Patient safety updates

GPhC reminder update on dispensing valproate COVID vaccination programme updates (including patient safety) Patient safety considerations for OTC medicines New measures for methotrexate MHRA stimulant laxatives drug safety update NPA resources – laxatives MHRA guidance on using emollient skin creams safely Direct-acting oral anticoagulants (DOACs) —increased bleeding risk – MHRA Drug Safety Update MHRA drug safety update on reducing risk of meningioma with cyproterone acetate Valproate Pregnancy Prevention Programme: temporary guidance issued by MHRA during COVID-19 pandemic NPA resource “Controlled Drugs legislation – letter of clarification (April 2020)” Domperidone –change in licensed age groups and weight ranges Opioids and tricyclic antidepressants – risk of severe interaction Metformin diabetes medicines – MHRA Update Superabsorbent polymer gel granule ingestion – risks of death and severe harm Fire hazards with Diprosone ointment and ondansetron use in pregnancy – updates from NICE…

Cannabis-based products for medicinal use (CBPM), and cannabidiol (CBD) products

Cannabis-based products for medicinal use (CBPM), and cannabidiol (CBD) products (December 2019) – updated briefing issued for NPA members

  Disclaimer: This NPA briefing on the sale and supply of cannabis-based products for medicinal (CBPM) use, and cannabidiol (CBD) products, is for NPA members and authorised users only, to be used for information purposes only, and not for further dissemination. The information contained in this document is, to the best of our knowledge, correct at the time of publication. However, no responsibility will be accepted for any consequences of decisions made or actions taken using this information. Contents NPA professional indemnity statement Cannabidiol (CBD) CBD novel food status CBD products availability Cannabis-based products for medicinal use Exempted product criteria Drug licensing factsheet: cannabis, CBD and other cannabinoids (from the Home Office) Consumer considerations Action points and key considerations for community pharmacies Further reading and references NPA Professional indemnity statement NPA Members and customers who are considering selling or supplying cannabis, cannabis-based products for medicinal use, cannabis oil products, or any CBD products or derivatives must ensure that they ascertain before doing so the status of such products, and whether they require a product or other licence and marketing or other authorisation. Failure to do so (and to be able to satisfy this requirement to NPA Insurance), will mean that in the event that a third party claim is made against the member’s or customer’s professional indemnity policy, or a request is made by the member or customer for legal defence or representation to respond to a Regulatory or Criminal investigation, that indemnity, legal defence or expenses cover may not be provided.…

National Patient Safety Alert: Class 1 Medicines Recall Notification issued for Co-Codamol Effervescent Tablets 30/500 (Zentiva Pharma UK Ltd)

Class 1 Medicines Recall Notification issued for Co-Codamol Effervescent Tablets 30/500 (Zentiva Pharma UK Ltd)- action by 21 June 2021

  The Medicines and Healthcare products Regulatory Agency (MHRA) has issued a Class 1 Medicines Recall Notification (NatPSA/2021/004/MHRA) for  Co-Codamol Effervescent Tablets 30/500, batch number 1K10121, manufactured by Zentiva Pharma UK Limited. The recall has been issued as a precautionary measure due to an issue with the homogeneity of the batch. This potentially means some tablets have too little active ingredients (codeine phosphate and paracetamol) in them and some tablets contain too much active ingredients causing a risk of overdose. Batch Number PL Number Expiry Date Pack Size First Distributed 1K10121 PL 17780/0046 December 2023 100 March 2021   Key actions for pharmacy teams to be actioned by 21 June 2021: Identify products with the above batch number and stop supplying these immediately Quarantine all remaining stock and return it to your supplier using your usual supplier approved process Identify and contact all patients who have been dispensed the impacted batch as soon as possible and inform them to urgently return this stock back to the pharmacy for a replacement The suggested patient letter can be used  to assist with contacting patients Advise patients to report any side effects to their healthcare professional and via the MHRA Yellow Card Scheme For more information or medical information queries please contact Zentiva Pharma UK Limited on 0800 090 2408 or email UKMedInfo@zentiva.com Please contact the Pharmacy Services team for further advice and support: Telephone: 01727891800 (Mon-Fri 9am to 6pm, Sat 9am to 1pm) Email: pharmacyservices@npa.co.uk  …

UPDATED: Cannabis-based products for medicinal use (CBPM), and cannabidiol (CBD) products

Cannabis-based products for medicinal use (CBPM), and cannabidiol (CBD) products (June 2021) – updated briefing issued for NPA members

In January 2019, cannabidiol (CBD) extract was confirmed as having a novel food status. Under the novel food regulations, food and food products which do not have a history of consumption prior to 1997 should be evaluated and authorised before being placed on the market. Relevant authorities called for all businesses producing CBD-containing food products to submit applications for validation and authorisation in order to be allowed to remain on, or enter, the market.   Updates: In March 2021, we updated our cannabidiol (CBD) and cannabis-based products for medicinal use (CBPM) resource with changes announced in regards to the legal status of CBD-containing products In June 2021, we have added additional information from the Food Standards Agency which is applicable for businesses in England and Wales   To access the updated briefing, please see: Cannabis based products – NPA briefing – June 2021    …

NHS flu vaccination service training requirements for 2021/22 announced

The NHS flu vaccination service training requirements for the 2021/22 season have been announced

Pharmacists must ensure they have the necessary skills and are appropriately trained to provide the NHS flu vaccination service. To help support pharmacy operations during the COVID-19 pandemic, NHS England and Improvement (NHSE&I) agreed that pharmacists who were due to undertake their repeat face-to-face training in 2020, could defer training until 2021. The requirement for pharmacists to undertake face-to-face training on a three-yearly basis has now resumed for the 2021/22 season. This means pharmacists who are due to undertake their refresher face-to-face training for basic life support (including administration of adrenaline) and vaccination training must do so this year.   Key points for pharmacy teams Pharmacists who last undertook refresher face-to-face training for basic life support (including administration of adrenaline) and vaccination training in 2017 and were due to complete face-to-face training in 2020, but were deferred due to the pandemic, will be required to complete their face-to-face training in 2021 Pharmacists who last undertook refresher face-to-face training for basic life support (including administration of adrenaline) and vaccination training in 2018 will also be required to complete their face-to-face training in 2021 Annual update training is expected to be completed by pharmacists each year to ensure they are working in-line with current practice and guidance This can involve using relevant reference sources (for example, the Green Book, relevant Services Specifications, Patient Group Directions and the annual flu letter) and/or undertaking online training from providers   Further reading PSNC: https://psnc.org.uk/our-news/flu-vac-confirmation-of-training-requirements-for-2021-22/…

Pfizer/BioNTech COVID-19 vaccine approved for use in children aged 12-15 years

The MHRA has approved the use of the Pfizer/BioNtech COVID-19 vaccine in children aged 12-15 years following a review of clinical trial data

The Medicines and Healthcare products Regulatory Agency (MHRA) has approved the use of the Pfizer/BioNTech COVID-19 vaccine to be used in children aged 12-15 years.  The decision for approval has taken place, following the review of clinical trial data in children aged 12-15 years for safety, quality and effectiveness of the vaccine by the MHRA and CHM.   Key points for pharmacy teams Clinical data was thoroughly assessed and reviewed by two groups within the CHM, the Paediatric Medicines Expert Advisory Group and the COVID-19 Vaccines Benefit Risk Expert Working Group; with no new side effects identified in children and the safety data obtained was comparable to those seen in young adults Having seen the quality, effectiveness and safety data gathered for the Pfizer/BioNTech COVID-19 vaccine which was used in over 2000 children aged 12-15 years, the MHRA has concluded that the benefits outweigh any risks for use of this vaccine in this age category and given temporary authorisation for use of this vaccine in children aged 12 years of age and over The Joint Committee on Vaccination and Immunisation (JCVI) will now need to advice if this age category will be vaccinated as part of the COVID-19 vaccination programme Pharmacy teams should report any side effects profiles for all UK approved COVID-19 vaccines via the  Yellow Card scheme (this will include children aged 12-15 years) which helps monitor safety   Further reading: UK: https://www.gov.uk/government/publications/regulatory-approval-of-pfizer-biontech-vaccine-for-covid-19   Please contact the Pharmacy Services team for further advice and support: Telephone: 01727891800 (Mon-Fri 9am to 6pm, Sat 9am to 1pm) Email: pharmacyservices@npa.co.uk…

Community Pharmacies can now provide free lateral flow tests to people in Scotland

  The new optional pharmacy service requires pharmacy contractors to order LF test kits from Alliance wholesaler, for supply on request in boxes of 7 tests. Record of the delivery date and the batch number of tests must be retained  The universal claim form should be used to claim each supply and a PMR record made of the lot number supplied. Specific COVID-19 self-testing advice must be provided to people collecting tests, including the purpose of the tests and how to use and report results. Remuneration is detailed in the circular as £2 distribution per kit, which can be collected for use by other household members. There is a one off participation fee to be claimed by email submission of Annex B of PCA(P)(2021)08 to National Services Scotland Practitioner Services at nss.psd-sgforms@nhs.scot An SOP is required for the service. NPA SOP for COVID-19 lateral flow test distribution from community pharmacies in Scotland, and accompanying risk assessment and FAQs are available here.  …

NPA Serious Shortage Protocol resources

The NPA has produced template Standard Operating Procedures (SOPs) and guidance resource to support you and your team in ensuring that requirements are met when medicines or appliances are supplied under a Serious Shortage Protocol (SSP).…

New endorsement for Serious Shortage Protocols (SSPs)

A new endorsement for Serious Shortage Protocols (SSPs) has been introduced from 1 June 2021

The Department of Health and Social Care (DHSC) has introduced a new endorsement to claim for supplies made under a Serious Shortage Protocol (SSPs) from 1 June 2021. The new endorsement uses the code ‘SSP’ and the three digit reference number that is specific to the SSP. Full details of the arrangements of the new SSP endorsement can be found in the June 2021 Drug Tariff Part II Clause 9E.   Key points for pharmacy teams Contractors should start using the new endorsement functionality to claim for supplies made under a SSP from 1 June 2021, where available From 5 October 2021, the NCSO endorsement will no longer be accepted A transition period from 1 June 2021 to 5 October 2021 (to include September SSP claims) has been implemented to allow contractors to continue to use the existing ‘NCSO’ endorsement where the functionality for the new endorsement is not yet available During the transition period, the NHS Business Services Authority (NHSBSA) will accept either the existing ‘NCSO’ or the new ‘SSP’ endorsement for any SSP claims The new SSP endorsement will only be accepted for electronic and paper prescriptions after the transition period has ended SSP claims made using EPS tokens after October 2021 will not be accepted for payment – claims for electronic prescriptions are to be made electronically For multiple dispensed product SSP (where a prescribed item is replaced by two or more items): some systems may allow the new SSP endorsement for both replacement items, whilst other systems may only allow the endorsement for one replacement item Where only one item can be endorsed, the NHSBSA will add and reimburse for the other replacement items The SSP endorsement guidance also applies to replacement items which are not listed in Part VIII of the Drug Tariff   The new update will affect all future SSPs including the following existing SSPs: SSP05: Fluoxetine 10mg tablets due to expire 13 August 2021 Prescriptions for SSP05 should be endorsed SSP005 SSP007: Fluoxetine 30mg capsules due to expire 13 August 2021 SSP012: Estradot 75 microgram patches due to expire 11 June 2021   Please note, the SSPs can be amended or revoked at any time.…

URGENT REMINDER: Claiming for the NHS Community Pharmacy COVID-19 Lateral Flow Device Distribution Advanced Service (Pharmacy Collect)

All pharmacies participating in the Pharmacy Collect Advanced Service must ensure that they submit the data and claims on the MYS portal each week.

  This is an urgent reminder to all pharmacies across England that are providing the Pharmacy Collect Advanced Service – you must ensure that you submit the dataset and claims on the MYS portal each week. The service aims to improve access to COVID-19 testing by making lateral flow device (LFD) test kits readily available at community pharmacies for asymptomatic people. Recording data and claiming payment All participating pharmacies must ensure they are recording the appropriate data to claim payment for the service as required under the service specification. A service fee of £1.50 + allowance for VAT per transaction can be claimed. To claim, you must enter the dataset listed below on the MYS portal by close of business on the pharmacy’s last trading day of the week: Information on LFD test kits received which includes: LOT number of each LFD carton received Quantity of cartons Supplying wholesaler name Invoice/delivery note number Answers to question 2 and 3 obtained from the individual requesting the LFD test kits: Why do you need tests? (only in relation to the first person requesting a test) What is the age range of the person using the kit? (for each box supplied)   Please note that the MYS portal opens every Friday at 00:01.…