National Pharmacy Association (NPA) - News updates

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Clarification and update on CD prescriptions’ appropriate dates and validity

Following a number of member queries regarding dispensing Controlled Drug (CD) prescriptions legally in relation to their appropriate date and validity, especially for days when the pharmacy may be closed, for example, over weekends/bank holidays, we would like to highlight the key points to take into consideration. Key points The item (in the case of instalment prescriptions for CDs, this would be the first instalment) must be supplied within 28 days of the appropriate date on the prescription as stated in The Misuse of Drugs (Amendment No. 2) Regulations 2006. For instalment prescriptions: the remainder of the instalments are required to be dispensed in accordance with the prescriber’s instructions. The appropriate date is the later of the dates on which the prescription was signed (issue date) or the date indicated on the prescription as to when it should be dispensed, as stated in the Human Medicines Regulations 2012. The presence of the Home Office approved wording “Please dispense instalments due on pharmacy closed days on a prior suitable day” allows instalments due on a day when the pharmacy is closed to be dispensed in advance. The pharmacist can exercise professional judgement on the appropriate supply date if the issue date on the prescription is before the treatment start date and the prescriber has included the appropriate HO wording; please refer to example below.…

NPA urges government to apply “robust mitigation” to the medicines supply chain to avoid shortages in Northern Ireland

In a letter sent to Mr Gove on 27 October, NPA chair Andrew Lane said the requirement for Northern Ireland to continue to comply with EU medicines regulations that will no longer apply in the UK (which is the main source of supply) would distort the medicines supply chain. He warns that the additional cost and complexity of getting medicines into Northern Ireland could result in some manufacturers not bringing products to the market. This in turn could lead to medicines shortages and an increase in procurement costs. Without a clear plan on a transition from the UK-wide system into one that serves only Northern Ireland, it is likely that manufacturers of medicines, particularly generic medicines, will simply stop producing packs that meet the requirements for supply in Northern Ireland, Mr Lane predicts in his letter. The NPA is urging the UK government to apply robust mitigation to the medicines supply chain from 31st December 2020 for a period of at least 18 months, to allow the supply chain to adapt to Brexit-related changes. Earlier this month, the UK Community Pharmacy Falsified Medicine Directive Working Group called on the government in Westminster to protect the supply of medicines into Northern Ireland following the end of the Brexit transition period.…

NHS Scotland Flu vaccination programme update on management of post vaccination fever

Fever is a common symptom post flu vaccination and is also associated with COVID-19. To provide consistent guidance for adults and children appropriate for all vaccination settings, the interim Chief Medical Officer for Scottish Government has detailed approved advice:   If someone develops fever post vaccination, this would normally be within the first 48 hours following vaccination AND usually resolve within 48 hours. This is a relatively common, expected reaction, and self-isolation and testing for COVID-19 are not required unless COVID is suspected based on other clinical criteria such as cough and/or anosmia. If fever starts beyond 48 hours post vaccination OR persists beyond 48 hours or an individual develops other COVID-19 related symptoms, then they should self-isolate and be recommended to have a test for COVID-19. Testing for COVID-19 may also be considered at any time following clinical assessment, or if there are other epidemiological indications such as being a close contact of a case or part of a cluster.   Read the CMO letter here…

Monitoring of patients taking warfarin and other anticoagulants during the COVID-19 pandemic

The MHRA has issued guidance reminding healthcare professionals and patients of existing advice on the potential for drug interactions between certain antibiotics/antivirals with warfarin or other vitamin K antagonists (VKA) and the requirement to monitor the international normalised ratio (INR) of patients who have illnesses during anticoagulant treatment. This follows concerns raised by King’s College Hospital in London to the MHRA about findings which show an increase in the number of patients with elevated INR values who are taking warfarin during the COVID-19 pandemic. This may be a result of a number of factors including use of antibiotics, reduced consumption of leafy green vegetables, increased alcohol intake and reduced adherence to regular medications caused by psychological reasons.   MHRA advice when dispensing warfarin and other anticoagulants: Advise patients who are taking warfarin or other VKAs that the effects of warfarin may be enhanced by an acute illness and should ensure that they continue to have their INR monitored – this also applies topatients with suspected or confirmed COVID-19 For patients that have been switched from warfarin to direct-acting oral anticoagulants (DOACs) to avoid the need for regular INR monitoring, check for interactions between DOACs and other medicines that patients are taken concurrently Check for any potential drug interactions that may occur for patients taking VKA or DOACs and prescribed certain antibiotics and/or antivirals for the treatment of COVID-19 – patients taking VKA’s will require INR monitoring if they start new medicines Refer patients to the prescriber if they have been switchedfrom warfarin to a DOAC but have not had their warfarin treatment stopped because there is a risk of over-anticoagulation and bleeding Advise patients who are taking VKAs and have symptoms of/or confirmed COVID-19 to inform their GP/healthcare team because it is important they continue to have their INR monitored while they are unwell Advise patients taking VKAs to inform their GP/healthcare team if they have made any changes to their diet (including alcohol intake), smoking habits, and medicines and/or supplements; instructions for usefor anticoagulant medicines should be carefully followed Advise patients taking VKAs to inform their GP/healthcare team if they: Have sickness or diarrhoea Experience a loss of appetite Are unable to attend their next appointment for a blood test for any reason   Access the MHRA guidance: https://www.gov.uk/government/publications/warfarin-and-other-anticoagulants-monitoring-of-patients-during-the-covid-19-pandemic?utm_source=govdelivery&utm_medium=email&utm_campaign=MHRA_COVID-19_updates&utm_content=HCP19…

SSPs issued for fluoxetine capsules 30mg (SSP007) and Salazopyrin EN-Tabs 500mg (SSP008)

The Department of Health and Social Care (DHSC) have issued two Serious Shortage Protocols (SSPs) following ongoing supply disruptions to fluoxetine capsules 30mg (SSP007) and Salazopyrin EN-Tabs 500mg (SSP008). Community pharmacy teams are required to implement the protocols with immediate effect.  SSP for fluoxetine capsules 30mg (SSP007) SSP007 has come into effect on Tuesday 20 October 2020 SSP007 is scheduled to expire on Tuesday 22 December 2020; however, this can be amended or revoked at any time Under SSP007, when presented with prescriptions for fluoxetine capsules 30mg, pharmacists can instead supply three fluoxetine capsules 10mg, or one fluoxetine capsule 20mg and one fluoxetine capsule 10mg SSP for Salazopyrin EN-Tabs 500mg (SSP008) SSP008 has come into effect on Tuesday 20 October 2020 SSP008 is scheduled to expire on Friday 4 December 2020; however, this can be amended or revoked at any time Under SSP008, when presented with prescriptions for Salazopyrin EN-Tabs 500mg, pharmacists can instead supply genericsulfasalazine gastro-resistant (GR) tablets 500mg.   Advice for pharmacy teams: Ensure all pharmacy team, including locums, who will be involved in dispensing an item in accordance with an SSP are trained and competent to do so The SSPs and further information is available from the NHS Business Services Authority (NHSBSA) website: https://www.nhsbsa.nhs.uk/pharmacies-gp-practices-and-appliance-contractors/serious-shortage-protocols-ssps…

NPA medication safety update (MSO report) Quarter 2 2020 (England)

During this unprecedented time we appreciate, you are all extremely busy with a massively increased workload currently. Pharmacies have had to adjust to new ways of working due to the COVID-19 pandemic.  However, patient safety incidents may occur in the course of your practice. During the coronavirus (COVID-19) pandemic, since March 2020, there has been a significant decrease in the number of patient safety incidents being reported.  Please continue to manage and report all patient safety incidents in line with your pharmacy process. This includes completing the recording of the incident details carefully and fully.   Medication Safety update presenting our analysis of patient safety incidents reported during the second quarter of 2020 (Q2) – access the full update here. Included in the medication safety update: Analysis of patient safety incidents reported during Q2 2020 Look alike sound alike (LASA) analysis Impact of COVID-19 pandemic Safe use of emollient skin creams Direct-acting oral anticoagulants (DOACs) increased bleeding risk Medical interventions: sodium valproate, primidos and pelvic mesh implants Valproate Steroid Emergency Card Isotretinoin – reminder of risks and precautions Alfentanil injections – risk of 10 times overdose Priadel (lithium carbonate) modified release 200mg and 400mg supply COVID-19: Yellow Card reporting Reporting patient safety incidents Relevant links & signposting Contact your MSO Summary of key findings from analysis of patient safety incidents reported during Q2 2020.…

Patient safety considerations for OTC medicines

Benadryl Challenge on TikTok: The United States Food and Drug Administration (FDA) has issued an alert warning parents/guardians about a new challenge on social media. The ‘Benadryl challenge’ on TikTok encourages social media users to take excessive doses of Benadryl to bring about diphenhydramine hallucinations. This can cause severe side effects and parents/ guardians are advised to be vigilant and notify the school if their child engages in this challenge. In the US, the active ingredient in Benadryl is diphenhydramine, which is different to the UK products which contain cetirizine, or acrivastine, or acrivastine with pseudoephedrine. However, as diphenhydramine is available as an over-the-counter (OTC) medicine in the UK, potential misuse as popularised on social media is a possible patient safety risk. Pharmacy teams should be aware of the potential for misuse associated with products containing diphenhydramine, or Benadryl, as the public may be unaware of the differences in active ingredients, and be vigilant to repeated requests for these products, or requests for large quantities, and monitor sales on a regular basis. If pharmacy teams are receiving increased requests for OTC diphenhydramine or Benadryl products, and are concerned about the potential misuse of them, please inform the NPA Pharmacy Services team via email pharmacyservices@npa.co.uk;…

Free COVID-19 PPE for the frontline – Register with the PPE Portal

COVID-19 is classed as the PPE that providers are using over and above business as usual (BAU) use, due to COVID-19 infection control guidance, rather than what would have been used pre-pandemic. While such PPE requirements will vary according to settings, contexts and individual circumstances, the PPE Portal’s order limits can serve as an indicative approximation of such requirements (especially where providers may be in doubt). Eligible primary care providers in England (including community pharmacists, optometrists, dentists, orthodontists and GPs) should now order PPE through the portal, free of charge, to meet the increased need that has arisen as a result of the COVID-19 pandemic. The DHSC has partnered with the NHS and the e-commerce industry to develop this service in order to ensure that those on the frontline have what they need. The overriding priority is to protect people and our wider communities, thereby reducing infections and saving lives. We must make sure everyone has the PPE they need so please do play your part in this collective effort. Register and access the portal using your CQC/MHRA/NHSE/NHS BSA registered email. The latest guidance on what PPE items you can order (including order limits) is also available. Call the customer service team on 0800 876 6802 if you have any questions about using the PPE portal (including registration and queries or if you think you should have been invited but have not been).…

NPA supportive of temporary authorisation of the supply of unlicensed products in interest of public health

The NPA, which responded to the consultation, said it is supportive of the proposal by the Joint Committee on Vaccination and Immunisation (JCVI) on advising the government to use a tested but unlicensed vaccine against Covid-19 in the interest of public health. Helga Mangion, Policy Manager at the NPA said: “We are pleased with the reassurance from DHSE and MHRA of their commitment to robust scrutiny, objectivity and safety. “In our submission we reiterated the need for their objectives to be reviewed on a regular basis in line with new research and pandemic progression. “We foresee community pharmacies will also have a crucial role to play in ensuring as many people as possible get protected by any future coronavirus vaccine. “Provided the appropriate safety, quality and efficacy measures have been put in place, the NPA is supportive of the deployment of effective and legal mechanisms for bringing this pandemic under control.” The consultation which ran from 28 August to 18 September concluded that there will be three key changes to the proposals set out in the original consultation document, including; robust scrutiny of the impact of regulation 174A (which is the new power to impose conditions and dealing with their consequences); promoting objectivity by changing the ‘objective bystander’ test that relates to loss of immunity from civil liability; and creating an additional level of reassurance in relation to the expanded workforce.…

Pharmacies should be permitted to conduct COVID antibody tests, says NPA

The NHS itself is now offering antibody tests to a limited population (in England this is people working in adult social care), with the patient taking a finger prick blood sample themselves at home. Community pharmacies should be allowed to offer tests as long as they comply with the relevant devices regulations as set out by Medicines and Healthcare products Regulatory Authority (MHRA), says the NPA. NPA board member, Olivier Picard, said: “We now have a situation where members of the public can take a sample themselves in their own home and find out whether they have Covid-19 antibodies, but a qualified pharmacist cannot administer a test within a registered pharmacy. This inconsistency makes no sense and its time Public Health England updated its guidance to catch up with the facts on the ground. “Many people want to have Covid-19 antibody tests, in order to understand what has – and has not – happened in their body. In particular, people who have experienced ill health in recent months can use an antibody test to determine whether the symptoms they experienced might be due to the effects of Covid-19. A negative result could in turn lead them to ask themselves whether there is an underlying health problem unrelated to coronavirus, and seek professional help if necessary.…