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Drug Expiry PowerPoint Presentation

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Description : All Medicines have expiry dates so you know when to use them by. After the expiry date medicines may not be safe or as effective. An expiration date “represents a promise that the medication is good at least that long, if properly stored,”

Tags : Drug Expiry,Drugs,about Drug expiry,medicine

Published on : Nov 22, 2023 | Views : 577 | Downloads : 2

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Slide 1-

DRUG EXPIRY WHAT DOES IT ACTUALLY MEAN? PH. Lubana Murshed Product Manager
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Why Do Medicines Expire? Taking old medicines can cause harm, or even be fatal, especially if you are taking them for a serious health condition: Medicines lose their effectiveness over time because they are made up of chemicals that break down as time passes. They may also become dangerous due to a change in their chemical make-up.
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Since 1979, the FDA has required pharmaceutical manufacturers to give FDA expiration dates on all the medication products. The legislation required that all pharmaceuticals and over the counter (OTC) medications display expiration dates
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Definition The expiry date is the date at which the manufacturer can still guarantee the full potency and safety of the drug It is between 12 and 60 months from the time the product was manufactured
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Drug expiration dates reflect the time period during which the product is known to remain stable. Which means it retains its strength, quality, and purity when it is stored according to its labeled storage conditions
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Expiration date would be set by the manufacturer and based on : The period of time when the maker guarantees the efficacy and stability of the product. which translates into safety for the patient.
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HOW ARE EXPIRATION DATES ESTABLISHED? The expiration date of a drug is estimated using stability testing under good manufacturing practices as determined by the Food and Drug Administration (FDA). Manufacturers are required to provide stability testing data with a proposed expiration date and storage conditions.
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Stability Testing Is a routine procedure performed on drug substances and drug products to provide: Evidence on how the quality of a drug varies with time under the influence of a variety of environmental factors such as temperature, humidity and light confidence that the product will meet the applicable standards of strength, quality, and purity throughout its shelf-life
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Stability Testing - Purpose Understand the molecule Select packaging Establish a retest period (API) or shelf-life Determine the best storage conditions
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What Types of Stability Studies are Commonly Conducted for Drug Products? Stability studies are required to be conducted on drug products under the conditions of storage indicated on the product label, including any other conditions that the drug product might be exposed to during manufacturing, storage and shipping activities. As a result, there are a number of stability conditions that are commonly employed to determine the stability of a drug product in its marketed package(s).
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Stability Testing - Protocol Stability Testing Accelerated Long Term
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Accelerated Stability Testing All accelerated stability studies are conducted under storage conditions of: 40 +/- 2oC with 75 +/- 5% RH. A stability study conducted under exaggerated conditions in an attempt to accelerate the aging process, i.e., the rate of chemical degradation and/or physical change. Minimum three points including t0 and tfinal e.g. 0, 3, 6
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EXTRAPOLATION Extrapolation: Extend the shelf life beyond the period covered by available long-term stability data A retest period or shelf life granted on the basis of extrapolation should always be verified by additional long-term stability data as soon as these data become available (commitments)
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Long Term Stability Testing A stability study conducted under controlled temperature and humidity approximating conditions of long- term storage. Syria in Zone I I
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A study that is conducted at 5 o C ( without humidity control) to determine the effect that freezing and subsequent thawing have on the stability of a product.
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A study that is conducted to determine the effect that either whole or ultraviolet l ight has on the stability of a product.
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A study that is conducted to determine the period of t ime that a product remains suitable for use after i ts container system has been opened and reclosed.
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Why do Some medicines have short expiry dates Some medicines are given a short expiry date due to them being less stable or there being greater risk if they are used for a longer time. Accelerated EYE DROPS PREPARED ANTIBIOTIC MIXTURES
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Stability-Indicating Quality Parameters Accelerated Long Term
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WHAT TYPES OF STABILITY STUDIES ARE COMMONLY CONDUCTED FOR DRUG PRODUCTS?
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IN CASE SIGNIFICANT CHANGES ARE OBSERVED Possible responses: Amend storage conditions Improve the packaging A serious problem may require reformulation of the FPP No allowed extrapolation Shorter shelf-life than covered by long term data
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Can Expiration Dates be Extended? The manufacturer of an approved drug product may extend the expiration date for the drug product based on their own testing and acceptable data. To help alleviate drug shortages, FDA has also approves extensions of expiration dates when data supporting the extension are available
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Shelf Life Extension Program Federal stockpiles are stores of certain drugs that might be needed to prevent or treat diseases or conditions which may occur during a public health emergency. The military was facing the daunting process of destroying and replacing its supply every 2 to 3 years To avoid the need to replace entire stockpiles at significant expense, the Shelf-Life Extension Program (SLEP) was established in 1986.
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In 2016, the DoD reported that the program had helped save the department $2.1 billion on replacing stockpiled medications. SLEP has found that 88% of 122 different drugs stored under ideal conditions should have their expiration dates extended more than 1 year with an average extension of 66 months, and a maximum extension of 278 months.
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DRUG EXPIRY EXTENSION EXAMPLES
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The expiration date doesn't really indicate a point at which the medication is no longer effective or has become unsafe to use. Loss of potency can be a major concern especially with lifesaving drugs. Medication's potency gradually decreases starting from the moment of its manufacture. Can I Take an Expired Medication?
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Expired drugs have not necessarily lost their potency and efficacy. The expiration date is only an assurance that the labeled potency will last at least until that date Solid dosage forms, such as tablets and capsules, are most stable past their expiration date. Drugs that exist in solution or as a reconstituted suspension may not have the required potency if used when outdated.
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WHICH MEDICATIONS ARE UNSAFE AFTER THEIR EXPIRATION DATE? Medicines that look old, powdery or crumbling medicine, drugs with a strong smell, or dried up medicine (as in the case of ointments or creams) should always be discarded, expired or not. If expired or not, always discard injections if cloudy, discolored or with visible floating particles.
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HOW TO STORE MEDICATION SAFELY? Keep the medication in its original container. Store the medication in a cool, dry place. Keep medications out of reach of children and pets. Never share your medication with others Keep a list of all the medications you take, including over-the-counter drugs and supplements. Have your medicines reviewed every 6 to 12 months.
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THANK YOU