understanding and minimizing the impact of current drug … · 2017-11-30 · understanding and...
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© U N I V E R S I T Y O F U T A H H E A L T H , 2 0 1 7
Understanding and Minimizing the Impact of Current Drug Shortages
Erin R. Fox, PharmD, BCPS, FASHP
@ f o x e r i n r
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DISCLOSURE
• This presentation represents my own opinions.
• University of Utah Drug Information Service receives some funding from Vizient™ to provide drug shortage content.
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LEARNING OBJECTIVES• Explain current trends in drug shortages and the
most recent data on causes of drug shortages.• Describe how recent manufacturing and drug
quality trends relate to drug shortages. • Evaluate progress towards drug shortage
solutions.• Identify best practices for minimizing the impact
of drug shortages.
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NATIONAL SHORTAGES AND UNIVERSITY OF UTAH DRUG INFORMATION SERVICE• UUDIS provides drug shortage content to
ASHP and Vizient™• Public website at www.ashp.org/shortages
– Partners since 2001– Receive voluntary reports submitted via web– Collaboration is key to success– Frequent communication with FDA drug
shortage team
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DIFFERENCES BETWEEN WEBSITES
ASHP• www.ashp.org/shortage• Drugs impacting clinical
practice (biologics, devices, dosage forms)
• How to access• Frequent updates• Alternatives, safety
FDA• www.fda.gov/cder• Fewer products• No biologics or
devices• Information from
manufacturer
https://www.ashp.org/Drug-Shortages/Current-Shortages/FDA-and-ASHP-Drug-Shortages
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© U N I V E R S I T Y O F U T A H H E A L T H , 2 0 1 7
CURRENT TRENDS
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© U N I V E R S I T Y O F U T A H H E A L T H , 2 0 1 7
NATIONAL DRUG SHORTAGES BY YEARJAN 1, 2001 TO JUNE 30, 2017
120
88
73
58
74 70
129
149
166
211
267
204
140
185
142154
77
0
50
100
150
200
250
300
01 02 03 04 05 06 07 08 09 10 11 12 13 14 15 16 17
@ f o x e r i n r
Erin R. Fox, University of Utah Drug Information Service
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© U N I V E R S I T Y O F U T A H H E A L T H , 2 0 1 7
ACTIVE AND ONGOING SHORTAGES – 5 YEAR TREND
0
50
100
150
200
250
300
350
Q2-12 Q3-12 Q4-12 Q1-13 Q2-13 Q3-13 Q4-13 Q1-14 Q2-14 Q3-14 Q4-14 Q1-15 Q2-15 Q3-15 Q4-15 Q1-16 Q2-16 Q3-16 Q4-16 Q1-17 Q2-17
@ f o x e r i n r
Erin R. Fox, University of Utah Drug Information Service
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ACTIVE SHORTAGES TOP 5 DRUG CLASSES
26
15
12
19 20
0
5
10
15
20
25
30
Antimicrobials Chemotherapy Cardiovascular CNS E-Lytes, Nutrition
University of Utah Drug Information [email protected], @foxerinr
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REASONS FOR SHORTAGES AS DETERMINED BY UUDIS DURING INVESTIGATION
52%
29%
15%
1%3%
2016
Unknown 52%
Manufacturing 29%
Supply/demand 15%
Regulatory 1%
Discontinued 6%
University of Utah Drug Information [email protected], @foxerinr
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WHAT DO THESE NUMBERS MEAN?• The rate of new shortages has decreased• Long-term active and ongoing shortages are not
resolving• Shortages of basics like sodium bicarbonate,
emergency syringes, antibiotics, electrolytes, and cardiovascular agents still impact large numbers of clinicians and patients
http://www.gao.gov/products/GAO-16-595
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WHY IS THIS HAPPENING?
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WHAT ARE KEY CAUSES OF DRUG SHORTAGES?
a.Raw material issuesb.Counterfeit productsc. US manufacturing moving overseasd.None of the above
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SHORTAGE REASONS –MYTHS VS. REALITY CHECK
• Europe, Canada, US• Rare cause• Issues at US facilities• No product to import• Rare cause, global problem• Complex problem
• US problem only• Raw materials• Foreign manufacturing• Imports are the fix• Counterfeits cause shortages
in US• One single reason for
shortages
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JUNE 2016 GAO ANALYSIS• GAO reviewed UUDIS, FDA data• Factors associated with shortages – 2012 to
2015– Fewer suppliers with at least 1 with a warning
letter for not following CGMP– Generic products – lower profit margins– http://www.gao.gov/products/GAO-16-595
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ARE SHORTAGES FDA’S FAULT?
a.Trueb.False
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ARE SHORTAGES FDA’S FAULT?NO
• FDA shortage team is extremely collaborative
• Violations must be extreme for a shut-down (safety first!)
• Work diligently to prevent shortages
YES • Enforcement actions can
cause shortages• Manufacturers may have
trouble complying with regulations
• Regulatory discretion = unintended consequences?
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FDA’S STRATEGY
• Prioritize medically necessary agents (determined on a case by case basis)
• Evaluate risks and benefits for patients• Offer assistance and advise, but up to
the manufacturer to fix• Success hinges on early notification
A Review of FDA's Approach to Medical Product Shortages. October 31, 2011.
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HOW DOES FDA PREVENT SHORTAGES?
• Regulatory discretion– Require filters, double checks
• Ask others to increase production• Expedite reviews (new product, longer
expiration, new raw material, new manufacturing sites)
• Imports
A Review of FDA's Approach to Medical Product Shortages. October 31, 2011.
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IMPORTS
• Multiple examples since 2010– propofol, foscarnet, ethiodol, thiotepa, norepinephrine,
capecitabine, leucovorin, levoleucovorin, methotrexate, doxorubicin liposomal, phentolamine, sodium bicarbonate, nitroglycerin, saline, bleomycin
• Limited by quantity available to share with US market– May be difficult to access or use– May not be an option for some clinical trials
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FDA STRATEGIC PLAN
• Mandated as part of FDASIA law • 2 key goals
– Enhance mitigation efforts– Develop long-term prevention
• Suggestions for external stakeholders– Manufacturing incentives– Use quality data when purchasing– Capacity, redundancy
http://www.fda.gov/downloads/Drugs/DrugSafety/DrugShortages/UCM372566.pdf
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© U N I V E R S I T Y O F U T A H H E A L T H , 2 0 1 7
HOW DID WE GET HERE?
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CASCADE OF EVENTS
2008
2009
2010+
Early 2000’s“Find productionefficiencies”
Heparin
Dr. Hamburg FDA increases scrutiny
Warning letters, 483’s document serious quality problems
Irvine plant closes
Ohio plant closesNew York plant closes30% manufacturing capacity is closed
http://oversight.house.gov/wp-content/uploads/2012/06/6-15-2012-Report-FDAs-Contribution-to-the-Drug-Shortage-Crisis.pdf
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FORM 483 AND WARNING LETTERS
• 483 - documents inspection findings• Warning letters – significant issues • Worth reading – even with redactions
– Metal particles, mold, contamination– Insects, animals– Urine– Manipulating data, mixing good with failed API
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FRAGILE SUPPLY CHAINGENERIC INJECTABLES• Few suppliers
• 3 manufacturers supply 71% of market• Only 1 or 2 manufacturers for > 1/3 products
• Capacity is limited– Concentrated, “just in time” production – Multiple products made on single line – No back up manufacturing lines
Clin Pharmacol Ther. 2013;93:170–176Mayo Clinic Proc.2014.89(3):361-373
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DRUG MANUFACTURING IS A BUSINESS
• Profitability• Manufacturing fixes• Capacity – most factories running 24/7• Prioritization (new opportunities)• Forecasting (contracts)• Aging facilities
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NO QUICK AND EASY FIX
• Complex manufacturing process– Quality problems are difficult to fix– Investigation of root cause takes time– Changes take time – Capacity or redundancy not available
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ECONOMIC DRIVERS OF DRUG SHORTAGES
Quality
Not Transparent
No Incentive
Clin Pharmacol Ther. 2013;93:170–176Mayo Clinic Proc.2014.89(3):361-373
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WHAT DOES QUALITY MEAN?
• Difficult to observe • Microbial contamination difficult to detect
(non-uniform, patients already sick)• Purchasers rely on FDA to ensure quality• FDA inspects, but relies on manufacturer to
self-report between inspections• Does quality = availability?
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NO REQUIREMENT TO REPORT MANUFACTURER OF PRODUCT
• Contract manufacturing means we don’t always know who makes the product
• No requirement to disclose manufacturer (or location) in product label (or 483)
• Your brand product may be manufactured by a generic company
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ISN’T THIS A FREE MARKET ISSUE?
• Supply and demand doesn’t work -choice, market entry not easy
• How to purchase for quality?• Shortages generally don’t impact profits• Patients and clinicians impacted, not
suppliers
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© U N I V E R S I T Y O F U T A H H E A L T H , 2 0 1 7
FIXING THE SHORTAGE PROBLEM
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INDUSTRY BASED EFFORTS
• Accelerated Recovery Initiative (2011) – GPhA developed plan– Partnership between IMS and generic
manufacturers– No case studies yet – capacity
Karlin S. Generic Rx Shortage Initiative Stuck: Too Few Manufacturers to Pick Up Slack. The Pink Sheet. July 8 2013: #00130708013.
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INTERNATIONAL SOCIETY FOR PHARMACEUTICAL ENGINEERING
• Survey -2013– Key deficits in quality systems, aseptic
processing equipment• Shortage initiative
– Root causes of manufacturing problems• Prevention Plan (October 2014)
– 6 dimension plan• Quality Metrics
International Society for Pharmaceutical Engineering (ISPE). http://www.ispe.org/drugshortages. 2013.
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QUALITY METRICS GOALS
• Modernize drug quality oversight• Risk based inspection scheduling, predictive
of drug shortages• Objective criteria including:
– Lot acceptance rate– Product quality complaint rate
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NEW IDEAS FOR MANUFACTURING
• Janet Woodcock advocates continuous manufacturing for:– Faster, improved quality, lower prices, fewer
shortages– Domestic plants – fully integrated from API to
finished product
Cox B. FDA Talks Up Continuous Manufacturing, Offers Assistance. The Gold Sheet. July 29 2014: # 08140724006.
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CONTINUOUS MANUFACTURING
• Traditional manufacturing = batch process– At every step, product is assessed
and collected– Off-line labs test finished product– Days to weeks processing time
• Continuous manufacturing = monitoring throughout– Minutes to hours processing time
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© U N I V E R S I T Y O F U T A H H E A L T H , 2 0 1 7
BEST PRACTICES TO MINIMIZE IMPACT
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DISASTER PLANNING FRAMEWORK
• Mitigation• Preparedness• Response• Recovery
NEJM , March 19, 2014
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MANAGING MEDICATION SHORTAGES
• No single emergency – daily emergencies
• Pharmacists and other clinicians successfully manage shortages every day
• Best practice = Have a Plan• Best practice = Make a Team
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TEAM CHECKLIST – WHO WILL…
Gather data, monitor the shortage?Make purchasing decisions? Make storage, preparation, and
dispensing change decisions?Make rationing decisions?Change technology?Communicate information?
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SHORTAGE MANAGEMENT TEAM COMMUNICATIONS• Make sure each member understands their
role and shares back information• Situations can change quickly• Efficient management relies on good team
communication• Timeliness is essential
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COMPLEX PROBLEM SOLVING
Patient Impact
ClinicalImpact
Operations Impact
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MANAGEMENT STRATEGY
• Customize – what type of shortage?– Some drug available
• Ration vs. use until gone – No drug available, use alternatives– No drug available, no alternatives
• Postpone therapy vs. no therapy Must customize for acuity / impact
– (IV fluids vs. chemotherapy vs. vaccine)
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MOST COMMON SITUATIONWE CAN GET SOME BUT…
• It’s a different strength• It’s in different packaging • It’s a different size• It’s from a different manufacturer• It’s imported• It’s not enough!
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WHICH SITUATION COULD LEAD TO THE GREATEST HARM?
a.Same drug – different strengthb.Same drug – different packagingc.Imported drug d.No drug available
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ANSWER• It depends….• Different strength most
concerning according to failure modes and effects analysis
– SALA errors possible with different packaging, manufacturers
– Imported product (lack of bar code, NDC, packaging differences)
– Range of patient impactHospital Pharmacy. 2011;46(12):943-951
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RATIONING AND ETHICS
• Don’t ration alone• Example tools available by drug class• Chemotherapy
J Oncol Pract. 2013 Mar;9(2):e21-3Arch Intern Med. 2012 Oct 22;172(19):1494-9.Oncologist. 2014;19(2):186-92.
• AntimicrobialsInfect Control Hosp Epidemiol. 2012 Jul;33(7):745-52
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MESSAGING
• Balance timeliness and completeness.• Initial plan and ongoing status updates:
– Will product look different – pictures!– Alternative agents - include dose, drug
interactions, safety issues. – Conservation strategy – which patients are eligible?– Decision making process transparency.
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SELF ASSESSMENT QUESTIONS
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THE TREND IN DRUG SHORTAGES FOR 2016 IS ONE OF:a.Decreasing new shortages and increasing
active shortagesb. Increasing new shortages but decreasing
active shortagesc. Slight increase in new shortages and
decreasing active shortagesd.Decreasing new shortages and a gradual
decrease in active shortages
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THE REASON FOR MOST SHORTAGES IS:
a.Raw material shortagesb.Natural disastersc. Manufacturing or quality problemsd.Corporate decisions
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PACKAGE INSERTS MUST INCLUDE:
a.Name of the company that manufactured the drug
b.Location of the factoryc. Country of origin for the active
pharmaceutical ingredient (API)d.None of the above
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FDA CAN PREVENT SOME SHORTAGES BY:
a.Prioritizing approvals of new productsb.Forcing companies to increase productionc. Forcing companies to continue to produce
a drugd.Decreasing drug prices
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DETERMINING POTENTIAL CLINICAL IMPACT OF A SHORTAGE INCLUDES:a.Whether an alternative is availableb. Identifying which patients will be most
impactedc. Determining if the product is life-saving or
curatived.All of the above
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FINAL THOUGHTS
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IT MAY GET WORSE BEFORE IT GETS BETTER….
• FDA increasing inspectors in India, China
• Factories with past problems sold – will $$ be spent to truly fix?
• Focus on biosimilars• Who will make the basics that we
need?
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BUT THERE IS SOME HOPE
• Trend of decreasing new shortages is real• Action is moving towards prevention,
early identification of manufacturing issues
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CONTACT
Erin R. Fox, PharmD, BCPS, FASHPSenior Director, Drug Information ServiceUniversity of Utah [email protected]: @foxerinr
@ f o x e r i n r