Topic: Expiry Date

Submitted To: Dr. Shaista Qamar

Submitted By: Abu Safyan 1221

 INTRODUCTION
 The shelf-life of a drug is the time it is known to stay within acceptable
specifications for potency and other important parameters.
 The expiry date is the date when a given batch reaches the end of its shelf-life.
 The lower potency limit of the drug is usually set at 90% of the stated label
claim.
What Does An Expiration Date Mean?
 The expiration date is the final day that the manufacturer guarantees the full
potency and safety of a medication.
 Drug expiration dates exist on most medication labels, including prescription,
over-the-counter (OTC) and dietary (herbal) supplements.
Significance Of Expiry Date Written On Drugs
 According to Dr. Rohr, there is no scientific evidence to suggest that expired medications
can be toxic or make you sick the way rotten food can. The drug is likely to lose some
potency after the expiration date, but it is not clear how much potency is lost over a
specific timeframe past expiration dates.
EXPIRATION DATE DEPENDS ON
Degradation
 The expiry date depends on specified storage conditions.
 Not all drugs have the same rate of decomposition, thus expiry dates will differ.
 Degradation processes include hydrolysis, oxidation and degradation by light.
 This is because of the chemistry of many of the functional groups in drug molecules and
the ubiquitous presence of water and oxygen.
 Even when factors such as water, oxygen and light have been controlled, degradation will
still occur, but at a reduced rate.
Hydrolysis
 The rate of hydrolysis is affected by access to water and is prevented or lowered by
reducing exposure to water.
 If a drug must be formulated in water, the solution is often buffered to a pH where the
rate of hydrolysis is minimal.
 Substances which are particularly susceptible to hydrolysis are often packed in
individual dose units e.g. soluble aspirin tablets are individually encased in foil.

Oxidation
 Many drugs will react with atmospheric oxygen, so oxidation is a prime cause of
degradation.
 A well known oxidation is the conversion of wine into vinegar; the ethanol is oxidized
to acetic acid.
 Oxidation is reduced by the exclusion of oxygen., usually removed from the
solution and the head-space by flushing with an inert gas before the ampoule is
sealed.
 If appropriate, antioxidants or chelating agents may also be used.
Photo-degradation
 The absorption of light energy may result in photo degradation.
 When light is absorbed by a molecule, it is either re-emitted or transformed into
physical or chemical energy.
 Physical energy is usually lost as heat.
 Chemical energy may be sufficient to cause either cleavage or rearrangement of
the molecular bonds.
 Protection from light is achieved by packaging the products in amber glass
bottles or by using colored film for blister packed products.
Formulation
 The formulation of a drug may have a pronounced effect on the shelf-life because of
the effect of excipients used in manufacturing.
 Some drugs may be quite stable in the pure form, but may undergo degradation rapidly
when combined with certain excipients.
 Excipients affect the stability of drugs by acting as surface catalysts, altering the pH of
the moisture layer and/or undergoing direct chemical reactions with the drug.
Storage And Transport
 Stability is a significant issue, and the importance of temperature on the chemical
stability of a pharmaceutical product cannot be over-emphasized.
 The rate of chemical reactions doubles for every 10°C rise in temperature.
 Products which are to be stored in the refrigerator, e.g. vaccines and insulin, should be
transported in refrigerated containers or vehicles.
 DRUG EXPIRATION DATES: HOW ACCURATE ARE THEY?
 Since 1979, the Food and Drug Administration (FDA) has required pharmaceutical
manufacturers to provide expiration dates on all their products. For the majority of drugs
sold in the United States, these dates range from 12 to 60 months from the date they are
manufactured.
 Expiration dates are basically guidelines. Your medications may expire before the
expiration date if improperly stored, or they may last well beyond their expiration date, as
some studies have shown.
 Pharmaceutical manufacturers determine a drugs shelf live, or expiration date, through
stability testing. This type of testing ensures that a drugs potency and integrity are intact
over a specific amount of time, which becomes the expiration date.
 It is important to note that the manufacturers expiration dates apply only to the original
packaging of the drug, and that once opened these dates no longer apply.
Variability
 Drugs vary widely in terms of dosage, form, and stability. Some drugs, like pediatric
liquid antibiotics, insulin, and certain injectable will expire more quickly than
medications in other forms, such as tablets.
 So, remember, your medications will work only as well as they are handled. Taking
them safely means storing them properly, reading all specific instructions carefully, and
not using them after the recommended amount of time or expiration date.
 FDA RULES, EXEMPTIONS AND TIPS
FDA Expiration Date Rules
1. The Federal Food, Drug, and Cosmetic Act give FDA the power to regulate drugs.
2. The laws regulating expiration dates and other aspects of medical drugs protect
consumers from ineffective drugs.
3. The FDA mandates that all drug companies test the expiration process of their drugs.
4. Drug expiration dates are meant to indicate the date at which the drug's potency
begins to diminish.
5. The purpose of this expiration date is to inform consumers about the potency and
effectiveness of the drug at the time of purchase.

FDA Exemptions
 The FDA grants some exemptions for certain drugs. Any drug that uses a company's
previous stock of tested chemicals can accelerate the testing process.
 This saves the company time and money. At one point the FDA gave an exemption to
drug companies that had to reduce the amount of iron in their medications.
 The iron in the drugs needed to be reduced, but in order to minimize manufacturer
burdens the FDA allowed drug companies to skip shelf-life testing.

FDA Tips
1. Some expired drugs may become discolored or become powdery after a certain amount
of time and should be discarded.
2. Even if it is relatively safe to ingest some medications after the expiration, the FDA and
doctors do inform consumers about the dangers of ingesting some expired drugs.
3. Expired drugs that are emitting an odor should be thrown out.
Reason for stock piling of expired medicines
 Poor determining of future demand, insufficiencies in the administration of a supply
chain and poor coordination between a national supply system and the development
accomplices offering to supply pharmaceuticals might be reasons for stocking up of
lapsed pharmaceuticals.
 Likewise, patients are not ready to utilize all the administered drugs because of adverse
effects, alteration of dosage, feeling healthy or medications reaching the expiration date.
DISPOSAL OF EXPIRED MEDICINES
 An investigation uncovered that most individuals discarded the unused and expired drugs
in the family trash.
 In a Korean report, found that housewives in Busan city of Korea disposed unused
medications using the standard garbage bag.
 Practice pursued by the general population in Kuwait, UK and USA for all the unused
and expired medication was to flush it down the toilet/drain, which is better suited for
liquid medications.
The Pharmacist At The Forefront
 Improper disposal of unused and expired medications is a potential threat and can be
harmful to humans, environment, and wildlife.
 It is a good practice to return unused and expired pharmaceuticals to medical stores for
correct disposal.
 Many countries have government-run Safe Medicine Disposal programs, Medications
Return Program or Take-back programs, but the best option for the safe disposal of
pharmaceutical waste is incineration.
 A significant role can be played by the community pharmacist being on the forefront in
guiding and providing proper education and awareness to the community on proper and
standard disposal practices of unused and expired medicines.
 The government should focus on the medicines provided free at public hospitals, as it has
been shown that free availability of medicine is associated with higher medication wastage.
 The government, pharmacist, and pharmaceutical industry are responsible to create
awareness for proper disposal of unused and expired medications.
 RECYCLING OF DRUGS FROM EXPIRED DRUG PRODUCTS
 Many people’s are not able to afford medication vital to their health and well-being.
 They either completely does without, skip doses, or fail to refill medication prescribed for
chronic medical conditions all because of the perceived high cost of medicines.
 Could we somehow get those unused tablets and capsules to those in need at a reasonable
price?
 Why not recycle widely used expensive medications ?

Benefit of this concept

 The recycling program is more effectively useful economically.
 It is easy to increase the economic development of pharmacy field and decrease the
annual economical lose due to expiration of cost effective drugs.