- Pharmacy Updates
By: Stephen Dickson
Cannabis products are everywhere – as a health professional, should you be engaging with this market and if so, how can you be safe, insured and compliant.
CBD is just a food supplement, right? I don’t need to worry about that as it’s just like selling vitamin C. Right?
Wrong and wrong! The UK CBD market has exploded in recent months, and as a health professional not only should you be prepared to answer questions about it from patients, but if you are selling or dispensing this – you need to be absolutely certain of the provenance of product, or risk not being insured at best and a jail sentence at worse.
The first thing you need to know is that Manufacturers of CBD are not pharmaceutical companies. The manufacturing process for that beautifully packaged product are absolutely nothing like pharma. In fact, in my investigations the majority of suppliers we have examined had standards way below what you would even expect of a food supplier.
The majority of manufacturers are small scale, home grown laboratories, run by (in the majority) non registered professions of a quasi-scientific background. They range from companies who take their duties seriously – but maybe don’t understand what they are – to cash-grab, fly by night cowboys taking advantage of the poor and sick in a quite disturbing way.
If you are expecting clean rooms, laminar flow cabinets, GMP certification, sterility testing, microbiological controls and standard operating procedures – well, I can say it is definitely NOT the norm.
Having tested a great number of samples from various manufactures from Ireland, Scotland, England and further afield – I can say that not only is the quality of the work often inconsistent, products in a majority of the time are not what the package says and even more concerningly – often contain illegal amounts of THC or related compounds, effectively making the products schedule 1 controlled drugs.
Furthermore, these products after manufacture are often being treated as a commodity. For a “food product” they are being stored and moved through conditions and processes you wouldn’t be happy with a packet of biscuits… but they fall into this grey zone where food regulators think they are a vitamin and healthcare thinks it’s a food. I haven’t come across many manufacturers doing anything more than rudimentary stability and safety testing.
Knowing what you are doing.
So – after this manic rant, should we be engaging with this market? I still say yes. Absolutely. After 10 + years of using cannabinoids in patients with everything from MS to cancer, I can’t say that I have not seen remarkable clinical benefit. The results can be remarkable, but you have to know what you are doing.
After working in the private sector in the industry and dispensing thousands of prescriptions for cannabinoids – myself and my colleagues have developed very safe, practical and reasonable treatment protocols and drug interaction awareness. We make this freely available through our pharmacy training provider.
You can get basic certification free at www.ukcannabisclinic.com/
We will also provide pharmacists and doctors with a “how to guide” based on our clinical knowledge FOC.
There are a huge number of significant interactions around CYP450/3A4 – and not being aware of these and making the appropriate interventions as a pharmacist would put you into serious professional risk. I’m not going to go into detail here / feel free to do the training – but simple drugs like sertraline and oxycodone can have serious problems with CBD. Do not sell any form of CBD unless you have had appropriate training and understand the basics. This is a bit like St John’s Wort!
As a very basic question – would you buy atenolol from a supply chain designed for toothbrushes? Of course not. Many pharmacists are purchasing CBD products from sundry wholesalers or 3rd party transfer orders. Doing this breach good distribution practice and may make the product not only non-compliant but potentially unsafe for consumption. Even if the manufacturer made the product correctly – it’s not likely to be the same thing when it’s been stored in a warehouse, in direct sunlight at 40 degrees C for 3 months.
I currently use Ethigen for supply chain, as they are national but capable of high levels of GDP whilst being cost effective.
Cannabinoids are available for retail sale only through a peculiar loophole in the law. The same products are also licensed medicines in the EU and USA. (Sativex and Epididolex as examples).
I tend to think of these products like a P / POM Medicine – and would encourage all pharmacists to think in the same way.
Do you have dosing information?
What about renal failure or liver impairment?
Does the packaging include a PIL? With drug interaction info from a reputable source?
What about THC content? Can you be sure it is zero?
What happens if a counter assistant makes a sale of a CBD product to a patient on oxycodone or fentanyl and they die from an overdose induced by CYP inhibition. If the product has no information for the patient and the pharmacist was in the toilet when the sale was made… these events are occurring right now but not yet being actively monitored by any regulator. This is changing rapidly.
From an insurance and legal standpoint, any pharmacist faces significant peril unless they have conducted a risk assessment and considered the above points.
I wouldn’t be writing this article if I hadn’t solved this problem already. The solution is multi factorial and involves 5 different health professional groups working together in a synergistic way.
My background, as I said earlier is that I have worked with cannabinoids for dispensing purposes for over a decade. I’m a superintendent for a small chain of 6 pharmacies one of which is a specialist MS clinic.
When pharmacy started getting involved in CBD, I realised that our team of doctors, nurses, pharma specialists and ancillary professions had amassed enough information that we should be able to help other pharmacists make compliant supplies.
The first think we did was to form a training and support retail group / we called it UKCC, the UK Cannabis Clinic and it provides training and support to pharmacists.
The second thing we did was form a research agency, by publishing and supporting clinical supply events through a UK Cannabis Clinic model.
The third and final thing we did was to form Canidol Pharmaceutics – a research and collaboration agency (specialists, GPs, prescribers, pharmacists and pharma compliance experts) independently verifying 0% THC in products, providing research training protocols and physical products suitable for retail – and dispensing purposes.
The UK Cannabis Clinic is currently being ported for Irish use but basically allows for a pharmacist to use a PGD type environment, that results in a prescription being printed locally issued by one of our experts. This limits vicarious liability immensely.
The basic message I have is – CBD is a minefield. If you are going to do it, do it properly and if you don’t have the time or energy to do the background research, risk assessments and supply chain management – come join us as a partner at Canidol Pharmaceutics.
At the very least – buy CBD from one of your usual wholesalers, like Ethigen (no I don’t have shares in Ethigen) – as incorrect storage of CBD can actually theoretically convert the CBD to THC!
Contact +44 141 404 6255