Revise Drug Production Guidelines to Prevent Shortages

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Target: Food and Drug Administration (FDA)

Goal: Prevent drug shortages from happening so that patients have access to vital treatments

Drug shortage in the United States is not a new issue. The Food and Drug Administration (FDA) currently has several methods to turn to once the agency is alerted of a drug shortage. The FDA can either approve the same drugs from a different manufacturer or approve oversea drug imports. Even though the FDA gets notified immediately about drug shortages, a new survey found that this problem continues to hurt hundreds of patients. Since the number of drug shortages is not dwindling, it is time that a new set of guidelines is created to combat this issue more effectively. The FDA must work with pharmaceutical companies and hospitals in developing a better system that could ultimately stop drug shortages.

The FDA reported 251 drug shortages in 2011. In 2012, the number reduced to 121. Despite the promising reduction, in a February report by the University of Utah Drug Information Service, there are already 320 reported cases of drug shortage in 2013. When people are diagnosed with any life altering diseases, receiving medical care and effective treatment is vital in combating the disease. However, due to drug shortages, some cancer patients are left with less effective drug therapies. According to 245 doctors who participated in the survey, 83 percent of them stated that they have reported a drug shortage. 92 percent of them stated that this drug shortage negatively affected patient care.

The study also revealed other startling statistics regarding drug shortage. Seventy nine percent of the doctors were forced to switch chemotherapy agents, which meant that a less effective cancer drug was used. About 38 percent of the doctors had to switch from the generic brand to the high-end brand, which increased cancer drug costs. Forty three percent of the doctors were forced to delay cancer treatment while 29 percent of the doctors had to omit doses. Twenty percent of the doctors chose to reduce the drug doses and 37 percent of the doctors ended up choosing which patients received the drugs and which ones would not. Seventeen percent of the doctors referred their patients to other doctors. The fact that drug shortages often leave doctors and patients with no other options is startling.

Although researchers do not know the extent of the damages done when a cancer patient is unable to receive care, other researchers have tied drug shortages to an increased relapse rate. The issue here is not that there are no treatment options but rather, these effective options are not attainable. The FDA must be more adamant about this issue and find a way to fix it.

PETITION LETTER:

Dear U.S. Food and Drug Administration,

Although your agency is notified in advance when there is a drug shortage, the methods you are able to take are still not dealing with the issue at hand. When there is a drug shortage, importing drugs from overseas or approving new drugs could take a while, which is why preventing drug shortages from occurring is more important.

A recent survey revealed that out of 245 doctors, 92 percent of them reported that a drug shortage affected patient care. On top of that, certain doctors are forced to give the drugs they have to some patients as opposed to others. The fact that doctors and hospitals must resort to give drugs to only a few patients is unacceptable. Drugs, especially since these drugs are effective in fighting against life-threatening disease, should never be unavailable.

Find a way to better control the drug shortage issue and prevent people from losing medical care from it.

Sincerely,

[Your Name Here]

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  • Alice Rim
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