imodium (loperamide) were the first medicines to go through Medicines and Healthcare products Regulatory Agency (MHRA)'s switch process
in 1983 to make them available over the counter - OTC.
Other reclassified medicines which were once available on prescription only include Voltarol (diclofenac dimethylammonium), Canesten (clotrimazole), Nexium
(esomeprazole), Nicorette, Nicotinell and Niquitin (nicotine replacement therapies), Regaine (minoxidil), Viagra Connect (sildenafil), Cialis Together
(tadalafil) for erectile dysfunction and Gina (estradiol hemihydrate) for the treatment of postmenopausal symptoms such as vaginal dryness.