Access Barriers to Specialty Medications

The limited availability of drug products has been a national concern for many years.  Specialty medications have some unique concerns when considering patient access during times of product unavailability, but there are several reasons why a specialty drug may not be available for patients in need of treatment.  
 
Product Shortages
There are times when a drug product is unavailable due to a supply shortage. In most cases, this shortage is the result of quality or production issues during the manufacturing process. Occasionally, shortages may result from changes in clinical practice guidelines or FDA approval of a new indication. 
 
In 2012, the United States experienced a drug shortage crisis, with more than 300 shorted products. Today, the number is much lower with 170 reported shortages, but health care providers continue to experience the challenges associated with a shortage event. 
 
Since specialty medications do not often have a variety of generic manufacturers to substitute during these times, product shortages can become a difficult challenge for patients and their health care providers. Clinicians may be required to locate an existing supply, compound the product, or substitute with an alternative therapy, if one is available. 
 
Depending on the specialty drug product, this situation can result in additional counseling, laboratory monitoring, or therapy failure for patients. 
 
Recalls
Medications are sometimes recalled by the FDA or manufacturer, depending on the circumstances. As Cardinal Health explains, “a recall is an action taken when a product is found to be in violation of laws and regulations administered by the FDA. Medications may be recalled for a variety of reasons including safety, mislabeling, contamination, and deviations in strength or potency.” 
The FDA is responsible for classifying a drug recall, which leads to removal of the defective drug product from the market. There are 3 classifications:
  • Class I: A dangerous or defective product that could cause serious health problems or death.
  • Class II: A product that might cause a temporary health problem or pose slight threat of a serious nature.
  • Class III: A product that is unlikely to cause any adverse health reaction, but that violates FDA labeling or manufacturing laws.
Like product shortages, if a drug recall is issued for a specialty medication, patients and clinicians may find themselves in a similar situation with limited or no therapy alternatives. A unique product recall example involved Triad alcohol prep pads in 2011. 
 
Although the recall did not affect a pharmaceutical drug product, it did indirectly result in a recall of several specialty drug products that contained the prep pads within their packaging. Some examples included Betaseron, Copaxone, Xtavia, Boniva, Fusion, Nutropin AQ, and Pegasys. 
 
Product Discontinuation
According to the definition provided by the FDA, “[products listed] as ‘discontinued’ are approved products that have never been marketed, have been discontinued from marketing, are for military use, are for export only, or have had their approvals withdrawn for reasons other than safety or efficacy after being discontinued from marketing.” 
 
In the case of specialty drug products, initial approvals are sometimes granted with programs such as Elements to Assure Safe Use or Risk Evaluation and Mitigation Strategies (REMS). These programs mitigate risk to ensure that the benefits of a medication outweigh the risks. 
 
An example of such a product is Zinbryta, a specialty drug product used to treat multiple sclerosis. Due to the risks of hepatic injury, including autoimmune hepatitis and other immune-mediated disorders, it was made available only through a REMS program that required prescriber and pharmacy certification, as well as patient enrollment. 
 
In March 2018, Biogen and AbbVie announced a decision to withdraw the global marketing application for Zinbryta due to the adverse reactions being reported by patients on therapy. As a result, patients and prescribers were required to find alternative therapies for the disease state. 
 
This was devastating for some patients who were experiencing successful outcomes with Zinbryta after failed attempts on other therapies. Another specialty drug product that was discontinued was Zecuity, a transdermal migraine therapy. 
 
In June 2016, Teva announced the discontinuation of their product due to reports of application site reactions. Ultimately, patient safety must come first, but this scenario does result in accessibility issues for patients and prescribers when it comes to drug product availability.
 


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