Introduction
A drug shortage can be defined as short-term unavailability of at least one dosage form of a drug from a given manufacturer. From 2005 to 2010, drug shortages have nearly tripled. According to President Obama, they “pose a serious and growing threat to public health.”  Drug shortages greatly impact the healthcare system, in addition to the lives of millions of patients.

Background
According to the FDA, a drug shortage can occur for many reasons including manufacturing and quality problems, delays, and discontinuations. The growing issue peaked in 2011 when a record-breaking 251 drugs were in short supply. Drugs that are vulnerable to drug shortages are typically oncology medications, injectables, generic drugs, and drugs subject to the FDA’s unapproved drugs initiative and single-source products and concentrated market share. These drug shortages have caused drastic changes to patients’ drug therapy schedules and have negatively impacted their medical conditions.

Issue
Are drug shortages affecting healthcare?

Rule

Drug shortages are affecting healthcare if:

  1. Drug shortages affect patient safety
  2. Drug shortages affect cost of care

Analysis

Affecting Patient Safety

Drug shortages have become quite controversial, putting physicians in very difficult situations. Healthcare professionals are being forced to ration life-saving medications by choosing patients that may deserve the limited supply of drugs more than others. According to Henri R. Manasse, president and CEO of Johns Hopkins Hospital, “patients are at risk when a needed drug is not available or when healthcare providers must work with substitute medications.” In 2010, a cancer drug shortage of Mechlorethamine led to cancer relapse in children and young adults. The doctors used a substitute drug that was deemed comparably safe; however, hospital records disagreed with this substitution. Physicians compared cancer relapse rates of 181 patients treated with the original drug and 40 patients treated with the substitute after the shortage emerged. They found that while 25% of patients receiving the new substitute regimen relapsed, only 12% receiving the original drug had relapsed. These results demonstrated a statistically significant difference.

Unfortunately, drug shortages cause patients suffering from life-threatening diseases to go weeks or months without taking proper medications. The unpredictability of when drug shortages may occur may be due to communication failure between pharmaceutical companies and the FDA. This occurs because the FDA cannot require a pharmaceutical company to manufacture a drug. In response, not only do healthcare practitioners have to explain to their patients why they will not be receiving their medications, but they also have no idea when the shortage will occur.

Affecting Cost of Care

An analysis and survey was conducted by the Premier Healthcare Alliance, stating that an ongoing shortage of prescription drugs is costing hospitals almost $200 million annually because healthcare practitioners are being forced to purchase more expensive drug alternatives. The high cost, which is not limited to only purchasing alternatives, is also a result of the expenses utilized by healthcare professionals in informing pharmacists and practitioners about these shortages and how to deal with them.

Conclusion

As previously mentioned, there is often a communication barrier between pharmaceutical companies and the FDA, which often leads to drug shortages. These drug shortages may cause patients to be without important medications that may alter their medical conditions, thereby increasing mortality. Physicians and pharmacists are being forced to look to more expensive alternatives for specific condition-related therapies in response to these shortages; however, sometimes an appropriate alternative may not be plausible. In these cases, the patient is the one that suffers as a result. If these communication barriers were lifted between pharmaceutical companies and the FDA, several potential drug shortages may be prevented and would stop affecting healthcare.

For more information on this issue, contact the Kulkarni Law Firm.