Pharmaceutical Waste: What s a Pharmacist To Do?

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1 Pharmaceutical Waste: What s a Pharmacist To Do? Andrew M. Peterson, PharmD, PhD Dean, Mayes College of Healthcare Business and Policy University of the Sciences

8 Objectives At the end of this presentation, the learner will be able to: Explain the current impact of pharmaceutical waste on the environment Discuss at least one issue relevant to the disposal of medications from the perspective of patients, institutions and pharmaceutical companies Discuss 2 means by which a pharmacist can help reduce pharmaceutical waste in the environment

disposal of medications from the perspective of patients, institutions and pharmaceutical

9 Waste Categories Solid Waste Regulated Medical Waste Hazardous Waste Universal Waste Pharmaceutical Waste Hazardous pharmaceutical waste

10 Solid Waste Typical waste found in the community generated by residences and businesses Also includes non-regulated medical waste Also known as municipal waste, black bag waste, clear bag waste Cost: $ $ 0.08 per pound. (Source: GreenHealth.com)

waste Also known as municipal waste, black bag waste, clear bag

11 Regulated Medical Waste The portion of the waste stream that may be contaminated by blood, body fluids or other potentially infectious materials Poses a significant risk of transmitting infection Also known as biohazardous waste or redbag waste Regulated at the state level but subject to OSHA s Blood Borne Pathogen regs Cost $0.50 per pound Source: GreenHealth.com

infection Also known as biohazardous waste or redbag waste Regulated at the state level but

12 Hazardous Waste Liquid, solid, contained gas, or sludge wastes that are dangerous or potentially harmful to human health or the environment bulk chemotherapeutic agents, xylene and other solvents, some paints and aerosol cans Governed by EPA Cost is $ $2.00 per pound Source: GreenHealth.com

chemotherapeutic agents, xylene and other solvents, some paints and aerosol

13 Universal Waste Hazardous waste such as Batteries, pesticides, mercury containing equipment and bulbs EPA governs the collection and management of these wastes but does so to encourage recycling States can modify within these regulations $1.00 per pound Source: GreenHealth.com

of these wastes but does so to encourage recycling States can modify

14 Pharmaceutical Waste Any chemical product, vaccine or allergenic, not containing a radioactive component, that is intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease or injury in man or other animals;

intended for use in the diagnosis, cure, mitigation,

15 Hazardous Pharmaceutical Waste Hazardous pharmaceutical waste is NOT synonymous with hazardous pharmaceuticals. Some drugs not considered hazardous drugs by NIOSH,OSHA and NIH are still regulated as hazardous waste by EPA-RCRA. Some drugs not considered hazardous waste by EPA are probable environmental hazards (some chemo).

Some drugs not considered hazardous drugs by NIOSH,OSHA and NIH are still

16 What are hazardous pharmaceuticals? A drug is hazardous if it has the ability to cause: Cancer, organ toxicity, fertility problems, genetic damage or birth defects Regulated by OSHA because they pose a risk to the workers in healthcare facilities and pharmaceutical industry Examples: Finasteride, cisplatin NIOSH list of hazardous pharmaceuticals

genetic damage or birth defects Regulated by OSHA because they pose a risk to the workers in

17 Hazardous Pharmaceutical Waste Defined under Resource Conservation and Recovery Act (RCRA) Listed chemicals The F-list (non-specific source wastes) Solvents The K-list (source-specific wastes) Sludge from petroleum refining The P-list and the U-list (discarded commercial chemical products). About 31 pharmaceuticals currently designated

(source-specific wastes) Sludge from petroleum refining The P-list and the U-list

18 RCRA Listing Examples P-listed Acutely Hazardous Epinephrine Nicotine Nitroglycerin * Phentermine Physostigmine Warfarin >0.3% U-listed Toxic Wastes Chloral Hydrate (CIV)2 Lindane Melphalan Mercury Saccharin Warfarin <0.3% * In 2001, the EPA relaxed the regulations allowing states to reclassify

3% U-listed Toxic Wastes Chloral Hydrate (CIV)2 Lindane Melphalan Mercury

19 Note about the listings Listings only apply to pharmaceuticals that contain the listed drug as the sole active ingredient. E.g. pharmaceuticals flavored by saccharin with other ingredients added would NOT be considered hazardous waste under RCRA

20 Regulations currently affecting medications in the environment Resource Conservation and Recovery Act (RCRA, 1976) NIOSH/OSHA FDA State level regulations Accrediting Agencies (JCAHO)

21 Scope of the Problem

22 How Do Pharmaceuticals Get into the Environment? Excretion of human and animal waste Manufacturing of pharmaceuticals Improper disposal, like flushing Leeching from municipal landfills Irrigating farmland with reclaimed wastewater that contains pharmaceuticals Residues transferred from skin (suncreens, ointments, etc)

23 Top 19 Drugs Found in Environment 1, 7-Dimethylxanthine Erythromycin Acetaminophen Fluoxetine Caffeine Gemfibrozil Carbamazepine Miconazole Cimetidine Salbutamol (albuterol) Codeine Sulfamethoxazole Cotinine Thiabendazole Dehydronifedipine Trimethoprim Diltiazem Warfarin Diphenhydramine Kinney, C.A., Furlong, E.T., Werner, S.L., and Cahill, J.D., 2006, Presence and distribution of wastewater-derived pharmaceuticals in soil irrigated with reclaimed water: Environmental Toxicology and Chemistry, v. 25, no. 2, p , doi: /05-187R.1.

24 Consequences of Pharmaceuticals in the Environment Effects on aquatic life Fish (Atlantic Salmon, Trout, Zebrafish) Frogs male fish that contain female genitalia and other genetic changes hermaphroditic and failure to reproduce Alligators small genitalia, especially in the males that hinders ability to reproduce

25 Consequences of Pharmaceuticals in the Environment (cont) Fluoxetine and fluvoxamine induced spawning in bivalves at low concentrations Fluoxetine enhances the release of ovary-stimulating hormones in crayfish. SSRIs elicit aggressive behavior in lobsters, causing subordinates to engage in fighting against the dominant member, and reducing the propensity to retreat.

26 Effects on Humans Currently, little evidence of effects on human health Pharmaceuticals are detected at subtherapeutic/toxic levels, thereby making it difficult to assess potential health effects Assessment is complicated due to mixtures of compounds - hard to prove cause and effect

28 Action Steps to Minimize Harm from Drugs in the Environment Design and develop greener drugs Reduce the quantity of drugs in the system Use appropriate disposal practices Improve wastewater treatment methods

29 Designing Greener Drugs Benign-by-Design Remove halogens Ciprofloxacin has a fluorine-carbon bond preventing its degradation in the environment Improve bioavailability Design drugs with bio-inactive metabolites Everts: Chemical and Engineering News. Accessed 9/20/2011

30 Reduce the Quantities of Drugs Reduce patient waste Voucher programs Reduce prescribing Short cycle dispensing Reduction of initial prescription to 7 day increments Part of the new Affordable Care Act but controversial» CMS delayed implementation until 2013 and allowed 14 day dispensing Example: MaineCare

31 MaineCare Fifteen Day Initial Script Select drugs are limited to a 15-day trial prescription if they have higher than average: expense side effects or discontinuation rates Unit of use packaging, (e.g., eye drops) are exempt Pharmacists will not be reimbursed for split prescriptions unless necessary to meet MaineCare policy

32 Example MaineCare Drugs Abilify Androgel Chantix Concerta Cymbalta Detrol Enbrel Exelon Fentanyl Focalin Geodon Lumigan Luvox Morphine Oxybutynin Oxycodone Paroxetine Risperidone Sandostatin Seroquel Tracleer Urispas

33 Questions to be Answered Do prescriptions for a full course of treatment, like 90 day supplies, increase leftovers? Do short term refills of maintenance medications lead to less leftover medications?

34 Use Appropriate Disposal Practices Public Education Consumer Collection Events Drug Take-Back Days Mail Back Programs

35 Public Education To Flush or Not to Flush? NO, except for Morphine and other opioids Methylphenidate Diazepam Use kitty litter or coffee grounds Websites with patient education ycling_home_toxics/medication_disposal

36 Collection Events Mail-in programs DEA drug take-back days Next one 10/29/ al/takeback/ Permanent collection locations Collection boxes at Pharmacies Police stations

37 Conclusion Pharmaceuticals in the environment MAY present a problem No data related to humans (yet) Health concerns regarding disposal is high on public s agenda Pharmacists can assist in educating the public regarding appropriate disposal Pharmacists can help health care practitioners increase awareness of their role

38 Contact Information Andrew M. Peterson, PharmD, PhD Dean Mayes College of Healthcare Business and Policy University of the Sciences W: (215) F: (215) USciences: Where healthcare and science converge

39 Source: /agenda.html

Managing Hazardous Pharmaceutical Waste

Managing Hazardous Pharmaceutical Waste Environmental Consequences Why the growing concern? Discovery of pharmaceuticals in surface, ground and drinking waters of the U.S. Small concentrations of endocrine