Society Congress endorses the medicinal use of cannabis and calls for its use to alleviate the effects of chemotherapy
Treatments Oils, capsules, vaporization... Routes of administration of medicinal cannabis (and none is smoking a joint)
Debate "The patient does not want to be under the psychotropic effect all day, we want to receive the medicinal properties of the plant and lead a normal life"
Much has been said about the therapeutic use of cannabis since Health Authorized in June to use this plant to combat certain symptoms that affect patients with certain pathologies.
The report that was approved mentioned the possibility that
pharmacy services, preferably hospital services, could make magisterial formulas from extracts or standardized cannabis preparations
for direct use in certain cases, ensuring their stability and uniformity, leaving the doors are open so that
community pharmacies can carry out this work as long as they meet certain requirements
The truth is that, although it is true that much has been said about the subject,
as far as master formulas with cannabis are concerned, there are many questions to be resolved.
How do they have to be done?
What technical difficulty do they have?
Do you need tools or specific means to make them?
What protocols must be followed?
We have asked several formulary pharmacists and they admit that they do not have an answer to these questions, because
in Spain they have never been
asked, so they are waiting to see if Health publishes any protocol or provides information.
And while this is happening, we have set our sights
master formulas with cannabis are indeed made,
and we have spoken with
, a compounding pharmacist in a pharmacy located in the surroundings of Treviso, with
extensive experience in this field,
to, thus, shed some light and see if their methods could be extrapolated to Spain.
Approved dosage forms
As Bortoletto explains, "
in 2014 the first prescriptions
for magisterial formulas with cannabis began to arrive, especially
for administration by inhalation
so that patients could make a decoction at home
To help pharmacists in this task,
the Italian Government approved decree DM 9/11/15
to make the pharmaceutical forms contemplated in it, which are "the
that the patient vaporizes at home and the
oil of 10% cannabis
sublingually, which is the most prescribed," he specifies.
Bortoletto explains that in these years many types of magisterial formulas have been made (beyond paper and oil), "until the Ministry declared itself against making those that were not included in the DM 9/11/15 ".
In fact, he remembers that
resins, decarboxylated cannabis capsules, eye drops, suppositories
, among other pharmaceutical formulas, were made.
Heavy of the cannabis flower.
From a technical point of view, this pharmacist points out that
the papers contain the herb as
it is and "it must be vaporized in
a vaporizer that provides a controlled temperature,
which is not too high so as not to deteriorate the cannabinoids."
Regarding the oil, it indicates that it is an
oily solution that needs to be filtered
to remove the cannabis contained in the oil.
-he clarifies- is
the time and temperature of decarboxylation
, which differ according to the variety of cannabis that needs to be used".
According to his experience,
the papers are the simplest formulas
, because "no special tool is required and they can be done in all pharmacies, since, by law, the pharmacy
is only required
a scale with a sensitivity of 1 mg
The same does not happen with oil, "more complex to make, but not impossible", clarifies the expert, who adds: "In these cases, more specific tools are required to formulate, such as a
to squeeze the cannabis and a
vacuum filtration system"
In his opinion, the
involved in this type of formula is the
standardization of cannabinoid extraction
, "which is
In fact, he points out that, even following the same standardized work protocol (SOP), all pharmacists can obtain different results." In addition, they have different extraction methods "and in some of them an ultrasound extraction is needed," he details. .
No therapeutic indication
In Italy, it says that
they do not have any specified therapeutic indication
admitted by the Italian Medicines Agency (AIFA), and
can be prescribed as an
drug , fundamentally for
pain and muscle spasticity in multiple sclerosis.
"It also has activity for the treatment of other symptoms - he recalls - such as Tourette's syndrome, eating disorders, nausea and vomiting, glaucoma...".
all doctors can prescribe a master formula with cannabis,
specifying that it is an
job , and
community pharmacies can prepare them,
yes, "the pharmacy that prepares it needs to be the one who is going to dispense the formulated medicine" , nuance
Extraction of cannabinoids in the oil at hot temperature in a water bath.
"Really, we do not have a ministerial procedure that limits the formulation of cannabis in pharmacies," he continues. "The problem is that it
is difficult to get the raw material
As in any other magisterial formula, in those made with cannabis it is very important to offer the patient the necessary advice for correct use and storage.
And this is very clear to Bortoletto.
When the formula is
, it must be indicated, as he himself points out, that "
it must be kept in the refrigerator
because this improves stability".
It is also advisable, he continues, "
to shake the product gently before using it
And, especially for the first administrations, he stresses that "the dosage has to be carefully regulated, because some patients may not tolerate cannabinoids. For this reason, it is advisable to
start little by little
, adding drop by drop until the therapeutic result is achieved. Therefore, the
dosage is totally individualized"
So much so that he says he has patients taking 20-30 gtt three times a day and others taking 1gtt three times a day with similar results.
"This depends - he assures - on the severity of the disorder and many other factors that will influence pharmacokinetics."
Asked if the working method followed in Italy could be applied in Spain, the pharmacist states that he believes that, like all substances,
more studies are needed
to understand the real therapeutic benefits they have, as well as to
control their use
, since many Sometimes it can lead to a substance of abuse.
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