Group items tagged

The General Pharmaceutical Council (GPhC) today decided to convene a new group, involving all the key stakeholders, focused on assurance of practice post-registration. The decision in today's (9 December) council meeting follows the recommendation of a working group chaired by council member and pharmacist Aamer Safdar on the role of the regulator in post-registration education and training. The new group will be tasked with articulating a set of guiding principles where patient safety is the overarching priority, after carrying out a horizon scanning exercise to pull together an understanding of the system wide approach currently in place. The working group noted that the wider approach, in relation to regulation of post-registration practice and not simply education and training, may require the GPhC reviewing and developing its own control measures, and involving patients and the public in the next stages of work. Reviewing the work on online pharmacy services, the council meeting supported the regulator's plans to continue to require pharmacy websites to be arranged so that a person cannot choose a prescription only medicine and its quantity before there has been an appropriate consultation with a prescriber.

Sun Pharma has announced that it will acquire all outstanding shares of Concert Pharmaceuticals through a tender offer for an upfront payment of $8.00 per share of common stock in cash, or $576 million in equity value. The upfront payment of $8.00 per share of common stock in cash represents a premium of approximately 33% to Concert's 30-day volume weighted average price as of January 18, 2023, the last trading day prior to today's announcement. Concert is a late-stage biotechnology company pioneering the use of deuterium in medicinal chemistry. Concert has an extensive patent portfolio, including its lead product candidate deuruxolitinib - an oral inhibitor of Janus kinases JAK1 and JAK2 for the treatment of Alopecia Areata, an autoimmune dermatological disease - which is in late-stage development. It has completed the evaluation of the efficacy and safety of deuruxolitinib in adult patients with moderate to severe Alopecia Areata in its THRIVE-AA Phase 3 clinical program and two open label, long-term extension studies are ongoing in North America and Europe. Sun Pharma's immediate focus would be to follow Concert's plan to submit a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) in the first half of 2023.

The Pharmacy Supervision Practice Group consisting of members from AIMp, APTUK, CCA, NPA, PDA, PFNI and RPS held its fourth workshop to continue discussions on the future modelling of pharmacy practice. The ideas around 'supervision' shared by the organisation earlier formed the basis of the discussion during the workshop and helped to expand understanding of where there was consensus and disagreement. Examples of ideas explored during the workshop include: the extent to which a pharmacist should supervise the medicines assembly process, the purpose and extent to which a pharmacist might be absent from the pharmacy and how this might affect patient safety as well as the nature of whether fixed rules versus a broad framework were preferable for future practice. Chair of the group, Dr Michael Twigg, Associate Professor of Primary Care Pharmacy, University of East Anglia, said "Once again the sector bodies have come together in a collaborative and positive manner to explore the concept of 'supervision' in the context of current and future community pharmacy practice. This session provided an opportunity to constructively challenge assumptions and viewpoints within the group with the aim of moving the discussion forward." As part of the session, the DHSC, GPhC and PSNI gave an overview of the difference between legislation, regulation and guidance which was helpful to inform the group's thinking. Each of the organisations have been asked to use the conversation to refine the ideas presented in advance of the next workshop.

The Medicines and Healthcare products Regulatory Agency (MHRA) has recalled Labetalol 200mg tablets (Tillomed Laboratories Ltd) directed to pharmacies and wholesalers. Manufacturer, Tillomed Laboratories is recalling one batch of Labetalol 200mg tablets due to an error on the foil blister packaging. The incorrect aluminium foil blister packaging states Labetalol 100mg tablets, however it should be labelled as Labetalol 200mg Tablets. This error has occurred at the primary packing operation. Tillomed Laboratories Limited has confirmed the actual tablet contained in the blister is Labetalol 200mg Tablets, which is the strength stated on the outer carton. This error is limited to the packaging of the batch with 100mg aluminium foil blister and does not impact the lot (batch) number or expiry as printed on the outer carton and aluminium foil blister. Healthcare professionals has been advised to stop supplying the batches immediately. Quarantine all remaining stock and return it to supplier using supplier's approved process.

Errors of any kind in medical settings can have dire consequences for patients and healthcare systems. Unfortunately, negligence, misdiagnosis, and medication errors aren't uncommon in the UK. In this article, we discuss the nature of medication errors in the NHS, outline potential causes, and delve into how and why technology could be turning the tide on the issue. Prevalence and consequences of medication errors Medication errors are incidents involved with the administering, prescribing, dispensing or monitoring of medicine to patients. It can happen at many different steps in the healthcare process and by any medical professional in the system. Many cases are avoidable. According to analysis from BMJ, there are an estimated 237 million medication errors made in England every year. The majority of these are minor errors, but 1 in 4 cases has the potential to cause moderate to serious harm to patients. Not only do these errors cost the NHS significantly, at almost £100 million every year, but there is a shocking cost to public health. Lives are being lost because of medication errors which is unforgivable and tragic for the families involved. Drains on NHS resources have widespread impacts on public health and the operations of healthcare organisations up and down the country. Individual errors and mistakes may seem inconsequential (in minor cases), but they all add up in the big picture to a significant concern for policymakers.

The Medicines and Healthcare products Regulatory Agency (MHRA) has cautioned people to stop using certain eye gels, highlighting a potential risk of microbial contamination that can cause an infection. As a precaution, the agency on Friday announced recall of specific batches of carbomer-containing lubricating eye gels branded Aacarb, Aacomer and Puroptics, which are generally used to relieve the symptoms of dry eye. Burkholderia cenocepacia is suspected to have caused the microbial contamination, and the issue was raised after an ongoing investigation conducted by UK Health Security Agency (UKHSA) identified a small number of cases of infection. Investigations are on to determine if there is a link between these products and the infections which have been identified. Meanwhile, retailers have been told to withdraw the affected products, and users are asked to return their product to the place of purchase immediately.