Online Evaluation, Self-Assessment and CE Credit

Transcription

1 Pharmaceutical Waste Management Faculty Speakers: Allen Brown National Accounts Director Stericycle Jerry Reed, RPh, MS, FASCP, FASHP Corporate Director, Pharmacy Services Community Health Systems 1 Online Evaluation, Self-Assessment and CE Credit Submissionof of anonline evaluation is the only way to obtain CE credit for this webinar Go to Webinar attendees will also receive an with a direct link to the web page Print your CE statement of completion online Credit for live or enduring only Deadline: September 26, 2014 CPE Monitor (applicable to pharmacists and pharmacy technicians) CE information automatically uploaded to NABP/CPE Monitor within 3 to 4 weeks of the completion of the self assessment and evaluation Event Code Code will be provided at the end of today s activity 2 1

2 How to Ask a Question Locate menu bar on your computer desktop Click No! Click orange arrow button Menu box will open Type question into question box Click Send Do not close menu box This will disconnect you from the Webcast Please submit questions throughout presentation Enter question Click Send 3 Accessing PDF Handout Click the hyperlink that is located directly above the question box Do not close menu box This will disconnect you from the Webcast Close other applications Click hyperlink No! 4 2

3 CE Activity Information & Accreditation (Pharmacist and Pharmacy Technician CE) 1.0contact hour Funding: This activity is self funded through CHSPSC. 5 Allen Brown National Accounts Director, Stericycle It is the policy of to ensure balance, independence, objectivity and scientific rigor in all of its continuing education activities. Faculty must disclose to participants the existence of any significant financial interest or any other relationship with the manufacturer of any commercial product(s) discussed in an educational presentation. Allen Brown is an employee of Stericycle. Jerry Reed has no relevant commercial and/or financial relationships to disclose. Please note: The opinions expressed in this activity should not be construed as those of the CME/CE provider. The information and views are those of the faculty through clinical practice and knowledge of the professional literature. Portions of this activity may include unlabeled indications. Use of drugs and devices outside of labeling should be considered experimental and participants are advised to consult prescribing information and professional literature

4 Objectives Define the nature, scope, and impact of pharmaceutical wastes on the environment. Identify regulatory agencies and other entities involved in pharmaceutical waste management. Describe core elements of an institution specific plan for managing pharmaceutical waste. Identify strategies that minimize the production of pharmaceutical waste. 7 USGS Water Survey Potential adverse effects: Water quality degradation Endocrine disruption Antibiotic resistance Impact on aquatic life Public perception EPA and JC Heightened Regulatory Activity Media Coverage (New York Times, AP, all the major networks 8 4

5 Media Coverage AP Probe finds drugs in drinking water Mar AP IMPACT Tons of drugs dumped into waterway ABC Drugs in the Water : Reason to Worry? MSNBC Pharmaceuticals found in fish across U.S. Mar. 09 CBS News Pharmaceuticals in Drinking Water Mar USA Today Health facilities flush estimated 250M pounds of drugs a year Sept What s in your Water? 9 Understanding Pharmaceutical Waste Two Methods of Entry into our Environment unmetabolized medications and those disposed. We are going gto focus on the medications disposed. RCRA Regulations encompass Pharmaceutical Waste 1976 A discarded pharmaceutical may be identified as a hazardous waste if it appears on a regulatory list of hazardous wastes (P or U) or exhibits one of four hazardous characteristics (ignitability, corrosivity, reactivity or toxicity)

6 REGULATORY ACTIVITY EPA Regulatory Activity Notice of Violations and warnings in NY, MA, CT, OH, NC Increasing regulatory scrutiny across the country Past 5 years 244 hospitals cited with fines ranging from $700 to $107,000 according to Modern Healthcare Magazine State Attorney General Independent enforcement initiative NY City Watershed/Clean Water Act The Joint Commission (TJC) Hazardous Waste chapters not new but TJC is putting more emphasis on these issues. (EC Compliance in 2009) Surveyors have been trained on what to look for during a survey. 11 Regulatory Agencies Involved Environmental Protection Agency (EPA) Department of Transportation (DOT) The Joint Commission (TJC) Local & State Regulators Drug Enforcement Agency (DEA) Occupational Safety & Health (OSHA) Publicly Owned Treatment Works (POTW)

7 Common EPA Violations Hazardous waste determinations not identified or incorrect Labelingof hazardous waste notprovidedorincorrect or incorrect Throwing HW down the drain Improper disposal of chemotherapy drugs Inadequate training for employees in HW management Notconductingproperweekly inspectionsofhwof storage None or inadequate HW manifests Improper management of expired pharmaceuticals Lack of emergency contingency plan 13 TJC Accreditation Issues MM Medication Management The hospital safely manages high alert and hazardous medications. EC Environment of Care The hospital minimizes risk associated with disposing hazardous medications. MM Medication Management The hospital minimizes risk associated with managing hazardous medications. LD.3.50 Leadership Services provided by consultation, contractual arrangements, or other agreements are provided safely and effectively. EM Emergency Management The organization prepares for how it will manage hazardous materials and waste

8 RCRA Hazardous Drugs Categories Two Categories of RCRA Hazardous Waste Include: Characteristic Waste 4 characteristics Ignitability, Corrosivity, Reactivity, Toxicity Listed Wastes P Listed (Coumadin, Warfarin, EPI, and nitroglycerin (some states have issued exemptions) U Listed (chemotherapy drugs) Other categories of Hazardous Waste Compatible vs. In Compatible Pharmaceutical Waste Drugs that can (Compatible) and CANNOT (In Compatible) be placed in the same container without danger of a chemical reaction 15 Pharmaceutical Waste Compliance Program

9 Program Four Key Components Identification Characterize your Formulary. Education On Site, Initially and on going Segregation Using color coded containers and sort codes Transportation and Destruction Coordinate the pickup and transportation of the waste. 17 How Rx Waste Will be Managed Non RCRA Hazardous Hazardous Sharps in Pharmacy and Rdil Radiology Sharp with Pharmaceutical still in it

10 SORT CODES FOR RX WASTE NO Code = Blue Container BKC = Black hazardous container PBKC =Packaging must go into zip lock bag then into black container. P Listed items only SP = Send to Pharmacy NO CONTROLLED SUBSTANCES CAN BE CAPTURED VIA THIS PROGRAM. FOLLOW YOUR CURRENT PROCEDURES. 19 Non RCRA/Hazardous Rx Waste Container Reusable, Non Hazardous Container Partial IV s, uncapped ointments, and unused pills (place in zip lock bag ) Unused IV s if not spiked All unused medications without a code No Code = Blue Container

11 Compatible Hazardous Waste Compatible Hazardous Waste Code=BCK Examples: Insulins, Lindane Packaging of Hazardous Waste Code = PBCK P-listed Waste items also require the packaging to be captured. Place and seal in zip lock bag. Examples: wafarin (Coumadin) packaging, Nicotine products packaging g Sharps disposal with medications still in them Code = None Syringe/ Ampoule/ Auto injector with Pharmaceutical still in it. More than residual amount. NO CONTROLLED SUBSTANCES 21 IV Waste Disposal Guidelines PLAIN DOWN THE DRAIN If no medications are added, d drain disposal is permitted. Examples: Saline, Dextrose, Electrolytes, and Lactated Ringers. IV WITH NON HAZARDOUS MEDICATIONS INSTILLED = BLUE CONTAINER, IF SPIKED, SEAL IN ZIP LOCK BAG. IV WITH HAZARDOUS MEDICATIONS INSTILLED=BLACK CONTAINER, IF SPIKED, SEAL IN ZIP LOCK BAG If IV bag is empty it goes into the trash

12 Healthcare Waste Streams Controlled Substances RCRA empty Chemo Bulk Chemo What is different? Pharmaceutical Waste Only when there is medication left in a vial, syringe, ampoule or IV bag, pills and capsules included Compatible Hazardous & Non Haz Hazardous/Non Comp. Sharp with Pharmaceutical 92% 7% 23 Does Your RX Waste Program Have You Covered? Insure your Rx Waste Program Has You Covered!

13 Jerry Reed, MS, RPh, FASCP, FASHP Corporate Director, Pharmacy Services 25 Why It Matters Earliest reports of pharmaceuticals in the environment were in late 90s, early 2000 Antidepressants Estrogens and other hormones Antibiotics In general, drugs and their by products are NOT removed by standard water treatment processes Impact??? Endocrine disruption Sexual differentiation Reproduction/growth Diminished intelligence Antibiotic resistance Sources Health care facilities Households/patients Agricultural businesses Drug manufacturers

14 27 What Agency Regulates Pharmaceutical Waste Disposal? A. Environmental Protection Agency B. State and local authorities C. Department of Transportation D. A and B E. All of the above

15 Interested Parties Environmental Protection Agency y( (EPA) Drug Enforcement Agency (DEA) Food and Drug Administration (FDA) Department of Transportation State and local authorities National Institute for Occupational Safety and Health (NIOSH) Occupational Safety and Health Administration (OSHA) Congress Health care professionals Public 29 RCRA Hazardous Waste Categories P listed: acutely hazardous U listed Arsenic trioxide Epinephrine (EXCLUDES salts) Nicotine Nitroglycerin (EXCLUDES some medicinal forms) Phentermine Physiostigmine Warfarin >0.3% Choral hydrate Dichlorodiflouromethane Hexachlorophene Lindane Paraldehyde Phenol Reserpine Resourcinol Saccharin Selenium sulfide Select chemotherapy agents (arsenic trioxide, chlorambucil, cyclophosphamide, daunomycin, diethylstilbestrol, melphalan, mitomycin C, streptozocin, and uracil mustard) Trichoromonpflouromethane Warfarin 0.3%

16 31 Comparison of EPA and OSHA (NIOSH) Hazardous Drug Classification EPA (Resource Conservation and Recovery Act) P listed U listed Other drugs with the following characteristics Ignitable Corrosive Reactive Toxic OSHA (NIOSH) Largely defined by drugs listed in Appendix A in NIOSH Alert on Hazardous Drugs (2004) and an update to that list issued in September 2010 Approximately 140 drugs on 2004 list; list now includes 157 drugs STATE AND LOCAL REGULATIONS Initial list had a strong focus on chemotherapy but revision includes biologics and other therapies Extends to drugs not listed that have the following characteristics: Carcinogenicity Teratogenicity Reproductive toxicity Organ toxicity at low doses Genotoxicity

17 CAUTION: State and Local Regulations May be More Stringent than EPA! 33 Hospital Concerns Inspections and enforcement vary by EPA region as well as state and municipality Fines are calculated per violation/per day Fines up to $250,000 have been reported Requires dedicated staff to assess and ensure compliance Extensive staff education, including departments external to pharmacy Cost of disposal

18 Implementation Strategies 10 Steps to Success Assembling the Team Plant Operations Environmental Services Pharmacy Nursing Laboratory Infection Control Compliance/Legal Administration Rx Waste Vendor Who else needs to know? Critical factor: Adequate time/resources from C-suite!!!!

19 2. Drug Inventory Review Formulary characterization Most pharmacies store up to 4,000 drug products Approximately 5% are RCRA hazardous Up to 15% should be managed as hazardous according to best practices Gather drug specific information, including vehicle information Document your assessment This should be an ongoing process! 37 Decreasing Waste Production Use unit of use and pre mixed packaging Batch preparation Buy only the amount needed estimate usage! Avoid purchasing in bulk disposal of unused product may negate up front savings Inventory management: first in, first out rule Establish take back contracts Decrease use of aerosols and other flammable products

20 3. Implementation Meeting Key stake holders Program overview Policy review Schedule implementation date Schedule training dates Review Central Accumulation Area (CAA) requirements Agreement on collection and transport of containers Pre Install Site Survey Scheduled following the implementation meeting Don t forget about Surgery, Anesthesia, and Procedural areas Vendor will complete the site survey Waste streams and department locations identified Distribution process aligned with program training Agreement on collection and transport of containers Review CAA, non HD, and clean container storage for compliance

21 5. Supplies Vendor will order all supplies after the site survey is completed. Supplies delivered 2 7 days prior to program implementation Training Policy review Initial Training Over a 2 consecutive day period Train the trainer Unit to unit Vendor involved in implementation and education Consists of webinar or on site clinician training prior to roll out notification and flyers Training and implementation exit meeting

22 7. Installation and Implementation Satellite Accumulation Area (SAA) containers, carts, baggies, and holders placed in all identified locations Informational posters Extra containers and supplies Additional instruction for EVS personnel Implementation exit meeting After Care Program Weekly vendor visits scheduled for the first month, twice in month two, and once in month three, then quarterly Retraining and education provided as needed Visual inspection for validation of proper segregation Inspection of CAA and non HD storage areas Review CAA inspection forms Written summary reports from vendor to facility after each visit

23 9. Process Improvement Tracking, measuring, and documenting your progress Conduct audits Use your vendor Continual Processes Installation is not the end. Educate and re educate staff. Maintain current knowledge. Information resources Hazardous waste data RCRA online Educational publications Laws and regulations

24 47 Your Questions, Challenges, and Feedback