FAKE DRUGS -- REAL DANGERS

In a previous post I talked about the California Pedigree Law, which will require tracking drugs whenever a change in ownership occurs from the sale of drugs to other trading partners, and how this may inevitably affect every state via a nationally mandated policy. Why? Here are three major reasons:
·    Federal regulators in February 2013 discovered another batch in a string of fake versions of the cancer drug, Avastin.
·    Early in 2013, a doctor in La Jolla pleaded guilty in federal court to treating patients with unapproved drugs.
·    Tainted steroids produced by a Massachusetts compounding pharmacy led to a fungal meningitis outbreak in September 2012 that killed 45 people and sickened more than 650.
As concerned caregivers, we cannot allow this to continue.

The problem of fake, contaminated or prescription drugs that don't meet proper quality standards may be worse in developing countries, but drug security is clearly a concern here, too. And I, like other health officials, believe that as we become more globalized it's more than likely the problem will only increase. So a national mandate may be part of our future.

A 360-page report from the Institute of Medicine and sponsored by the U.S. Food and Drug Administration states that "...quantifying the problem in the United States is difficult, but the trade of adulterated prescription drugs is considered more profitable than that of illicit drugs, like heroin...".

"Many of these fake drugs are the subject of sophisticated criminal networks," said Larry Gostin, professor of health law at Georgetown University, who headed the committee that produced the report.

And the tragedy continues when expired or adulterated prescription drugs often fall into the hands of unwitting health care providers from a secondary wholesaler offering what appears to be a good deal for the medication, because the United States at present has no national system to track and trace drugs through the maze of wholesalers and secondary marketers.

No one system or technology will completely resolve the problem because of its complexity, but the Institute of Medicine report calls for a variety of potential solutions, such as better ways to authenticate packaging so that regulators may be able to identify and detect counterfeit drugs. This could include better inks, holograms or other security features that could outwit counterfeiters.

The report also calls for improved tracking systems for keeping tabs on every time a drug changes hands. This "electronic pedigree," could better secure the supply chain, leaving fewer opportunities for bad drugs to enter the health market.

Bar-coding and wireless radio-frequency identification, or RFID, are some of the technologies being used or considered to better track drugs. Much of the technologies are focused on securing company drug packaging so it is more difficult to counterfeit.

Use of a trusted drug repackager is another step one can take to ensure safety in the drugs you provide for your patients. As a highly regulated drug repackager, Shamrock Medical is required to ensure that the safety, identity, strength, quality, and purity of the drugs we handle are maintained. We take every precaution to verify the identity and legitimacy of suppliers sending us products through the “normal channel of distribution”. Now, and always, we continue to remain vigilant, both with you and for you, our customer.


Here's to better solutions, 

Dave Bystrom