Expired Medicines are hazard to humanity.To maintain potency and safety of medications, cosmetics and packaged food, storage conditions, following the instructions of packaging and the packaging integrity are all key things irrespective of expiry date on the product.
Will you use a lipstick that is older than say, 2 years? Will you be comfortable taking cough syrup that is just a month away from expiry date? Will you consume a Tetra Pak drink that shows best before date, on the date when you want to consume? The answer to all above questions is likely: NO! In most high quality sweet shops, there is a recommendation that certain Bengali sweets are for immediate consumption and not to be stored for later consumption. All this is because product aging has impact on product profile.
Concept of expired medicines
Products of almost every type suffer deterioration of attributes and quality parameters with time. Before the launch of any packaged product, whether food or drug or cosmetic, the product is studied in detail to understand what changes happen to the product with time. The normal pattern is deterioration of product, there are chemical changes that do not appeal to the senses, for example discolouration or smell or off-taste. Besides chemical deterioration, bacterial decomposition may set in causing the product to do harm rather than intended good.
One important point is that packaging integrity and storage conditions are vital influencers of product attributes. At times, users do not put back the tube cap,contents in the left open tube deteriorate faster than mentioned as per shelf life. Another case is when cap is not replaced tightly after opening, in case of syrups and suspensions. This too leads to faster deterioration on keeping. There are tablets like Vit. C, which absorb moisture to cause product discolouration and deterioration. Hence, to maintain potency and safety of medications, cosmetics and packaged food, storage conditions, following the instructions of packaging and the packaging integrity are all key things irrespective of expiry date on the product.
Expiry date on medicines
In 1979, US FDA (Food and Drug Administration of USA) analyzed and concluded that drugs can undergo decomposition and may lose potency or become harmful after certain time. Formulators of pharmaceutical, cosmetic and food products, perform stability studies to understand how the product profile fares with time. Thus, products are seen to have either short expiry or long expiry. Some liquid formulations have 12 months expiry. The concept of expiry date is also called shelf life of a product. The repurposed drug favipiravir against Covid-19, for emergency use, was given shelf life approval of only 3 months during launch phase. So the idea is that a product should retain same properties from date of manufacture to end of shelf life. It is with this background, to ensure safety of patient or consumer that packaged food, cosmetic and drug items the world over, have an expiry date or shelf life concept.
Risky expired medicines
The impact of expired medicines is on safety and potency. Changes in expired medicines include the varying chemical composition and decrease in strength. When expired sub-potent antibiotics are used, the risk of not recovering from infection is more, and there is chance of complications plus antibiotic resistance. Using heart medications that are expired is extremely dangerous since lack of potency or other complicating factors may increase heart problems. Thus, it is better to be safe than sorry by using products within recommended shelf life.
What to do with expired medicines?
In advanced countries, there are well established systems to take back expired medicines from homes. In USA, there is even a NATIONAL PRESCRIPTION DRUG TAKE BACK DAY. In addition, there is a ‘drug take back location’ such as bins or other spots in the pharmacy for expired medicines: just drop it in the box. There are also other programs from time to time that drug manufacturers provide to take back expired medications, near expiry medicines, partly opened unused medicines and unused medicines, on a campaign basis, right from homes.
Environmental contamination through expired medicines
Disposal of medicines through trash or flushing down has its consequences on the environment. A German Govt. study of 2016 has revealed that 631 active ingredient contaminants have been seen in the soil, water, and seas of 71 countries of all continents. There are instances of fish addiction to amphetamine contaminant in water. The main source of drug contamination is urban waste water (containing thrown-away medicines and excreted urine having the medication and metabolites).
It is high time that the Govt. of India takes up the problem of expired medicines, unused medicines, partially used medicines and near expiry medicines at homes, and works with manufacturers and pharmacists (retailers) for a process to ensure safe disposal mechanism. It will be interesting to have a NATIONAL PRESCRIPTION DRUG TAKE BACK DAY as done in USA. This will certainly have a positive impact on the environment and safety of people.
Karnataka Regd. Pharmacists Association (KRPA), Mysuru https://krpaindia.com/ has recently won a fellowship from Govt of India to help run a program to take away and processexpired medicines, unused medicines, near expiry medicines and partially used medicines, from homes. KRPA has launched the ‘KRPA Medsbin’ program to help achieve this objective. In this program, select pharmacies and colleges have kept a bin where people can drop their expired medicines, near-expiry medicines, partially and unused medicines for safe disposal.
Medicines have potent substances in them. Improper storage and disposal or consumption of expired deteriorated medicines poses a hazard to humanity.
Sunil S Chiplunkar
M Pharm (Pharmacology) MBA (Marketing) PGDHRM (PhD)
VP – Business Development, Group Pharmaceuticals, Bangalore
E mail: 1969sunilchiplunkar@gmail.com
Mob: 63645 78669
