Ranbaxy Labs Ohm clearance in line; Hanmi launches Nexium equivalent Ranbaxy's Ohm Labs facility has received an Establishment Inspection Report (EIR) from the US-FDA. This establishes Previous Reco clearance of the previously unresolved 483 at this facility n All other US-FDA facilities such as Paonta Sahib, Dewas and Target Price Mohali are still under import alert and consent
Counterfeit and adulterated prescription drugs | attention-de.Counterfeit and Adulterated Prescription Drugs | Attention-Deficit/Hype.
Pharmacy Times - Attention-Deficit/Hyperactivity Disorder
Counterfeit and Adulterated Prescription Drugs
Several years ago, I attended the annual conference of the National Association of Drug Diversion Investigators (NADDI) in Tennessee.
The speaker, who was the head of corporate security for a large pharmaceutical company, displayed photos of 1 of its prescription drugs on the large screen designed for viewing by over 200 attendees. The familiar logo of the pill, its color, and other identifiers were prominently shown. He presented 3 slides overall, each with 2 pills displayed side by side. He asked the audience to decide which pill was the legitimateproduct, and which was the labor of counterfeiters. I was certainly confident that I could identify the counterfeit substance on each slide, or at least 2 out of the 3 examples. However, when the presentation was over, I had failed on all 3 slides, as I picked the counterfeit pill each time. The speaker went on to say that not only were the drugs displayed only a copy of the color and logo of the real product, but that in mostcases none of the active ingredients were present. Of course in addition to this being an elaborate scam, patient health is a major issue when pharmaceutical drugs are counterfeited and/ or adulterated. More sophisticated criminals have found that the profits in counterfeiting and adulterating high-priced noncontrolled substances faroutweigh the diversion of scheduled drugs that are sold on the street. Drugs singled out for this type of diversion include Procrit, Epogen, Lipitor, Serostim, Zyprexa, the AIDS drugs Combivir and Retrovir, and others. One of the main problems is with unscrupulous wholesalers and the ease with which they can obtain licenses to distribute pharmaceuticalsto pharmacies and hospitals. The ability of some to replicate manufacturer’s labels in exact detail increases the chance of counterfeitsubstances making their way to the unsuspecting patient.
Florida Gov Jeb Bush recently signed the Prescription Drug Protection Act that targets the problem of counterfeiting and adulteratingpharmaceuticals. Florida’s SB2312 provides new criminal offenses and increases the penalties on existing crimes related to the wholesaledrug industry.
The bill also requires that wholesale drug distributors must keep and maintain a detailed written record referred to as a “pedigree paper.”This paper will be mandatory for each drug processed. The hope is that this paper will better ensure the integrity of the drug being distributed.
Wholesalers will also have to undergo stricter background checks and higher bonding requirements, and they will be required to designatea contact person who will be responsible for all the transactions for the drugs they distribute. The bill also increases the regulatory authority of the Florida Department of Health. It allows the department to shut down wholesalers inviolation of their rules and to confiscate drugs that may be creating a danger to the general public. Although most experts agree that this problem currently affects only a very small percentage of pharmaceuticals distributed in the UnitedStates, the fear is that the problem may grow to more epidemic proportions. Huge profit is the driving force for this type of diversion, but experts also agree that if the leaks are not patched, it could become an invitingcrime for those interested in undermining and terrorizing our country. The thought of a large-scale, deliberate adulteration of our nation’s drugsupply, is a scary one.
This is a growing problem of drug diversion that law enforcement, regulators, health professionals, and elected officials need to betteraddress. Florida has taken significant steps to attempt to curb this problem, and it is time for all of us to become better educated on the issue,and to take action to prevent disaster.
John Burke, director of the Warren County, Ohio, drug task force and retired commander of the Cincinnati Police Pharmaceutical Diversion Squad, is a 32-year veteran of law enforcement. For information, he can be reached by e-mail at email@example.com, by phone at 513-336-0070, or via the Web site www.rxdiversion.com Normal Version
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