Impact of Drug Shortages - a Pharmacist Perspective

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A record 267 occurred in the United States in 2011 (Kaakeh et al., 2011). Most shortages occur in the supply of generic injectable drugs. The shortages can result in disruptions in the timing of treatments, changes in dose or regimen administered or even missed doses when alternative agents are unavailable. In many cases, equivalent therapeutic substitutions are not available or do not exist. Using alternative medications creates the risk of suboptimal treatments, increased potential for adverse effects, and decreased evidence of efficacy. Drug shortages also lead to higher costs when other more expensive medications must be purchased. Costs are also increased as pharmacists must dedicate more time to finding and procuring substitute medications as well as sharing and receiving approvals from other health care staff regarding these changes and substitutions (McBride, Holle, Westendorf, Sidebottom, Griffith, Muller, & Hoffman, 2013).

Purpose

The purpose of this study is to find which aspects of health care pharmacists believe are directly affected by prescription medication shortages and increased drug costs and which of these issues are impacted most significantly.

Significance

Drug shortages are a critical issue that has national significance and affects patient care at every hospital, pharmacy and health care facility. When a necessary medication is not available or in short supply, it forces the health care providers to choose a less effective alternative or ration medication for only certain patients or for only the most ill individuals. Drug shortages can also lead to fraudulent formulations of a medication being dispensed or short cuts occurring in medication preparation, transportation and storage. Safety may also suffer due to the unavailability of necessary drug preparation materials such as intravenous solutions and containers. This leads to increased drug manipulations and the increased likelihood of possible defects or contamination. Massive increases in medications costs, commonly three hundred to over one thousand percent, are making it impossible for some patients to afford treatment and forcing health care facilities to limit medications in inventory and reserve treatment for only specific patients or indications. For example, the cost increase at just one hospital for five necessary medications will be an estimated $1,000,000 over last year (American Society of Health-System Pharmacists, 2015).

Nature of the Study

This study will employ a survey format listing questions and a Likert scale of 0 to 5 where 0 correlates to least important and 5 correlates to most important. While not listed on the actual survey, the survey will be broken down into sections when after completions and evaluated into sections that will include the following: patient care, pharmacy inventory, health care facility costs and impact on health care provider. Each section will have a total score and the section with the highest numeric total score should theoretically be the area most impacted by medication shortages or increased costs.

The selected sample will include registered pharmacists. Surveys will be emailed to participants via the ASHP data base of all active members who identify themselves as pharmacists, directors of pharmacy, pharmacist specialists or clinical pharmacists. The ASHP members were chosen as members who are actively involved in a professional organization may be more likely to want to participate and will respond to the survey.

Definition of Terms

1. Drug Shortage: A supply issue that affects how the pharmacy prepares or dispenses a

drug product or influences patient care when prescribers must use an alternate agent

(Kaakeh et al., 2011).

2. Management: Collective time spent by all involved parties to identify and purchase

alternatives, modify databases, stock products, and notify staff (Kaakeh et al., 2011).

3. Non-traditional Distributor: Vendor who obtains products in short supply for the

purpose of reselling them at substantially higher prices to end users who are unable

to acquire them through normal suppliers (Fox, Birt, James, Kokko, Salverson,

Soflin, 2009).

4. Oncology Drug: All drugs essential in the care of cancer patients, including

chemotherapy and supportive care agents (McBride, et al, 2013).

Chapter II

LITERATURE REVIEW

History and Introduction

Drug shortages have significantly impacted patient care for over a decade. Determining the true frequency can be challenging because a drug shortage can mean different things to different entities. For example, a manufacturer or wholesaler may use the term back order in place of drug shortage. Whatever the terminology used, it is evident that fluctuations in drug supply have increased. In 2000, the average frequency of drug shortages was 7 percent. By December, 2001, the rate of drug shortages had increased to 23 percent (Fox & Tyler, 2003).

The American Society of Health-system Pharmacists (ASHP) and the Food and Drug Administration (FDA) along with the drug information service at the University of Utah Health Center (UUHC) tracked a total of 224 shortages between January 1996 and June 2002 (Kaakeh et al., 2011). In 2007, 129 new shortages were identified with 166 additional shortages listed in 2009 (Kaakeh et al., 2011). In 2010, the number of drug shortages reached 211, but would continue to peak in 2011 at 267 drug shortages reported (Kaakeh et al., 2011).

The impact of drug shortages is very broad. Over 50 percent of health care practitioners believe that shortages have impacted their practice and lead to inferior patient care. Drug shortages often impact some of the most vulnerable populations including cancer patients and neonates, for which few or no alternative therapies exist. Drug shortages may cause practitioners to prescribe less commonly used medications and concentrations which can lead to medication errors (Caulder, Mehta, Booksaver, Sims, & Stevenson, 2015).

The estimated financial impact of drug shortages in the United States is estimated