February 8-10, 2013 The Meadows Events & Conference Center Altoona, Iowa D2: Technician: Drug Shortages: An Unprecedented Na onal Impediment of Pa ent Care and Safety 1:45pm - 2:45pm ACPE UAN 107-000-13-019-L05-T Ac vity Type: Knowledge-Based 0.1 CEU/1.0 Hr Learning Objec ves for Technicians: Upon comple on of this CPE ac vity par cipants should be able to: 1. Iden fy the leading causes of drug shortages 2. Recognize the past, current, and emerging trends regarding drug shortages 3. Explain poten al consequences of drug shortages upon healthcare opera ons, pa ent care, and medica on safety 4. Describe past, current, and poten al future legisla on concerning drug shortages 5. List at least two resources which may be accessed in order to obtain current informa on regarding medica ons on na onal shortages Speaker: Andrew M. North, PharmD, MBA, received his Doctor of Pharmacy and Master of Business Administra on degrees at Drake University in Des Moines, Iowa during May of 2012. While at Drake University, North was ac ve with several pharmacy and college commi ees and organiza ons. He served as the Drake University Student Representa ve on the Iowa Pharmacy Associa on Board of Trustees from 2010 to 2011, has previously contributed to the Policy Commi ee on Professional Affairs for the Iowa Pharmacy Associa on, and currently par cipates in teleconferences for the e-prescribing Subcommi ee of Iowa e-health. He received the Karbeling Leadership Award at the Iowa Pharmacy Associa on Annual Mee ng in 2011 and the Karbeling Memorial Leadership Award at the 2012 Pharmacy Hooding Ceremony at Drake University for his professional involvement, leadership, and poli cal advocacy. North is currently a Postgraduate Year 1 (PGY-1) Pharmacy Prac ce Resident at the University of Wisconsin Hospital & Clinics in Madison, Wisconsin, and also serves as a Clinical Instructor for the University of Wisconsin-Madison School of Pharmacy. His clinical interest areas include: emergency medicine, advanced cardiac life support (ACLS), cri cal care, cardiology, medica on safety, and Health Informa on Technology. Speaker Disclosure: Andrew North reports no actual or poten al conflicts of interest in rela on to this CPE ac vity. Off-label use of medica ons will not be discussed during this presenta on.
Drug Shortages: An Unprecedented National Impediment of Patient Care & Safety Andrew M. North, PharmD, MBA PGY-1 Pharmacy Practice Resident & Clinical Instructor University of Wisconsin Hospital & Clinics Faculty Disclosure Andrew North reports he does not have actual or potential conflicts of interest associated with this presentation Andrew North has indicated that off-label use of medications will not be discussed during this presentation Learning Objectives Upon completion of this activity, pharmacy technicians should be able to: 1. Recognize past, current, and emerging trends regarding drug shortages 2. Identify leading causes of drug shortages 3. Explain potential consequences of drug shortages upon healthcare operations, patient care, and medication safety 4. Describe past, current, and potential future legislation concerning drug shortages 5. List at least two resources which may be utilized to obtain current information regarding medications on national shortage 1
Recent Drug Shortage Headlines... The Article Which Sparked It Mechlorethamine used as chemotherapy for Hodgkin s lymphoma since 1960s Drug shortage of mechlorethamine starting in 2009, so cyclophosphamide used as a replacement drug Study looked at differences between two treatments results after 1.5 years: No change in death rate, BUT Patients treated with cyclophosphamide instead of mechlorethamine were ~2x more likely to have relapse cancer episodes require further treatments which can cause complications acyclovir fosphenytoin daunorubicin leucovorin calcium doxorubicin mitomycin atorvastatin tablets ciprofloxacin tablets dextrose doxycycline tablets/capsules Sources: ASHP & FDA Current Drug Shortage Lists midazolam atropine Select Drugs Currently on National Shortage (as of January 2013) dextroamphetamine tablets diazepam heparin epinephrine mannitol fluticasone propionate & salmeterol inhalation tetracycline capsules nimodipine capsules doxazosin tablets 2
Common Drug Classes in Short Supply 70 Number of Drugs (#) 60 50 40 30 63 49 20 35 26 24 26 10 21 23 23 15 15 13 14 9 11 13 8 8 7 9 5 6 7 9 0 Nervous Antibiotics Chemotherapy Electrolytes Heart & Blood Ears, Eyes, Digestive Tract Hormone System Vessels Nose, Throat Medication Type *Data through June 30, 2012 2010 2011 2012* Source: Drug Shortages - University of Utah Perspective New National Drug Shortages Since 2001 (by year) 300 250 Number (#) 200 150 100 50 120 88 73 58 74 70 267 211 195 149 166 129 0 2001 2002 2003 2004 2005 2006 2007 2008 2009 2010 2011 2012 Year Sources: Drug Shortage Update - Current Status & Significant Trends, Survival Tactics for the Perfect Storm, & How a Drug Shortage Hiked Relapse Risks for Lymphoma Patients Active Drug Shortages, by Quarter 300 250 Number (#) 200 150 100 50 152 167 176 188 239 246 256 273 260 211 0 Q1-10 Q2-10 Q3-10 Q4-10 Q1-11 Q2-11 Q3-11 Q4-11 Q1-12 Q2-12 Quarter Source: Drug Shortages - University of Utah Perspective 3
Contributing Factors: From Materials to Patients Raw material availability (~80% used in drugs from outside of U.S.) Drug recalls Production halts Capacity limitations Business decisions Stockpiling of drugs on shortage Unexpected increases in demand/usage (ex. infection outbreaks or SHORTAGES) Gray market distributors Source: FDA Drug Supply Chain Example & ASHP Guidelines on Managing Drug Product Shortages Reasons for Drug Shortages (2011) 13% 23% 6% 55% Unknown Manufacturing Supply/Demand Discontinued Drug Source: Drug Shortage Update Current Status & Significant Trends Impact of Drug Shortages: Patient Care % % % % Alternative medication provided, but not drug of choice, led to inadequate treatment Error with alternative drug used as a substitution Omission of vital medication leading to nontreatment Error when pharmacy attempted to compound a product or drug strength no longer available Source: ISMP A Shortage of Everything Except Errors 4
http://infusionnurse.org/2011/09/28/drug-shortage-then-and-now/ Impact of Drug Shortages: Patient Care Delayed or omission of treatment/therapy Example: delayed transplants or inability to treat cancer Alternative treatments? Are they as effective & safe? Are the costs similar & will the patient s insurance cover it? Drug allocation = drug rationing; selecting which patients should receive the medication Product changes - may cause errors! Stock drug products substitutions (ex. different concentrations or versions) Medication made in a different way (ex. vial vs syringe) Source: ISMP A Shortage of Everything Except Errors Impact of Drug Shortages: UWHC Example Emergency Medication Trays (Previously) 5
Impact of Drug Shortages: UWHC Example Emergency Medication Trays (New as of 1/25/13) Nitroglycerin changed on 1/25/13 due to drug shortage! Impact of Drug Shortages: UWHC Example A Closer Look at the Nitroglycerin Change Nitroglycerin ready-to-use bottle Nitroglycerin do-it-yourself kit Potential issues with the change: 1. Pharmacists now must make; may result in errors 2. Longer time to prepare = longer time before patient receives 3. Greater chance for contamination due to manipulation 4. Where are the needles & syringes to make it? 5. Risk of sticking yourself with needle UWHC Emergency Trays Other Shortages epinephrine: now have 6 instead of previous 4 due to shortage Sodium bicarbonate: only 2 prefilled syringes (vs 4) since March 2012 nitroglycerin: may need to prepare from syringe & IV bag calcium chloride: may have vials instead of syringes atropine: may have vials instead of syringes vasopressin: may only have 2 vials instead of 4 dextrose 50%: may be replaced with dextrose 10% liter bags diazepam: may be vial or s epinephrine: extremely short 6
Impact of Drug Shortages: Cost drug costs Resort to non-preferred wholesalers The gray market companies that buy drugs on shortage & sell them for excessive markups (drugs average of 6.5x more costly) More staff required to manage drug shortages At UWHC, shortages cost ~$50,000/month more for drugs & ~$11,000/month for staff (~$732,000 per year!) Source: Buyer Beware Drug Shortages & the Gray Market Past Legislation President Obama s Executive Order (Oct. 2011) FDA Charges Advance notice of manufacturer production issues of drugs that are life supporting or life saving, or that prevent debilitating disease Expedited reviews of new drug suppliers & manufacturers Monitor for stockpiling of medications or charging of excessive prices & report findings to Department of Justice for review Obama Administration also increased resources for FDA s Drug Shortages Program Source: Executive Order 13588 Reducing Prescription Drug Shortages Past Legislation Food & Drug Administration Safety & Innovations Act (June 2012) Early notification system drug manufacturers to notify FDA of production issues or discontinuation Failure to comply = letter from FDA Source: ASHP Legislative Summary (S. 3187) & ASHP News Capsule Drug Shortages Bill Headed to White House 7
Future Legislation? Preserving Access to Life-Saving Medications Act of 2011 Requires manufacturers to notify if actual or potential discontinuation/interruption in drug manufacturing (6 months notification, if possible) Failure to comply = letter from FDA Patient Access to Drugs in Shortage Act of 2012 Medicare reimbursement for certain generic injectable drugs Costs paid by manufacturers to government Sources: H.R. 2245 & H.R. 6611 How Can You Assist with Drug Shortages? 1. 2. 3. 4. 5. Pharmacy Technician Role in Drug Shortages Follow Shortages Drug Preparation Communication Inventory Management Purchasing 8
Pharmacy Technician Role in Drug Shortages Follow Shortages Drug Preparation Communication Inventory Management Purchasing Drug Shortage Lists - FDA www.fda.gov Drugs tab Drug safety & availability Drug Shortages Current Drug Shortages Index Drug Shortage Lists - ASHP https://www.ashp.org/shortages 9
There is an app for that! - RxShortages (As long as you are not a Windows Phone user) ipad/iphone Android Organization Drug Shortage Communications Organization Drug Shortage Communications 10
Pharmacy Technician Role in Drug Shortages Follow Shortages Drug Preparation Communication Inventory Management Purchasing Pharmacy Technician Role in Drug Shortages Follow Shortages Drug Preparation Communication Inventory Management Purchasing Pharmacy Technician Role in Drug Shortages Follow Shortages Drug Preparation Communication Inventory Management Purchasing 11
Pharmacy Technician Role in Drug Shortages Follow Shortages Drug Preparation Communication Inventory Management Purchasing Conclusions Drug shortages affecting all aspects of healthcare system Increasing trend of active drug shortages demonstrated over time No single answer for drug shortage causes many different entities/reasons Shortages negatively impact patient care, change workflow, & increase healthcare costs FDA early notification system lack of penalties at present time; no impactful legislation under consideration Pharmacy technicians have a role in managing drug shortages References 1. Neporent L. Cancer drug shortage leads to less-effective substitute drugs, study finds. ABC News. 2012. Available at: http://abcnews.go.com/health/cancer-drug-shortage-harm-kidsstudy-finds/story?id=18069448#.un8xn-tafto. 2. Study ties drug shortage to poorer cancer survival. Fox News. 2012. Available at: http://www.foxnews.com/health/2012/12/27/study-ties-drug-shortage-to-poorer-cancer-survival/. 3. Metzger ML, Billett A, Link MP. The impact of drug shortages on children with cancer the example of mechlorethamine. NEJM. 2012;367:2461-2463. 4. Current Drug Shortages Index. US Food and Drug Administration. Available at: http://www.fda.gov/drugs/drugsafety/drugshortages/ucm050792.htm. 5. Drug Shortages. American Society of Health-System Pharmacists. Available at: http://www.ashp.org/menu/drugshortages. 6. Fox ER. Drug Shortages: University of Utah Perspective. 2012. Available at: http://www.nasemso.org/meetings/annual/presentations2012/documents/drugshortages-fox.pdf. Accessed January 26, 2013. 7. Fox ER. Drug Shortage Update: Current Status & Significant Trends. 2011. Available at: http://www.fda.gov/downloads/drugs/newsevents/ucm274565.pdf. Accessed January 26, 2013. 8. Fox S. Drug Shortages: Survival Tactics for the Perfect Storm. Medscape Pharmacists News. 2012. Available at: http://www.medscape.com/viewarticle/776480. Accessed January 26, 2013. 9. Stein R. How a Drug Shortage Hiked Relapse Risks for Lymphoma Patients. 2012. Available at: http://www.npr.org/blogs/health/2012/12/26/168038307/how-a-drug-shortage-hikedrelapse-risks-for-lymphoma-patients. 10. Graphic A Drug Supply Chain Example: From Supplier to Patient. US Food and Drug Administration. 2011. Available at: http://www.fda.gov/drugs/drugsafety/drugshortages/ucm277626.htm. 11. Fox ER, Birt, A, James KB, et al. ASHP Guidelines on Managing Drug Product Shortages in Hospitals and Health Systems. Am J Health-Syst Pharm. 2009;66:1366-1406. 12. A Shortage of Everything Except Errors: Harm Associated with Drug Shortages. ISMP. 2012. Available at: http://www.ismp.org/newsletters/acutecare/showarticle.asp?id=20. Accessed January 26, 2013. 13. Cherici C, McGinnis P, Russell W. Buyer Beware: drug shortages and the gray market. Premier. 2011. Available at: https://www.premierinc.com/about/news/11-aug/gray-market/gray- Market-Analysis-08152011.pdf. 14. Executive Order 13588 Reducing Prescription Drug Shortages. 2011. Available at: http://www.whitehouse.gov/the-press-office/2011/10/31/executive-order-reducing-prescriptiondrug-shortages. 15. Legislative Summary: Drug Shortages Provisions within the Food and Drug Administration Safety & Innovation Act (S. 3187). ASHP. 2012. Available at: http://www.ashp.org/doclibrary/advocacy/gad/reauthorization-of-pdufa.aspx. 16. News Capsule: Drug Shortages Bill Headed to White House. ASHP. 2012. Available at: http://www.ashp.org/menu/news/newscapsules/ Article.aspx?id=442. Accessed: January 26, 2013. 17. H.R. 2245 Preserving Access to Life-Saving Medications Act of 2011. Open Congress. Available at: http://www.opencongress.org/bill/112-h2245/show. 18. H.R. 6611 (112 th ): Patient Access to Drugs in Shortage Act of 2012. GovTrack. Available at: http://www.govtrack.us/congress/bills/112/hr6611/text. 19. Lamb M. New Threat to 340B Pharmacy Benefits Program. Association of Clinicians for the Underserved. Available at: http://clinicians.org/new-threat-to-340b-pharmacy-benefitsprogram. 12
Drug Shortages: An Unprecedented National Impediment of Patient Care & Safety Andrew M. North, PharmD, MBA PGY-1 Pharmacy Practice Resident & Clinical Instructor University of Wisconsin Hospital & Clinics Email: anorth@uwhealth.org Questions or Comments? 13
Drug Shortages: An Unprecedented National Impediment of Patient Care & Safety Andrew M. North, PharmD, MBA PGY-1 Pharmacy Practice Resident & Clinical Instructor University of Wisconsin Hospital & Clinics References 1. Neporent L. Cancer drug shortage leads to less-effective substitute drugs, study finds. ABC News. 2012. Available at: http://abcnews.go.com/health/cancer-drugshortage-harm-kids-study-finds/story?id=18069448#.un8xn-tafto. Accessed January 26, 2013. 2. Study ties drug shortage to poorer cancer survival. Fox News. 2012. Available at: http://www.foxnews.com/health/2012/12/27/study-ties-drug-shortage-to-poorercancer-survival/. 3. Metzger ML, Billett A, Link MP. The impact of drug shortages on children with cancer the example of mechlorethamine. NEJM. 2012;367:2461-2463. 4. Current Drug Shortages Index. US Food and Drug Administration. Available at: http://www.fda.gov/drugs/drugsafety/drugshortages/ucm050792.htm. 5. Drug Shortages. American Society of Health-System Pharmacists. Available at: http://www.ashp.org/menu/drugshortages. 6. Fox ER. Drug Shortages: University of Utah Perspective. 2012. Available at: http://www.nasemso.org/meetings/annual/presentations2012/documents/drugs hortages-fox.pdf. 7. Fox ER. Drug Shortage Update: Current Status & Significant Trends. 2011. Available at: http://www.fda.gov/downloads/drugs/newsevents/ucm274565.pdf. 8. Fox S. Drug Shortages: Survival Tactics for the Perfect Storm. Medscape Pharmacists News. 2012. Available at: http://www.medscape.com/viewarticle/ 776480. 9. Stein R. How a Drug Shortage Hiked Relapse Risks for Lymphoma Patients. 2012. Available at: http://www.npr.org/blogs/health/2012/12/26/168038307/how-adrug-shortage-hiked-relapse-risks-for-lymphoma-patients. Accessed January 26, 2013. 10. Graphic A Drug Supply Chain Example: From Supplier to Patient. US Food and Drug Administration. 2011. Available at: http://www.fda.gov/drugs/drugsafety/drugshortages/ucm277626.htm. Accessed January 26, 2013.
11. Fox ER, Birt, A, James KB, et al. ASHP Guidelines on Managing Drug Product Shortages in Hospitals and Health Systems. Am J Health-Syst Pharm. 2009;66:1366-1406. 12. A Shortage of Everything Except Errors: Harm Associated with Drug Shortages. ISMP. 2012. Available at: http://www.ismp.org/newsletters/acutecare/ showarticle.asp?id=20. 13. Cherici C, McGinnis P, Russell W. Buyer Beware: drug shortages and the gray market. Premier. 2011. Available at: https://www.premierinc.com/about/news/ 11-aug/Gray-Market/Gray-Market-Analysis-08152011.pdf. Accessed January 26, 2013. 14. Executive Order 13588 Reducing Prescription Drug Shortages. 2011. Available at: http://www.whitehouse.gov/the-press-office/2011/10/31/executive-orderreducing-prescription-drug-shortages. 15. Legislative Summary: Drug Shortages Provisions within the Food and Drug Administration Safety & Innovation Act (S. 3187). ASHP. 2012. Available at: http://www.ashp.org/doclibrary/advocacy/gad/reauthorization-of-pdufa.aspx. 16. News Capsule: Drug Shortages Bill Headed to White House. ASHP. 2012. Available at: http://www.ashp.org/menu/news/newscapsules/ Article.aspx?id=442. Accessed: January 26, 2013. 17. H.R. 2245 Preserving Access to Life-Saving Medications Act of 2011. Open Congress. Available at: http://www.opencongress.org/bill/112-h2245/show. 18. H.R. 6611 (112 th ): Patient Access to Drugs in Shortage Act of 2012. GovTrack. Available at: http://www.govtrack.us/congress/bills/112/hr6611/text. Accessed January 26, 2013. 19. Lamb M. New Threat to 340B Pharmacy Benefits Program. Association of Clinicians for the Underserved. Available at: http://clinicians.org/new-threat-to- 340b-pharmacy-benefits-program.
2013 IPA s Educational Expo February 8 10, 2013 Drug Shortages: An Unprecedented National Impediment of Patient Care & Safety Andrew M. North, PharmD, MBA Post Assessment Questions 1. What are two organizational websites which may serve as a resource for current and resolved drug shortages? A. American Pharmacists Association (APhA) & FDA B. American Pharmacists Association (APhA) & Centers for Disease Control and Prevention (CDC) C. American Society of Health System Pharmacists (ASHP) & FDA D. American Society of Health System Pharmacists (ASHP) & Centers for Disease Control and Prevention (CDC) 2. How did the number of new drug shortages in the year 2012 compare to that of 2011? A. Fewer in 2012 than 2011 B. Same (approximately) in 2011 & 2012 C. More in 2012 than 2011 3. Which of the following best describes President Obama s Executive Order as a means for reducing prescription drug shortages? A. Requires 6 months advance notice of manufacturers prior to discontinuation or interruption in supply B. Mandates drug manufacturers to notify FDA in advance of production issues or discontinuation of medications C. Suggested that the FDA should use its capabilities to ensure that drug manufacturers report production issues or discontinuation of medications in advance 4. Of the following list, which was found to be most likely to cause a drug shortage in 2011? A. Discontinued medications B. Manufacturing C. Patients D. Supply & Demand 5. How have drug shortages impacted patient care and health care costs? A. Decreased quality & decreased costs B. Decreased quality & increased costs C. No change in quality & decreased costs D. No change in either quality or costs