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Europe Sees Surge in Generic Medicines Withdrawals - 0 views

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    Adding to the growing evidence of global medicine shortages, a new study has revealed that the European generic medicines market is "not in shape" to help Europe meet its public health priorities. In the past decade, the rate of generic medicines withdrawals has risen by 12 per cent, while there has been a three per cent decrease in the launch of generic products, as per Teva Pharmaceuticals' recent analysis of IQVIA data. Within the mental therapeutic area, seven per cent of generic products disappeared between 2013 and 2023, while there was a seven per cent decrease in the availability of generic cancer medicines in just six years (2017-2022). These medicines were listed on the Union List of Critical Medicines to help avoid potential shortages, as the European Commission (EC) said this could cause "significant harm to patients and pose important challenges to health systems." While mature generic products constitute the majority of the List, they remain susceptible to withdrawals, despite containing products crucial for safeguarding Europe's public health, the Teva analysis report noted. Since 2013, the number of generic products for the treatment of schizophrenia and bipolar disorder has declined by 25 per cent, with Hungary and Bulgaria experiencing the biggest loss at 83 per cent and 58 per cent respectively.
pharmacybiz

Teva UK launches generic version of Apixaban - 0 views

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    Recently launched generic version of Apixaban by Teva UK is said to bring savings to the NHS drug bill while making sure patients get the medicine they need. The generic apixaban is available for the prevention of stroke and systemic embolism in adult patients with non-valvular atrial fibrillation (NVAF), with one or more risk factors, such as prior stroke or transient ischaemic attack (TIA) and treatment of deep vein thrombosis (DVT) and pulmonary embolism (PE), and prevention of recurrent DVT and PE in adults. Previously there was only a 'branded' product available, but Castleford-based Teva UK succeeded in invalidating the apixaban patent and SPC (supplementary protection certificate) in the UK High Court and so is now able to launch its own 'generic' version - which will bring savings for the NHS while making sure patients get the medicine they need. "We've always said that we stand up for the patient", said Kim Innes, General Manager of Teva UK and Ireland. "The launch of generic apixaban emphasises Teva's commitment to doing the right thing by putting patients at the heart of everything we do by giving them and the NHS access to affordable treatments." Apixaban is an anticoagulant which directly inhibits factor X (factor Xa), inhibiting thrombin formation and the development of thrombi (blood clots). For at-risk patients, such as those with, or at risk for DVT, or NVAF, the risk of stroke related to blood clots forming in the body and traveling to the brain is a serious concern. Each year, DVT affects around 1 person in every 1,000 in the UK and if left untreated, about 1 in 10 people with a DVT will develop a PE.
pharmacybiz

DHSC imposes 20% rise in generic discount deduction rates - 0 views

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    Department of Health and Social Care (DHSC) has increased the rate of discount deduction for generics from 17.52 per cent to 20 per cent. The Drug Tariff for April 2023 will contain changes to the discount deduction arrangements for pharmacy contractors, which will include- all concession lines to be considered as Group Items for Discount Not Deducted i.e. DND or zero discount (ZD) items; and rate of discount deduction for generics to increase from 17.52% to 20% The Pharmaceutical Services Negotiating Committee (PSNC) and DHSC agreed on the changes for all concession lines to be considered as Group Items for Discount Not Deducted. Therefore from 1 April 2023, a new category will be introduced into Part II of the Drug Tariff 'Drugs for which discount is not deducted'. However, the committee had rejected the changes in the rate of discount deduction for generics. It said, "Following pressure from NHS England, Ministers have now chosen to impose changes to the previously agreed discount deduction arrangements, which come into effect from 1 April, and will be kept under review."
pharmacybiz

Teva UK updates packaging across generics portfolio - 0 views

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    Teva UK has begun replacing its existing packaging with a new design which is "clearer and easier to read". The new look is "unique, recognisable and distinctive." It "enhances safety and provides a recognisable and distinguishable pack range." One of the UK's leading generics manufacturers, Teva UK supplies more than 500 generic pharmaceutical products to retail and hospital pharmacies. The company says each product within the portfolio is distinguishable by colour, ensuring no two different packs have the same drug and strength colours and with additional product information on the side of the pack and a simplified back, it makes it even easier to identify the correct product when dispensing and supports patients when taking their medication. "Our medicines impact the lives of millions of people every day and our packaging is often the first touchpoint for our patients and our customers", said Kim Innes, general manager of Teva UK and Ireland.
pharmacybiz

BGMA:Judicial review on being excluded from VPAS negotiation - 0 views

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    The British Generic Manufacturers Association (BGMA) has sought a judicial review of the Department of Health and Social Care's (DHSC) decision to negotiate a new Voluntary Scheme for branded medicines with the Association of the British Pharmaceutical Industry (ABPI). Mark Samuels, Chief Executive of BGMA said: "The Government has decided not to involve the trade body representing these medicine suppliers in its negotiations on the voluntary scheme for branded medicine pricing (VPAS). "We are deeply concerned by this decision. It has left us no choice but to take legal action." "While not all generic drugs fall within VPAS, four out of ten products in the current scheme are branded generics or biosimilars. As the representative trade body for both generic and biosimilar UK manufacturers, we must play a full part in the VPAS negotiations for the next period of the scheme from 2024 to 2028." "The VPAS tax has risen five-fold in under two years, an unprecedented tax increase. Yet our sector currently has no input into the negotiations on future schemes or rates; this is untenable as any decisions made on VPAS could significantly define the future of our sector in the UK and its ability to supply the NHS. The association had raised its full participation in the negotiations with the Government last November.
pharmacybiz

Novartis:Operating profit grow amid spin off Sandoz generics - 0 views

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    Novartis on Wednesday (February 1) predicted that core operating income would grow in a "mid single digit" percentage range in 2023 following stagnation last year, as the Swiss drugmaker prepares to spin off its Sandoz generics business. Full-year core operating income was broadly flat at $16.7 billion, it said in a statement, coming in slightly below market expectations of $16.8 billion. Adjusted for overall negative currency effects, group sales in 2022 advanced 4 per cent to $50.5 billion as gains from heart failure drug Entresto and multiple sclerosis (MS) drug Kesimpta were partly offset by competition from cheap generic copies of established MS drug Gilenya. Novartis said it was on track to spin off its generics unit Sandoz in the second half of the year as part of its effort to sharpen its focus on its patented prescription medicines. Analysts have welcomed a programme unveiled in 2022 to trim costs and cut 8,000 jobs and plans to focus on fewer therapy areas and drug technologies. But the market has been underwhelmed by prospects for medium-term growth from new drugs.
medsdeltaonline

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pharmacybiz

BGMA:VPAS exemption for branded generics and biosimilars - 0 views

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    The British Generic Medicines Association (BGMA) has called for exemption from the Voluntary Scheme for Branded Medicines Pricing and Access (VPAS), an agreement between the UK Government, NHS England, and the pharmaceutical industry for branded generics and biosimilars. "Due to the rising rate of VPAS on top of existing competition, manufacturers are finding the additional levy economically unviable given their already low prices," the association said. According to research by the Office of Health Economics OHE and Professor Alistair McGuire (LSE) the rising rate of VPAS will force manufacturers pull out of the market which may lead to prices rise due to a lack of competition and critical savings to the NHS will be lost. The new study stated that Government levy on medicines designed to increase access to new treatments and promote affordability could actually be denying the NHS billions of pounds of annual savings due to the impact it is having on branded generics and biosimilars.
pharmacybiz

From Mentorship to Mastery: Building Resilient Pharmacists Ready for Tomorrow - 0 views

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    The healthcare landscape has dramatically changed over the years, due to a number of factors, firstly having to navigate Covid-19 and now the advancement of artificial intelligence (AI) and machine technology, to name a few. As a result, training the next generation of healthcare leaders is more important now than ever. Let's look at three ways to effectively train the next generation of pharmacists: Robust Induction Programme Induction programs are an effective way of training the next generation of pharmacists as they have the ability to provide knowledge, skills and practical experience to deal with and manage common challenges they're likely to experience in their careers. These programs usually include training in pharmacokinetics, drug dosages, medication administration, and pharmacotherapy.
Kaushik Bansal

Generic & Branded Isoflurane by Piramal Critical Care - 0 views

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    Generic & Branded Isoflurane (Terrell and Attane) manufactured by Piramal Critical Care are used as inhalation anesthetics for human & veterinary use. It is used in induction and maintenance of general anesthesia. It is exported to more than 100 countries across the globe by Piramal Critical Care.
pharmacybiz

Diane DiGangi Trench: BGMA appoints its new vice-chair - 0 views

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    The British Generic Manufacturers Association (BGMA) has elected Diane DiGangi Trench to be its new vice-chair. DiGangi Trench takes up the position replacing Xiromed's Peter Ballard and in 12-months' time will assume the association's chair role from Accord's Peter Kelly. With over 25 years of pharmaceutical industry experience, DiGangi Trench has held a number of senior commercial roles including stints with Takeda and Astra Zeneca. She joined Sandoz in 2018 in the US, where she served as Vice-President, Market Access and Patient Services. In 2021, she became the head of Sandoz' UK business and in her two years in role, she has led the organisation through a post-COVID recovery and growth phase to prepare for the proposed spin out of the company from its parent, Novartis, expected later this year. She said: "It's a great honor to take on the role of Vice Chair of the BGMA. The success of the generics and biosimilar industry is essential to the functioning of the NHS. Generic medicines fill four out of five UK prescriptions and biosimilars enable the NHS to expand access to more patients. I am passionate about increasing the sustainability of our industry so we can continue to play our vital part in the health of the nation." Mark Samuels, BGMA chief executive, said: "We are extremely fortunate to be able to call upon the expertise of Diane who has already added significant value through her role on the BGMA board and leadership of a key strategic committee.
pharmacybiz

UK :Smoke-Free Generation with New Tobacco and Vapes Bill - 0 views

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    The UK government's proposal to introduce a tobacco and vapes bill received support from the public to create the first 'smokefree generation'. The historic law to ban the sale of tobacco products to children aged 14 and younger from legally being sold cigarettes in England. King Charles delivered his first speech as monarch at the state opening of Parliament on Tuesday, 7 November. The monarch announced the introduction of the "tobacco and vapes bill" in his speech, and it read: "My Government will introduce legislation to create a smoke-free generation by restricting the sale of tobacco so that children currently aged 14 or younger can never be sold cigarettes, and restricting the sale and marketing of e-cigarettes to children."
pharmacybiz

NHS England Surpasses Targets, Delivers 358M GP Appointments - 0 views

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    NHS England delivered 358 million general practice (GP) appointments, including Covid-19 vaccinations, in the 12 months to October 2023, an increase of 50.9 million compared to October 2019. This equals to 44 more appointments per practice per working day, with over 70 per cent of these taking place within two weeks of booking, data published by NHSE on Thursday (30 November) showed. Health Minister, Andrea Leadsom, thanked GPs and primary care teams across the country for making it possible to deliver around 32,500 more appointments every day, which clearly demonstrate that "more people are getting the care they need, when they need it." "While this is positive news, we know that there is more to do to make it easier and quicker for patients to contact their general practice and continue to focus on delivering the Primary Care Recovery Plan," she added. The Primary Care Recovery Plan published earlier this year is focused on improving access to primary care. It provided GPs in England with £240 million to support them to embrace the latest technology to tackle the 8am rush, and handle more appointments. As of August 2023, more than 1,000 general practices had signed up to digital upgrades to make booking GP appointments easier.
pharmacybiz

Generics shortages could get way worse across Europe - 0 views

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    When Ignasi Biosca-Reig heard there were shortages of amoxicillin in Spain, he quickly added shifts at his drug company's factories to boost production of the popular antibiotic. But a few extra shifts was as far as he could go. Much as he would have liked to significantly increase supplies, Biosca-Reig said he couldn't justify investing millions of euros in new production lines unless he was paid more for the generic drug to cover sharply rising costs. But, like many other European countries, Spain set the price manufacturers are paid for paediatric amoxicillin when the generic version of the drug was first launched in the country two decades ago, and it has barely budged since. "It's a non-business," said Biosca-Reig, chief executive of Spanish drugmaker Reig Jofre. "We wanted to react, but we had a problem," he said. "The costs go up, the price remains the same."
pharmacybiz

GSK licenses Aurobindo,Cipla,Viatris for cabotegravir - 0 views

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    British drugmaker GSK has signed deals with three companies allowing them to make inexpensive generic versions of its long-acting HIV preventive medicine for use in lower-income countries, where the majority of new HIV cases occur. The injected drug cabotegravir is approved by regulators in Britain and the United States. Last July, GSK announced a program with the United Nations-backed healthcare organisation, the Medicines Patent Pool, aiming to get poor countries access to new HIV therapies far earlier than they did for previous HIV medicines. During the HIV/AIDs epidemic in Africa in the 1990s and early 2000s, in which many millions of people died, treatments used widely in wealthy countries were unavailable on the continent. GSK said last year the new program could result in the generic form of its injection being available in lower-income countries beginning in 2026. The drugmaker's HIV treatment division, ViiV Healthcare, said in a statement on Wednesday it had issued voluntary licenses - waiving intellectual property rights - to Aurobindo, Cipla and Viatris, which will manufacture the generic versions of injectable cabotegravir.
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medsdeltaonline

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pharmacybiz

Dr Reddy's Generic Covid Merck At About 50 Cents A Pill - 0 views

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    Indian drugmaker Dr Reddy's Laboratories will launch its generic version of Merck's antiviral Covid-19 pill, molnupiravir, and price it at 35 rupees ($0.4693) per capsule, a company spokesperson said on Tuesday (January 4). The overall cost for a patient treated with a 5-day course of 40 capsules of the generic drug, to be sold under brand name 'Molflu', will come up to 1,400 rupees ($18.77). In comparison, the treatment with Merck's pill in the United States costs $700. "Molflu is expected to be available from early next week in pharmacies throughout (India) with particular focus on states with high caseload of Covid-19," the company spokesperson said. India last week gave emergency use approval to along with two vaccines, as the country braces for a possible spike in coronavirus cases due to the rapidly spreading Omicron variant.
pharmacybiz

Blackwells Chemist London:Fails to meet all GPhC standards - 0 views

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    Blackwells Chemist, a community pharmacy in South East London did not meet all the General Pharmaceutical Council (GPhC) standards. The pharmacy was inspected on Thursday (01 June) and it was found it did not keep all its records up to date and accurate, particularly its responsible pharmacist records. Investigation report stated that the principle of Governance and principle of Services, including medicines management was 'not met at all'. Under the principle Governance, the report stated: "The pharmacy generally manages the risks associated with its services adequately. People using the pharmacy can provide feedback or raise concerns. And staff generally protect people's personal information well. Team members know what to do to help protect the welfare of a vulnerable person. The pharmacy has written procedures, but these are not easily accessible to team members to refer to. And they are not regularly updated. So, they may be less useful to staff, and may not reflect current best practice." In the inspection it was found that the pharmacy does not always store its medicines properly. It cannot show that it stores all its medicines requiring cold storage at the appropriate temperatures.
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