The Big Picture… The cost of purchasing alternative therapies approaches $200M Hospital pharmacists are spending an additional 8-12 hours per week dealing with shortages $216M additional annual labor cost to deal with shortages (ASHP 2012)
Safety concerns 1800 pharmacists surveyed September 2011 1000 adverse events related to shortage – 25% medication errors – 20% adverse drug reactions (ASHP Survey 2011)
Aborting shortages 2011 195 shortages prevented 201212 shortages prevented Early notification of FDA noted to be key in resolution
Top 3 FDA actions to avert shortages Asking other firms to increase production (31%) Working with manufacturers to identify ways to mitigate quality issues, i.e. flexibility through regulatory discretion (28%) Expediting review of regulatory submissions (26%).
The challenge… Under current law and regulation, manufacturers are not required to report to FDA when they experience an interruption in the production of their products, unless that drug is “life supporting, life sustaining, or intended for use in the prevention of a debilitating disease or condition.” The same holds true when manufacturers choose to discontinue a product.
The Food and Drug Administration Safety and Innovation Act
“The Society, in collaboration with key partners, including the American Hospital Association (AHA), the American Society of Anesthesiologists (ASA), the American Society of Clinical Oncology (ASCO), and the Institute for Safe Medication Practices (ISMP), worked closely with legislators to develop the drug shortages provisions in the legislation, which also reauthorizes funding for the Prescription Drug User Fee Act”.
What the FDASIA does Broadens the scope of the early notification requirement by requiring all manufacturers of covered drugs to notify FDA of potential discontinuances. Manufacturers are required to report discontinuances to FDA regardless of whether they intend to discontinue the product permanently or temporarily Enables FDA to require mandatory reporting of shortages of biological products. Makes clear that the notification requirement applies to drugs that are used in emergency medical care or during surgery (if they are intended for use in the prevention of a debilitating disease or condition). Requires FDA to issue a non-compliance letter to manufacturers who fail to comply with the drug shortage notification requirements and to make the letter and the company’s response to the letter available to the public.
Requires FDA to submit an annual report to Congress on drug shortages and FDA’s efforts to address shortages. Requires FDA to establish a task force to develop and implement a strategic plan for enhancing our response to drug shortages. The strategic plan must be published and submitted to Congress within one year after enactment of FDASIA. Requires that, prior to taking any enforcement action or issuing any warning letter that reasonably could be anticipated to lead to a disruption in supply, appropriate offices within FDA communicate about the action and evaluate the relative risks and benefits to patients from the shortage and enforcement action or warning letter. Expressly states that FDA may expedite review of certain applications and expedite inspections that could help to mitigate or prevent a shortage. What the FDASIA does
Requires FDA to maintain a publicly available, up-to-date list of drugs in shortage, including the cause and estimated duration of the shortage. If a shortage involves a controlled substance, FDA must notify the Drug Enforcement Administration (DEA) of the shortage and request that DEA increase the quota of the product to alleviate the shortage. A hospital is not required to register with FDA as a manufacturer solely because the hospital repackages drugs declared to be in shortage for use within hospitals within the same health system and if done in response to the shortage to extend the hospital system’s supply of the product. Requires a GAO report examining the causes of drug shortages and formulating recommendations to prevent or alleviate shortages. What the FDASIA does
Critical issues… Physician extension of expiration dates –Efficacy (lot analysis) –Safety –Authority Compounding pharmacies State scope of practice Public health emergency declaration Foreign purchase Physician extension of expiration dates –Efficacy (lot analysis) –Safety –Authority Compounding pharmacies State scope of practice Public health emergency declaration Foreign purchase
In summary… This problem is here to stay The solutions are complex, but doable One size will not fit all Pay close attention to patient safety Pay attention to regulation and legislation Keep an eye on changes Share best practices… This problem is here to stay The solutions are complex, but doable One size will not fit all Pay close attention to patient safety Pay attention to regulation and legislation Keep an eye on changes Share best practices…