LETTERS

4. Naranjo CA, Busto U, Sellers EM, et al. A method for estimating the probability of adverse drug reactions. Clin Pharmacol Ther. 1981;30:239–245.

Causes and root causes of a multistate fungal meningitis outbreak In a recent issue of this Journal, Teshome et al. used government reports and sworn testimony before Congress to detail the events that led up to the New England Compounding Center (NECC) catastrophe.1 Given the magnitude of this tragedy, observers and students of pharmaceutical policy and regulation are apt to find a root cause analysis of the event both provocative and instructive. Public policies, not unlike medicines themselves, can have unanticipated and undesirable consequences. A series of seemingly unrelated policies may interact to magnify the risk of an adverse outcome. We believe the following events preceded—and possibly set the stage for—the large-scale compounding crisis in the drugdistribution system: ❚❚ The United States Pharmacopeia chapter set industry standards for sterile compounding. Many small hospitals and clinics were not able to support the facilities and personnel needed to comply, and they turned to outside sources of supply. Thus created a widely distributed market for large-scale sterile compounding.2 ❚❚ Persistent problems with drug shortages added to the demand for sterile compounding services to fill the gap. Since 1996, the University of Utah has maintained list of drugs in short supply. Despite debates at the Food and Drug Administration and investigations by Congress capped by an executive order from the White House, physicians and patients found themselves anxiously seeking sources for medications in short supply.3 118

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Market exclusivity is awarded to manufacturers who repurpose existing drugs by reformulating them and providing evidence supporting new indications. Two prime examples are hydroxyprogesterone caproate injection (Makena—Lumara Health) and ranibizumab (Lucentis—Genentech). In both cases, sterile products for new indications were priced at levels far exceeding the nominal cost of compounding existing products for the new indication. The high prices were attributed to the expense and risk associated with establishing value for new indications.4,5 Any one of these factors taken independently might have raised cause for concern, but the potential for synergy among them is captivating. At the end of the day, we find ourselves lured to ongoing examination of the NECC case and its similarities with the problem of preventable drug-related morbidity. Do we have an example of an outcome that was preceded by identifiable and controllable events (i.e., was the event foreseeable through rigorous policy evaluation and therefore preventable)? A number of articles have appeared with recommendations for the regulation and enforcement of compounding at the national level. Questions have been raised about whether the Drug Quality and Security Act will resolve the problem. Our view suggests that we may need a deeper look at the circumstances to identify contributing factors and prevent a recurrence. References 1. Teshome BF, Reveles KR, Lee GC, et  al. How gaps in regulation of compounding pharmacy set the stage for a multistate fungal meningitis outbreak. J Am Pharm Assoc. 2014;54:441–445. 2. Candy TA, Schneider PJ, Pedersen CA. Impact of United States Pharmacopeia chapter 797: results of a national survey. Am J Health Syst Pharm. ja p h a.org

2006;63:1336–1343. 3. Woodcock J, Wosinska M. Economic and technological drivers of generic sterile injectable drug shortages. Clin Pharmacol Ther. 2013;93:170–176. 4. Lie W, Knox CA, Brushwood DB. Discretion of the Food and Drug Administration to enforce compounding rules. Am J Health Syst Pharm. 2013;70:1538–1543. 5. Hutton D, Newman-Casey PA, Tavag M, et al. Switching to less expensive blindness drug could save Medicare Part B $18 billion over a ten-year period. Health Aff (Millwood). 2014:33:931–939. Earlene E. Lipowski, PhD, Professor [email protected] W. Thomas Smith, PharmD, JD, Clinical Associate Professor and Director Online MS Program in Pharmaceutical Outcomes & Policy Robert P. Navarro, PharmD, Clinical Professor Pharmaceutical Outcomes & Policy University of Florida Gainesville, FL doi: 10.1331/JAPhA.2015.14220

Pharmacists’ role in tuberculosis: prevention, screening, and treatment Which health care providers are most accessible and able to educate patients and screen for tuberculosis (TB)? Nurses and physicians are often thought of, but why not the pharmacist? Lack of awareness, literature, and documentation of pharmacist’s role in TB may discourage pharmacists from incorporating these education and screening programs into their practices. But with pharmacies being open at more convenient times for patients (some 24 hours), a pharmacist could easily administer a purified protein derivative (PPD) skin test, read the results, and provide education to the patient. This is an area for improvement and involvement for our profession, as well as an additional source of revenue. Administering and reading TB skin tests requires training, supplies, and short amount of time, all of which the pharmacist can perform and incorporate into

Journal of the American Pharmacists Association

Causes and root causes of a multistate fungal meningitis outbreak.

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