Published: 26 June, 2020
Contents
Top 10 bpacnz articles
Our ten most viewed resources by website users in New Zealand over the last 12 months were:
- Antibiotics guide
- Contraception series
- Primary care update series
- COPD prescribing tool
- Melatonin: is it worth losing any sleep over?
- Vildagliptin: a new treatment for type 2 diabetes
- A rising tide of diabetes in younger people: what can primary care do?
- What's new in cardiovascular disease risk assessment and management for primary care clinicians
- Weight loss: the options and the evidence
- Topical antibiotics for skin infections: when are they appropriate?
COVID-19 case definition updated
The Ministry of Health has updated the
case
definition for testing for COVID-19 infection. People who are symptomatic and meet the criteria for
a "Higher Index of Suspicion (HIS)" are prioritised for testing, e.g. recent international travel, contact with a probable or confirmed case,
worker at international airport. Other people presenting to primary care with symptoms consistent with COVID-19 should be encouraged to be
tested even if they don't meet the HIS criteria.
A Ministry of Health COVID-19 information page for primary care, including a quick reference guide to the latest changes, is
available
here.
New asthma guidelines published
The Asthma + Respiratory Foundation NZ guidelines for the management of adults and adolescents with asthma have just
been published today in the New Zealand Medical Journal. These guidelines, along with the newly updated asthma management
in children guidelines, are also available on the
Respiratory Foundation website.
bpacnz will be publishing articles on these new guidelines within the next few weeks.
Fluoxetine brand change
The funded brand of fluoxetine is changing from Arrow-Fluoxetine to Fluox (both are generic brands):
- June, 2020 - Fluox 20 mg dispersible tablets available
- September, 2020 - Fluox 20 mg capsules available
Stock of dispersible tablets has been low. Stock shortages of fluoxetine capsules earlier in 2020 caused an increase in demand for tablets.
As a result, stocks of the Arrow-Fluoxetine dispersible tablet have been low. PHARMAC
reports that the Fluox brand of dispersible tablet is now being distributed to pharmacies, therefore resolving the stock issue.
Supply of fluoxetine 20 mg capsules is available. Arrow-Fluoxetine is expected to be supplied until approximately September, 2020 when the Fluox brand becomes available.
N.B. Ideally, fluoxetine tablets should only be prescribed to patients who cannot swallow capsules or who require a low dose of fluoxetine, i.e. half a tablet.
Further information about fluoxetine changes is
available here.
New regulations for prescribing medicinal cannabis products
Medicinal cannabis products are defined as any product containing substances extracted from cannabis for therapeutic
use. Sativex is currently the only Medsafe approved medicinal cannabis product in New Zealand. New regulations have
now come into effect, to improve the prescribing process; the aim is to streamline the approval of products, while ensuring
a minimum quality standard, via the recently established Medicinal Cannabis Agency. As of 1 April, 2020, any practitioner
can now prescribe Sativex and any other medicinal cannabis product that meets the quality standards*, for any indication
(within their scope of practice and where there is a clinical need).
* No applications for product assessments have currently been received by the Medicinal Cannabis Agency
Read more
Until recently, Sativex could only be prescribed without external approval as an adjunct treatment for people with
moderate to severe spasticity due to multiple sclerosis. Prescribing Sativex for off-label use, or prescribing any
other medicinal cannabis product, required case-by-case ministerial approval.
From 1 April, 2020. All practitioners can now prescribe any medicinal cannabis product that meets
the Medicinal Cannabis Agency minimum quality standards, for any indication (within their scope of practice and where
there is a clinical need), without ministerial approval or specialist recommendation. To date, no applications have
been received by the Medicinal Cannabis Agency for product assessment; in the future, any products that meet the
standards will be listed on this page.
Between 1 April and 1 October, 2020. A six-month transition period will exist allowing current prescribing
(e.g. existing prescription with Ministerial approval) and supply rules to continue. From 1 October, suppliers will
need to provide evidence of products meeting the quality standards to continue supplying them. N.B. this is separate
to the Medsafe approval process for medicines; a product that meets the Medicinal Cannabis Agency quality standards
is not an approved medicine and is not necessarily currently available in New Zealand.
All patients must have a prescription to be supplied a medicinal cannabis product. Prescriptions should:
- Be handwritten on a controlled drug prescription form (except for CBD products which are not classified as controlled drugs – see below)
- Specify the brand and prohibit any generic substitutions
- Not be for a product in a form intended for smoking
- Not be for a product meeting the definition of "food"under the
Food Act 2014
- Not be for a product in a sterile dosage form, e.g. eye drops
- Be prescribed under Section 29 of the Medicines Act if an unapproved medicine
- Be for no more than a one-month supply if an unapproved medicine
- Be for no more than a three-month supply if an approved medicine, i.e. only Sativex currently, or a CBD product
Dispensing of prescriptions can be done via a pharmacy, or through direct supply. If a medicinal cannabis product
does not meet the minimum quality standard, or is awaiting review, it can still be prescribed if ministerial approval
and specialist recommendation is obtained. In this instance, products will need to be imported directly to supply
to the patient.
What are CBD products and how do they differ?
Cannabidiol (CBD) products are still a type of medicinal cannabis product, however, they are not classified as controlled drugs under the
Misuse of Drugs Act 1975. This is because CBD products mainly contain the non-psychoactive CBD from cannabis, and less than 2% of the total
concentration of active cannabinoid components can be tetrahydrocannabinol (THC) or other related psychoactive substances.
Evidence for medicinal cannabis use
Medicinal cannabis products are often considered a “last resort” once other conventional treatment options have
been exhausted. It is likely that interest will widen as a result of the new regulations. There is some limited
evidence that medicinal cannabis products may be effective in the treatment of conditions such as:
- Chronic pain (particularly neuropathic)
- Spasticity associated with multiple sclerosis
- Seizures associated with refractory epilepsy
- Chemotherapy-induced nausea and vomiting
However, the quality of evidence derived from clinical trials is not considered to be strong, with heterogeneity existing between the methodology
and results of different studies. While the short-term effects of medicinal cannabis products are generally mild and well tolerated, additional
research is required to understand the impact of long-term use. As such, it is important that prescribers investigate the evidence for/against
each indication, so they can make an informed decision along with the patient as to whether a medicinal cannabis product is appropriate.
2019 position statement from the Royal Australian College of General Practitioners (RACGP) on the use of medicinal
cannabis products is available here.
For more information on the new regulations and prescribing, visit the Ministry
of Health or Medsafe websites.
Paper of the week: Should probiotics be recommended to patients with gastrointestinal conditions?
Over the last twenty years there has been a boom in the production, marketing and use of probiotics based on their
reported health benefits. However, there has been little objective guidance for clinicians about appropriate use of
these products. The American Gastroenterological Association (AGA) has just released a clinical practice guideline examining
the role of probiotics in patients with gastrointestinal conditions.
The main findings were:
- There are significant knowledge gaps in the current evidence
- For the majority of gastrointestinal conditions, probiotics
have not been found to be either safe or effective
Read more
- There was low-quality evidence that some probiotic strains or combinations of strains may help to prevent infection
with Clostridium difficile for both adults and children, however, there is a potential for harm especially
for people who have severe illnesses or who are immunosuppressed.
- Similar findings of low-quality evidence or knowledge gaps also applied to patients with irritable bowel disease
or inflammatory bowel disease, and for treatment in those with confirmed C. difficile infection.
- Although there was some evidence of benefit in children with acute infectious gastroenteritis, the group recommended
against the use of probiotics in these patients (two high quality North American studies did not show any benefit).
- The one area where there was reasonable quality evidence (moderate-high) of benefit was for probiotics containing Lactobacillus species
and Bifidobacterium species in the prevention of necrotising enterocolitis (NEC) in preterm, low birth-weight
infants.
This analysis differed from many other systematic reviews and meta-analyses on this topic because “probiotics”
were not assessed as a single group and instead the effect of individual strains or combinations was examined. It
is now widely accepted that biological effect of probiotics is specific to a species or even a strain and individual
effects therefore cannot be extrapolated to all probiotics.
However, the authors acknowledge several issues with the current evidence that makes it difficult
to provide clear recommendations including:
- Significant heterogeneity between studies
- Wide variability in the probiotic stains studied
- A lack of consistency in reporting harms
- Poor understanding of the mechanism(s) resulting in benefit or harm
- A lack of detailed information about the products themselves
- Limited regulatory requirements for over-the-counter products
It is expected that in the future if high-quality studies can address some of the issues outlined above then the
recommendations for clinical practice may change.
Su G, Ko C, Bercik P, et al. AGA Clinical Practice Guidelines on the role of probiotics in the management of gastrointestinal
disorders. Gastroenterology 2020; [EPub ahead of print]. doi: https://doi.org/10.1053/j.gastro.2020.05.059.
This Bulletin is supported by the South Link Education Trust
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