The Problem

1. How To Supply Your Drug Habit: Creating Simulated Pharmaceuticals from Laboratory Supplies Cory Soto, B.S., Jamie Stiner, Rukhsana Khan, M.P.H., Daniel Noji, B.S., and Jeffrey Rusheen, M.D. 700 Westwood Plaza, Suite A222 LRC, Los Angeles, CA 90095 • The Problem • Facilities that offer high fidelity experiential training have been able to integrate increasingly realistic settings, confederate actors and medical devices into their simulations. However, the availability and utilization of drugs and other pharmaceuticals have lagged behind for several reasons: • Expired medications may, depending upon State law, require “reverse distributor”1 licensure and keeping in-date drug may require tight record keeping, vault storage and auditing by Boards of Pharmacy.2 • In-date and expired medications are safety hazards for participants and staff. They also contaminate simulation equipment and require strict adherence to proper disposal of pharmaceutical waste.3 • Commercial simulated drugs are expensive and limited in the variety available. • The safest and most cost effective means of meeting the need for simulated drugs is to produce them yourself! Production Cost Analysis • Integration • Production based upon the needs assessment resulted in the creation of 33 different simulated pharmaceuticals, with more in development. • The simulated drugs are stored in various locations including crash carts, anesthesia carts and in our simulated pharmacy. • When new drugs are needed for cases, we utilize an online label creation program (SOPHIE TM) to produce labels that can be affixed to prefilled vials to minimize turnaround. • The flexibility and cost-efficiency of this simulated pharmaceutical program have enabled us to readily respond to impromptu and unexpected needs that comes with simulation. • Borosilicate serum vials in 2 mL, 5 mL, 10 mL and 20 mL volumes covered much of the needed drugs for simulation. • The true cost of a simulated drug vial was derived from two parts: • Material costs were calculated by adding the price per unit for the vial, stopper, flip-off cap, contents, labels and syringes. • Labor costs were calculated for an entry-level simulation specialist at $20/hr and for a non-simulation specialist (part-time work-study student) at $14/hr. A total of 26 hours were allotted for the production of 500 vials. 13 mm stopper (left) and flip-off cap (right) 2 mL Vial • The outside diameter, or O.D., is a measurement taken at the mouth of the vial. The 2 mL vial has a 13 mm O.D. while the 5 mL, 10 mL and 20 mL all have 20 mm O.D. • Make sure measurements match the vial, stopper, cap and crimper as there are more varieties of O.D. than the ones listed! • The contents of the vials were standardized to be a 0.9% NaCl solution taken from IV bags. Total Cost Per Vial Made References 1. United States Justice Department, Drug Enforcement Administration. Web Site. http://www.deadiversion.usdoj.gov/fed_regs/rules/2005/fr0502.htm. Accessed July 17, 2013. 2. California State Board of Pharmacy Business & Professions Code Chapter 9, Division 2, Article 2, Section 4031. Web Site. http://www.pharmacy.ca.gov/laws_regs/lawbook.pdf. Accessed July 16, 2013. 3. United States Environmental Protection Agency. Web Site. http://www.epa.gov/waste/hazard/generation/labwaste/rule.htm. Accessed July 15, 2013. • Assessing Specific Needs • A survey was sent to each simulation facilitator soliciting requests for items that would be valuable in their individual program. • 1. Do you see a need for simulated medications to enhance realism and learning during the scenarios? • 2. Are there any injectable drugs you would like specifically created for your simulations? (If so, please include concentration and volume) • 3. Do you have any suggestions for injectable drugs that may be useful for simulation, in general? (If so, please include concentration and volume) • 4. Do you know of any colleagues who would be interested in pharmaceutical simulation or integrating simulated pharmaceuticals into their teaching at the Simulation Center? If so, please provide their name and I will contact them. • Responses were collected and the most frequently requested items were included in the initial production queue to guide the choice of equipment and supplies to purchase. • Vials produced by a non-technician are cheaper than commercially available options. Total Yearly Cost Using In-House Simulated Drugs Versus Commercial Drugs for Anesthesia Residents Stopper insertion (left) and placement of cap (right) Acknowledgments We thank the faculty of the UCLA Simulation Center for their help in selecting drugs for simulation and for their encouragement of our work. Special thanks to Yue Ming Huang, Ed.D and Randolph Steadman, M.D. for their advice and mentoring during the planning, production and implementation of the program. Crimper mounted on vial assembly • The stopper fits into the neck of the vial, the flip-off cap slides snugly over the stopper and the crimper envelops the assembly to seal the foil of the cap. • Labels for the simulated drugs were designed to clearly state they are not for use on humans. • Precautions were taken to add a large bolded “SIMULATED” above each drug name and “For simulation only. Not for human consumption” where the expiration of the drug would be checked. Assumption: A year’s worth of simulated drug for Anesthesia residents is based upon 3 vials of simulated drug used during each simulation, 3 simulations per Wednesday, 4 Wednesdays per Month, 12 months per year which equals 432 vials with 68 vials as a buffer in case more are needed throughout the year. Further Information Any questions or comments regarding the material presented can be directed to the team at: E-mail: sim@mednet.ucla.edu Visit our website at: www.sim.ucla.edu Total Yearly Cost Using In-House Simulated Drugs Versus Commercial Drugs for a Class of 60 Nursing Students Sealed vial (left) and simulated drug labels (right) Assumption: A nursing program with 60 students learning how to draw medications for intravenous administration. Each uses three 10 mL vials of 0.9% NaCl at each practice session. There are four sessions per year.