1. Minimizing Pharmaceutical Waste in Clinical Care: A Medical Perspective Dr. Joel Kreisberg, DC, MA Dr. Ilene Ruhoy, MD, PhD

2. Module Outline Current methods of drug development and its relationship with unused pharmaceuticals is the focus of this clinically minded session. Improving our understanding of the complete life-cycle of pharmaceutical use and disposal will better prepare clinicians to meet the growing concerns for sustainable medical prescribing. Emphasis is placed on reducing unused and left-over pharmaceuticals through better knowledge of prescribing patterns, patient compliance, and tendency for accumulations of medications in the home. Review of disposal options and action steps to reduce unused pharmaceuticals will be discussed.

3. Learning Objectives 1 Outline the cradle-to-grave life cycle of prescription pharmaceuticals Review current research as to the patterns of prescribing that lead to pharmaceuticals accumulated in the home 2 Identify current disposal policy and options including six actions steps to reduce pharmaceutical waste. 3

4. Cradle-to Grave Lifecycle: Production Life cycle of Pharmaceutical Manufacturing The Reality of Non-compliance What is Accumulating & How do we know? Facts about Disposal in the US Minimizing Pharmaceutical Waste In Clinical Care

5. 1.Cradle-to Grave Life Cycle Drug Production: five phases Pre-discovery Discovery Pre-clinical Clinical Approval

6. Pre-Discovery A The first step is target identification:choosing a disease to target with a drug. The final step is target validation:testing the target and confirming its mechanism in the body. Worldwide more than $70 billion is spent annually on health research and development (R & D) by the public and private sectors. Source: http://www.oneworldhealth.org/global_burden Z

7. Drug Discovery Acandidate, or a “lead compound” is identified. Nature is a primary source for drug discovery 30% of new drugs are completely synthetic in origin. The other 70% were derived from or were similar to chemicals found in nature Scientists also develop medicine de novo, creating molecules from scratch using advanced computer modeling.

8. Manufacturing Active Pharmacological Ingredients Typically, about 100 kg of material raw material is used for every 1 kg of active pharmaceutical ingredient produced--1% material efficiency Compared to the production of fine chemicals (20%) and bulk chemicals (50%) efficiency

9. Pre Clinical Phase In this stage, the pharmaceutical manufacturer submits an Investigational New Drug Application (IND) to obtain FDA approval to test on human subjects. The number of potential medicinal compounds is drastically reduced from 10,000 to 5 or fewer in this phase

10. Clinical Phase Phase zero: first in-human trials Phase one:tests on a small group of healthy volunteers (20-100) Phase two: occur larger groups (20-300) Phase three: multi-centered trials (30-3000) Phase four- Post Marketing Surveillance Trial Last an average of 6-7 years

11. Approval When clinical tests prove a drug to be effective, it goes through the approval phase. Once approved by the FDA, the drug goes into the manufacturing process. This phase is responsible for the majority of damage to natural capital within the drug development process.