Issue 36 - June 2020
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Welcome to June's edition of Tablets, a prescribing newsletter produced monthly by the Medicines Management team at Midlands and Lancashire CSU.



The Midlands and Lancashire CSU has a dedicated COVID-19 webpage which is updated daily.

Please note that this information is up to date at the time of publication. 

The list of resources will be updated as new material becomes available so please check back regularly for updates.

This page groups the resources by subject matter. The same list of resources is also available grouped by the organisation that issued it.

COVID-19 Resources

Safety Update

Please click here for a summary of safety updates and SPC updates in May.

European Medicines Agency (EMA) review finds risks of Ingenol mebutate (Picato) for actinic keratosis outweigh benefits
05 May 2020
Review compared Picato with imiquimod. After 3 years, 6.3% of patients treated with Picato (15/240) developed skin cancer, particularly squamous cell carcinoma, in the treated skin area vs. 2% of imiquimod patients (5/244 patients). 

Yellow Card Reporting Site For Healthcare Products Used In Coronavirus (COVID-19)
05 May 2020
The Medicines and Healthcare products Regulatory Agency (MHRA) has launched a dedicated Yellow Card reporting site for healthcare products that are used in Coronavirus (COVID-19) treatment to be easily reported:

Chiesi release batch specific variation for Clenil 100 microgram inhaler owing to temporary increased demand
06 May 2020
To address the current increased demand of Clenil Modulite 100mcg additional batches are to be released into the UK supply chain following authorisation by the MHRA for a batch-specific variation. The batches are beige and yellow (as opposed to brown and beige).

PRAC concludes review of new information on the known risk of breast cancer with hormone replacement therapy
15 May 2020
The European PRAC has recommended updating the current safety information for HRT, following new evidence confirming the known higher risk of breast cancer, and suggesting this may continue to be increased for at least 10 years after stopping, if it has been used for >5 years.

Valproate Pregnancy Prevention Programme: temporary advice for management during coronavirus (COVID-19)
22 May 2020
This Drug Safety Update discusses recent guidance issued for specialists to support adherence to the pregnancy prevention requirements for girls and women of childbearing potential taking valproate during the pandemic, particularly those shielding due to other health conditions.


Prescribing News

NICE Rapid Guidelines May 2020

There have been four rapid guidelines and evidence reviews and two evidence summaries related to COVID-19 published in May 2020 by the National Institute for Clinical Excellence which has impact upon primary care.

The COVID-19 rapid guideline: rheumatological autoimmune, inflammatory and metabolic bone disorders guideline has been updated and published. The updated guideline highlights factors to consider when considering temporarily stopping some drugs for children and young people.   

The COVID-19 rapid guideline: children and young people who are immunocompromised guideline has been updated and published. The update aims to maximise the safety of children and young people who are immunocompromised during the COVID-19 pandemic.

The COVID-19 rapid guideline: chronic kidney disease guideline has been updated and published. The update aims to maximise the safety of adults with chronic kidney disease during the COVID-19 pandemic.

The COVID-19 rapid guideline: interstitial lung disease guideline has been updated and published. It aims to maximise the safety of adults with interstitial lung disease, including idiopathic pulmonary fibrosis and pulmonary sarcoidosis, during the COVID-19 pandemic.  

The COVID-19 rapid evidence summary: angiotensin-converting enzyme inhibitors (ACEIs) or angiotensin receptor blockers (ARBs) in people with or at risk of COVID-19 evidence summary has been published. This analysis found two observational studies that were of poor quality and subject to bias and confounding. As such conclusions cannot be drawn without further research.

The COVID-19 rapid evidence summary: Long-term use of non-steroidal anti-inflammatory drugs (NSAIDs) for people with or at risk of COVID-19 evidence summary has been published. A literature search identified no evidence from published scientific studies. However, it is noted that NSAIDs and COVID-19 can both contribute to respiratory, cardiovascular, and renal complications.

Clinicians should be aware of these guidelines and implement any necessary changes to their practice. 

CKS Updates May 2020

During the month of May 2020, the following Clinical Knowledge Summaries were published or updated: The Sprains and strains topic has been restructured and recommendations have been updated in line with current evidence.
Clinicians can use the updated and new information when reviewing patients.
The information in the Prescribing News section has been adapted from the Prescribing Advice for GPs blog

Useful Resources 

Drug Availability

Products in Short Supply and Product Discontinuations

The following links provide prescribers with up to date information on commonly prescribed products which are currently in short supply from the manufacturers.
The information held on these lists is not exhaustive. Availability can vary geographically and also between wholesalers. Up-to-date information should be sought from manufacturers, local community pharmacies and suppliers.

Supply Issue Update for Primary and Secondary Care

Registered users can access the monthly drug availability update for primary and secondary care produced by the Department for Health and Social Care (DHSC), on the Specialist Pharmacy Service (SPS) website. 

Please note you must be registered with SPS, with the relevant permissions, and logged in to view this page. Click on ‘sign in’ in the top right hand.

Drug Tariff Changes

Drug tariff price changes for June are summarised as the top 10 price reductions and top 10 price increases since last month, the top 25 increases and decreases compared to three months ago, and the top 50 changes since last year.

Antimicrobial Update

Please click here for a full summary of antimicrobial related guidelines and SPC updates in May.

Oral fluconazole use in the first trimester and risk of congenital malformations: population based cohort study 
Study of 37,650 pregnancies exposed to oral fluconazole and 82,090 to topical azoles found oral fluconazole use in first first trimester not linked to oral clefts or conotruncal malformations, but was linked to musculoskeletal malformations (RR 1.30; 95% CI, 1.09 to 1.56). 

Cardiovascular Toxicities Associated with Hydroxychloroquine and Azithromycin: An Analysis of the World Health Organization Pharmacovigilance Database 
Reports of potentially lethal acute cardiac proarrhythmogenic effects leading to ventricular arrhythmias have been described mainly with azithromycin but also with hydroxychloroquine. Their combination yielded an even stronger signal. 

Systematic Review

Reappraisal of the treatment duration of antibiotic regimens for acute uncomplicated cystitis in adult women: a systematic review and network meta-analysis of 61 randomised clinical trials 
Review of 61 RCTs (n=20,780) suggests shorter courses of third- and fourth-generation fluoroquinolones than that currently recommended are associated with similar effects; evidence for third generation cephalosporins and co-amoxiclav was of low quality. 

Media and Commentaries

Vaccine update: issue 307, April 2020, World Immunization Week 
This issue discusses European and World Immunization Week, maintaining immunisation services during the COVID-19 pandemic, managing locally held vaccine stock in primary care, school-age immunisation programmes, PPV and PCV13 schedule changes, and other topics. 

RCGP TARGET antibiotics newsletter May 2020
This issue provides an update on resource development, COVID-19, ongoing research and recent publications.

Influenza season 2019/20: ending the prescribing and supply of antiviral medicines in primary care 
Circulation of influenza in the community has returned to baseline levels, therefore prescribers in primary care should no longer prescribe antiviral medicines, for the prophylaxis and treatment of influenza, and community pharmacists should no longer supply antiviral medicines. 

The national flu immunisation programme 2020/21 
This letter sets out which groups are eligible for flu vaccination this and sets out actions to prepare for this autumn’s vaccination campaign. Further guidance will be issued in September 2020, nearer the planned start of the programme. 

Urinary tract infections in children 
This review article covers incidence, pathophysiology, treatment of upper and lower urinary tract infection, and investigation of atypical and recurrent episodes. 

Lyme borreliosis: diagnosis and management 
Review covers early signs, late manifestations, diagnostic factors and management options of Lyme borreliosis, the most common vectorborne disease in the northern hemisphere. 

PrEP to be phased into routine commissioning across England during 2020/2021 
Rollout of PrEP from a trial to routine commissioning was supposed to happen in Apr 2020, however, in light of COVID-19 pandemic, the DHSC has confirmed to The Pharmaceutical Journal that routine commissioning of the drug has been delayed, with phased rollout in 2020/2021. 

Summary of Product Characteristics Updates

Avelox (moxifloxacin) tablets 
Delirium (rare), pancytopenia, SIADH, hypoglycaemic coma (very rare), acute generalised exanthematous pustulosis and rhabdomyolysis (frequency unknown) have been added as potential adverse effects of treatment. 

Bexsero Meningococcal Group B vaccine for injection in pre-filled syringe 
SPC updated to include new dosing recommendations for primary immunisations in infants from 2 months of age. The dosing schedule is either 3 doses of 0.5 ml with an interval of not less than 1 month, or two doses of 0.5 ml with an interval of not less than two months.  

Colomycin 1 and 2 million International Units (IU) Powder for solution for injection, infusion or inhalation
SPC now includes information on drug delivery characteristics for three different nebulisers, technique for reconstituting the product, appearance of the final prepared product, and precautions for appropriate method of inhalation, and an update to solvents for reconstitution. 

Fasigyn (tinidazole) 500mg film-coated tablets 
SPC notes tinidazole is contraindicated in the first trimester of pregnancy. There is no evidence it is harmful during the latter stages, but it should only be used in the second and third trimesters where absolutely necessary. Animal data on fertility has been added. 
Please note that the information in this newsletter is correct at the time of publication.
Clinicians should always refer to the most up to date information.

Kieron Donlon: - 0151 296 7076

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