Expired Medications : What You Should Know ?

EXPIRED MEDICATIONS : WHAT YOU SHOULD KNOW ?

Have you ever come across an expired medicines and thought about different consequences it may hold? If you are a medical practitioner or anyone who is under medications, then this subject definitely might have bothered you at least once, so here is what you should know.

What are expired medications?

When you check the label of most of the medications you may come across “EXP. DATE” or “expired date” or “best before”. All of these represents the expiry date of a medication which denotes that the medicine is no longer as effective or stable as it should be after that particular date. Beyond the expiration date, safety, quality, purity and effectiveness of that particular medicine is not guaranteed by the manufacturer. However, an expired date doesn’t mean that the drug is completely degraded but rather means that the time period has been tested.

Since 1979, FDA requires each medication packaging, including prescription, over the counter (OTC) and dietary supplements to have an expired date. Section 30 of Drug Act, 2035, Nepal prohibits sales and distribution of such date expired drugs for the safety reasons.

Using expired medical product can be risky and possibly produce harmful effects hence, it is important for a pharmacist to recheck the expiration date prior dispensing and even consumers must be alert at the time of taking their medicines. Each chemical has its degradation rate so you cannot assume the expiry date of one medication to be same as of other medications too.

How is an exact expiration date determined for each chemical?

Every drug manufacturer performs stability testing of each drug to estimate its purity and effectiveness. This testing includes analysis of drugs stability in normal and accelerated temperature and humidity. Based on these findings shelf-life (drugs active time period) is determined. Containers and packaging suitable to protect the drug from environmental conditions are also examined.

However, the true shelf life of a particular drug can never be determined as some drugs are still effective beyond expiration dates. One of the reason is carrying out stability studies for decades can be costly and economically impossible. As a result, manufacturers are permitted to choose an arbitrary time frame to test and establish a drug’s expiration date. Regulatory bodies require manufactures to provide stability testing data with a proposed expiration date and storage conditions when they submit an application for approval before marketing.

Is it safe to use medicines past their expiration date?

This totally is based upon the active chemical ingredient and nature of excipients used in a drug formulation. Efficacy of some medications may decrease considerably due to change in their chemical composition. Such medications may not be able to meet the clinical outcome as it has lower strength that regular products. It’s important to be aware that several potential harms might occur from taking an expired medicine. Based on analysis reports, solid dosage forms mainly tablet and capsules, appear to be most stable past their expiration date but drugs that exist in solution be it syrups or any parenteral dosage form are prone to bacterial contamination.

Medications that contain preservative can be unsafe past their expiration date. If these products appear cloudy or discoloured, then it should be discarded immediately. There are some life threatening reports caused by expired medications for example degraded by products of tetracycline can cause renal tubular damage known as Fanconi syndrome. Overall, do not use medications after date of expiry.

Do medicines degrade before their shelf life?

Not always manufacturer provided expiry date determines the stability of a product. Sometimes storage of products can also hamper the stability and effectiveness of that compound hence it is necessary to follow the storage conditions provide in the label of the container. For example, keeping oral solutions away from light in tightly closed containers. This information can easily be assessed from label and package insert or you can ask your pharmacist. On dispensing or during consumption if a pharmacist or a patient respectively, encounters any physical change in the medicine like discoloration of tablets or precipitation of suspensions, then such medicines should be better avoided and reported to the concerned authority.

Another confusion may arise when your pharmacist suggests you not to use medicines like eye/ear drops or ointments after 1 month to 3 months of its opening date. This is different than the expired date given by the manufactures because once the original container is broken the original expiration date stamped on label cannot be relied upon as the product is affected by various climatic conditions. Some medications are prone to microbial contamination and hence they are not suitable for use after its opening and should be followed by patient.

What to do when you come across an expired medication?

Handling of expired medications can be crucial as this might cause a lot of harm if not taken care. Proper disposal is a matter of concern as reports show children are admitted to hospital after accidentally consuming expired medication from their parent’s cabinet. This shows that expired medicines not only puts the person to risk but also can harm children and pets. When you find medications out of date on your first aid box at your home then it’s better to take back the medication to the place where it was brought from. If this isn’t possible then such medications can be diluted and flushed but before you do this make sure to check FDA’s flush list as flushing medications can cause harm to the environment. Drugs that can’t be flushed must be carefully thrown along with the municipal waste.

Retailers and wholesalers can return expired drug to the manufacture for safe disposal. Healthcare members especially pharmacist must educate patients on proper disposal techniques of expired and unused medications. Infographics provided by the FDA can be displayed in clinics and pharmacies to increase patient awareness.

Conclusion

Though a drug may or may not lose their potency past their expiration date U.S. Food and Drug Administration (FDA) strictly recommends not to consume drugs beyond expiration date as it can cause indefinite health risks. Shelf Life Extension Program (SEP) held by FDA showed no degradation of few drugs past their expiration date but these research data are very limited and based on controlled conditions. Sub-potent medications not only interfere with clinical outcome but can also have serious side effects on patient’s health. Mostly drugs that contain preservatives such as sterile solutions might not inhibit bacterial growth in presences of outdated preservative. It is always best to use a drug before its expires and immediately refill your prescription before your medication expires. If you encounter an expired medication you need to immediately discard medications to keep them away from children. One of the most recommended practice to dispose date expired medicines is to return it to the manufacturer or donor.