Study: Substandard & Falsified TB Drugs

(From the 2011 TB Progress Report)

# 6914

 

A topic we’ve looked at before – the proliferation of substandard or fake medications – is back in the news today with the publication of a field analysis of the quality of first line anti-Tuberculosis drugs (isoniazid and rifampicin) collected from pharmacies from 17 low- and middle-income countries.

 

The results are reminiscent of those we saw a year ago in an report in The Lancet that looked at the quality of Malarial drugs (see Lancet: 1/3rd Of Malaria Drugs Fake Or Sub-Standard).

 

Not only can using substandard (or fake) drugs endanger the person taking them, their use can lead to the rise of greater drug resistance.

 

And that endangers everyone.

 

Last October, in Interpol & FDA: Operation Pangea V, we looked at some of the International efforts to curb the trafficking in counterfeit drugs.

FDA PSA on Counterfeit Drugs

 

Today’s study, published this month in the International Journal of Tuberculosis and Lung Disease, found  9.1% of the drugs tested failed to have the requisite levels of API (Active Pharmaceutical Ingredients) or failed a disintegration test. 

 

The abstract was published on PubMed last month.

 

Substandard and falsified anti-tuberculosis drugs: a preliminary field analysis

R. Bate, P. Jensen, K. Hess, L. Mooney, J. Milligan.

Abstract

SETTING: Pharmacies in 19 cities in Angola, Brazil, China, Democratic Republic of Congo, Egypt, Ethiopia, Ghana, India (n = 3), Kenya, Nigeria, Russia, Rwanda, Thailand, Turkey, Uganda, United Republic of Tanzania and Zambia.

OBJECTIVE: To assess the quality of the two main first-line anti-tuberculosis medicines, isoniazid and rifampicin, procured from private-sector pharmacies, to determine if substandard and falsified medicines are available and if they potentially contribute to drug resistance in cities in low- and middle-income countries.

DESIGN: Local nationals procured 713 treatment packs from a selection of pharmacies in 19 cities. These samples were tested for quality using 1) thin-layer chromatography to analyze levels of active pharmaceutical ingredient (API), and 2) disintegration testing.

RESULTS: Of 713 samples tested, 9.1% failed basic quality testing for requisite levels of API or disintegration. The failure rate was 16.6% in Africa, 10.1% in India, and 3.9% in other middle-income countries.

CONCLUSIONS: Substandard and falsified drugs are readily available in the private marketplace and probably contribute to anti-tuberculosis drug resistance in low- and middle-income countries. This issue warrants further investigation through large-scale studies of drug quality in all markets.

 

While the study appears to be available only to subscribers at the Journal, I found it available on the American Enterprise Institute website in its entirety at the link below:

 

Substandard and falsified anti-tuberculosis drugs: A preliminary field analysis

Roger Bate, Lorraine Mooney, Kimberly Hess, Julissa Milligan, Paul Jensen | The International Journal of Tuberculosis and Lung Disease

 

Roger Bate also authors a commentary that warns of the dangers of these drugs - published on Feb. 5th in the International Herald Tribune - called:

 

Feeding a Disease With Fake Drugs

By ROGER BATE

Published: February 5, 2013

UK: Warning On Counterfeit Condoms

 

Photo Credit CDC PHIL

 

 

# 6830

 

Although its not exactly a new problem (reports go back several years), the number of cheap, unreliable, counterfeit condoms reaching retailers shelves in the UK is rising, prompting the Medicines and Healthcare products Regulation Agency (MHRA) to issue fresh warnings.

 

For the consumer, the problem is these knock-offs are almost impossible to tell apart from the real thing. Counterfeiters probably spent more on the misleading packaging, than on the product itself.

 

And according to the MHRA, these condoms are far more likely to fail than their legitimate counterparts, which can lead to unwanted pregnancies, and the spread of disease.

 

This from  BBC News.

 

New warnings over a rise in counterfeit condoms

Page last updated at 06:05 GMT, Monday, 7 January 2013By Greg Dawson

The government's health regulator has warned there are a rising number of counterfeit condoms being smuggled into to the UK.

 

The Medicines and Healthcare products Regulation Agency (MHRA) claims millions have been illegally imported in the last 18 months.

 

Family planning experts say the bogus condoms don't provide protection against STIs or pregnancy.

(Continue . . . )

 

 

Lest anyone think this problem is limited to the UK, in 2011 a U.S. immigrant from China was sentenced to more than three years in prison by a Brooklyn, NY judge for importing more than a million `fake’ Trojan condoms.

 

Counterfeit Condom Trafficker Gets 37-Month Sentence

By Thom Weidlich - Aug 11, 2010 5:11 PM ET

(EXCERPT)

Jian “Jimmy” Wang was sentenced today by U.S. District JudgeBrian Cogan in Brooklyn, New York. Condoms tested from the same batch as Wang’s were found to burst, leak and lack spermicide, prosecutors said. The brands seized were Trojan Magnum, Trojan-ENZ, Trojan Ultra Ribbed and Trojan Mint Tingle, according to court papers.

 

There are undoubtedly millions of these cheap, unreliable, and potentially dangerous condoms in circulation around the globe, often sold in small shops or from vending machines.

 

Given how closely these counterfeit products resemble the brand name, officials warn the best way to avoid getting stung is to buy condoms from reputable dealers and pharmacies. 

 

A sensible enough protection that - like the condom itself - isn’t 100% reliable, but can substantially reduce the risk of pregnancy or disease.

FDA Warning On Fake Adderall

 

 

 

# 6356

 

 

Counterfeit drugs are a problem that has been around for some time, but appears to be getting worse as manufacturing delays and drug shortages send desperate customers in search of new sources for medications that they need.

 

A little more than a week ago, we saw from the Lancet: 1/3rd Of Malaria Drugs Fake Or Sub-Standard, and when the H1N1 pandemic was just getting started, we looked at the burgeoning business of selling fake antivirals in Spamalot: Fake Tamiflu

 

 

Yesterday the FDA issued a warning on a new internet drug scam, one that is selling counterfeit Adderall – a medication commonly used for attention deficit hyperactivity disorders (ADHD) and narcolepsy.

 

In recent months, Adderall has been one of hundreds of drugs that have come in short supply (see FDA’s Current Drug Shortages list), prompting some desperate parents and patients to seek online sources for the drug.

 

Unfortunately, what some of these people got was not Adderall – but a potentially dangerous mixture of Tramadol and acetaminophen.

 

Here is the FDA announcement, with information on how to spot fake, or counterfeit medications.

 

FDA NEWS RELEASE

For Immediate Release: May 29, 2012
Media Inquiries: Shelly Burgess, 301-796-4651, shelly.burgess@fda.hhs.gov
Consumer Inquiries: 888-INFO-FDA

FDA warns consumers about counterfeit version of Teva’s Adderall

Tablets purchased on the Internet contain wrong active ingredients

The U.S. Food and Drug Administration is warning consumers and health care professionals about a counterfeit version of Teva Pharmaceutical Industries’ Adderall 30 milligram tablets that is being purchased on the Internet. Adderall, which is approved to treat attention deficit hyperactivity disorders (ADHD) and narcolepsy, is a prescription drug classified as a controlled substance – a class of drugs for which special controls are required for dispensing by pharmacists.

 

FDA’s preliminary laboratory tests revealed that the counterfeit version of Teva’s Adderall 30 mg tablets contained the wrong active ingredients. Adderall contains four active ingredients – dextroamphetamine saccharate, amphetamine aspartate, dextroamphetamine sulfate, and amphetamine sulfate. Instead of these active ingredients, the counterfeit product contained tramadol and acetaminophen, which are ingredients in medicines used to treat acute pain.

 

Currently on the FDA’s drug shortage list, Adderall is in short supply due to active pharmaceutical ingredient supply issues. Teva continues to release product as it becomes available. Consumers should be extra cautious when buying their medicines from online sources.  Rogue websites and distributors may especially target medicines in short supply for counterfeiting.

 

The counterfeit Adderall tablets are round, white and do not have any type of markings, such as letters or numbers. Any product that resembles the tablets or the packaging in the photos below and claims to be Teva’s Adderall 30 mg tablets should be considered counterfeit. The counterfeit versions of Adderall should be considered as unsafe, ineffective and potentially harmful.

 

Authentic Adderall 30 mg tablets produced by Teva are round, orange/peach, and scored tablets with “dp” embossed on one side and “30” on the other side of the tablet. Teva’s Adderall 30 mg tablets are packaged only in a 100-count bottle with the National Drug Code (NDC) 0555-0768-02 listed.

Pictures of the counterfeit version of Teva’s Adderall 30 mg tablets and packaging

The Adderall 30 mg product may be counterfeit if:

1. The product comes in a blister package.

2. There are misspellings on the package.

• “NDS” instead of “NDC”
• “Aspartrte” instead of “Aspartate”
• “Singel” instead of “Single”

3. The tablets are white in color, round in shape, and are smooth.

4. The tablets have no markings on them.

Pictures of authentic Adderall 30 mg tablets (immediate release) by Teva (front and back side of tablet)

Anyone who believes they have the counterfeit version of Teva’s Adderall 30 mg tablets should not take or should stop taking the product. Consumers should talk to their health care professional about their condition and options for treatment.

 

Consumers and health care professionals are encouraged to report adverse events or side effects from the suspect counterfeit Adderall to the FDA’s MedWatch Safety Information and Adverse Event Reporting Program:

• Complete and submit the report online: www.fda.gov/MedWatch/report.htm.
• Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178.

Consumers who believe they have received counterfeit Adderall should contact the FDA’s Office of Criminal Investigations (OCI) at 800-551-3989 or http://www.fda.gov/OCI.

 

 

 

The problem isn’t just limited to Adderall and Tamiflu.

 

While there are scores of legitimate online pharmacies, it doesn’t take much searching to find sites (particularly out of India and Asia) that offer to sell everything from antibiotics to narcotics – often without a prescription.

But what you get when you order these meds is anyone’s guess. 

 

The FDA has an online FAQ on Buying Medicines and Medical Products Online.