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Saturday, December 24, 2011

E-Pharmacies Alert


Americans take pills for all their ills and inconveniences -- to diet, to sleep, to focus, to perk up, to have better sex. The list of maladies supposedly helped by pills is monumental in number and distribution is encouraged by both pharmaceutical companies pushing profits and medical doctors fearing under-prescibing the symptoms of pain. In short, it seems almost everyone, even more and more youngsters, are taking prescription medication. One author recently called production, distribution, and consumption the “pharmaceuticalized American life.” (Michiko Kakutani, from book Tense? Lonely? There’s Promise in a Pill, The New York Times, September 30, 2005

"The total number of annual prescriptions in the United States now stands at about three billion (figures from 2005)," says Greg Critser, author of Generation Rx. "The cost per year? About $180 billion, headed to an estimated $414 billion by 2011." He adds that spending on all forms of drugs to treat childhood and adolescent behavioral disorders rose by 77 percent between 2000 and 2003, "with 65 percent of all children on such drugs taking at least one antidepressant." (Michiko Kakutani, from book Tense? Lonely? There's Promise in a Pill, The New York Times, September 30 2005)

Professor Michael Wilkes of U.C. Davis School of Medicine claims that “Americans have grown accustomed to having a drug for every single problem and for things we wouldn’t think of as problems.” ("Healthcheck: Are Doctors Over-Prescribing Medications?" CBS  television broadcast, February 9, 2006) This way of thinking has created an environment in which physicians, under pressure from their harried patients, are not under-prescribing, which would be neglectful, but actually over-prescribing.

Prescription writing has become more and more patient driven. Here is how it works. Patients walk into their doctors' offices and demand that the physicians prescribe them a certain medicine. (Amy Harmon, "Young, Assured and Playing Pharmacist to Friends." The New York Times, November 16, 2005) Of course, the pharmaceutical companies, in their slick and slanted advertising campaigns, have created intense desires for the products and essentially promised that these prescriptions will "cure what ails you."

Make no mistake, physicians who won’t prescribe what the patients want soon find themselves one patient short because the patient will move on to find a doctor willing to prescribe whatever he desires. (Amy Harmon, "Young, Assured and Playing Pharmacist to Friends." The New York Times, November 16, 2005) This has become commonly known as "doctor shopping." As patients actually go from doctor to doctor to find a doctor that will prescribe what they want, they become the self-appointed, primary purveyors of their own needed treatment, and they often ignore doctors' diagnoses.

Driven by drug companies, who convince shoppers with clever ad campaigns that rx drugs no longer carry the taboo they did in the past, these doctor shoppers have modified the course of normal treatment. No longer do doctors absolutely control the supply of meds. Knowing this, the pharmaceutical firms' focus on sales has changed prescription management from being reliant on doctors' expertise and evaluation to being patient driven and very often irresponsible.

This dependence on prescriptions is not just reserved for the adult population. America’s children are being placed on drugs to solve all sorts of “disorders.” (Gardiner Harris, "Sleeping Pill Use by Youths Soars, Study Says," The New York Times, October 19, 2005)  A recent study found that the use of sleeping pills among children and very young adults increased eighty-five percent from 2000 to 2004.147 Many children taking sleeping pills are also given pills to treat attention deficit and hyperactivity disorder (ADD and ADHD).

We have become a 21st century culture that accepts the idea that pills can cure virtually any discipline problem or other social difficulty as it presents itself in life. Sociologist Christopher Lasch, in his book, The Culture of Narcissism, writes about the tendency to seek medical treatment for life and family problems. This inclination results in “people who grow up thinking there’s a pill for every ill and who seek quick fixes for life’s troubles.” (Christoper Lasch, The Culture of Narcissiam: American Life in an Age of Diminishing Expectations, 1991)

E- Pharmacies

America demands more and more convenience at reduced prices to accommodate their pharmaceutical needs and desires. Pharmacies which conduct business on the Internet (e-pharmacies) have grown exponentially over the past fifteen years. Two million packages of pharmaceuticals arrive annually by international mail from Thailand, India, South Africa and other points. Still more packages come from online pharmacies in Canada.("Millions of Americans Look Outside U.S. for Drugs," Washington Post, October 23 2003) These types of pharmacies provide many advantages to consumers, including convenience and reduced prices.

Authorities are concerned with the prevalence of e-pharmacies because the Internet simplifies bypassing pharmaceutical safeguards. (Janet Woodcock, Hearing Before the Subcomm. on Oversight and Investigations of the H. Comm. on Commerce, 106th Congress. 1999),  The Internet makes it easier for patients to bypass pharmaceutical safeguards because some pharmacies dispense drugs without a prescription or without appropriate identity verification. These e-pharmacies allow prescription drug users to obtain their medications without having to comply with state prescription drug regulations.

There are e-pharmacies that offer legitimate services and adhere to the safeguards, but there are
also “rogue” pharmacies that circumvent them. Herein lies the problem -- some of these e-pharmacies are making doctor shipping relevant.

Rogue drug sites often trace back to complex organized criminal networks that are manufacturing unregulated and dangerous medicines and are knowingly peddling these dangerous drugs to consumers around the world. Rogue Internet drug sites are often a major source of funds for criminal networks.

There are basically three types of online pharmacies:

 1. Mail-order Pharmacies

General's Acct. Off. Report ot Congressional Requesters, Internet Pharmacies , 2000) These pharmacies abide by the safeguards which are in place and offer many advantages to consumers. Because they follow pharmaceutical regulations, these
pharmacies are considered safe and are not under strict scrutiny by federal and state authorities. They, generally, are not seen as contributors to the diversion and abuse of prescription drugs.

2. Questionnaire Pharmacies

A second type of pharmacy, questionnaire pharmacies, provide medication without a physical examination by the doctor. (See U.S. General's Acct. Off. Report ot Congressional Requesters, Internet Pharmacies , 2000) The examination is replaced by a medical questionnaire in which the patient details medical symptoms. These types of pharmacies typically have a physician on staff who evaluates the questionnaires and makes a diagnosis based upon the questionnaire. Questionnaires are often brief and very general in nature.

Here is an example of a questionnaire operation. According to their plea agreements, from March 2005 to October 28, 2005, Jose Riopedre opened and operated Waterview Pharmacy (Waterview), located in Laurel, Maryland, with the assistance of his wife, Susana Mende and from April 2006 to October 2006, Riopedre and Mendez were involved with the operations of Union Pharmacy (Union), located in Silver Spring, Maryland, which was owned by co-conspirator Josiah Akinsoji.

"Both of these pharmacies received all of their prescriptions orders from the Internet and were part of an Internet pharmacy business that was connected to a network of websites, businesses, and doctors who utilized the Internet unlawfully to sell controlled substances to customers throughout the United States.

 

"The unlawful Internet pharmacy websites, several of which were controlled by co-conspirator Eduardo Garcia, allowed customers to place orders for various prescription drugs, including controlled substances, after the customer completed a brief on-line questionnaire describing the customer’s medical background and the customer’s reason for requesting the prescription drug. 

"The questionnaires were forwarded to a group of licensed physicians located in Puerto Rico, who purportedly reviewed the questionnaires and approved the requests for the controlled substances. The customer never met or spoke with a doctor, or had his or her questionnaire verified. The controlled substances were not issued for a legitimate medical purpose because the customers ordering the controlled substances and the doctors approving the orders had not established a valid doctor-patient relationship. 

"Customers were not required to submit a valid form of identification or a valid prescription prior to ordering the controlled substances through either ordering method. The unlawful Internet pharmacy websites lacked controls to prevent customers from ordering multiple prescriptions for the same controlled substance on the same day or before a previous prescription should be refilled.
  

"Mendez and Riopedre also operated two businesses that collected the payments from the customers, ordered and paid for the controlled substances to fill the drug orders, paid the brick and mortar pharmacies which actually filled each prescription and paid the coconspirator doctors for each customer order reviewed.


"During their respective periods of operation, Waterview and Union filled and distributed by overnight delivery thousands of prescriptions for Phentermine, a drug generally used for weight loss, outside the scope of professional practice and not for a legitimate medical purpose. These drug orders were filled in Maryland and shipped to customers in numerous states including Louisiana, Ohio, Florida and Texas. This business netted Riopedre and Mendez in excess of $1,500,000." (Ausa Vickie E. Leduc and Marcia Murphy, "Two Conspirators Sentenced In Illegal Internet Distribution of Prescription Diet Drugs," http://www.justice.gov/usao/md, July 15 2009)

3. Rogue Pharmacies

The third type of pharmacies have been called “rogue” pharmacies because they do not require a prescription or consultation and do not even pretend to require a medical history by using a questionnaire. (See U.S. General's Acct. Off. Report ot Congressional Requesters, Internet Pharmacies , 2000)

These pharmacies dispense prescription drugs without any type of physical examination and typically do not employ physicians to review questionnaires. Generally, these types of pharmacies allow consumers to easily obtain prescriptions without verifying identification or the existence of a legitimate medical problem. These sites are frequently used to obtain the types of drugs that are abused most often. (Jerry Markon, "Online Drug Ring Bust in Virginia Charges 10 People in 3 States: Federal Probe Alleges 6 Million Doses Dispensed Illegally," Washington Post, December 4, 2003

Here is an example of such a business. Rx-commission.com is a rogue operation. The drugs consumers get from the site all come from India. Proprietors of this program are from outside of the United States and have a strong Russian connection. (Brian Krebs, "FDA Targets Rogue Internet Pharmacies," The Washington Post, November 19 2009)

"The FDA's office of criminal investigations said it sent 22 warning letters to the operators of such sites, and alerted the appropriate ISPs and domain name registrars that the sites were selling phony pharmaceuticals, all without requiring a prescription.The agency said none of the sites represent pharmacies located in the United States or Canada, as many people claim.

"According to the letters sent to owners of the 136 targeted sites, the online stores hawked everything from powerful controlled substances, including Valium and Xanax, to lifestyle drugs like Viagra and Levitra. Some sites even offered prescription drugs that have not yet been approved for distribution or sale in the United States, such as the anti-obesity drug Acomplia. 


"'Many U.S. consumers are being misled in the hopes of saving money by purchasing prescription drugs over the Internet from illegal pharmacies,' FDA Commissioner Margaret A. Hamburg said in a prepared statement. 'Unfortunately, these drugs are often counterfeit, contaminated, or unapproved products, or contain an inconsistent amount of the active ingredient. Taking these drugs can pose a danger to consumers.'"

"Many of the sites named in the complaint, such as wellknowndrugs.com
and 24-7meds.com, already have been yanked offline. FDA spokeswoman Karen Riley said at least 90 of the sites named in the letters have been taken down so far."


Tell-tale Signs of a Rogue Pharmacy

They are not currently licensed by federal or state regulatory agencies or are not certified by the NABP's (National Association of Boards of Pharmacy) VIPPS (Verified Internet Pharmacy Practice Site) program.

They do not require you to visit your doctor to get a prescription. They advertise "NO PRIOR PRESCRIPTION REQUIRED" or "FREE ONLINE DOCTOR CONSULTATION."
They do not list their address. Even a site purporting to be "just across the border in Canada" may be located in Thailand, Sri Lanka, or China.
Rather than carry a full inventory of drugs as do legitimate pharmacies, they emphasize highly popular drugs, such as painkillers, weight loss, smoking cessation, and impotence drugs.
They inundate consumers with unsolicited e-mails (spam) and promote the illegal aspects of their services on large search engines.
Addressing the Problem

Recent research conducted by the Partnership at Drugfree.org found that 1 in 6 Americans - 36 million people - purchase prescription medication via the Internet without a valid prescription. When consumers purchase from a website that does not adhere to U.S. law governing the use of prescriptions, they bypass all the protections put in place to protect them; namely, that the medicines are safe and have been prescribed by a physician, and that the prescription has been dispensed by a licensed U.S. pharmacist in a licensed U.S. pharmacy. (Libby Baney, "Rogue Internet Drug Sellers Put Us At Risk," The Washington Times, November 10 2011)

The NABS has found that at least 92 percent of entities offering to sell drugs online are illegitimate and operate in clear violation of U.S. laws that were put in place to protect patients. Current data indicates approximately 80,000 websites that do not meet the U.S. standards for legitimacy, such as VIPPS, have offered prescription drugs in the last year.


The growing problem of illicit sales of medications online has garnered legislative attention. Last month, Reps. Lamar Smith, Texas Republican; John Conyers Jr., Michigan Democrat; Bob Goodlatte, Virginia Republican; Howard L. Berman, California Democrat, and eight other members of Congress introduced the Stop Online Piracy Act in the U.S. House of Representatives. It is companion legislation to a bill authored in the Senate earlier this year.

The bill addresses a number of important intellectual-property issues. 
It also helps protect consumers against the public health threat of illicit sales of medications online. 
The bill encourages private companies to stop doing business with illegal online drug sellers 
that endanger public health. Included are companies that host these sites, 
provide associated advertising or help facilitate their payment transactions. 
If enacted, this legislation could help shut down the worst-of-the-worst rogue Internet drug sellers. 

 (Libby Baney, "Rogue Internet Drug Sellers Put Us At Risk," The Washington Times, November 10 2011)

IN THE WAR ON PRESCRIPTION DRUG ABUSE, E-PHARMACIES ARE MAKING DOCTOR
SHOPPING IRRELEVANT,  2007 Amy L. Cadwell, Houston Journal of Health Law & Policy
ISSN 1534-7907.
Read this here: http://www.law.uh.edu/hjhlp/issues/vol_71/hhl103.pdf
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