Drug Shortage Preparedness

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1 PURDUE UNIVERSITY COLLEGE OF PHARMACY S CENTER FOR MEDICATION SAFETY ADVANCEMENT Drug Shortage Preparedness Survey and Tips for Improvement Developed by: Jonathan Weir, PharmD Candidate in collaboration with Steve R. Abel, PharmD, FASHP and John B. Hertig, PharmD, MS; Purdue University College of Pharmacy s Center for Medication Safety Advancement 11/5/2012 The drug shortage problem continues to present an ongoing challenge to the healthcare system today. This survey was developed to assess the readiness and effectiveness of healthcare systems in handling drug shortages. This survey also provides tips based on available literature on ways healthcare systems can improve how they handle and prepare for drug shortages. During this pilot, this tool should be utilized for two distinct purposes. (1) This tool should first be utilized to give a preliminary assessment of an institution and their overall shortage readiness. By using this toolkit, gaps can be identified and proactively addressed before a shortage even occurs. (2) Secondly, the tool should be used each time a drug shortage occurs. This more acute use of the tool will enable the team to assess whether the appropriate processes were in place and worked to help mitigate that specific shortage. Each time a shortage occurs, the team should do a Shortage De-brief to determine what worked well and what should be improved in the future. Use of this tool will help healthcare systems manage drug shortages in an organized manner. Healthcare system can also continue to improve upon their preparedness and effectiveness in handling drug shortages with the goal of minimizing the impact of drug shortages on the healthcare system. Following completion of this pilot program the brief survey at this end of this toolkit should be taken to help assess the effectiveness of this tool and offer tips for improvement.

2 Prior to shortage do/have you Yes No Investigated potential shortages on a daily basis? 1,3,4,7 Assigned a staff member to identify drug shortages? 2 Is the staff member above a pharmacist? If no, have you assigned a designated pharmacist to work with the staff member above? 1,3,4,5 N/A Designated a primary contact individual for people to contact regarding shortages? 2,6 Setup a system for warning providers in advance of impending drug product shortages? 1,2,3,4,6 Developed and implemented strategies and processes for optimizing the safe and effective use of therapeutic alternatives? 1,2,4 Setup collaborative arrangements with other institutions? 1,2,4,5 Decided on your philosophy on purchasing drugs from gray market? 1,5 When shortage is identified do you Yes No Validate the shortage and its anticipated duration? 1,2,3,4,7 Count the inventory on hand and estimate the time period it will cover? 1,3,4,6 Estimate how long the system can endure a shortage? 1,3,4,7 Determine availability of supplies from alternative sources? 1,4 Locate and procure alternatives supplies if available? 1,4,7 Investigate compounding the product? 1,2,4 Identify therapeutic alternatives? 1,2,3,4,6,7 Research and provide education about alternative agents and the cost of all scenarios? 1,2,3,4,7 Convert the inventory of alternative drugs into common measurement units to augment estimates of use? 1,4 Communicate the needed information to all professionals involved and to affected patients when warranted? 1,2,3,4,6,7 Prioritize patients to ensure that available medication is dispensed appropriately? 2,3,4,5,6,7 Develop a contingency planning strategy to prepare for the possibility of a prolonged drug shortage? 1,3,4,7 Evaluate effect on patient care and safety? 1,2,3,4,6,7 Consider changes in procedures for look-alike and sound-alike medications, bar coding, contract compliance, distribution paths, and the effect on automation, and final product preparation? 1,4 Restrain from stockpiling? 1,2,4,5 Total Number of Yes/No Answers*: *Number of Yes/No should be used for your purposes to evaluate your health system. Every system is different and not all strategies may work in your health system.

3 Drug Shortages The questions in this survey were developed from a multiple of sources to determine the most commonly used methods to prepare for and cope with drug shortages. Expanded tips for each of these methods are listed below. Additional helpful resources are also listed to aid in researching suspected shortages. Tips on Preparing for Drug Shortages Assign a staff member to identify drug shortages and investigate for potential shortages on a daily basis. 1,2,3,4,7 Use of the purchasing agent to identify shortages is typically the most convenient. This individual must be aware of fluctuations in the supply chain that may indicate that a drug shortage is coming. Assign a designated pharmacist to work with the staff member above. This pharmacist could serve as the primary contact for people to contact regarding shortages. 1,3,4,5 Setup a system for warning providers in advance of impending drug product shortages. 1,2,3,4,6 Processes for optimizing the safe and effective use of therapeutic alternatives should be developed and implemented. 1,2,4 Setup collaborative arrangements with other institutions. 1,2,4,5 Larger health systems often can withstand longer drug shortages by sharing inventory among sites. Decide on your philosophy on purchasing drugs from gray market. 1,5 Tips on Handling Drug Shortages Taken from: Fox ER, Birt A, James KB, et al; ASHP Expert Panel on Drug Product Shortages. ASHP Guidelines on Managing Drug Product Shortages in Hospitals and Health Systems. Am J Health-Syst Pharm 2009; 66: Validate shortage and anticipated duration. 1,2,3,4,7 Helpful resources listed below. Duration of shortages can vary based on reason for the shortage. Count the inventory on hand and estimate time period it will cover. 1,3,4,6 These counts should include anywhere in the health system the medication is stored (pharmacy, automated dispensing cabinets, carts and trays). Estimate how long the system can endure a shortage. 1,3,4,7 This is based on historical usage. Determine availability of supplies from alternative sources. 1,4 Locate and procure alternative supplies if available. 1,4,7 Investigate compounding the product. 1,2,4 Identify therapeutic alternatives. 1,2,3,4,6,7 Decisions should be made in collaboration with medical, nursing, and pharmacy representatives with the approval of the appropriate medical committees.

4 Health care facilities should also prepare for shortages of alternative agents. Research and provide education about alternative agents and the cost of all scenarios. 1,2,3,4,7 Budgetary concerns need to be known prior to selecting alternative of choice. Inventory counts of alternative drugs should be converted into common measurement units to augment estimates of use. 1,4 Communicate the needed information to all professionals involved and to affected patients when warranted. 1,2,3,4,6,7 The Joint Commission requires the notification of drug prescribers who may be affected by a shortage. Communication should include information on drug product shortages, alternative therapies, temporary therapeutic guidelines, and implementation plans. Prioritize patients to ensure that available medication is dispensed appropriately. 2,3,4,5,6,7 Decisions on allocation of medications should not be a decision made solely by the pharmacy department. Pharmacists should lead these discussions, but it should be a collaborative decision between pharmacists, physicians, and the institution s ethics committee. Develop a contingency planning strategy to prepare for the possibility of a prolonged drug shortage. 1,3,4,7 Evaluate effect on patient care and safety. 1,2,3,4,6,7 Risk management and liability concerns should be evaluated. Consider changes in procedures for look-alike and sound-alike medications, bar coding, contract compliance, distribution paths, and the effect on automation, and final product preparation. 1,4 Restrain from stockpiling. 1,2,4,5 Helpful Resources: Stockpiling can depleted existing stores and worsen shortages. ASHP Drug Shortages Website FDA Drug Shortage Website CDC Vaccine Shortage and Delays Website Product Manufacturers References: 1. Fox ER, Birt A, James KB, et al; ASHP Expert Panel on Drug Product Shortages. ASHP Guidelines on Managing Drug Product Shortages in Hospitals and Health Systems. Am J Health-Syst Pharm 2009; 66: Mark SM. Understanding and Managing Challenges Posed by Drug Shortages. ASHP Advantage Accessed at: 3. Fox ER, Tyler SL. Managing drug shortages: Seven years experience at one health system. Am J Health-Syst Pharm 2003; 60: Ventola CL. The Drug Shortage Crisis in the United States: Causes, Impact, and Management Strategies. P T 2011; 36 (11): Manolakis M. Ethical integrity in managing drug shortages. Am J Health-Syst Pharm 2012; 69: Paparella SF. Drug Shortages in the Emergency Deparment: Managing a Threat to Patient Safety. J Emerg Nurs 2012; 38 (5): Griffith MM, Patel JA, Sutton SH, et al. Prospective Approach to Managing Antimicrobial Drug Shortages. Infect Control Hosp Epidemiol 2012; 33 (7):

5 Satisfaction Survey The drug shortage preparedness survey was developed to help healthcare facilities assess their readiness and effectiveness in handling drug shortages. Following completion of the drug shortage preparedness survey, please complete this survey regarding the usefulness of the drug shortage preparedness survey in helping your health system assess its current practices in preparing for and handling drug shortages. Strongly Disagree Strongly Agree This is a useful tool for managing drug shortages This tool helped to identify areas for improvement I learned things my health system does well from this tool This tool will help me to manage drug shortages in an organized way I will make changes in my health system due to this tool I will continue to use this tool to evaluate my health system This tool can be used to continually evaluate the success at handling each individual medication shortage. Comments for improvement:

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