Friday, April 19

this will be the implementation of medical cannabis in Spain


Madrid

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Patients with pain will have, in six months, medical cannabis as another possible treatment against it. This has been agreed by a subcommittee of the Congress of Deputies, which has prepared a report that, when approved by the Health Commission, will inform the Government of the findings that have been exposed in the same in the last half year. This is how the introduction of cannabis as a therapeutic use in Spain will be:

When will it be available?

According to the report, which must now be voted on in the Health Commission, the Spanish Medicines Agency (Aemps) has six months so that, through current regulations, medicines derived from cannabis in its composition can be prescribed and dispensed.

Which patients will be able to benefit from this?

The agreement of the political groups highlights the strongest evidence of the usefulness of cannabis to treat spasticity in patients with multiple sclerosis, some forms of epilepsy, nausea and vomiting caused by chemotherapy, endometriosis, cancer pain and chronic non-cancer pain (including neuropathic pain). It also leaves the door open for it to be extended to other therapeutic indications when the studies provide consistent indications.

How will it be consumed?

Extracts or standardized preparations of cannabis that currently do not have a marketing authorization will be marketed. These can provide guarantees of composition, dosage and safety. However, “the development of experimental projects” with flowering tops of cannabis (the flower) or with preparations of another type available in EU countries will be valued.

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Who will prescribe it?

The text states that the prescription will be carried out exclusively by health professionals in a context free of potential conflicts of interest, such as that offered by health services. “Preferably” it will be done by medical professionals who are specialists with skills in the areas that attend to the indications authorized at any given time.

Who will dispense it?

The way in which the competent pharmacy services can prepare master formulas from extracts or standardized cannabis preparations for direct use in certain cases should be assessed. Dispensing, according to the agreement, must be carried out “from the health system pharmacy network”, preferably in hospitals but exploring the alternative of community pharmacies that may meet the requirements.

Will it be approved in more areas?

Not at the beginning. The agreement reached calls for “avoiding” that the therapeutic use of preparations or extracts be confused “with a generic invocation of the general use of cannabis for the population. It is requested to avoid that availability can also lead to greater availability and consumption of cannabis outside the health context.

How will it be evaluated?

Every year for the next ten years, the Health and Consumption Commission of the Congress of Deputies will hold a session focused on this issue, to assess the situation and its evolution. Annually, the Aemps will prepare a report on the therapeutic use of standardized cannabis extracts or preparations, which will include information on the available options, the services prescribed, patients treated and the volume of products dispensed, as well as their efficacy and safety.

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