Where To Buy Prescription Drugs [PORTABLE]
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where to buy prescription drugs
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Not all websites are the same. The U.S. Food and Drug Administration warns that there are many unsafe online pharmacies that claim to sell prescription drugs at deeply discounted prices, often without requiring a prescription. These internet-based pharmacies often sell unapproved, counterfeit or otherwise unsafe medicines outside the safeguards followed by licensed pharmacies.
Earlier this year, the Governor announced that the counties of Los Angeles, Santa Clara, Alameda and San Francisco, among the largest public purchasers of prescription drugs in California, will partner with the state to use our combined market power to take on drug companies and lower the cost of prescription drugs.
Buying prescription drugs from other countries is one way some Americans have coped with rising drug prices. A new University of Florida study, published today in JAMA Network Open, finds that 1.5% percent of adults, or more than 2 million Americans, purchase their prescription drugs from outside the U.S. to save money.
The UF researchers caution that with the rapid growth in unemployment related to the COVID-19 pandemic and subsequent loss of health insurance, the number of Americans searching for cheaper prescription drugs is likely to rise. Their findings may actually be an underestimation.
Last year, the Trump administration announced plans to allow importation of drugs from Canada in an effort to stimulate price competition. The U.S. Food and Drug Administration introduced the Safe Importation Action Plan, with proposed pathways to allow for the safe importation of drugs originally intended for foreign markets. If finalized, the plan would permit U.S. consumers to purchase certain drugs from Canada.
Safety is a real concern with purchases of international drugs, UF researchers say. The World Health Organization conservatively estimates that 1 in 10 medications sold in the world are substandard or falsified.
For the study, researchers analyzed data from the 2015-2017 National Health Interview Survey, a nationally representative study conducted by the National Center for Health Statistics in order to track health status and health services use. Participants were asked if they had purchased prescription drugs from countries outside the U.S. to save money. Those who had were more likely to be older, be an immigrant, and have inadequate insurance coverage and financial constraints that impact their ability to refill prescriptions. They were also more likely to use the internet for health care information.
The high cost of prescription drugs continues to be a top health priority for the public. Policymakers at the federal and state level are pursuing a range of options to lower drug prices for Americans, one of which would allow for the safe importation of prescription drugs from Canada and other countries, based on evidence showing that people often pay more for medications in the U.S. than elsewhere. In an executive order issued July 2021, President Joe Biden directed the Food and Drug Administration (FDA) to work with states to import prescription drugs from Canada, an approach that was put into place by the previous Administration and has bipartisan support among the general public (Figure 1).
These FAQs discuss recent efforts related to prescription drug importation, the history of this approach, challenges that previous efforts to carry out importation proposals have faced, and stakeholder views.
Current law allows for the importation of certain drugs from Canada under defined, limited circumstances, and only if the Secretary of the United States Department of Health and Human Services (HHS) certifies that importation poses no threat to the health and safety of the American public and will result in significant cost savings to the American consumer. In September 2020, the Trump Administration issued a final rule and final FDA guidance, creating two new pathways for the safe importation of drugs from Canada and other countries, and then-HHS Secretary Alex Azar certified that importation of prescription drugs poses no risk to public health and safety and would result in significant cost savings.
Many studies have shown that people in the United States often pay more for their prescription drugs than in other developed countries, including Canada. According to one analysis of a subset of single-source brand-name drugs, Canadian drug prices are about 28% of the price in the United States, while another analysis of a broad range of drugs found that Canadian prices are 46% of those in the United States.
The Medicare Modernization Act of 2003 (MMA) amended the Section 804 importation language that was added by the MEDS Act. The MMA specifies that wholesalers and pharmacists can only import prescription drugs from Canada, not other industrialized countries. The MMA also authorizes the Secretary to terminate such importation programs if they do not meet safety standards or result in a significant reduction in costs for consumers. The MMA also requires the HHS Secretary to issue regulations that would grant waivers to individuals to import drugs for personal use under certain circumstances.
Importation of prescription drugs under conditions set forth first by the MEDS Act, and then by the MMA, could allow wholesalers and pharmacists to obtain FDA-approved drugs at lower prices than are available in the U.S. by purchasing them from foreign sellers, and pass these savings on to U.S. consumers.
In September 2020, the Trump Administration issued a final rule and final FDA guidance for the importation of prescription drugs. The final rule would authorize states, territories and Indian tribes, and in certain future circumstances wholesalers and pharmacists, to implement time-limited importation programs, known as Section 804 Implementation Programs or SIPs, for importation of prescription drugs from Canada only. States, territories, and Indian tribes could submit proposals to the HHS Secretary to manage these SIPs and act as SIP sponsors.
In order for a proposal to be approved by HHS, a SIP sponsor would need to specify: the drugs it seeks to import; the foreign seller in Canada that would purchase the drug directly from its manufacturer; the importer in the U.S. that would buy the drug directly from the foreign seller in Canada; the re-labeler or re-packager of the drug itself that would ensure the drug meets all labeling requirements in the U.S.; the qualifying lab that would conduct testing of the drug for authenticity and degradation; and steps that would be taken by the SIP to ensure the supply chain is secure. SIPs would initially be authorized for 2-year periods with the possibility of 2-year extensions.
Under the final rule, which allows states and other entities to facilitate importation of drugs from Canada, only drugs that are currently marketed in the U.S. would be eligible for importation. As under current law, certain types of drugs are excluded from the definition of a prescription drug eligible for importation including: controlled substances, biological products (including insulin), infused drugs, intravenously injected drugs, and inhaled drugs during surgery. Furthermore, drugs that are subject to risk evaluation and mitigation strategies (REMS), which are high-risk products with serious safety concerns, such as opioids, are not eligible for importation.
Under the final FDA guidance, which allows manufacturers to import drugs to the U.S. that were manufactured and intended for sale in other countries (not limited to Canada), prescription drugs, including biological products excluded under the final rule, could be imported and made available to patients. These drugs must also currently be marketed in the U.S. to be eligible.
In most circumstances, it is illegal for individuals to import FDA-approved drugs from other countries for personal use. However, based on changes enacted by the MMA, personal importation of prescription drugs that have not been approved by the FDA for use in the U.S. is permitted on a case-by-case basis. Under this statutory authority, FDA has put out guidance that lays out certain circumstances where importation of non-FDA approved drugs for personal use might be allowed. For example, personal importation is generally allowed if the treatment is for a serious condition, there is no effective treatment available in the U.S., and there is no commercialization of the drug for U.S. residents. Typically, only a three-month supply is allowed, and individuals most confirm in writing that the drug is for personal use and provide information about the physician responsible for their treatment. 041b061a72