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Pharmecovigilance and the Environmental Footprint of Pharmaceuticals Ilene S

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Pharmecovigilance and the Environmental Footprint of Pharmaceuticals Ilene S PharmEcovigilance and the Environmental Footprint of Pharmaceuticals Ilene S. Ruhoy, MD, PhD Touro University Nevada Institute for Environmental Medicine Henderson, NV Christian G. Daughton, PhD U.S. Environmental Protection Agency Office of Research and Development Las Vegas, NV US EPA Notice Although this work was reviewed by EPA and approved for publication, it may not necessarily reflect official Agency policy. PPCPs as Environmental Pollutants? PPCPs are a diverse group of chemicals comprising all human and veterinary drugs (available by prescription or over-the-counter, including “biologics”), diagnostic agents (e.g., X-ray contrast media), “nutraceuticals” (bioactive food supplements such as huperzine A), and other consumer chemicals, such as fragrances (e.g., musks) and sun-screen agents (e.g., 4-methylbenzylidene camphor; octocrylene); also included are “excipients” (so-called “inert” ingredients used in PPCP manufacturing and formulation; e.g., parabens). 1st National Survey Revealed Extent of PPCPs in Waterways • USGS “Reconnaissance” study in 1999-2000 was first nationwide investigation of pharmaceuticals, hormones, & other organic contaminants: – 139 streams analyzed in 30 states – 82 contaminants identified (many were pharmaceuticals) – 80% streams had 1 or more contaminant – Average 7 contaminants identified per stream • Since 1998, peer reviewed papers on PPCPs have increased from fewer than 200 per year to greater than 1,000 per year Kolpin DW,et al. "Pharmaceuticals, hormones, and other organic wastewater contaminants in U.S. streams, 1999-2000: a national reconnaissance." Environmental Science & Technology 2002, 36(6):1202-1211; doi:10.1021/es011055j Source: DOI 10.1897/09-138.1 Prescription Drugs Found in Tap Water Drug Disposal Overview • Unused medications become pharmaceutical waste – Historically, consumers and other institutions have been advised to dispose of the drugs via the toilet or the trash Ultimately can enter the environment – If not disposed, concern is availability for inappropriate usage of drugs Diversion and poisonings • Take-back events and programs • Controlled Substances Act (CSA) 1970 • Stakeholders & Beneficiaries: EPA, DEA, ONDCP, FDA, USFWS, state and local governments, municipal water districts, pharmacy & pharmaceutical industries, healthcare industry, insurance industry Models of Change • “Take-back” events – NERC – “No Drugs Down the Drain” – Great Lakes – US EPA grants – Various states • California, Pennsylvania, Indiana, Massachusetts, Oregon, Washington National Guidance • ONDCP original guidelines, February 2007 – Collaboration with FDA and EPA – Updated October 2009; defers to FDA for list of drugs to be disposed via sewers • DEA, Controlled Substances Act – Recent ANPRM • Encouraged to standardize process for what constitutes an exemption for law enforcement personnel • Encouraged to standardize recordkeeping requirements • Define what constitutes an appropriate destruction of controlled substances • Asked to consider many collection options for take back programs State Legislation • Maine, Minnesota, Oregon, and Florida have legislation pending that would require drug manufacturers to operate and pay for statewide systems to collect, transport, and dispose of leftover pharmaceuticals from the public and certain facilities Federal Legislation • HR 1191 Safe Drug Disposal Act of 2009 – Provide for disposal of controlled substances by ultimate users and care takers through state take- back disposal programs – Prohibits pharmaceutical company recommendations on drug labels for disposal by flushing • HR 1262 The Water Quality Investment Act – Includes provisions requiring federal agencies to study the presence of pharmaceuticals and personal care products in the waters of the US A Clarification • In this presentation, the actual chemical substances with which we are concerned regarding contamination of the environment are the active ingredients in pharmaceuticals – known in the industry as APIs. But we sometimes loosely (but incorrectly) refer to drugs or pharmaceuticals themselves as being the contaminants • These terms are all often used interchangeably ALIMENTARY Dolasetron VITAMINS Calcium Chloride Amiloride Felodipine Flucytosine Fluocinolone Acetonide Tioconazole Terazosin TRACT AND Granisetron Paricalcitol Cyclothiazide Nitrendipine Miconazole Triamcinolone Ketoconazole Calcium Chloride METABOLISM Ondansetron Vitamin D4 CARDIOVASCULAR Furosemide Perhexiline Econazole Flumethasone Pivalate Miconazole Finasteride STOMATOLOGICAL LAXATIVES (Dihydrotachysterol) SYSTEM CARDIAC Eplerenone Nifedipine Sertaconazole Hydrocortisone Econazole PREPARATIONS Lactulose THERAPY Hydroflumethiazide Bepridil Ciclopirox Mometasone Candicidin SYSTEMIC Doxycycline Magnesium Sulfate MINERAL Phentermine Indapamide AGENTS ACTING ON Hydrocortamate Ciclopirox HORMONAL Clotrimazole Mannitol SUPPLEMENTS Dofetilide Chlorothiazide THE RENIN- PREPARATIONS FOR Clocortolone Clindamycin PREPARATIONS, Triamcinolone Calcium Acetate Midodrine Bumetanide ANGIOTENSIN TREATMENT OF Prednisolone OTHER EXCL. SEX Epinephrine ANTIDIARRHEALS, Magnesium Sulfate Milrinone Hydrochlorothiazide SYSTEM WOUNDS AND Methylprednisolone GYNECOLOGICALS HORMONES AND Amphotericin B INTESTINAL Potassium Chloride Ranolazine Trichlormethiazide Valsartan ULCERS Clobetasol Cabergoline INSULINS Hydrocortisone ANTIINFLAMMATO Calcium Chloride Disopyramide Ramipril Isosorbide Dinitrate Fluocinonide Carboprost PITUITARY AND Tetracycline RY/ANTIINFECTIVE Lidocaine PERIPHERAL Remikiren Prednicarbate Tromethamine HYPOTHALAMICs Natamycin AGENTS ANABOLIC AGENTS Ibutilide Fumarate VASODILATORS Olmesartan Medoxomil ANTIPRURITICS, Budesonide Lisuride HORMONESI AND Chlorhexidine Beclomethasone FOR SYSTEMIC USE Mexiletine Phentolamine Fosinopril INCL. Dexamethasone Naproxen PANALOGUES Metronidazole Betamethasone Oxandrolone Phenylephrine Nicergoline Trandolapril ANTIHISTAMINES, Ritodrine Gonadorelin Aspirin Vancomycin Nandrolone Digoxin Tolazoline Benazepril ANESTHETICS, ETC. ANTISEPTICS AND DinoprostoneA Nafarelin Neomycin Guanidine Acetyldigitoxin Pentoxifylline Enalapril Lidocaine DISINFECTANTS Ibuprofen Carbetocin Minocycline Prednisone OTHER Metaraminol Phenoxybenzamine Losartan Procaine Hexachlorophene Dinoprosted Amlexanox Nystatin ALIMENTARY Adenosine Ergoloid mesylate Moexipril Tripelennamine Chlorhexidine Tromethamine CORTICOSTEROIDS Miconazole Amphotericin B TRACT AND Epinephrine Lisinopril Oxybuprocaine Ethanol vBromocriptine FOR SYSTEMIC USE Dexamethasone Hydrocortisone METABOLISM Methoxamine VASOPROTECTIVES Perindopril Promethazine Proflavine o Betamethasone Hydrocortamate PRODUCTS Nitroglycerin Lidocaine Candesartan Diphenhydramine r SEX HORMONES Triamcinolone DRUGS FOR ACID Polymyxin B Sulfate Nitisinone Alprostadil Fluorometholone Eprosartan Benzocaine MEDICATEDp AND MODULATORS Prednisone RELATED Sulfasalazine Miglustat Fenoldopam Betamethasone Quinapril Bromodiphenhydramine DRESSINGSp OF THE GENITAL Fludrocortisone DISORDERS Natamycin L-Carnitine Dobutamine Sodium Tetradecyl Telmisartan Trimeprazine aFramycetin SYSTEM Hydrocortisone Pantoprazole Loperamide Cysteamine Isosorbide Dinitrate Sulfate Irbesartan - Chlorhexidine Diethylstilbestrol Prednisolone Omeprazole Prednisolone Quinidine Fluocinolone Acetonide Captopril ANTIPSORIATICSA Chlorotrianisene Rimexolone Sucralfate Neomycin BLOOD AND BLOOD Levosimendan Flumethasone Pivalate Acitretin ANTI-ACNE Conjugated Estrogens Methylprednisolone Lansoprazole Balsalazide FORMING ORGANS Dopamine Pentosan Polysulfate LIPID MODIFYING MethoxsalenD PREPARATIONS Etonogestrel Trilostane Cimetidine Diphenoxylate ANTITHROMBOTIC Isosorbide Mononitrate Procaine AGENTS FTazarotene Erythromycin Desogestrel Dexamethasone Nizatidine Streptomycin AGENTS Procainamide Hydrocortisone Pravastatin Etretinate Adapalene Megestrol Pirenzepine Miconazole Ticlopidine Ibuprofen Hydrocortamate Lovastatin Fluorometholone Levonorgestrel THYROID THERAPY Homatropine Kanamycin Argatroban Tocainide Prednisolone Colestipol he ANTIBIOTICS AND Chloramphenicol Dydrogesterone Liothyronine Methylbromide Rifaximin Treprostinil Deslanoside Ethanol Cerivastatin t CHEMOTHERAPEUTI Azelaic Acid Progesterone Carbimazole Esomeprazole Budesonide Phenindione Arbutamine Fluocinonide Dextrothyroxinef CS FOR Prednisolone Raloxifene Levothyroxine Ranitidine Fondaparinux sodium Amiodarone Benzocaine oClofibrate DERMATOLOGICAL0 Methylprednisolone Norgestrel Propylthiouracil Famotidine ANTIOBESITY Warfarin Bretylium Heparin l Simvastatin 6USE Isotretinoin Medroxyprogesterone Misoprostol PREPARATIONS, Clopidogrel Propafenone Dexamethasone l Colesevelam 4 Idoxuridine Clindamycin Testosterone CALCIUM Rabeprazole EXCL. DIET Tirofiban Flecainide a Ezetimibe , Sulfanilamide Dexamethasone Estrone HOMEOSTASIS PRODUCTS Aspirin Encainide BETA BLOCKING Fenofibrate1 Penciclovir Estradiol Cinacalcet DRUGS FOR Phentermine Phenprocoumon AGENTSly Atorvastatin> Sulfadiazine OTHER Mifepristone FUNCTIONAL Fenfluramine Dipyridamole ANTIHYPERTENSIVrEsmolol Fluvastatin Mupirocin DERMATOLOGICAL Clomifene ANTIINFECTIVES GASTROINTESTINA Mazindol Iloprost ES a Betaxolol Rosuvastatin Chloramphenicol PREPARATIONS Dienestrol FOR SYSTEMIC USE L DISORDERS Diethylpropion Heparin Reserpine e Metoprolol Gemfibrozil Amikacin Pimecrolimus Norgestimate ANTIBACTERIALS Oxyphenonium Orlistat Enoxaparin Bethanidinen Atenolol Sulfamethizole Minoxidil Ethinyl Estradiol FOR SYSTEMIC USE Oxyphencyclimine Sibutramine Epoprostenol Nitroprusside Timolol Oxytetracycline Monobenzone
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