A Guide to Investigating Your Own Drugs
Since the publication of Bottle of Lies, hundreds of patients have contacted me, essentially asking the same question. How can they figure out where their drugs are made and whether they are safe? There are no perfect or easy answers. Laws need to be changed, so that patients get more information. However, I have tried to boil down what patients can do in this step-by-step guide.
STEP 1: Find Out Who Manufactures Your Drug
That information is typically on the dispensing label. When getting a new prescription, you can call in and ask the pharmacist that question before picking up the drug. That way, you can request a manufacturer change in advance, if need be. (More on that in a minute.)
Ditto for mail-order pharmacies: call and ask a human that question, before the drug arrives on your doorstep. Once you know the manufacturer, now what?
STEP 2: Research the manufacturer
Has the company making your drug been in trouble with the FDA? What, if anything, does that trouble means for you? That’s a tough one. But you can start on the FDA’s website. You can find out here if the manufacturer has received a warning letter, which is pretty serious. It means the FDA found objectionable conditions and the company failed to fix those sufficiently. For overseas manufacturing plants, warning letters can lead to import alerts, which means the drugs are restricted from entering the country.
Though warning letters can read like mumbo-jumbo, one regulatory expert advises to be on the lookout for two big problem categories: sterility and data integrity. (Data integrity issues can mean that a plant is altering or fabricating data, or has inadequate control over its data.) When both issues are present, it can be a flashing red light that a company’s plant is not operating in a state of control.
Then, there’s good old Google. Are other patients complaining about the same drug by the same manufacturer? Here’s one resource at the People’s Pharmacy, where some of my book research started.
Step 2A: Find Out (or not) Where Your Drug Was Made
Unfortunately, this is largely impossible right now. Drug makers are not required to disclose either the country or the plant where they make their drugs, or where they purchased the active ingredients. This information is deemed proprietary. Both should be disclosed on the dispensing label, which will require new laws. Until then, you’ll need an investigative journalist (like me) to figure it out for you.
STEP 3: How to Change Manufacturers
So, you didn’t like what you found out, and would like to change manufacturers (something I do all the time). First, find out what other manufacturers make your drug. You can do that at the FDA’s Orange Book.
Talk to your pharmacist about whether you can get a different generic version (they may have to order it from their wholesaler).
One thing to look for is an “authorized generic.” That’s a generic version that has been authorized by the brand-name company, and therefore likely made using the same formula, time-release mechanism, often with the same additional ingredients (and sometimes even manufactured in the same plant).
STEP 4: Pay Attention to Symptoms and Side Effects
Does your new prescription work as well as your old one? Are your symptoms under control? Are you suffering side effects? As pharmacies switch us from one version to another of the same drug, these are all questions to keep in mind. You may be reacting badly, or better, to a different formulation. Keep track of what works, and demand to stay on it.
Step 5: Educate Your Doctors and Pharmacists
Some doctors are keenly aware of variations between different generic versions, particularly cardiologists, neurologists, psychiatrists, endocrinologists and other doctors who prescribe drugs that require precise dosing (so-called narrow therapeutic index drugs). But some doctors (and pharmacists) have not thought much about this and might opt for a different treatment – when what you really need is a different version of the same drug. Educate them, perhaps with a copy of Bottle of Lies in hand.