- Email: [email protected]
Pharmacists’ role in tuberculosis: Prevention, screening, and treatment
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 <797> 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 <797> 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
JAPhA | 5 5 :2 | M AR/AP R 2 0 1 5
❚❚
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
LETTERS
daily workflows. Doing so will only enhance our move toward gaining provider status. TB is a major health concern throughout the world. While not as prevalent in the United States, the disease does occur in this country. In 2012, the number of cases and the corresponding case rate decreased by approximately 5–6% from the previous year.1 Despite successful declines in TB cases and case rates over the past 60 years, current control and prevention efforts are unlikely to result in elimination (<1 case per 1,000,000 population)2 in this century. As TB incidence declines, achieving elimination will depend on both reducing transmission in the United States and controlling the importation of TB through immigration and international travel.3 Through collaboration, health professionals, control programs, and local and state health departments can continue to decrease case rates. Pharmacists can be an effective participant in this TB-control effort. TB screening has long been performed by other health professionals, with pharmacist’s role usually involving the prevention and treatment of tuberculosis. Pharmacists continue to be the most accessible health professional and are well positioned to take on a new role in TB screening, in addition to management of the disease and medications. The Center for Health and Wellness at Sullivan University College of Pharmacy has capitalized on the concept of pharmacist-administered TB screenings for more than 2 years. The Center was first approached by local rheumatologists to perform screenings before patients started immunosuppressive biologic therapy for treatment of rheumatoid arthritis. Additionally, pharmacists at The Center recognized that students would need TB skin testing before experiential rotations, another reason the service was incorporated into their work model. Located in Louisville, KY, The 120
JAPhA | 5 5 :2 | M AR/AP R 2 0 1 5
Center for Health and Wellness embraced the need for availability of additional TB screening beyond of the College of Pharmacy. At 70%, Kentucky’s immigrant population had the seventh highest percentage growth of all states between 2000 and 2012.4 As of 2013, more than 45% of all reported TB cases in Kentucky occurred in patients born outside the United States.5 Because of the increasing rate of immigrants, The Center for Health and Wellness has offered to provide screenings in other worksites, businesses, and shelters. Preventive medicine and vaccination provision an increasingly important part of pharmacy practice. TB-screening services are a natural addition to the services commonly offered by pharmacists. As with vaccinating and point-of-care testing, which are taught in doctor of pharmacy programs throughout the nation, TB skin testing could easily become another public health service offered by the pharmacist. Other sites could use TB screening as another wellness service, in addition to the immunizations already administered by their pharmacists.a With pharmacists providing TB skin testing, additional opportunities will be created for patient education and medication management in those with this disease. The pharmacist can support the patient throughout the entire disease progression, from screening to management of drug therapy to potentially reaching latency of the TB infection. Not only does this emphasize the importance of the pharmacist in public health matters, such a service could support the initiative to gain provider status for pharmacists. The pharmacist would assume the role of preventing and screening for TB, as well as managing antitubercular medications, all while excelling in provision of patient care and medication education. a To perform TB skin testing at a site, the local health department should be contacted for information ja p h a.org
on certification, in accordance with the state law. Lauren E. Glaze, PharmD PGY-1 Pharmacy Resident The Center for Health & Wellness Stacy L. Rowe, PharmD, MBA Associate Professor Sullivan University College of Pharmacy Louisville, KY doi: 10.1331/JAPhA.2015.14215
30/60/10 Rule of effective performance planning Traditionally, managers use performance evaluations as a way to provide feedback to employees and as a tool to optimize an employee’s performance. However, these performance evaluations are usually completed on an annual basis and often do not accomplish their intended purpose of optimizing employee performance. One of the reasons for this is infrequent performance evaluations. Managers and employees see performance evaluations as more of a task than an opportunity to help the employee improve their performance, reflect on past issues, and plan for future development. Infrequent performance evaluations can also result in feedback overload, which could result in very little change by the employee in the subsequent year. Moreover, employees tend to view some of the feedback received during performance evaluations as a surprise because feedback wasn’t given to them throughout the year. This same concept can also be applied to completing projects, reviewing job functions, and communicating information between preceptors and students or residents. Although the intent of performance evaluations is sound, the term “performance evaluation” is outdated and does not serve its intended purpose. A new method of providing feedback and optimizing performance is through performance planning. The intent of performance planning is to facilitate
Journal of the American Pharmacists Association
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 <797> 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 <797> 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
JAPhA | 5 5 :2 | M AR/AP R 2 0 1 5
❚❚
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
LETTERS
daily workflows. Doing so will only enhance our move toward gaining provider status. TB is a major health concern throughout the world. While not as prevalent in the United States, the disease does occur in this country. In 2012, the number of cases and the corresponding case rate decreased by approximately 5–6% from the previous year.1 Despite successful declines in TB cases and case rates over the past 60 years, current control and prevention efforts are unlikely to result in elimination (<1 case per 1,000,000 population)2 in this century. As TB incidence declines, achieving elimination will depend on both reducing transmission in the United States and controlling the importation of TB through immigration and international travel.3 Through collaboration, health professionals, control programs, and local and state health departments can continue to decrease case rates. Pharmacists can be an effective participant in this TB-control effort. TB screening has long been performed by other health professionals, with pharmacist’s role usually involving the prevention and treatment of tuberculosis. Pharmacists continue to be the most accessible health professional and are well positioned to take on a new role in TB screening, in addition to management of the disease and medications. The Center for Health and Wellness at Sullivan University College of Pharmacy has capitalized on the concept of pharmacist-administered TB screenings for more than 2 years. The Center was first approached by local rheumatologists to perform screenings before patients started immunosuppressive biologic therapy for treatment of rheumatoid arthritis. Additionally, pharmacists at The Center recognized that students would need TB skin testing before experiential rotations, another reason the service was incorporated into their work model. Located in Louisville, KY, The 120
JAPhA | 5 5 :2 | M AR/AP R 2 0 1 5
Center for Health and Wellness embraced the need for availability of additional TB screening beyond of the College of Pharmacy. At 70%, Kentucky’s immigrant population had the seventh highest percentage growth of all states between 2000 and 2012.4 As of 2013, more than 45% of all reported TB cases in Kentucky occurred in patients born outside the United States.5 Because of the increasing rate of immigrants, The Center for Health and Wellness has offered to provide screenings in other worksites, businesses, and shelters. Preventive medicine and vaccination provision an increasingly important part of pharmacy practice. TB-screening services are a natural addition to the services commonly offered by pharmacists. As with vaccinating and point-of-care testing, which are taught in doctor of pharmacy programs throughout the nation, TB skin testing could easily become another public health service offered by the pharmacist. Other sites could use TB screening as another wellness service, in addition to the immunizations already administered by their pharmacists.a With pharmacists providing TB skin testing, additional opportunities will be created for patient education and medication management in those with this disease. The pharmacist can support the patient throughout the entire disease progression, from screening to management of drug therapy to potentially reaching latency of the TB infection. Not only does this emphasize the importance of the pharmacist in public health matters, such a service could support the initiative to gain provider status for pharmacists. The pharmacist would assume the role of preventing and screening for TB, as well as managing antitubercular medications, all while excelling in provision of patient care and medication education. a To perform TB skin testing at a site, the local health department should be contacted for information ja p h a.org
on certification, in accordance with the state law. Lauren E. Glaze, PharmD PGY-1 Pharmacy Resident The Center for Health & Wellness Stacy L. Rowe, PharmD, MBA Associate Professor Sullivan University College of Pharmacy Louisville, KY doi: 10.1331/JAPhA.2015.14215
30/60/10 Rule of effective performance planning Traditionally, managers use performance evaluations as a way to provide feedback to employees and as a tool to optimize an employee’s performance. However, these performance evaluations are usually completed on an annual basis and often do not accomplish their intended purpose of optimizing employee performance. One of the reasons for this is infrequent performance evaluations. Managers and employees see performance evaluations as more of a task than an opportunity to help the employee improve their performance, reflect on past issues, and plan for future development. Infrequent performance evaluations can also result in feedback overload, which could result in very little change by the employee in the subsequent year. Moreover, employees tend to view some of the feedback received during performance evaluations as a surprise because feedback wasn’t given to them throughout the year. This same concept can also be applied to completing projects, reviewing job functions, and communicating information between preceptors and students or residents. Although the intent of performance evaluations is sound, the term “performance evaluation” is outdated and does not serve its intended purpose. A new method of providing feedback and optimizing performance is through performance planning. The intent of performance planning is to facilitate
Journal of the American Pharmacists Association