Low-Strength Melatonin Will No Longer Require Prescription

melatonin iceland

Following a recent statement by the Icelandic Medicines Agency, Lyfjastofnun, melatonin under a concentration of 1 mg/ day will no longer require a prescription.

Melatonin is a naturally occurring hormone in the body which is released to regulate our sleeping cycles. It is often taken as a dietary supplement and as a medication to treat sleep disorders.

Up until now, melatonin has been classified as a medicine under Icelandic law, regardless of strength. In many other countries, however, melatonin is sold as a dietary supplement and is available without prescription. According to the Icelandic Medicines Agency, these differences in regulation between countries have caused confusion among both Icelanders and tourists, who have purchased melatonin abroad legally, but were not allowed to bring it into the country. In recent years, some of the Nordic countries have decided to allow over-the-counter sale of melatonin in low doses. In other countries, such as the United States, melatonin is sold in higher doses with no prescription needed.

Earlier this year, the Icelandic Food and Veterinary Authority, MAST, requested a reconsideration of melatonin’s classification status. Low-dose melatonin will now be available without prescription, as long as the marketing and packaging makes no claim to treat disease or act as a preventative measure.

 

New Regulations on Rx Pick-Up Take Effect

New regulations governing the pick-up of prescription medication will go into effect next week. Per a statement on the on Government of Iceland website, starting on Tuesday, March 10, medication will only be given over to the person to whom the prescription was written, or to someone who has that person’s express written authorisation. Anyone who is picking up a prescription will be required to show valid identification.

These changes are going into effect on the basis of incidents where medication has been given over to someone other than the prescription holder without their authorisation and thus represents a violation of privacy.

Authorisation for a proxy to pick up medication must be in writing and must also bear the signatures of two witnesses, along with their full names and kennitala (Iceland’s national ID number). The original authorisation or a copy of it will then be kept at the pharmacy. This authorisation can specify if the proxy is empowered to pick up any medication on behalf of the prescription holder for an indefinite period of time or just a single medication for a limited amount of time. Parents are permitted to pick up medication for children 16 years and younger without written authorisation.

More than 80 Medications Unavailable in Iceland

Prozac pills

Drug manufacturers’ preference for larger markets means that dozens of medications are currently unavailable in Iceland, RÚV reports. Pharmacist Aðalsteinn Jens Loftsson says the situation can make it difficult for locals to obtain the right medications and can be outright dangerous. Even Brexit is affecting the availability of a certain drug on the Icelandic market.

“We run into this on a daily basis, no question, to a varying degree. Some situations are more serious than others and more difficult to solve,” Aðalsteinn says. Medication for haemorrhoids is one example of a drug that has been unavailable. “The manufacturer of these suppositories decided to stop manufacturing them and sell the licence to another manufacturer. They showed no interest in Iceland and decided to just return the market licence so the drug is delisted.”

Working around such challenges has proven difficult in many cases. Though some importers have attempted to obtain exceptional licences to import unavailable drugs or other drugs similar to them, “it hasn’t gone well enough at all,” says Aðalsteinn. Last summer, thyroid drugs and nasal spray for allergies were both unobtainable in Iceland. Beta blockers, prescribed for high blood pressure, have also been unavailable. “You can name one more. An old and good antibiotic which was simply delisted this summer. It was the only drug in its category.”

Burden on health care system

In many cases, when a prescribed drug is unavailable, pharmacists do not have legal authority to prescribe an alternative. Patients then have no choice but to consult a doctor again. This not only leads to higher expense for the patient, but also “an additional burden on clinics, doctors, specialists, and the hospital,” Aðalsteinn says. “So I would say it would be desirable for those who are dealing with these issues to gather together for one good meeting and seek solutions.”

New drugs seek big markets

Aðalsteinn points out that new drugs can also take time to reach Iceland, as they are often marketed in larger countries first. “That’s no secret.”

The Icelandic Medicines Agency website publishes a list of currently unavailable medications.