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The General Pharmaceutical Council (GPhC) has alerted pharmacists, pharmacy technicians, and pharmacy owners via email regarding new emergency legislation governing the prescribing and supply of puberty-suppressing hormones, commonly known as 'puberty blockers', for children and young people under 18 in England, Wales, and Scotland. The regulations apply to gonadotropin-releasing hormone (GnRH) analogues, used to suppress puberty as part of treating gender incongruence or gender dysphoria in individuals under 18. Effective from 3 June 2024, new private prescriptions for GnRH analogues from prescribers in the European Economic Area (EEA) or Switzerland who are not UK registered are banned from being dispensed in Great Britain for patients under 18. The emergency ban on these medicines will remain in effect until September 3, 2024, the Department of Health and Social Care (DHSC) announced on 29 May, stating that the action has been taken to address risks to "patient safety."

The Department of Health and Social Care (DHSC) has published plans to amend current pharmacy legislation on dispensing errors and clarify how registered pharmacies are governed. The Department's response to a public consultation on rebalancing medicines legislation and pharmacy regulation programme first proposed in summer 2018 was delayed due to Brexit and the Covid-19 pandemic. The programme aims to clarify and strengthen the organisational governance arrangements of registered pharmacies, specifically to define and clarify the core purpose of the Responsible Pharmacist and Superintendent Pharmacist roles. It will also give the General Pharmaceutical Council (GPhC) powers to define in professional standards how those roles are fulfilled.

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."

Considering the shortage of Fluoxetine 10mg tablets, the Department of Health and Social Care (DHSC) has extended the serious shortage protocol (SSP) for the medicine to February 11, 2022. Earlier the SSP for Fluoxetine 10mg tablets was set to expire on November 12. Extension of the transition period will enable use of No Cheaper Stock Obtainable (NCSO) endorsement and use of EPS tokens to claim for supplies made in accordance with SSPs. The NHS Business Services Authority (NHSBSA) has accepted that either the new 'SSP' or existing 'NCSO' endorsement for any SSP claims can be submitted using electronic prescriptions (EPS) tokens of FP10 paper prescriptions, during the period.

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."

Hospitals and healthcare providers across the UK have been notified about the shortage of an anti-inflammatory medicine caused by a manufacturing failure. The Department of Health and Social Care (DHSC) on Friday (3 May) issued a National Patient Safety Alert stating that Erelzi 50mg solution for injection in pre-filled pen will be out of stock from early May until mid-July 2024. "The supply issues have been caused by a manufacturing failure resulting in delays in production and the implementation of global allocations," it said. However, it noted that homecare providers (Alcura, Healthnet and Sciensus) have sufficient stock to supply existing patients until mid/late May 2024. Although Erelzi 50mg pre-filled syringes (PFS) are still available, they cannot support a full increase in demand, the DHSC warned.

Department of Health and Social Care (DHSC) has issued a medicine supply notification for GLP-1 receptor agonists used in the management of type 2 diabetes on Tuesday (27 June). "There are very limited, intermittent supplies of all glucagon-like peptide-1 receptor agonists (GLP-1 RAs) licensed in the management of Type 2 Diabetes Mellitus (T2DM)," said DHSC. The supply issues have been caused by an increase in demand for these products for licensed and off-label indications and it is not expected to return to normal until at least mid-2024. Pharmacists are urged to refer to the SPS Tool for Medicines Shortages for an up-to-date supply stock situation and clinical guidance on alternative treatment options.

The Department of Health and Social Care (DHSC) has added further 28 new products to the list of 'Drugs for which Discount is Not Deducted' (DND) in Part II of the Drug Tariff from 1 August 2022. PSNC said, "It will continue its 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, accordingly." A total of 529 products have been granted DND status following checks made by PSNC within the past 26 months.

Department of Health and Social Care (DHSC) has issued a medicine supply notification for three tablets- Meptazinol (Meptid) 200mg film-coated tablets, Medroxyprogesterone (Provera) 2.5mg tablets and Lamotrigine 5mg dispersible tablets on Wednesday (15 February). Meptid tablets will remain out of stock until late June 2023. DHSC suggested that an alternative analgesic products including non-opioids remain available. Provera 2.5mg tablets are out of stock until mid-March 2023. "Medroxyprogesterone (Provera) 5mg and 10mg tablets remain available but cannot support an uplift in demand," said DHSC. "Norethisterone 5mg tablets remain available and will be able to support an increase in demand." Branded lamotrigine (Lamictal) 2mg and 5mg dispersible remain available but are unable to support the increase in demand as Lamotrigine 5mg dispersible tablets are out of stock until late March 2023.

The Serious Shortage Protocol (SSP), for Estradot 50mcg patches will expire at 23.59pm on Friday 24 February 2023. Department of Health and Social Care (DHSC) has confirmed that sufficient stock of Estradot 50mcg patches are now available to meet normal demand. "After 24th February, any prescriptions for Estradot 50mcg patches must be dispensed in accordance with the prescription, and SSP048 will no longer be valid for use," said DHSC. Top tips for SSP claims by PSNC: Where available, use the claim amend facility on the PMR system to rectify any incorrect EPS claims already submitted this month. For any supplies made in accordance with SSPs, check that the correct number of patient charges are collected and declared on the end of month FP34C submission. NHSBSA advise that contractors must follow the specific endorsement guidance issued with each SSP and endorsements should be clear and unambiguous - NHSBSA processing staff must be able to determine what has been supplied. NHSBSA have published information on common SSP endorsing errors they see when processing claims.

The Department of Health and Social Care (DHSC) and the Medicines and Healthcare Products Regulatory Agency (MHRA) have added five more medicines that cannot be hoarded or exported from the UK market. The government has taken the following action to address the "critical shortage" of attention deficit hyperactivity disorder (ADHD) drugs. In a crucial development on October 9, this strategic move aims to enable wholesalers to fulfil their legal obligation to supply these essential medicines to patients across the UK. The updated list of drugs incorporated "all" available strengths and pharmaceutical formulations, ensuring comprehensive coverage for patients' medical needs.

The British Generic Manufacturers Association has backed the UK government's proposed changes to the Statutory Scheme for branded medicines, which includes a 'Life Cycle Adjustment' (LCA) mechanism to permit a lower rebate rate for medicines sold in competitive markets. The association underscored the necessity for crucial amendments to forestall unintended consequences and ensure a practical alignment with market operations. A precisely tailored approach is crucial in ensuring sustainability and growth in this sector, the BGMA said in a statement on Oct. 11. The Department of Health and Social Care is currently working on the successor to the 2019 voluntary scheme for branded medicines and pricing access (VPAS) agreement, slated to end in 2023. Negotiations for this successor, scheduled to begin on January 1, 2024, are already underway. "We are pleased that the Statutory Scheme consultation recognises that branded generic and biosimilar medicines are subject to different market dynamics and competitive pressures," said Mark Samuels, Chief Executive of BGMA. "As such, a one-size-fits-all approach across all branded products is not suitable for the next five years. It is crucial to adopt a precisely tailored approach to this sector, ensuring both sustainability and growth."

The regulatory amendments proposed will enable pharmacists to dispense medicines in their original packaging for private prescriptions starting this Autumn, according to the Department of Health and Social Care. In the recently published draft OPD regulations, the DHSC has indicated that the alterations, permitting pharmacists to vary the dispensed quantity by up to 10 per cent to avoid splitting medicine packs, will be implemented for private prescriptions 'immediately upon the enforcement of the Human Medicines Amendment Regulations in the autumn,' as highlighted in a briefing by Community Pharmacy England. CPE stated that the regulations related to NHS prescriptions will come into effect when the pharmaceutical terms of service regulations expressly apply the OPD amendments. Moreover, new directive mandating the dispensing of sodium valproate products solely in their original packaging (except when an assessment of risk necessitates an alternative approach) will align with the rollout of the private prescription regulations during the autumn. CPE further noted that these regulations are currently in draft, indicating that they are not currently in effect and may undergo revisions prior to their implementation.

Pharmaceutical Services Negotiating Committee (PSNC) has expressed its support for alterations in the Human Medicines Regulations 2012 to enable original pack dispensing (OPD) and supply of medicines containing sodium valproate by pharmacists. PSNC's support for changes was in response to the consultation on OPD, initiated by the Department of Health and Social Care (DHSC). The consultation had proposed regulatory changes to allow pharmacists to dispense (up to 10 per cent) more or less than the prescribed quantity of a given medicine in the manufacturer's original packs. Key aims of the proposal are to "support increased patient safety by ensuring patients receive the necessary information that is included in the original manufacturer's packaging about the safe and effective use of a product," DHSC said.

he Healthcare Distribution Association (HDA) and the Pharmaceutical Services Negotiation Committee (PSNC) have urged the NHS England and the Department of Health and Social Care (DHSC) to issue urgent communications requesting that all those involved in medicines supply do not hoard, stockpile or over-prescribe Strep A antibiotics. In a statement HDA said that the sudden spike in demand for antibiotics used for the treatment of Strep A has meant that there is not enough of these medicines in the supply chain currently to meet this increased demand. As a result, wholesalers are working extremely hard with manufacturers to increase the supply of antibiotics. It added: "As regards pricing, the prices charged to pharmacies by HDA wholesale distributors will directly reflect the increase in prices wholesalers are having to pay for these medicines from manufacturers at the moment, in order to be able to continue supplying these medicines to pharmacies. This will be the case until supply and demand are more in sync."

Bambuterol 10mg tablet, used in the treatment of asthma and chronic obstructive pulmonary disease, is facing supply disruption as sole supplier of the medicine, Astra Zeneca, is discontinuing its production, according to an update by the Department of Health and Social Care (DHSC). The available stock of the medicine is expected to be exhausted by the end of June 2022. Meanwhile, other oral β2-agonists, which are the preferred route of administration, remain available, DHSC said.

Department of Health and Social Care (DHSC) has issued a medicine supply notification for Clomifene (Clomid) 50mg tablets on Monday (5 June). It said: "Sanofi will be out of stock of clomifene (Clomid) 50mg tablets from w/c 12 June 2023 until w/c 18 September 2023." "Generic clomifene 50mg tablets remain available from Wockhardt who are able to partially uplift supplies until the end of July 2023. Unlicensed supplies of clomifene 50mg tablets may be sourced, lead times vary. Alternative medicines for use in infertility remain available," it added. The specialist importers- Orifam and Target Healthcare have confirmed to DHSC they can source unlicensed clomifene 50mg tablets. "If there is currently no listing on dm+d for the imported product for prescribers to select using their prescribing systems an EPS prescription for unlicensed clomifene 50mg tablets cannot be issued," said Community Pharmacy England.

The Government has been forced to intervene formally 50 times in the past two years to authorise the use of alternative drugs because of serious medicine shortages hitting patients, new analysis by the National Pharmacy Association (NPA) has found today. 78 per cent of all Serious Shortage Protocols, produced by the Department of Health and Social Care (DHSC) due to medicine shortages, were issued in 2022/24 - more than three times the rate in the previous two years. The NPA, which represents independent community pharmacies in the UK, is warning that shortages are leading to pharmacists having to increasingly turn patients needing vital medication away. Analysis by the NPA of the NHS's Serious Shortage Protocols (SSPs) issued to pharmacies and other providers over the last five years has found that: The number of SSPs issued in the last two years is 3.5 times higher than in the previous two years.

The Department of Health and Social Care has issued a Serious Shortage Protocol (SSP) in response to a significant ongoing disruption to the supply of Paracetamol 120mg and 240mg suppositories. Effective from Tuesday (Jan 25), SSP015 provides that for every Paracetamol 120mg or 240mg suppository originally prescribed, one Paracetamol 125mg or 250mg suppository must be supplied. SSP015, authorised by the Secretary of State, has been developed by clinicians and provides pharmacists with procedures to follow in providing either of these suitable alternative products to help reduce the number of patients having to return to their prescriber for a replacement prescription. The SSP may be amended or revoked at any time but currently expires on 18 February 2022 - PSNC will update contractors on any changes.

The Association of the British Pharmaceutical Industry (ABPI) on Thursday (February 2) called for the government to scrap its plans to raise the repayment rates for drugmakers, to avoid possible setbacks in the sector. Drugmakers that are part of the government's voluntary scheme agreement, which makes branded medicines affordable for people, are required to pay a part of their drug revenue to the government. The Department of Health and Social Care plans to raise the revenue clawback rate to 27.5 per cent from 24.5 per cent. The country's ongoing attempt to raise rates is likely to send the "worst possible signal" to global investors and boardrooms, said the ABPI. "Hiking these clawbacks to such uncompetitive levels risks undermining the UK's offer to global life sciences companies," Richard Torbett, chief executive of the ABPI, said in a statement. Pharmaceuticals giants AbbVie and Eli Lilly withdrew from the UK's voluntary drug pricing agreement in January after the repayment rates surged to 26.5 per cent.