Every so often articles pop up claiming that transgender hormone therapy is “experimental” or “unapproved”. HRT has been used by transgender people since the 1950s, so it definitely isn’t experimental though like all medicine it’s always improving. However it is “unapproved”, or, as it’s more commonly known, off-label.
This isn’t strange though, many medicines are used off-label. One that I’ve had before is bupropion which comes in multiple brands with different approvals. The only approved brand of bupropion in New Zealand is Zyban, and its approval is only for an aid to quit smoking in 150mg doses. Overseas the Wellbutrin XL brand, which has the same active ingredient and same doses as Zyban, is approved as an anti-depressant. Because Wellbutrin isn’t approved in NZ doctors just prescribe Zyban, this is off-label but backed by overseas approvals.
Bupropion is also used for ADHD. While this is backed by emerging research it isn’t approved for ADHD treatment anywhere, so all ADHD treatment with Zyban is off-label.
Using approved medicines for off-label uses is permitted under NZ law at the discretion of doctors, the safe treatment levels and side effects are established so the risk is minimal. Unlike completely unapproved medicines there’s no special requirement to record these prescriptions.
So why don’t manufacturers apply for these uses? Because it costs money. To get approval in NZ you need a sponsor in the country - normally the importer - and have to submit all the documentation to Medsafe, pay them, and wait. While overseas approvals do help the process they aren’t automatically recognised. So if you make Wellbutrin are you going to go through this, knowing that Pharmac won’t fund it because they already fund one sort of bupropion? Nope. If you make Zyban are you going to pay for the update to the approved indications and submit all the documentation given that doctors can already prescribe? Unlikely.
The only time the Medsafe fee is worth paying is for medicines advertised direct to consumer, as only approved indications can be advertised. This also applies for advertisements sent to clinicians, but there are ways to avoid that and clinicians do read published studies so are likely to be aware of changes.
So where does this leave HRT? The market is small, so the expensive studies required are both hard to justify and hard to find participants for, the medicines are already approved and available, and safe levels are established in literature (and given the hormones are bio-identical easy to validate). This means no manufacturer is going to go to the effort of getting their medicine approved for transgender HRT - menopausal HRT is the vast majority of its use.
Disclaimer: I’m not a medical professional, but I’ve got familiar with the terms from them. I hope this will help others understand what medical professionals mean.
I’m going to cover two things in this post, what informed consent means in the broader medical context and what it means to transgender healthcare.
What is informed consent?
Informed consent is the underlying basis of all modern non-emergency medicine. In order to provide any medical treatment the patient must consent to the treatment and the patient must be provided the risks, benefits, and method of the treatment, and the clinician must be sure the patient understands the information. This is one of those things that seems pretty obvious, but historically has been far from the truth.
So whenever you see a doctor and they prescribe any form of treatment there’s a mental checklist they do:
Has the patient been informed about this treatment, either now or in the past?
Does the patient understand this information?
Has the patient consented?
Of course humans are human and this isn’t done perfectly every time, so it’s repeated. This is why (good) pharmacists will check you understand the medicine as well, and surgeons re-check your understanding before they start the procedure.
There are two factors that aren’t quite obvious here. One is that for things like medicine you can opt not to take them, so full details don’t have to be provided in the appointment and instead an information sheet can be given to you. The other is that to understand if the patient understands the risks the clinician themselves must understand them, this is why sometimes you’ll be referred to a specialist to confirm a prescription even though it could have been done by the first clinician.
Informed consent in transgender healthcare
Now this is slightly different, it relates to the historical pathologisation of transgender people. This means requiring a formal diagnosis of gender dysphoria by a psychiatrist prior to commencing HRT, which may require several sessions withe the psychiatrist and historically the awful practice of “lived experience” - living full-time as your true gender prior to any form of medical treatment. Thankfully most areas in NZ don’t require psychiatric evaluation (looking at you Otago and Nelson) and lived experience is consigned to the history books.
So informed consent means two things here, first the medical basis of treatment, and secondly your ability to request gender-affirming treatment without any formal diagnosis - in fact being transgender is not considered a medical condition at all.
Of course the prescriber still needs to be sure you fully understand the effects and risks of HRT. This may mean requiring a psychiatric evaluation to ensure your understanding (but not for a diagnosis), or referral to a specialist gender centre. Both WPATH and PATHA are clear that withholding HRT is not a neutral stance and is likely to lead to worsening of mental health, but unfortunately this message hasn’t got through to everyone.
To be clear this is also true of any other medical treatment, but GPs tend to be much more risk-averse with conditions they haven’t encountered a lot. There are also some areas in NZ with particularly backwards health authorities who insist on psychiatric evaluations and other gatekeeping, even though this is against the national guidelines and the practitioners might be comfortable with evaluating by themselves..
And this is the cause of a lot of confusion. Informed consent means one thing to medical professionals and a similar but subtly different thing to the transgender community. While clinicians used informed consent to mean validating the patient’s understanding of the treatment, we use informed consent to mean removing the old barriers to treatment, so get very frustrated when these are still present.
Ideally patient-driven therapy would be more accepted, where patients can set their own hormone targets and clinicians monitor for unsafe dose levels or negative health effects. Unfortunately this is a significant step for healthcare providers and unlikely to happen, even though it would get people off DIY HRT on to safer methods. This wouldn’t be universal, a lot of people feel safer or just prefer having doctors set the treatment plan.
Lastly the lack of an actual diagnosis does put transgender healthcare in a slightly weird spot; it’s not considered a medical condition, but we still need medication. This does have some implications that I’ll explore in a later post.
I’ve now heard from multiple people that their doctors or endocrinologists have told them laboratory tests for oestrogen levels are either inaccurate or cannot detect exogenous oestrogen, so there’s either no reason to test or no reason to take action based on test results. This always seems to be used to deny increase in hormone doses, but for decreases the blood levels are always trusted. Interesting that…
What are we measuring anyway?
Oestrogen isn’t one substance, but the oestrogens we’re interested in are oestrone (E1) and oestradiol (E2). In general E2 is the predominant oestrogen in adults and the most common form for HRT. In New Zealand we only have tests for oestradiol available, which lines up nicely with what we want to measure.
What is HRT oestrogen?
All HRT oestrogen is oestradiol. There are two common forms of oestradiol in New Zealand, oestradiol valerate - the ester of valeric acid1 and oestrdiol - and oestradiol hemihydrate which is pure oestradiol with extra water in the crystalline structure (yes I’m vastly simplifying this) 2.
Oestradiol valerate is a prodrug - it is not biologically active, but it is metabolised in to oestradiol and valeric acid in the body 3. There’s no need to measure oestradiol valerate as it’s not active, only the oestradiol it’s metabolised in to.
Oestradiol hemihydrate doesn’t need any metabolism, it’s already oestradiol. The extra water is broken away as the oestradiol hemihydrate dissolves in to your bloodstream.
In both cases the biologically active component is identical to oestradiol produced in your body, so would be detected by any system that detects oestradiol.
Chances are you’ve used one! The general concept is the same as the COVID-19 self-test I’m sure many of us have used, except with far tighter tolerances so actual numbers can be derived. The basic principal is an antibody is developed that attaches to the desired molecule - oestradiol in this case - and the number of matches is counted. This is done by introducing a second competitive molecule that attaches to the same antibodies but fluoresces, then you can measure the light given off to determine the amount of antibodies that weren’t bound to the oestradiol. If you know how many antibodies you included in the first place and the amount of light each molecule will emit you can calculate the total oestradiol there must have been! Simple!
Not really. There’s a bunch of consideration here. The affinity of the antibodies for oestradiol, the sensitivity of the photosensor, the variability of fluorescence, how consistent the reagents are in antibody count, the potential for things other then oestradiol to also bind to the antibody, and a whole bunch of other things I don’t understand.
Fortunately modern laboratories can quantify these problems and produce error ranges for their assays. However there are limits to the detection, and different assays are often not comparable - that is if you use a single assay type you can compare the numbers, but if your lab changes their system then the numbers can’t be compared.
What assays does NZ use?
It’s hard to tell, labs don’t always disclose this which is quite annoying.
From what I’ve been able to find New Zealand’s labs have standardised on Roche assays 5. I found the Roche technical documentation on their oestradiol tests, and while I can’t be certain this is what the labs use it lines up with their stated performance and machines.
This assay can detect down to 18.4pmol/L, but can only accurately quantify levels over 91.8pmol/L. Even then their data tables show the measurements are only accurate to ±7% at 100pmol/L, but this improve to ±3% at 200pmol/L and ±2% by 500pmol/L. So a constant level may fluctuate slightly over multiple readings, but it’s good enough to establish trends over multiple tests. A single test with an unexpected level should be repeated though as there is a remote possibility for a bad read (However depending on the records the lab has about your gender they may have already done this). Additionally the amount of oestradiol in your blood will vary based on activity, time of day, diet, all sorts, even on a fairly constant dose system like patches.
So can we measure HRT oestradiol, and accurately?
Yes, we can detect HRT oestradiol. It’s identical to regular human oestradiol.
Yes, the tests used in New Zealand are accurate for levels over 100pmol/L. There will be variance because the tests aren’t exact, but they are accurate enough to establish trends - if your oestadiol levels are going up the results will trend upwards, or vice versa. Or be around the same values.
Valeric acid is named after the plant valerian, where it’s found in the roots. Valerian root is often used as a herbal sedative or sleep aid.
William Rosner, Susan E. Hankinson, Patrick M. Sluss, Hubert W. Vesper, Margaret E. Wierman, Challenges to the Measurement of Estradiol: An Endocrine Society Position Statement, The Journal of Clinical Endocrinology & Metabolism, Volume 98, Issue 4, 1 April 2013, Pages 1376–1387, https://doi.org/10.1210/jc.2012-3780
There was an interview on RNZ’s Nine to Noon programme this morning about why transgender patients are turning to DIY HRT. They had one of the doctors who works on the New Zealand gender-affirming healthcare standards on and her answers were infuriating to say the least. The mental leaps to go “we don’t prescribe injected HRT, therefore we don’t know its safety, therefore we don’t prescribe it” is astonishing, and her lack of acknowledgement of overseas experience just iced the cake.
That said, I decided to write down why injected oestrogen is different to the currently available patches and pills. This post contains maths!
In a nutshell, bioavailability. This is the term for how much of a medicine you take actually makes it in to your body in an effective form. For example, paracetamol has a bioavailability of 63-89%1. Why the range? Everybody’s different, some people absorb more than others, and some people have a more efficient liver.
So lets look at bioavailability of oestrogen, and I’ll include maths on my levels.
How much oestrogen do you need daily?
This has two factors, the target level in your blood, expressed in picomoles per litre (pmol/L) of blood, and the metabolic clearance rate. The metabolic clearance rate is the rate at which your body removes the substance from your blood, expressed in litres of blood that will be fully cleansed per day.
We’re interested in estradiol, since that’s the type of oestrogen used in most feminising hormone therapy. There’s no consensus on what a good target level is, so I’ll pick . NZ standards say is the upper limit 2, 350 is half that and co-incidentally (or not) the level I could achieve on oral oestrogen.
Annoyingly while estradiol is measured in moles per litre the medications are measured in grams, so we have to do some maths… The molar mass of estradiol is 3, and the typical adult has around 5 litres of blood, for a total of 1,750 picomoles of estradiol, or moles. Doing the math gives , or of estradiol total. Wikipedia says the metabolic clearance rate of estradiol is around 1200L/day, and given the previous calculation this means that of estradiol, or , per day would be needed to balance out the metabolic clearance rate.
Actually that would leave you with zero oestrogen, so lets make that to make sure there’s enough left at the end.
OK, what’s the point of all this?
Oral oestrogen (pills)
The main oestrogen in pill form in NZ is estradiol valerate. You can also get estradiol hemihydrate, but that’s only partially funded. When I was taking the pills my blood estradiol levels were around 350pmol/L, varying between 330 and 370 probably due to time since the dose.
I was taking 6mg daily. 6mg, for an active amount totalling 114.8µg the day. That’s 1.9%. 1.9% of the total estrogen I was taking was making it in to my bloodstream to have an effect. And yes, this is the expected amount, the documented bioavailability is <5%.
Why? The liver! All the blood that runs through your digestive system gets directed through your liver to remove anything toxic. One of the things your body really wants to keep out is hormones, and your liver is extremely good at this! (not as good as a hamster’s liver with alcohol, but that’s another topic). This means the only way to get estradiol in to your body orally is by taking so much that your liver simply cannot process it all, this isn’t dangerous to your liver but can interfere with metabolism of other drugs.
Also the pills are instant release, with a peak immediately following taking them which drops off by the next day. Having hormones do this isn’t great for your mental healt, and the peaks do mean oral oestrogens have a higher risk of blood clots than other methods.
Patches bypass the liver by using allowing the estradiol to diffuse through the skin in to the bloodstream, consequently the bioavailability is higher, and also the level is more stable because they release medication continually.
I’m on a 200µg/day patch at the moment (actually two 100µg/day patches because 100µg is the highest dose they make) and this gives me an estradiol level of 450nmol/L. Lets re-do the math above. . That gives 147µg/day, a bit shy of the 200µg they claim!
200µg in a Standard Human would give 600pmol/L, but there’s no such thing as a standard human. My liver might process a bit faster, I might have a bit more than 5L of blood, or my skin might be slightly less porous. Also despite being a more continuous dose patches still have an initial peak and slowly drop over their treatment window.
So what about bioavailability? The datasheet for the patches states they contain 1.64mg for the 100µg per day delivery, and they last 3.5 days. So of the 1.64mg, 0.3mg is effective, or about 18%. Ten times higher than pills!
And the downside? The glue! The glue is awful, it’s very hard to remove (rub baby oil in to it before you shower) but if you don’t it will irritate your skin, and some people have reactions to the adhesive. Also you can sensitise over time, which would force you to stop using patches.
Gel-based formulations have the same absorption issue, just no glue.
Interestingly the oestrogen is in the adhesive, getting oestrogen in to and out of plastic is extremely difficult.
How is this about injections again?
Intramuscular injected oestrogen is 100% bioavailable. If you listen to the doctors in New Zealand they’ll tell you that injected oestrogen results in supra-physiological peaks which increases the risk of blood clots, and they’re not wrong. However they’re ignoring the fact that this isn’t the case for all estradiol esters - compounds that contain estradiol that the body metabolises over time to release the oestrogen.
Lets look at the graph to the left sourced from Wikipedia4 and you will see that estradiol valerate has high peaks and is gone very fast, needing frequent injections. However the cypionate and enanthate esters have a much slower release profile, only needing injections every two weeks. This is not new research, the Wikipedia citations show it’s from the 1980s and 1990s! (Ignore the units, the USA uses pg/mL rather than pmol/L)
The slow and consistent release profiles of appropriate estradiol esters also allows for another possibility - monotherapy. Oestrogens are anti-androgenic, but the levels required are higher than is safe with patches or pills. For some people an oestradiol level of 600-700pmol/L - still within the known physiological levels - is enough to suppress testosterone levels without any anti-androgen, and anti-androgens have more side-effects than bio-identical oestrogen.
So the downside? You have to inject it every 10-14 days, assuming cypionate or enanthate esters. However type 1 diabetics have been self-injecting insulin for decades now, this is a solved problem. The other one, only estradiol cypionate is manufactured commercially and is not approved in NZ. See my post about Medsafe for more detail on that. Both estradiol cypionate and enanthate can be sourced from a compounding pharmacy though.
What about synthetic oestrogens?
Synthetic oestrogens are manufactured analogues of natural oestrogen. They can be tailored to bypass liver metabolism while still interacting with the oestrogen receptors in the body, a good example is ethinylestradiol which is widely used in contraceptive pills. Synthetic oestrogens aren’t considered a good option for transgender hormone therapy as they don’t bind to oestrogen receptors in the same proportion as natural oestrogens. While this isn’t a problem if you have plenty of your own oestrogen when you’re relying entirely on exogenous hormones this could present an issue. We know how bio-identical hormones work, because everyone alive has them!
As I’m a software developer I love edge cases… well, when I don’t have to deal with them anyway. Over the years I’ve learnt about the various types of business that exist in New Zealand. It’s a bit esoteric, but interesting to me so I’m going to write about it!
The most common businesses are sole traders - a person, partnerships - several people, and limited liability companies - a legal entity that pretends to be a person until you try to put it in jail. So here are some examples of none of the above!
First, lets look at the AA (or the New Zealand Automobile Association, inc. Not Alcoholics Anonymous). The AA is an incorporated society, this is a type of member-owned business that has to operate for the benefit of its members. Everyone who pays for an AA membership ‘owns’ part of the AA while their membership lasts, and everything the AA does must be for the benefit of its members - in the AA’s charter this is providing roadside assistance and advocacy for motorists. In addition an incorporated society cannot make a profit, and can only retain surplus funds if there’s a justification. In reality the AA’s main business is selling its membership database, but this subsidises the roadside rescue. Which is contracted out to the lowest bidder…
OK. What next? Fonterra! Fonterra is a producer co-operative*! This is another type of membership-owned* business, with ownership of the company being granted in proportion to the member’s contribution*, in the case of Fonterra the amount of milk each farmer produces* defines their ownership*. Unlike an incorporated society, a co-operative does make a profit, but this must be distributed to its members. So Fonterra’s job is to make the most money for the milk produced as they can, which is then distributed back to the CEO’s pocket the farmer’s in proportion to their ownership*.
What’s with the *s? Fonterra is weird and has special laws that make it different to other co-operatives. But for other producer co-ops like Tatua (dairy), Zespri (the kiwifruit people!) and the co-operative I used to work at, Ion Technologies (software consulting), don’t have the *s, though the exact way contribution determines ownership varies.
Speaking of co-operatives, The Co-operative Bank is a co-operative. It’s in the name! However it’s a consumer co-operative - it’s owned by everyone who deposits money in the bank, and consequently all profits get distributed back to the account holders rather than siphoned off to Australia (For anyone who knows a bit about finance, this sounds a lot like a credit union… but the Co-operative Bank, or rather its predecessor PSIS, is specifically excluded from being a credit union by law). Farmlands is also a consumer co-operative, the members are farmers who use their collective buying to get better deals.
What’s next? Another sort of co-operative! They’re everywhere! Foodstuffs - New World, PAK’nSAVE, Four Square etc - is a co-operative. Actually it’s two, one for the North Island and one for the South Island. So are ITM and Mitre10, but these are all vendor co-operatives. Their co-operative combines bulk purchasing and centralises advertising and branding to get a better deal for the store owners - not the consumers!
One last one, Southern Cross Health Society. It’s not an incorporated society like the AA, and it’s not a for-profit company. It’s a Friendly Society, which is yet another kind of member-owned business, but for specific kinds of mutual insurance. Unlike a for-profit insurer whose goal is to take in more fees than it pays out, Southern Cross has a legal obligation to only take in exactly as much as it pays out each year (plus administrative overheads). This is significant as some people regard for-profit insurance as gambling, but a Friendly Society is mutual aid.
Friendly Societies are regulated by the Friendly Societies and Credit Unions Act 1982. Credit unions? Yes, this is the act that specifically says The Public Service Investment Society Limited, or PSIS, or now the Co-operative Bank, isn’t a credit union, despite walking and quacking like one. Why? Alas I’m not a lawyer.
After my last post I feel it’s a good idea to go over the dangers of doing DIY HRT. I’m sure most people are aware, but it’s one of the things that can’t be overstated. If you’re thinking about DIY then it pays to be aware.
The biggest risk is the product. Without proper certification you have no way of knowing what standards the product is made to, if the ingredients are pure, or if it’s safe to use at all. While they may be as good as licensed pharmaceutical companies you can’t be sure of this and they have no accountability for the product made. Despite what doctors here in New Zealand think, even compounding pharmacies have oversight.
If you have access to a commercial lab you can validate the products, and some people do this, but it’s an expensive option.
Secondly, if you’re taking medication without oversight from a medical professional they may unknowingly prescribe something with a bad interaction. This is unlikely with hormones but it’s definitely a risk.
And finally, it’s illegal, at least here in New Zealand. Possession of prescription medicines without a valid reason (eg a prescription for yourself or your dependant) is an offence, though I’ve never heard of anybody prosecuted for non-controlled substances. Same goes with importing them, though again if it’s not a controlled drug and it’s your first time it probably won’t be severe.
Of course if I do decide to get my own HRT I won’t write about it or where I get it from
Starting my transition journey was pretty easy everything considered, I started later in life and had no (recorded) mental health issues which eliminated a lot of the gate-keeping. It still took four months from telling my doctor I wanted to start HRT to getting it because of Process.
Living in Auckland the main clinic is Auckland Sexual Health Service (ASHS), and as most GPs are not familiar with transgender healthcare they often forward questions to ASHS. ASHS have a very particular view of what transitioning looks like, at least for transfeminine people - you will be binary transgender and aiming for gender-confirmation surgery (even though that’s essentially not available…). If you step outside that box the best you’ll get is “this is our recommended treatment” with no change, the worst is refusal to provide HRT.
Once I started HRT the problems started appearing. It was plain sailing for the first year, I didn’t encounter the problems I hear a lot. I started oestrogen and testosterone blockers at the same time - having no dominant sex hormone is a recipe for depression, and I stepped up to the full dose of oestrogen within a year. I even switched anti-androgens between cyproterone acetate and spironolactone a couple of times before settling on spironolactone without an issue.
Then I wanted to look at progesterone. I know progesterone is controversial, the scant research that has been done on trans women is inconclusive, but anecdotal reports said it has effects I was looking for and as bio-identical progesterone is now available the risk is minimal. The answer I always got was “there is no evidence it has any effect”, which is true but omits that there’s no evidence that it doesn’t. I eventually found a sympathetic GP who’d prescribe it to me, but it was a mission to get there and only oral progesterone is available in NZ (see my rant about Medsafe) which has far lower bioavailability (about 5%) compared to transdermal delivery. Synthetic progestins have better oral availability, but they have other problems.
As part of that I switched to oestrogen patches from pills to give more consistent, and hopefully higher, hormone levels. I was looking at switching to injected oestrogen for better absorption but it turns out that ASHS are using their position to force GPs away from prescribing injections rather than considering patient wishes. ASHS have also instituted an arbitrary limit of 500pmol/L of oestadiol even though many other countries consider 1000pmol/L the limit - or rather levels above this as supra-physiological. This is important as high oestrogen levels are clinically linked to blood clots. My level on patches is around 450pmol/L at the moment.
After a year on patches my skin is getting quite irritated though, and that coupled with the patch shortage has made me consider switching to injections again. Pills affected my liver, so I’d rather not go back on them.
It’s also notable that the only oestrogen for injection sold in New Zealand is oestradiol valerate, which requires twice-weekly injections and has a rather rapid release profile. Other esters like oestradiol cypionate and oestradiol enantate have much longer life and and only need injections fortnightly. See Medsafe again.
So that’s where I ended up. I can’t get the oestrogen levels I’d like on pills, the patches irritate my skin and aren’t available, and progesterone isn’t available in the form I’d like. I don’t want to DIY this, it’s far more risky than the approved medicines, but if they refuse to prescribe and the alternatives are not working what else can you do?
If the specialists who control HRT considered patient wishes rather than their own opinions we wouldn’t have as many people on DIY and I certainly wouldn’t be considering it. I don’t think they should be changing the standard regime, but when somebody asks for injected oestrogen or progesterone then they should follow the informed consent process - let us know the risks and alternatives and make our own decision about our bodies.
I’m going to start a series of blog posts here, hopefully with contributors to show the extent of the problems faced for transgender people in New Zealand. It’s far from the worst place in the world to transition, but we could do so much better.
I intend to cover:
Lack of access to medications with low risk profiles such as bio-identical progesterone.
Refusal to consider injected oestrogen even in the face of shortage of oestrogen patches.
Incorrect dosing of medications with high risk profiles at inappropriate doses, like prescribing 100mg of cyproterone acetate for over a year.
Requiring people to go on extended periods with no sex hormones.
Gatekeeping transition with mental health requirements.
Dismissal of non-binary transition goals.
Extended wait times for consultations.
The lack of medical autonomy granted to transgender people.
And what ever else comes my way.
Hopefully I can get enough voices to get some attention. It’s very hard to find out who makes the policies or give them feedback, so shaking the tree a bit might get us heard. My goal is to improve access to medication options so people aren’t forced to DIY to get the transition they desire.
Contributing to this series
I can’t just tell my own story - that would be boring. I would like to hear from others in the New Zealand community about the problems they’ve faced, or if they’ve opted out of the medical system and are doing DIY hormone therapy. All contributions will be held in confidence, I don’t need your real name if you don’t want to share it.
You can contact me via Mastodon (or other activitypub platforms), @firstname.lastname@example.org or @email@example.com, via email at transgendernz at thea.hutchings.gen.nz, or via the comment form on this blog (just between you and me, it doesn’t check the name or email fields).
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.