Chemotherapy formulation verification – ProofMed-CH™ Scanner V1.0
During treatment for cancer, patients receive multiple doses of highly toxic drugs. Annually, in the US, >1.2M US cancer patients receive more than 20 million doses of chemotherapy during treatment in oncology clinics; worldwide, it is estimated that more than nine million cancer patients receive chemotherapy1.
These drugs/doses may be ineffective or even more toxic if mixed or stored improperly, or compounded with substandard ingredients2,3. Publications have reported that contamination with bacteria/fungi or endotoxins during mixing has sickened/killed patients4. Because there is no on-site (Point-Of-Care) technology to assess dose composition, quality, formulation, and/or contamination, doses are very rarely checked – it is assumed doses are formulated correctly. If checked after formulation and immediately prior to administration, adverse patient reactions and deaths can be avoided.
There are currently no readily-available (i.e., portable), inexpensive, real-time (at the time of compounding/mixing), Point-Of-Care technologies for checking the correct formulation of chemotherapy drugs or for detecting degradation/contamination of these life-saving drugs prior to administration; this lack of extant technology/solutions may be due to such factors as cost, portability, potential interruptions to workflow, or a perception that risk for patients is low, but one can effectively argue that the death of even a single patient from a preventable formulation error is, and should be, unacceptable5. There is no competitor presently that can do it as efficiently as our proposed approach. There is clearly a need.
Using our proprietary Raman spectroscopy-based technology, we will create and commercialize an analytical device for real-time validation of proper formulation of parenteral cancer chemotherapy drugs by comparing formulated doses with reference chemotherapy standards and databases.
Internal marketing research has determined the customers for our technology and proposed device are oncology clinics/practices (in-hospital, outpatient) and specialty pharmacies. According to the American Society of Clinical Oncology, more than 2000 US sites exist where chemotherapy is mixed for treating patients. Our proposed solution introduces the capability to verify safe formulation for more than 20M doses currently given annually.
Our proposed approach has been applied and validated across a number of other analogous applications. For example, devices based on the same technical approach have been created for automated molecular urinalysis and detecting criminal diversion of narcotics. The proposed device – ProofMed-CH™ Scanner V1.0 – will analyze 10 samples in a single 20-minute cycle. Based on our experience and established design/fabrication/manufacturing framework, this device will be validated and beta-tested within 18 months.
1Sources: https://seer.cancer.gov/statfacts/html/all.html; Lancet Oncol 2019: 20:769-780 (published online http://dx.doi.org/10.1016/S1470-2045(19)30163-9: Kirkwood, et. al., https://doi.org/10.1200/JOP.18.00149
2Source: Sidhu J, Gogoi MP, Agarwal P, Mukherjee T, Saha D, Bose P, Roy P, Phadke Y, Sonawane B, Paul P, Saha V, Krishnan S. Unsatisfactory quality of E. coli asparaginase biogenerics in India: Implications for clinical outcomes in acute lymphoblastic leukaemia. Pediatr Blood Cancer. 2021 Nov;68(11):e29046. doi: 10.1002/pbc.29046. Epub 2021 May 3. PMID: 33939263; PMCID: PMC7613163
3Source: Gilbert RE, Kozak MC, Dobish RB, Bourrier VC, Koke PM, Kukreti V, Logan HA, Easty AC, Trbovich PL. Intravenous chemotherapy compounding errors in a follow-up Pan-Canadian observational study. J Oncol Pract. 2018 May;14(5):e295-e303. doi: 10.1200/JOP.17.00007. Epub 2018 Apr 20. PMID: 29676947; PMCID: PMC5952328.
4Source: CDC, National Center for Emerging and Zoonotic Infectious Diseases. SAFE HEALTHCARE: Webinar: Outbreaks in Outpatient Oncology Settings: Lessons Learned and Key Considerations for Handling Sterile Medications, Thursday, August 9, 2018
5Source: Watson, C.J., Whitledge, J.D., Siani, A.M. et al. Pharmaceutical compounding: a history, regulatory overview, and systematic review of compounding errors. J. Med. Toxicol. 17, 197–217 (2021). https://doi.org/10.1007/s13181-020-00814-3