Unprecedented Drug Shortages in the United States: What it means for Children’s Hospitals
March 20, 2011
Posted by chcablogadmin in : Industry Trends, Quality
Editor’s Note: Please read the entire article for important information regarding drug shortages. Below are highlights.
Drug shortages are at their highest level in a decade. Some experts believe we are experiencing the worst shortage in 30 years and it will probably not improve anytime soon. What does this mean for your hospital and what efforts are underway to plug the holes in the dam?
The University of Utah Drug Information Service (UUDIS), who provides drug shortage information and content to the American Society of Health-System Pharmacists (ASHP) and Novation and works closely with the FDA, tracked a record 211 shortages in 2010—the highest in 10 years of monitoring shortages. In the first two months of 2011, more than 50 drug shortages have been reported.
Drug Shortage Side Effects
Patient safety: In an Institute for Safe Medication Practices (ISMP) survey last summer, 1,800 respondents reported more than 1,000 drug shortage-related “near misses,” errors and adverse patient outcomes including at least two deaths and several extended hospitalizations. Therapeutic drug substitutions with infrequently used products can create medication errors, unknown side effects and dosage errors.
Increased costs: Hospitals also report substantial drug shortage-related costs including the administrative burden to investigate and locate alternate supplies, create and implement crisis plans for shortages, and prepare and administer dosing and drug alternatives. Direct costs for procurement of drugs are increased dramatically if the pharmaceutical product in short supply is only available through alternate suppliers or other vendor relationships.
No Single Cause=No Easy Solution
There is no single solution to the problem. According to the FDA, about 54 percent of the shortages in 2010 were due to product quality problems. Two of the largest manufacturers of sterile injectables, such as propofol, had product recalls last year after the FDA found particulates in the syringes. Another 21 percent of the shortages stemmed from production delays, while 11 percent were caused from discontinuing a product, usually for business reasons. The rest were due to increased demand, raw material shortages and manufacturing sites’ consolidation or closure.
What is Being Done?
CHCA and Premier are:
- Working to ensure product alternatives are available and on-contract;
- Working with suppliers regarding product allocations;
- Regularly updating members regarding drug shortage statuses; and
- Premier PDIN newsletter provides drug shortage updates directly from FDA and ASHP Drug Shortage web sites.
In 2009, Premier launched a Failure to Supply program which helps alliance hospital members optimize recovery for drug shortage costs. This program is representing more than 1,100 members and has netted more than $3.5 million in costs recovered for failure to supply in its first year.
Last November, the American Society of Clinical Oncology (ACOS), American Society of Anesthesiologists, American Society of Health-System Pharmacists and ISMP convened an important summit along with manufacturers, wholesalers, distributors, group purchasers and the Food and Drug Administration and other regulators. In January, the group released recommendations for preventing drug shortages including: improving communication across the supply chain, removing barriers to suppliers and the FDA to minimize the impact of drug shortages, and clarifying the regulatory definition of “medically necessary,” which could prompt earlier reporting of impending shortages to the FDA.
CHCA and Premier are also identifying and participating in opportunities to lobby Congress for relief from the current drug shortage crisis. We are also in communication and collaboration with our counterparts at HIGPA and National Association of Children’s Hospitals and Related Institutions in their advocacy efforts.
Recent legislation has been introduced to address drug shortages. The Preserving Access to Life Saving Medications Act (S. 296) proposed by Sens. Amy Klobuchar (D-Minn.) and Robert Casey (D-Pa.), is an important first step towards preventing the patient harm that often occurs when a medication is in short supply. The bill would require manufacturers to provide the FDA with early notice of impending shortages, and to expedite importation of substitutes when necessary. The Obama administration is also launching a federal research institute to speed development of new drugs, though this will not address shortages of existing compounds.
What You Can Do?
1. Institutional Approach
- Create a crisis plan: identify drug shortages proactively along with therapeutic alternatives; prioritize patients and usage limits; conduct failure analysis to avoid look-like errors; establish a drug shortage network (CHCA can help); implement an organizational policy on alternate suppliers, and monitor shortage-related adverse events.
- Involve the medical staff in dealing with the shortages.
- Raise awareness of drug shortages and increase communication about the issue at all levels within your hospital.
- Consider establishing collaborative and reciprocal relationships with other institutions including local adult hospitals to share supplies and resources for alternative therapies.
- Reassure the patients; the majority of them won’t be affected by drug shortages.
2. Utilize Existing Relationships and Alliances
- Utilize CHCA and Premier support. CHCA will continue to provide current shortage information, leverage manufacturer relationships to secure products, and communicate with the pharmacy directors and Pharmacy Buyers Forum.
- Leverage your own vendor and manufacturing relationships.
- Reach out to other children’s hospitals in your state or region to arrange a reciprocal sharing program or even adult hospitals in your community.
We almost completely ran out of neostigmine to stock our 60+ anesthesia trays. We exhausted all of our options—Cardinal, American Reagent direct, Baxter direct and even personal contacts at AmerisourceBergen—to no avail. Through his contacts, Ben Lizak at CHCA was able to place an order the same day to obtain an emergency supply until our next anticipated release date. – Aaron Sinner, Pharm. D., Pharmacy Operations Manager, Phoenix Children’s Hospital.
Contact me (johnvaneeckhout@chca.com) or Ben Lizak (ben.lizak@chca.com) with an urgent drug shortage issue and we will do our very best to help you attain the necessary drugs without disruption of care.
3. Support Legislation and Advocacy
- Add your voice in support of resolving the drug shortage issues and the safety, access and quality of care, and financial burden felt by children’s Hospitals.
- Engage your government relations and public advocacy professionals on this issue.
- Urge your senators to cosponsor the Preserving Access to Life Saving Medications Act (S. 296).
- Contact your senators and let them know about the impact of drug shortages on the patients you serve.
- Michael Link, M.D., MPH
CHCA and children’s hospitals can also support additional legislative efforts to give authority to the FDA to respond more quickly particularly with indication and labeling drugs for usage. In addition, support efforts to review efficacy of expired drugs and their potential so that expiration dates may be extended safely as well as work with payers to understand and accept temporary substitution regimens and not stick the patients with the price. – Michael Link, M.D., MPH, Pediatric Oncologist at Lucile Packard Children’s Hospital and Stanford and ASCO President-Elect
4. Don’t Buy from Gray Marketers
- Gray marketers are charging hospital 10 to 20 times contract price for these short supply products.
- Quality cannot be assured since you don’t know how they gained access to the product.
- The drugs could be counterfeit and since pedigrees aren’t officially documented and tracked, you assume a huge liability risk when dealing with these distributors.
- Recognized distributors have a documented chain of custody.
Working Together
The drug shortage issue is not going to be quickly or easily resolved. It may get more intense with supplies increasingly dwindling before resolution occurs. If we can get some discussion beyond the FDA and the regulatory realm, we can begin to resolve these issues. Without robust dialogue and proactive plans of action, denial of treatment or an increase in adverse events may be inevitable and devastating to your patients and their families as well as your staff.
We hope you will talk with your pharmacy directors and leadership teams and plan your course of action to resolve these issues. CHCA and your children’s hospital colleagues are available to help you navigate this issue.
1 comment so far | add a commentChildren’s Insurance Policies Reinstated in CA
January 9, 2011
Posted by chcablogadmin in : Community Benefit, Healthcare Reform, Industry Trends
By Richard Cordova, FACHE, President and Chief Executive Officer, Children’s Hospital Los Angeles
Richard Cordova
In recent years, many parents in California found that health insurance coverage for their children was out of reach either because insurance companies denied coverage due to a pre-existing condition or parents simply could not afford the insurance premiums. A pre-existing condition could be as innocuous as an ear infection to something as serious as asthma.
On top of that, cuts to California’s Medicaid (Medi-Cal) program had a profound effect on children statewide. Families USA reports that more than a quarter of a million children lost health coverage, and another 160,000 were vulnerable to proposed further cuts.
Thankfully, good news is on the way with the passage of a new law that took effect Jan. 1.
With this new law and the subsequent reversal of health plan restrictions on selling these policies, parents now have more options to acquire insurance coverage for their children who were previously excluded from coverage due to a pre-existing condition. This dramatic change will offer coverage to an additional 80,000 children who are currently not insured by family policies or by their parents’ employer-based insurance coverage.
In terms of how this will affect Children’s Hospital Los Angeles, we serve a high portion of Medi-Cal patients. Efforts are underway to improve our payer mix and we expect to see more private pay patients over the next year, coinciding with the opening of our new patient tower in July 2011.
An added economic benefit of this new law is that California will now have an opportunity to save millions of dollars it has earmarked to fund state health insurance for our kids.
Good news, indeed.
Editor’s Note: For more information, read the L.A. Times article describing the new law, reinstatement of policies and insurance company reactions.
add a commentACO Update: Issue #2
December 19, 2010
Posted by chcablogadmin in : Healthcare Reform, Industry Trends, Innovation
Jacqueline Kueser
We hope you enjoyed last month’s premier issue of the ACO Update and found the contents valuable for discussing future plans and strategies with your leadership team. Our goal is to bring you a new perspective from one of our children’s hospitals in each issue as well as a state overview. This time we’ve interviewed representatives from Massachusetts—a state who has been on the frontline and a model of reform for several years, as well as California—a state in financial flux with innovative approaches to reform. You will also find some key information about California’s lessons learned and how two constituency groups, the National Committee for Quality Assurance (NCQA) and several united physician groups, are identifying their role and standards in the development of ACOs.
I welcome your comments and suggestions as well as your questions. Please feel free to contact me directly.
Jacqueline Kueser, Vice President, CHCA
Jacqueline.kueser@chca.com
- What’s happening at Boston Children’s?
- What’s it like at L.A. Children’s?
- Lessons Learned from California ACOs
- NCQAs Proposed ACO Standards
- Physician Groups Issue ACO Principles
You may also access the newsletter (ACO Update_12-20-10) as a document to print and share within your hospital.
add a commentCheck Out the ACO Update
December 5, 2010
Posted by chcablogadmin in : Healthcare Reform, Industry Trends
Look for the new tab on the CHCA First Round Blog web page: ACO Update. This newsletter was created with you in mind. We hope it will help answer your questions about accountable care intiatives. Our goal is to track CHCA Owner Hospital responses to state adoption of payment and program models.
The newsletter will be published as part of the CHCA CEO blog periodically and eventually quarterly. This issue highlights the state of Colorado and the The Children’s Hospital’s (Denver, CO) plan to move forward with Medicaid accountable care collaborative. You will also find information about the following:
- So What Is an ACO and How Will They Impact Children’s Hospitals?
- Some Non-ACO Provisions of the Healthcare Reform Act Could Impact Children’s Hospitals as Well
- How Will ACOs Work Financially?
- Public Policy as It Impacts Children’s Hospitals
- Large Employers’ Health Plan Design Changes Could Impact Revenues
Find out more about our contributors, editors and objectives by reading the entire ACO Update content. You may also access the newsletter (ACO Update_12-6-10) as a document to print and share within your hospital.
We welcome your comments and suggestion as well as your questions. Please direct these to Jacqueline Kueser at CHCA (Jacqueline.kueser@chca.com).
add a comment
