Sativex, an oral spray with cannabis extract, has been approved since 2011 to treat spasticity in multiple sclerosis, but is also used for severe pain, despite evidence that cannabis-containing preparations have an analgesic effect.
For several years, the number of patients who obtained the drug from the pharmacy remained largely unchanged. But now something seems to have happened.
Last year, 650 patients got Sativex from drugstores, compared to 415 in 2020. This corresponds to an increase of nearly 60 percent.
The Medicinal Products Agency has not received any indications about the problems with the increased use of cannabis in health care, according to Karl Michael Kalkner, a clinical researcher at the authority.
— In the absence of indications about the problem with prescriptions, the Medicinal Products Agency is not working on sales volume, he says.
It also indicates that although the increase is significant in percentage terms, it occurred from a low level.
And Emmanuel Packred, chief medical officer at the Center for Pain and Rehabilitation at the University Hospital Linköping, sees no clear explanation.
-Whether the increase is due to increased use in MS care or whether it is an “off-label” prescription in pain care that explains the increase cannot be said based on these statistics, he says and continues:
– I would ask someone to actually look at it in a study, especially if the trend continues. I think this is an important knowledge gap.
At the same time, the previous increase in requests for prescribing cannabis preparations appears to have stopped.
Last year, 140 applications for licensing prescriptions were submitted to the Medicinal Products Agency, according to statistics released by the agency on behalf of Läkartidningen.
That’s 61 down from the previous year, when there were about 201 requests – the highest number to date.
In terms of approved applications, there were roughly the same number in 2021 and 2020: 106 and 107, respectively.
In 2020, Epidyolex was approved as a drug in Sweden – to treat two unusual epilepsy syndromes – and no longer requires a license. But that partly explains the difference between 2020 and 2021. In 2020, the Medicinal Products Agency received 13 license applications for Epidyolex.
Emmanuel Packard can think of several possible explanations for the fact that interest in prescribing medical cannabis on a license appears to have cooled. He mentions, among other things, “frustrated prescribers” as a potential factor.
I have personally tried both Sativex and its licensed medications for patients with severe nerve pain. But I’m done with too much of that. None of them had any effect. It really isn’t a magic bullet for pain.
Karl-Olav Stiller is chief medical officer of clinical pharmacology and chair of the Stockholm Medicines Committee and the Drug Expert Group for Pain and Rheumatic Diseases, who stated last year that cannabis preparations should not be used for pain relief purposes in healthcare.
He notes that a decrease in the number of licensing applications does not necessarily mean that interest in medical cannabis has declined.
– As a patient, you may have found other channels, if you tried to get them with a license but were refused. Then you might not think it makes sense to try again, he says.
Karl Mikael Kälkner stated that, after all, there are a fairly limited number of licensing applications, which makes it difficult to draw any definitive conclusions.
He also notes that the statistics say nothing of the number of patients who received medical cannabis under license.
– When we place an order for the first time, we do so for three months. The effect is then evaluated, and if it is good enough and the prescriber applies it again, we give a one-year license. Each application is counted in statistics.
Still, the list of license applications is still topped by the preparation Bediol, which consists of ground plant parts of the cannabis plant. But both the number of applications for granted licenses has decreased. Last year, the Medicinal Products Agency received 61 applications, compared to 107 in 2020. A total of 47 applications were granted, compared to 58 in 2020.
As previously reported by Läkartidningen, Dr. Claes Hultling, Professor of Medical Sciences and founder of the Spine Clinic, has long planned a double-blind, randomized, placebo-controlled clinical study to evaluate the effect of Bediol on neuropathic pain in patients with spinal cord injury. The idea was that it would be the first major study of its kind.
But two years ago, the plans were on ice.
One reason is that the analgesic effect in a preparatory pilot study in 12 patients was rather modest, another problem was the dosage form. The preparation must be inhaled by a so-called “vaporizer” or vaporizer. But for the study to take place, an oral preparation is required, according to Claes Holtling.
– It wasn’t a “crushing blow”. It did not turn out to be the result we were hoping for. To have sufficient ‘power’ in the study, we would need to recruit 200 patients instead of 100 patients. We felt uncontrollable.
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Preparing with weak evidence
- The scientific evidence for the use of medicinal cannabis for pain relief is weak.
- Cannabis preparations for pain relief should not be used in healthcare, for example, the pharmacological expert group of the Stockholm Medicines Committee for Pain and Rheumatic Diseases stated in last year’s recommendation.
- According to the expert group, the evidence for sedative effects is small or completely absent, and at the same time there is a high risk of serious long-term side effects, especially psychosis and cognitive disorders.
Läkartidningen 11-12 / 2022