Hopefully a short rant this time!
What is Medsafe?
Medsafe is New Zealand’s medication regulatory authority. Except in a few cases all the medications on sale in New Zealand, and certainly any you see on shelves or advertised, have Medsafe approval.
This is a very important role - Medsafe ensures medicines meet the quality and efficacy the manufacturers claim, is safe to use in the way the manufacturer has specified, has appropriate guidance for patients and prescribers, and has a secure distribution network.
So why is this a problem?
Medsafe is industry funded. That is, to sell a medication in New Zealand you first have to pay Medsafe for the privilege of approval, supply all the documentation that Medsafe require, and wait for Medsafe to process your application.
This process can cost from NZ$10,000 to over $100,000 depending on the category of medicine. Medsafe do not recognise any overseas approvals.
The end result is unless a manufacturer or importer can justify the cost of Medsafe approval they won’t apply for it. Medications that are perfectly usable are unavailable in New Zealand because the cost is too high. This can be seen with the current oestrogen patch shortage - two brands which are just as effective as the only approved one are being prescribed under Section 29 of the Medicines Act, but they’re unapproved because there isn’t the demand to pay for Medsafe approval.
What about Section 29?
Section 29 allows for registered doctors - not nurse practitioners, dentists, or other medical practitioners who could prescribe an approved medicine - to prescribe medicines without Medsafe approval.
However, when something is prescribed under S29 the name of the patient, prescriber, supplier, and the medicine have to be sent to the supplier, who must store this information and forward on information about the medicine supplied (but not patient details) to Medsafe.
This means any supplier of S29 medicines has to maintain a database of what they’ve supplied and who they sent it to. Which isn’t great for things like hormones…
Additionally doctors seem wary of prescribing under S29 unless they’re really familiar with the medication. I don’t know why.
How could we address this?
Make Medsafe work for the health of New Zealanders, either by funding its work or by recognising overseas authorities. We collaborate with Australia on food regulations, why not medication?
Of course these things take far too long. It was recommended that the maximum length for a prescription be increased from three months to six, and from one to three for controlled drugs. Only the latter has actually happened. At least they’ve dropped the $5 kick-in-the-teeth when you’re sick charge.
With the shortage of Estradot I’ve seen quite a few people wondering what all the different ways medication is described in New Zealand actually mean. What is an unapproved medication? What is a special authority? Hopefully I’ll answer that!
This isn’t an exhaustive list, just the ones you’re likely to see.
Funding (and Pharmac)
Lets start with the funding because it’s the easiest to understand, this comes from Pharmac - the buyer of most medication prescribed in New Zealand. There are four common funding states - unfunded, partially funded, fully funded, and special authority.
I’m only discussing the community schedule which you can handily search online - just put a medication brand or generic name in the search box to find out the funding status.
Pharmac have a set budget so fund the medications they believe will have the most impact for the amount they cost.
This is the easiest one - unfunded medications do not have any funding from Pharmac, you’ll pay the full market price.
Some less-common medications attract partial funding, for example some preparations of povidone-iodine are partially funded, so you’ll pay the market price less the Pharmac funding. For example Betadine Skin Prep attracts a $1.63 subsidy but the remainder has to be paid by the patient.
This is the most common state for medications prescribed in New Zealand. These are the ones that (from July 2023) are free to collect from the pharmacy as Pharmac pays the full cost of the medicine. However…
Sometimes there are funding restrictions, generally due to cost of medicine or likelihood of wastage. A great example is the Estradot oestradiol patch. These are funded for a maximum of two per week, or 8 per 28 days, so if you need 200mcg at a time you have to pick up the second pack yourself. Fortunately this is only around $18 per 8 patch box.
These restrictions are only on quantity supplied - either minimum, maximum, or only in whole packs.
For both partially and fully funded medications Pharmac will fund any use, they just pay the pharmacies. However there’s a case where they do care about the reason, so we have
Special Authority funding is for medications where Pharmac only fund for specific conditions or cases. These require a form to be filed with the pharmacy and Pharmac to get the subsidy - which may be full or partial - and a renewal of authority on a schedule. An example that comes to mind is the ADHD medication Concerta. Concerta is only available for patients who have some reason to not take the immediate-release versions, either addiction liability, lack of response, or an allergy to the ingredients (Ritalin IR contains wheat!).
Special Authority doesn’t prevent prescription, only Pharmac subsidy. The Utrogestan brand of micronised progesterone used to be special authority for funding (only specific cases of menopausal HRT) but could be freely prescribed, as long as patients would pay the full price (around $25 for 28 days if I recall).
So that’s funding. However funding isn’t the full picture, what about approved and unapproved? Section 29? These are nothing to do with Pharmac, so now we introduce the other half of the equation, Medsafe.
Approval (and Medsafe)
Medsafe are the regulator of medicines in New Zealand. Most medicines have MedSafe approval and approved indications, but practitioners can prescribe unapproved medicines. So lets look at these
Medsafe are an industry-funded government department, this means that if you want an approved medicine in New Zealand you have to pay the Medsafe fee. It costs between $50,000 and $110,000 to get a medication approved, plus the costs of getting the required data in to the format Medsafe need. This means that manufacturer or importer won’t apply for approval for medication unless they think they’ll be able to make their money back.
As an aside, Medsafe approval only covers conditions specified in the application for approval. However nothing stops an approved medication being prescribed for an unapproved indication - also known as “off label” - such as bupropion which is only approved as an aid to smoking cessation but is also used as an antidepressant.
Unapproved medications and Section 29 of the Medicines Act 1981
Because approval is industry-driven when they wrote the Medicines Act they realised that sometimes an unapproved medicine will be needed, for example with rare conditions or new medicines before approval is obtained. So Section 29 allows any doctor (specifically a doctor, not a nurse practitioner or pharmacist) to prescribe any unapproved medicine. However this must be reported to Medsafe by the supplier, Medsafe use this to monitor the use of unapproved medicines and direct practitioners to use approved ones where possible.
Section 29 prescriptions are for a named patient and a specific brand, so pharmacies can only supply the exact brand and quantity asked for (or an approved generic substitute, but in general that wouldn’t happen for an S29 prescription).
Additionally Section 25 allows a practitioner or pharmacist to import a medicine not otherwise available in New Zealand.
How this relates to Estradot
Estradot - and oestradiol patches in general - are in short supply worldwide. Estradot is the only patch that is approved for sale by Medsafe, and also fully funded (*with restriction to one pack per month 😞) by Pharmac.
Due to the shortage Pharmac have sourced alternate patches, Estraderm MX and Oestradiol TDP Mylan, but these are unapproved. This means there’s an odd situation where a doctor has to prescribe Estraderm MX under S29, but these are still fully funded because approval and funding aren’t linked. Pharmacies can legally substitute approved Estradot for unapproved Estraderm MX, but not the other way around.
I hope this makes things a little more clear…
An aside - controlled drugs
Completely unrelated to the above, controlled drugs are specified by the Misuse of Drugs Act 1975. There is no prohibition for prescribing controlled drugs - and in fact all classes of controlled drugs are available if hospital only use is considered. Medsafe and Pharmac do not consider the controlled status, only the medical utility. Controlled drugs can be prescribed under S29 if the prescriber can justify the use - this is how medicinal cannabis is currently managed.