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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.

The British Generic Manufacturers Association (BGMA), the trade body for off-patent medicines, has made several recommendations to alleviate medicine shortages, which not only have serious consequences for patients but also increase workloads for pharmacists. England is currently experiencing twice as many medicine shortages as it did two years ago, with some products remaining out of stock for many months, the BGMA reveals in a report, noting that "the vast majority are commonly used generic medicines." "We have witnessed the number of products facing supply challenges double in the past two years and remain at a high level since September 2023," says BGMA chief executive Mark Samuels. In its report titled 'Solutions to UK medicines shortages' published on 1 October 2024, the BGMA proposes policy changes to tackle medicine shortages, including incorporating supply chain resilience and past performance in hospital medicines tenders. "Tender scoring should include whether supply issues were reported with adequate notice. Suppliers should be informed of changes in prescribing more quickly," the report says.

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 Royal Pharmaceutical Society (RPS) in England and 19 other organisations have written to health secretary Wes Streeting, calling for a cohesive cross-government strategy to tackle medicine shortages across the UK. The letter stresses the need for actions to build supply chain resilience, support UK manufacturing, improve data connectivity, protect access to life-critical medicines, and reduce duplication across the NHS. As the government works on its 10-Year NHS Plan, the signatories emphasise the importance of ensuring patients' continued access to vital medicines, which are "an investment in their health." They underscore that the strategy would require engagement by the government across the NHS and the whole of the medicines supply chain, including manufacturers, suppliers, health professions, and patients. The letter also highlights that delays in accessing medicines could be reduced by changing legislation to empower community pharmacists to make minor amendments to prescriptions when shortages occur.

A recent report by the British Generic Manufacturers Association (BGMA) has shed light on ongoing supply challenges in England's generic medicines market, revealing significant issues impacting patient care. The report highlights significant challenges faced in supply of medicines as currently, 51.72 per cent of generics in short supply lack licensed alternatives, posing substantial hurdles to ensuring continuous patient care. Additionally, 39.08 per cent of affected generics are branded, indicating widespread disruptions across the market. A notable 26.44 per cent of generics experiencing shortages have been affected for over six months, highlighting persistent difficulties in supply chain management. The report indicates that 0.15 per cent of generic medicine presentations listed in the Drug Tariff are currently facing supply issues, impacting accessibility nationwide.

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."

A new report from the Royal Pharmaceutical Society (RPS) has called on the government to create a national strategy to manage medicine shortages and to change legislation to empower community pharmacists to amend prescriptions when medicines are in short supply. Currently, patients are required to return to their GP to get their prescriptions amended, leading to delayed access to medication, increased bureaucracy, and additional strain on an already overburdened system. The RPS report, backed by charities and patient groups, proposes allowing pharmacists to make minor amendments, such as adjusting the quantity, strength, or form of prescribed medicines to ensure timely access for patients. Additionally, the report highlighted key factors causing medicine shortages, including manufacturing and supply chain issues, exacerbated by cost pressures and consolidation of manufacturing outlets. This along with unplanned spikes in demand, such as shifts in prescribing practice or increased diagnosis of some conditions, have created "a perfect storm of unstable supply"

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.

Laganside Crown Court, on Friday, sentenced Gerard Cullinan, a 48-year-old pharmacist and Director of Castlereagh Pharmacy Ltd in East Belfast, for unlawfully supplying controlled prescription medicines, including co-codamol and fentanyl, and for failing to maintain controlled drugs registers. Cullinan was sentenced to 11 months imprisonment, suspended for three years, and his pharmacy was fined £8,000. The sentencing follows an investigation by the Department of Health's Medicines Regulatory Group (MRG), which uncovered that Cullinan's pharmacy on Castlereagh Road had illegally supplied over 300,000 co-codamol tablets between January 2017 and June 2020. Additionally, the MRG investigation identified significant breaches in record-keeping for Class A controlled drugs such as fentanyl, tapentadol, methylphenidate, morphine, and oxycodone. "It is a serious criminal offence to sell or supply prescription only medicines without a prescription," said Peter Moore, Senior Medicines Enforcement Officer at the MRG, who led the investigation.

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.