Today pharmaceutical companies conduct extensive research to obtain Food & Drug Administration (FDA) approval of a new medication. Typically this pre-approval research is structured in three phases: Phase I, a small (20-100) group of healthy volunteers to assess safety; Phase II, larger groups (20-300) to assess how well the drug works; and, Phase III, randomized controlled trials on large patient groups (300–3,000 or more ) to assess effectiveness vis-à-vis with the current ‘gold standard’ treatment.
Phase IV trials involve the safety surveillance of a drug after it receives permission to be sold. The safety surveillance is designed to detect any rare or long-term adverse effects over a much larger patient population and longer time period than is possible during the Phase I-III clinical trials.
There are opportunities to use data from Electronic Health Records (EHR) for Phases II and III, but the larger opportunity, and the one addressed here, is Phase IV, post approval surveillance.
Theoretically it should be possible to use the growing body of data in EHRs to track patients for whom a new medicine is prescribed. However, EHR adoption is still very limited; almost all reports show adoption rates less than 10%. More important, there are more than 200 vendors providing EHRs, all of which are built using limited standards for the information to be acquired, the coding for diagnosis and treatment, and for the exchange of information.
Historically, it has proven very difficult to exchange information among multiple systems within a single organization. The generally accepted solution is an enterprise resources program (ERP) which is complex, costly, and difficult to implement.
The collection and exchange of medical information is simpler in some ways and more difficult in others. The efforts of the Federal Government to develop and implement EHR standards will help but there is a great deal to do and the final definition and implementation of standards will take time—probably several years. Even with standards, there will be minor differences among systems developed independently by a large number of vendors that will limit the industry’s ability to exchange information and will raise questions about the quality of the data.
When a significant body of common data becomes available, pharmaceutical companies should be able to use that data to track a sample of patients using a new medication in “near real time,” perhaps within a week after a doctor sees a patient. This could provide four major benefits.
• First, regulatory agencies may give earlier approval subject to effective ongoing sampling and reporting of any adverse reactions—earlier to market.
• Second, any adverse reactions could be found early and evaluated to minimize damage to patients—minimize patient harm.
• Third, early warning could lead to examination of additional data from existing medical records of patients receiving the medication relatively quickly and at relatively low cost. This will further define the risk and whether or not there are patient, disease, or treatment conditions that create or reduce risk. It may be possible to eliminate a risk just by restricting use based on definable conditions—protection for both the patient and market value of the medication.
• Fourth, timely responses to an identified risk will make it difficult for plaintiff’s attorneys to successively demand punitive damages. Compensatory damages will be smaller and punitive damages will be smaller or non-existent—reduced legal costs.
There is enough information about current and near term EHR systems for pharmaceutical companies to develop strategies to use more and better data they will offer. The time to begin the development of those strategies is now.
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