Importing drugs: a viable solution?The cost of prescription drugs prescription drug Prescription medication Pharmacology An FDA-approved drug which must, by federal law or regulation, be dispensed only pursuant to a prescription–eg, finished dose form and active ingredients subject to the provisos of the Federal Food, Drug, continues to be a serious access issue in the United States United States, officially United States of America, republic (2005 est. pop. 295,734,000), 3,539,227 sq mi (9,166,598 sq km), North America. The United States is the world's third largest country in population and the fourth largest country in area. . It is of particular concern for the elderly and the disabled who utilize the most prescription drugs. [ILLUSTRATION OMITTED] A growing number of people are responding to this situation by purchasing their medications at lower prices from other countries, principally Canada. President Bush recently signed a Medicare prescription drug benefit, and a number of private sector health plans are developing options that provide increased prescription drug coverage. However, even if these and related initiatives are implemented, many individuals will still experience significant out-of-pocket expenses out-of-pocket expenses n. moneys paid directly for necessary items by a contractor, trustee, executor, administrator or any person responsible to cover expenses not detailed by agreement. for their prescription drugs. Importation as a solution to the problem Wide-scale importation of prescription drugs from other countries for use in the U.S. is being explored by several states as a partial solution to reducing the cost of prescription drugs. This activity is driven by the significant price differential between the costs of prescription drugs in the United States compared to the cost of the same drugs in other countries. For example, one study showed that, based on the average price of prescription drugs in each country, $1 of cost for prescription drugs in the U.S. translates to 64 cents in the United Kingdom, 60 cents in Germany and Sweden, 51 cents in France and 49 cents in Italy. The reason for this price disparity is that governments in many other countries regulate drug prices. This regulation may involve direct price controls (France, Italy, and Canada); indirect control through limits on reimbursement Reimbursement Payment made to someone for out-of-pocket expenses has incurred. under social insurance systems (Germany and Japan); or through controls on profits (United Kingdom). Currently, importation of drugs for the purpose of direct sale to consumers is illegal in the U.S. However, pharmaceutical manufacturers may import drugs that have been manufactured by or for them in another country if the manufacture and distribution of these drugs meet the standards set by the Food and Drug Administration (FDA FDA abbr. Food and Drug Administration FDA, n.pr See Food and Drug Administration. FDA, n.pr the abbreviation for the Food and Drug Administration. ). In response to the restrictions on prescription drug importation, several states have announced plans to set up systems to make such importations legal (Illinois and Vermont) to save money for both the state and consumers. The state of Illinois has estimated that the state could save taxpayers about $90 million per year. They also believe they can do this in a safe manner. The city of Springfield, Massachusetts Springfield is a city in Massachusetts, United States. It is the county seat of Hampden County.GR6 In the 2000 census, the city population was 154,082. has already set up a program that is facilitating access to medications from Canada. Since 1999, members of the U.S. Congress have also become involved in the effort to make it legal to import prescription drugs for direct sale to consumers. In 2000, Congress passed the Medicine Equity and Drug Safety Act (H.R. 5426) that allowed the importation of prescription drugs with the restriction that the secretary of Health and Human Services Noun 1. Secretary of Health and Human Services - the person who holds the secretaryship of the Department of Health and Human Services; "the first Secretary of Health and Human Services was Patricia Roberts Harris who was appointed by Carter" would have to certify that such imports would not increase health risk. However, both the Clinton and the Bush Administrations decided that the safety concerns were too great to permit implementation of that law. This act is still in effect and could be used to authorize To empower another with the legal right to perform an action. The Constitution authorizes Congress to regulate interstate commerce. authorize v. to officially empower someone to act. (See: authority) the importation of drugs. In 2003, several bills were introduced in Congress designed to permit the importation of prescription drugs from other countries. The House of Representatives passed one of these, H.R. 2427, (The Pharmaceutical Marketing Access Act of 2003). Under the terms of this Act, the FDA must design and implement a system to grant individuals, pharmacists This is a list of notable pharmacists.
v. in·dus·tri·al·ized, in·dus·tri·al·iz·ing, in·dus·tri·al·iz·es v.tr. 1. To develop industry in (a country or society, for example). 2. nations abroad. In addition, the bill does not require the certification of importation of drugs as in H.R. 5426. The Senate has received this bill but has not yet considered it. Of potentially greater significance is the Drug and Medicare Improvement Act of 2003, separate versions of which were passed in the House and the Senate (i.e., H.R. 1 and S 1, respectively). [ILLUSTRATION OMITTED] The House version included a provision that would permit the importation of prescription drugs from Canada. In contrast, the Senate version did not include provisions for drug importation. The two versions are now in a conference committee for resolution. It is widely believed that a compromise will be reached to permit reimportation re·im·port tr.v. re·im·port·ed, re·im·port·ing, re·im·ports To bring back into a country (goods made from its exported raw materials). re·im to be a component of this act. This would then become law if the Drug and Medicare Improvement Act is approved and sign into law. Positions for and against importing drugs The FDA opposes the importation of prescription drugs. It contends that many drugs from foreign sources are of unknown quality and some of them pose a hazard to the health of those who consume them. Examples of such hazards include drugs that are expired, subpotent, contaminated contaminated, v 1. made radioactive by the addition of small quantities of radioactive material. 2. made contaminated by adding infective or radiographic materials. 3. an infective surface or object. , counterfeit To falsify, deceive, or defraud. A copy or imitation of something that is intended to be taken as authentic and genuine in order to deceive another. A counterfeit coin is one that may pass for a genuine coin and may include a lower denomination coin altered so that it may , improperly packaged or contain an incorrect dose. In addition, improper packaging and instructions in languages other than English LOTE or Languages Other Than English is the name given to language subjects at Australian schools. LOTEs have often historically been related to the policy of multiculturalism, and tend to reflect the predominant non-English languages spoken in a school's local area, the are ongoing concerns. A series of spot examinations of mail shipments of foreign drugs to consumers in the U.S. conducted by the FDA in July and August of 2003 found that of the 1,153 drugs examined, 88 percent did not meet FDA standards. Violations recorded from this review revealed several previously unrecognized categories of non-compliance with FDA regulations and included the presence of veterinary drugs not approved for human use, drugs withdrawn from the market and drugs with dangerous interactions. A recent study from Illinois noted that prescription medications from Canada were safe and effective. The study stated that Canadian authorities using standards that were "substantially equivalent" and sometimes exceeded U.S. standards regulated drugs sold in Canada. The study concluded that reimportation from Canada was safe. The major pharmacy associations The following is a list of organizations for professionals involved in the practice of pharmacy. Such organizations are typically professional societies, as opposed to trade associations. in the United States also oppose the importation of prescription drugs. Their analysis of the situation adds several additional concerns to the debate. For example, they point out that the FDA has very limited resources for inspecting shipments of prescription drugs from abroad and would be unable to detect many of the unsafe drugs that cross the border. In addition, they point out that the individuals or corporations responsible for the creation, distribution or selling of these substandard substandard, adj below an acceptable level of performance. prescription drugs would become difficult to trace since it would often be impossible to tell precisely where the drugs came from or the conditions under which they were manufactured or distributed. Finally, they believe that some drugs from Canada or the European Union European Union (EU), name given since the ratification (Nov., 1993) of the Treaty of European Union, or Maastricht Treaty, to the European Community may often not meet FDA standards. Strong support for the importation of prescription drug comes from consumer advocate groups. They emphasize the growing inability of seniors to pay for their prescription drugs and the human tragedies that result. They also emphasize the high levels of profitability of the pharmaceutical industry, the amount of money that the industry spends on marketing, and the vast differential in prices charged for prescription drugs in the United States as compared with most other countries in the world. What happens next? Problems associated with the high cost of prescription drugs in the United States are serious and appear to be growing over time, with no clear resolution in sight. Public opinion polls indicate strong public support for the importation of cheaper drugs from other countries. Many people in the U.S. are resorting to this practice even though it is currently illegal but rarely enforced. However, this practice is a perilous one as indicated by data from the FDA on the many potential and real health threats from imported drugs, and the fact that even if the practice were made legal, FDA does not have sufficient staff to adequately monitor the safety of imported drugs. Recently the Governors of Iowa The following is a list of the Governors of the State of Iowa and Iowa Territory.
While the ultimate solution is a comprehensive, affordable Medicare prescription drug benefit, few observers believe that the benefits proposed under the current versions of this legislation will totally resolve the issue. Therefore, health care providers and organizations can probably look forward to continuing turmoil in the area of prescription drug costs for the foreseeable future. At the end of the day, affordable, safe and effective pharmaceuticals should be available for all Americans. After all, equal access to the miracle of modern medicine depends on it. Resources 1. The newsletter with Jim Lehrer/Kaiser Family foundation/Harvard School of Public Health, "National Survey on Prescription Drugs," September 2000. (Available at www.kff.org) 2. AARP/Research Center, "Medicare Beneficiaries and Prescription Drugs: Costs and Coverage," 2003. (Available at www.reaearch.aarp.org) 3. Current legislation on drug importations pending in Congress includes H.R. 2427 The Pharmaceutical Marketing Access Act of 2003 and S.R 1 and H.R. 1 Drug and Medicare Improvement Act of 2003. 4. Web site of Representative Bernie Sanders Bernard "Bernie" Sanders (born September 8, 1941) is the current junior United States Senator from Vermont. Sanders was elected on November 7, 2006, and is presently a member of the 110th United States Congress. , "U.S. vs. the World: Prescription Drug Prices," 2003. (Available at www.bernie.house.gov/prescriptions/high.cost.asp) 5. Committee on Government Reform, Subcommittee on Human Rights The Subcommittee on Human Rights (DROI) is a subcommittee of the Committee on Foreign Affairs of the European Parliament. Standing Committees of the European Parliament 6. U. S. Food and Drug Administration, "FDA/US Customs Import Blitz Exams reveal Hundreds of Potentially Dangerous Imported Drug Shipments," September 29, 2003. (Available at www.fda.gov/bbs/topics/NEWS/2003/NEW00948.html) 7. Danzon, P M., "Making Sense of Drug Prices" Regulation, Volume 23, No. 1, 2000. 8. An example of a state request (i.e., from Illinois) to import prescription drugs addressed to the FDA may be found at www.affordabledrugs.il.gov/letters.cmf. Georges C. Benjamin, MD, FACP FACP Fellow of the American College of Physicians. FACP abbr. 1. Fellow of the American College of Physicians 2. Fellow of the American College of Prosthodontists , is executive director of the American Public Health Association The American Public Health Association (APHA) is Washington, D.C.-based professional organization for public health professionals in the United States. Founded in 1872 by Dr. Stephen Smith, APHA has more than 30,000 members worldwide. in Washington, D.C. He can be reached by phone at 202-777-2430 or by e-mail to georges.benjamin@apha.org Richard Levinson Richard Levinson (August 7, 1934 - March 12, 1987) was an American writer and producer who often worked in collaboration with William Link. He was born in Philadelphia, Pennsylvania, and attended the University of Pennsylvania, where he earned a Bachelor's Degree in Economics in , MD, DPA DPA - Data Protection Act , is associate executive director for scientific affairs at the American Public Health Association. By Georges C. Benjamin, MD, FACP and Richard Levinson, MD, DPA |
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