Prof. Lieberman is very pleased to report that she has received financial backing from VWR International, a global laboratory supplier and distributor of chemicals, consumables, equipment, and instruments. Through their relationship with Notre Dame, VWR is providing Prof. Lieberman with $10,000 per year of chemicals and consumables for the lab, which will support efforts to identify fake medications in Kenya and other countries in East Africa. A big thank you to VWR for their interest in and support of this important 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.
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 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.
In the third week of September, 2011, a worker loaded white powders from drums and plastic bags into a mixing machine at Efonze Chemical Industries to produce Batch J093 of a drug called Isotab. It had been ordered by a cardiac clinic in Pakistan. One of the drums, labeled as pre-gelatinized starch, was probably filled with pyrimethamine. A batch of this antimalarial medicine had arrived in a moldy container earlier in the month and been transferred to a blue drum, the same type of drum used to hold starch. Perhaps no-one updated the label. In any case, over 20 Kg of pyrimethamine was somehow added to the batch of isosorbide mononitrate. Each heart pill that was pressed contained over 50 mg of this drug in addition to the intended active ingredient; patients who took the heart medicine would receive doses of 100-150 mg pyrimethamine per day. The recommended dose of pyrimethamine is just 25 mg per week. The consequences to hundreds of Pakistanis would be devastating.