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IMPORTED MEDICATIONS SAFETY REGULATIONS
The evident increase in the cost of prescription drugs has prompted local government and state officials to explore the importation of drugs from countries in Europe and Canada in order to save money. The process is, however, faced with many challenges as the importation programs violate federal laws regarding the importance of drugs. It is evident through an analysis of challenges arising from the importance of medications and possible solutions.
The medication importation practices pose a myriad of challenges relating to liability, feasibility, safety, and legality. In regard to the legality, the programs involved continue importing prescription drugs; this occurs despite the violation of numerous federal and state laws. They disregard the regulations regarding pharmacy licensing and registration (Khodeli 1). Liability is a major problem due to the ineffective laws; there seems to be nobody liable for the safety of imported drugs. The importation programs are also not feasible or sustainable according to analysts. The program results in an underestimation of the true costs and overestimation of money the government expects to save through the importation. There is also uncertainty over the ability of imported medication to meet U.S. drug demand.
Subsequently, the medications are a risk to the safety of human health as some of the imported medications do not meet the standards set by U.S. Food and Drug Administration. The drugs may contain untested substances. Some of the ingredients used in the medications, although legal in other countries, may need evaluation for safety and effectiveness; they may contain addictive or other dangerous chemicals (FDA 1). The situation worsens due to the language and labeling issues; the labels for imported medicine include instructions for side effects and use. The language may, however, be difficult to comprehend. It may also include medical claims for untested uses.
The lax laws and regulations also increase the chances of the importation of counterfeit medication and other dangerous products into the U.S. market. The patients fail to get the expected therapeutic benefit from their use (Pfizer Inc. 3). The situation is worsened by the ease of drug acquisition through the internet; this allows people to purchase drugs of unknown origins (FDA 1).
Though the importation of medications must continue, there is a need for efficient procedures in establishing their safety. They must undergo testing to ensure they are of the highest quality and not counterfeits. The FDA can improve the situation by scaling up its regulations on foreign-manufactured medications. It includes the adequate inspection of foreign manufacturing facilities to ensure they adhere to the strict regulations of domestic facilities and products. Consistent enforcement of the Food, Drug, and Cosmetic Act by the courts prevents any companies, or people from circumventing the prohibitions on the import of counterfeit medications (Schleiter 1).
In order to ensure citizens access drugs that are safe for their use, governments must ensure they import only from safe manufacturers. According to Bast (1), medications imported from Canada are safe. Canada enforces strict rules and regulations in regard to medication production. US officials have inspected Canadian factories and pharmacies and found them in compliance with laws and best practices similar to those in USA. With the high healthcare costs, the importation of medications must continue in order to ensure those who cannot afford it also get healthcare services; it can, for instance, facilitate the provision of free medication for uninsured residents by the government.
Medications importation procedures that adhere to government laws and ensure the provision of high-quality medication will have a positive impact on the economy. It will guarantee cost savings for the state, uninsured citizens, and individuals involved in government-administered medical programs according to Khodeli (2). It occurs by ensuring the activities are carried out according to safety, feasibility, and liability.
The importation of foreign medications continues in USA and other countries worldwide. The practice is fueled by the need to cope with increasing prescription drug cost in USA; policy makers thus embrace the importation of less-expensive pharmaceutical products according to Kesselheim et al. (614). Despite the challenges of safety, feasibility, liability and legality, the government can enhance the efficiency and safety of the import program. Through enforcement of strict FDA rules and regulations, the importation of safe and affordable medications from Canada and other countries will be beneficial to the people, government, and the economy.
Bast, Joseph. “The Pros and Cons of Importing Drugs from Canada.” The Heartland Institute. Web. Available from: < http://heartland.org/press-releases/2004/04/19/pros-and-cons-importing-drugs-canada > [Accessed January 27, 2015]
Food and Drug Administration. “Imported Drugs Raise Safety Concerns.” U.S. Department of Health and Human Services. Silver Spring, MD: U.S. Food and Drug Administration (2011): Web. Available from: < http://www.fda.gov/Drugs/ResourcesForYou/Consumers/ucm143561.htm > [Accessed January 27, 2015]
Kesselheim, Aaron S., and Choudhry, Niteesh K. “The International Pharmaceutical Market as a Source of Low-cost Prescription Drugs for U.S. Patients.” Annals of Internal Medicine, Volume 148 (2008): Pages 614-619. Available from: < http://scholar.harvard.edu/nkc/files/2008_international_drugs_for_us_patients_annals.pdf > [Accessed January 27, 2015]
Khodeli, Irakli. “Prescription Drug Importation.” Trends Alert. Lexington, KY: The Council of State Governments (2004): Web. Available from: < http://www.csg.org/knowledgecenter/docs/TA0406DrugImport.pdf > [Accessed January 27, 2015]
Pfizer Inc. Counterfeit Pharmaceuticals: A serious threat to patient safety. (2007): Web. Available from: < http://www.pfizer.com/files/products/CounterfeitBrochure.pdf > [Accessed January 27, 2015]
Schleiter, Kristin E. “Court Support for FDA Regulation of Drug Importation.” Virtual Mentor, Volume 1. Number 7(2009): Pages 521-526. Web. Available from: < http://virtualmentor.ama-assn.org/2009/07/hlaw1-0907.html > [Accessed January 27, 2015]
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