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Thorrun Govind, a former chair of the English Pharmacy Board of the Royal Pharmaceutical Society, has joined Brabners' regulatory & professional conduct team. With nearly a decade of experience as a GPhC-registered pharmacist, Govind will provide guidance on regulatory and professional conduct issues. Govind's expertise extends to healthcare advisory and disputes involving NHS Trusts and social care organisations. She has been recognised as the 'Young Pharmacist of the Year' by Pharmacy Business Magazine and is a frequent commentator on public health and healthcare law for major television networks. Her appointment underscores Brabners' commitment to offering top-tier legal services to the healthcare industry.

Global logistics company, JAS has received the Wholesale Distribution Authorisation (WDA(H)) license from the UK's Medicine and Healthcare Products Regulatory Agency (MHRA) for its Pharma and Healthcare Division. In a press release issued on Thursday (22 February), the company said that securing the license empowers its UK healthcare division to "seamlessly connect" with its more than 40 GDP (Good Distribution Practice) certified overseas stations, strengthening its capabilities for handling pharmaceutical shipments. Headquartered in Atlanta, Georgia, USA, the company boasts a team of over 7,000 professionals, with operations spanning over 100 countries. Adrian Frodsham, Regional Director for JAS, said that they were granted the WDA(H) license after a "stringent audit process." "JAS UK's pharma and healthcare division prides itself of offering innovative solutions for the international delivery of pharmaceutical products, further enhancing the growth of our pre-established healthcare division," he added.

Following concerns raised about cracked cartridges and insulin leaks, the Medicines and Healthcare products Regulatory Agency (MHRA) has issued a national patient safety alert for the NovoRapid PumpCart prefilled insulin cartridge and the Roche Accu-Chek Insight Insulin pump system. The regulator have asked patients to check the pre-filled glass insulin cartridge for cracks before use. It advised against using the cartridge if it has been dropped even if no cracks are visible and urged to closely follow the updated handling instructions in the pump user manual when changing pre-filled glass insulin cartridges. In some of the reported leakage incidents, the cartridges were found to be cracked and provided an inadequate supply of insulin to patients. Leakages also occurred in cases where no cracks in the cartridge were visible, the regulator said. In some patients there were consequences of not receiving enough insulin from their pump system, including reports of severely high blood sugar and diabetic ketoacidosis, a serious complication of diabetes when the body produces high levels of blood acids called ketones. Healthcare professionals are being advised to contact patients over the next six months using said device to discuss their individual needs and source an alternative pump where appropriate. "Because of the rare risk of insulin leakage from the Roche Accu-Chek Insight Insulin Pump, patients should check the pre-filled glass insulin cartridge for any cracks prior to usage," Dr June Raine, MHRA chief executive, said.

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 General Pharmaceutical Council (GPhC) has urged health and care professionals to meet relevant regulatory standards amidst the shortage of GLP-1 receptor agonists (GLP-1 RAs). The council said: "We are concerned to hear that people with Type 2 diabetes are experiencing problems accessing GLP-1 receptor agonists (GLP-1 RAs). We know that these are being widely prescribed for weight loss purposes and in some cases prescribed off-label." "We recognise the adverse impact that shortages and supply chain issues can have on patients, the public and wider health and care teams. The Council understands that health and care professionals are using their professional judgement and making decisions in challenging situations, balancing a range of factors such as individual patient needs, wider public health and pressures and limitations on available resources such as medicines shortages or other supply chain issues.

The World Health Organization (WHO) issued a warning on Thursday regarding falsified semaglutide medications used for treating type 2 diabetes and obesity in select countries. This WHO Medical Product Alert addresses three falsified batches of the specific brand Ozempic that were detected in Brazil (October 2023), the United Kingdom and Northern Ireland (October 2023), and the United States (December 2023). These falsified semaglutide products were distributed through the regulated supply chain. Novo Nordisk, the genuine manufacturer of Ozempic, confirmed that the three products mentioned in the alert are falsified and were not produced by the company. Healthcare professionals, regulatory authorities and the public are advised to remain vigilant regarding these falsified batches of medicines. Dr Yukiko Nakatani, WHO Assistant Director-General for Access to Medicines and Health Products, urged stakeholders to stop any usage of suspicious medicines and report them to relevant authorities.

The Medicines and Healthcare products Regulatory Agency (MHRA) has issued a class 2 medicines recall for Sabril 500 mg film-coated tablets & Sabril 500 mg granules for oral solution. Sanofi UK has recalled the batches of Sabril tablets and Sabril granules as a precautionary measure due to the detection of traces of tiapride in the batches of the source material of the manufacturer for vigabatrin. Sabril (vigabatrin) is indicated for adjunctive treatment of focal seizures with or without secondary generalisation not satisfactorily controlled with other antiepileptics (under expert supervision) and monotherapy in the treatment of infantile spasms (West's syndrome). All patients are advised not to discontinue Sabril tablets or Sabril granules without consulting with their prescriber. The risks of suddenly stopping medication for seizures/epilepsy is higher than the potential risk presented by the presence of tiapride. Sanofi UK have confirmed to DHSC that no other batches are impacted, and other stock remains available.

The Medicines & Healthcare products Regulatory Agency has initiated a recall of three batches of Quantum Pharmaceutical's Diltiazem HCl 2% Cream, which is an unlicensed medicine. MHRA issued a precautionary recall of the cream due to a change in the product's appearance that affected its thickness. Pharmacists are instructed to halt supply, quarantine remaining stock, and contact Quantum Pharmaceutical to return affected batches M1402497, M1402574, and M1402680. Patients using this product may encounter application issues with the cream due to its consistency. However, MHRA said that this has not impacted the product's effectiveness or posed any risk to patient safety. The MHRA also reported that medac GmbH (t/a medac Pharma LLP) is conducting a recall of two batches of Sodiofolin 50 mg/ml solution for injection/infusion (400mg/8ml vial) with batch numbers G220393B and G220393C. This class 2 medicines recall is a result of particles detected during long-term stability tests.

Online pharmacies have to operate from bricks & mortar premises that are registered with the General Pharmaceutical Council, but recent cases show that, in reality, the practices of online pharmacies are often very different to other pharmacies, and the regulation of online pharmacies is also different - and evolving as issues arise. For a start, the General Pharmaceutical Council (GPhC) is only one of the regulators taking an interest in online pharmacy services. Other regulators include the Medicines and Healthcare products Regulatory Agency (MHRA) which enforces the advertising and promotion of medicines, and the Care Quality Commission (CQC) which regulates prescribing services. The different regulation of online pharmacies is attributable to the higher risk to patients and the public from medicines bought online. These risks often arise from a combination of patients who do not tell the truth in order to obtain medicines and the nature of a transaction in which a pharmacist does not see patients face-to-face. "The GPhC has strong enforcement powers that it uses when it considers its premises standards have not complied with." However, there are also things that go wrong because pharmacists have simply failed to act professionally or take sufficient care, as well as cases where things have gone wrong through misfortune.

The General Pharmaceutical Council reiterated its stand on Covid-19 vaccination, saying, "Pharmacists and pharmacy technicians working in all settings across Great Britain should be vaccinated against Covid -19, unless they are medically exempt." In a statement issued today (February 11), it strongly urged all pharmacyprofessionals, students and trainees to get fully vaccinated at the earliest. This reiteration follows the government's announcement on January 31, 2022 that it would not proceed with Covid vaccination as a mandatory condition of deployment for health and care staff providing CQC-regulated services in England. The Council stated that clinical trials have proven the efficacy and safety of Covid vaccines and the Medicines and Healthcare products Regulatory Agency (MHRA) has authorised their use in the UK.

The International Pharmaceutical Federation (FIP) has issued a new policy statement which encourages a "life-course" approach to vaccination by pharmacists. In the statement, published on September 27, FIP backed expansion of vaccine schedules and strategies so that patients of all age groups could be vaccinated throughout their entire lifespan, from infancy to old age. A life-course approach in public health and healthcare focuses on an individual's health and well-being, including vaccination, administered throughout their entire lifespan, from infancy to old age. FIP urged governments and policymakers to eliminate regulatory barriers, enabling pharmacists to prescribe and administer all relevant vaccines throughout the life-course. Additionally, FIP recommended that policymakers develop remuneration models for pharmacies to deliver sustainable life-course vaccination services within the private and public sectors.

The Medicines and Healthcare products Regulatory Agency (MHRA) and the Committees of Advertising Practice (CAP) have issued a joint enforcement notice about the 'illegal' advertising of Kenalog injections on digital platforms. The notice warns all organisations offering Kenalog as a 'hay fever treatment' to stop advertising it in any of their social media or website advertising. "Kenalog is a prescription-only medicine (POM), which must not be directly or indirectly advertised to the public. Kenalog is not licensed for the treatment of hay fever in the UK, although it is offered by some beauty and aesthetics clinics, under the personal responsibility of an individual prescriber, and advertised widely on social media," said MHRA. "Now, advertisers must ensure that all references to Kenalog in the text, images or emojis on social media are removed, as well as commonly-used descriptive phrases for the jab such as 'hay fever injection' or hay fever jab' or any account names, testimonials or memes by 29 August 2022." After this date, the CAP's compliance team will remove non-compliant ads using targeted software and those who continue to promote it may be referred to the MHRA for further enforcement action.

The Medicines and Healthcare products Regulatory Agency (MHRA) has reclassified codeine linctus, a medicine used for the treatment of dry cough, from a pharmacy-only medicine (P) to a prescription-only medicine (POM) owing to the risk of dependence, addiction, and overdose. This implies that the dry cough syrup, which is also known as codeine oral solution, can only be dispensed upon the submission of a prescription at a pharmacy, rather than being accessible over the counter upon request. Patients are cautioned that as an opioid medicine, codeine can be addictive, and the risk of addiction may increase, particularly with prolonged use over an extended period. According to the medicines regulator, codeine is converted into morphine by the liver enzyme CYP2D6. In individuals identified as ultra-rapid metabolizers, this conversion from codeine to morphine occurs at a faster rate than in others. "If you want to stop taking it and have been taking codeine linctus for a long time, then it is important to reduce the amount you take slowly with the help of your prescriber," the agency said in its drug safety update issued on Tuesday, 20 February.

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) has asked the pharmacies and wholesalers to stop supplying and quarantine all remaining stock of Dr Reddy's Laboratories (UK)'s Lacidipine 4 mg Film-Coated tablets. The company has recalled two batches of Lacidipine 4 mg Film-Coated tablets as a precautionary measure due to the presence of an unknown solvent-like odour. MHRA said: "The tablets are normally odourless. However, in the affected batches, a solvent-like odour is present when the individual blisters are opened. Additionally, some patient complaints have noted that the tablets have an unusual taste. The investigation to determine the root cause and to identify and quantify the odour is ongoing. "The issue is confined to batches B2202043 and B2202044 only. Other batches of Lacidipine 4 mg Film-Coated tablets marketed by Dr Reddy's Laboratories (UK) are not affected."

A diabetes medicine, Mounjaro, has been approved by the Medicines and Healthcare Products Regulatory Agency (MHRA) to treat overweight patients. The weight loss medication originally developed for Type 2 diabetes is now accessible to individuals aged 18 and over who are dealing with obesity and weight-related health issues. The active ingredient, tirzepatide, works by making the patient feel fuller and reducing food cravings. The injection helps individuals lose 20 per cent of their body weight, and are advised to follow a reduced-calorie diet and increase physical activity simultaneously. Although it is not authorised to use on the NHS as yet but future approvals can be predicted.

The Medicines and Healthcare products Regulatory Agency (MHRA) has launched new guidance to highlight the latest safety advice on the steps to take during anaphylaxis. On the start of World Allergy Week (19 June), an annual initiative led by the World Allergy Organization, aiming to raise awareness of allergies, their management and prevention, the MHRA has collaborated with allergy awareness advocates to share an easy step-by-step infographic guide and video outlining the latest advice from the CHM's working group on the safe and effective use of AAIs. Steve Barclay, Secretary of State for Health and Social Care said: "A severe allergic reaction can be life-threatening. One in five people in the UK suffer with at least one allergy, so it's vital people are equipped with the knowledge to keep themselves safe. Adrenaline auto-injectors - also known as AAIs or by their brand names such as EpiPen - are highly effective and convenient for the immediate treatment of anaphylaxis. If you have been prescribed one, please carry it with you at all times and make sure you are up to date on the latest safety guidance - it could save your life."