Benefits of Approved medical cannabis Vs illegal market cannabis

Even though New Zealanders can be prescribed legal products containing CBD (cannabidiol) and THC (tetrahydrocannabinol), there is still widespread use of illegal-market cannabis to treat medical symptoms.

This article will discuss some of the inherent risks of using illegal-market cannabis for medicinal purposes and the benefits of regulated medicinal cannabis.

Reasons for illegal market medicinal cannabis use

While doctors can prescribe medicinal cannabis products, there are various reasons why patients may turn to illegal cannabis-based alternatives for medicinal purposes.

Firstly, most doctors are not comfortable prescribing medicinal cannabis. This is largely due to inadequate knowledge and/or training in the effects of medicinal cannabis. It has been suggested that only about a quarter of general practitioners in New Zealand felt that they knew enough about medicinal cannabis to feel comfortable prescribing it. Similarly, many patients are not aware of the availability of legal medicinal cannabis or its potential applications.

Cost is also a significant hurdle that restricts patient access to medicinal cannabis products. Legal production of medicinal cannabis must be completed under strict guidelines such as good manufacturing practice (GMP). They must also adhere to the strict medicinal cannabis scheme’s quality guidelines. This results in high costs of manufacture and hence expensive products for patients. Furthermore, it is unlikely that Pharmac will subsidise medicinal cannabis products; hence, legal medicinal cannabis may remain significantly more expensive than its illegal-market counterparts.

Risks of illegal market medicinal cannabis use

The use of illegal-market cannabis is, by its very nature, unregulated both on the manufacture and consumer/user level. There is no patient selection, meaning people with contraindications to cannabis may not be appropriately excluded. Paying for a script to get a regulated cannabis product may cost more than following the self-prescription route, but it ensures there are no contraindications to cannabis use and also that there is a valid indication cannabis can treat.

There are also no product regulations in illegal-market medicinal cannabis, so doses may not be accurate or reproducible. The temptation to buy homegrown cannabis products is very real because they are usually cheaper. However, the lack of regulation of either active ingredients (relative levels of CBD and THC or terpenes) or contaminants such as mycotoxins or heavy metals may result in harm to the end-user.

There is the risk when using illegal-market cannabis products that the therapeutic end goal is not met, not because medicinal cannabis is ineffective, but because the active ingredients in unregulated products have varied concentrations and in some cases may not be present at all.

Benefits of regulated medical cannabis

The Medicinal Cannabis Agency oversees the Medicinal Cannabis Scheme and ensures that medicinal cannabis products meet a minimum standard of quality. The Medicinal Cannabis Scheme enables the commercial cultivation of cannabis for medicinal use and regulates the manufacture and supply of cannabis-based products.

A series of upper limits, restrictions, forms, and processes that must be adhered to are also defined by this scheme. In practical terms, this means final medicinal cannabis products must meet the Minimum Quality Standards set by the Ministry of Health.

Contamination

The minimum quality standard sets testing requirements and maximum limits (e.g., limits for microbial contamination) that medicinal cannabis products and ingredients must comply with.

Medicinal cannabis must be tested for:

• Active compound concentrations
• Microbial contamination
• Heavy metals
• Pesticides
• Absence of aflatoxins
• Ochratoxin A
• Foreign matter
• Loss on drying
• Total ash
• Residual solvents

This regulation ensures that the final product is not contaminated with elements that could cause adverse reactions. There is a risk with homegrown products that there could be microscopic, unrecognised contamination e.g. aflatoxins, and these could result in adverse reactions ranging from rashes to anaphylaxis. Regulating contaminants negates this risk.

Other quality requirements

The Minimum Quality Standard sets a standardised list of requirements that are essential for regulating the quality of a medicinal cannabis product. These ensure the product contains the correct ingredients, is consistent through its shelf life, is packaged and labelled appropriately and does not contain any ingredients that could pose a risk of harm.

Active ingredients

For the purposes of the minimum quality standard, the active ingredients in cannabis-based ingredients and medicinal cannabis products are:

• Delta-9-tetrahydrocannabinol (THC) and its corresponding acid, delta-9-tetrahydrocannabinolic acid (THCA)
• Cannabidiol (CBD) and its corresponding acid, cannabidiolic acid (CBDA)
• Any other ingredient derived from cannabis and whose stated content is at least 1.0% of the ingredient or product by weight or volume

This regulation ensures that the amount of active ingredient in the product is consistent with an expected therapeutic endpoint. There is a risk with homemade products that they could theoretically contain very little, no, or in some cases, dangerously high levels of an active ingredient.

Shelf life and storage conditions

For the entirety of its shelf life, the ingredient or product must remain compliant with the minimum quality standard requirements for:

• Microbiological contamination
• Loss on drying
• Assay limits for active ingredients
• Form and dosage form

Although homemade products may be adequate immediately after production, there is a risk the product may degrade or become compromised due to incorrect handling, packaging, or storage.

With exposure to the elements, there may be degradation of active ingredients, making the medication less effective, and increasing the risk of contamination. Regulated products, on the other hand, have specific requirements for packaging and storage that need to be met in order to ensure that the product does not degrade or become contaminated. There is control over product batches as well as expiration dates.

Container material

The container for a cannabis-based ingredient or medicinal cannabis product must be regulated, safe, and meet minimum quality requirements. An inferiorly made container can lead to contamination of the cannabis product as well as product degradation. Ensuring that the container meets certain requirements is also important to prevent accidental overdose and tampering by children i.e., child-resistant packaging.

Labelling

Medicinal cannabis products must meet the packaging and labelling requirements for medicines. This is very important, and one of the very obvious factors that delineate regulated cannabis products from unregulated ones.

Correct labelling allows for more accurate prescribing and dispensing. The label should state levels of active and inactive ingredients, ensuring that the prescribing doctor, the dispensing pharmacist and the patient all know precisely what has been prescribed and is being taken. It is unlikely that homemade products would achieve this.

Dosage form

Medicinal cannabis products (including CBD products) must be in a pharmaceutical dosage form that is regulated and standardised. The importance of this cannot be overstated. The risk with illegal-market products is the potential to receive inconsistent dosing even with the same material. This means that in addition to each product having potentially significantly different ingredients, the amount consumed in each dose may also be inconsistent.

When the product’s manufacturing is regulated so that dosage forms are standardised, doctors and patients can be assured of more predictable responses. This is imperative for achieving therapeutic control.

Restrictions to control contamination, adulteration and form

The minimum quality standard includes restrictions to control any contamination or adulteration and the form of medicinal cannabis products. This may be as simple as a seal on a product, to ensure that the product has not been tampered with or adulterated. Unfortunately, because of the cost involved in these extra safety steps, homemade products do not necessarily include them; however, they are important for patient safety.

Good Manufacturing Practice

Good Manufacturing Practice (GMP) is the term used to describe the systems that manufacturers of medications have in place to ensure that their products are consistently safe, effective and of acceptable quality. Medsafe uses GMP regulations to determine approval of medications. GMP is not specific to medicinal cannabis products, but by choosing cannabis products that follow GMP, doctors can be confident in the quality and safety of the product.

GMP ensures, among other things:

• The product is of a certain quality and that it contains the active ingredients that it claims to
• That the levels of active ingredient are consistent; that the product is safe and is not contaminated
• and that the sourcing, manufacture and distribution of the product adhere to standardised protocols.

A product that is regulated under the principles of GMP drastically reduces the inherent risks of illegal-market or unregulated products.

Why is medical cannabis better off being legal?

There is ample evidence to support the safety and efficacy of medical cannabis. A legal medicinal cannabis market allows for careful patient selection. This excludes patients with risk factors for, or contraindications to, medicinal cannabis. It also provides a framework for consistent medicines. Choosing prescribed medicinal cannabis mitigates risks associated with an illegal unregulated medicinal cannabis market.

Prescribed medicinal cannabis products are backed up by the quality process and strict regulations required by GMP. These regulations and processes ensures that the product contains the active ingredients that it claims to. The product has been through rigorous testing and has the concentration and ratio stated on its label.

Illegal-market medicinal cannabis may well be cheaper in the short term because of the costs associated with GMP compliance. Patients benefit from the safety and predictable therapeutic outcomes in the long-term, however, when using regulated medicinal cannabis products these benefits far outweigh the cost difference.

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