Economic Analysis of the Causes of Drug Shortages. Appendix A: Drug Shortages Followed by the University of Utah DIS.

10/28/2011

Another source for tracking drug shortages is the American Society of Health-System Pharmacists, which is managed by the Drug Information Service (DIS) of the University of Utah Hospitals and Clinics, with support from ASHP and Novation (a group purchasing organization).  The DIS defines drug shortages from the perspective of a health care organization, considering a drug shortage to be a supply issue that affects how the pharmacy prepares a product or influences patient care when prescribers must choose an alternative therapy.

The University of Utah DIS reported 211 shortages in 2010 and 166 shortages for all of 2009.  DIS drug shortages declined from 120 in 2001 to 58 in 2004, and have risen steadily from 74 in 2005 and 70 in 2006 to 166 in 2009.  The University of Utah also reports reasons for shortages.  Unknown reasons are reported for 47 percent of drug shortages; manufacturing problems for 28%; supply/demand  for 14 percent; discontinuations for 7 percent;  raw materials for 3 percent; and regulatory issues for 1 percent.  The large percentage of drug shortages attributed to unknown reasons complicates comparison with the FDA data on reasons for drug shortages. The number of shortages followed by the DIS is generally larger than the number followed by FDA, because of the different definitions of shortages mentioned above, as shown in table A1.  Additional information on FDA’s data on reasons for drug shortages is provided in the companion FDA report, “A Review of FDA’s Approach to Medical Product Shortages.”

 

Table A1:
Drug Shortages Reported Annually by FDA Drug Shortage Program and American Society of Health-System Pharmacists/University of Utah Drug Information Service
Year ASHP/Utah
Drug Shortage
FDA Drug
Shortage
FDA Drug Shortage,
Sterile Injectables
FDA Percent
Sterile Injectables
2005 74 60 30 50.0
2006 70 55 25 45.5
2007 129 92 42 45.7
2008 149 110 40 36.4
2009 166 157 75 47.8
2010 211 178 132 74.2

The University of Utah DIS shared their data on drug shortages with ASPE in August, 2011.  In addition to the drug name, the DIS drug shortages are also categorized by type of drug, using the first tier of the classification system of the American Society for Health System Pharmacists.  We conducted descriptive analyses of a subset of the DIS data, for shortages beginning in 2001.  We excluded from our analysis the categories of blood derivatives and devices, and we combined those categories having a small percentage of drug shortages into a new category, “other”.  There were 1252 drug shortages, from 2001 through 2011 in the subset of drug shortages we analyzed.

Figure A1 shows the analysis of time trends of drug shortages by type of drug.  We looked at the three drug types with the largest numbers of shortages in the DIS data, anti-neoplastic (oncology), anti-infective and neurologic (CNS) drugs, and combined the other types into a larger “other” category.  Shortages of anti-neoplastic (oncology) drugs became more prominent in 2010 and 2011.  Figure A2 shows the trend in drug shortages by whether the drugs are injectable.

Figure A1:

 

Figure A1: Drug Shortages by Year and Type of Drug. See text for explanation of chart.

From analysis of the DIS data
Antineoplastic=oncology drugs; CNS=central nervous system, 2011 data are through August, 2011

Figure A2:

 

Figure A2: Drug Shortages by Injectable Status, 2001-2011. See text for explanation.

From analysis of the DIS data

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