Based on Curriculum of BPH, TU

1. DRUG EXPIRY
For BPH 1st Year
Dr. Pravin Prasad
3rd Year Resident, MD Clinical
Pharmacology
Maharajgunj Medical Campus
27th April, 2017(Baishak 14,2074),
Thursday

2. OBJECTIVES
■ Define and Understand: “Drug Expiry Date”
■ Exploring the Consequences of Use of
Expired Drugs (ED)
■ Strategies to Minimise the problems of
Drug Expiry

3. DRUG EXPIRY DATE (ED):
THE TERM
■ The date appearing on a pharmaceutical
product and established by the
manufacturer, beyond which the
manufacturer will not guarantee the
potency, purity, uniformity or bioavailability
of the product
■ Usually 2-5 years from production date
Should we USE the Drugs that have crossed
expiry date then?

4. ED: Various Terminologies
Wording on packaging Definition
Best before Jan 2014 Discard 31/12/2013
Use before end Jan 2014 Discard 31/01/2014
Use by January 2014 Discard 31/12/2013
Discard after Jan 2014 Discard 31/01/2014
Expires January 2014 Discard 31/01/2014
Use within one month of
opening
Self explanatory
Discard 7 days after
opening
Self explanatory

5. Issues with EDs
■ Potency and Efficacy:
– Losing potency is not a one-time process
– Shelf Life Extension Programme (SLEP) by FDA
for Department of Defense, US
– Shelf life extension attempted by Nepal
Pharmaceuticals (NPL)

6. Issues with EDs
■ Safety and Toxicity:
– Little scientific evidence that expired drugs are
toxic
– Renal tubular damage due to degraded
tetracycline (GW Frimpter et al, JAMA 1963;
184:111).
– Expired medication toxicity is not a well-
researched field.

7. Drugs that should never be used
post ED
■ Narrow therapeutic index drugs
– Anticonvulsants, Digoxin, Warfarin
■ Drugs losing potency very quickly
– Phenytoin, Phenobarbital, Nitroglycerin,
Theophylline, Epinephrine, Insulin

8. Drugs that should never be used
post ED
■ Procan SR - sustained release procainamide
■ Thyroid preparations
■ Paraldehyde
■ Oral contraceptives
■ Eye drops - eyes are particularly sensitive to
any bacteria that might grow in a solution
once a preservative degrades.

9. Effects of using ED
■ The effectiveness of the drug may change
■ The break down of the drug may be toxic
and harmful to the patient
■ Increased risk of contamination

10. ED: Effects of Improper disposal
■ May be found by unintended recipients
resulting in misuse, abuse and poisoning.
■ May end up in landfill and damage the
environment (soil, air)
■ May get exposed to water sources that
bears potential to harm the humans as well
as animals
■ Resale of expired medicines
Should we USE the Drugs that have crossed
expiry date then?

11. WHEN IT COMES TO
HEALTH: SAFETY
FIRST
It is probably not wise to use drugs that have crossed ED!!

12. How to minimise the problems of
ED??
■ By not using EDs
■ By decreasing the quantity of EDs
■ By proper disposal of the EDs

13. Decreasing quantity of ED: Drug
Management Cycle
■ Why Manage Drugs??
– Link between the patient and health services.
– Poor drug management is a critical issue;
– No longer the responsibility of health workers
only

14. Decreasing quantity of ED: Drug
Management Cycle

15. Proper Disposal of ED
Categories
Landfill
Sewer
Waste
encapsulati
on
Waste
inertization
Incineratio
n
Return
Use
Solids, Semi-solids,
Powders
Liquids
Ampoules
Anti-infective drugs
Anti-neoplastics
Controlled Drugs
Aerosol Canister
Disinfectants

16. Proper Disposal of ED
■ Returning the EDs to centres with proper
disposal facility
– National Return of Unwanted Medicines
(NatRUM) Programme of Australia
■ Includes both expired, near expiry date medicines, as well as those
that are not to be used again, irrespective of expiry date
■ Informing Prescriber’s of what is being
returned

17. THANK YOU!
Next Class will be taken by Dr. Rakesh Ghimire
Any Queries?