Methodological norms appeared. How expired drugs will be collected from the population

Both state and private hospitals are obliged to place special containers in their courtyards for collecting expired medicines from the population. In the case of small towns, where there are no hospitals, containers can be placed next to dispensaries. This is what the new law on the collection of medical waste looks like, which entered into force on January 1, but until now it had no methodological norms.

What do we do with expired medicines – Photo Archive

Since the beginning of the year, medicines should be collected in hospital yards, according to Law 269 of October 10, 2023, but the Ministry of Health has only now issued the methodological norms that were published in the Official Gazette. Hospital managers were awaiting instructions to implement the law that came into effect on January 1. Expired medicines are considered hazardous waste and their disposal can lead to water and soil pollution, which ultimately leads to health problems for people.

What do we do with expired pills?

Thus, hospital managers will be obliged to set up containers in the courtyards of medical units for the collection of medical waste in places accessible to citizens, but which must be protected and monitored, either by security personnel or by video surveillance cameras. In the case of small towns, where there are no hospitals, containers for the collection of expired medicines can be placed near the dispensaries. The costs of the final disposal of expired drugs will be covered by money from the state, not from hospital funds.

Hospitals can organize the collection of drug waste from the population on pre-set days and time intervals.

Drug waste resulting from the population is represented by expired drugs, drugs that are no longer used, drug residues, drugs that have damaged containers, drugs withdrawn from the market, etc.“, the official document states.

It also shows that drug waste is collected separately from that resulting from the hospital's medical activity. The law requires the inclusion of the warning: “EXPIRED MEDICINES MUST BE RETURNED TO HOSPITALS” on drug labels, with the implementation of this provision until December 31, 2028.

The costs for carrying out operations (…) by public or private hospitals are ensured by transfers from the state budget, through the budget of the Ministry of Health, to the budget of the unique National Health Social Insurance Fund. The methodology is established by rules approved by order of the Minister of Health“, the law provides.

Implementation

From our point of view, it is quite difficult to put this burden behind the hospital. Out-of-circuit pharmacies should have done that, because in a hospital, hundreds of people come in every day. Records must be kept, they must be secured: one man comes and throws some medicine, and then the second one comes and starts rummaging to see what would interest him from what the previous one threw away. Hospitals have a lot of activities, to burden them with the collection of expired drugs from the entire population is an excessive task. I could pretend to do something, put a trash can at the entrance to the hospital that says Expired Medicines. Throw them away, but there are a lot of other problems, of keeping track of these drugs, of securing them“, recently explained Dr. Cătălin Apostolescu, manager of the National Institute of Infectious Diseases “Prof. Dr. Matei Balș” from Bucharest, for “Adevărul”.

Last week, at the Institute “Matei Balș”a place was set up for the collection of this waste, at the main entrance to the hospital.

Although the initiator of the law, Adrian Wiener, primary physician at the base, said that things will be simplified, because in the hospital yards “there will be some one-way containers, (…) close to the entrance from the street, so that they are visible“, in which people put expired medicines – the hospitals say that they must be secured. Moreover, he insists that there is no need for specific implementing rules. The law would also eliminate the forms, the minutes of surrender, as the cited source mentions.

What was happening until now

Even until now, the situation of this waste was not very clear, considering that some pharmacies received it and others did not. Pharmacists refrained from collection on the grounds that the drugs that are part of the category “toxic and narcotic” they involved a lot of forms to fill out and for which a lot of details were required.

Anca Crupariu, spokesperson of the College of Pharmacists, recently said that “some norms were still expected” so that pharmacies can collect expired drugs and, even if there have been several proposals to solve the problem of drug waste, no clear rules have ever been given. Thus, until the end of last year, the legislation in the field stipulated that expired medicines from the population should be deposited at pharmacies, but did not establish the obligation for them to receive them.

Drug pollution

It is estimated that 1,500 tons of expired drugs end up in the garbage or in the sewage system every year. Just over a ton goes to the Medicines and Medical Devices Agency, which is also the only institution authorized to destroy them. A research, cited by the initiators of the bill, shows that in 65% of running waters, including the Danube, the level of 14 of the most common antibiotics exceeds the maximum allowed limits by 300 times. Thus, pollution with these substances leads to increased resistance to antibiotics, but also to pollution with hormones, cytostatics or antidepressants.