National Pharmacy Association (NPA) - News updates

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Class 2 medicines recall – Action within 48 hours – Ranitidine effervescent tablets 150mg and 300mg

Ref: EL (19)A/27 17 October 2019 Ranitidine effervescent tablets 150mg Ranitidine effervescent tablets 300mg (Manufactured by Teva UK limited t/a ratiopharm GmbH) PL 15773/066 PL 15773/067 A Class 2 medicines recall has been issued by the Medicines & Healthcare products Regulatory Agency (MHRA) for several batches of ranitidine effervescent tablets 150mg and 300mg – this is a pharmacy level recall alert which requires action within 48 hours of the alert being issued on 17 October 2019: Ranitidine effervescent tablets 150mg   (PL 15773/066) Batch Number Expiry Date Pack Size First Distributed 17007672 30/04/2020 1 x 60 tablets 01 September 2017 17011546 30/06/2020 1 x 60 tablets 19 December 2017 17017838 30/09/2020 1 x 60 tablets 28 March 2018 18001231 31/12/2020 1 x 60 tablets 15 August 2018 18006590 31/03/2021 1 x 60 tablets 20 November 2018 18006591 31/03/2021 1 x 60 tablets 03 December 2018 18010644 30/06/2021 1 x 60 tablets 06 November 2018 18010645 30/06/2021 1 x 60 tablets 05 June 2018 Ranitidine effervescent tablets 300mg   (PL 15773/067) Batch Number Expiry Date Pack Size First Distributed 17001878 31/01/2020 1 x 30 tablets 27 June 2017 17011702 30/06/2020 1 x 30 tablets 09 July 2018 Teva UK Ltd is recalling all unexpired stock of the above preparations from pharmacies due to potential contamination of ranitidine with N-nitrosodimethylamine (NDMA) as an impurity — this is a precautionary measure as NDMA has genotoxic and carcinogenic potential.…

NPA launches flu information chart for 2019/20 flu season

The NPA has launched the “Flu information pack 2019/20: vaccine information” to be used alongside previously published flu resources, to support you in delivering flu vaccination services either under the NHS or against a private Patient Group Direction (PGD). The flu vaccine information chart includes the following details: Age suitability of vaccines Ovalbumin content – Flucelvax® Tetra (Seqirus UK Limited) is egg-free. Patients with an egg allergy require an egg-free vaccine or inactivated flu vaccine with an ovalbumin content of less than 0.12μg/ml (0.06μg/0.5ml dose) Antibiotics, gluten, human blood products, lactose, latex, nut and sulfur content Suitability for vegetarians and halal/kosher certification Further information for the 2019/20 flu season, including adrenaline auto-injectors availability, standard operating procedures and promotional materials can be found on the dedicated NPA webpage for the flu service (NHS and private). For further information on this or any other query, please contact the NPA Pharmacy Services team on 01727 891 800 or email pharmacyservices@npa.co.uk. Produced by the NPA Pharmacy Services team October 2019.…

Class 4 drug alert – Caution in Use – Xonvea gastro-resistant tablets 10mg/10mg

Ref: EL (19)A/26 16 October 2019 Xonvea gastro-resistant tablets 10mg/10mg (Manufactured by Alliance Pharmaceuticals Limited) PL 16853/0147 A Class 4 drug alert has been issued by the Medicines & Healthcare products Regulatory Agency (MHRA) for specific batches of Xonvea gastro-resistant tablets 10mg/10mg. Batch Number Expiry Date Pack Size First Distributed 1510 30/11/2021 1 x 20 tablets 25 September 2018 1525 31/12/2021 1 x 20 tablets 05 December 2018 1527 31/01/2022 1 x 20 tablets 17 December 2018 Alliance Pharmaceuticals Ltd has stated that the Patient Information Leaflet (PIL) has not been updated with the possible side effects from post-marketing experience and the related class effects as listed in the Summary of Product Characteristics (SPC). A full list of the information that is missing from the PIL can be found in the MHRA drug alert document All patients should seek immediate medical attention if they notice any of the side effects or class effects listed within the SPC. Pharmacists and pharmacy teams should check the Marketing Authorisation holder and the batch number when dispensing the product. When dispensing any of the affected batches, ensure patients are aware of the missing information using the up-to-date SPC available on the eMC website. Further information can be found on the MHRA section on the GOV.UK website.…

Class 4 drug alert – Caution in Use – Rifadin (rifampicin) capsules 150mg

Ref: EL (19)A/25 16 October 2019 Rifadin (rifampicin) capsules 150mg (Manufactured by Aventis Pharma Ltd t/a Sanofi) PL 04425/5915R A Class 4 drug alert has been issued by the Medicines & Healthcare products Regulatory Agency (MHRA) for a specific batch of Rifadin (rifampicin) capsules 150mg. Batch Number Expiry Date Pack Size First Distributed 9G020A 12/2021 1 x 100 capsules 16 October 2019 Sanofi has stated that the Patient Information Leaflet (PIL) has not been changed within the required timeframe. The change involves the addition of: A potential side effect “Acute Generalized Exanthematous Pustulosis (AGEP)” A widespread red, scaly rash with bumps under the skin, blisters and a fever which  occurs on  initiation of treatment A potential side effect “risk of severe bleeding” Inclusion of drug-drug interactions with: Hepatitis C drugs (such as indinavir, efavirenz, amprenavir, nelfinavir, atazanavir, lopinavir, neviparine, daclatasvir, simeprevir, sofosbuvir and telaprevir) All patients should seek immediate medical attention if they notice any of the above symptoms. Pharmacists and pharmacy teams should check the Marketing Authorisation holder and the batch number when dispensing the product. When dispensing any of the affected batches, the PIL within the packaging should be replaced with the correct, updated version available from the eMC website.…

Supply disruption for all oral preparations of generic ranitidine

A Supply Disruption Alert has been issued by the Department of Health and Social Care (DHSC) stating that all oral preparations of generic ranitidine are expected to be out of stock with no date of anticipated availability. The contaminant, N-nitrosodimethylamine (NDMA), has been identified in samples of ranitidine active substance; all UK-manufactured stock has been quarantined whilst the Medicines and Healthcare products Regulatory Agency (MHRA) conducts investigations. A Class 2 medicines recall drug alert (Ref: EL(19)A/24) was also recently issued by the MHRA for all unexpired stock of four Zantac products. The following oral formulations of ranitidine are affected: Oral formulation type  Strengths Effervescent tablets 150mg and 300mg Tablets 75mg*, 150mg, 300mg Oral solution 150mg/5ml, 75mg/5ml * Over-the-counter generic ranitidine tablets are also affected by the supply disruption Pharmacists and pharmacy teams should be aware of the following: Remaining limited stock of unaffected oral ranitidine preparations which are still in the supply chain should be reserved for patients in whom specialists have considered that there are no clinically suitable alternative treatment options Some IV ranitidine stock has been affected; however, there is adequate stock of unaffected IV ranitidine to meet current UK demand IV ranitidine stock is under review and this situation may change Patients requesting repeat prescriptions of any oral ranitidine preparation should be reviewed to assess whether ongoing treatment is needed; prescribers should supply clinically appropriate alternatives DHSC recommends that prescribers and pharmacists work together closely to achieve a better understanding of treatment options Patients should be referred to a specialist where there is no clinically appropriate alternative DHSC has produced a table of alternative products to consider for patients requiring ongoing treatment  (page 3 of the Supply Disruption Alert); key points to consider include: Omeprazole is the first-line choice of proton pump inhibitor, where clinically appropriate There is currently sufficient stock of omeprazole to meet an increase in demand Patients should not be switched to a different H2-receptor antagonist (such as cimetidine) – this may reduce the availability of these products which are sufficient to meet current demand Pharmacists requested by prescribers to provide advice on clinically suitable alternatives should request a full medication history for the patient from the prescriber, where appropriate, before suggesting alternatives.…

Ask Your Pharmacist Week campaign materials now available

The Ask Your Pharmacist initiative is part of ongoing efforts by the NPA, the NHS and others to promote community pharmacy as a provider of clinical care and the first port of call for help with minor illnesses. Campaign materials include: Digital assets – imagery for Twitter and Facebook and template social media posts Window posters (downloadable in various sizes) and leaflets Web banner and suggested form of words for websites Template local newspaper column PowerPoint presentations & talk notes for community talks Pull up banners and leaflets for public exhibitions NPA Head of Communications, Stephen Fishwick, said: “The focus will be on the suitability of community pharmacy as a place to get clinical advice, in particular about common illnesses like coughs, colds and earache.” “Pharmacists in England will understand the timeliness of this message for the NHS Community Pharmacist Consultation Service, which begins at the end of October.” “However, the core theme resonates in Scotland, Wales and Northern Ireland too.  A selection of resources is available so that pharmacies anywhere in the UK can participate.” NHS England and NHS Improvement has supported the development of Ask Your Pharmacist Week 2019 and the campaign assets carry NHS branding.…

Adrenaline – urgent patient safety update and reminder on ordering process for EpiPen®, and stock availability

To support community pharmacies, we have created a dedicated ‘adrenaline stock availability table’ which is updated regularly to reflect the latest stock availability of AAIs and adrenaline solution for injection ampoules. This open-access resource can be accessed by all community pharmacies. EpiPen® The prescription validation process for EpiPen® 0.3mg remains in effect and has now been extended to include EpiPen® Jr 0.15mg. Pharmacies can supply patients with a maximum of two AAIs per prescription; this will continue until steady supply is re-established. Prescription validation process Send the anonymised prescription to Alliance Healthcare’s prescription validation service by email at scriptvalidation@alliance-healthcare.co.uk or by fax on 0330 332 8126 Ensure the Alliance Healthcare account number has been included Pharmacy teams should check they are faxing to the intended recipient Supply is limited to a maximum of two EpiPen® 0.15mg and two EpiPen® 300mcg AAIs per prescription Alliance Healthcare has advised that the process will take up to 72 hours, followed by a further 24 hours for delivery of the device(s) Community pharmacy teams are reminded to take the above timeframe into consideration when placing orders and advising patients ordering repeat prescriptions. The Medicines and Healthcare products Regulatory Agency (MHRA) has advised that patients carry two adrenaline auto-injectors at all times.…

NHS dental prescriptions – updated information from NHSBSA on reimbursement for different stamped and prescribed quantities

The NHS Business Services Authority (NHSBSA) has provided updated information regarding reimbursement for handwritten information on NHS dental prescription forms (FP10D). Dentists often use a stamp for prescribing items such as Colgate® Duraphat (or sodium fluoride toothpaste).  Sometimes, in addition to the stamp, the dentist states a handwritten quantity of the prescribed medicine that is different from the stamped quantity, with no date and prescriber initials/signature marking the additional information (countersignature). Previously, the NHSBSA had informed the NPA Pharmacy Services team that there would be reimbursement implications for prescriptions written in this way; the NHSBSA provided advice on the quantity pharmacy contractors should dispense, based on whether or not the handwritten information had been countersigned by the prescriber. Updated information from NHSBSA The NHSBSA has confirmed that where a NHS dental prescription states a stamped quantity with additional handwritten information from the prescriber stating a different quantity, pharmacy contractors will be paid based on the handwritten quantity, as long as this has clearly been endorsed on the prescription. The prescriber is not required to countersign the additional handwritten information because this is not considered to be an amendment. NHSBSA has further clarified that a handwritten amendment is only when a prescriber crosses out one quantity and adds a new quantity; in this case, the prescriber is required to countersign the amendment.…

Members are invited for their thoughts and comments to the Prevention Green paper

Class 2 medicines recall drug alert of Zantac (POM) products

A Class 2 medicines recall drug alert (Ref: EL(19)A/24) has been issued by the Medicines and Healthcare products Regulatory Agency (MHRA) for all unexpired stock of four Zantac products listed in the table below — this is a pharmacy level recall alert which requires action within 48 hours of the alert being issued on 8 October 2019: Zantac product Product licence (PL) number Zantac Syrup 150mg/10ml PL 10949/0108 Zantac Injection 50mg/2ml PL 10949/0109 Zantac Tablets 150mg Pl 10949/0042 Zantac Tablets 300mg PL 10949/0043 GlaxoSmithKline is recalling all unexpired stock of Zantac prescription-only-medicines (POM) from pharmacies due to potential contamination of the active ingredient in Zantac (ranitidine) with N-nitrosodimethylamine (NDMA) as an impurity — this is a precautionary measure as NDMA has genotoxic and carcinogenic potential. The MHRA’s press release provides further details about this drug alert. Advice for healthcare professionals, including pharmacy teams Pharmacists and pharmacy teams are required to: Stop supplying the affected products immediately Quarantine all remaining stock and return it to their supplier using their agreed process Provide the following advice to patients making enquiries about the issue: Do not stop taking their medicines – stopping treatment can pose more of a health risk than the contaminant presents Patients do not need to see their doctor until their next routine appointment/treatment review Speak to their doctor if they have concerns GSK can be contacted as below: Stock control enquiries — refer to the GSK website or contact 0800-221-441 Medical information enquiries — email ukmedinfo@gsk.com, or via the Live Chat facilityor on 0800 221 441 (option 2) It is important to note that an MHRA investigation into other potentially affected products is continuing.…