terça-feira, 11 de agosto de 2015

Countering the Spread of False Medications



Mon, 08/10/2015 - 5:45pm

Don McDaniel, Manager, Product Management, Thermo Fisher Scientific, Waltham, Mass.

Raman spectroscopy helps in the ongoing battle against counterfeit medications.

Handheld Raman spectroscopy instruments help identify counterfeit medications. Image: Thermo Fisher Scientific

Handheld Raman spectroscopy instruments help identify counterfeit medications.

Image: Thermo Fisher Scientific

The ongoing battle against counterfeit medications has long held the attention of the U.S. Food and Drug Administration (FDA). Efforts by sophisticated counterfeiters around the world, for instance, led the FDA to form a counterfeit drug task force in July 2003 to help ensure criminal operations don’t deliver fake medicines to unknowing consumers.

Fast forward to June 2015, when the FDA announced it has taken action against more than 1,050 Websites—issuing regulatory warnings and, in some cases, seizing medicines and medical devices—that illegally sell fake and potentially harmful prescription medications. The FDA action was part of an international operation, called Pangea VIII, aimed at the removal of counterfeits from the global supply chain.

While the counterfeiters themselves continue to seek methods to stay ahead of the authorities in their efforts to develop and sell fake medicines, the technology available to pharmaceutical manufacturers continues to evolve as well, and is now in the hands of even more personnel in the industry.

Lab to field
The growing trend of bringing laboratory technologies into the field has left an indelible mark on numerous industries. In the area of material identification in the pharmaceutical industry, the ability to take handheld instrumentation outside of the lab has allowed even non-expert chemists to identify counterfeit drugs and help ensure they don’t enter the supply chain.

The technical advances that have helped to put these instruments into the hands of less-experienced users have also led to new approaches for chemical identification. One such analytical method is a probabilistic approach—comparing measured data to library spectra—using Raman spectroscopy. Significant enhancements in optical components used for Raman spectroscopy have contributed to the development of more rugged and portable instrumentation, which is especially critical for those users in the pharmaceutical industry who are working in challenging environments and sampling conditions.

A probabilistic analysis typically incorporates an embedded algorithm within the instrument that looks for features that contradict the reference material, as opposed to features that determine similarities between the two spectra. Such statistical methods, unlike a traditional “hit quality index” approach, are specifically designed for the immediate decision-making necessary for operation in the field. Because the algorithm essentially does the work—converting data into qualitative results—instrument users don’t need to be spectroscopy experts.

Impact of GMPs
The value in having non-expert chemists or spectroscopists capable of operating innovative material identification instruments is magnified by pharmaceutical industry standards such as the Pharmaceutical Inspection Co-operation Scheme (PIC/S), Annex 8. Annex 8 requires individual sampling from all incoming containers, with an identity test conducted on each sample, before a full batch can be released to a manufacturer.

PIC/S, Annex 8, which is quite different from the conventional method of composite sampling of a batch’s statistical subset and identity testing of the single composited sample, places higher demands on the analyst. By employing spectroscopic material identification techniques, in a portable form-factor, non-experts, such as receiving personnel at the loading dock, can handle sample testing.

How is this possible? By keeping the smarts within the instrument. The latest technology allows the instrument to acquire the Raman spectrum of the material of interest and, in real time, determine the uncertainty of that measurement, given factors such as the sample characteristics, instrument telemetry, environment and testing environment. Is the measurement of the test material statistically consistent with the measurement of the reference material? Simple “pass/fail” or “positive match/no match” designations are determined by the multivariate difference between the measured and reference spectrum, providing the starting point of an answer.

The current picture
While it’s not realistic to expect the FDA will soon disband its counterfeit drug task force, or that PIC/S will soon discontinue its oversight of packaged materials, groundbreaking technology can certainly help in the fight. The technological strides made in raw material identification and product inspection have brought more sophisticated, portable approaches to pharmaceutical manufacturers.

The key to the many advances in Raman spectroscopy is accessibility. When less of the analytical burden, method development and decision-making is on the shoulders of a device’s user, the user can rely on the robustness, ruggedness and intelligence embedded in the device. Non-experts in chemistry can now use tools to identify materials in a manner that’s widely accepted for pharmaceutical validation requirements. With field-capable instrumentation in the hands of more personnel in the pharmaceutical industry, the distribution of dangerous counterfeits can be halted before they even enter the supply chain.



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