Browse bulletin items by A-Z

Published: 26 November, 2021


Contents

A century of insulin

100 years ago at the University of Toronto, researchers began experiments that would revolutionise the management of patients with diabetes. Insulin, as it was soon called, was a life-saving treatment and the early trials were described as “nothing short of miraculous”. The impact of this discovery for millions of people with diabetes cannot be overemphasised. The crucial role of researchers at the University of Toronto is documented here and provides an interesting insight into the initial work and also the ongoing advancements in medicine that resulted.


COVID-19 vaccination in pregnancy: no safety concerns with Pfizer vaccine

Medsafe and the COVID-19 Vaccine Independent Safety Monitoring Board (CV-ISMB) have found no safety concerns when the Pfizer vaccine is administered during pregnancy. There are significant risks associated with COVID-19 infection in pregnancy to both the mother and baby including an increased risk of severe infection, death and pre-term birth. The infant is also more likely to require neonatal intensive care and pregnant women are three times more likely to require ICU treatment compared with non-pregnant women.

In New Zealand approximately 10 – 20% of pregnancies result in miscarriage. The Centre for Adverse Reactions Monitoring (CARM) received 17 reports (up to 27 October, 2021) of miscarriage in women who received the vaccine while pregnant which is lower than the expected rate. The CV-ISMB has found no evidence to suggest that the Pfizer vaccine increases the risk of miscarriage.

The available safety information supports routine vaccination with the Pfizer COVID-19 vaccine during pregnancy. Click here for further information on COVID-19 vaccination during pregnancy, breastfeeding and for those planning pregnancy. The Ministry of Health and Immunisation Advisory Centre (IMAC) also have an information page covering some common queries about vaccination during pregnancy and breastfeeding.

N.B. Medsafe and the COVID-19 Vaccine Independent Safety Monitoring Board (CV-ISMB) have also released a statement about the lack of any evidence of a link between administration of the Pfizer vaccine and menstrual disorders or unexpected vaginal bleeding.


Thrombosis versus thrombosis with thrombocytopenia (TTS) following COVID-19 vaccination

Medsafe has produced a resource for healthcare professionals to distinguish between thrombosis and thrombosis with thrombocytopenia syndrome (TTS) following COVID-19 vaccination. TTS has been associated with adenovirus vector-based vaccines, e.g. AstraZeneca and Janssen, and is not currently associated with mRNA vaccines, e.g. Pfizer.

From 26 November, 2021, the AstraZeneca vaccine will be available to people in New Zealand aged 18 years and older who cannot receive the Pfizer vaccine or for those who would like a different vaccine. Although TTS is rare (approximately 1 in 100,000 people), it is important that clinicians know how to identify and manage the condition, and that patients are aware of the symptoms and signs to look out for. Click here for a patient handout.

The Centre for Adverse Reactions Monitoring (CARM) received 107 reports* of thrombosis after COVID-19 vaccination up to 28 September, 2021, which is lower than the expected background rate in New Zealand (approximately 800 per 1,000,000 people). Thrombosis is not currently considered to be an adverse effect of the Pfizer vaccine.

*A report following vaccination does not necessarily imply a causal link to the vaccine, often these events occur coincidently

Treatment for TTS is different to the standard treatment of thrombosis and should not include heparin, for screening and treatment advice see: https://www.thanz.org.au/documents/item/590.

To read more about the risk of thrombosis and TTS with the AstraZeneca vaccine, see Bulletin 24.


Preparations containing bufexamac should be disposed of

Medsafe has announced that the consent to distribute topical products containing bufexamac was revoked on 9 November, 2021, following a recommendation from The Medicines Adverse Reaction Committee (MARC), based on safety concerns related to serious skin reactions. Bufexamac is a topical NSAID contained in creams used for the treatment of insect bites, stings, itches, minor burns and sunburn. Two products were previously available in New Zealand (Antiseptic Soothing Cream and Paraderm Plus Topical Cream), however, these are no longer available. Patients should be advised to return any unused product to their pharmacy for disposal, including any product they have acquired directly from overseas.


PHARMAC to fund biosimilar adalimumab

PHARMAC has announced that they are to fund Amgevita, a biosimilar adalimumab from 1 March, 2022. A biosimilar is a comparable version of a biological medicine (the innovator – in this case Humira) that already has regulatory approval, i.e. the reference medicine. From 1 March, 2022, patients currently taking Humira should be changed to Amgevita and for any new patient, Amgevita will be the only funded option. Changes to Special Authority criteria for Amgevita include widened access criteria, removal of dosing restrictions and extension of the renewal time period to two years. Amgevita is an approved medicine in New Zealand and is widely prescribed internationally. It is a citrate-free formulation which is likely to reduce the injection site pain that some patients experience with Humira.

For further information on biosimilars see “Biosimilars: the future of prescribing biological medicines"


PHARMAC medicine supply issues

The following issues relating to medicine supply have recently been announced by PHARMAC


Paper of the Week: ACE inhibitors and ARBs can prevent new-onset type 2 diabetes

Lowering blood pressure is a well-known strategy to prevent the vascular complications of type 2 diabetes. Until now, the role of blood pressure lowering in the prevention of diabetes has been uncertain.

An individual participant data meta-analysis was performed from 19 randomised controlled trials (including 145,939 participants) between 1973 and 2008 and concluded that blood pressure lowering was effective at preventing new-onset type 2 diabetes; angiotensin-converting enzyme (ACE) inhibitors and angiotensin II receptor blockers (ARBs) showed the strongest protection, whilst beta-blockers and thiazide diuretics increased the risk of new-onset type 2 diabetes.


If you have any information you would like us to add to our next bulletin, please email: editor@bpac.org.nz

ASK A COLLEAGUE: Are they receiving these bulletins? Sign up to our mailing list here

Made with by the bpacnz team

Partner links