Drug expiry 2017

Based on Curriculum of BPH, TU

1. Drug Expiry For BPH 1 st Year Dr. Pravin Prasad 3 rd Year Resident, MD Clinical Pharmacology Maharajgunj Medical Campus 27 th 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. Decreasing quantity of ED: Drug Management Cycle Selection : Type of drug and dosage form Considering cost-effectiveness and affordability Availability of safe, effective and good-quality drugs Based on National Health/Drug Policy; Quality and type of care provided; Disease prevalence pattern; Available human resources; financial resources Procurement : Proper estimation of drug requirements: drug types and quantities required Return of excess stock Management of donated drugs

16. Decreasing quantity of ED: Drug Management Cycle Storage and Distribution : First In First Out (FIFO) First To Expire First Out (FEFO) Not dispensing expired drugs Expiry date legible on the drugs sold Prescribing initial smaller quantities when therapeutic agents is likely to change Use : Not using expired drugs Avoid stockpiling unused drugs Encourage patients to complete the course of medication and not save some for future use Advise patients to return the unused/expired medicine to centres with proper disposal facilities Proper storage condition at home

17. Proper Disposal of ED Categories Landfill Sewer Waste encapsulation Waste inertization Incineration Return Use Solids, Semi-solids, Powders Liquids Ampoules Anti-infective drugs Anti- neoplastics Controlled Drugs Aerosol Canister Disinfectants