If you have an expired medicine at home, do not take it. After the expiry date, defined by the manufacturing companies according to stringent international guidelines (ICH)processes may occur degradation of the active ingredient or excipients which may result in a lower effectiveness of the active ingredient, in the formation of toxic compounds dangerous to your health or in a contamination bacterial. Furthermore, if not stored in a suitable manner, as indicated on the packaging (for example: keep in the fridge) they can degrade even before the expiry date. They should not be dispersed into the environment, but disposed of correctlythrowing them into the appropriate bins outside the pharmacies. It will then be the pharmacist’s task to dispose of them in turn by relying on specialized companies who will send the medicine to special disposal plants. waste-to-energy.
What happens if you take a drug after its expiration date
Beyond the expiry date, the active ingredient, whether it is an antibiotic, a contraceptive or a “simple” antacid, can degrade and, in the best case scenario, lose effectiveness. In practice, you have less active ingredient in the tablet and when you take it it has no effect on you. You understand that if an antacid doesn’t work for you after Christmas dinner, you could be having a bad night.
But this is only the mildest case. In addition to the active ingredients, drugs also contain other inert ingredients, i.e excipients (from Latin excipiens-entisi.e. welcomed) who have the task of facilitate the journey of the active ingredient into our body: for example they favor the dissolution of the tablets, or protect the drug from the attack of the acid present in our stomach. Degradation of the active ingredient or excipients can lead to the formation of toxic degradation substances (just call degradation impurities) and therefore dangerous for our body, to the point of being able to cause a fatal allergic reaction!
Finally, especially for products in liquid formulation, such as syrups, eye drops or injectables, there is a risk of bacterial contamination! In practice, don’t trust your eyes and nose: even if it hasn’t changed color or smell, an expired medicine can already be dangerous for your health.
Why do medications have an expiration date?
The expiration date of medicines, like all expiration dates, is used to guarantee us that what we are consuming or taking does not represent a danger to our health. In fact, it indicates the deadline within which the manufacturer guarantees full availability stability, safety and efficacy.
That of medicines is indicated by the wording “expiry date”, “expires on”, “expires” or simply with the symbol of a hourglass followed by day/month/year or just by month and year: in this case, it is considered the end of the month. Obviously you shouldn’t imagine a small timer inside the medicines that at the stroke of midnight on the expiry date starts Armageddon inside your tablets, but beyond that date you no longer have the guarantee of taking a safe product! In fact, unlike the Minimum Conservation Date (“best before”), beyond the date indicated on the package, drugs they can no longer be hired.
Be careful even before the expiration date
Store medications in unsuitable places (for example near heat sources, in humid areas, exposed to light or high temperatures) can prematurely compromise its stability and safety. In short, don’t put eye drops in the kitchen near the oven! And in reality, not even the bathroom is such a safe place, because it is often there most humid room in the house. The expiry date refers to the product being packaged intact And properly stored!
For liquid formulations, for example eye drops, attention must also be paid to the so-called secondary deadlinethe famous “after opening, consume by”. Many multidose eye drops (i.e. in a single vial) after opening can be used for a maximum of 28 days from opening (as indicated by the European Medicines Agency), despite the expiry date indicated on the package being in two years.
It is therefore essential to always follow the storage instructions indicated on the information leaflet (for example, “store at temperatures between 2°C and 15°C” or simply “store in the refrigerator”). If there are no particular indications, as reported by the Istituto Superiore di Sanità: keep the medicine a room temperatureaway from heat sources, away from direct light and excessive humidity.
Where to throw expired medicines: correct disposal
For us consumers it’s easy: they should absolutely not be dispersed into the environmentbut we have to bring them to the special binders present in pharmacies with all their packaging. Only the outer box and the information leaflets which must be disposed of in the paper are excluded. So if you have only used three tablets and you still have four left in the medicine bin the whole blister goes, you don’t have to remove the tablets.
Even if they are about to expire syrups and liquid formulationssuch as eye drops or injection vials, the entire container should be thrown away (the glass bottle or vial, for example) inside the pharmacy bin. The liquids they absolutely must not be thrown down the sink or in the toilet, because the drugs inside them can reach the sea and rivers. The problem in this case is not only that there we pollutebut that we can select bacteria resistant to antibiotics (if for example you were to empty a liquid antibiotic into the house drain).
We are obviously talking about expired drugs that are left behind unused, the matter is different for i empty containers which should instead be disposed of in separate waste collection. So, if you have used all the tablets, taken all the syrup, and the blister or bottle are emptyyou can dispose of them normally (usually in plastic or glass depending on the case). If there are still tablets or syrup, they go in the pharmacy bin!
How do pharmacies dispose of them?
According to Presidential Decree n.254 of 15 July 2003, expired drugs are classified as “healthcare waste that requires particular management systems“. Pharmacies fill out a special form, called the Waste Identification Form (FIR) and entrust the expired medicines, both those present in the appropriate bin and those found on the shelves (yes, medicines can also expire in the pharmacy) to specialized companies authorized by the ASL.
The drugs collected in this way are then sent to specific locations waste-to-energy plants. In fact, waste-to-energy treatment guarantees the complete destruction of the active ingredient and the homogenization of the disposal process. However, don’t try to take shortcuts: you can’t burn them at home. Waste-to-energy plants and incinerators have special systems to collect and eliminate even the noxious fumes that develop, something that we don’t have at home.
How to establish the expiry date of a drug
This is decided by the manufacturing company, which must carry out specific tests to evaluate it before it can sell a drug stability, impurity contents and physical parameters over time. The protocols to be followed for these tests are described by the international ICH guidelines (The International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use) and the results are included in the dossier that the company delivers to the EMA or AIFA to obtain the Marketing Authorization (AIC) for the drug.
To establish the expiry date, long-term tests must be carried out on the packaged and intact product for at least 12 months at regular intervalsto the environmental conditions of the country in which you want to market the drug (obviously in different countries humidity and temperature also change a lot). If the company wants to propose a expiration exceeding 12 monthsthese tests must be done for the entire period you intend to propose. For example: if you propose a 3-year deadline, the tests must be done for all three years.
ICHs also expect to be able to make some accelerated testingin which the drug is subjected to extreme environmental conditions for a more limited period of time (usually 6 months), and then extrapolated the data to extend the expiration date.
Finally, preparations that require dilutions, reconstitutions (such as some injectable drugs that need to be reconstituted by mixing a powder and a liquid) or that are opened and are at risk of being contaminated (such as multi-dose eye drops) must be subjected to specific stability tests in-use, that mimic the conditions of use.
The US experiment to extend use
The USA wondered whether the expiry date of some medicines could be extended: for this reason the Food and Drug Administration (FDA) started the SLEP (Shelf-Life Extension Program). In fact, based on some studies, if preserved perfectlysome drugs may be used even beyond their expiration date. The program serves primarily to avoid waste resulting from the purchase of large stocks of drugsfor example for military forces or in the case of health emergencies, which would need to be replaced every few years due to expiration.
However, this is a government program designed solely for products whose Storage conditions are under strict government control and which should absolutely not be taken as an example for everyday life. Indeed, the FDA itself advises citizens against taking expired drugs! We must therefore stick to the expiry date indicated on the packaging of the medicines, the only one approved by the health authorities, and take care to store them correctly once at home.
