Drug Expiration Date, What Does It Mean?

The expiry date is the final day that the manufacturer guarantees the full potency and safety of a medication. In general, drugs expiration date is 2-5 years from production date. The expiration date does not indicate a point when a medication loses potency and is no longer effective or becomes harmful. Below is a table defining what the expiry dates are for various manufacturer descriptions.

Potency and efficacy of expired drugs
In fact, a medication’s potency gradually decreases starting from the moment of its manufacture. This process is not in any way spontaneous after the expiry date. Expired drugs have not necessarily lost their potency and efficacy. Studies show that, stored under optimal conditions, many drugs retain 90% of their potency for at least five years after the labelled expiration date, and sometimes longer. A recent ProPublica investigation found that most medicines still work beyond their marked expiration dates, though it stopped short of recommending that consumers go ahead and take expired drugs. A few drugs they tested did actually expire, but most expired 5.5 years past the listed date—some even worked up to 20 years after the date.

Shelf life
Shelf life is the period of time from the date of manufacture that a drug is expected to remain within its approved product specification while stored under defined conditions. Shelf life is typically expressed in units of months, i.e. 24 months, 36 months, to a maximum of 60 months. The shelf life of a product is determined by either how quickly the breakdown of the active drug occurs, or the risk of contamination from bacteria or other microbes. Not all drugs deteriorate at the same rate, and so expiry dates can vary from product to product.

Is it safe to take expired medication?
Should patients use expired medications, or not? It’s always best to use medications that are not expired; it’s just the safest route. If a medication is essential for a chronic and potentially life-threatening disease, for example, a heart condition, cancer treatment, seizure, or life-threatening allergy, it is probably wise to get a new prescription before it expires and keep up with refills as needed.
If an expired medication is for a minor health problem and the patient is not able to replace the expired medication, for example, headache, hay fever, or mild pain, it may also be safe to take it, although drug potency might not be 100% and it may not work as well. Some medications run the risk of becoming toxic after their expiration date, for example, tetracycline causing renal tubular damage, known as Fanconi Syndrome. Contrary to common belief, there is little scientific evidence that expired drugs are toxic.

Which medications are unsafe after their expiration date?
Biological products, insulin, refrigerated liquid, eye drops, injectables, and hormones. Certain medications have a narrow therapeutic index and little decreases in the pharmacological activity can result in serious consequences for patients. Long-expired antibiotics (e.g. amoxicillin, azithromycin, cephalexin, doxycycline) can contribute to increased antibiotic resistance and treatment failure.
• Dilantin, phenobarbital: very quickly lose potency
• Nitroglycerin: very quickly lose potency
• Theophylline: very quickly lose potency
• Oral contraceptives
• Epinephrine: very quickly lose potency

Consequences of using expired stock
• The active drug becomes chemically unstable.
• The effectiveness of the drug may change.
• The breakdown of the drug may be toxic and harmful to the patient.
• Increased risk of contamination from bacteria and other microbes.

 

 

 

 

 

 

 

 

Legal aspects of expired drugs as per GON: Drug Act 2035, Chapter 7, Section 30 has prohibited the sale or distribution of date-expired drugs. Section 34 has made provision of penalties for act against Section 30 ranging from fine of Rs.5000 to life Imprisonment, depending on the risk associated.

Resources / references
 Continuing Professional Pharmacy Education (CPPE) Supporting Care Homes in Medicines Management April 2007.
 NHS Rotherham CCG good practice guidance for Care and Nursing homes on expiry dates of medicines Ratified 26th October 2016
 A glimpse on expiry date of pharmaceutical dosage forms. PHARMANEST – An International Journal of Advances In Pharmaceutical Sciences
 Stability Profiles of Drug Products Extended beyond Labeled Expiration Dates. Journal of Pharmaceutical Sciences, VOL. 95, NO. 7, JULY 2006

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