- Email: [email protected]
When Pharmacies Cause Harm: Response
Mihaela S. Stefan, MD Peter K. Lindenauer, MD Springfield, MA Affiliations: From the Department of Medicine and Center for Quality of Care Research, Baystate Medical Center; and Tufts University School of Medicine, Boston, MA. Financial/nonfinancial disclosures: The authors have reported to CHEST that no potential conflicts of interest exist with any companies/organizations whose products or services may be discussed in this article. Correspondence: Mihaela S. Stefan, MD, Baystate Medical Center, 759 Chestnut St, Springfield, MA 01199; e-mail: Mihaela. [email protected] © 2013 American College of Chest Physicians. Reproduction of this article is prohibited without written permission from the American College of Chest Physicians. See online for more details. DOI: 10.1378/chest.13-1066
References 1. Stefan MS, Rothberg MB, Shieh M-S, Pekow PS, Lindenauer PK. Association between antibiotic treatment and outcomes in patients hospitalized with acute exacerbation of COPD treated with systemic steroids. Chest. 2013;143(1):82-90. 2. Niewoehner DE, Erbland ML, Deupree RH, et al; Department of Veterans Affairs Cooperative Study Group. Effect of systemic glucocorticoids on exacerbations of chronic obstructive pulmonary disease. N Engl J Med. 1999;340(25):1941-1947. 3. Vollenweider DJ, Jarrett H, Steurer-Stey CA, Garcia-Aymerich J, Puhan MA. Antibiotics for exacerbations of chronic obstructive pulmonary disease. Cochrane Database Syst Rev. 2012; 12:CD010257.
When Pharmacies Cause Harm To the Editor: In a recent commentary published in CHEST (April 2013), Guharoy and colleagues1 provided a detailed analysis of the context in which compounding pharmacies have operated and the regulatory loopholes that permitted unsafe manufacturing practices, leading to grave illnesses and death in many patients. This preventable tragedy prompted remarkable coordinated efforts among the clinicians, patients, and regulatory agencies to address the situation. The pulmonary and critical care readership of CHEST may also be interested to learn that the majority of retail pharmacies throughout the United States contribute to harm by selling tobacco products, chiefly cigarettes. These pharmacies, more numerous and more familiar to the public than compounding pharmacies, continue to brazenly market tobacco products nearly 50 years after the landmark 1964 Surgeon General’s report on smoking and health. Stand-alone pharmacies account for 4.2% of all US cigarette sales, according to 2006 data.2,3 Additionally, hundreds of other pharmacies operate in supermarkets where cigarettes are sold.4 This situation raises a number of ethical and public health concerns, to put it mildly. Pharmacy tobacco sales make it difficult for pharmacists to credibly counsel smoking cessation because the establishment that they represent sells tobacco products. In addition, these sales implicitly associate tobacco products with good health and contribute to the normalization of tobacco use. The association of tobacco sales with health-care facilities becomes starker and even more troubling when these facilities open primarycare clinics and offer services such as influenza vaccination and BP screening.
Although a number of professional organizations have issued policy statements condemning pharmacy tobacco sales, including the American Pharmacists Association, the issue has not engendered the kind of outrage as have other corporate conflicts of interest. Even the American Heart Association continues to partner with and accept large donations from Walgreen Co, CVS, and Rite Aid Corp, despite their ongoing practice of selling the leading preventable cause of heart disease and stroke in thousands of drugstores nationwide.5 In an age of corporations bound to shareholders by fiducial responsibility, corporations practicing unethically will often only yield when enough social pressure is applied. Practicing pulmonologists and intensivists are unusually qualified to help apply this pressure because we daily witness the harms of tobacco. Vinayak M. Jha, MD Washington, DC Affiliations: From the George Washington University and TobaccofreeRx.org. Portions of this correspondence pertaining to the efforts of TobaccofreeRx.org were presented in abstract form (D3-P239) at the 15th World Conference on Tobacco/Health, Singapore, March 23, 2012. Financial/nonfinancial disclosures: The author has reported to CHEST the following conflicts of interest: Dr Jha is the founder of TobaccofreeRx.org. Correspondence to: Vinayak M. Jha, MD, The George Washington University, Pulmonary and Critical Care Medicine, 2150 Pennsylvania Ave, 8th Floor, Washington, DC 20037; e-mail: [email protected] © 2013 American College of Chest Physicians. Reproduction of this article is prohibited without written permission from the American College of Chest Physicians. See online for more details. DOI: 10.1378/chest.13-0869
References 1. Guharoy R, Noviasky J, Haydar Z, Fakih MG, Hartman C. Compounding pharmacy conundrum: “we cannot live without them but we cannot live with them” according to the present paradigm. Chest. 2013;143(4):896-900. 2. National Association of Chain Drug Stores. Chain Pharmacy Industry Profile 2010-2011. 13th ed. Arlington, VA: National Association of Chain Drug Stores; 2010:42. 3. Centers for Disease Control and Prevention. Economic facts about US tobacco production and use. Centers for Disease Control and Prevention website. http://www.cdc.gov/tobacco/ data_statistics / fact_sheets / economics / econ_facts /# sales . Accessed April 19, 2013. 4. SK&A, A Cegedim Company. National Pharmacy Market Summary. Irvine, CA: SK&A; 2010. 5. TobaccofreeRx.org. Letters to and from the American Heart Association. TobaccofreeRx.org website. http://www. TobaccofreeRx.org. Accessed April 19, 2013.
Response To the Editor: We thank Dr Jha for his feedback on our commentary.1 Although not directly related to the topic of our article, protecting patients from harm represents a common theme. We agree that tobacco sales in retail pharmacies are contradictory to the pharmacists’ role as patient care providers. It is hypocritical for a pharmacy where pharmacists provide counseling for medication adherence, smoking cessation, and vaccinations to also engage in selling tobacco products.
journal.publications.chestnet.org
Downloaded From: http://journal.publications.chestnet.org/ by David Kinnison on 08/06/2013
CHEST / 144 / 2 / AUGUST 2013
717
Although national tobacco sales decreased by 17.43% between 2005 and 2009, US pharmacies increased their sales by 22.7% during the same period.2 Pharmacies account for almost 5% of total cigarette sales in the country. Independently owned pharmacies are less likely to sell tobacco products than retail chain pharmacies.2 The majority of professional organizations, including the American Society of Health System Pharmacists with a 36,000-plus membership, strongly opposes the sale or distribution of tobacco products in all establishments where health-care services are rendered.3 Despite the overwhelming professional opposition, the sale of tobacco products by chain pharmacies and grocery markets that contain pharmacies continues to increase. Tobacco use is a major leading preventable cause of chronic illness and death in the United States. It is responsible for one in five deaths annually in the United States and increases health-care spending by $193 billion annually.4 The Institute of Medicine recommended in 1994 to ban tobacco sales in US pharmacies as part of a comprehensive strategy to reduce tobacco use among young people.5 However, with the exception of a few cities, pharmacies and health-care facilities are not legally prohibited from selling tobacco products.2 All the stakeholders involved in health-care delivery and the advocates of patient safety need to collaborate to ban tobacco sales in pharmacies across the country. The moral incentive of first do no harm to the patients should arise as a priority before the financial incentive. With the majority of pharmacists not supporting tobacco sales in pharmacies, the right time to act is now. Roy Guharoy, PharmD, MBA, FCCP St. Louis, MO John Noviasky, PharmD, BCPS Syracuse, NY Ziad Haydar, MD, MBA St. Louis, MO Mohamad G. Fakih, MD, MPH Detroit, MI Christian Hartman, PharmD, MBA Boston, MA Affiliations: From Ascension Health (Drs Guharoy and Haydar); University of Massachusetts Medical School (Drs Guharoy and Hartman), Worcester, MA; SUNY-Upstate Medical University Hospital at Community General (Dr Noviasky); St. John Hospital and Medical Center (Dr Fakih); and Wayne State University School of Medicine (Dr Fakih). Financial/nonfinancial disclosures: The authors have reported to CHEST that no potential conflicts of interest exist with any companies/organizations whose products or services may be discussed in this article. Correspondence to: Roy Guharoy, PharmD, MBA, FCCP, Ascension Health, 11775 Borman Dr, Ste 340, St. Louis, MO 63146; e-mail: [email protected] © 2013 American College of Chest Physicians. Reproduction of this article is prohibited without written permission from the American College of Chest Physicians. See online for more details. DOI: 10.1378/chest.13-1116
References 1. Guharoy R, Noviasky J, Haydar Z, Fakih MG, Hartman C. Compounding pharmacy conundrum: “we cannot live without them but we cannot live with them” according to the present paradigm. Chest. 2013;143(4):896-900. 2. Seidenberg AB, Behm I, Rees VW, Connolly GN. Cigarette sales in pharmacies in the USA (2005-2009). Tob Control. 2012;21(5):509-510. 3. ASHP therapeutic statement on the cessation of tobacco use. Am J Health Syst Pharm. 2009;66(3):291-307.
4. Garrett BE, Dube SR, Trosclair A, Caraballo RS, Pechacek TF; Centers for Disease Control and Prevention (CDC). Cigarette smoking-United States, 1965-2008. MMWR Surveill Summ. 2011;60(suppl):109-113. 5. Lynch BS, Bonnie RJ, eds; Committee on Preventing Nicotine Addiction in Children and Youths, Institute of Medicine. Growing Up Tobacco Free: Preventing Nicotine Addiction in Children and Youths. Washington, DC: National Academy Press; 1994.
Simulation-Based Bronchoscopy Training To The Editor: We read with great interest an article by Kennedy and colleagues1 in a recent issue of CHEST (July 2013) in which a systematic review and meta-analysis of studies revealed significant improvements in skills and behaviors when comparing simulation-based bronchoscopy with no intervention. However, the article also identified gaps in evidence, such as the lack of clear understanding of optimal design or choice of modalities in relation to simulationbased bronchoscopy training. Based on our experience of setting up a regional simulation bronchoscopy program, we are able to address these issues. We established five clinical skills laboratories that deliver simulation bronchoscopy training. We also set up a group of regional experienced bronchoscopists responsible for the development of simulation bronchoscopy training. We have run 15 courses and trained . 60 candidates. Although initially we used different formats for the courses, the trainees’ overall experience of simulationbased bronchoscopy was extremely positive. Based on our initial experience, we established that the optimal design for delivering simulation-based bronchoscopy courses should incorporate a blend of short lectures, e-learning, and hands-on experience using simulation. To be successful, simulation-based bronchoscopy requires a high trainer-to-trainee ratio (ideally 1:2), and, therefore, we established a faculty of experienced bronchoscopists with a special interest in procedural training. Our results confirmed significant improvement, for both novices and more experienced trainees, in the technical ability of handling bronchoscopes, their understanding of anatomy and identification of bronchial segments, and their knowledge of the procedure; the improvements were in the range of 20% and 30% when using high fidelity alone and in combination with low-fidelity bronchoscopy simulation, respectively.2 We observed that the best outcomes were achieved by combining sessions on a virtual reality bronchoscopy simulator with lowfidelity manikin and real scope modules. Our real-life experience showed that it is possible to set up a large and successful regional simulation bronchoscopy training program, which is now offered to all of our trainees (before exposure to patients). Training in bronchoscopy is a complex process and has been traditionally based on an apprenticeship model, which raised concerns of patient safety and variable level of experience, with reports suggesting that one-fifth of trainees may not be achieving the required number of procedures.3 Although simulation-based bronchoscopy can overcome many of these issues, it has only been incorporated into 36% programs in the United States.4 The article by Kennedy and colleagues1 and our experience, therefore, provide important evidence to encourage wider use of simulation for bronchoscopy training.
718
Downloaded From: http://journal.publications.chestnet.org/ by David Kinnison on 08/06/2013
Jack A. Kastelik, MD Faiza Chowdhury, MBChB
Correspondence
References 1. Stefan MS, Rothberg MB, Shieh M-S, Pekow PS, Lindenauer PK. Association between antibiotic treatment and outcomes in patients hospitalized with acute exacerbation of COPD treated with systemic steroids. Chest. 2013;143(1):82-90. 2. Niewoehner DE, Erbland ML, Deupree RH, et al; Department of Veterans Affairs Cooperative Study Group. Effect of systemic glucocorticoids on exacerbations of chronic obstructive pulmonary disease. N Engl J Med. 1999;340(25):1941-1947. 3. Vollenweider DJ, Jarrett H, Steurer-Stey CA, Garcia-Aymerich J, Puhan MA. Antibiotics for exacerbations of chronic obstructive pulmonary disease. Cochrane Database Syst Rev. 2012; 12:CD010257.
When Pharmacies Cause Harm To the Editor: In a recent commentary published in CHEST (April 2013), Guharoy and colleagues1 provided a detailed analysis of the context in which compounding pharmacies have operated and the regulatory loopholes that permitted unsafe manufacturing practices, leading to grave illnesses and death in many patients. This preventable tragedy prompted remarkable coordinated efforts among the clinicians, patients, and regulatory agencies to address the situation. The pulmonary and critical care readership of CHEST may also be interested to learn that the majority of retail pharmacies throughout the United States contribute to harm by selling tobacco products, chiefly cigarettes. These pharmacies, more numerous and more familiar to the public than compounding pharmacies, continue to brazenly market tobacco products nearly 50 years after the landmark 1964 Surgeon General’s report on smoking and health. Stand-alone pharmacies account for 4.2% of all US cigarette sales, according to 2006 data.2,3 Additionally, hundreds of other pharmacies operate in supermarkets where cigarettes are sold.4 This situation raises a number of ethical and public health concerns, to put it mildly. Pharmacy tobacco sales make it difficult for pharmacists to credibly counsel smoking cessation because the establishment that they represent sells tobacco products. In addition, these sales implicitly associate tobacco products with good health and contribute to the normalization of tobacco use. The association of tobacco sales with health-care facilities becomes starker and even more troubling when these facilities open primarycare clinics and offer services such as influenza vaccination and BP screening.
Although a number of professional organizations have issued policy statements condemning pharmacy tobacco sales, including the American Pharmacists Association, the issue has not engendered the kind of outrage as have other corporate conflicts of interest. Even the American Heart Association continues to partner with and accept large donations from Walgreen Co, CVS, and Rite Aid Corp, despite their ongoing practice of selling the leading preventable cause of heart disease and stroke in thousands of drugstores nationwide.5 In an age of corporations bound to shareholders by fiducial responsibility, corporations practicing unethically will often only yield when enough social pressure is applied. Practicing pulmonologists and intensivists are unusually qualified to help apply this pressure because we daily witness the harms of tobacco. Vinayak M. Jha, MD Washington, DC Affiliations: From the George Washington University and TobaccofreeRx.org. Portions of this correspondence pertaining to the efforts of TobaccofreeRx.org were presented in abstract form (D3-P239) at the 15th World Conference on Tobacco/Health, Singapore, March 23, 2012. Financial/nonfinancial disclosures: The author has reported to CHEST the following conflicts of interest: Dr Jha is the founder of TobaccofreeRx.org. Correspondence to: Vinayak M. Jha, MD, The George Washington University, Pulmonary and Critical Care Medicine, 2150 Pennsylvania Ave, 8th Floor, Washington, DC 20037; e-mail: [email protected] © 2013 American College of Chest Physicians. Reproduction of this article is prohibited without written permission from the American College of Chest Physicians. See online for more details. DOI: 10.1378/chest.13-0869
References 1. Guharoy R, Noviasky J, Haydar Z, Fakih MG, Hartman C. Compounding pharmacy conundrum: “we cannot live without them but we cannot live with them” according to the present paradigm. Chest. 2013;143(4):896-900. 2. National Association of Chain Drug Stores. Chain Pharmacy Industry Profile 2010-2011. 13th ed. Arlington, VA: National Association of Chain Drug Stores; 2010:42. 3. Centers for Disease Control and Prevention. Economic facts about US tobacco production and use. Centers for Disease Control and Prevention website. http://www.cdc.gov/tobacco/ data_statistics / fact_sheets / economics / econ_facts /# sales . Accessed April 19, 2013. 4. SK&A, A Cegedim Company. National Pharmacy Market Summary. Irvine, CA: SK&A; 2010. 5. TobaccofreeRx.org. Letters to and from the American Heart Association. TobaccofreeRx.org website. http://www. TobaccofreeRx.org. Accessed April 19, 2013.
Response To the Editor: We thank Dr Jha for his feedback on our commentary.1 Although not directly related to the topic of our article, protecting patients from harm represents a common theme. We agree that tobacco sales in retail pharmacies are contradictory to the pharmacists’ role as patient care providers. It is hypocritical for a pharmacy where pharmacists provide counseling for medication adherence, smoking cessation, and vaccinations to also engage in selling tobacco products.
journal.publications.chestnet.org
Downloaded From: http://journal.publications.chestnet.org/ by David Kinnison on 08/06/2013
CHEST / 144 / 2 / AUGUST 2013
717
Although national tobacco sales decreased by 17.43% between 2005 and 2009, US pharmacies increased their sales by 22.7% during the same period.2 Pharmacies account for almost 5% of total cigarette sales in the country. Independently owned pharmacies are less likely to sell tobacco products than retail chain pharmacies.2 The majority of professional organizations, including the American Society of Health System Pharmacists with a 36,000-plus membership, strongly opposes the sale or distribution of tobacco products in all establishments where health-care services are rendered.3 Despite the overwhelming professional opposition, the sale of tobacco products by chain pharmacies and grocery markets that contain pharmacies continues to increase. Tobacco use is a major leading preventable cause of chronic illness and death in the United States. It is responsible for one in five deaths annually in the United States and increases health-care spending by $193 billion annually.4 The Institute of Medicine recommended in 1994 to ban tobacco sales in US pharmacies as part of a comprehensive strategy to reduce tobacco use among young people.5 However, with the exception of a few cities, pharmacies and health-care facilities are not legally prohibited from selling tobacco products.2 All the stakeholders involved in health-care delivery and the advocates of patient safety need to collaborate to ban tobacco sales in pharmacies across the country. The moral incentive of first do no harm to the patients should arise as a priority before the financial incentive. With the majority of pharmacists not supporting tobacco sales in pharmacies, the right time to act is now. Roy Guharoy, PharmD, MBA, FCCP St. Louis, MO John Noviasky, PharmD, BCPS Syracuse, NY Ziad Haydar, MD, MBA St. Louis, MO Mohamad G. Fakih, MD, MPH Detroit, MI Christian Hartman, PharmD, MBA Boston, MA Affiliations: From Ascension Health (Drs Guharoy and Haydar); University of Massachusetts Medical School (Drs Guharoy and Hartman), Worcester, MA; SUNY-Upstate Medical University Hospital at Community General (Dr Noviasky); St. John Hospital and Medical Center (Dr Fakih); and Wayne State University School of Medicine (Dr Fakih). Financial/nonfinancial disclosures: The authors have reported to CHEST that no potential conflicts of interest exist with any companies/organizations whose products or services may be discussed in this article. Correspondence to: Roy Guharoy, PharmD, MBA, FCCP, Ascension Health, 11775 Borman Dr, Ste 340, St. Louis, MO 63146; e-mail: [email protected] © 2013 American College of Chest Physicians. Reproduction of this article is prohibited without written permission from the American College of Chest Physicians. See online for more details. DOI: 10.1378/chest.13-1116
References 1. Guharoy R, Noviasky J, Haydar Z, Fakih MG, Hartman C. Compounding pharmacy conundrum: “we cannot live without them but we cannot live with them” according to the present paradigm. Chest. 2013;143(4):896-900. 2. Seidenberg AB, Behm I, Rees VW, Connolly GN. Cigarette sales in pharmacies in the USA (2005-2009). Tob Control. 2012;21(5):509-510. 3. ASHP therapeutic statement on the cessation of tobacco use. Am J Health Syst Pharm. 2009;66(3):291-307.
4. Garrett BE, Dube SR, Trosclair A, Caraballo RS, Pechacek TF; Centers for Disease Control and Prevention (CDC). Cigarette smoking-United States, 1965-2008. MMWR Surveill Summ. 2011;60(suppl):109-113. 5. Lynch BS, Bonnie RJ, eds; Committee on Preventing Nicotine Addiction in Children and Youths, Institute of Medicine. Growing Up Tobacco Free: Preventing Nicotine Addiction in Children and Youths. Washington, DC: National Academy Press; 1994.
Simulation-Based Bronchoscopy Training To The Editor: We read with great interest an article by Kennedy and colleagues1 in a recent issue of CHEST (July 2013) in which a systematic review and meta-analysis of studies revealed significant improvements in skills and behaviors when comparing simulation-based bronchoscopy with no intervention. However, the article also identified gaps in evidence, such as the lack of clear understanding of optimal design or choice of modalities in relation to simulationbased bronchoscopy training. Based on our experience of setting up a regional simulation bronchoscopy program, we are able to address these issues. We established five clinical skills laboratories that deliver simulation bronchoscopy training. We also set up a group of regional experienced bronchoscopists responsible for the development of simulation bronchoscopy training. We have run 15 courses and trained . 60 candidates. Although initially we used different formats for the courses, the trainees’ overall experience of simulationbased bronchoscopy was extremely positive. Based on our initial experience, we established that the optimal design for delivering simulation-based bronchoscopy courses should incorporate a blend of short lectures, e-learning, and hands-on experience using simulation. To be successful, simulation-based bronchoscopy requires a high trainer-to-trainee ratio (ideally 1:2), and, therefore, we established a faculty of experienced bronchoscopists with a special interest in procedural training. Our results confirmed significant improvement, for both novices and more experienced trainees, in the technical ability of handling bronchoscopes, their understanding of anatomy and identification of bronchial segments, and their knowledge of the procedure; the improvements were in the range of 20% and 30% when using high fidelity alone and in combination with low-fidelity bronchoscopy simulation, respectively.2 We observed that the best outcomes were achieved by combining sessions on a virtual reality bronchoscopy simulator with lowfidelity manikin and real scope modules. Our real-life experience showed that it is possible to set up a large and successful regional simulation bronchoscopy training program, which is now offered to all of our trainees (before exposure to patients). Training in bronchoscopy is a complex process and has been traditionally based on an apprenticeship model, which raised concerns of patient safety and variable level of experience, with reports suggesting that one-fifth of trainees may not be achieving the required number of procedures.3 Although simulation-based bronchoscopy can overcome many of these issues, it has only been incorporated into 36% programs in the United States.4 The article by Kennedy and colleagues1 and our experience, therefore, provide important evidence to encourage wider use of simulation for bronchoscopy training.
718
Downloaded From: http://journal.publications.chestnet.org/ by David Kinnison on 08/06/2013
Jack A. Kastelik, MD Faiza Chowdhury, MBChB
Correspondence