Medication Beyond Their Expiration Date

Medication Beyond Their Expiration Date

The expiration date stamped on medication packaging serves as a marker beyond which the pharmaceutical manufacturer does not guarantee the safety and efficacy of the product. However, the question of whether medications remain viable beyond their expiration date has spurred debate and curiosity. This essay explores the factors influencing medication stability, potential risks, and considerations associated with using medications beyond their expiration date.

The expiry date is that point in time when a pharmaceutical product is no longer acceptable specifications for potency and stability. Drug expiration dates exist on medication labels, including prescription, over-the counter and dietary supplements. The expiration date on the label indicates that the medication is effective until the last date of the month listed. For example, if the expiration date is listed as July 2014, the medication would be expected to remain effective until July 31, 2014. The shelf life of a drug is the time within acceptable specifications for potency and other important parameters. During the period of shelf life, the potency of the drug should be maintained above 90 per cent. In general, shelf life of drugs will be 1 to 5 years. In India, shelf life of drug and its storage methods are regulated under Drug and Cosmetic Schedule B act. Stability of a pharmaceutical product is defined as the “extent to which a product retains, within specified limits and throughout its period of storage its use, the same properties and characteristics that it possessed at the time of manufacture’’. The expiration date of a drug is estimated using stability testing as determined by the Food and Drug Administration (FDA).

A product must meet standards for five types of stability; 1. Chemical 2. Physical 3. Microbiological 4. Therapeutic 5. Toxicological 1. Chemical Stability: It means that the chemical structure of the active ingredient remains intact and that the potency is acceptable. Generally, a drug product must retain 90% of its potency to be considered acceptable. 2. Physical Stability: It refers to the way the product appears (eg. discolouration), taste and smells. 3. Microbiological Stability: It means the product remains free of bacteriological and fungal growth. 4. Therapeutic Stability: It refers that the product is able to exert the same actions in the body, leading to its effects against the disease it is intended to treat 5. Toxicological Stability: It indicates that an increase in toxicity does not occur as time passes.

Medications beyond their expiration date

• The most common consequences of an expired medication are loss of potency and thus effectiveness the product does not guaranteed. Even after expiry date, most oral medications do not pose major safety concerns. Adverse effects directly related to expired medications are rare. But, some reports were available for usage of expired medicines with toxic effects. One such example is the antibiotic tetracycline, which decomposes to toxic products. Utilization of expired tetracycline caused serious damage to kidneys which is known as ‘Fanconi Syndrome’. · Solid dosage forms, such as tablets and capsules, appear to be most stable past their expiration date. · Drug exists in solution forms or a reconstituted suspension, and that require refrigeration may not have the required potency if used when outdated. · Antibiotic after its expiration date may lose its potency. Hence, usage of antibiotic after its expiration date may lead the major problem of antibiotic resistance. · Epinephrine injection should not be used after its expired date as lose its potency. · Ophthalmic (eye) drops should not be used after its expiration date. Because outdated preservatives in the eye drops may allow bacterial growth in the eye drops. · Insulin may be susceptible to degradation after its expiration date. · Oral nitroglycerin may lose its potency quickly once the medication bottle is opened. · Vaccine, biological and blood products could also be subject to quick degradation once the expiration date is reached. · The variation in the heat and humid climates affect the potency of the oestradiol patch. · Drugs exist in solution, especially injectable drugs, should be discarded if the product forms a precipitant or look cloudy or discoloured. Storage conditions of medicines Proper storage of medications under recommended conditions remain stable with their potency. Special precaution may be necessary for protecting the medication from temperature variation and light. Light, especially ultraviolet light, may cause photochemical reactions to occur, leading to drug degradation. The medications have to be stored as per the manufacture instructions. From this review, it can be concluded that, medicines has to be stored as recommended and discard them after the expiry date.

Definitions for temperature and humidity:

 

SR.No. ——Condition ———–Temperature Requirements

1. Freezer -250 to -100 C (-130 to -140 F)
2. Cold (Refrigeration) 20 to 80 C (360 to 460 F)
3. Cool 80 to 150 C (460 to 590 F)
4. Room temperature Temperature in work area
5. Warm 300 to 400 C (860 to 1040 F)
6. Dry place            Humidity must be less than 40% at controlled room temperature

Factors Influencing Medication Stability

1. Chemical Degradation:

• Medications may undergo chemical changes over time, leading to a decrease in potency or the formation of potentially harmful byproducts. Factors such as exposure to light, heat, and moisture can accelerate these processes.

2. Container Integrity:

• The packaging and storage conditions significantly impact the stability of medications. Damaged or compromised packaging may allow air or moisture to enter, affecting the composition and efficacy of the medication.

3. Type of Medication:

• Different medications exhibit varying degrees of stability. While some drugs may degrade rapidly, others, particularly solid dosage forms like tablets and capsules, may remain stable for extended periods under suitable storage conditions.

4. Storage Conditions:

• Medications stored in environments outside the recommended temperature and humidity ranges are more likely to experience accelerated degradation. Proper storage in a cool, dry place is critical to maintaining stability.

Risks Associated with Using Expired Medications

1. Reduced Potency:

• Expired medications may lose potency, rendering them less effective in treating the intended condition. This is particularly concerning for life-saving or critical medications.

2. Formation of Harmful Byproducts:

• Chemical degradation may lead to the formation of impurities or byproducts that could pose health risks when consumed.

3. Ineffectiveness:

• Using medications beyond their expiration date may result in inadequate treatment, leading to the persistence of symptoms or the exacerbation of the underlying condition.

4. Microbial Contamination:

• Contamination by microorganisms becomes a greater risk as medications age, especially if they are stored in conditions conducive to microbial growth.

Considerations for Using Medications Beyond Expiration

1. Drug Stability Studies:

• Some medications may remain stable and retain efficacy beyond their labeled expiration date, as evidenced by ongoing research. However, this varies by drug, and generalized assumptions should be avoided.

2. Storage Conditions:

• Medications stored in ideal conditions, away from direct sunlight, heat, and moisture, are more likely to retain stability. Proper storage plays a crucial role in extending a medication’s shelf life.

3. Liquid Medications:

• Liquid medications, especially those containing water or alcohol, may be more susceptible to microbial contamination and degradation. Special attention should be given to the expiration dates of such formulations.

4. Manufacturer Guidance:

• Following the recommendations of the pharmaceutical manufacturer is paramount. If the manufacturer provides information on stability beyond the expiration date, it should be carefully considered.

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. U.S. pharmaceutical manufacturers are required by law to place expiration dates on prescription products prior to marketing.

For legal and liability reasons, manufacturers will not make recommendations about the stability of drugs past the original expiration date.¹ However, for most drugs, it’s just an arbitrary date, usually 1 to 5 years out, that the manufacturer selects to test drug stability. Once the container of medication is opened after production, that expiration date is no longer guaranteed.

How are drug expiration dates determined?

The expiration date of a drug is estimated using stability testing under good manufacturing practices as determined by the Food and Drug Administration (FDA). Drug products marketed in the US typically have an expiration date that extends from 12 to 60 months from the time of manufacturer. Once the original container is opened, either by the patient or the health care provider who will dispense the drug, that original expiration date on the container can no longer be relied upon. However, the actual shelf life of the drug may be much longer as stability studies have shown.

At the pharmacy, “beyond-use” dates are often put on the prescription bottle label given to the patient. These dates often say “do not use after…” or “discard after…” and are required by the Board of Pharmacy in many states. These dates are typically one year from the date of fill. But why would these expiration dates be different?

• According to the manufacturer, the stability of a drug cannot be guaranteed once the original bottle is opened.
• Heat, humidity, light, and other storage factors can affect stability.

Drug Expiration Dates – Are Expired Drugs Still Safe to Take?

You pull a bottle of medicine from your cabinet, but see it expired a year ago. You may ask:

• Can I safely take a medication if it has reached the drug expiration date?
• Are there recommendations about the best way to store my medications?
• Which drugs should never be used past their expiration date?

For many patients, these questions arise because medications can be expensive and it is costly to frequently replace expired — but unused — medications. But is it safe to use medicines past their expiration date?

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. U.S. pharmaceutical manufacturers are required by law to place expiration dates on prescription products prior to marketing.

For legal and liability reasons, manufacturers will not make recommendations about the stability of drugs past the original expiration date.¹ However, for most drugs, it’s just an arbitrary date, usually 1 to 5 years out, that the manufacturer selects to test drug stability. Once the container of medication is opened after production, that expiration date is no longer guaranteed.

How are drug expiration dates determined?

The expiration date of a drug is estimated using stability testing under good manufacturing practices as determined by the Food and Drug Administration (FDA). Drug products marketed in the US typically have an expiration date that extends from 12 to 60 months from the time of manufacturer.¹ Once the original container is opened, either by the patient or the health care provider who will dispense the drug, that original expiration date on the container can no longer be relied upon.² However, the actual shelf life of the drug may be much longer as stability studies have shown.³

At the pharmacy, “beyond-use” dates are often put on the prescription bottle label given to the patient. These dates often say “do not use after…” or “discard after…” and are required by the Board of Pharmacy in many states. These dates are typically one year from the date of fill. But why would these expiration dates be different?

• According to the manufacturer, the stability of a drug cannot be guaranteed once the original bottle is opened.
• Heat, humidity, light, and other storage factors can affect stability.

Pharmacies, both retail and hospital, nursing homes, and consumers toss away billions of dollars of medications each year based on stamped expiration dates on stock bottles. In fact, according to a report from Allen, hospitals alone discard over $800 million in drugs annually.

The United States Pharmacopeia (USP), the body that sets the standards for pharmaceutical quality in the U.S., recommends using “beyond use” dates. The “beyond use” date would never be later than the expiration date on the manufacturer’s bottle.

Do expired medications lose their potency?

The best evidence suggesting that some drugs can last past their expiration date is from the Shelf Life Extension Program (SLEP) undertaken by the FDA for the Department of Defense.

The original purpose of the SLEP program was twofold: to determine the actual shelf life of stockpiled military medications for future use, and to save government dollars.

• Over 3000 lots, representing 122 different drug products, were assessed in the SLEP program. Potency, pH, water content, dissolution, physical appearance, or presence of impurities were assessed.
• Based on stability data, expiration dates on 88% of the lots were extended beyond their original expiration date for an average of 66 months. Of these, roughly 12% more lots remained stable for at least 4 years after the expiration date. Of these 2652 lots, only 18% were terminated due to failure.
• Examples of common drug products that were tested with no failures included amoxicillin, ciprofloxacin, diphenhydramine, and morphine sulfate¹⁰Drug expiration extension dates on these products ranged from 12 months to 184 months (over 15 years).^3,10 Biologics are not included in the SLEP program.
• Potassium iodide, which has been stockpiled in the US for a radiation emergency, showed no significant degradation over 20 years in the SLEP study.
• In June 2020, FDA stated that expirations dates could be extended for certain stockpiled influenza antivirals such as Tamiflu (oseltamivir) 75 mg capsules and Relenza (zanamivir) if stored under labeled conditions and for emergency use in individual states. Expiration dates could potentially be extended for 15 years for Tamiflu and 10 years for Relenza.
• Also, testing reported in The Medical Lettershowed that many medications were still potent decades beyond their expiration dates. The authors note that there are no published reports of human toxicity due to ingestion, injection, or topical application of a current drug formulation after its expiration date.
• These results suggest that many drug products mayhave extended shelf lives beyond their expiration date. However, it is difficult for any one consumer or health care provider to know which product in a medicine cabinet could have an extended shelf life or expiration date.
• The ability for a drug to have an extended shelf life would be dependent upon the actual drug ingredients, presence of preservatives, temperature fluctuations, light, humidity, and other storage conditions. Additionally, the drug lots tested in the SLEP program were kept in their original packaging. Once a drug is repackaged into another container, as often happens in the pharmacy, the shelf-life could decline due to environmental variations

Is it safe to take expired medications?

The U.S. Food and Drug Administration (FDA) recommends never taking drugs beyond their expiration date as it is risky with many unknown variables.⁸ For example, how your drug is stored before you receive it, chemical make-up, and original manufacturing date can all affect potency of a drug.

The antibiotic tetracycline is one case in point. Reports have been published that tied degraded tetracycline use with a form of renal tubular (kidney) damage known as “Fanconi Syndrome”. However, that formulation of tetracycline is no longer marketed in the U.S.

Solid dosage forms, such as tablets and capsules, appear to be most stable past their expiration date. Drugs that exist in solution or as a reconstituted suspension, and that require refrigeration (such as amoxicillin suspension), may not have the required potency if used when outdated. Loss of potency can be a major health concern, especially when treating an infection with an antibiotic. Additionally, antibiotic resistance may occur with sub-potent medications.

Drugs that exist in solution, especially injectable drugs, should be discarded if the product forms a precipitate or looks cloudy or discolored. Liquid drugs such as eye or ear solutions, oral liquids, or topical solutions may undergo evaporation of solvents over time. Expired medications that contain preservatives, such as ophthalmic (eye) drops, may be unsafe past their expiration date. Outdated preservatives may allow bacterial growth in the solution.

Which medications are unsafe after their expiration date?

There’s really no way to know if a drug is safe unless its tested for potency, but here are some common sense measures:

• Insulin is used to control blood sugar in diabetes and may be susceptible to degradation after its expiration date.
• Oral nitroglycerin (NTG), a medication used for angina (chest pain), may lose its potency quickly once the medication bottle is opened.
• Vaccines, biologicals or blood products could also be subject to quick degradation once the expiration date is reached.
• One review has noted that outdated tetracycline antibiotics, chemotherapy agents, antiviral drugs, aminoglycosides, and anticonvulsants may lead to Fanconi Syndrome.
• 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.
• Discard any expired injectable medication. If expired or not, always discard injections if cloudy,

• discolored or with visible floating particles.

How should I store my medicines to maintain their shelf life?

Proper storage of medications may help to extend their potency. The bathroom and medicine cabinet are not ideal places to store medications due to heat and humidity. Similarly, medications should not be left in a hot car or glovebox, or in freezing weather.

Most oral, solid medications remain most stable in dry, cool spaces away from light. Keep the prescription bottle caps tightly closed and always keep medications out of reach of children and pets.

Look at your package insert for proper storage instructions, or ask your pharmacist. Be careful to follow any instructions for refrigeration or freezing.

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, get a new prescription before it expires and keep up with refills as needed. If you take an expired medication and you notice the drug has little or no effect, the medication should be replaced immediately.

These drugs may potentially pose serious problems if they’re expired:

• a biologic product
• insulin
• a refrigerated liquid or other medicine
• eye drops

• injectable medicine
• a specially compounded medication
• any drug that looks like it is degraded or cloudy, or has a noxious smell, should be discarded and replaced immediately; do NOT use.

Ask your pharmacist or doctor questions about expired medications who can offer the best information and advice specific to your situation.When in doubt, it’s always best to get a new, unexpired medication, and safely discard the old one.

Conclusion

The decision to use medications beyond their expiration date requires a thoughtful and cautious approach. While some medications may remain effective for a certain period, the risks associated with degradation, reduced potency, and potential harm should not be underestimated. Patients and healthcare providers must strike a balance between minimizing waste and prioritizing patient safety. Ultimately, adherence to recommended storage conditions, awareness of expiration dates, and consultation with healthcare professionals are integral to making informed decisions about the use of medications beyond their labeled shelf life. As research in this area evolves, a nuanced understanding of each medication’s stability characteristics will contribute to more accurate assessments and guidelines regarding the extended use of pharmaceuticals.

Compiled  & Shared by- This paper is a compilation of groupwork provided by the

Team, LITD (Livestock Institute of Training & Development)

 Image-Courtesy-Google

 Reference-On Request.