Archive for 2013
27 Drug Safety Tips For Doctors
French Customs Seizes 1.2 Million Doses of Counterfeit Aspirin
View larger map On May 25, 2013, France’s Ministry of Economy announced the largest seizure of counterfeit medication ever made by France and the European Union. French customs agents in Le Havre discovered 1.2 million doses of counterfeit aspirin hidden in a shipment of tea originating from China. The goods in the shipment were destined…
[...]Generic Drug Maker Ranbaxy Settles with DOJ in Adulterated Drugs Case
The US Department of Justice reports that a plea agreement by the US branch of Indian generic drug giant Ranbaxy is the largest ever against a generic drug manufacture. Ranbaxy admitted to selling unapproved and adulterated prescription drugs in the United States.
According to the Department of Justice statement on this case, the drugs manufactured at two different plants in India, one in Dewas, and another in Paonta Sahib. The manufacturers failed to follow Current Good Manufacturing Practices (cGMPs) as mandated by the FDA. In many cases the drugs were not up to FDA standards and degraded much faster than their authentic counterparts. The Department of Justice also reports that Ranbaxy knowingly made false statements to the FDA as to the testing, content and quality of the drugs it sold in the United States.
[...]Spreading the word about safety on World Anti-Counterfeiting Day
May 28 2013 is World Anti-Counterfeiting
Day. The
Global Anti Counterfeiting Network has announced Interpol and the Malaysia Health Service as the winners of their 15th
Annual Global Anti Counterfeiting Awards. While
not an event traditionally widely observed, this day gives us a chance to try and highlight our work to protect
patients from counterfeit drugs. If
you’re reading this, you probably care about protecting patients, but you
haven’t done anything to prepare for the event. The Partnership for Safe Medicines has made
it easy for you to highlight patient safety on this day, by giving you easy
resources for writing tweets, posting to Facebook, sending email, or writing a
letter to the editor on this day.
If you’re planning to help, please send us a note and we’ll keep an eye out for your messages!
Quick links:
- Campaign homepage: http://www.safemedicines.org/patient-and-doctor-tips-shareable-content.html
- TIPS for American patients: http://www.safemedicines.org/drug-safety-tips-for-patients.html
- TIPS for American physicians: http://www.safemedicines.org/drug-safety-tips-for-doctors.html
What we have planned
We are launching our patient and physician TIPS campaign on
World Anti-Counterfeiting Day. The
campaign includes 25+ tips on how patients can avoid counterfeit drugs, and
physicians can avoid unauthorized distributors selling counterfeit drugs. The tips have short versions that can fit in
a tweet or Facebook message, or longer versions that can fit in an email or
print newsletter. Each one contains an
original illustration like this one:
Ways you can help
Post a tip to Facebook or Twitter.
Post a note of support for the campaign recognizing PSM’s efforts on Twitter.
Send a tip to your mailing list, with links to more.
Post a blog post on your website.
Post a link to our campaign on your website, either in text or with one of
the tips graphics.
Write an op-ed.
[...]Tennessee Pharmacist Pleads Guilty to Supplying Dialysis Clinics with Misbranded Chinese Iron Sucrose
A pharmacist in Tennessee named Robert Harshbarger has pleaded guilty to charges he replaced FDA-approved iron sucrose for use in kidney dialysis with unapproved foreign versions of the drug which he then sold to kidney dialysis clinics, including Kansas Dialysis Services. Several patients at Kidney Dialysis Services were treated with the misbranded drugs, but none…
[...]PSM Supports HR 1919, ‘Safeguarding America’s Pharmaceuticals Act’
Dear Speaker Boehner and Chairman Upton:
On behalf of the Partnership for Safe Medicines (PSM), we write today in strong support of H.R.
1919, the “Safeguarding America’s Pharmaceuticals Act”.
PSM is a not for profit, consumer focused organization that seeks to
keep Americans safe from counterfeit drugs through patient and healthcare
provider education and awareness. In
the US we work with a coalition of over 70 healthcare professional and patient
groups to improve patients’ and their
healthcare providers’ knowledge about where they obtain their medication, how
they can save money safely, and how to safely identify licensed pharmaceutical
distributors.
PSM strongly supports the creation of a national uniform track and trace
or pedigree system that would allow all participants in the supply chain to
verify a product’s history of sale.
Malaria Medication in Nigeria
Malaria Medication in Nigeriaby World Bank Photo via Flickr.
[...]Chinese Medicine Manufacturer Steps Up To Ensure Patient Safety
Chinese pharmaceutical manufacturer Guilin Pharmaceuticals is rolling out SMS-text message codes on packaging to ensure authenticity of its antimalarial medication in Nigeria.
Guilin’s artesunate meets world-wide quality assurance standards and has been pre-qualified by the World Health Organization (WHO). The Prequalification Programme applies unified standards of quality, safety and efficacy to medicinal products and includes manufacturing inspections, and evaluation of ingredients. Though the program is mainly used by UNAIDS and UNICEF to guide procurement, other agencies use it as a guide to determine safety at an international level, reports the WHO.
Now, purchasers of the medication can guard against purchasing counterfeit versions by scratching off a hidden identification code on drug packages. Patients can send the code via text message to a computer that will send back a safety message if the package is authentic, reports The Financial Times.
[...]FDA Releases Video on Counterfeit Detection Device 3
The FDA has released more information about their new counterfeit drug detection device, Counterfeit Detection Device 3 (CD-3). In this newly-released video, Nico Ranieri, the FDA research biologist who developed this new technology talks about how important such innovations are to patient safety.
In
2005, it first occurred to Nicolas Ranieri to try to use the type of
ultra-violet light devices deployed in crime scene investigations in a
hand-held counterfeit drug detection device.
Up to that point, drug testing equipment was both delicate, expensive, and
also required highly-trained scientists to
perform the tests for fakes. Says
Ranieri, “We wanted to find counterfeits, and we wanted to find them as fast as
possible,” reports the FDA.
Rx360 Launches Physician Education Campaign on the Risks of Counterfeit Drug Wholesalers
Rx360 has launched a new campaign educating healthcare providers to the risks of buying diverted and suspect products advertised directly to doctors’ offices via fax blast, direct email and online marketing.
Lewis T. Kontnik, team lead for the education campaign, says, “Some of the recent
problems with counterfeit and diverted medicines in the US, including
the counterfeit versions of Avastin, resulted in part from a lack of
awareness by physicians and medical practice administrators
of the risks of counterfeit and diverted medicines. The ads of the
professional diverters can appear tempting when they promise ‘genuine’ medicine and substantial discounts, however the facts are different and
the consequences can be very serious.”