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PharmacyChecker Informs Surgeon General and HHS On Safe Use of Online Pharmacies To Improve Medication Adherence

The problem of Americans not taking medications is caused by high costs of prescription drugs, undesirable side-effects, health literacy, forgetfulness among other reasons. Medication non-adherence is a $317 billion problem. The U.S. Surgeon General and the Department of Health and Human Services issued a request to individuals and organizations to submit information about the national problem of medication adherence. Specifically, the government’s request presents “the opportunity to identify issues relevant to all levels of government, as well as individuals, health care providers, and industry and private organizations in efforts to improve medication adherence in adults with chronic conditions.”

Since cost is one of the critical factors inhibiting Americans from getting needed medication, we believe the government should take more proactive steps to provide useful information about how to obtain affordable medication online. Our analysis and recommendations are published below. For a PDF copy click here.


The Honorable Howard K. Koh, MD., M.P.H.
Assistant Secretary for Health
The Honorable Vice Admiral Regina M. Benjamin, M.D., M.B.A.
Surgeon General of the United States
Room 710-H
200 Independence Ave., SW
Washington DC 20201

Re: Request for Information on Prescription Medication Adherence

Submitter: Gabriel Levitt, Vice President, PharmacyChecker.com, 333 Mamaroneck Avenue, White Plains, NY 10605. (718) 387-4526, Gabriel.levitt@pharmacychecker.com.

Prescription medication non-adherence should be treated as a national crisis since so many Americans suffer as a result. Some of the reasons for non-adherence are health literacy, psychological issues, side effects of medications, and lack of support systems. There are also tens of millions of Americans who simply can’t afford medication. A survey by the Commonwealth Fund found that 48 million Americans did not fill a prescription in 2010 due to high medication costs.[i] The data show the negative health and economic effects of non-adherence to prescription medication. First, it’s been reported that 121,000 people die each year due to prescription non-adherence.[ii] Second, according to the FDA, non-adherence to prescription medication costs the country $290 billion annually in additional health care costs.[iii] Third, numerous studies have shown that cost is either the number one reason, or a major factor for non-adherence. [iv]

Access to safe and affordable medication should be encouraged through all available sources, including personal drug importation. Over the past 15 years millions of Americans have obtained needed prescription drugs through non-U.S. online pharmacies, despite its technical illegality. Currently, the U.S. Food and Drug Administration does not prosecute people for small quantities of personal drug imports.

The FDA discourages Americans from ordering from any non-U.S. online pharmacy, not because it’s illegal but for safety reasons. Its position is that the drugs ordered from Canadian and other foreign pharmacies are not regulated by the FDA, and are therefore unsafe. That position is simply unsubstantiated. Fortunately for people living in other countries there are other national regulatory authorities that regulate drugs to make sure they are safe and effective.

We’ve established that the problem of prescription medication adherence is so severe in large part due to high drug prices.  If it is safe to order less expensive medication online that allows Americans to adhere to their doctor’s prescription then we should encourage their use. Are non-US online pharmacies safe?

The evidence shows that properly credentialed non-US online pharmacies which fill orders from licensed pharmacies, require a valid prescription, and provide verifiable contact information on their websites safely dispense genuine medication. The medication purchased for personal drug importation is often the same brand name product – from the same manufacturer – sold here but at a much lower price, often 80% less than U.S. pharmacies. A consumer is almost certain to receive proper care and safe medications from one that meets the aforementioned criteria and is certified in the PharmacyChecker.com Verification Program.[v] In fact, U.S. Government Accountability Office studies have shown the relative safety of Canadian online pharmacies compared to U.S. online pharmacies.[vi]

We recommend that the Secretary of Health and Human Services instruct the U.S. Food and Drug Administration to:

  1.      Correct its website and consumer communications about online pharmacies to reflect the facts demonstrated by over a decade of studies and consumer experience.  The FDA website should communicate that “if you decide to purchase medication online from Canada or another country then only use properly credentialed websites.”
  2.     Explicitly allow, at least on a temporary basis, personal drug importation through properly credentialed non-US online pharmacies.

By taking these steps fewer Americans will go without needed prescription medication because it will be affordable.  Moreover, more people taking prescribed medication will lead to fewer hospitalizations and emergency room visits, resulting in lower healthcare costs for the nation.

Sincerely,

Gabriel Levitt
Vice President
PharmacyChecker.com, LLC


[i] Commonwealth Fund: http://www.commonwealthfund.org/Surveys/2011/Mar/2010-Biennial-Health-Insurance-Survey.aspx.

[ii] Cut Copayments to Bolster Adherence”, The Center for Medicine in the Public Interest, See http://www.cmpi.org/in-the-news/in-the-news/cut-drug-copayments-to-bolster-adherence/(last accessed July 27, 2011).

[iii] Campaign to Improve Poor Medication Adherence (U18), A Notice by the Food and Drug Administration on 03/09/2011, See http://www.federalregister.gov/articles/2011/03/09/2011-5287/campaign-to-improve-poor-medication-adherence-u18#p-13, (last accessed July 27, 2011).

[iv] For more information see: http://www.federalregister.gov/articles/2011/03/09/2011-5287/campaign-to-improve-poor-medication-adherence-u18; http://www.nclnet.org/images/PDF/adherence_focus_groups.pdf; http://www.hsph.harvard.edu/news/press-releases/2008-releases/poll-usa-today-kaiser-harvard-prescription-drugs.html (last accessed July 27, 2011)

[v] Bate, Roger, Ginger Zhe Jin and Aparna Mathur. “Unveiling the Mystery of Online Pharmacies: An Audit Studay”. National Bureau of Economic Research. Working Paper #17655 (http://www.nber.org/papers/w17955.pdf). April 2012.

[vi] U.S. Government Accountability Office. Some Internet Pharmacies Pose Safety Risks For Consumers, GAO-04-820. Washington, DC. Government Accountability Office June 2004. See http://www.gao.gov/new.items/d04820.pdf (last accessed June 26th, 2011).

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Fake Adderall Sold Online According to FDA, Warns Consumers

Consumers searching for Adderall online should use extreme caution. The FDA announced that it found fake Adderall, a drug for Attention Deficit Hyperactivity Disorder and Narcolepsy, is being sold online. Adderall is a controlled substance, a prescription drug with greater addictive potential and subject to strict regulatory controls. Reputable international online pharmacies, such as those approved in the PharmacyChecker.com Verification Program, do not sell this product or other controlled substances to Americans.

Sales of controlled substances online are governed by the Ryan Haight Online Pharmacy Consumer Protection Act, which expressly bans the sale to Americans of controlled substances online from pharmacies that are not registered with the U.S. Drug Enforcement Agency. The Act also prohibits pharmacies from dispensing controlled medication based only on a remote medical consultation, meaning the patient’s prescription must be the result of an initial physical exam. For more see PharmacyChecker.com: Controlled Substances and Online Pharmacies – Use Extreme Caution.

The FDA did not identify the websites that are selling the fake Adderall. According to the FDA, the fake Adderall contained Tramadol and acetaminophen, which is medication to treat pain. The FDA’s announcement also included pictures of authentic and fake Adderall.

Legitimate Adderall manufactured by Teva

Legitimate Adderall

Counterfeit Adderall discovered by the FDA

Counterfeit Adderall

Whether the problem is lack of supplies, which is a current problem for Adderall, or high costs, it is understandable that Americans are trying to find access online to needed medication that they cannot get at their local drugstores. But it’s critical to use common sense and only buy from credentialed online pharmacies. This will enable you to get most medications you need and protect yourself from falling victim to fake and dangerous drugs.

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McCain Amendment, CBS News and World Leaders on Online Pharmacies

McCain Amendment.

Senator John McCain (R-AZ) introduced an amendment to the Pharmaceutical Drug User Fee Act authorization bill that would create explicitly legal access to and facilitate safe and affordable medicine from Canadian pharmacies through a government list of online pharmacies. Sen. McCain should be applauded for continuing his efforts on this issue. Unfortunately, the amendment was voted down 43 to 54.

In his floor statements, predicting his amendment’s failure, Senator McCain communicated that too many of our elected representatives are beholden to the pharmaceutical industry. For that reason, we can expect future legislative actions to curb access to safe personal drug imports. Due to FDA’s current regulatory practices, Americans are not prevented from obtaining needed medications from verified international online pharmacies.


CBS News On Online Pharmacies and Drugs Safety

In a recent article, CBS News informs American consumers on critical issues of drug safety. When it comes to ordering prescription drugs online, especially from outside the United States, the article is clear that Americans should only shop from properly credentialed online pharmacies, such as those approved by PharmacyChecker.com.

Americans should take other precautions as well. For instance, you should only take prescription medications prescribed to you from your doctor. Check expiration dates to make sure your prescription product is still effective. Before taking medication, look at it closely for any indication something is not right, including disintegration or discoloration.


Online pharmacies discussed by world leaders at G8 summits

 Leaders from the world’s most advanced economies discussed online pharmacies at the recent G8 conference.  The topics discussed also included economic growth and development, food and nutrition, and international security. Global health experts criticized the G8’s agreement, as published in the Camp David Declaration, for an over-emphasis on intellectual property protection in its section that mentioned drug safety.

Americans who buy medication safely from properly credentialed international online pharmacies should be concerned about high level talks that address this issue. The pharmaceutical industry’s anti-consumerist positions on intellectual property rights are often overrepresented in such international organizations, and the industry seeks global action to shutdown safe international online pharmacies.

On the other hand, looking at the glass half-full, the Camp David Declaration makes clear that public safety – not intellectual property rights – are the goal in fighting rogue online pharmacies and counterfeit drugs:  “To protect public health and consumer safety, we also commit to exchange information on rogue internet pharmacy sites in accordance with national law and share best practices on combating counterfeit medical products.”

We strongly support international actions to thwart the sale of dangerous medications online to protect both American and global patients. In fact, PharmacyChecker.com has been dedicated for almost a decade to evaluating online pharmacies in order to provide information about those that sell safe and affordable medication.

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