Introduction

Both the American Society of Health-System Pharmacists and the FDA keep track of current and past drug shortages, giving information on the current status of the shortage. Ever since drug shortages became more pertinent, many patient care facilities and drug distributors have been suffering costs and facing other problems. Since then, the FDA has stepped in by assisting companies in resolving these drug shortage problems for patients who vitally need certain medication.

Background

With increasing medical technology and intellect, disease states that were not treatable a few decades ago are now curable. Having invested millions of dollars in researching and designing drugs, drug companies have created new drug entities that help keep people alive. After formulating the drug, there come the processes of delivering drugs to the patients who need it most. However, with recent drug shortages, patient care facilities are forced to scramble for a solution. With shortages of certain drugs, patients are not able to receive their needed medication due to a break somewhere in the supply. Many are put in a grave situation where the drug that once kept them living is no longer there. Healthcare facilities are then the ones who must look for solutions to the dependency of shortage drugs to help their patients in need.

Many healthcare practitioners have found that a large problem due to drug shortages is lack of warning. Manufacturers are not required to tell everyone in advance that they are not going to continue creating a drug or that there is a problem with the production line. They are required to report to the FDA; however, there is no enforcement on continued manufacturing of their drugs. Healthcare providers are then forced to look quickly for alternatives that may not be recommended in the guidelines, creating a problem for healthcare institutions on providing optimal patient care.

Issue

Do drug shortages cause significantly increased expenses in healthcare facilities?

Rule

Drug shortages cause significantly increased expenses in healthcare facilities if:

1)      It causes hospitals and other care facilities to spend thousands of dollars to find alternatives for the shortage

Analysis

In 2010, the Institute for Safe Medication Practices surveyed 1,800 healthcare practitioners finding that:

  • 84% of the respondents said they had never received advance warning of a shortage from manufacturers or the FDA.
  • 80% said they faced difficulty obtaining comparable drugs.
  • 78% said there were significant costs to obtaining comparable drugs.
  • 70% said they had been unable to find comparable alternatives.
  • 64% believed that shortages posed a risk of adverse patient outcomes.
  • respondents reported more than 1,000 adverse events and near-misses attributable to drug shortages.

Shortages in the United States have been taxing for healthcare providers, causing a scramble for various comparable drugs and other alternatives. Another survey found that hospitals spend at least $200 million a year in costs for drug substitutes which may cost 10 times more than the drug on shortage. This means a great amount of resources is wasted to purchase drugs and creates a market where price gougers can make quick money off of these unfortunate events. The drug shortages have created non-traditional suppliers to quickly purchase the remaining quantity of drugs from traditional warehouses. In doing so, they then increase the price of the drug, forcing hospitals to pay a much greater price than from the traditional supplier.

Not all drug shortages, however, are unmanageable. Many drugs have other equivalents that can be used to help patients. However, as seen by the survey above, many healthcare providers must spend more time intervening and checking for new therapeutic levels and drug interactions, costing hospitals and other facilities money. Doctors also may not be familiar with the substitutes,  forcing nurses and pharmacists to have to calculate or spend time to create equivalency charts that may not be backed by clinical evidence. By having these shortages, more human resources are searching and calculating viable alternatives to help achieve optimal patient care. Therefore, more time is spent fixing patient therapy regimens rather than optimizing the recommended care, creating a loss for healthcare providers altogether.

When solutions and alternatives are found for the drug that is in shortage, a sudden demand for the alternative is placed on the suppliers, sometimes pushing the alternative drug into shortage as well. This pushes healthcare suppliers to invest in creating more or increasing the infrastructure of their production line to meet the demands of the healthcare institutions. An example was when IV furosemide became limited, creating a demand for alternatives. Bumetanide was chosen as the alternative; however, since it was not manufactured to supply such a great demand, it went into shortage as well.

Conclusion

Drug shortages are very costly overall to the healthcare system. By forcing patients into other alternatives, strain is pushed onto other manufacturers and healthcare providers to spend time and money researching the best solution to the problem. Millions of dollars are spent purchasing more expensive alternatives, which leads to other complications such as recalculations of drug doses and creating drug equivalency charts. Doctors, nurses, and pharmacists then spend more time and money fixing drug shortage problems rather than focusing on patient care. Drug shortages therefore pose a significant cost on the healthcare system and are only beneficial to non-traditional businesses who wish to make money off of the shortage.

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