EMA Proposes That a Fentanyl Antidote Be Sold over the Counter in Pharmacies

The European Medicines Agency (EMA) has approved a naloxone nasal spray, a life-saving medicine used to reverse overdoses, most commonly involving fentanyl. The agency recommends that member states allow the spray to be sold over the counter in pharmacies. In Bulgaria, however, naloxone has yet to be included on the Positive Drug List. The Ministry of Health and the Ministry of the Interior are urgently seeking a solution to ensure supplies of the life-saving medicine.

Emergency medical teams are on the front line of the growing threat posed by the rapid spread of fentanyl. Dr Tania Alekova can hardly remember a shift when she has not had to use the life-saving medicine.

Dr Tania Alekova, emergency physician, Sofia: “We use naloxone in our practice almost every day. Over a 24-hour period, we may need to administer it once or twice.”

Emergency medical bags contain only ampoules of the medicine, which is administered by injection.

Dr Tania Alekova, emergency physician, Sofia: “This formulation acts the fastest. Depending on the amount of opioid taken, more than one ampoule may be needed. Two can be administered over a specified period, of course.”

However, supplies of the medicine have been severely disrupted for some time. Only one manufacturer has been granted marketing authorisation in Bulgaria, but it has no interest in registering the product.

Dr Desislava Velkovska, Director of the Medicines Policy Directorate, Ministry of Health: “There is currently no medicinal product named naloxone on Bulgaria’s Positive Drug List, which means it cannot be paid for or supplied using public funds. Naloxone is also absent from the register of maximum prices for medicines, which means it cannot be purchased freely in pharmacies.”

Despite this, the Ministry of Health says it has secured sufficient quantities of naloxone to supply all emergency departments across the country for at least a year. The medicine is being purchased through hospitals as a product that is not registered in Bulgaria.

However, the ministry believes that allowing the nasal spray recommended by the European Medicines Agency to be sold over the counter will also increase commercial interest in the Bulgarian market.

Dr Desislava Velkovska, Director of the Medicines Policy Directorate, Ministry of Health: “But for that to happen, the medicinal product must have an officially established price.”

The holder of the marketing authorisation in Bulgaria has said there are no obstacles to registering the product under the new arrangements. Sales through pharmacies are not expected to begin for at least five months. Pharmacists also see no problem with making the medicine freely available.

Corresponding Member of the Bulgarian Academy of Sciences Professor Georgi Momekov, Dean of the Faculty of Pharmacy, Sofia University: “It carries no risks in itself. It is an antagonist, meaning that antagonists block receptors. Because the opioid peptides in our bodies are highly specialised, blocking their receptors does not lead to any negative effects.”

As well as being easy to use, the nasal spray could significantly improve the chances of survival for people with drug dependencies who experience an overdose.

Corresponding Member of the Bulgarian Academy of Sciences Professor Georgi Momekov, Dean of the Faculty of Pharmacy, Sofia University: “The idea is to ensure access. When acute intoxication occurs, it is only a matter of time before the person dies. The respiratory centre is suppressed.”

Fentanyl is spreading rapidly in Bulgaria. Since it was first detected in the country in 2024, traces have now been found in 17% of used syringes in Sofia and 94% in Plovdiv. More than 100 deaths have been reported following overdoses.