Pharmacy CSI: Solving the Drug Diversion Mystery
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Pharmacy CSI: Solving the Drug Diversion Mystery
Pharmacy CSI: Solving the Drug Diversion Mystery Contact Information June 2, 2015 Rutgers University-Busch Campus Student Center Mitch G. Sobel, BS Pharm, MAS, FASHP Director of Pharmacy Services St. Joseph’s Health Care System Disclosure Declaration I do not have (nor does any immediate family member have) a vested interest in or affiliation with any cooperate organization offering financial support or grant monies for this continuing education activity, or any affiliation with an organization whose philosophy could potentially bias my presentation. This presentation is solely for informational purposes and does not represent the views, statements, or opinions of the New Jersey Board of Pharmacy, New Jersey Division of Consumer Affairs and /or the New Jersey Office of the Attorney General. St. Joseph’s Health Care System Department of Pharmacy Services (973) 754 – 3028 (973) 754 – 3036 fax [email protected] 703 Main Street, Paterson, New Jersey 07503 Objectives Define classes of narcotics and controlled substances Describe the different rules and regulations concerning the handling of controlled substances Describe methods of controlled substances documentation, surveillance, and preventing diversion 1 Diversion Overview Controlled substances are managed at all levels: Adherence to Federal and State laws Procurement Inventory management Distribution Dispensing Surveillance and documentation Diversion and system evaluation Waste There has been a fourfold increase in drug overdose deaths from prescription drug abuse in the last decade – 2011 – 6.1 M non-medical use including oxycodone, oxycontin, hydrocodone, carisoprodol, and alprazolam† 40 Americans die daily from CDS prescription abuse – Greater deaths than cocaine and heroin combined 15% of pharmacists are confronted with alcohol and/or drug dependency 10% of nurses are dependent on drugs – 3.1 M RNs in U.S. = 300,000 RNs dependent 8% of physicians are dependent on drugs †2011 Annual National Survey on Drug Use and Health Buzzeo, R, Neal, M, Hospital Drug Diversion and Abuse – Creating an Effective Surveillance and Prevention Program, CEGEDIM Realtionship Mgt, 1/2013 http://www.nj.gov/lps/ca2/pmp/ Importance of Controlled Substances Management There a 3 factors that influence the need for managing controlled substances. Federal and State Laws and Regulations 2. Patient Safety 3. Pain Management and Practice 1. Federal and State Laws and Regulations Controlled Substance Act (CSA) – Title II of the Federal Comprehensive Drug Abuse Prevention and Control Act of 1970, under Title 21 United States Code, starting at Section 801. – Federal and State laws may differ in degree of severity. Follow which ever rule is more strict. – www.dea.gov provides many links and documents 2 Federal and State Laws and Regulations Federal and State Laws and Regulations Example of Controlled Substances Schedules. – CI (~119 cmpds) Heroin, Lysergic acid diethylamide, Marijuana, 3,4methylenedioxymethamphetamine (ecstasy). Controlled substances classified according to: – CII (~64 cmpds) Amphetamine, Fentanyl, Methadone, Opiates. – Abuse potential – Accepted medical use – Potential physical or psychological dependence – CIII (~66 cmpds) Anabolic steroids, Barbiturates, ketamine, opium combination products (< 15 mg/dose hydrocodone, < 90 mg/dose codeine). – CIV (~68 cmpds) Barbiturates (Phenobarbital, Secobarbital), Benzodiazepines (clonazepam, diazepam, midazolam), Chloral hydrate. Schedules are listed as CI to CV – CV (~7 cmpds) Low dose combination of narcotic and non-narcotics (e.g. Not more than 200 milligrams of codeine per 100 milliliters or per 100 grams - Robitussin AC, Phenergan w/ codeine). Federal and State Laws and Regulations Regulatory Agencies Prescribing and handling of controlled substances privileges granted to: Physicians and Physician Assistants Nurses (incl. Practitioners, Midwives, Anesthetists) Optometrists Ambulance Services Pharmacists Different States may vary in privileges and laws. – Division of Department of Justice Federal - Drug Enforcement Agency NJ Department of Law and Public Safety Office of the NJ Attorney General – Bureau of Drug Control/Enforcement – NJ State Board of Pharmacy Regulates practice of Pharmacy Can change schedules of controlled substances NJ State Department of Health – Enforces Fed and State Laws 3 Patient Safety National Emphasis on Patient Safety – – – – Institute of Safe Medication Practices (ISMP) The Joint Commission (JC) Det Norske Veritas (DNV) United States Pharmacopoeia (USP) Medication Error Reporting Program Education and concern for narc prescription use Separate and highlight Look/Sound Alike medications – Morphine vs. Hydromorphone (use “Equiv. to Dilaudid®”) – Morphine IR vs. Morphine ER Co-sign, double check, and document all transactions HCAHPS Survey Questions 12. During this hospital stay, did you need medicine for pain? ・ Yes ・ No ・ If No, Go to Question 15 13. During this hospital stay, how often was your pain well controlled? ・ Never ・ Sometimes ・ Usually ・ Always 14. During this hospital stay, how often did the hospital staff do everything they could to help you with your pain? ・ Never ・ Sometimes ・ Usually ・ Always Pain Management and Practice Complex pharmacotherapy and formulations (patches, PCA, concentrations) Pharmacist interventions improve safety and outcomes (monitoring, conversions) Essential Patient Right: – Pain is the 5th vital sign. – Pain assessment should occur before, during, and after pain therapy. HCAHPS – Hospital Consumer Assessment of Healthcare Providers and Systems* – Pain assessment is part of the 27 item survey for patients – Developed by Centers for Medicare and Medicaid (CMS) and the Agency for Healthcare Research and Quality (AHRQ) – 2007 – Inpatient Prospective Payment System *http://www.hcahpsonline.org. Centers for Medicare & Medicaid Services, Baltimore, MD. October, 29, 2012 HCAHPS Survey Questions 15. During this hospital stay, were you given any medicine that you had not taken before? ・ Yes ・ No ・ If No, Go to Question 18 16. Before giving you any new medicine, how often did hospital staff tell you what the medicine was for? ・ Never ・ Sometimes ・ Usually ・ Always 17. Before giving you any new medicine, how often did hospital staff describe possible side effects in a way you could understand? ・ Never ・ Sometimes ・ Usually ・ Always 4 Sample DEA 222 Form Procurement Co-signatures are required for receiving controlled substances inventory to provide accountability and accuracy. Use DEA 222 Form to order CII. CIII to CV may be ordered like all other legend and OTC medications. DEA 222 Form (blue) and Purchase invoice should be matched with delivery invoice. Store controlled substances into a locked room or vault. For ordering CII narcotics only http://www.deadiversion.usdoj.gov /pubs/manuals/narcotic/appendixb/222d.htm CSOS CSOS Controlled Substances Ordering System – Approval from D.E.A. – Certificate Authentication – Manufacturer specific – – – – – – – Takes some time and effort to set up Very convenient, electronic, no paper work Quicker turn-around time Security Computer specific Increased accuracy Decreased order errors Enroll on-line www.deaecom.gov – Registrant – Coordinator – Power of Attorney (POA) www.deaecom.gov 5 Inventory management. Automated controlled substances dispensing system allows greater control and security (CII Safe®, Omnicell®). Access should be restricted. Separate and identify look/sound alike medications. Although CIII to CV may be stored with legend inventory, it is better to store all schedules (CII to CV) in vault for greater security and accountability. Sample Automated Controlled Substances Vaults Distribution Different pharmacist distributes narcotics to patients or patient care areas than the one that receives the wholesaler inventory. Designate a different person to deliver controlled substances to the patient care areas. Limit the number of personnel that handles delivery and transport of controlled substances. Two pharmacists should perform periodic inventory of controlled substances stock as a “blind” count. Two nurses should perform daily inventory of controlled substances stock on patient care areas as a “blind” count. Pyxis CII Safe® http://www.carefusion.com/medical-products/medication-management/ medication-technologies/pyxis-ciisafe-system.aspx Omnicell Secure Vault® http://www.omnicell.com/Products/Central_Pharmacy_ Automation/Controlled_Substance_Management_System.aspx# Sample Automated Dispensing Machines Located On Patient Care Units Omnicell®) http://www.ehealthreporter.com/en/noticia/verNoticia/291/omnicell Carefusion Pyxis ® http://www.carefusion.com/medical-products/medication -management/medication-technologies/pyxis-medstation-system.aspx 6 Sample Controlled Drug Administration Record (CDAR) Dispensing Controlled substances orders should have automatic stop dates built into the patient medication profile. Monitor patient profiles for duplicate therapy. Assist nurses and physicians with conversion formulas when switching types and forms of controlled substances. Joe's Medical Center Controlled Substances Administration Record Date Time Patient Name Room Medication Dose Qty Admin By Co-sig for waste Reason for waste Document all transactions with a co-signature. NJ Prescription Monitoring Program (NJPMP) National epidemic of CDS prescription abuse 2 in 5 teenagers think CDS are safer than illicit drugs Each day 2,500 teenagers try CDS to get high for the first time Division of Consumer Affairs - N.J.S.A. 45:1-45 NJ Database – Daily record of Pharmacy CDS and HGH dispensing Prescriber and Pharmacist access HIPAA compliant Surveillance and documentation. Co-signatures are the keys to preventing errors and diversion and provide accountability. – Document: Patient name, date, time, patient care area, medication name and dose, quantity, physician and/or nurse administering and/or wasting. Automated dispensing machines (ADMs) can match and follow transactions involving ordering, receiving, dispensing, and delivery of controlled substances. Follow through on all discrepancies. Inventory stock: – Biennial Inventory – Perpetual Inventory 7 Surveillance Reports ADM Compare – Comparison of patient care area and narc vault ADMs transactions Proactive Diversion – Standard Deviation of users Open Discrepancy Notification – real time alerts Documented Discrepancy – validate reasons entered Waste and Return – excessive entries Override – user overrides without prescriber Rx All Events – management review for trends; compare to pt record Inventory Verification – perpetual spot check Outdated Inventory – commonly overlooked Usual rule to follow http://meetville.com/images/quotes/Quotation-Proverb-funny-Meetville-Quotes-14354.jpg http://41.media.tumblr.com/tumblr_m7teqt5aF81r36vzto1_500.jpg 8 Or this one… Q&A A good inventory management system contains the following: 1. Restricted access Highlighted Look/Sound Alike drugs Storage areas that provide accountability and security Co-signatures on documentation “Just in Time” Inventory Certain tasks are delineated by different staff members All of the above 2. 3. 4. 5. 6. 7. https://lh6.googleusercontent.com/-FUeWScP0MDw/VDi1RBJpjfI/AAAAAAAALbw/1VJNIoZ9ZI8/w656-h577/10616471_10153165717999062_3784880976383473292_n.jpg Q&A Q&A A good inventory management system contains the following: Which is not a good controlled substances distribution method: 1. Restricted access Highlighted Look/Sound Alike drugs Storage areas that provide accountability and security Co-signatures on documentation “Just in Time” Inventory Certain tasks are delineated by different staff members All of the above 1. Different pharmacist delivers narcotics to patient than the pharmacist that receives the narcotics wholesaler order Limited number of staff handles delivery and transport of controlled substances Periodic inventory validation of controlled substances stock is performed to confirm known count Controlled substances not picked up by patients should be left on the front counter as a reminder 3 and 4 None of the above 2. 3. 4. 5. 6. 7. 2. 3. 4. 5. 6. 9 Q&A Diversion and System Evaluation Which is not a good controlled substances distribution method: 1. Different pharmacist delivers narcotics to patient than the pharmacist that receives the narcotics wholesaler order Limited number of staff handles delivery and transport of controlled substances Periodic inventory validation of controlled substances stock is performed to confirm known count Controlled substances not picked up by patients should be left on the front counter as a reminder 3 and 4 None of the above 2. 3. 4. 5. 6. Use an interdisciplinary and collaborative approach to prevent controlled substances diversion. Joint policies and procedures. Create a non-punitive culture. Hospital personnel involved with diversion are a danger to the patient, institution, and themselves. Diversion Red Flag! Noticeable Trends of Diversion Patient complaints of poor pain management after pain therapy. http://www.superstock.com/stock-photos-images/1660R-17157 https://www.mcssl.com/content/27384/mnct/sine-base-1.jpg Behavioral/personality changes Absenteeism Declining job performance Poor documentation Unexplained disappearances Numerous bathroom breaks Excessive time with CDS supply Wearing long sleeves when inappropriate Deteriorating personal hygiene Patient/staff complaints Personal/professional isolation http://www.vitaminddeficiency.me/always-tired-no-energy-no-motivation/ http://www.health.com/health/gallery/0,,20396232,00.html http://tridiculous.blogspot.com/2011/05/stoned-sandwich-burrito-artists.html http://www.deadiversion.usdoj.gov/pubs/brochures/drug_hc.htm 10 Methods of Enabling Employee Diversion Remember—Some diverters show no signs at all DO NOT rely on physical trends as sole evidence Philip Seymour Hoffman Actor, born 7/23/1967; died 2/2/2014 http://i.guim.co.uk/static/w-620/h--/q-95/sys-images/Guardian/Pix/pictures/2014/2/2/1391367146868/4cfcc77e-6643-4f93-8761-a46c19802f4c-620x372.jpeg Narcotic Diversion Schemes CDS pull for excessive amounts of patients Pull larger dose than patient receives Remove CDS from IV drips Vial breakage is clean. Vials are sheared without fragments. Intact CDS thrown in trash Disposal of CDS into sharps containers Fentanyl Patches removed from patient Pattern of broken vials and ampoules. Excessive “accidents”. Check rubber stoppers for punctures. Failure to recognize warning signs Attributing signs to other causes (stress, illness, etc.) Provides coworker with password Co-signing wastage not observed Making excuses for person not following narcotic handling procedures Professional and legal responsibility to report CDS abuse and diversion – Health Care Professional Responsibility and Reporting Enhancement Act – DEA Form 106 Decoy http://the-adventurers-club.typepad.com/the_adventurers_club/resident-evil/ http://www.organizeit.com/ mini-swing-top-trash-can-grey.asp http://www.bringmethenews.com/2012/09/05 11 Narcotic Diversion Schemes Decoy continued… www.mushsmush.com Substituting diluent for active injectable narcotic in IV bags IV Pump tampering Heated needle through IV bag Curved needle used to go between metal lid and rubber stopper on vials Users are created and deleted in a short period of time. Upon review, users are fictitious Employees work and make transactions during off-shifts or unscheduled times Substituting look alike legend drug tablets for active narcotic tablets (Bingo cards, blister packs) Pulverized or broken tablets. Pieces of http://www.movingbusiness.net/1330/ http://www.fotosearch.com/yellow_pillls/ punching-the-clock-an-outdated-process/ tablet or powder of capsule missing http://images.ddccdn.com/images/pills/nlm/634810623.jpg http://images.medscape.com/pi/features/drugdirectory/octupdate/MMW01230.jpg Drugs and Chemicals of Concern Decoy http://images.rapgenius.com/c49aa5f1f090653a27bb1f132db46024.259x194x1.jpg https://02d4c74.netsolstores.com/images/email/UDDR-4.png http://sr.photos3.fotosearch.com/bthumb/DGT/DGT389/42-29183923.jpg Fentanyl (Trade names: Actiq®, Duragesic®) Gamma Hydroxybutyric Acid (Street Name: GHB, Liquid Ecstasy, Liquid X, Goop, Georgia Home Boy, Easy Lay) Hydrocodone (Trade Names: Vicodin®, Lortab®) Hydromorphone (Trade Names: Dilaudid, PalladoneTM) Ketamine (Street Names: Special K, "K", Kit Kat, Cat Valium) Oxycodone (Trade Names: Tylox®, Percodan®, OxyContin®) Phencyclidine (Street Names: PCP, Angel Dust, Supergrass, Boat, Tic Tac, Zoom, Shermans) Salvia Divinorum (Street Names: Maria Pastora, Salvia) Tramadol (Trade Name: Ultram®) http://www.nationaltreatmentcenters.org/l http://ibogainetoday.com/ibogaine-treatment-for-oxycontin-addiction/ http://www.123rf.com/photo_4457127_close-up-of-colorful-tablets-and-pills.html 12 Future Diversion Trends Future Diversion Trends Expect continued pressure from the DEA against hospitals – Fines: $185 M from 2008-2012 – Hospitals, pharmacies, manufacturers and distributors – Lack of Policies and Procedures – Prescription Monitoring Programs “know your customer” initiatives Expect diversion trends to continue to change: – Was - manufacturer or distributor – Then - Pain clinics and internet pharmacies – Now - Healthcare community: MDs, nurses, or pharmacists – Future – diversion for sales users vs. dealers Buzzeo, R, Neal, M, Hospital Drug Diversion and Abuse – Creating an Effective Surveillance and Prevention Program, CEGEDIM Realtionship Mgt, 1/2013 Handling and Documentation of Expired and Wasted Narcotics An effective method of preventing drug diversion is: 1. Create joint policies with other professionals Resolve discrepancies quickly Be aware of behavioral changes of staff Visually confirm narcotic waste and destruction Recognize poor pain management control Use a lock box for expired controlled substances Utilize Public Flogging for staff members that make errors 1 through 6 Documentation and cosignature required with narcotic waste. 2. Medication Pending Destruction Report. 5. Use at least two or more pharmacists to verify, document (DEA 41), and destroy narcotics. Expect increased U.S. State and FDA review of compounding pharmacies. – NECC – Ameridose – MedPrep Q&A Locked drop box - Secure expired/wasted narcotics in the pharmacy. Expect comprehensive DEA investigations – Policy and Procedure review – File maintenance – Compliance documentation – Workflow process Buzzeo, R, Neal, M, Hospital Drug Diversion and Abuse – Creating an Effective Surveillance and Prevention Program, CEGEDIM Realtionship Mgt, 1/2013 Expect volume as a primary factor for DEA action 3. 4. 6. 7. 8. http://www.pppmag.com/article/629/November_2009/Preventing_Controlled_Substances_Diversion/ 13 Q&A An effective method of preventing drug diversion is: 1. Create joint policies with other professionals Resolve discrepancies quickly Be aware of behavioral changes of staff Visually confirm narcotic waste and destruction Recognize poor pain management control Use a lock box for expired controlled substances Utilize Public Flogging for staff members that make errors 2. 3. 4. 5. 6. 7. 8. 13:39-7.10 PRESCRIPTIONS TRANSMITTED BY FACSIMILE – original signed prescription forwarded to pharmacist except: direct administration to a patient by parenteral, intravenous, intramuscular, subcutaneous or intraspinal infusion resident of a long-term care facility hospice patient from a hospice certified by Medicare under Title XVIII or licensed by the State 1 through 6 Public flogging, although enticing, does not support a “Just Culture” SUBCHAPTER 9. PHARMACEUTICAL SERVICES FOR HEALTH CARE FACILITIES 13:39-9.10 PHARMACEUTICALS; DRUG SUPPLY; INVESTIGATIONAL DRUGS; CONTROLLED DANGEROUS SUBSTANCES The pharmacist-in-charge shall be responsible for Drug Supply as it relates to: – – – – Types used for treatment of patient population – Formulary Inventory Management – quality vs quantity Pharmacy Buyer procurement process Inventory purchase reviewed by RPIC or designated pharmacist Policy and Procedures – control, content, and security – – – – Inventory Investigationals Controlled Substances Accountability A pharmacist may fill a faxed prescription for a Schedule II controlled substance provided: 13:39-5.10 RESTRICTION ON STORAGE OF PRESCRIPTION LEGEND DRUGS AND CONTROLLED DANGEROUS SUBSTANCES Prescription legend drugs, devices and controlled dangerous substances shall be: – Stored securely without access to general public – Stored in a designated Pharmacy Area Exception: Healthcare facilities – automated dispensing cabinets or locked cabinets in patient care areas – Secured after the pharmacy is closed in a secure location with a drop-off device that is a one-way, irretrievable and secure design. – Secured on the premises with a security system 14 Theft or Loss 13:45H-2.5 PHYSICAL SECURITY CONTROLS FOR PRACTITIONERS Controlled substances listed in Schedules II, III, IV and V shall be stored in a securely locked, substantially constructed cabinet. – However, pharmacies may disperse such substances throughout the stock of noncontrolled substances in such a manner as to obstruct the theft or diversion of the controlled substances. 13:45H-3.7 SEALING OF CONTROLLED SUBSTANCES Securely affixed to the stopper, cap, lid covering or wrapper of such container a seal to disclose upon inspection any tampering or opening of the container. Theft or Loss – Significant quantity 5% rule – Patterned loss Notify* – – – – Drug Control Unit DEA Local Law Enforcement When in doubt, report it in! *Notification is based upon situation, impact, and methodology of loss or theft DDC-52 form Documentation is key! 13:45H-3.7 SEALING OF CONTROLLED SUBSTANCES Securely affixed to the stopper, cap, lid covering or wrapper of such container a seal to disclose upon inspection any tampering or opening of the container. Good practice tip: Initial and date after sealing MGS 9/8/13 http://www.novavisioninc.com/pages/prd_tamper_evident_tape.html www.tampervue.com/tipseals http://www.novavisioninc.com/pages/prd_tamper_evident_tape.html www.tampervue.com/tipseals 15 Q&A Which is not the best practice tip for storing opened stock bottles of controlled substances 1. Tamper evident tape or seal should be placed on the stock bottle before putting away The contents remaining in the bottle should be counted Narcotic quantity remaining should be documented on a narcotics log A label with the pharmacist's initials and date should be placed on top of the tamper evident seal when the dispensing activity is complete The remaining count should be placed on the initials and date label 2. 3. 4. 5. Q&A Which is not the best practice tip for storing opened stock bottles of controlled substances 1. Tamper evident tape or seal should be placed on the stock bottle before putting away The contents remaining in the bottle should be counted Narcotic quantity remaining should be documented on a narcotics log A label with the pharmacist's initials and date should be placed on top of the tamper evident seal when the dispensing activity is complete 2. 3. 4. The remaining count should be placed on the initials and date label 5. A “blind count” process should be practiced to prevent count bias and errors Q&A It is the responsibility of the Pharmacist to store narcotics in a secure, locked, substantially constructed cabinet with appropriate surveillance mechanisms to prevent and deter diversion True or False Q&A It is the responsibility of the Pharmacist to store narcotics in a secure, locked, substantially constructed cabinet with appropriate surveillance mechanisms to prevent and deter diversion Duh 16 Q&A Q&A Which scenario should be reported to the authorities? A single occurrence of 5 tablets of Percocet® are missing, you dispense 5,000 tablets per month 4 tablets of hydromorphone are found crushed inside the manufacturer’s bottle You dropped a vial of morphine 100mg/50ml An intact bottle of 100 tablets of acetaminophen and codeine #3 was found on the employee bathroom floor An Ewok came into the Pharmacy and took 7 boxes of fentanyl patches Which scenario should be reported to the authorities? 1. 1. A single occurrence of 5 tablets of Percocet® are missing, you dispense 5,000 tablets per month 4 tablets of hydromorphone are found crushed inside the manufacturer’s bottle You dropped a vial of morphine 100 mg/50 mL An intact bottle of 100 tablets of acetaminophen and codeine #3 was found on the employee bathroom floor An Ewok came into the Pharmacy and took 7 boxes of Fentanyl Patches None of the above 2. 2. 3. 4. 5. 6. 3. 4. 5. 6. None of the above If you see an Ewok you need to call a psychiatrist, not the police http://cool-toy-spot.com/star-wars-wicket-the-ewok-vinyl-figure/ Documentation of Quantity Dispensed Conclusion New Jersey Board of Pharmacy Newsletter July 2012 Accurate records of all prescription medication received and dispensed are maintained Policies are in place regarding accurate dispensing and labeling of prescriptions and that such policies are followed Pharmacist should clearly describe the situation to the patient with complete instructions regarding when to return to the pharmacy to receive the remaining quantity Pharmacist must document clear and concise description of short fill on prescription record Important and expected pharmacist responsibility Document, document, and document Interdisciplinary involvement Education and training Policy and Procedures Be proactive, progressive, and vigilant. N.J.A.C. 13:39-6.2(f)2; N.J.A.C. 13:39-6.2(f)3, Pharmacy Jurisprudence, L.L.C. and Select CE® 2013 17 Questions and discussion http://www.dreamstime.com/ http://ocw.mit.edu/courses/health-sciences-and-technology /hst-151-principles-of-pharmacology-spring-2005/index.htm 18
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