Professional opinion on "Expiry date of a drug: is it myth?"
•Download as PPTX, PDF•
2 likes•977 views
Is expiry drug os a drug is real? what is the basis? Do we really need to worry about it?
Recommended
More Related Content
What's hot
What's hot (20)
Similar to Professional opinion on "Expiry date of a drug: is it myth?"
Similar to Professional opinion on "Expiry date of a drug: is it myth?" (20)
Recently uploaded
Recently uploaded (20)
Professional opinion on "Expiry date of a drug: is it myth?"
- 1. Expiry date of a drug: is it a myth ??A Professional Opinion by Dr. Ranjan 27-04-19 about history Guideline s Unsafe.. Safe.. Vsn
- 2. about history timeline teams services follow Drug expiration is the date after which a drug might not be suitable for use as manufactured. FDA Sec. 211.137 • Since 1979, the US FDA - Stability proof - With New drug application Expiry date? Expiration date?? Shelf life??? • The expiry date can be found printed on the label or stamped onto the bottle or carton. • Standard advice- To dispose expired
- 3. about history timeline teams services follow In 1920 , Chicago, US Al Capone Meadowmoor Dairies Marks & Spencer’s 1950 Shelf life In 1979, FDA- Mandated expiry date
- 4. about history teams services follow HEADING YOU CAN ADD SOME BRIEF TEXT HERE 2014 HEADING YOU CAN ADD SOME BRIEF TEXT HERE 2015 HEADING YOU CAN ADD SOME BRIEF TEXT HERE 2016 Calcul.. n Zone 1 TEMPERATE (UK, N.Europe, Russia, USA) Zone 2 Sub-tropical (Japan, S.Europe) Zone 3 Hot Dry (Indian Subcontinent, W. Asia) Zone 4 Hot Humid ( Latin America, SE Asia) Calculating expiry date • Drug products are put through accelerated degradation testing/Stress testing. • Exposure to heat, light, Oxidation, humidity etc • After exposing over different time periods, API is quantified in the formulation to asses efficacy of drug. • Liquid & Injectables – Bacterial purity & Chemical stability are required. (ICH
- 5. about history Calcul.. n Regula. follow 01 02 03 INDIA CDSCO Drug & Cosmetic act EUROPEAN UNIONEMEA Article 11 of directive 2001/83/EC USA FDA Food, Drug & Cosmetic act • The regulations stipulates that, every medicine must have date of expiry of its use. • It is to be mentioned in terms of month and year. • Unused, Unsold medicine will be cleared out of pharmacies within 15 days of DOE.
- 6. about history timeline Unsafe ? Which medications are unsafe after their expiration date? • Insulin is susceptible to degradation after its expiration date. • Oral nitroglycerin (NTG), 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. • Tetracycline may produce a toxic metabolite- Fanconi’s Syndrome!? • Chloroquine can produce toxic reactions- Photochemical degradation. Medicines that looks old: powdery or crumbling medicine, drugs with a strong smell, or dried up medicine (as in the case of or ointments or creams) Michael Dawson. Expiry dates. Exp Clin Pharmacol.1994;17:46-8
- 7. about history timeline Unsafe ? Safe..!? Do expired medications lose their potency? Lee Cantrell -Tested closet of the pills predated to the 1969 moon landing. Most were 30 to 40 years past their expiration dates. Over 90% drugs showed ≥90% potency The AMA gave green signal to the Shelf Life Extension Program (SLEP) undertaken by the FDA for the Department of Defense. Over 3000 lots, representing 122 different drug products, were assessed in the SLEP program. 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 2652 lots, only 18% were terminated due to failure. American Medical Association. "Pharmaceutical Expiration Dates." Report 1 of the Council on Scientific Affairs (A-01). July 25, 2001
- 8. about history timeline Safe..? Safe..? Can we use an expired drug? Epipens are used in life-threatening situations like anaphylaxis, so there can be a major health threat with an expired EpiPen. However, 2017 research on expired EpiPens has been published. A small evaluation of almost 40 expired, unused EpiPens gathered from patients showed that the pens retained 80% of their potency. Simons FER, et al. Outdated EpiPen and EpiPen Jr autoinjectors: past their prime? J Allergy Clin Immunol 2000;105:1025. Accessed May 29, 2018 at https://www.ncbi.nlm.nih.gov/pubmed/10808186 Expired EpiPens May Still Help Save a Life: Study. Drugs.com. May 9, 2017. Accessed May 29, 2018 at https://www.drugs.com/news/expired-epipens-may- still-help-save-study-65503.html
- 9. about history Guide.. Safe..? Safe..? Fruits Of SLEP • Each year the federal governments are saving $600 million to $800 million because of reuse of expired medication. • Department of Defense in 2016 spent $3.1 million to run the extension program — which saved the department from replacing $2.1 billion in expired drugs. It's like spending a dollar to save $677. • Citing the federal government’s extension program, the AMA sent letters to the FDA, the U.S. Pharmacopeial Convention, which sets standards for drugs, and PhRMA asking for a re-examination Expiration Dating Extension, U.S. Food and Drug Administration (FDA). Updated: March 2, 2018. Accessed April 26, 2019
- 10. about history Unsafe..? Safe.. Vs “Patient safety is our highest priority. Expiration dates are chosen based on the period of time when any given lot will maintain its identity, potency and purity, which translates into safety for the patient.“ Olivia Shopshear Director of PhRMA. "We didn't have any idea that some of the products would be so damn stable — so robustly stable beyond the shelf life, It's a shame to throw away good drugs," Ajaz S.Hussain
- 11. about history Unsafe.. Safe.. Vs Conclusio n Environmental concernImproper disposal Contamination of waterbodies Social ConcernRisk of accidental exposure Resources Wastage of valuable time & Manpower Shelf Life Extension Program (SLEP)By FDA Drug shortage Reused -retaining potency of drugs after DOE Economic ImpactWastage Of resources in healthcare system CONCLUSION Fate Of Expired Drugs
- 13. about history Unsafe.. Safe.. Vs Opinion Retaining potency varies with the drug, the preservatives & the storage conditions, especially heat and humidity. My Opinion Solid dosage formulations stored under reasonable conditions in their original unopened containers retain their potency for many years. There are no reports of toxicity from degradation products of currently available drugs. When no suitable alternative is available, outdated drugs may be used.