"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"

• Health Commission Congress endorses the medicinal use of cannabis and calls for its use to alleviate the effects of chemotherapy

• Dispensing Oils, capsules, vaporization... Routes of administration of medicinal cannabis (and none is smoking a joint)

• Regulation "Today it makes no sense for Spain to be last in terms of treatment with medical cannabis"

Last Monday, the Health Commission of the Congress of Deputies debated and voted on the report on the use of medicinal cannabis, giving the green light to legalize it.

Already the previous Tuesday, June 21, in the subcommittee the report had been approved with a sufficient majority and on Monday 27 it confirmed this accolade, although it was rejected that it go through the plenary session of the Lower House and it will be sent directly to the Spanish Agency of Medicines and Health Products (Aemps) to prepare the necessary recommendations and guidelines.

Since this issue began to be debated and now that there is a final vote, there have been many criticisms that have been made on this issue, largely due to ignorance and confusion with cannabis for recreational use.

The truth is that

, people who live with pain every day.

, 12% from moderate to severe, that is, it interferes with normal activities, and even rest and sleep.

What patients have been demanding for years is

(Spain was, together with Belgium, the only European country without a regulation on the subject)

to alleviate their pathologies after going through operating rooms, various therapies and in many cases not being able to move from bed.

As a result of prejudice and stereotypes, these patients have to listen on the street and read on the networks that they are 'stoners' or 'perroflautas' who want medical cannabis to be legalized in order to smoke joints.

Mistake 1:

.

There are other ways of dispensing, with a specific content of certain cannabinoid substances, under medical prescription, not even for all pathologies (for now some very specific) and with medical control and monitoring.

For years they have been doomed to the black market.

"First I started buying on the street. A recent study by the Complutense University said that the quality of cannabis that is bought on the street is not suitable for consumption because it has a lot of E-coli [faecal bacteria]. So,

.

A cannabis club is better than the street, although there are no doctors, no product tests and you don't know the cannabinoid content it has.

But when the pandemic arrived, these clubs closed, it is as if the pharmacies had closed.

We patients were abandoned, we have had to look for life.

That is why it is so important when the purposes are medicinal that there is regulation, to avoid all the legal and health insecurity, stress and pain that we have experienced," explains Carola Pérez, patient and president of the Spanish Observatory of Medicinal Cannabis (OECM).

Pérez recalls that we are the second largest consumer of opioids and the first consumer of benzodiazepines in the world, according to data from the INCB (International Narcotics Control Board).

"That is to say, Spain has a lot of people suffering, it has a lot of patients and substances as addictive as benzodiazepines or opioids are being used, so

.

EL MUNDO wants to delve into this debate that divides the opinions of society and

, and for this we have sought answers about the positive and negative aspects of this approval, the myths in around therapeutic cannabis, the differences with other countries and other issues from

.

For this we have spoken with the aforementioned Carola Pérez;

María Madariaga, anesthesiologist specializing in chronic pain at the Pain Unit of the Infanta Sofía University Hospital (San Sebastián de los Reyes) and at HM Torrelodones, and president of the Spanish Pain Society (SED);

and Ana López-Casero, member of the Directive Committee of the General Council of Pharmaceutical Associations.

These are your answers.

Questionnaire

1.

Positive and negative aspects (if you find any 'but') of the approval to regulate cannabis for medicinal use?

2.

There are many myths surrounding medical cannabis.

Many people think of it as smoking a joint (like those typical images in movies of patients receiving chemo while smoking a joint);

other people, even some health professionals, mention the specter of addiction (although there are also other drugs that are potentially addictive);

some believe that this means a free pass for self-cultivation, but it cannot be grown at home... How can these misconceptions be counteracted?

3.

Differences for and against between what has been approved in Spain and what has been approved in other countries that have had therapeutic cannabis programs for years.

4.

Aemps has six months to prepare the recommendations and guidelines.

Is there a need to make the issue more agile, now that we are on the subject, and for it to be done in less time?

5.

Could there be a future extension of medicinal cannabis to patients with other diseases that are not currently contemplated?

(For example, in Alzheimer's, HIV/AIDS or glaucoma)

6.

Importance of including master formulas to fully personalize the treatment of each patient.

I don't know if this could be good, perhaps to avoid interactions with other medications that these patients are receiving...

Carola Pérez, patient and president of the Spanish Observatory of Medicinal Cannabis (OECM)

1.

Regarding the positive aspects of the regulation, for us it is a very important recognition, particularly in my case, as a patient, it also helps me to have the fact of having to use cannabis recognized, it

so far patients.

We know that there are many doctors who already want to start working with cannabinoids because there are many thousands of patients on the black market and these doctors have been seeing in their consultations how their patients have been improving and they have told them about it, but they could not help the patient because they could not prescribe it.

The fact of removing the stigma, of providing rigor, science, traceability to products, the protection of Social Security itself and of specialists, I think is a big step.

Yes there are some 'buts', of course.

There are some

.

People who are having difficulties with eating disorders and that there is already ample evidence that these people could benefit when it comes to whetting their appetite, calming their anxiety and even being able to sleep better.

We also miss

, since cannabinoids are usually quite effective when it comes to not only inducing sleep, but also improving its quality, or even people suffering from post-

It also helps them a lot to not have nightmares.

Some pathologies have been left out, but I believe that they will be included little by little as science and studies advance and products are tested in a controlled and safe environment.

On the other hand, we asked that all doctors be able to prescribe, since access to some specialists in the national health system is quite slow, there is a long waiting list, and

, just as they prescribe opioids or antidepressants because they are health professionals, and

, that right now they will not be able to enter.

The fact of dispensing in hospital and community pharmacy is not very clear to us either how it is going to be done because now we have a period in which the Aemps prepares the project, the report that we now have is three pages, it is very brief, and it has to work well in the next six months on the how, the financing of the products, etc.

So we still have a lot of work ahead of us.

2.

.

On the one hand, we use the oral route through the use of oils, different CBD cannabinoids, THC, CBG with different levels of terpenes... Then also when we require the inhaled route, what we recommend is the use of vaporizers, which They are devices that heat the flower to a temperature between 175º and 195º to extract the therapeutic components of the plant and help a lot to all those people who need quick relief, for example.

When someone takes an oil, it usually takes an average of 45 minutes or an hour to take effect, but there are patients who need quick rescue, either because they may be undergoing chemotherapy and have a lot of nausea and vomiting or patients with anxiety attacks or , in my case,

The inhaled route is the one that can be confused a little more with smoking, but these devices are medical, have passed clinical studies and are the route in which certain hospitals in Canada, in Israel, etc., usually treat patients. patients.

There is also the topical route, the vaginal route, suppositories, transdermal patches, nasal sprays so that the dosage also arrives very quickly.

But everything can be absolutely controlled and in the end

.

It is true that there is a lot of stigma and that things are mixed, but all this is also due to the fact that there has been no regulation.

If there is a regulation and if the doctors have training, it will be much easier for them to teach the patient,

, they can use their tinctures, their oils in this case, and all of that it is done with the same naturalness with which a patient has to be medicated.

As for

, I am going to have to be medicated all my life, just as I have been medicated since I was very little and since I was 18-19 years old when I started with opioids, I am already using drugs that are addictive.

In the end

.

Benzodiazepines are psychoactive substances, opioids are psychoactive substances, cannabinoids are psychoactive substances, and that is what helps the brain to better tolerate situations of such extreme pain, of extreme suffering.

Therefore, having the label of cannabis addiction when a patient is going to have to be medicated for life, I do not see that someone who has to use insulin is called an addict because he needs it all his life, and instead we have to be all the time trying to justify that we are not addicts, that we simply have a dosage of a medication and that's it.

Logically,

.

But we must balance the benefit-risk, and above all the fact of overdose, which is something that we must also take into account: according to data from the Spanish Pain Observatory, between 2010 and 2017 there were more than 7,000 deaths in Spain by prescription opioid overdose and these deaths could have been prevented.

I could have been one of them, like many other patients, so when cannabinoids enter our body and work well for us, because cannabis is not a panacea and that it helps everyone in any case, but

because taking 25 or 30 pills a day, in addition to the mixture of interactions, also destroys you a bit as a human being and makes you very dependent: having to be with the medicine bag all the time setting alarms to take the medications or not feel withdrawal because if you skip an opioid dose you do have withdrawal, but on the other hand,

and makes him not be so dependent.

So it really strikes me that people talk about cannabis addiction in a medical setting, but don't take into account that many patients, when we have to withdraw from opioid or benzodiazepine medication,

, since detoxification clinics are normally designed for other types of substance users and in our case there are no specialized centers for people who want to remove or reduce opioid medication, for example, this is a reality in Spain.

It is very important that people understand that it is not the same to use cannabis in one way than in another.

If someone is against it because they have prejudices or lack information about the endocannabinoid system or because they have really seen the effects of abusers, then I understand it and

.

That is why all this has to be very clear and very specified in the products that are going to be given to patients, where we know how much there is so that the doctor can also prescribe well, know how much THC we are talking about, if it is accompanied by CBD for reduce the psychotropic nature of the product, know if it is going to be more relaxing, if it is going to be more euphoric and also be able to study the pharmacological interactions with the other medications that we have.

3.

The US is a slightly different model because there the health system is private and the patient goes to a doctor who gives him a prescription and from there he goes to a dispensary and looks for the best.

On the other hand, the European model, for example, or the Canadian or the Israeli are different models with hospitals, pain units, neurologists or the specialist that touches, and

, according to the needs of the patient, and

.

Italy has a model, Greece has another, Portugal, another... Each country has been regulating in a quite different way and one of the things that we request from the IACM Patient Council, which is a worldwide organization of patients of which we form part and we are coordinators, is the fact of being

.

Right now, an Italian patient, for example, cannot travel to Spain with cannabis flowers, even if she has a prescription.

The fact of having to cross borders,

or imagine that there are dogs or anything, already

, and one of the things that we are requesting and that we are going to start working on now after the summer is that all European countries have the same rights and the same obligations because when a patient travels they need to travel with their medication.

And if in this case your medication is cannabinoids, then so be it.

For example, in Canada the patient receives the medication, it is sent

directly to their home

In Italy, for example, the Army was cultivating it for a while.

Then they saw that they were not capable of doing it well because, logically, the Army is not the one who should make a GMP crop with pharmaceutical quality and they have begun to import.

In Portugal, for example, right now they only have access to Sativex and a type of flower that is also quite expensive and you have to buy a lot of it.

We could do an analysis of all the countries, but of course

and there are countries that have very good things about something, but worse things in another aspect.

For example, in the UK, the public health system has only given three prescriptions in the entire country and the patient has to do it through a private health service that costs a lot of money per month for the medication.

It would be necessary to analyze a little country by country to know the differences, but of course

.

4.

Indeed, the Aemps has 6 months to give shape to everything that has been agreed in the Subcommittee and the truth is that today we cannot know very well

, if they are going to want to listen to patient organizations from other countries or medical organizations like the IACM, which have been working at a scientific level for 20 years.

My wish would be that within six months the first patient could collect the first oil from her in a hospital, but we really don't know very well how she is going to go in terms.

On the other hand, we must work

because in order for them to prescribe cannabis they have previously had to receive training.

And you have to

so that they know how to prepare these magisterial formulas and these oils.

In other words, there is a lot of work to be done and what we ask of the Agency, of course, is that it be agile and open-minded because if the model is very restrictive or puts a lot of bureaucracy on the patients or the pharmacies themselves hospitals are not enough... Our part has already been done, now what we need is for the next party to be able to comply with their agreements and for this message that we have given to society that medical cannabis is already regulated in Spain and a patient You may have the right to your treatment, so let it be as quickly

So, the sooner we start, the sooner doctors will learn and the machinery of pharmacies, hospitals or community will begin, and the sooner we can legally receive what we need to live.

5.

There will be an expansion of pathologies because it is no longer just the research that is going to be done in Spain, but all the research that is being done worldwide.

For example, if you put 'cannabis' in Pubmed, each time you see that the number of studies grows and multiplies.

and it was thanks to the war veterans who fought and fought and we owe a lot to them too.

The post-

that I have mentioned, people who have suffered

, for example, we also deal with this a lot in the Dosemociones association, these nightmares, these panic attacks.

All this in the end requires that little by little it expands.

6.

Logically, the master formula is fundamental because if we compare it, for example, with the medicine Sativex, which has a 1:1 ratio, that is, it has an equal proportion of CBD and THC, in my case I make a ratio of 3 :1, three parts of CBD to one of THC.

There are patients who do 1:3.

There are patients who need a 5:1, even a 20:1, so the fact of the compounding formula is what will allow the doctor to correct the dosage precisely taking into account these pharmacological interactions and how the patient feels, and to be able to prescribe and hit the key with precision.

Because if you only have one option, then you only have that option, which is a 1:1 ratio such as Sativex, but if you can balance it so that the patient obtains the relief they need with the best possible therapeutic effect, Well, this is going to be, I think, one of the most powerful things we have achieved, which is already being done in Germany and in many other countries and that is how it should be.

, and the fact that it can be prepared

for each patient I think is super important.

María Madariaga, anesthesiologist specializing in chronic pain and president of the Spanish Pain Society (SED)

1.

, that is, opening the door to the regulation of a therapeutic substance that can relieve pain for many patients and that until now was on the black market or in the paramedic, is always good news.

.

We have some deadlines to prepare the entire prescription, dispensing and monitoring system for a drug that is relatively new in terms of its medical management in Spain, which has not been used until now, and which requires a certain time to prepare, the pharmacies to dispense it and doctors to prescribe it.

Much information is still lacking on the use of medicinal cannabis in chronic pain.

2.

Indeed, a myth is to think that this is about smoking a joint, clearly, this is not the case.

It is a drug prepared through different combinations of cannabinoid substances, in a traceable way, with a precise dosage that combined can help certain types of ailments, that is, it is about dispensing masterful formulations or medicinal cannabis extracts

.

In no case is it a free way for self-cultivation, that is not what we are regulating in Spain, although there are other countries where it is allowed, for example, Canada.

Probably the only way to counter the myths surrounding medical cannabis is

, that this is a type of medication.

3.

.

In Spain we are starting to regulate the therapeutic use of medicinal cannabis, in other countries they have much more travel.

For example, in Canada apart from medicinal cannabis extracts and the preparation of masterful formulations, the use of the inflorescence, the raw flower and the granules, among others, is authorized.

In all countries, Canada, Europe, Israel... the prescription is medical and the dispensing is pharmaceutical.

In Germany and Italy the use of the raw flower is also allowed.

In Spain at the moment, it seems, this regulation is limited only to standardized extracts of medicinal cannabis and not to the raw flower, unless it is in the context of a clinical trial.

4.

Yes, indeed, Aemps has only six months to prepare recommendations, guides and the entire prescription and dispensing structure.

Of

.

5.

Obviously, there may be a future extension of the indications to certain patients that are not currently considered and in whom there is already evidence of improvement, but which still requires that this evidence, that is, that these conclusions of clinical trials be more robust.

For example,

, among others.

There are other pathologies in which medicinal cannabis could be used, but

.

6.

The master formulas to personalize the patient's treatment allow different types of cannabinoids to be combined, that is the difference with respect to the Nabiximols that we had available until now, such as Sativex.

Obviously, not only does it personalize treatment for each patient, as well as having a greater dosage range, but it also allows control, which is the most important thing,

, including interactions with other medications that these patients are receiving, of course.

Ana López-Casero, member of the Steering Committee of the General Council of Pharmaceutical Associations

1. Whenever a new drug is authorized, it is a positive milestone, a reason for joy and hope.

It should be noted that, for now, the widespread use of medicinal cannabis in Spain has not been approved.

There are currently only two drugs available on the market with active ingredients derived from cannabis, authorized for use in very specific diseases: multiple sclerosis and some forms of epilepsy.

What is being analyzed in the process that has recently been promoted by the Congressional Subcommittee is the evaluation of the possible use of other medications and compounding formulas with components derived from cannabis for use in different diseases,

, among others.

The Aemps will be the body in charge of deciding on the possible approval of certain products based on the analysis of the available clinical data.

The situation that occurs with the therapeutic use of cannabis and its products, as stated in the report approved by the Subcommittee, is precisely that the scientific evidence is limited.

.

It is with this objective that, from the Collegiate Pharmaceutical Organization, the network of pharmacies has been made available to the authorities to be able to advance in the verification of the efficiency of cannabis within a medicinal use.

In the event that certain medicines and compounding formulas are approved, which is what we pharmacists want in order to solve a serious problem for patients, and once that uncertainty is clarified,

.

To this end, dispensing by pharmacists, both in hospital pharmacy services and community pharmacies, will be the tool that ensures it.

2.

We are not in that debate.

.

The recreational use of cannabis is outside the scope of the future regulation of its medicinal use.

, for example.

We are talking about a serious and serious health problem for thousands of people with pain.

We are talking exclusively about the medicinal use of cannabis and this medicinal use refers to the use of preparations with a level of active ingredients that can exert a predictable and beneficial pharmacological effect in certain groups of patients.

It is true that one of the risks associated with its therapeutic use is the content of tetrahydrocannabinol, the psychoactive component that can induce addiction and dependence processes (but not cannabidiol, another of its active ingredients).

What we must ensure is that, with the future regulation that may be approved,

to patients are limited.

Pharmacists have extensive experience in relation to other potentially addictive drugs that have been present in therapy for many years, such as

, for example, and we have a lot to say in the process of using cannabis-derived drugs in order to to mitigate the risks of addiction;

for example, in

.

And we have a privileged position of closeness to society that allows us to act in health education: providing truthful and scientifically rigorous information to the population is undoubtedly the best way to combat myths about medicinal cannabis.

Having pharmacists integrated into the care team and the network of hospitals and pharmacies in our country is a guarantee of safety in the proper use of these medications by patients.

3.

Indeed, there is

surrounding medical cannabis on the international scene, even among the EU countries.

In Spain there is still nothing regulated, and we cannot compare.

But now we have a good opportunity to review the evidence that has been generated in clinical studies and with use in those countries to make the most convenient decisions in favor of patients, guaranteeing the safety of its use, and establish new evidence, route in which the pharmacy can play an important role.

We are in favor of a

and for this reason we not only contemplate accessibility through the country's pharmacy network, but we also have the opportunity to be more ambitious by integrating the pharmacist with the rest of the healthcare team. through a follow-up protocol that guarantees patient safety and decision-making by the medical team.

4.

The priority here is to

, which must be well-founded.

The evaluation of the available evidence that will be carried out by the Aemps experts will be exhaustive and, therefore, requires a period that guarantees the suitability of the process.

Bearing this in mind, the more we expedite, the better for patients.

5.

at the time are met, the indications for use of the authorized medicines may be extended.

Always, let us remember, based on scientific evidence -of good quality- derived from clinical trials that may appear.

We must remember that, as with any other medication, it could also be the case that the uses of cannabis-derived medications are limited if data appear in the future that question their benefit-risk balance.

6.

First of all, we must not forget that

.

It is the medicine prepared by the pharmacist for an individualized patient to fulfill a medical prescription.

The development of drugs carried out by the industry over the last decades has generated a spectacular advance in the quality and life expectancy of numerous patients.

However,

.

Hence, the importance of the master formulation as a way to obtain this personalized treatment, and the role of the pharmacist, as he is the only professional trained to carry it out.

En ese sentido, la formulación magistral constituye la mejor vía para preparar el medicamento individualizado -con su forma farmacéutica y dosis definida- que mejor se adapte a cada paciente en concreto. Podemos ver esta posibilidad de que los farmacéuticos preparen fórmulas magistrales con productos derivados del cannabis como una oportunidad que beneficiará al paciente: además de que se eviten interacciones con otros medicamentos, se puede adaptar el medicamento, por ejemplo, a pacientes que puedan tener problemas de deglución mediante la preparación de soluciones orales o mediante el ajuste de dosis concretas a pacientes concretos, en función de sus necesidades. De forma óptima, la composición de estas fórmulas debe ser estandarizada, según lo que defina la Aemps.

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