The Drug Shortage Crisis

4/23/2012

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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

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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


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


Trace elements Manufacturing or



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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!!’

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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


Patient Safety

Procurement

Purchasing outside normal channels (gray or black market, compounding facility)

Hoarding/stockpiling

Stress on staff to find and purchase alternative products


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


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


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

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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


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


Patient Safety


Using products similar in appearance

Increased manipulation of products

Transfer of product from original

container

Pooling of small volumes into larger

source containers


Patient Safety


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


Patient Safety


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.


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

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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


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


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


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


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


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

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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

The Drug Shortage Crisis

Documents

Transcript of The Drug Shortage Crisis