Where Have All The Drugs Gone?
By Katie Imhof, PharmD // June 6, 2012
(Video by CBS News)
EDITOR’S NOTE: The drug shortage in America is now at crisis level. An online survey was sent out recently by the American Society of Anesthesiologists to its members to gauge the impact of this drug shortage on the practice of anesthesiology and associated surgical outcomes, and to have some data to share with Congress and other policymakers grappling with a nationwide situation that has sent hospitals scrambling for antibiotics and anesthetics and brought them to the brink of being unable to treat some childhood cancers.
Unfortunately, of the 3,063 survey respondents 97.6% said they were currently experiencing a shortage of at least one drug, and seven U.S. anesthesiologists reported that drug shortages resulted in deaths of their patients.
Although the online survey cannot be considered scientific, it provides clear insight into the growing shortage of anesthetics and painkillers used before, during and after surgery, and the potentially fatal consequences when those are unavailable.
In the fall, President Obama issued an executive order that gave the Food and Drug Administration power to respond more quickly to drug shortages by requiring drug manufacturers to notify the FDA 6 months in advance of ceasing production on any critical FDA-approved drug. Since then the FDA has also begun allowing overseas imports of key drugs for leukemia and cancer, and approved new suppliers to alleviate shortfalls.
As of the first week in May it appears that the administration’s efforts are paying off. The Food and Drug Administration said there are fewer new drug shortages as compared with this time last year, and, in a blog post, FDA Commissioner Dr. Margaret Hamburg wrote that there has been a “six-fold increase” in notifications from manufacturers since October, when the agency asked drug manufacturers to voluntarily report potential supply disruptions.
There are currently 42 new drug shortages, compared with 90 new shortages that were reported at this time last year.
To provide our readers and viewers a closer look at the drug manufacturing problems, shrinking numbers of generic drug makers and increasing demand contributing to this crisis, SpaceCoastDaily.com welcomes clinical pharmacist Dr. Katie Imhof.
Drug shortages have become a significant problem for health care practitioners as well as patients across the nation. Unfortunately, drug shortages are occurring more frequently with little to no warning or explanation as to why.
These shortages have tripled in the last five years with nearly 80% being injectable drugs, most notably anesthetic and IV chemotherapy agents that directly affect acute care facilities, primarily larger hospitals, outpatient surgical centers and cancer care centers.
The Domino Effect
The impact of one drug shortage has a ripple effect that influences not only economic issues, but clinical issues as well. Economically, the increased price of alternative drugs and the extensive manpower used to deal with the increasing number of shortages is a significant financial factor in health-care settings.
Clinically, when an alternative drug must be substituted and a practitioner is less familiar with the medication, there exists the potential risk for medication errors and an increase in patient adverse outcomes.
Unfortunately, manufacturers are not presently required to report reasons for drug shortages or the expected duration of a shortage to the FDA.
Multiple Causative Factors
It is important to recognize that drug shortages are multi-factorial and quite often do not have an exact cause. There are predictable as well as unpredictable factors that may influence any drug supply.
Predictable Factors Include:
- Reduction in manufacturer production
- Restricted distribution by the manufacturer
- Manufacturer discontinuation of a product
- Industry consolidations (mergers resulting in discontinued products)
- Market shifts (supplies diverted over seas due to military conflict for example)
- Unexpected demand (increased use due to unlabeled uses)
- “Grey” market vendors (buying and selling excessive quantities of a medication for profit)
Unpredictable Factors Include:
- Natural disasters (hurricanes inflicting damage to a facility)
- Raw materials (multiple manufacturers producing a drug product from only one source of raw material)
- Non-compliance with Regulatory Standards (FDA halts production of a medication that does not adhere to Good Manufacturing Practices [GMPs])
- Voluntary manufacturer recalls (especially problematic when that manufacturer is the primary supplier of a product)
In November 2010, representatives from the American Society of Anesthesiologists, the American Society of Clinical Oncology, the American Society of Health-System Pharmacists and the Institute for Safe Medication Practices co-convened for the Drug Shortages Summit. The goals of the summit were to discuss the scope and causes of drug shortages, shed light on the impact of drug shortages to patients, discuss potential need for changes in public policy to prevent patient harm due to shortages and develop an assertive action plan.
The outcomes of the Drug Shortages Summit included development of initial recommendations and to continue collaborative efforts to address issues associated with drug shortages.
The recommendations emanating from the Drug Shortage Summit captured the attention of lawmakers in Washington, D.C, and, shortly after the summit, Congress appeared to take notice of the severity of ongoing drug shortages and the impact these shortages have on patient care.
The “Preserving Access to Life-Saving Medications Act” (Senate Bill 296/House Bill 2245) was proposed in February 2011, which, if enacted, would require manufacturers to notify the government of any manufacturing “discontinuances” that would likely result in a shortage of a product. Failure to notify under the Act would trigger a significant fine from the federal government on the pharmaceutical manufacturer. At this time the Bill is still pending action by Congress.
Progress Toward Addressing the Problems
In October 2011, President Obama took steps to help manage and hopefully ease the mounting shortages of key drugs in the United States by signing an executive order that allowed the FDA broader latitude in its efforts to control drug shortages. At the end of 2011, the FDA enacted a rule, which became effective January 18th of this year that extends the circumstances under which the sole manufacturer of a critical FDA-approved drug product must notify the FDA about ceasing production. No manufacturer of a critical drug product will be exempt from the requirement to give the FDA 6-months advance notice.
While President Obama’s actions appear to be easing some drug shortage issues, it is important that drug shortages be recognized to result from multiple overlapping and complex causes that stem from economic, legal, regulatory, policy and clinical decisions that are interconnected. Senate and House bills are still in the works, but these government mandates will by no means make shortages go away.
Manufacturing problems and drug discontinuations will continue to occur and thus the supply of related drugs or alternatives will in turn be strained. Each institution should have a strategic plan to best meet the needs of their patients. Communication is a key component to inform those that will be affected including physicians, nurses as well as the patients themselves.
For more information on drug shortages go to:
Dr. Katie Imhof is a Clinical Pharmacist at Holmes Regional Medical Center and has worked for Health First for the last 11 years. She received her Bachelor of Science degree in Biology from the University of California at Irvine, her Doctor of Pharmacy degree from Creighton University in Nebraska, and completed a General Pharmacy Residency at the University of Colorado Medical Center in Denver. In her free time, she enjoys spending time with her husband and daughter.