The People's Perspective on Medicine

Show 1163: Should You Trust Your Prescription Drugs?

Where are your prescription drugs made and how do they get to you? Are you satisfied that they are of the best quality possible?
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Should You Trust Your Prescription Drugs?

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Do you use mail order for your prescription drugs to get a better price? Many insurance companies strongly encourage people to order online from preferred sources so they can control how much they have to pay. Most of us like to save money. However, are there any downsides to getting your medicines mailed instead of picking them up at the pharmacy?

Too Hot or Too Cold?

The FDA and the drug makers set standards for how your prescription drugs should be stored. In most cases, these also apply to how they should be shipped. Yet shipping vehicles may easily become much too hot in the summertime or too cold in the winter. How does such temperature variation affect the potency of the medicines?

Weighing Price vs Quality:

Shockingly high prescription medication prices in the US have led many Americans to focus almost exclusively on price. That is the allure of cheap generic drugs made in places with lower wages. Is there a trade-off against quality, though? Now that more than 80 percent of our generic drugs come from overseas, the FDA has difficulty carrying out inspections. The recent recalls of the blood pressure pills losartan, valsartan and irbesartan due to contamination with cancer-causing chemicals underscores the importance of maintaining manufacturing quality.

A Whistleblower Speaks Up:

Dinesh Thakur was a drug developer in the US for more than a decade, but he was excited to have a chance to work in the pharmaceutical industry in his home country of India. However, when he discovered that the company he worked for had a practice of falsifying drug quality data, he blew the whistle. He notified the US FDA of the problems. As a result, the agency banned the company from exporting some of its products to the US. Ultimately, the firm paid $500 million in fines and pleaded guilty.

Problems persisted, however. Mr. Thakur explains the difficulties of monitoring manufacturing quality in India and elsewhere. American consumers and their doctors need to learn to pay attention to medication quality as well as price. You may find this challenging, but you can check online for the reputation of the manufacturer listed on your prescription drugs bottles.

This Week’s Guests:

Stephen F. Eckel, PharmD, MHA, BCPS, is Associate Dean for Global Engagement and Interim Chair of the Division of Practice Advancement and Clinical Education at UNC Eshelman School of Pharmacy. He is also a clinical associate professor there.

Dr. David Gortler is a former FDA Medical Officer and has worked as a pharmacology expert in the area of drug safety for two decades. He is a professor of pharmacology and biotechnology in Washington, DC. He consults for the group www.FormerFDA.com.  He has written articles regarding America’s dependence on low-quality imported generic drugs and the FDA’s repeated failures to regulate such medications properly.

Dinesh Thakur is a public health activist focused on improving the quality of affordable medicines around the globe. His current focus is to improve health policy and drug regulation in both the US and India. As a whistleblower, he was responsible for the prosecution of Ranbaxy Laboratories for supplying adulterated drugs to the US market in 2013. The company pled guilty to criminal felonies in the US court and paid $500 million in fines. The need for data integrity has become a global issue in drug manufacturing since his case became public.

His website is:  www.dineshthakur.com You can find him on Twitter: @d_s_thakur

Listen to the Podcast:

The podcast of this program will be available the Monday after the broadcast date. The show can be streamed online from this site and podcasts can be downloaded for free. CDs may be purchased at any time after broadcast for $9.99.

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About the Author
Terry Graedon, PhD, is a medical anthropologist and co-host of The People’s Pharmacy radio show, co-author of The People’s Pharmacy syndicated newspaper columns and numerous books, and co-founder of The People’s Pharmacy website. Terry taught in the Duke University School of Nursing and was an adjunct assistant professor in the Department of Anthropology. She is a Fellow of the Society of Applied Anthropology. Terry is one of the country's leading authorities on the science behind folk remedies. .
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I have been taking a generic ACE inhibitor, Fosinopril (brand name Monopril) since 1996. All those years, the pills were a reasonable size and texture. Suddenly, the bottle I have now contains miniscule pills, half the size of the standard one, and so hard and brittle that a number of the pills in the bottle were chipped by the end of the first week. I have a 90-day supply.

When I complained to he pharmacy, all they could tell me is that these are what they “were sent from the warehouse.” IMHO, they ought to have sent them back to the warehouse and had the standard pills sent over to the store instead. I also complained to the my insurance company’s customer service/pharmacy. Maybe the next bottle will be back to the standard pills, but in the meantime, I have to go three months on these pathetic teeny things, which I have to break in half! I did put one half a pill in water with a few drops of vinegar, and it did dissolve properly.

Its shocking. Chinese and Indian companies to blame
A friend of mine was prescribed generic Acyclovir for shingles. 4 days later the rash was spreading and painful. She called and I said check the manufacturer–Ranbaxy. She got another script for the real thing and got better. So was the active ingredient adulterated? Inactive? fake?
So now I ALWAYS ask for a non generic brand when I get a script filled.

Why cant the Us get their drugs from Australian companies?
Are there Canadian companies that manufacture IN CANADA?

https://www.nytimes.com/2019/05/11/opinion/sunday/generic-drugs-safety.html

and this old article which refers to Thakur above

http://fortune.com/2013/05/15/dirty-medicine/

I don’t trust the drug companies for a variety of reasons, mostly because of money. Most drugs are comming out of China and India. And India outsources to China, and that’s scary because given Chinas’ lack of human rights and profit over people I highly distrust most prescription drugs.

I, too have had varied results with generics and wonder what can be done, if anything. Is there a website that has info to help us?

When I email my legislators, especially at the federal level, I get the standard form letter and never any real help.

It is high time that medications were manufactured in the USA with strict quality controls rather than in other countries with low quality control standards. The issue of low quality meds and the lack of availability of common meds is a serious public health crisis that needs to be regulated by the government.

If you want name-brand medications, your physician must state that on the prescription. Otherwise, you will be given a generic.

I agree that the generic meds need serious monitoring. Sadly, insurance will not pay for the non-generic medications OR a person has to be rich to pay for them.

Aside from the problems pointed out, I’d like to know why a small amount of pills are put in very large plastic bottles? It’s a huge waste and could be circumvented by using bio-degradable bags, making the containers smaller or allowing your pharmacist to refill bottles and just paste on the new label. I’m sure there are many other, better ideas. If we destroy the environment with plastic, medication will become irrelevant anyway.

Lyn, I agree with you. FDA should send out the inspectors to the foreign countries. I now wonder just what is in the pills that are supposed to help everyone.

Bobby, I never even thought about looking for the manufactuerer’s name of the bottle of pills. Thank you for mentioning that. I’ll look to see if I see a mfg name on my bottle. If the mfg is not listed then I feel that the FDA should require the name.

My doctor had to write to the insurance company for me to return to name brands on some of my prescriptions because the generics just weren’t working. I have my doubts about many generics because there doesn’t seem to be much quality control over where the ingredients come from. I wonder sometimes about name brands and where they get the ingredients for those. In the effort to increase profits and greed, companies don’t seem to care about quality and the effect on people taking their products.

In spite of the escalating problems with the quality of pharmaceuticals, I see no concomitant reduction in the escalating prescribing of drugs nor the constant introduction of new drugs (sometimes for newly-named “diseases”). I guess it’s because of the ever escalating generation of wealth.

We need your help: Publish the few websites where a patient can look up the country of origin and name of company there that produced the medication, and where recall or other fines have been levied against that company. This is a major challenge for most people, and even for the computer savvy and determined it is not always possible. I always check since drug distributors here for chain pharmacies often change sources for medications.

I’ve always wondered about my pills. I take 12 a day. I get them all at a military facility. A lot of the times, they are filled in-house, and I can’t see where they come from. Most are generic. I know the government likes to get the least expensive for their money. I’m always concerned about quality, no matter where it’s filled.

I understand the difficulties in traveling to other countries to review their manufacturing process, but why can’t we just test the products for ingredients and purity once they arrive in the U.S. similar to what ConsumerLab does with vitamins and supplements? Any company found providing medications that do not meet specifications could be suspended from shipping that product until it is re-tested and found compliant. If the FDA doesn’t have sufficient funds, then the U.S. companies selling the product could be held responsible for testing and ensuring the medication they are providing to patients contains the active ingredient and is not contaminated.

The FDA should send inspectors to countries who have problematic issues regarding drug manufacturing safety. We rely on foreign countries to do what’s right, and they’re not. The FDA needs to step up to the plate and station inspectors around the world where our drugs are being manufactured, and not believe that drugs are being made correctly.

As a recently retired MD I thought your show was interesting. I have two comments. Obviously sending FDA inspectors to India is problematic. Why not instead do random inspections of all imported drugs to the USA to insure quality, bio-equivalencies, and lack of adulteration. Secondly, the speaker’s suggestion to bring a problem with a given genetic drug to the attention of their doctor is close to useless. What is the doctor supposed to do? If he or she writes a new prescription the patient may get the same or worse drug. The only control the doctor has is to write for Brand name. Unfortunately, these can be very expensive. I would submit that even the pharmacist does not know on a day to day basis what and where his wholesale purchases are coming from and even whether they are safe and effective.

What about non-prescription drugs like naproxen? I had a hip replacement 12 days earlier and took generic naproxen which had just been purchased, so this was the first pill from the bottle. I was dizzy and hyperventilating and spent 24 hours in the ER. After a multitude of tests, nothing was found, and I went home feeling fine. I am sure the naproxen was made overseas and caused a bad reaction. I will now purchase name brand but how can we be sure they are not also contaminated?

This story was interesting, and concerning. I have heard about issues with medications, or at least their precursors, being manufactured overseas for some time, and it is quite worrying. While I don’t use mail order pharmacies, by choice, I can see the issue you brought up with the conditions during shipping. Honestly, I hadn’t thought about it, but the same problem probably effects medications at the pharmacy, too, depending on how the pharmacy is supplied.

As a former instrumentation engineer, whose area of expertise was in temperature measurement in particular, I have some thoughts on what could be done to help protect patients. Irreversible temperature sensing labels are available. These operate when a calibrated material is heated beyond a calibrated temperature, it changes color (typically from white to black), and it stays the changed color, even if the temperature drops back below the target temperature. Some labels are available that have multiple calibrated temperature sensors. A quick look on-line indicates purchased in small lots, these labels only cost about a $1.50. I’m sure if they were purchased in extremely large numbers, that price would drop to a few pennies each. It seems to me that this would be a cheap way for on-line pharmacies to help customers know if their medications exceeded recommended temperatures.

It’s a small thing, but it’s something.

Thanks for the great shows. Keep up the great work.

Apparently I missed the live version – I’d be curious 1) from what countries can drugs be imported “safely” – specifically Canada? Perhaps some EU countries? 2) I hear the concerns about sitting in a hot UPS Truck … is the process for delivery to my local CVS any different?

Thanks

I don’t see a manufacturer’s name on the bottles of my pills. The only thing on the label is the drug name and what the name brand drug it is a generic for.

How do I check online for quality of the company supplying my generic drugs?

Since our FDA is so underfunded, it’s no wonder things happen. I never understood why many of our drugs are made outside our own country. Isn’t it time to stop this? When I took Neurontin, it was great. Then Gabapentin has not been so great, especially lately, I’m looking forward to the new shipment of this same drug, hoping it will help the way it used to. Knowing it might be inferior is no help since I’ve taken it for over 25 years. My hubby’s retirement pays on our drugs and always the generics, of course. We don’t think there is much choice. :o(

My neurologist insisted I change to local pharmacy for my seizure medicine after her patients and another physician had a seizure while taking the mail in medicine.

I am so discouraged. I am a senior with very serious pain and health issues. The painkillers I have taken for yrs are produced in my state. They are high quality Lortab by WATSON, very hard, dissolve slowly (WHICH SHOULD BE THE CASE). All pharmacies here get the CHEAPEST which I researched come from obscure TINY companies produced in asian countries.

I called the companies, the FDA, and complained to pharmacists. The pills on market are like chalk…fall apart like powder in the mouth at once before one gets water, have quick results, and are not hard and release slowly. They make me ill in the stomach. They are horrid quality. WHERE CAN I GET HELP? My doc wrote “generic brand” (Watson) on the prescription to assure the former quality that worked for years. No…the pharmacists say ( plural) we only have these…the terrible quality ones.

WHEN DO SERIOUSLY ILL PEOPLE GET A LOBBY? EVERYTHING IS ABOUT OPIOID ADDICS. NO ONE CARES FOR SENIORS OR THEIR PROBLEM. PLEASE HELP.

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