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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."

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.

The British Generic Manufacturers Association (BGMA) has warned of the significant implications for future supply as a result of the crippling VPAS rate. The warning comes after the association's judicial review into the Government's decision to bar it from being a full part of the negotiations for the next five-year VPAS period was dismissed. The voluntary scheme for branded medicines pricing and access (VPAS) is an agreement between the Department of Health and Social Care (DHSC), NHS England and The Association of the British Pharmaceutical Industry (ABPI). The scheme aims to limit increases in spending on branded medicines to no more than 2% per year via a rebate system which is charged on companies' sales revenues. Two years ago, the rate was 5.1%, but in 2023 it has soared to 26.5%. All biosimilars and a proportion of the generics market falls into the scheme.

The Pharmaceutical Services Negotiating Committee (PSNC) has raised concerns over the impact that high medicine price rises are having on contractor. Recently, the Department of Health and Social Care (DHSC) has granted the final list of price concessions for December 2022. The latest additions bring the total number of concessionary prices granted for the month of December to 198, surpassing the previous record of 159 granted in September 2022. PSNC has heard from hundreds of community pharmacy contractors who are paying inflated prices for antibiotics used for the treatment of Strep A and who have rightly been concerned about the lack of certainty around the final reimbursement prices for these medicines. It added: "We welcomed the involvement of the Competition and Markets Authority (CMA) to look into the pricing of antibiotics. But the number of reports we are getting from contractors about medicines price rises are just not acceptable and this goes far beyond the antibiotic crisis."

Hypovase (prazosin) 500 microgram tablets, manufactured by drug major Pfizer, will remain out of stock until mid-January 2022 due to a manufacturing issue. The Department of Health and Social Care (DHSC) and NHS England and Improvement (NHSE&I) have issued a supply disruption alert for the medicine that is used to treat heart-related troubles. Pfizer, the sole supplier of prazosin 500mg tablets in the UK, is out of stock from late November 2021, and had discontinued the Hypovase® (prazosin) 1mg tablets in May 2021. Advice for healthcare professionals In the given situation, prescribers need to review all affected patients to discuss management plans. Meanwhile, alternative medicine alpha blockers remain available to support an uplift in demand.

Pharmacists can dispense Paracetamol 120mg suppositories in accordance with the prescription, as the Department of Health and Social Care (DHSC) has confirmed that sufficient stocks are available to meet normal demand. This means the Serious Shortage Protocol - SSP033 - for Paracetamol 120mg suppositories has now expired since 26 August 2022. Top tips for SSP claims 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. Any paper prescriptions with SSP claims need to be placed in the red separator provided by the NHSBSA. Although an SSP cannot be used outside its period of validity, claims can be submitted up to three calendar months after expiry or withdrawal of the SSP to help manage any owings for other items issued on the same prescription form. For example, for SSP033 Paracetamol 120mg suppositories, which expires at 23.59pm on Friday 26 August 2022, the NHSBSA would continue to look for the "SSP" endorsement on prescriptions for Paracetamol 120mg suppositories that are submitted with the August batch (submitted by 5 September), September batch (submitted by 5 October) and October batch (submitted by 5 November).

Pfizer has recalled all stocks of Accupro - including 5mg, 10mg, 20mg, 40mg film-coated tablets - as a precautionary measure due to the identification of a nitrosamine above the acceptable limit. "Following testing, N-nitroso-quinapril, has been observed at a level above the acceptable limit. Nitrosamines may increase the risk of cancer if people are exposed to them above acceptable levels and over long periods of time. The recall is at pharmacy and wholesaler level," the Pharmaceutical Services Negotiating Committees (PSNC) reported. The Department of Health and Social Care (DHSC) said: "All strengths of quinapril (Accupro) tablets have been recalled with a resupply date to be confirmed. Pfizer are the sole supplier of quinapril tablets in the UK. Alternative ACE inhibitors remain available and can support an uplift in demand."

Any prescription for Promethazine hydrochloride 10mg tablets x 56 submitted for payment to the NHSBSA for July 2022 will be reimbursed at the new price of £17.77 not as per the price concession of £13.45 announced in the 4th concessions update published on 29 July 2022, said the Pharmaceutical Services Negotiating Committee (PSNC). In July 2022, PSNC received several reports from contractors unable to obtain Promethazine hydrochloride 10mg tablets (56) at the published Drug Tariff price of £4.24. Therefore, it submitted a request for a price concession, which was granted and subsequently published but this was later withdrawn after confirmation from the Department of Health and Social Care (DHSC) that due to the price change mechanism, the reimbursement price for Promethazine hydrochloride 10mg tablets has increased from £4.24 to £17.77 for July 2022. PSNC said, "Following the price change mechanism rules, for generic drugs (excluding drugs in Category M), a price change up to and including the 8th of the month takes effect for prescriptions dispensed in that same month. Any price change after the 8th takes place in the following month."

The British Generic Manufacturers Association (BGMA) has published a positioning paper which sets out the objectives that need to be delivered through the next Voluntary Pricing and Access Scheme (VPAS) on Thursday (15 June). The paper details how a financially sustainable VPAS can support widened medicines access to patients. VPAS is an agreement between the Department of Health and Social Care (DHSC), NHS England and The Association of the British Pharmaceutical Industry (ABPI). The scheme aims to limit increases in spending on branded medicines to no more than 2% per year via a rebate system which is charged on companies' sales revenues. Two years ago, the rate was 5.1% but for 2023 it has soared to 26.5%. Last year, the association had raised concerns over the rise in the VPAS rate for 2023 to 26.5 per cent. "The rocketing rate is in large part due to the growth in spend in on-patent medicines since 2019. Looking at the four completed years of the current VPAS scheme, data shows that the average annual growth rate for on-patent medicine sales value from 2019-22 was 18% compared to just 2% for off-patent products," said the association.

With higher than usual number of cases of scarlet fever, caused by invasive Group A streptococci (iGAS) infections being reported in children across the country, Chief Pharmaceutical Officer for England David Webb has assured pharmacies of sufficient supply of antibiotics. In a letter, shared by the PDA, Webb also urged the pharmacies to order antibiotic stocks sensibly. "Local pharmacy teams may be experiencing a temporary interruption of supply of some relevant antibiotics due to increased demand. On a national level, sufficient stock exists for the NHS," he said. He said NHS is working closely with the Department of Health and Social Care (DHSC) and has taken actions to help ensure medicines continue to be available. He explained that the supplies of antibiotics for the treatment of Group A Strep, particularly phenoxymethylpenicillin presentations, have seen a surge in demand, leading to potential constraints at certain wholesalers and pharmacies,

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

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.

The regulators have reduced the notice periods for change to supplementary opening hours for community pharmacy contractors from 1 October 2022. Following the Pharmaceutical Services Negotiating Committee (PSNC)'s discussions with the Department of Health and Social Care (DHSC) and NHS England as part of Year 4 negotiations, it has been agreed that the required notice periods for changes to supplementary opening hours will reduce to five weeks. Community pharmacy contractors who want to change their supplementary opening hours are required by their terms of service to notify NHS England. "If a contractor wants to increase supplementary opening hours at the pharmacy, this can be done with no notice - but notification of the change must still be given to NHS England," said PSNC. "To decrease supplementary opening hours at the pharmacy, at least five weeks' notice must be given to NHS England prior to implementing the change."

The Pharmaceutical Services Negotiating Committee has announced that the Department of Health and Social Care (DHSC) has granted further price concessions for the month of December 2021. A price concession only applies for the month in which it is granted. No additional prescription endorsement are required as the new price is automatically applied by the NHS BSA to all items submitted for payment in the same month for which a price concession is granted. Contractors can find information and learn about the process involved on PSNC's website.

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 (DSHC) has launched a consultation to seek views on changes to pharmacy supervision, which is being considered as part of the Primary Care Recovery Plan. Plans set out in the consultation include making better use of pharmacies, improving access to primary care and maximising the contribution of pharmacy professionals across healthcare. In the consultation, the DSHC has set out proposals to amend the Medicines Act 1968 and The Human Medicines Regulations 2012. The proposals aim to allow pharmacists to authorise registered pharmacy technicians to carry out the preparation, assembly, dispensing, sale and supply of pharmacy and prescription only medicines in their absence. Currently, these services can only be carried out by, or under the supervision of, a pharmacist.