Eighth Medical Innovation Impact Index Issued by Fairleigh Dickinson University’s Initiative for Patient-Centered Innovation (iPCI)

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MI3 Alert for Compounding Pharmacies from Initiative for Patient Centered Innovation (iPCI)

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The eighth Medical Innovation Impact Index (MI3 TM) Alert considers the contribution of compounding pharmacies to the advancement of health, as well as the unintended consequences as a result of disjointed and competing state and federal regulations. An MI3 Alert score of +0.5 (range -10 to +10) was rendered for the impact of compounding pharmacies by the Initiative for Patient Centered Innovation (iPCI) of Fairleigh Dickinson University’s (FDU) Lewis Center for Health Innovation and Technology.

The main concern with respect to compounding pharmacies is the “vast number of unchecked compounders that are functioning more as distribution centers than as providers of ‘one-offs’ custom products to patients with specific needs,” said Michael Avaltroni, Dean of the School of Pharmacy and Health Sciences of Fairleigh Dickinson University. This is not the definition of traditional compounding, and it has led to (1) significant safety issues, (2) dubious business practices that increase drug prices, and (3) the dispensing of products that may not have clinical activity. The most concerning issue from a patient safety perspective is the preparation of sterile products, prompting the FDA to issue four new guidance documents and notices over the past several weeks.

In our eighth MI3 Alert, we offer several recommendations to address the safety concerns that have emerged in recent years with compounded products; these changes would result in a very favorable composite MI3 score of 7.5.

The Medical Innovation Impact Index (MI3) is a succinct, real world analysis and scoring system based on interviews with legal and medical experts who interact with government agencies regularly in the review of new products in development. The purported benefits and potential positive impacts on medical innovation are listed and scored zero to +5, based on the likelihood of achieving these objectives; the unintended consequences and potential negative impacts on medical innovation are listed and scored 0 to -5, based on the likelihood of these untoward effects happening. A final composite score (ranging from -10 to +10) is calculated and a recommendation is provided.

Currently, no analysis exists to evaluate rules solely with respect to their impact on the advancement of medical innovation, which is the purpose of the Medical Innovation Impact Index. MI3 alerts will be issued monthly.

About Fairleigh Dickinson University
Devoted to the preparation of world citizens through global education, Fairleigh Dickinson is New Jersey's largest private university and features more than 100 liberal arts and professional degree programs, two international campuses, dozens of partnerships with internationally renowned institutions and special programs and status within the United Nations.

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Dina Schipper
Fairleigh Dickinson University
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