Sweden makes naloxone spray an OTC product, to prevent opioid overdose deaths [Advocacy Lab Content]

Naloxone nasal spray, which can save opioid users from overdoses, will soon be available without prescription in Sweden. The move seeks to increase early interventions outside healthcare settings, marking a major shift in Swedish drug policy.

Sweden will join France and the UK in making a naloxone nasal spray available to individuals over the counter. The drug has been used in American and European healthcare for more than 50 years as a potent opioid antagonist drug, that rapidly reverses the effects of opioid-based drugs.

“The opioid reversal drug naloxone saves lives, but its availability in Sweden has been too low. I am pleased to announce today that it will soon be sold over the counter in Swedish pharmacies. This will save lives,” said the Social Affairs Minister and Christian Democrat, Jakob Forssmed.

The announcement came after the Swedish Medical Products Agency decided on 19 March 19 to allow the over-the-counter sale of Respinal, a naloxone nasal spray made by the Norwegian company DNE Pharma.

More suppliers of naloxone may soon follow since Jakob Forssmed told the media that he has been talking to other manufacturers, asking them to apply to the agency for OTC approvals.

Making naloxone widely available

The Swedish centre-right government’s ambition is to increase the availability of naloxone outside hospitals and medical receptions. This bid was announced in November of last year, as Euractiv reported.

“This is an important step in the government’s work to reduce the deaths from opioid poisoning, as most of these do not occur in a healthcare setting,” the minister said.

For many years, Sweden has had take-home programs for drug users in various regions, where the antidote is available free of charge on prescription. These will be continued.

But in the latest bid to increase the availability of the fast-acting nasal spray, efforts also turn to friends and family of opioid users, hoping they will buy the spray to have on hand in case an overdose occurs.

One naloxone spray dose can first be given in one nostril, and if the respiratory depression of an individual is not reversed, a second dose can be given in the other nostril.

“With a prescription, a kit with two spray doses today costs around 400–500 Swedish krona [€35 – €43,7] as it is sold within the national high-cost protection program. What the price will be when sold over the counter is so far unknown, senior investigator Paulina Tuvendal at the Swedish Medical Products Agency said to Euractiv.

“When the naloxone kit is sold over the counter, it will not be subsidised by the state,” she added.

Pharmacists need to train

Her chief executive, Björn Eriksson, the director general of the agency, also told the media that pharmacy employees first need to undergo training on how to give their customers instructions on how to administer the nasal spray to a person.

According to Eriksson, Sweden is among the first countries in Europe to provide naloxone nasal spray over the counter. It has also been made available in Swedish ambulances.

Furthermore, the Swedish government awaits stakeholders’ views on proposals published by the Drug Commission of Inquiry last autumn, which would like to see legislative changes that would allow naloxone also to be available to more professional groups, such as police officers and security guards.

The European Commission approved the drug for EU-wide marketing in 2017.

France and the UK have been pioneers in Europe in making the antidote more readily available. France piloted a nasal spray version back in 2016. But Denmark and Estonia have also taken similar steps to increase accessibility.

Two years in the making 

As mortality from overdoses and poisonings in Sweden surpasses 900 cases a year, a possible change in Swedish drug policy was first seen two years ago when the current government assigned a special investigator, the Drug Commission of Inquiry, to propose how Sweden’s restrictive drug policy at the time could be combined with effective drug prevention.

Along with other good care and harm reduction measures, this aims to ensure that no one dies as a result of medicines and drug poisoning.

[By Monica Kleja, edited by Vasiliki Angouridi, Brian Maguire | Euractiv’s Advocacy Lab]

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