Standards vary for foreign-made genetic drugs

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Most people assume that a drug is a drug — that Lipitor, for example, or a generic version, is the same anywhere in the world, so long as it’s made by a reputable drug company that has been inspected and approved by regulators.  That, at least is what Katherine Eban, in her new book,  says “is the logic that has driven the global generic-drug revolution: that drug companies in countries like India and China can make low-cost, high-quality drugs for markets around the world. These companies have been hailed as public health heroes and global equalizers, by making the same cures available to the wealthy and the impoverished.

The problem is the manufacturing standards are different depending on the country buying their drugs, a practice that could endanger not just those who take this lower-quality medicine but for the population at large. Generic drugs are as safe and effective as brand name drugs. While these generic drug manufacturers take their biggest swaps of high- quality to low-quality ingredients, Eban writes, the countries that receive the short-cut produced drugs are markets with very poor regulation such as sub-Saharan Africa, Southeast Asia, and areas of South America.

“As the cost of prescription medication soars, consumers are increasingly taking generic drugs,” Eban writes. Often health insurance plans require patients to switch to generics as a way of controlling costs.”

She warns that “some of these medications might not be as safe, or effective as we think.”

Eban notes that most of the generic medications being sold in the United States are manufactured overseas, mostly in India and China. The U.S. Food and Drug Administration contends that it holds foreign plants to the same standards as U.S. drug makers, but Eban challenges that notion. She writes that the FDA often announces its overseas inspections weeks in advance, which gives plants where generic drugs are made the chance to fabricate data end results.

CBS News in a broadcast this year began with”It is something we have heard before. Generic drugs are the same as brand name drugs. They contain the same active ingredients and the manufacturers are supposed to prove they work the same way as their brand name counterparts.”

But it pointed out that many of the generics are produced outside the United States with 80 percent of active ingredients and 40 percent of finished drugs made by overseas suppliers.

There is also a category of drugs known as “Narrow Therapeutic Index Drugs. ” There are different definitions of these drugs, but put simply it means those pharmaceuticals which have a narrowly defined range between risk and benefits.

Different states have different rules and regulations concerning these drugs and how they act. The North Carolina Board of Pharmacy defines these drugs one way, again the narrowly defined range between risk and benefit. Canada defines these Narrow Therapeutic Range drugs as a ratio between the lowest concentration at which clinical toxicity occurs to the median concentration providing a therapeutic effect — less than or equal to two. This came from a report published in 2009 and written by Pharmacist Nathan D. Pope. The latter was never a term I heard while I was practicing pharmacy. Examples of drugs that are NTI drugs are Digoxin, Lithium, Phenytoin, Theophylline and Warfarin

The U.S. drug supply is not immune to quality crises. Over the last 10 months, dozens of versions of the generic blood pressure drugs Valsartan, Losartan, and Irbesartan have been subject to large recalls.

In Africa, for instance, pharmaceuticals used to come from more developed countries, through donations and small purchases. So when Indian drug reps offering cheap generics started arriving, the initial feeling was positive. But Africa soon became an avenue to “to send anything at all” said Kwabena Ofori-IKwake, associate professor in the Pharmaceutics Department at the Kwame Nkrumah University of Science and Technology in Kumasi, Ghana.

Many hospitals also keep a stash of what they call “fancy drugs” – either brand name drugs or higher quality generics – to treat patients who should have recovered after a round of treatment but did not.

Dr.Aaron Kesselman M.D. writing for JAMA said, “When people hear the word ‘generic,’ they associate it with inferior quality but for the vast majority of people, generic drugs are as safe and effective as brand name drugs.”

I personally take several drugs, all generic, and am very satisfied with the results. I would recommend that anyone who suddenly has a problem with a drug that formerly was no problem, ask the pharmacist if they are dispensing a different manufacturer than before. Your physician is your best guide to whether your medical condition requires a brand name drug when a generic is available, not your insurance company.

Bertram Drachtman R.Ph.

Great Neck

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