Medsaway XL FAQ s. Why can t I just toss unused meds into the toilet? How does Medsaway work?

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1 Medsaway XL FAQ s Why can t I just toss unused meds into the toilet? In recent years, it has become widespread knowledge that pharmaceuticals are being detected in our waterways and drinking water supplies. As of 2009, there were over 1000 published reports of the occurrence of pharmaceuticals in sewage, surface waters, ground waters, and elsewhere 1,2. Because of these findings, most federal, state and local authorities are now recommending (and many requiring) that pharmaceuticals NOT be disposed in the toilet or sink. 1. Daughton CG and Ruhoy IS Environmental footprint of pharmaceuticals: the significance of factors beyond direct excretion to sewers. Envir Tox and Chem 28(12): Daughton CG and Scuderi MST, "Pharmaceuticals and Personal Care Products (PPCPs): Relevant Literature," U.S. Environmental Protection Agency, Las Vegas, NV (a comprehensive database of literature references; first implemented 19 February 2008); available: How does Medsaway work? Each Medsaway pouch contains an inner packet of a drug deactivating ingredient: Medsorb activated carbon. The pharmaceuticals placed in the pouch will dissolve in water, and then will become deactivated once the dissolved drug contacts the inner carbon pack. The pharmaceutical molecules bond to the surface of the carbon, and they are neither water-soluble nor physiologically active when bonded. In fact, many emergency rooms will administer activated carbon to persons accidentally ingesting too many drugs, so as to deactivate the stomach contents of drug. Activated carbon is also used in the purification of municipal and household water. What drugs will Medsaway deactivate? What drugs won t work? Virtually all drugs are organic molecules, and as such these molecules are comprised of varying chains of connected carbon atoms. The Medsorb contained in each Medsaway pouch is specially designed to bond with organic molecules having the molecular size typical for pharmaceuticals, in a process known as adsorption. Medsorb carbon has miniature channels (micropores) so as to provide a maximum bonding surface area. Each pouch has total carbon surface area equivalent to several football fields. There are a very few drug molecules that aren t organic, and examples include iron supplements and lithium. However, even using these substances with Medsaway will be beneficial in that they will be contained in a protective pouch and directed to landfill where release to groundwater is minimized. What about mixing medications with cat litter (or coffee grounds or sawdust). How does that compare? Cat litter, coffee grounds, and sawdust do not deactivate the drug to any significant degree. We have performed scientific testing and found that Medsorb carbon is far superior in deactivation and prevention of release to water supplies. Results of our study are available upon request. Can I just use charcoal instead? Charcoal will be relatively ineffective unless it has been activated. Activation of carbon involves a process using steam, air, carbon dioxide, oxygen, zinc chloride, sulfuric acid, phosphoric acid or some combination of these substances and reacting them with the carbon at temperatures of 500 C to 900 C (900F to 1600F). Activated carbon comes in a number of forms designed for different applications. Medsorb is designed to work best for molecules sized similarly to pharmaceutical compounds.

2 How quickly does the deactivation process work? With Medsaway, the process of deactivation starts immediately, but it takes time to complete. Some highly soluble drugs will dissolve and react rapidly, while other less soluble drug types will take longer to dissolve and react. In general, the majority of drug will be reacted by hours. It is important to keep Medsaway out of the reach of children and pets as the product is discarded. What happens to the drug if the bag breaks at the landfill? Will it be released to groundwater? Does the drug last forever at the landfill? Once a drug is adsorbed onto activated carbon, it becomes insoluble in water. It remains strongly bound to the carbon, even if subsequently exposed to the environment. In our Medsaway testing, we completely exposed deactivated drug (e.g. the inner contents with no protective bag), to a fresh water solution (250 mls water for each 10 tablets deactivated) in an environmental washout test for a number of model drug compounds (reference Fowler white paper). We found an average of 98.7% of the drug was protected from washout. A recent publication has pointed out the fate of pharmaceuticals in landfills include anaerobic or aerobic biotransformation, sorption, or removal with leachate (reference: Cook et. al., Environ. Sci. Technol, 2012, 46, pp ). With biotransformation reactions, pharmaceuticals are eventually decomposed by microorganisms into smaller gaseous compounds, principally methane. Aren t we just adding to landfills? Isn t incineration of unused pharmaceuticals the best environmentally? A recent study conducted by researchers from the University of Michigan has found that directing pharmaceutical waste to landfill is better when considering the total environmental impact, because pharmaceutical take back programs can involve transport and incineration processes that release global warming gases, smog inducing gases, ozone depleting agents, carcinogenic compounds, and other by-products (reference: Cook et. al., Environ. Sci. Technol, 2012, 46, pp ). What is the capacity of Medsaway for pharmaceuticals? What if I accidentally added more drugs than the amount recommended? The recommended capacity is listed on each Medsaway package, and is based on results we obtained from testing of a variety of different drugs. Adding drugs to Medsaway in amounts at (or less than) our recommended capacity will result in optimal deactivation efficiency. In our testing, we were able to achieve an average of over 90% at recommended capacity levels. If one were to add more than the recommended pharmaceutical capacity, deactivation of additional drug will still occur but at a reduced efficiency. However, even in the case of reduced efficiency, deactivation will still be superior to cat litter, coffee grounds or sawdust. What would happen if I didn t add water? What if I added too little or too much? We recommend adding water to the Medsaway pouch after the pharmaceuticals are added, so as to facilitate the dissolving of the drug and subsequent deactivation reaction. Medsaway will still work if one were to add water at a less than recommended level, but it will slow down the deactivation time. Putting Medsaway into a used shopping bag can help for concealment, while also adding extra protection from leakage. If one were to not add any water, deactivation of the pharmaceutical will not occur until the inner contents are exposed to water. Because deactivation takes time to occur, the filled Medsaway bag needs to be handled with appropriate precaution: out of reach of children and pets, and concealed and protected from any persons that may have misuse intentions.

3 Have Government Agencies endorsed Medsaway? Government agencies do not endorse products. However, Verde has recently been awarded a contract from the National Institute of Drug Abuse (NIDA), a part of the U.S. National Institute of Health (NIH), for the commercialization of at-home drug deactivation products. Are different sizes of Medsaway available? Yes. Medsaway is available in home-use versions of a single pack design (recommended capacity of 45 pills, 6 oz. of liquid or 6 transdermal patches) or a smaller single-prescription SP size (capacity of 10 pills or 2 transdermal patches or 2 oz of liquid). Larger sized versions are available as Medsaway Professional in a 3-Pack design (recommended total capacity for the 3 packs of 270 pills, 36 oz. of liquid or 36 transdermal patches), and Medsaway XL, a one gallon larger size with a recommended total capacity of 450 pills, 60 oz. of liquid or 60 transdermal patches. Does Medsaway come with a biodegradable bag? Not yet. We are actively pursuing bag materials that are biodegradable, and are making progress. We plan to one day upgrade Medsaway to have this biodegradable feature. How can I comply with local EPA regulations? State and local authorities often regulate disposal of hazardous substances generated by large healthcare facilities, and have historically defined hazardous substances being particularly combustible, flammable, acidic, caustic or highly toxic. Interestingly, very few pharmaceuticals fall within the traditional definition of hazardous waste, even though they do present significant environmental hazard. Compliance with local regulations can usually accomplished by a simple cross check to make sure the pharmaceutical to be disposed of is not on the P, U, or D list of hazardous chemical substances (<5% of drugs, such as highly toxic chemotherapy compounds). Examples of pharmaceuticals that are P, U, and D listed are found in tables of Appendix A. We have found state and local authorities to be very helpful, and they can usually be conveniently contacted for questions. I work in a Healthcare Facility with a DEA registration. We encounter the need to dispose of controlled substances. Can I use Medsaway for this purpose in compliance with my registration? Medsaway works well for the deactivation of narcotics. If you work in a facility with a DEA license, we recommend you first contact your local DEA office and submit a letter of request to the Special Agent in Charge for authorization. With his/her permission, you can use Medsaway. How does Medsaway compare to competitive products? Medsaway is intended to be a convenient, cost-effective and environmentally responsible option for disposal of pharmaceuticals. Medsaway is approximately 4X better than mixing with cat litter, coffee grounds, etc. Take-back and incineration programs are effective, but with limitations of their own (driving distances, greenhouse gas emissions, etc.). Mail-back programs do not allow transport of narcotics, and if one is not careful they can sometimes allow others to see sensitive patient information.

4 Appendix A: Examples of RCRA Listed Pharmaceuticals (from Example RCRA P-Listed Waste Codes Note: must contain constituent as sole-active ingredient and be unused or discarded Waste Code Constituent of Concern Product Name Examples: P001 Warfarin & salts (concentration > 0.3%) P012 Arsenic trioxide Trisenox Coumadin; Warfarin P042 Epinephrine Adrenalin; EpiPen; Eppy/N; Epifrin; Epinal; Anaphalaxis kit; Epinephrine (inhalants, injectibles, kits); Racepinephrine; Racord; Primatene aerosol inhaler P046 Phentermine Phentermine (CIV) P075 Nicotine & salts Nicotine patches; Habitrol; Nicoderm; Nicorette; Nicotrol; Tetrahydronicotyrine P188 Physostigmine salicylate aka Eserine salicylate P204 Physostigmine aka Eserine Example RCRA U-Listed Waste Codes Note: must contain constituent as sole-active ingredient and be unused or discarded Waste Code Constituent of Concern Product Name Examples: U010 Mitomycin C Mitomycin; Mitomycin C; Mutamycin; Mutamycin VHA Plus U015 Azaserine Chemotherapy for leukemia U034 Chloral / Chloral hydrate Chloral hydrate (CIV) U035 Chlorambucil Leukeran U044 Chloroform Not commonly seen U058 Cyclophosphamide CTX; Cytoxan injection, Lycophilized/VHA Plus; Neosar; Procytox U059 Daunomycin Daunorubicin, Cerubidin, DaunoXome, Rubidomycin; Liposomal; Idarubicin/Idamycin; Daunomycin U075 Dichlorodifluoromethane Dichlorodifluoromethane U089 Diethylstilbesterol Diethylstilbestrol, DES (synthetic estrogen), Stilphostrol U121 Trichloromonofluromethane Trichlorofluoromethane U129 Lindane G-Well shampoo; Kwell; shampoo U132 Hexachlorophene Phisohex disinfectant U150 Melphalan Alkeran; L-PAM; Melphalan U151 Mercury Mercurochrome; Mercury iodide; Mercury chloride; Mercury sulfate U182 Paraldehyde Paral; Paraldehyde (CIV) U187 Phenacetin Acetophenetidin; typically veterinary U188 Phenol Phenol; Liquified phenol U200 Reserpine Resperine U201 Resorcinol Resorcinol U205 Selenium sulfide Exsel shampoo; selenium sulfide; Selsun U206 Streptozotocin Streptozotocin; Streptozocin; Zanosar U237 Uracil mustard Not commonly seen: Uracil mustard; Uramustine U248 Warfarin & salts (concentration 0.3%) Warfarin

5 Example RCRA Characteristic Waste Codes Waste Code Characteristic Waste Example Drug Formulations with these Characteristics: Ignitable D001 Aqueous drug formulation containing 24% or more alcohol by volume. (261.21(a)(1)). Liquid drug formulations, with a flashpoint of less than 140º F or 60º C, except aqueous solutions containing less than 24% alcohol. Oxidizers or materials that readily supply oxygen to a reaction in the absence of air as defined by the DOT. Flammable aerosol propellants meeting the DOT definition of compressed gas (261.21(a)(3)). Erythromycin gel 2% Texacort solution 1% Taxol Injection Flexible collodion - Flashpoint = 45º C Amyl nitrite inhalers Silver nitrate applicators Primatene aerosol Corrosive D002 Corrosive 1 Any solution with ph 2 Any solution with ph 12.5 Reactive D003 Reactive 2 Any compound that is unstable and readily undergoes violent change; reacts violently, forms potentially explosive mixtures or generates toxic fumes when mixed with water; cyanide or sulfur waste that releases toxic fumes at ph between 2 and 12.5; or is explosive or capable of detonating at standard temperature and pressure. Toxic D004 Arsenic Any P012 listed waste; Arsenic trioxide (also P012); Carbasone; Glycobiarosol; Thiacetarsamide D005 Barium Barium sulfate (used in radiology); Barium sulfidel Barium hydroxide; Barium chloride D007 Chromium Multiple mineral preparations; Chromium; Chromium trioxide; Multiple Trace Element (also D010) D009 Mercury Any U151 listed waste; Any drug w/ thimerosal or phenylmercuric acetate (vaccines, eye drops, nasal spray, etc) D010 Selenium Any U205 listed waste; Dandruff shampoo, multiple mineral preparations D011 Silver Silver sulfadiazine cream; Silver nitrate (also D001); Silvadene; Argyrol S.S.; Arzol silver nitrate (also D001) D013 Lindane Treatment of lice, scabies D022 Chloroform Not commonly seen D024 M-cresol Insulin w/ cresol 1 Most corrosive waste will be compounding chemicals. Although compounded pharmaceuticals are eligible for management under the Interim Enforcement Policy, the compounding chemicals themselves must be managed under the Dangerous Waste Regulations. 2 Nitroglycerin is the only pharmaceutical that we are aware of that may be considered reactive. Most medical formulations of nitroglycerin are not reactive. Medical formulations of Nitroglycerin that are not reactive are not considered P081 listed waste.