Pharmaceutical drug importation

This is a research paper topic suggestion on the impact of pharmaceutical drug importation. With the rising costs of Rx drugs, solutions will be examined. Custom research papers on the medical industry are Paper Masters specialty.

Background of the Problem of Drug Imports

At the current time, the FDA prohibits the importation of prescription medications by private consumers, retailers and distributors, although the practice takes place despite the prohibitions. Pharmaceutical firms, however, are permitted to import FDA approved drugs, with the drugs presumably manufactured by the foreign operations of these firms. The FDA has adopted its position against the importation of prescription medications based on the premise that the quality of the drugs does not meet American standards for safety and effectiveness. This position does not make exceptions based on the nation of origin, and includes the re-importation of prescription medications that were originally manufactured in the Untied States and exported to another nation. Despite the prohibitions against importing drugs, the FDA does not vigorously enforce the regulations for private individuals.

Paper Masters suggests that a research paper on drug importation in the pharmaceutical industry should have the following elements:

1. Overview:
   1. Rising costs of Rx drugs
   2. FDA's laws on drug importation
   3. Reasons for Pharma drug importation
   4. Damage caused by drug importation to the Pharma industry (possible $ losses)
2. Drug Importation - a source of counterfeit?
3. Republican's vs. Democrats' view on Pharmaceutical drug importation (How does the recent shift in congress perhaps change the future drug import?)
4. Economic costs of counterfeiting
5. Anti-counterfeiting strategies

Background of the Problem of Pharmaceutical Drug Importation

The United States has the highest global prices for prescription medications yet has a regulatory structure that prohibits the private importation of prescription medications from other nations that have lower market prices. This results in a greater financial burden for consumers of prescription medications in the United States, with the higher price having a disproportionate impact on individuals that are less affluent and have difficulty affording prescription medications. Because financial issues have an impact on the behaviors of individuals, the high price of prescription medications can have significant health consequences for a patient population. At the same time, permitting the importation of drugs from foreign sources that are beyond the regulatory jurisdiction of the United States creates safety and efficacy issues.

The issue of high prices for prescription medications has a direct impact on nursing because it influences compliance due to the financial difficulties that some patients may experience in adhering to a drug regimen. In addition, a high cost of prescription medications can result in some individuals making decisions that involve the reduction in nutrition or other types of necessities in order to afford their drug therapy. There is also evidence indicating that patients take less than the recommended dose of a high priced prescription drug to lower costs, reducing the therapeutic effectiveness of the treatment. In the most extreme cases, the patient may not be able to undertake the drug therapy at all due to financial considerations. The high price of prescription medications also has a disproportionate impact on the elderly, with evidence indicating that approximately 14% of the social security benefit is used to pay for drugs. The problem may be compounded by inappropriate drug prescribing or by prescribing from multiple sources, which can result in the patient taking more prescription medications than necessary. As a result, nursing may become involved in a determination of the overall appropriateness of the patient's prescription drug regimen.

The importation of prescription medications from foreign sources creates safety and efficacy issues with the Food and Drug Administration (FDA) determining that 88% of the imported drugs do not meet FDA standards. The implication for nursing involves the quality of the drugs used by patients, with the potential that some imported drugs will not have sufficient therapeutic value. A sub-therapeutic dose can also compound compliance issues with patients. In addition, there is the possibility that some imported generic drugs may be unsafe due to variability in the actual dosage. There is also evidence provided by the FDA that some imported drugs include counterfeit substances and drugs that have been withdrawn from the American market due to safety concerns.