Preparing for External Reviews in Pharmacy and Handling Hazardous Drugs Session 163

1. 1 Preparing for External Reviews in Pharmacy and Handling Hazardous DrugsSession 163 George Knight John Lowe

2. 2 Objectives List the most common findings from OIG and SOARS reviews Identify the new areas of focus for OIG and SOARS in 2010 Use self assessment tools to identify areas of vulnerability Understand hazardous waste regulations Discuss pharmacy waste handling systems that comply with EPA requirements

3. 3 External and Internal Review Programs Office of Inspector General Combined Assessment Program (OIG CAP) System-wide Ongoing Assessment & Review Strategy (SOARS) Joint Commission Government Accountability Office Drug Enforcement Agency

4. 4 OIG CAP PURPOSE Evaluate how well VA�s are providing access to quality care Determine if management controls are in place to minimize vulnerability to fraud, waste and abuse Provide fraud and integrity awareness training to VA staff

5. 5 OIG Organization Office of Investigations Office of Audits and Evaluations Office of Healthcare Inspections Contract Review Office Support 522 employees

6. 6 Current OIG CAP Topics Suicide prevention Contracted/agency registered nurses Quality management Environment of care Coordination of care Medication management

7. 7 Current OIG CAP Topics Emergency/urgent care operations Survey of health care experiences of patients Physician privileges Community Based Outpatient Clinics Site specific information gathering Compliance with performance measures Onsite inspections Contract review

8. 8 TRADITIONAL OIG CAP FOCUS AREAS IN PHARMACY Purchase cards Physical security Inventory management (returns, stock levels) Controlled substances

9. 9 OIG Highlights March 2010 Postal employee arrested for diverting more than 2000 tablets of VA medications from the mail VAMC employee arrested for taking 1300 oxycodone tablets from outgoing mail packages in VA mailroom VAMC nurse arrested for diverting hydromorphone and Percocet, giving patients only a portion of the drugs prescribed

10. 10 OIG Summary ReportApril � September 2009 Inventory controls inadequate for non-controlled drugs in CMOP Accountability lacking for non-controlled drug inventory in VA facilities VA pharmacist stole $850,000 worth of non-controlled drugs Pharmacy technician entered refills for patients, changed address and mailed controlled substances to his residence

11. 11 OIG Summary ReportApril � September 2009 VA nurse diverted controls from Pyxis and failed to proper document waste procedure VA nurse removed hydromorphone from syringes and replaced with saline Nursing instructor misrepresented herself to pharmacy, obtained access to Acudose and diverted hydromorphone

12. 12 OIG Audit of VA CMOP Inventory Accountability 2009 Inadequate wall to wall inventories Inadequate tracking of dispensing by software Significant differences between actual and projected on hand inventory Inadequate control of inventory balance adjustments Lack of control for drugs held for return Inadequate separation of duties over critical system functions Inadequate Econolink system access controls (everyone used the same password)

13. 13 OIG Audit of VA CMOP Inventory Accountability 2009 VHA Response Wall to wall inventories completed quarterly Each CMOP Director certified compliance with policy for returned drugs Developed a statement of work to rewrite software to ensure complete tracking of inventory Developed management policy to review inventory adjustments monthly Established procedures to restrict one person from ordering, receiving and adjusting inventory Generic password for Econolink was disabled

14. 14 OIG Audit of VHA Management of Non-Controlled Drugs 2009 Findings (Review of 31 facilities) Drug dispensing not accurately and consistently recorded (transfer and returns to stock) State home dispensing Automatic Replenishment/Ward Stock Label reprint function used inappropriately to dispense drugs Drugs returned to stock not accurately captured Lack of policy to monitor high risk non-controlled drugs Wall to wall inventory data not used to improve accountability

15. 15 OIG Audit of VHA Management of Non-Controlled Drugs 2009 VHA Response VHA will identify high risk drugs to monitor PBM will re-emphasize the importance of tracking all dispensing activity and survey results PBM will remind staff that drugs that leave pharmacy cannot be returned to stock Inventory balances must be adjusted for drugs that don�t leave pharmacy and are returned to stock Access to label reprint will be limited PBM will develop standardized electronic formats for inventory and hold managers accountable for accuracy

16. 16 Current Focus Areas for OIG CAP Polypharmacy in nursing home and mental health 30 day medication reviews in nursing homes Environment of care in pharmacy USP Chapter 797 compliance Medication management

17. 17 Medication Management Use of erythropoiesis stimulating agents in chronic kidney disease After hours coverage for non-24 hour pharmacies Flu vaccine in Community Living Centers

18. 18 Remaining OIG CAP Reviews for FY 2010 Louisville 9/13/2010 Canandaigua 9/13/2010 West Palm Beach 9/20/2010

19. 19 How to Prepare Review data requested Use OIG survey guides if available Use SOARS tools for self assessments Conduct mock surveys in addition to table top reviews Review OIGCAP reports on website

20. 20 SOARS System-wide Ongoing Assessment and Review Strategy

21. 21 Background Chartered by the NLB (National Leadership Board) at the Secretary�s Request in 2003 (voluntary visits) Became a more permanent tool in 2004 and later mandatory for all facilities in 2006 Now complete 50-55 site visits a year using permanent team leaders and up to 250 trained consultants from VACO, VISNs and medical centers Complete exit presentations using a Baldrige type scoring system and follow-up with a formal report with recommendations

22. 22 KEY PRINCIPLES Use Baldrige methods of looking at Approach, Deployment and Results for key systems Work to resolve areas of repeat citations Consult not inspect- work with the staff to help them understand the intent of standards Affirm strengths and spread learning (through visits and through consultant experiences) Teach to continually complete risk assessments Involve leadership in all aspects of the visit

23. 23 ONGOING INITIATIVES Bi-monthly education sessions for the field facilities, SOARS Multi-segment films, strong practice dissemination Maintain �state of the art� assessment guides Continually updated trend reports for facilities, VISNs and program offices on the SOARS website Monthly reports to the Under Secretary�s Coordination Committee for Quality and Safety (USCCQS) with top findings Bi-monthly �heads up� report to the NDs for top issues to address Change site visit report formats to simpler display with much more timely delivery

24. 24 SOARS Areas of Emphasis in Pharmacy Controlled Substances Pharmacy Tour General security based on VA Handbook 0730 Vault security and access Inventory management (including high cost-high risk drugs) Emergency drug cache Environment of care (refrigerator monitoring) Compliance with USP 797

25. 25 SOARS Areas of Emphasis in Pharmacy Anticoagulation (may include patient tracer) Handling pharmaceutical waste National patient safety goals

26. 26 Common Findings in Pharmacy and Medication Management Access to automated dispensing equipment (Pyxis, OmniCell) not terminated when employees leave Pharmacy physical security not meeting requirements National patient safety goals not fully implemented Eye wash stations not tested and staff unable to demonstrate use Controlled substance inspections not completed according to requirements

27. 27 Common Findings in Pharmacy and Medication Management Management of look alike/sound alike medications and other high risk drugs (anticoagulants) not consistent Lack of effectiveness of medication reconciliation in all areas Labeling and dating of multi-dose vials not consistently completed

28. 28 Preparation for SOARS Use assessment guides Pre-reviews with internal facility and VISN teams Use SOARS as practice session for Joint Commission Contact SOARS pharmacists with questions in advance (approximately 35 pharmacists trained as SOARS consultants)

29. 29 SOARS Website Assessment guides Training films List of strong practices Upcoming visit schedule Trends report http://soars.vssc.med.va.gov/Pages/default.aspx

30. 30 Handling Hazardous DrugsVA eHealth University 2010Caesars Palace, Las Vegas, NV August 9-12George Knight, RPhVISN 2 Network Pharmacy Executive/PBM Manager

31. 31 Hazardous Waste training for healthcare workers?? What�s Up? The EPA considers some chemicals, including some drugs, to be hazardous waste when discarded. Having addressed the manufacturing industry, the EPA is now focusing on the Health Care System as the next largest contributing factor to environmental contamination.

32. 32 Why Focus on Pharmaceuticals? They are being found in the environment and in our public water works Regulatory emphasis by all levels of the EPA(Environmental Protection Agency) local, state and federal Standards require compliance with regulations; Joint Commission, Commission on Accreditation of Rehabilitation Facilities (CARF)�� VA Directive 2003-030 Management of Hazardous Chemicals Why the focus on Pharmaceuticals? Hospitals have been placed on the Federal EPA�s �hit list� because they are viewed as major polluters. For years the industry has gone with little scrutiny. Now with endocrine disruptors and other pharmaceuticals being found in drinking water, regulatory agencies are taking a closer look at the medical industry specifically, hospitals. These regulations are not new. They have been around since the 1980�s. However, they have never really been enforced at hospitals. With the focus on enforcement also comes new interpretations as applied to healthcare and new regulations. Where Have Waste Drugs Gone in the Past? Primarily hospitals were concerned with rendering drugs unrecoverable They would make slurries and sewer them, burn them in hospital incinerators, landfill them. Today they are: Sewered, treated as hazardous waste, burned as non-hazardous waste at a permitted facility, and treated as medical waste. Why the focus on Pharmaceuticals? Hospitals have been placed on the Federal EPA�s �hit list� because they are viewed as major polluters. For years the industry has gone with little scrutiny. Now with endocrine disruptors and other pharmaceuticals being found in drinking water, regulatory agencies are taking a closer look at the medical industry specifically, hospitals. These regulations are not new. They have been around since the 1980�s. However, they have never really been enforced at hospitals. With the focus on enforcement also comes new interpretations as applied to healthcare and new regulations. Where Have Waste Drugs Gone in the Past? Primarily hospitals were concerned with rendering drugs unrecoverable They would make slurries and sewer them, burn them in hospital incinerators, landfill them. Today they are: Sewered, treated as hazardous waste, burned as non-hazardous waste at a permitted facility, and treated as medical waste.

33. 33 Potential Problems Increased Occurrence of Cancer Unusual Physiological Processes (Reproductive Impairment) Antibiotic-Resistant Bacteria Augmented Toxicity of Chemical Mixtures

34. 34 Not just a fish story�.

35. 35 Not just a fish story� In a major northeastern waterway, a 3 foot long northern pike was caught. Not remarkable until we are told that from the gills back, behind the grossly enlarged head, the fish had two complete bodies.

36. 36 Pharmaceutical Waste Generation IV Preparation General compounding Spills/breakage Partially used vials/syringes Discontinued/unused Unused repacks (unit dose) Patient�s personal medications Outdated pharmaceuticals

37. 37 Hazardous Waste Regulations Require Proper Identification Segregation & Storage Manifesting and Transporting Proper Disposal, i.e. Incineration at a federally permitted incinerationsSite

38. 38 Resource Conservation and Recovery Act (RCRA) RCRA regulates the disposal of solid wastes enforced by the EPA and the States Defines hazardous waste and procedures for handling and disposal of wastes Most States have a hazardous waste program approved by the EPA

39. 39 EPA Universal Waste Rule Proposed addition of hazardous pharmaceutical waste to the Universal Waste Rule Streamlined Management Encourage disposal of non-hazardous pharmaceuticals as Universal Waste Facilitate collection of personal medications from the public Michigan and Florida have done this at the State level

40. 40 Categories of RCRA Hazardous Wastes: P-Listed Acutely hazardous Sole active ingredient - unused Empty � only if triple rinsed Rinse solution is hazardous, or �. Manage un-rinsed containers as hazardous (vials, IV tubing)

41. 41 Examples of P-Listed Wastes Arsenic Trioxide (chemotherapy) Epinephrine (excluded if in used syringe; may be discarded as regulated medical waste) ** not EPI salts ** except MN Nicotine (patch backing but not wrappers) Warfarin > 0.3% (all Rx dosages) Nitroglycerin (excluded federally and some states if in final dosage form) Phentermine (1 of 2 Controlled Substances)

42. 42 Categories of RCRA Hazardous Wastes: U-Listed Toxic - not as disastrous as P Sole active ingredient - unused Empty containers All contents have been removed through normal means and < 3% by weight remains = not hazardous Residues removed from containers must be managed as hazardous waste

43. 43 Examples of U-Listed Wastes Chloral Hydrate (2nd CS) Chlorambucil Lindane Warfarin < 0.3% (all Rx dosages exceed this percentage) Saccharin

44. 44 Categories of RCRA Hazardous Wastes: Characteristic (D-Listed) Pharmaceutical, chemical formulations not on P-List or U-List, which exhibit one or more of the following characteristics: Ignitability (nitroglycerin inj.) Toxicity (M-cresol or thimerosol as preservative; fluvax; reserpine) Corrosivity Reactivity

45. 45 Examples of D-Listed or Characteristic Wastes Used or Unused, but only when present in concentrations at or above the indicated RCRA regulatory level: Chloroform � 6.0 mg/L Mercury � 0.2 mg/L; contains thimerosol and fails this threshold Silver � 5.0 mg/L; silver nitrate applicators Selenium � 1.0 mg/L; Selsun Blue

46. 46 When is an Outdated Drug Waste? At the time and place the decision is made to discard it If a Reverse Distributor is used and the decision to discard is made there � we are still the generator of the waste. We can ship creditable outdates to a reverse distributor as product. All non-credit materials must be handled as hazardous waste on-site, once we know they are not creditable. Keep a list.

47. 47 Uncreditable Items: Keep a list Ivax Pharmaceuticals Inc. Albuterol aerosol American Reagent Labs, Inc. Alcohol, dehydrated Purdue Frederick Betadine solution HUMCO Collodion, flexible

48. 48 Pharmacy/Ward Procedures P-Listed: Use black container U-Listed: Use black container D-Listed: Use black container Unlisted: Use red container Regulated medical waste Incinerated vs. sterilized Un-creditable pharmacy returns Partials, sweep-ups

49. 49 Labeling & Education Black dot labeling; U-Listed & Characteristic (D-Listed) Caution Label; Special disposal required P-Listed + containers Med cart containers Listing by location Develop a comprehensive Facility and departmental SOP

50. 50 Formulary List Cyclophosphamide Injection * U-listed Black dot label Toxic [U058] Dexamethasone Injection * Characteristic Black dot label Flammable [D001] Warfarin Sodium * P-listed - Conc. >0.3% Caution Label Toxic [P001]

51. 51 Chemotherapy Waste (U-Listed) Two waste streams for this waste are required Trace Waste (Yellow chemo containers in Pharmacy) EMPTY vials, syringes, IV bags Soft waste: gowns, gloves, goggles, tubing and wipes UNLESS overtly contaminated Container holding any amount of free liquid Overtly contaminated garments Spill cleanup kits

52. 52 Chemotherapy Waste (U-Listed) Bulk Waste (black chemo containers) EMPTY vials, syringes, IV bags. A container holding any amount of free liquid, overtly contaminated garments and spill cleanup kits. Only style used on the nursing units

53. 53 Satellite Accumulation Good Idea to label as Satellite Accumulation Must have the words �hazardous waste� Must have a clear description of the waste Date not required

54. 54 Storage Labeling Requirements The words �Hazardous Waste� must be on the container. Clear description of the waste type must be neatly printed on the label. Accumulation start date for 90 or 180 day areas.

55. 55 Generator Status Large quantity generator > 2.2 lbs. �P� > 2200 lbs./mo. non-acute Small quantity generator < 2.2 lbs. �P� < 2200 lbs./mo. non-acute

56. 56 Additional Points Incompatible wastes must be properly segregated. Weekly inspections are required to be documented for all long term hazardous waste storage areas (90 or 180 day areas).

57. 57 Additional Points Must have spill response equipment & containment equipment in the area Secondary containment is required to prevent uncontrolled spills Training requirements for long term storage areas Within 6 months Annual requirement "Cradle-to-grave� responsibility

58. 58 Consequences of Non-Compliance Compliance inspections Fines / Penalties / Imprisonment License revocation Criminal citations / Civil actions Corrective orders 08/18/2009 Department of Veterans Affairs Eastern Kansas Health Care System - civil penalty $51,501 & VA must also spend at least $482,069 on a management project. There are serious repercussions to violations of the Hazardous Waste Regulations. Some states have even succeeded in getting criminal convictions against polluters (i.e. individuals within a company or institution) The handling of hazardous waste must be taken seriously. Not only because fines can be levied but also because we need to live in the same environment that is being polluted. Simply put it is the right thing to do. If you have questions please feel free to contact the Safety Department at ext. 2017.There are serious repercussions to violations of the Hazardous Waste Regulations. Some states have even succeeded in getting criminal convictions against polluters (i.e. individuals within a company or institution) The handling of hazardous waste must be taken seriously. Not only because fines can be levied but also because we need to live in the same environment that is being polluted. Simply put it is the right thing to do. If you have questions please feel free to contact the Safety Department at ext. 2017.

59. 59 Managing Our Waste Streams Regular Trash Packaging Empty Bottles Paper Plastic Recycle where possible Sewer System Non-Haz IVs NaCl, D5W

60. Managing Our Waste Streams Hazardous Waste P-listed & containers U-listed Characteristic waste (D-listed) Requires proper segregation, labeling & storage Chemo Waste Trace chemo Should be sent to a medical incinerator Bulk chemo Follows the requirements of the hazardous waste stream

61. 61 Questions, comments, concerns? Be sure to evaluate your area Do you have waste that has not been evaluated (cleaning rags, other chemicals, equipment that automatically dumps into the sewer system)? Do you have ample/proper spill kits? Do you have proper postings? Emergency contacts, spill plans, exit routes�.