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Community Pharmacy England (CPE) has explained MPs on instability that puts operational pressures on pharmacies, financial pressures on businesses at a Parliamentary drop-in event held on Monday (10 July). The association has been in Parliament today alongside patient representatives and others to highlight our ongoing concerns about medicines supply to MPs. It said: "Medicines supply remains a critical issue for community pharmacies with disruption causing problems both accessing medicines and procuring them cost effectively." In CPE's recent sector polling, community pharmacy owners rated medicines supply instability as being the most severe pressure facing their businesses. This echoed the results of CPE's Pressures Survey which found 97% of pharmacy owners survey are facing significant increases in wholesaler and medicine supply issues, with 71% saying this was leading to delays in prescriptions being issued. During the Parliamentary drop-in event, CPE talked MPs through the issues and set out what it believe needs to happen to resolve them, calling for- Reform of Serious Shortage Protocols; Allowing generic substitution; An overhaul of the concessions system; and a strategic Government review of medicine supply and pricing with a shift to focusing on how to improve the functioning of the supply chain rather than solely on the drive to depress prices and margins.

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The National Pharmacy Association (NPA) has asked the Secretary of State for Health and Social Care to convene a 'medicines supply taskforce', following weeks of problems with antibiotics supplies. The NPA's chief executive Mark Lyonette wrote a letter to Steve Barclay this week. It cited the precedent of the HRT Taskforce which this summer brought together representatives from across the supply chain after months of supply problems affecting women. "We strongly believe that this situation calls for a similar response from the government. It is imperative that we resolve this supply situation urgently and therefore we request that you convene a Medicines Supply Taskforce, with all the relevant stakeholders in the supply chain, to urgently discuss and agree practical solutions to address the disruptions to the supply of medicines. HRT and antibiotics are the most visible examples of a wider problem with medicines supply which needs to be addressed." NPA board members Olivier Picard and Reena Barai were among the stakeholders joining meetings convened by the HRT Taskforce this summer.

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A couple in Maidenhead, Berkshire has been handed suspended sentence for illegal possession and supply of £1.6m of unlicensed medicines. Following investigations initiated by the MHRA, Karina Filimonova and Andrejs Stolarovs were caught with the unlicensed medicines which included prescription-only medications. Southwark Crown Court sentenced each "to eight months imprisonment suspended for 18 months and 150 hours unpaid work" for possessing and intending to supply medicinal products contrary to the Human Medicines Regulations 2012. "This was a sophisticated operation illegally bringing unlicensed medicines into the UK from Singapore and India, and then distributing them across the country and abroad," said Andy Morling, MHRA Deputy Director of Criminal Enforcement. "Criminals trading in medicines illegally like this are not only breaking the law, but they also have no regard for your safety. These are powerful medicines that can lead to serious adverse health consequences if taken without appropriate medical supervision." In 2020, the Royal Mail Group (RMG) informed the MHRA about parcels containing unlicensed medicines discovered during their investigation into suspicious parcel activity. Following this, the MHRA's Criminal Enforcement Unit, in cooperation with local police, launched an investigation and apprehended the couple at their residence in Kidwells Close, Maidenhead.

A report released by Community Pharmacy England (CPE) has warned that pharmacies across England are grappling with daily medicine supply challenges, posing significant risks to patients' health. The Pharmacy Pressures Survey 2024: Medicines Supply Report, which is based on the views of the owners of over 6,100 pharmacy premises in England and 2,000 pharmacy team members, has exposed some alarming trends concerning medicine supply problems in the country. Almost all pharmacy team members surveyed (97 per cent) reported patients being inconvenienced due to medicine supply issues, and 79 per cent of the participants said that the worsening situation is putting patient health at risk. Nearly all respondents reported patient frustration stemming from medicine supply issues, with 84 per cent of them saying they had experienced aggression from patients. Additionally, 98 per cent indicated an increase in 'owings,' where patients receive only part of their prescription and must return to the pharmacy for the remaining medication(s) at a later time."

The Department of Health and Social Care (DHSC) has allowed pharmacists to supply alternative penicillin to treat Strep A. It has issued Serious Shortage Protocols (SSPs) for three penicillin medicines. "The SSPs will help mitigate local supply issues of oral penicillin and allow pharmacists to supply alternative forms of the medicine if they do not have the specific formulation stated on the prescription," said DHSC. SSPs have been issued across the UK for 3 penicillin medicines on Thursday (December 15. "Issuing an SSP allows pharmacists to legally supply a specified alternative medicine, removing the need for the patient to return to the prescriber - which saves time in GP practices and inconvenience for patients." "Demand for penicillin has risen recently as it is used to treat strep A and scarlet fever, and the increased demand means that some pharmacists are experiencing temporary and localised supply issues and may not have the specific formulation listed on the prescription."

The European Commission is prepared to rewrite European Union law on medicines to ensure stable supply of generic and life-saving medicines in Northern Ireland. In a press statement issued on Friday (Dec 17), the commission said it put forward a package of measures to ensure the continued long-term supply of medicines from Great Britain to Northern Ireland. In the context of the Northern Ireland Protocol, this means that the same medicines will continue to be available at the same time across the United Kingdom. Commenting on the news, policy manager at the National Pharmacy Association (NPA) Helga Mangion said: "We are encouraged by the EU's statement on medicines availability in Northern Ireland, though of course we await the final outcome of the negotiations. We have been talking to the government, the MHRA and other stakeholders about these issues for months, highlighting the concerns of our members in Northern Ireland."

Insuman Comb 50 100units/ml suspension for injection 3ml cartridges has been discontinued with stocks being exhausted imminently, notified Department of Health and Social Care (DHSC). The department has issued a medicine supply notification for Insulin isophane biphasic human 50/50 (Insuman Comb 50) 100units/ml suspension for injection 3ml cartridge. "Humolog Mix 50 remains available, as do other biphasic insulin preparations, and the manufacturers can support a full uplift in supply," said DHSC. A copy of this medicine supply notification, including further information, has been sent to all pharmacy NHS email addresses. DHSC and NHSE/I's newly launched online Medicines Supply Tool provides up to date information about medicine supply issues. The contents of these MSNs can now be viewed on the Tool.

Pharmacist supervision has been the subject of debate for as long as I can remember. Strikingly, no one is sure what supervision requires. The Human Medicines Regulations 2012 say it is a criminal offence to sell or supply Pharmacy medicines or Prescription Only Medicines unless a pharmacist makes the sale or supply or, if the transaction is carried out by a non-pharmacist, that person acts under the supervision of a pharmacist. Over the years, some people have argued that supervision requires a clinical check. Others say it requires an accuracy assessment. Yet others have asserted that it requires a final check before a medicine leaves the pharmacy. Things are made more uncertain by the NHS terms of service which require prescription medicines to be supplied under the direct supervision of a pharmacist. No one knows what the word "direct" adds. The wording of the Human Medicines Regulations is not identical to the wording of earlier legislation. In particular, on the only occasions when the courts have been called upon to interpret the requirement for supervision, the Pharmacy and Poisons Act 1933 was in force. In cases decided in 1943 and 1953, the courts decided that a pharmacist who was upstairs when a supply was made could not have been supervising; and that a sale was supervised by pharmacist standing at the cash desk because the pharmacist could intervene if a sale would not be appropriate.

Following Community Pharmacy England's Parliamentary drop-in event on medicines supply issues last week, several MPs have since raised questions to the Health Secretary during a Health Questions session on July 18th. According to CPE, MPs from all Parties displayed great engagement with the current pressures facing community pharmacies, particularly regarding medicines supply issues. During last week's event, Mike Amesbury, the MP for Weaver Vale, was present and directed a question to the Health Secretary: "Eighteen community pharmacists in my constituency are reporting challenges with medicine supplies. What further actions will the Minister take to address and resolve this situation effectively?" In response, Health Secretary Steve Barclay MP stated, "We have a dedicated team in the Department that focuses on medical supplies, which are an ongoing concern. Challenges in this area are a routine part of our business."

The government has launched a consultation into radically changing the Statutory Scheme for branded medicines (known as the Statutory Scheme). The consultation comes as delicate negotiations for replacing the alternative Voluntary Scheme are underway, potentially undermining these talks, while also further damaging industry confidence in the UK as a viable place to research, launch and supply medicine. The government proposals seek to hold average revenue clawback rates under the Statutory Scheme at historic highs of between 21-27%, compared to the pre-pandemic averages of 9.4% for the Statutory Scheme (2019-2021), and 6.88% for the Voluntary Scheme (2014-2021). The accompanying cost-benefit analysis ignores any negative impact this may have on medicine supply and wrongly claims it will boost investment. The consultation comes on the heels of government data last week showing UK life sciences foreign direct investment (FDI) fell by 47% between 2021 and 2022, down by £900m year on year. This large fall in investment coincided with a rise in the main UK clawback rate under the Voluntary Scheme from 5% to 15%, and led to the UK falling from 2nd to 9th out of 18 comparator countries for life sciences FDI in 2022. The Voluntary Scheme clawback rate now sits at a record 26.5% in 2023.

Community Pharmacy England (CPE) has cautioned that patients in the UK will continue to encounter difficulties in accessing medicines unless the government addresses supply problems and resolves the critical financial state of community pharmacies. CPE Chief Executive Janet Morrison and Mike Dent, Director of Pharmacy Funding, on Monday 19 February, gave evidence to the Health and Social Care Select Committee's Pharmacy Inquiry, highlighting the impact of ongoing medicines supply issues on pharmacies and patients. Morrison indicated that a combination of the ongoing "financial squeeze, operational pressures, and medicines supply and pricing issues" has left pharmacy businesses fighting for survival. "As the NHS continues to grapple with wider challenges, this is a battle that patients cannot afford for pharmacies to lose," she said. Morrison warned that if pharmacies continue to close, not only business owners and pharmacy teams will suffer, but patients and local communities will also face the consequences.

In the parliamentary drop-in-event hosted by Community Pharmacy England last week, Members of Parliament (MPs) questioned the Health Secretary on the rising issue of medicines supply. "Eighteen community pharmacists in my constituency are reporting challenges on medicine supplies. What more is the Minister going to do to get a grip of this situation?", Mike Amesbury MP for Weaver Vale, who was present at the event last week, asked the Health Secretary. In his response, the Health Secretary, Steve Barclay MP said: "We have a long-standing team in the Department focused on medical supplies, which are a continual issue; as a matter of routine business, there are often challenges in that area." The Shadow Pharmacy Minister, Karin Smyth MP, also asked: "People across the country rely on local, accessible pharmacies, but whether it is high street closures or supply problems leading to the absurd situation where women are phoning or visiting multiple pharmacies for a prescribed dose of hormone replacement therapy and other drugs…They have repeatedly announced plans to expand the role of community pharmacies but have failed to update legislation that could possibly help. … Why will they not do so?

Northern Ireland will see changes in the regulatory landscape following the issuance of the Windsor Framework on 27th Feb 2023 and the corresponding EU Commission proposal. An agreement, in principle, has been reached by the UK and EU. The new path forward of the Windsor Framework marks a turning point in how both the UK and the EU will work together collaboratively and constructively to ensure that the same medicines are available in Northern Ireland at the same time as they are in the rest of the United Kingdom. Whilst this is a successful result for Northern Ireland patients, this is major change for companies that have made specific provisions in their supply chains for Northern Ireland. The supply chains of companies where provisions and changes were made such as introduction of GB specific pack may be impacted as a result. However, the burden on the UK Pharma supply chain will be eased. Prime Minister Rishi Sunak walks with European Commission chief Ursula von der Leyen in Windsor on February 27, 2023 Pharma companies will need to carefully consider making changes within their processes and supply chains pending the issuance of clear guidance from the MHRA on the regulation changes resulting from the Windsor Agreement and the corresponding EU Commission proposed regulatory changes associated with medicinal products within the Northern Ireland market. Smooth access to the EU market for Northern Ireland pharmaceutical and medical technology firms has been safeguarded within the constraints of the agreement. The pragmatic dual-regulatory system protects business, patients and healthcare services, and reflects that it is an essential state function to maintain and oversee the supply of medicines within the whole United Kingdom.

From over-the-counter flu tablets to crucial antibiotics and antidepressants, medicines are running scarce in UK pharmacies this year, causing concerns among patients, the government, and the wider pharma industry. Drug shortages have accelerated over the past year due to a clutch of problems including the after-effects of the pandemic on supply chains, the war in Ukraine, and soaring input costs weighing on manufacturers. More recently, a sudden spike in respiratory infections - another by-product of Covid-19 that neither pharma companies nor the government were able to predict - has deepened the crisis, with 70 commonly taken drugs out of stock in Britain as of February. The problem is not unique to the UK. In a recent survey of groups representing pharmacies in 29 European countries, three quarters said shortages were worse this winter than a year ago, with a quarter reporting more than 600 drugs in short supply. The US is also facing significant shortages of popular prescription drugs like amoxicillin and Adderall, an ADHD medication. To some extent, the current disruption is laying bare wider challenges facing the industry for several years that were only exacerbated by the pandemic. The over-reliance on foreign suppliers for most active pharmaceutical ingredients (APIs) is one of them. This model has left companies more susceptible to supply shocks, which have in turn increased in frequency and severity due to pandemic lockdowns, the war in Ukraine and other issues such as the shortage of shipping containers. Pharma's long and opaque supply chains, alongside regulatory complexities, also mean it is taking longer for drugmakers to reconfigure manufacturing and distribution in times of additional need.

Proposed changes to a European Union pharmaceuticals law will include stronger obligations for the supply of medicines and earlier notifications of shortages, EU Health Commissioner Stella Kyriakides said last week (January 17). Kyriakides told a session of the European Parliament that shortages of antibiotics are a growing problem for many European countries. She said the European Commission's proposal to revise the pharmaceuticals legislation is planned for March. "Our objective is and remains to secure access to medicines for all patients in need and to avoid any market disruption of medicines in the EU," Kyriakides said. Shortages of antibiotics have been reported in 26 European countries, the European Medicines Agency says. The unseasonably early upsurge in respiratory infections in Europe this winter and insufficient production capacity are the root causes of the shortages, Kyriakides said. Numerous EU lawmakers speaking at the session said the shortages needed to be tackled urgently. But experts say shortages of essential generic medicines like antibiotics are likely to be recurrent in Europe due to problems in the sector such as the gradual migration of generic manufacturing to Asia.

The Equality Act (which replaced the Disability Discrimination Act in 2010) is often cited as a reason for supplying medicines in a compliance aid. This is a complex piece of legislation, but, in essence, provides a statutory duty on businesses to make "reasonable adjustments" in relation to the service that they provide to take into account any relevant disability of a service-users. This statutory obligation might include the provision of a compliance aid where a patient would be at a "substantial disadvantage" without. However, the need to provide medicines in a compliance aid under the Equality Act needs careful consideration and is a balancing exercise. The NHS Terms of Service for community pharmacies in England state that medicines should be provided in original packs save in certain circumstances, which include because of patient needs.

The Medicines and Healthcare Products Regulatory Agency (MHRA) is considering the reclassification of Aquiette 2.5mg tablets contains oxybutynin hydrochloride that is used to treat women with milder symptoms of overactive bladder from Prescription-Only-Medicine (POM) to Pharmacy (P) medicine. The agency is encouraging pharmacists, GPs and other health care professionals, the public and women to take part in the reclassification consultation to make a treatment for overactive bladder available for women without the need for a prescription. Public consultation on a set of proposals to make Aquiette 2.5mg Tablets (oxybutynin hydrochloride) available from pharmacies will close on 13 May, 2022. It would be the first time a medicine for the treatment of overactive bladder would be available without prescription, if the reclassification consultation receives positive responses. After the decision is made to reclassify this treatment, pharmacists will have access to training materials and a checklist to enable them to identify women who can be supplied this medicine safely.

New amendments to the Human Medicines Regulations will soon allow registered pharmacy technicians to supply and administer medicines under Patient Group Directions (PGDs). Laid before Parliament at the end of May, the legislative changes will come into effect from June 26, 2024, the Community Pharmacy England (CPE) announced today. The introduction of this new legislation follows an announcement made by the Department of Health and Social Care (DHSC) earlier this year. The regulatory adjustments provide the legal framework for pharmacy technicians to engage in the supply and administration of medicines under PGDs in the course of their professional practice. However, there will be no immediate change in the provision of community pharmacy services, the CPE noted