Paper Analytical Device Project

A global problem

Many of the pharmaceuticals that are purchased in the developing world are substandard or outright fake drugs. Although there is no global system for monitoring the quality of medicine, study after study reveals pervasive poor quality and products that are worthless or even harmful to patients.  Many countries in the developing world do not have the technological infrastructure or regulatory resources to keep low quality medicines off the market shelves. And since the pharmaceutical trade is a lucrative global market, low quality medicine can cross borders and harm people anywhere in the world. 

Root causes:

Negligence by manufacturers

• A heart medicine called "Isotab" killed over 200 people in Pakistan when one batch was manufactured using toxic quantities of an antimalarial medicine in place of the inert filler that was supposed to be added.  According to the Pakistani government's report (pathology_of_negligence_pic_drug_inquiry_report_2012.pdf)  the antimalarial drug got wet during delivery, and was moved into a drum marked "starch".  No-one ever changed the label or noticed the substitution.  

Deliberate falsification by manufacturers or distributors

• Fortune Magazine has a great investigatory report on Ranbaxy's contribution to this area.
• Even secure supply chains fall victim;  see this WHO report on testing company Semler Research faking bioequivalence studies.  

New ways to find fake medicines

Paper analytical devices (PADs) are test cards that can quickly determine whether a drug tablet contains the correct medicines. They are cheap and easy to use. They don't require power, chemicals, solvents, or any expensive instruments, so they can be deployed rapidly at large scale whereever a problem with pharmaceutical quality is suspected.

Partnering with regulatory agencies

By sharing our results directly with medical regulatory agencies, we help them quickly discover poor quality medicines in their markets.  This enables them to negotiate with manufacturers and distributors from a position of knowledge and to take other regulatory and legal actions to protect patients from poor quality products.

Bringing market forces to bear

In the developing world, most buyers have to trust what the seller tells them about the quality of the pharmaceuticals they purchase. Unscrupulous manufacturers and distributors know that there is little chance that their medicines will be screened in a lab. These paper test cards don't need a lab, and they will enable people all over the world to quickly detect low quality medicines and remove them from the market.  

 

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News

Madeline Smith won an outstanding poster award at the Gordon Conference

Published: June 12, 2019

Author: Marya Lieberman

Madeline's poster was titled, "The chemoPAD: A Paper Analytical Device for Detection of Four Chemotherapy Drugs," and Ayenew Ashenef from Addis Ababa University is a co-author.  Congratulations to Madeline!  

 

The 2019 Gordon Research Conference on Preclinical Form and Formulation for Drug Discovery focused on cutting edge research on the development, characterization and manufacture of formulations that span multiple modalities., such as …

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Kat Hayes and Vincent Schmitz awarded $30,000 in pitch competition

Published: June 12, 2019

Author: Marya Lieberman

The Disease Diagnostic INventors Challenge provides funding to focus measurement science and engineering creativity at Purdue, IU, IBRI and Notre Dame on innovations with the potential to address unmet biomedical needs. Kathleen Hayes and Vincent Schmitz brought together the research strengths of the Whalen and Lieberman groups at Notre Dame to tackle the difficult task of detecting bad quality or fake oxytocin.  There is currently no field test available for oxytocin quality, and studies show that about 1 in 4 vials dispensed to women in Africa do not meet quality standards.  Good luck to these energetic first year grad students!…

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