Efforts Towards Securing the Supply Chain: Challenges with Falsified / Substandard Medications and the Role of Portable Spectrometers

Substandard and falsified pharmaceuticals continue to be a burden to global public health due to the increased safety and efficacy risk to the end user, including the potential to cause further resistance to certain medications. There are several reasons poor-quality pharmaceuticals can be found, namely poor process controls from the manufacturer, improper storage during distribution, and product falsification. Extensive reports can be found in the literature to outline the range of poor-quality medicines that have been found in the market across a variety of health indications. While traditional pharmacopeia techniques can be used to assess poor quality medications, considerable effort has been made to develop and utilize a variety of other techniques that can be used in more remote settings, often using fewer resources. Spectroscopic techniques, particularly those using portable instrumentation, are well positioned to be a powerful analytical approach toward combating poor quality medications in the global market. Specific to certain procurement programs, spectroscopy-based assessments have been used to assess a falsified oral contraceptive problem and a tablet cracking incident due to moisture gain in hot and humid environments. To expand the impact of spectroscopic techniques within these programs, extensive efforts are underway to develop and validate various qualitative and quantitative methods of pharmaceuticals with portable spectrometers, particularly with near-infrared and Raman spectroscopy.