Post on 03-Feb-2022
4/23/2012
1
The Drug Shortage Crisis
Jay M. Mirtallo, MS, RPh, BCNSP, FASHP
Director, MS in Health System Pharmacy
Associate Professor of Clinical Pharmacy
The Ohio State University, College of Pharmacy
President, American Society for Parenteral and Enteral Nutrition
Objectives:
Discuss drug shortages and the reasons
(causes) for their occurrence
Describe the impact of product shortages on
the quality and safety of patient care
List five actions clinicians should take in
response to the PN product shortages
Financial Impact of Drug Shortages
$216 million – Labor costs associated with
managing drug shortages in the U.S.
$200 million – Cost to purchase more
expensive generic or therapeutic
substitutes
Kaakeh R, et al. Am J Health-Syst Pharm. 2011;68:e13-21 Cherici C, et al. Navigating Drug Shortages in American Healthcare: A Premier healthcare alliance analysis. March 2011.
U.S. Drug Shortages
61 56
90
110
157
178
3123
40 38
72
132
0
50
100
150
200
2005 2006 2007 2008 2009 2010
All Medications
Injectables
FDA Center for Drug Evaluation and Research Trends. Courtesy CAPT. Valerie Jensen, Center for Drug Evaluation and Research (Feb 2011)
Parenteral Nutrition (PN) Shortages
Since Spring 2010
Amino Acids*
Ascorbic acid
Calcium chloride
Calcium gluconate
Copper
Cyanocobalamin
IV fat emulsion
L-cysteine
Multivitamins
Potassium acetate
Potassium phosphate
Selenium
Sodium acetate
Sodium chloride
Sodium phosphate
Trace elements
Vitamin A
Zinc
*Resolved
ASHP Drug Shortages, accessed August 31, 2010
4/23/2012
2
Pharmaceutical Supply Chain Reasons for Sterile Injectable Shortages
4%2%3% 5%
54%
11%
21%
Product quality issues
Discontinuations
Delays/capacity
Raw material
Loss of manufacturing site
Componentproblems/shortages
Increase demand due toanother shortage
Adapted from Jensen, FDA CDER. ISMP 2011
Effect of Drug Shortages on
Patient Safety Institute for Safe Medication Practices
Drug Shortages National Survey 2010
• 1800 responses
• 1000 errors and adverse patient
outcomes due to shortages
Premier Drug Shortage Survey 2010
• 311 pharmacy experts
• Hospitals and other healthcare sites
• 89% experienced shortages that
may have caused a medication
safety issue or error in patient care
31%44%
25%
Near Misses Reached Patient
Patient Harm
ISMP. Drug shortages: National survey reveals high level of frustration, low level of safety. ISMP Medication Safety Alert! September 23, 2010;15(19):1-5. Cherici C, et al. Navigating Drug Shortages in American Healthcare: A Premier healthcare alliance analysis. March 2011. http://www.premierinc.com/about/news/11-mar/drug-shortage-white-paper-3-28-11.pdf
A.S.P.E.N. PN Product Shortages Survey
June-July 2011 P
erce
nt o
f R
espo
nden
ts
Reasons for PN Product Shortages
PN Product Reason for Shortage
Fat Emulsion Manufacturing or
production line issues
Amino Acids Consolidation of industry
Raw material supply
Electrolytes/minerals Manufacturing or
production line issues
Consolidation of industry
Raw material supply
Business decisions to
withdraw from market
Reasons for PN Product Shortages
PN Product Reason for Shortage
Multivitamins Raw material supply
Consolidation of industry
Trace elements Manufacturing or
production line issues
Consolidation of industry
4/23/2012
3
The Wall Street Journal, December 8, 2011
http://online.wsj.com/article/
SB10001424052970204844504577098870278510832.html
Hospitals Cut Doses Amid
Drug Shortages
The Wall Street Journal, December 8, 2011
http://online.wsj.com/article/
SB10001424052970204844504577098870278510832.htm
Hospitals are grappling with a
shortage of nutrition drugs and
disinfectant products that has led
doctors to cut doses and ration
supplies, prompting patients at a
handful of facilities to get sick.
The New York Times, March 30, 2011
http://www.nytimes.com/2011/03/31/us/31intravenous.html
Deaths of 9 Alabama Patients
Tied to Intravenous Supplement
Effect on Safety of Parenteral Nutrition
Less desirable or familiar product
Confusion in prescribing process due to
substitution
Patches in work flow circumvent safety
checks
Effect on Safety of Parenteral Nutrition
‘Rules’ for constraining inadequate supply
Priority patients
Lower than normal doses
Suboptimal therapy
Predisposition to nutrient deficiencies
Increase monitoring
Starvation
Drug Shortages – the Patient Perspective
‘Imagine knowing your child needs vitamins
– VITAMINS -
and there is none available to give him
knowing this will cause a decline in his health
and well being and you have to, in essence,
watch your child ‘starve’ because in this Great
country there are drug shortages!!’
4/23/2012
4
Parenteral Nutrition: A System of Care
Assess PN Indication
Ordering PN Standardized order form
Standard PN
PN Order Review
Verification Complete, balanced
Dosing
Stability, compatibility
PN Compounding/
Preparation Sterile preparation
Safety checks/testing
Dispensing PN Labeling
Delivery Storage
PN Administration Order verification: label vs order
Access Infusion
Infection control
Monitoring Mechanical: access
Metabolic
Outcome
Documentation Medical record
Transitional care
Prescriber Pharmacist
Nurse, Patient caregiver
Dietitian, NSS
Health system medication safety system: error reporting
Interdisciplinary care
Effect of PN Product Shortages on
Patient Safety
Procurement
No warning of shortages
Increased labor and time searching market for sources of products; various vendors
Increased drug expenditures; exceed budget
Purchase less desirable/unfamiliar products
Effect of PN Product Shortages on
Patient Safety
Procurement
Purchasing outside normal channels (gray or black market, compounding facility)
Hoarding/stockpiling
Stress on staff to find and purchase alternative products
Effect of PN Product Shortages on
Patient Safety
Management Increased time and labor to develop and revise
policies & procedures for alternative products,
rationing measures, prescribing systems
Difficult to keep all staff up-to-date on shortages,
alternative products, changes in preparation,
dispensing, etc.
Strained relationships with providers, other health
care staff, patients, families, etc.
Time spent managing shortages vs. clinical care
Effect of PN Product Shortages on
Patient Safety
Prescribing
Increased prescribing errors
Prescribe suboptimal therapy due to
shortages or rationing
Elect not to prescribe PN as unable to
prevent/treat complications
Effect of PN Product Shortages on
Patient Safety
Prescribing
Unable to keep up with shortages, alternative
products, rationing, restrictions, etc.
Prescribing process constantly changing
based on product availability, alternative
products, rationing, etc.
Work arounds that may circumvent safety
checks
4/23/2012
5
Effect of PN Product Shortages on
Patient Safety
Order Review Difficulty keeping up-to-date on shortages, alternative
products, etc.
Work arounds may circumvent safety checks
Increase number of prescribing errors
Increase number of phone calls to correct or clarify
orders
Strained relationships with providers and health care
colleagues
Effect of PN Product Shortages on
Patient Safety
Compounding & Dispensing
Difficult/stressful trying to keep up-to-
date on shortages, alternative products,
rationing, etc.
Work arounds that circumvent safety
checks
Using unfamiliar products
Effect of PN Product Shortages on
Patient Safety
Compounding & Dispensing
Using products similar in appearance
Increased manipulation of products
Transfer of product from original
container
Pooling of small volumes into larger
source containers
Effect of PN Product Shortages on
Patient Safety
Compounding & Dispensing
Prepare PN’s without data to support stability, compatibility (Ca chloride, Mg chloride)
Frequent changes in automated compounding device (ACD) configuration
Increase manual additives when alternative products cannot be configured for ACD
Effect of PN Product Shortages on
Patient Safety
Compounding & Dispensing
Preparation of sterile injectables from source powders
PN orders and bag labels may not match due to frequent changes in order process, alternative products, rationing, etc.
Effect of PN Product Shortages on
Patient Safety
Administration Difficult/stressful trying to keep up-to-date on
shortages, alternative products, rationing, etc.
PN orders and bag labels may not match due to frequent changes in order process, alternative products, rationing, etc.
Necessary to administer additional IV supplements (e.g. Ca chloride)
Increased infection risk when accessing intravascular access multiple times to administer supplements
4/23/2012
6
Effect of PN Product Shortages on
Patient Safety
Monitoring Increased costs for additional labs to
monitor for deficiencies or complications Increased time to monitor and review lab
results and revise patient care plans
Effect of PN Product Shortages on
Patient Safety
Patient Outcomes
Deficiencies due to vitamin shortages
Thiamin-lactic acidosis
Vitamin A-night blindness
Multiple deficiencies when stopped oral vitamins
Contaminated PN resulting in deaths-amino acids shortage
Hypophosphatemia due to giving less/none
Effect of PN Product Shortages on
Patient Safety
Patient Outcomes
Unable to provide neonates with adequate calcium and phosphorus for bone accretion due to lack of L-cysteine used to enhance solubility
Hyperkalemia from administering oral Na/K phosphate products to patients who needed P but not K
Hyperglycemia when increasing dextrose intake to meet energy needs when IV fat emulsion not available
Effect of PN Product Shortages on
Patient Safety
Patient Outcomes Hyperchloremic metabolic acidosis due to lack of acetate
salts
Hyponatremia due to lack of sodium products
Increased incidence of refeeding syndrome
Electrolyte abnormalities after changing to amino acid
product containing electrolytes or different electrolyte
profile during amino acids shortage
Effect of PN Product Shortages on
Patient Safety
Patient Outcomes Fluid overload due to preparing PN’s with less
concentrated amino acids and IV fat emulsion
Diarrhea when administering oral electrolyte supplements
Increased catheter-related blood stream infections when ethanol locks unavailable
Increased infection risk when accessing intravascular access to administer supplements
Effect of PN Product Shortages on
Patient Safety
Patient Outcomes Increased hospitalizations for electrolyte
abnormalities or catheter-related infections
Unable to transfer patients from acute care hospitals to SNF’s or LTACH’s due to increased cost of PN’s
Patients transferred to another hospital for PN therapy
4/23/2012
7
Managing Parenteral Nutrition
Product Shortages Shortages Information Resources
FDA Center for Drug Evaluation and Research (CDER) Drug Shortage Program (DSP) http://www.fda.gov/Drugs/DrugSafety/DrugShortages/default.htm
Potential or actual shortages
Medically necessary products
ASHP Drug Shortages web site http://www.ashp.org/DrugShortages/Current/
All medication shortages
A.S.P.E.N. Documents Library http://www.nutritioncare.org
Considerations for Managing PN Product Shortages
Manufacturer’s web site
Managing PN Product Shortages
Recommendations for shortages
Multivitamins – adult and pediatric
IV fat emulsions
Amino acids
Electrolytes/minerals
Trace elements – adult and pediatric
L-cysteine
A.S.P.E.N. web site www.nutritioncare.org
Search specific product shortage
Professional Resources>A.S.P.E.N. Documents
Library
Drug Shortage Legislation
Drug Shortage Prevention Act
Intra-agency communication at FDA
Communication between FDA, distributors,
providers and patients
Definitions
Critical drug
Critical drug shortage
National Critical Drug List
National Critical Drug Shortage List
A.S.P.E.N. Collaboration
A.S.P.E.N. Staff
And Volunteers
Food and Drug
Administration
American Society of Health-
System Pharmacists (ASHP) www.ashp.org/shortage
Manufacturers A.S.P.E.N. members
and non-members
Institute for Safe
Medication Practices (ISMP)
Conclusion
The drug shortage crisis is a threat to the safest
pharmaceutical supply chain in the world which
has impacted the access to and quality of PN
therapy in the U.S. health system
Collaboration with health care professionals,
professional societies, regulatory and accrediting
bodies as well as manufacturers is necessary to
avoid major problems in the care of patients
receiving PN