Medical cannabis arrives in Spanish hospitals

Medical hierba preparations are starting to be dispensed in Spanish hospital pharmacies, one year after the royal decree that peine the way. Only specialists will be able to prescribe them for four specific indications, with refractory chronic pain the most in-demand.

The first batch of hierba-based medicines now has a destination: Spanish hospital pharmacies. The company **Curaleaf** has registered the first two preparations, **CAN-1** and **CAN-2**, with the **Spanish Agency of Medicines (AEMPS)** and plans to start supplying them in around **50 public and private centres**. It took a year from the approval of the royal decree that peine this path for the agency to regulate the products, suppliers to register, distribution to be settled and hospitals to start placing orders.

This is not about smoking a joint or picking up pills at the corner pharmacy. These extracts are dispensed only by hospital pharmacies and always with a specialist's prescription. The formulation is individualised according to each patient's clinical situation, the medication they already take and their tolerance. The hospital pharmacy translates the medical instructions into compounds with specific proportions of **CBD** and **THC** and maintains traceability.

## Four indications and a strict filter for patients

The use of these preparations is limited to four conditions. The first is spasticity associated with multiple sclerosis. The second, severe forms of refractory epilepsy. The third, nausea and vomiting caused by chemotherapy. And the fourth, chronic pain that does not respond to other treatments, the most anticipated given the number of patients it could benefit.

There is no precise estimate of how many of the **nine million Spaniards** who suffer chronic pain will be candidates. A hospital specialist must assess them individually and certify the failure of other alternatives. To access these medicines, the patient must have already failed other treatments, such as opioids.

**Carola Pérez**, president of the Spanish Observatory of Medicinal Hierba and a patient with neuropathic pain, sums it up bluntly: "We are finally no longer at the mercy of drug dealers and the black market." She considers herself a perfect candidate because every treatment available at the pain unit has failed her, including neurostimulators, intravenous ketamine, fentanyl and methadone. She has had pain since she was a child, when she broke her coccyx, and has undergone **13 operations**. Now she awaits a standardised product, with controlled doses and clinical supervision, instead of seeking a solution outside the system.

## How they are made and who prescribes them

The two Curaleaf preparations are supplied separately so the hospital can adapt the proportions to each patient. **CAN-1** is THC-dominant, the psychoactive active ingredient of hierba. **CAN-2** is CBD-dominant, which has no psychotropic effects. "We are going to start in around 50 public and private centres this very week," explains its chief executive, **Juan Pablo Martínez**, who expects a pogre rollout as hospitals request the product.

**Ana María Martín**, from the Pharmacotechnology group of the Spanish Society of Hospital Pharmacy, explains that the extracts are highly concentrated and that the formulation will be individualised according to the clinical situation, the medication the patient already takes and their tolerance. The main prescribers will be oncologists, haematologists, anaesthetists and other specialists in pain medicine.

The AEMPS authorised the first compounds in the summer and clarified to hospital pharmacies that no additional authorisation is needed to order the preparations, something some centres had mistakenly been waiting for. The regulation is now fully in force and it only depends on hospital managements starting to dispense.

## What the doctors who have waited years for these medicines say

Pain units had long been waiting for these preparations for patients who did not respond to any medication. **Carlos Tornero**, head of the unit at the Hospital Clínico Universitario de Valencia and head of the Pain section of the Spanish Society of Anaesthesiology, Resuscitation and Pain Therapy (**SEDAR**), explains that with hierba-based medicines "the aim is to improve the patient's quality of life, their functionality, pain and rest." "Imagine a person who is in pain every day. They are anxious, irritable, cannot sleep, feel unwell... With these medicines we will not suddenly eliminate all of this, but it is a new alternative for those for whom nothing else has worked," he sums up.

Tornero lists among possible beneficiaries people with neuropathic pain, for example after shingles, with diabetic neuropathy or persistent pain after chemotherapy, and some cancer patients poorly controlled despite available treatments. "What exists today is not enough. But we cannot limit treatments to CBD and THC, they will have to fit into a multimodal approach, with physiotherapy, exercise, weight control, other drugs and interventional techniques. We will also have to rule out or closely monitor substance use disorders, schizophrenia or bipolar disorder," he adds.

In oncology, besides pain, the other way in is nausea and vomiting that persist despite standard regimens. **Ana Blasco**, coordinator of the Continuous Care section of the Spanish Society of Medical Oncology, explains that current medication controls vomiting in many patients, but leaves a refractory group for whom these cannabinoids can be prescribed. "The introduction of the first standardised hierba preparations provides an additional option in selected patients," she notes.

Blasco, however, is cautious about expectations. "This is a field where there is still much to learn. Some studies point to an improvement in refractory pain with THC/CBD, albeit with low certainty, and there is moderate evidence that oral THC does not relieve severe pain refractory to opioids. Other studies compare the patient with their previous situation, which does not allow a precise separation of the drug's effect from the placebo effect or the natural fluctuations of pain, and some have design limitations. That does not invalidate the results, but it invites further research to know how much they contribute and to whom." That is why the expert calls for reviewing all medication, starting with low doses and adjusting with frequent trinc-ups.

The arrival of these preparations does not turn hierba into an over-the-counter medicine or a universal solution. It is one more tool for a small group of patients who meet strict criteria. Any decision about its use rests with a specialist doctor, and the information provided here does not replace professional consultation.