Group items tagged

The regulators have added 10 new products to the 'Drugs for which Discount is Not Deducted' (DND) list from Thursday (01 June). Community Pharmacy England on behalf of its members had made further applications to the Department of Health and Social Care (DHSC) and the NHS Business Services Authority (NHSBSA), resulting in the inclusion of 10 new products in the DND. More than 610 products are granted DND status following checks made by Community Pharmacy England's dispensing & supply team over the past 3 years to ensure fair reimbursement for our members. The DND list is updated monthly by the DHSC and includes grouped and individual items. Individual items are separately listed in Part II of the Drug Tariff. Any items covered by the 'Group Items' heading are not listed again individually in Part II. "We will continue our work to assess whether other drugs and appliances fulfil the current DND entry requirements under either the 'Group' and 'Individual item' criteria and make applications to NHSBSA and DHSC, on behalf of our members accordingly," said Community Pharmacy England.

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.

To curb the supply issue of HRT medicine, the government has taken a further action by issuing SSPs for Oestrogel, Ovestin cream, Lenzetto transdermal spray and Sandrena gel sachets - with appropriate alternatives. The move aims to allow community pharmacists to supply specified alternatives to the prescribed HRT products without needing to seek authorisation from the clinician who has prescribed the medicine. The regulator said that the availability of Premique Low Dose has impoved 'thanks to SSPs issued on 29 April to restrict dispensing for Oestrogel, Ovestin and Premique Low Dose to three months' supply'. "Since these measures were implemented, further deliveries of all three products have been made, with Premique Low Dose returning to good availability this week. The manufacturers of Oestrogel and Ovestin, as well as suppliers of alternative HRT products, are taking action to increase UK supply." It added, "SSPs restricting prescriptions to a maximum of three months' supply will also be issued for substitute products, as a precautionary measure to ensure the supply of those substitutes is maintained."

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.

To help the pharmacists understand the Serious Shortage Protocols (SSPs) for three Hormone Replacement Therapy (HRT) products that was recently announced by the Department of Health and Social Care (DHSC)'s, the Pharmaceutical Services Negotiating Committee has shared top tips on the correct SSP endorsement and submission requirements. Top Tips by PSNC for pharmacists on HRT SSPs: Always double check that endorsements reflect the requirements outlined in the supporting guidance published for each SSP on the dedicated page of the NHSBSA's website. When endorsing using EPS, contractors are reminded to select the SSP endorsement and input the correct three-digit reference number leaving a space in between 'SSP' and the three-digit reference number for example, SSP 019. Remember to insert the leading zero in the three digit reference number. Each of the affected HRT medicines has its own SSP reference number. Check that the correct SSP number is endorsed for e.g. for Oestrogel® Pump-Pack 0.06% gel the SSP endorsement should be 'SSP 019'. Please note the 'NCSO' endorsement is no longer accepted for SSPs. Endorse the SSP product dispensed including the quantity. Ensure your endorsements are accurate and clear - NHSBSA processing staff must be able to determine what has been supplied. Contractors should note that SSP claims submitted using EPS tokens are no longer permitted.

HayMax, maker of the famous organic drug-free allergen barrier balm has been awarded the 'British Made Award' for Best British Allergy Product 2022. The award celebrates businesses that work tirelessly to make their region one of the most diverse and dynamic the UK has to offer. HayMax MD and creator Max Wiseberg comments: "This award means a great deal to us. We've always been proud that our products have been manufactured in the UK. We are passionate about reducing the cost to the environment so being British-made means we keep the miles down and reduce our carbon footprint." HayMax balms are manufactured in the UK. It buys local to reduce the cost to the environment, even if it means it costs a bit more. HayMax's current pots are now made in the UK, which has been great for reducing their carbon footprint. Its tins come from London. The new pots can be recycled and re-used. The brand has now switched to using sugar cane to make its pots and has also reduced the amount of material used in the pots by just over 54%. And they have switched from the plastic labels to paper labels.

Nine more new products have been classed as 'Drugs for which Discount is Not Deducted' (DND) from 1 July 2022, announced Department of Health and Social Care (DHSC). This takes the total number of products granted DND status over the past 2 years to over 500 following checks made by the Pharmaceutical Services Negotiating Committee. The Committee had made an application to DHSC and NHSBSA for the following 9 products to be added to the DND list of Individual items to which the discount deduction scale will no longer apply from July 2022: Fludrocortisone 50micrograms/5ml oral suspension (Group) Lorazepam 1mg/5ml oral suspension (Group) Lorazepam 500micrograms/5ml oral suspension (Group) Zopiclone 3.75mg/5ml oral solution (Group) Zopiclone 7.5mg/5ml oral solution (Group) GA explore5 oral powder 12.5g sachets HCU explore5 oral powder 12.5g sachets MSUD explore5 oral powder 12.5g sachets TYR explore5 oral powder 12.5g sachets The DND list is updated monthly by the DHSC and includes grouped and individual items. Individual items are separately listed in Part II of the Drug Tariff.

Health leaders have said that delivering faster and more productive patient care would be difficult unless NHS capital budgets are nearly doubled to at least £14.1 billion from the current spending of £7.7 billion. The NHS Confederation has highlighted the impact that low levels of capital investment have had over the last decade in its report published today (29 November). The report, 'Investing to save: The capital requirement for a more sustainable NHS in England', revealed that the UK has lagged behind other comparable countries in terms of health capital investment for more than five decades, resulting in less productivity. It revealed that the NHS now has the sixth lowest number of CT and MRI scanners per million people of the OECD countries.

The Royal Pharmaceutical Society (RPS) has said that it strongly supports the UK government's proposal that individuals born on or after 1 January 2009 should be prohibited from legally purchasing tobacco products. It has also shown its agreement to several other actions proposed by the Department of Health and Social Care's (DHSC) for 'Creating a Smokefree Generation and Tackling Youth Vaping' including: The inclusion of all tobacco products, cigarette papers, and herbal smoking products in the new legislation. Restrictions on the sale and supply of disposable vapes, and vape flavours. RPS President, Professor Claire Anderson, said: "Our recommendations reflect a commitment to creating a future free from the harms of tobacco and youth vaping. It's crucial to prohibit access for the youngest generation, regulate all tobacco-related items, and address the allure of flavoured e-cigarettes."

Pharmaceutical recalls are complicated and expensive, just like in any other business. Pharmaceutical recalls, however, pose a further risk because they might change both short- and long-term health effects. To ensure smooth recalls with few negative effects on public health, it is crucial to understand the pharmaceutical product recall procedure and the roles of each key player. Throughout the recall procedure, patient safety is crucially ensured by the FDA, pharmaceutical companies, pharmacy technicians, and other healthcare professionals. Learning about pharma recalls, procedures, and responsibilities is essential for guaranteeing patient safety for key actors like the Food and Drug Administration (FDA), manufacturers, and other medical specialists. RECALL CLASSIFICATIONS Recalls can fall into one of three categories-class I, II, or III-with class I being the most serious and lethal. Products that have the potential to result in serious, permanent complications or death are subject to Class I recalls. Class II recalls are recommended for product flaws that have a low likelihood of harmful events or that can result in reversible side effects. Last but not least, class III recalls typically arise from problems with packaging that do not pose a risk. Since they are frequently issued out of an abundance of prudence rather than due to any negative impacts, many people may even describe this kind of recall as benign.

The Medicines and Healthcare products Regulatory Agency (MHRA) has issued a company-led drug recall for Sodium Chloride Eye Drops 5% 1x10ml (unlicensed medicine) Stockport Pharmaceuticals. Stockport Pharmaceuticals said that the above batch of Sodium Chloride Eye Drops 5% w/v as the sterile eye droppers supplied with the medicinal product have expired (Jan 2022). The authority said, "This recall is being issued as a company-led medicines recall, as this product is only supplied to a small number of customers, and the manufacturer has full traceability of the product's distribution." "Remaining stock of the above batch should be quarantined and returned to Stockport Pharmaceuticals directly."

Essential Pharma, an international speciality pharma group, has procured an establishment and manufacturing licences in Switzerland and Malta. Following a successful inspection by Swissmedic, the company has been granted an establishment licence in Switzerland, which will allow the company to significantly enhance its supply chain efficiency for a wide range of important medicinal products. It will apply to transactions for both finished and unfinished pharmaceuticals, allowing importing, exporting, wholesaling and trading abroad. Essential Pharma has also received a manufacturing and importation authorisation (MIA) in Malta, following a successful Good Manufacturing Practice (GMP) inspection by the Malta Medicines Authority. The MIA will allow the company to import medicinal products into the European Union where manufacturing has taken place in a third country. This will allow greater flexibility in how the business manages the flow of medicines across its territories. These approvals strengthen the company's geographical expansion, improve its operational efficiencies, and enhance its offering as a global business partner. They will also provide new strategic opportunities for the company and will play a fundamental role in driving value creation through functional improvements to scale and productivity.

A total of 14 Serious Shortage Protocols (SSP) will expire today (12 May) as the Department of Health and Social Care has confirmed availability of the products to meet normal demand. The products include Sandrena 0.5mg and 1mg gel sachets, Lipitor 10mg chewable tablets, Phenoxymethylpenicillin 125mg/5ml and 250mg/5ml oral solution, sugar free variant of both doses and 250mg tablets, and Paracetamol 120mg and 240mg suppositories. The expiring SSPs include three related to Sandrena gel sachets, one for Lipitor, eight concerning Phenoxymethylpenicillin and two for Paracetamol. These will expire at 23.59pm on Friday 12 May and any prescriptions for these products must be dispensed in accordance with the prescription after that.

The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has recommended approving an oral therapy to treat myelofibrosis patients with moderate to severe anaemia. Myelofibrosis is a rare blood cancer that affects the body's normal production of blood cells, and the affected patients are likely to develop anaemia over the course of the disease. British drugmaker GSK, the manufacturer of the oral therapy known as momelotinib, said that it can be used to treat "both newly diagnosed and previously treated myelofibrosis patients." The medicine helps address disease-related splenomegaly (enlarged spleen) or symptoms in adult patients who are Janus kinase (JAK) inhibitor naïve or have been treated with ruxolitinib, as stated by the company. Nina Mojas, Senior Vice President of Oncology Global Product Strategy at GSK, said that receiving the positive CHMP opinion "is a significant step in bringing momelotinib to patients in the EU with this difficult-to-treat blood cancer."

The Medicines and Healthcare Products Regulatory Agency (MHRA) confirmed that Ozempic has been found at two UK wholesalers on 18 October. The pre-filled falsely labelled pens have been purchased from legitimate suppliers in Austria and Germany. However, there has been no evidence that fake Ozempic has been supplied to UK patients. Dr Alison Cave, MHRA Chief Safety Officer spoke about closely with regulatory partners to ensure patients' safety. He said: "Buying semaglutide from illegally trading online suppliers significantly increases the risk of getting a product either falsified or not licensed for use in the UK. "Products purchased in this way will not meet our strict quality and safety standards, and taking such medicines may put your health at risk," he added.

Drug shortages have become a global issue, with many countries struggling to maintain a consistent supply of common medications, including antidepressants, immunosuppressants and drugs to treat type 2 diabetes and ADHD. Earlier last month, the British Generic Manufacturers Association (BGMA), the trade body for off-patent medicines, warned that 111 products were facing supply problems, the highest on record in the UK, and more than double the number recorded at the start of 2022. More than half of products affected (55) are branded generic drugs, which represent 10 per cent of prescription products used in the UK. The trade body blamed the escalating rebate rate of the government's voluntary scheme for branded medicine pricing and access (VPAS) for these shortages, but Brexit is also cited as another reason for the problem.

The Medicines and Healthcare products Regulatory Agency (MHRA) has launched a public consultation on plans to reclassify a locally-applied hormone replacement therapy product to treat the cause and relieve the symptoms of vaginal atrophy. The MHRA is proposing that Gina 10 microgram vaginal tablets, containing oestradiol, be made available over the counter as a "self care" product, under the supervision of a pharmacist. The Commission on Human Medicines too has advised that the application by Novo Nordisk, which is used to treat vaginal dryness, caused by oestrogen deficiency in postmenopausal women, can be made available as a pharmacy (P) medicine. The MHRA has been asking GPs, pharmacists and members of the public for their opinions on whether the tablets can be made available to women aged 50 and over who have not had a period for at least a year. If the reclassification goes ahead, pharmacists will be given training materials and a checklist to help them supply the medicine safely.

When it comes to supplements, more and more people are starting to become interested in them. This is because supplements have a lot of benefits that can improve a person's health in many ways. However, with the increasing popularity of supplements also comes an increase in the number of low-quality and ineffective supplements on the market. Because of this, it is important for people who are interested in taking supplements to know how to choose quality ones that will be beneficial to their health. In this article, we will discuss some tips on how to do just that. CHOOSE SUPPLEMENTS FROM A REPUTABLE COMPANY Finally, one of the best ways to ensure that you're getting a quality supplement is to choose one from a reputable company. There are many different supplement companies out there, but not all of them are created equal. Some companies are more interested in making money than they are in providing their customers with safe and effective products. Therefore, when you're looking for supplements, it's important to do some research on the different companies that sell them. See if there have been any complaints filed against the company or if their products have been recalled by the FDA. Also, look for customer reviews of the company's products to see what other people have thought about them. As explained by the folks from Supplement First, A good supplement company will have no problem providing you with this information and will be happy to answer any questions you have. Doing some research on the company beforehand can save you a lot of time and money in the long run.