Showing posts with label counterfeit. Show all posts
Showing posts with label counterfeit. Show all posts

Wednesday, March 20, 2013

Legislation to Allow Foreign Mail-Order Pharmacies to Dispense to Patients in Maine Poses Danger to Public Health, Warns NABP


March 20, 2013

Stressing the potential danger to patients, NABP expressed its opposition to legislation introduced in Maine that would allow the dispensing of drugs from mail-order pharmacies located around the world. Maine Legislative Document 449 proposes to amend the definition of the “practice of pharmacy” to allow mail-order pharmacies located in Australia, Canada, Israel, Japan, New Zealand, Switzerland, South Africa, and the European Union to dispense drugs to patients in Maine. In a letter (PDF) to Maine Senators John L. Patrick and Douglas Thomas, and Maine Representative Erin D. Herbig, NABP notes the concern that this action, by effectively circumventing the federally regulated United States medication supply chain, would open the door to unapproved, substandard, and counterfeit drugs and pose a significant risk to patient safety. The letter highlights the fact that medications dispensed by foreign mail-order pharmacies are not approved by the US FDA, or, in many cases, by any public health authority. Since such drugs are dispensed outside the tightly regulated US drug supply chain, there is no way of knowing whether the products are substandard, adulterated, contaminated, or even toxic. As indicated in the letter, the distribution of fake cancer medication purchased from foreign sources in February 2012 serves as a prime example. The Association also expressed its concern that the proposed legislation would condone and foster violation of federal law, placing residents of Maine who might use such mail-order pharmacies in jeopardy, both legally and from a public health standpoint. Organizations providing testimony in opposition to the proposed legislation included the Partnership for Safe Medicines and Rite Aid Corporation, and both entities presented NABP’s letter to Maine legislators.
Quoted from NABP located here

Large Shipments of Fake Drugs Seized by Federal Authorities From South Carolina Warehouse


March 20, 2013

Federal authorities seized $3.6 million-worth of counterfeit drug products from a warehouse in Columbia, SC. Fakes of medications such as Viagra® and Cialis® were shipped from India and stored in the warehouse for re-shipping, indicates the US Department of Homeland Security, Immigration and Customs Enforcement. South Carolina’s Secretary of State, whose office worked with federal agents during the investigation, told The State that he is happy the products are off the streets, and he stressed the health risks of using counterfeit medications.

Thursday, February 14, 2013

Report: Common Action Needed Against Fake, Substandard Drugs


(USA.gov)
A report from the Institute of Medicine, part of the National Academies in the U.S., calls for a new agreement on an international code of practice on drug quality to counter the growing health risks from illegimiate medicines. Among the recommendations in the report are a mandatory drug tracking system and tightening the licensing requirements on U.S. drug wholesalers.
Fake and substandard medicines not only fail to provide the protection or relief promised on the drug labels, says the report, they also can expose patients to dangerous medical conditions. An example is the recent case in the U.S. of a compounding pharmacy in Massachusetts that produced a medication that sickened more than 600 people and killing 44. In addition, fake versions of the cancer drug Avastin appeared in the United States in 2011 and 2012

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Kaiser Report: IOM Proposes State, FDA Actions To Stop Growth Of Counterfeit Drugs


Feb 14, 2013

The Institute of Medicine Wednesday urged a series regulatory changes to help protect the public against buying fake or poorly made drugs. Medpage Today: IOM: Work Needed On Counterfeit Drug Problem
State licensing boards should restrict their licensing activities to drug wholesalers who have been vetted by the National Association of Boards of Pharmacy (NABP) as a way of strengthening the nation's drug distribution system, the Institute of Medicine (IOM) said Wednesday. Also, FDA should establish a public database to share information on suspended or revoked wholesale licenses, the body suggested as part of its long list of recommendations. "Some states require NABP accreditation of wholesalers, but unscrupulous businesses can seek out states with lower standards for their headquarters," the IOM's "Countering the Problem of Falsified and Substandard Drugs" report stated. "And, because the wholesale trade is national, weaknesses in one state's system can become vulnerabilities in another” (Pittman, 2/13).


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Sunday, December 30, 2012

Counterfeit Prescription Drugs: How to Protect Yourself

by on December 5, 2012

The World Health Organization defines a counterfeit medicine as one "which is deliberately and fraudulently mislabeled with respect to identity and/or source. Counterfeiting can apply to both branded and generic products and counterfeit products may include products with the correct ingredients or with the wrong ingredients, without active ingredients, with insufficient (inadequate quantities of) active ingredient(s) or with fake packaging."
counterfeit drugsCounterfeit medicines are defined broadly throughout the world by the World Health Organization. On April 1-3, 1992, experts from the world over met in Geneva for the first international meeting which gathered together member states and other organizations, such as INTERPOL, World Customs Organization (at the time known as Customs Cooperation Council), International Narcotics Control Board, International Federation of Pharmaceutical Manufacturers and Associations (IFPMA), International Organization of Consumer Unions, and the International Pharmaceutical Federation (FIP) in response to a World Health Assembly resolution (WHA41.16)."
The number of counterfeit drugs continues to grow. According to SafeMedicines.org, counterfeit drugs have killed an estimated 700,000 people from malaria and tuberculosis alone.
Up to a third of all anti-malarials are suspect, and around 10% of all essential drugs in emerging markets fail basic quality tests.
No country is safe. India is the world’s largest manufacturer of generic drugs, but it’s estimated that from 12-25% of their supply might be contaminated with substandard or counterfeit medicines. The WHO reports that many of those medicines find their way to Africa, where some nations may have up to 40% of their drug supply contaminated.

Which drugs are most commonly counterfeited?

Here in the U.S., certain drugs are more likely to be counterfeit.
Cardiovascular Medications
Cardiovascular drugs are for a serious need, one which many Americans turn to foreign drug-makers for. But, points out Haiken, the danger isn't that the Americans won't get the medications--rather it's that they will get a dangerous counterfeit instead.
Antibiotics
Of course a counterfeit version might very well not heal you--but it could also make you sicker, as fake meds can be tainted with heavy metals or some other dangerous ingredients.
Cancer Drugs
Fake cancer drugs have been found in both Israel and China--and just February of this year in the U.S. In fact it's possible that doctors' offices and clinics might have bought counterfeit Avastin, containing no real drug, but rather acetone and water.
ED Medications
The Pharmaceutical Security Institute reports that 37% of all fake medicines seized are ED drugs. ED drugs are offered for sale via thousands of fake online pharmacies without prescription requirements. Writes Ms. Haiken, "The real danger of buying these drugs from a non-VIPPS approved pharmacy is that there is a very good chance they will not just be counterfeit, but poison."
Treatments for Chronic Ailments Like HIV, Diabetes & Alzheimer’s
Because chronic ailments respond slowly to treatment. it's hard to know if the drugs are really fake.
Psychiatric Medications
A Google search for Xanax, Ativan, Adderrall, or Ambien reveals hundreds of websites offering these powerful drugs without a prescription.
It is a dangerous world out there, and one where you have to keep your senses about you, since the matter can very easily be the difference between life and death.

Common Sources of Counterfeit Drugs

India and China are most commonly the source of counterfeit drugs. Havocscope, which keeps track of counterfeit medicines worldwide, found that genitourinary medicines, anti-infective drugs, and central nervous system drugs are the most frequently counterfeited kinds of medications. Just this August, according to Scientific American, "$182,000 worth of fake medicines for diabetes, high blood pressure, and cancer were seized in China."
Dr Sneh Khemka, Bupa International's medical director, notes that so many of the world's counterfeit medicines come from Asia, particularly China, that it is a dangerous area when you're searching for medical purity. Khemka writes that across the country between 50-85% of some drugs are fake and kill up to 300,000 people per year, which is the equivalent of wiping out the entire population of Iceland every year.
Don't think you're safe if you buy your drugs in any other country, however.
According to the CBS news, the FDA found in April 2012 that a counterfeit version of Roche’s Altuzan (bevacizumab), an injectable cancer medication, contained no active ingredient.
In an article entitled “Fake pharmaceuticals: Bad medicine,” in October 13, 2012's, issue of Economist, the authors determined that Pfizer found 20 counterfeit versions of their drugs in 81 countries in January 2009, and by July 2012, Pfizer reported finding 60 of their counterfeit drugs in 106 countries.
Create.org in a whitepaper on health and safety risks of counterfeits asserts that up to 40 million U.S. prescriptions are filled each year with counterfeits.
"Pharmaceutical counterfeiting is a low-risk, high-profit criminal enterprise that attracts entrepreneurs and organized criminals," says John P. Clark, vice president and chief security officer for the drug company Pfizer. "What was once seen as a problem limited to lifestyle medicines is now recognized as a threat from which no therapeutic area is immune."
In September/October, Computer World reported, an Interpol operation involving 100 countries seized $10.5 million worth of counterfeit drugs. Nearly 18,000 websites selling fake drugs were shut down during the operation, and 3.7 million doses of counterfeit drugs were seized.
Despite the way counterfeit drugs have encroached upon the U.S., CBS news points out that most of the ingredients in fake American medicines still come from other countries, including China and India, which are known to have weak regulatory systems. The FDA only inspects about 12% of overseas facilities a year.

How to know Whether Your Prescription Drugs are Counterfeit

The World Health Organization estimates that over half the drugs sold online via websites that hide their physical address are counterfeit. Writes the WHO:
"Criminal organizations manufacture these counterfeits, not in quality-controlled laboratories, but in hidden rooms with unsanitary conditions. And instead of patented ingredients, these meds can contain a haphazard mix of chemicals and fillers like highway paint, floor wax and boric acid — ingredients and doses that can actually harm you and your family."
It is a serious problem, one which the Department of Justice recognizes poses great danger, and the government recognizes that they need help--our help.
Attorney General Eric Holder launched a massive public education campaign, calling for help from all corners, from the TV, the radio, the newspapers, and blogs."
Because the government can't stop the onslaught alone, in his public campaign, Holder has asked that all Americans be proactive when buying their medications.
He strongly encouraged online-prescription-buyers to follow these tips to avoid counterfeit and possibly harmful products, and these are his warnings verbatim:
  1. Don’t buy drugs from sites that sell prescription drugs without a prescription from your own physician.
  2. Consult the National Association of Boards of Pharmacy, which maintains a list of accredited online pharmacies" [to be sure that the pharmacy from which you're buying the medication is valid].
  3. If using an online pharmacy, make sure it has a legitimate brick-and-mortar street address, as well as a pharmacist on duty and available.
  4. Discard the medication if it is of a different size or color, or if it has a different or odd-looking brand insignia from the medication you are used to taking.
  5. Discard the medication if it dissolves differently or badly or has a strange or bitter taste that you are not accustomed to.
  6. If you suspect a website is selling counterfeit meds, report it here.
  7. And for more info on buying medicine on the Internet, go to fda.gov/ForConsumers/ConsumerUpdates or nabp.net/programs/consumer-protection/buying-medicine-online/counterfeit-drugs/.
By following these simple tips suggested by the FDA, you can help ensure that the medication your family buys online is what it claims to be."
A new technology may aid in tracking down counterfeit medications. This September, the Food and and Drug Administration unveiled the Counterfeit Detection Device #3 or CD3.
Battery-operated, the machine can emit up to 10 different wavelengths of ultraviolet and infrared light and can be used on capsules, tablets, powders, and packaging like inks, papers and covert markings. It's also capable of detecting products that have been tampered with, re-labeled, or re-glued. It has already analyzed nearly 100 counterfeit products, finding counterfeits masquerading as Crestor, Lipitor, Oxycontin, Viagra, Tamiflu, Singular, Plavix, and Wellbutrin.

Protecting Yourself

Huffington Post has a few ideas. Know that Pfizer has partnered with the National Association of Boards of Pharmacy® (NABP) and several other organizations on a YouTube channel, SpotFakeMeds, that allows consumers to hear firsthand from anti-counterfeiting experts about what to look out for and how to buy online safely.
Despite the threats posed by counterfeit medicines, it is possible to safely purchase legitimate, FDA-approved prescription medicines online if you keep your eyes open. For example, one way to purchase your meds if you have a valid prescription is to ensure that you are buying from a legitimate site. All legitimate sites receive VIPPS® (Verified Internet Pharmacy Practice Sites) accreditation from NABP, which indicates one can find there FDA-approved medications for purchase. A list of VIPPS-accredited pharmacies can be found on the NABP website, www.AWARERx.org.
Dr. Sneh Khemka, publishing on Bupa International, runs through some clues to a counterfeit pill:
  • Spot the difference. Is the lettering on the packaging hazy and printed flat (rather than raised), or is the expiry date missing?
  • Read carefully. Are the labeling and patient information in a language you understand? If there are misspelled words, contact the manufacturers – it can be a telltale sign.
  • Use your senses. Is the medicine the same size, shape, texture, colour and taste as your previous prescription?
  • Feel for consistency. When you handle the drug does it fall apart easily? If so, it could signal a fake.
  • Do a price check. Does the cost of the drug seem very cheap in comparison with your official provider? If it’s much lower, it could be a scam.
Now, let's say you're buying the medicine online--what should you keep a close eye out for?
  • Prescriptions. Make sure the website you buy from requires a prescription and has a pharmacist you can contact for questions.
  • Licensing. Only buy from certified online pharmacies. Search the website for a declaration of authenticity or certification and double- check this with your country’s official drug regulatory agency. For example, pharmacies in the UK that are registered with the Royal Pharmaceutical Society of Great Britain can display a logo on their website.
  • Security. Don’t supply any credit card numbers unless you are sure the website has policies in place to protect your information and has a secure online payment system.
  • Promises. Statements such as ‘no risk’ and ‘money-back guarantees’ can be key giveaways of a counterfeit website.
In short, if the way you're getting your medicine seems just too good to be true--then it very likely is, and the dangers of buying your medicine that way are manifold. It is in your own greatest interest to make sure that the drugs you are buying are indeed what they advertise themselves to be--and are not chemicals that create even more problems than they claim to address


Source: Counterfeit Prescription Drugs: How to Protect Yourself - Drugsdb.com http://www.drugsdb.com/blog/counterfeit-prescription-drugs.html#ixzz2GXn3Z6VG

Saturday, December 22, 2012

FDA Warns Against Unapproved Drugs From Foreign Suppliers

Dec 21, 2012

More than 350 medical practices in the United States may have received unapproved medications, including unapproved versions of Botox, from a foreign supplier, the US Food and Drug Administration (FDA) warned on its Web site this week.
"These medications may be counterfeit, contaminated, improperly stored and transported, ineffective, and/or unsafe. Medical practices that purchase and administer illegal and unapproved medications from foreign sources are placing patients at risk and potentially depriving them of proper treatment," the agency said.
The FDA has sent a letter to the physicians or medical practices involved informing them of the situation.
A list of the doctors and clinics that received the letter is available here.
Products Not FDA Approved
To reduce the chance of patients receiving an unapproved, counterfeit, unsafe, or ineffective medication, the FDA is asking that medical practices stop administering the unapproved versions of Botox and any other products they have received from foreign suppliers owned and operated by Canada Drugs and known under the following names: Quality Specialty Products (QSP), A+ Health Supplies, QP Medical, Bridgewater Medical, or Clinical Care.
"Many, if not all, of the products sold and distributed by these suppliers have not been approved by FDA. Therefore, FDA cannot confirm that the manufacture and handling of these products follow U.S. regulations or that these medications are safe and effective for their intended uses," the FDA said. Medications not approved by the FDA may also lack the necessary and required labels that ensure their appropriate and safe use, the agency reminds clinicians.
So far in 2012, the FDA has issued letters to medical practices in the United States that purchased unapproved medications from foreign suppliers 5 times: on February 10, April 5, April 23, June 28, and September 10.
The FDA is asking healthcare providers to examine their purchasing practices to ensure that products are purchased directly from the manufacturer or from state-licensed wholesale drug distributors in the United States.
"Health care professionals, pharmacies, and wholesalers/distributors are valuable partners in efforts to protect consumers from the risks of unsafe or ineffective products that may be stolen, counterfeit, contaminated, or improperly stored and transported. The receipt of suspicious or unsolicited offers from unknown suppliers should be questioned, and extra caution should be taken when considering them," the FDA said.
Healthcare providers are asked to report suspected criminal activity to FDA's Office of Criminal Investigations (OCI) by calling 1-800-551-3989 or visiting the OCI Web site.
The FDA has provided information on its Web site on how to verify that a wholesale drug distributor is licensed in the state(s) where it is conducting business.
Adverse events related to the use of suspect medications may be reported to MedWatch, the FDA's safety information and adverse event reporting program, either online at https://www.accessdata.fda.gov/scripts/medwatch/medwatch-online.htm by telephone at 1-800-FDA-1088, by fax at 1-800-FDA-0178, or with postage-paid FDA form 3500, available at http://www.fda.gov/MedWatch/getforms.htm to MedWatch, 5600 Fishers Lane, Rockville, Maryland 20852-9787.
Source found here

Wednesday, December 5, 2012

FDA Fights Web Pharmacies Selling Unapproved Drugs

posted: Oct 05, 2012 3:55 PM CDTUpdated: Oct 05, 2012 3:55 PM CDT
WASHINGTON (AP) -- The Food and Drug Administration is stepping up its fight against counterfeit and other potentially harmful medicine sold over the Internet.
The agency is ordering operators of about 4,100 websites to immediately stop selling unapproved medications to U.S. consumers.
The FDA has sent warning letters to three companies behind most of the websites. It's also seized some illegal medicines, filed civil and criminal charges against companies and people, and contacted Internet registrars and service providers, asking them to suspend the 4,100 websites.
Those efforts are part of a global crackdown on online sellers of counterfeit and illegal medical products. Interpol, the international police agency, says about $10.5 million worth of medicines were seized worldwide last week and more than 18,000 illegal pharmacy websites were shuttered.
Source found here
 


Tuesday, June 26, 2012

Counterfeit Version of Avastin in U.S. Distribution

Counterfeit Version of Avastin in U.S. Distribution

Statement Issued: Feb. 14, 2012
FDA sends letters to 19 medical practices about counterfeit product and other unapproved cancer medicines  
The U.S. Food and Drug Administration (FDA) is warning health care professionals and patients about a counterfeit version of Avastin 400mg/16mL, which may have been purchased and used by some medical practices in the United States.  Avastin is an injectable medicine used to treat cancer and is administered to patients in clinics, hospitals, and doctors’ offices. The counterfeit version of Avastin does not contain the medicine’s active ingredient, bevacizumab, which may have resulted in patients not receiving needed therapy. 
In a related action, FDA has issued letters to 19 medical practices in the United States that purchased unapproved cancer medicines that may include the counterfeit Avastin.  The counterfeit version is labeled as Avastin, manufactured by Roche. Roche is the company that  manufactures Avastin approved for marketing outside of the United States. 
Roche conducted laboratory tests that confirmed the counterfeit version of Avastin.  Packages or vials may be counterfeit if they:
  • are labeled with Roche as the manufacturer
  • display batch numbers that start with B6010, B6011 or B86017 
The only FDA-approved version of Avastin for use in the United States is marketed by Genentech (a member company of Roche). The FDA-approved version does not include the Roche logo on the packaging or vials.  In addition, Genentech’s FDA-approved version of Avastin vials and packaging have a 6-digit numeric batch number and expiration dates in a 3-letter month and 4-digit year format (e.g., JAN 2014).  Genentech’s Avastin products are safe and effective for their intended uses.
The 19 medical practices in the United States purchased unapproved cancer medicines and, potentially, the counterfeit Avastin, from Quality Specialty Products (QSP), a foreign supplier that may also be known as Montana Health Care Solutions.  Volunteer Distribution in Gainesboro, Tennessee is a distributor of QSP’s products.  FDA has requested that the medical practices stop using any remaining products from these suppliers.  FDA cannot ensure the safety or efficacy of any of these unapproved products.
Based on information to date, FDA has determined that none of the unapproved cancer medicines received by these medical practices from Volunteer Distribution are in shortage in the United States.  FDA-approved versions of these medicines are available in adequate supply to meet current demand. 
Medical practices that have obtained unapproved products from foreign sources, in particular from Volunteer Distribution and/or QSP, should stop using them and contact the FDA.  These products should be retained and securely stored.
To report suspect counterfeit products and other suspect unapproved products obtained from Volunteer Distribution or QSP/Montana Health Care Solutions or other sources:
Health care professionals and consumers are asked to report adverse events related to the use of suspect injectable cancer medicines to the FDA’s MedWatch Safety Information and Adverse Event Reporting Program either online, by regular mail, by fax, or by phone. Health care profssionals and consumers can either:
  • Complete and submit the report online: www.fda.gov/MedWatch/report.htm, or
  • Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178. 
FDA continues to evaluate this counterfeit medicine situation and we will provide updates.
For information about this counterfeit medicine, see Roche’s statement: http://www.gene.com/gene/news/press-releases/press_statements/ps_021412.htmldisclaimer icon
 
 
Pictures of the counterfeit version of Avastin are shown below:
box of counterfeit Avastin
 back of box of counterfeit Avastin

Prosecution for Introduction of Misbranded Prescription Drugs Imported From China

U.S. Department of Justice Press Release

 
For Immediate Release
June 14, 2012


United States Attorney
Southern District of Texas
Contact: Angela Dodge
Public Affairs Officer
(713) 567-9388



HOUSTON – A Houston federal jury has convicted Luis Angel Garcia Torres, 41, of Patillas, Puerto Rico, has been convicted of 12 counts in relation to the trafficking of counterfeit goods, United States Attorney Kenneth Magidson announced today. Torres was found guilty just a short time ago by a jury sitting in Houston following four days of trial and five hours of deliberation.
The jury convicted Torres of one felony count of conspiring to traffic in counterfeit goods, causing the introduction of misbranded prescription drugs into interstate commerce and causing the introduction of counterfeit prescription drugs into interstate commerce. He was also convicted of six felony counts of trafficking in counterfeit goods as well as three misdemeanor counts of causing the introduction into interstate commerce of drugs that are misbranded and two misdemeanor counts of trademark counterfeiting.
Torres used the Internet to obtain and distribute counterfeit Viagra and Cialis pharmaceutical drugs, which are Food and Drug Administration (FDA)-approved prescription drugs used in the treatment of erectile dysfunction. Viagra is manufactured and distributed exclusively by Pfizer Pharmaceuticals, while Cialis is manufactured and distributed exclusively by Eli Lilly. Both are registered trademarks on the principal register in the United States Patent and Trademark Office.
During trial, evidence established that Torres offered Viagra and Cialis tablets for sale. The retail cost at the time for Viagra and Cialis ranged from $15.00 to approximately $20.00, but evidence established he was offering them for sale for just $2.00 each. Evidence also established he was purchasing the tablets for $.45 each.
Testimony further established that Homeland Security Investigations (HSI) agents, working in an undercover capacity, purchased approximately 3600 Viagra and Cialis tablets from Torres via the Internet from Jan. 25, 2010, through Aug. 16, 2010. Evidence indicated the pharmaceuticals were exported from China and shipped from a Puerto Rico address used by Torres to undercover agents in Houston. The pharmaceuticals were later analyzed by the trademark holders and the FDA Forensic Chemistry Center and determined to be counterfeit. Agents also obtained a search warrant for the email address used by Torres and found proof he had obtained counterfeit pharmaceuticals from China and discussed techniques to evade detection and seizure by law enforcement officials with individuals residing in China.
Torres faces a maximum sentence of 10 years in federal prison, without parole, and a $2 million fine at his sentencing hearing, set for Aug. 30, 2012. United States District Judge Keith Ellison, who presided over the trial, has permitted Torres to remain free on bond pending that hearing.
The charges brought against Torres were the result of a joint investigation which began in November 2009 by HSI and the FDA-Office of Criminal Investigations. This case is being prosecuted by Assistant United States Attorney Andrew Leuchtmann and Assistant United States Attorney Samuel Louis.
For additional information click here.