Langston EL. The Quality Quandary. California Western Intl Law J. 2005;36:19-32.
America’s physicians write over three billion prescriptions a year for patients1—and they need to know that when patients fill those prescriptions, the drugs they take are safe. Physicians want their patients to be able to get those drugs at the lowest price possible. Patient safety and drug quality are the overriding issues, as physicians work with their patients to make prescription drugs more available and affordable. Patients are rightly concerned over the cost of prescription medication and are seeking alternative sources to fulfill their prescription drug needs. Many are turning to international pharmacy outlets as a resource and the Internet. The Internet option creates a special concern for physicians, as not all Internet sources are reliable or ethical. Further, importation creates safety issues. Using Canada as an example, there is considerable misunderstanding within the general public regarding the authenticity of medications imported or reimported from Canada. Many drugs sold there are manufactured in othercountries where the U.S. Food and Drug Administration (FDA) has no authority. These issues and others become even more complex and are not easily addressed simply by contracting with an international pharmaceutical drug distributor, as many states have done or are considering. Therefore, to ensure that patient safety is the primary concern, drugs should be FDA-approved, the distribution chain should remain closed, products should be subject to track and trace technology, and FDA resources should be adequate to ensure authenticity and integrity of imported or reimported drugs.