In search of fentanyl to alleviate María Josefa's debilitating pain: Are there supply problems?

All It began about ten years ago, when María Josefa was diagnosed with a benign brain tumor. The best solution doctors found was to perform radiosurgery , which was a success. However, due to what may be possible malpractice—according to the family after conversations with other doctors—after a year she began to feel discomfort in her mouth and its opening was getting wider and wider. After several treatments and tests, the doctors detected that her jaw was "completely necrotic." As a result, she suffers " horrible pain " that can only be alleviated with a medication, a type of mouth stick, whose active ingredient is fentanyl . For a few weeks now, Alfonso, her husband, has reported having difficulty finding it.

"I've never had any problems until a month and a half ago, when I called the pharmacy and they told me they didn't have it," she recalls. It's a prescription-only medication called Actiq . Since her pain is practically daily and at its highest level on the scales, she has to take it every day , and they usually prescribe her a box of 30 for four days. She's also under very strict supervision: she can't pick up more than four boxes at a time, and every so often she has to renew a visa. And that's how María Josefa, who is 52, has been doing for nine years.

They live in Puerto de Santa María (Cádiz) and from the moment their usual pharmacy ran out of the product, they began their search : first, with the help of the pharmacist who found it elsewhere and brought it to them, and then, over the phone. " I'm like crazy calling all the pharmacies, along with my son, to ask about their stock. For example, in Cádiz they have a box of 15 units reserved for me ," he says.

Alfonso dreads the moment when all options are exhausted, his partner is left "with nothing," and withdrawal symptoms set in, which he says are "very severe." "It starts with vomiting, shaking, and screaming from the pain," he laments.

The word fentanyl has been on many people's lips in recent years, as it is also consumed as a drug and in 2023 it left great havoc in countries like the United States, killing more than 150 people a day . In its medical use, the Spanish Agency for Medicines and Health Products ( AEMPS ) explains that it is an opioid-type analgesic, indicated to treat chronic and intense pain that needs to be controlled with opioids. This drug was first used in the 1960s.

In Cima , the AEMPS's online drug information center, there is a section where supply problems with medications are recorded . In the case of Actiq, the medication María Josefa needs, there are five open orders . The first is for Actiq 200 micrograms, lozenges with an integrated oral applicator, 30 tablets, whose incident start date dates back to December 27, 2024, and with no set reinstatement date. " There are other medications with the same active ingredient and for the same route of administration," she emphasizes. There are two more strengths that do not have a set date for when they will be back in stock, while for the rest, we will have to wait until July or August.

But it's not the only medication with fentanyl as its active ingredient that's been experiencing problems. The same is true for Durogesic , a transdermal patch available in five different strengths. In this case, there's no specific recall date.

The Spanish Agency for the Promotion of Public Health (AEMPS) explains to this newspaper that there are currently more than 170 presentations of medications containing fentanyl as the active ingredient in Spain, in different doses, pharmaceutical forms, and uses. "This allows for alternatives with the same dosage and dosage in all cases of current supply problems , so no patient has problems obtaining their medication," they argue.

In the case of Actiq, these sources comment that they are reporting capacity issues at the manufacturing plant and have had other issues with serialization and labeling, essential issues for marketing the drug. "In any case, the supply problems for some of its formulations will be reestablished today ," they told El Confidencial a few days ago. At Durogesic, the problem is due to a detected quality issue.

The General Council of Pharmaceutical Associations reports that its Drug Supply Information Center ( Cismed ), which draws on information from more than 12,000 pharmacies, does not list any medications containing the active ingredient fentanyl as causing the most problems, "although this does reflect an increase in incidents in recent weeks."

"This incident may be due to official supply problems with some fentanyl formulations reported to the AEMPS and recorded in Cima," these pharmaceutical sources explain. Despite these circumstances, they insist that " there is no access problem ," as does the Spanish regulatory agency, as other formulations of the same active ingredient, pharmaceutical form, and dosage are available.

El Confidencial has contacted stakeholders in the medical and associative sectors focused on drug addiction, and they agree that they are not encountering many problems with fentanyl used as a drug, so this shortage is not related to fraudulent use.

All It began about ten years ago, when María Josefa was diagnosed with a benign brain tumor. The best solution doctors found was to perform radiosurgery , which was a success. However, due to what may be possible malpractice—according to the family after conversations with other doctors—after a year she began to feel discomfort in her mouth and its opening was getting wider and wider. After several treatments and tests, the doctors detected that her jaw was "completely necrotic." As a result, she suffers " horrible pain " that can only be alleviated with a medication, a type of mouth stick, whose active ingredient is fentanyl . For a few weeks now, Alfonso, her husband, has reported having difficulty finding it.