Background We previously described experiences of clinicians who published adverse drug reaction ... more Background We previously described experiences of clinicians who published adverse drug reaction reports. We now report on threats and intimidations leveled against clinicians and scientists who received publicly documented threats after communicating safety, efficacy, or data integrity findings contrary to corporate interests. Methods Data on threats and intimidations were obtained from transcripts of governmental hearings or agencies, university-affiliated reports, media interviews, and investigative journalism articles. Content and timing of threats and intimidation, subsequent harms, numbers of persons seriously injured or who died from individual toxicities, financial payments from sponsors related to safety, efficacy, or data integrity concerns, and civil settlements and criminal findings were evaluated. Findings Twenty-six individuals who communicated safety, efficacy, or data integrity concerns were targets of threats and intimidation from corporate employees (twenty-three i...
The objective of this opinion paper was to identify and describe potential clinical pharmacists&#... more The objective of this opinion paper was to identify and describe potential clinical pharmacists' services for the prevention and management of patients infected with the hepatitis C virus (HCV). The goals of this paper are to guide the establishment and development of pharmacy services for patients infected with HCV and to highlight HCV research and educational opportunities. Recommendations were based on the following: a review of published data on clinical pharmacist involvement in the treatment and management of HCV-infected patients; a consensus of clinical pharmacists who provide direct patient care to HCV-infected patients and practice in different pharmacy models, including community-based and academic settings; and a review of published guidelines and literature focusing on the treatment and management of HCV infections. The recommendations provided in this opinion paper define the areas of clinical pharmacist involvement and clinical pharmacy practice in the treatment a...
Following the observation of the decreasing occurrence of campylobacteriosis in HIV-infected pati... more Following the observation of the decreasing occurrence of campylobacteriosis in HIV-infected patients. This study examines the incidence of campylobacteriosis in patients who had received rifabutin prophylaxis against Mycobacterium avium complex (MAC) infection compared with the incidence observed among patients treated before the advent of rifabutin. A retrospective analysis (February 1992 to November 1995) was conducted in a hospital HIV inpatient unit. The study included two patient groups: 73 HIV-infected patients with CD4 counts of < 100 cells/microL (mean 30 cells/microL) who were treated between February 1992 and July 1993 and who had not received rifabutin prophylaxis (Group R-), as well as 90 HIV-infected patients with CD4 counts of < 100 cells/microL (mean 22 cells/microL) who had received rifabutin 300 mg/day as primary prophylaxis against MAC bacteremia between July 1993 and November 1995 (Group R+). For the patient population as a whole, 20 episodes of campylobacter infection were observed in 13 patients. Causative pathogens were Campylobacter jejuni (n = 10), C. coli (8), and unidentifiable (2). Seventeen episodes (in 12 patients) of campylobacter infection occurred in Group R- versus 3 episodes (in 2 patients) in Group R+ (p < 0.0005). The rate of symptomatic infection per 100 patient-months was 0.251 in Group R+ versus 2.02 in Group R-. The results of this study indicate that rifabutin prophylaxis was associated with a decrease in the rate of campylobacter infection in HIV-infected patients. These findings are supported by evidence that rifabutin is active against C. jejuni in vitro.
Tenofovir disoproxil fumarate (TDF) and emtricitabine (FTC) are nucleoside reverse transcriptase ... more Tenofovir disoproxil fumarate (TDF) and emtricitabine (FTC) are nucleoside reverse transcriptase inhibitors approved as pre-exposure prophylaxis (PrEP) against human immunodeficiency virus (HIV). Prophylactic TDF-based regimens have been shown to reduce the risk of HIV infection by 74 to 92% among participants with detectable drug levels. Adverse events observed in clinical trials include nausea, elevated creatinine and liver enzymes, and decreased bone mineral density. This article reviews the pharmacology, pharmacokinetics, and the safety profile of TDF and FTC used as PrEP for HIV infection. TDF-FTC can have a large impact in preventing HIV infections among high risk individuals when taken daily. Although TDF-FTC is associated with adverse events, they can be minimized with clinician-guided monitoring.
Journal of the American Pharmacists Association : JAPhA, Jan 8, 2017
To describe the first community pharmacy-based hepatitis C antibody (HCV-Ab) point-of-care (POC) ... more To describe the first community pharmacy-based hepatitis C antibody (HCV-Ab) point-of-care (POC) screening program and its outcomes in California. Community pharmacy. Community pharmacists perform HCV-Ab POC testing, counsel patients about HCV transmission and prevention, and provide linkage to care. Pharmacists implement an HCV-Ab POC screening program in collaboration with the local public health department. Descriptive data of the demographics of the persons receiving HCV-Ab POC screening and qualitative assessment of the attitudes and knowledge of the trained pharmacists involved in its implementation. During the 3-month pilot, 6 community pharmacists performed 83 HCV-Ab rapid POC tests with 1 positive result (1.2%). Risk factors for the positive result included injection drug use, crack cocaine or methamphetamine use, and being in the high-risk birth cohort. Although some expressed reservations, pharmacists attested to the feasibility of incorporating HCV screening into their r...
Human immunodeficiency virus (HIV) infection has become a treatable chronic disease with near-nor... more Human immunodeficiency virus (HIV) infection has become a treatable chronic disease with near-normal life expectancy when patients receive antiretroviral therapy (ART). Family physicians and other primary care clinicians commonly provide long-term comprehensive care for persons with HIV infection. This article describes the scope of initial care, including obtaining a thorough history; physical examination for HIV-associated manifestations; attention to HIV-specific immunization schedules; routine and HIV-specific laboratory evaluation; and ensuring standard health care maintenance to prevent HIV- and non-HIV-related morbidity and mortality. Clinicians should encourage combination ART as early as possible, although careful assessment of patient readiness and ability to sustain lifelong treatment must be weighed. After ART initiation, monitoring viral load and CD4 lymphocyte response is essential to ensure viral suppression and evaluate immune system restoration. Opportunistic infect...
California has an estimated 175,000 State Prisoners. The prevalence of HIV in the incarcerated po... more California has an estimated 175,000 State Prisoners. The prevalence of HIV in the incarcerated population ranges from 2-5% or an estimated 4000 HIV-infected inmates in State prisons. Complicating the issue of caring for this number of patients, is the fact that California has 33 prisons over a wide, mostly rural geographical area. The University of California, San Francisco's Correctional Medicine Consultation Network (CMCN) has developed a model of care that combines periodic on site consultation with weekly telemedicine clinics. We have established Primary Care HIV Consultative Clinics at various institutions throughout the state where we are able to provide a more cohesive approach to the care of the HIV-infected patient by developing and operating within interdisciplinary collaborative teams that bridge the CMCN clinical staff with local prison staff. Interest by Students, Residents, and Health Care Educators in Correctional Medicine and in Increasing Access to the Underserv...
Background We previously described experiences of clinicians who published adverse drug reaction ... more Background We previously described experiences of clinicians who published adverse drug reaction reports. We now report on threats and intimidations leveled against clinicians and scientists who received publicly documented threats after communicating safety, efficacy, or data integrity findings contrary to corporate interests. Methods Data on threats and intimidations were obtained from transcripts of governmental hearings or agencies, university-affiliated reports, media interviews, and investigative journalism articles. Content and timing of threats and intimidation, subsequent harms, numbers of persons seriously injured or who died from individual toxicities, financial payments from sponsors related to safety, efficacy, or data integrity concerns, and civil settlements and criminal findings were evaluated. Findings Twenty-six individuals who communicated safety, efficacy, or data integrity concerns were targets of threats and intimidation from corporate employees (twenty-three i...
The objective of this opinion paper was to identify and describe potential clinical pharmacists&#... more The objective of this opinion paper was to identify and describe potential clinical pharmacists' services for the prevention and management of patients infected with the hepatitis C virus (HCV). The goals of this paper are to guide the establishment and development of pharmacy services for patients infected with HCV and to highlight HCV research and educational opportunities. Recommendations were based on the following: a review of published data on clinical pharmacist involvement in the treatment and management of HCV-infected patients; a consensus of clinical pharmacists who provide direct patient care to HCV-infected patients and practice in different pharmacy models, including community-based and academic settings; and a review of published guidelines and literature focusing on the treatment and management of HCV infections. The recommendations provided in this opinion paper define the areas of clinical pharmacist involvement and clinical pharmacy practice in the treatment a...
Following the observation of the decreasing occurrence of campylobacteriosis in HIV-infected pati... more Following the observation of the decreasing occurrence of campylobacteriosis in HIV-infected patients. This study examines the incidence of campylobacteriosis in patients who had received rifabutin prophylaxis against Mycobacterium avium complex (MAC) infection compared with the incidence observed among patients treated before the advent of rifabutin. A retrospective analysis (February 1992 to November 1995) was conducted in a hospital HIV inpatient unit. The study included two patient groups: 73 HIV-infected patients with CD4 counts of < 100 cells/microL (mean 30 cells/microL) who were treated between February 1992 and July 1993 and who had not received rifabutin prophylaxis (Group R-), as well as 90 HIV-infected patients with CD4 counts of < 100 cells/microL (mean 22 cells/microL) who had received rifabutin 300 mg/day as primary prophylaxis against MAC bacteremia between July 1993 and November 1995 (Group R+). For the patient population as a whole, 20 episodes of campylobacter infection were observed in 13 patients. Causative pathogens were Campylobacter jejuni (n = 10), C. coli (8), and unidentifiable (2). Seventeen episodes (in 12 patients) of campylobacter infection occurred in Group R- versus 3 episodes (in 2 patients) in Group R+ (p < 0.0005). The rate of symptomatic infection per 100 patient-months was 0.251 in Group R+ versus 2.02 in Group R-. The results of this study indicate that rifabutin prophylaxis was associated with a decrease in the rate of campylobacter infection in HIV-infected patients. These findings are supported by evidence that rifabutin is active against C. jejuni in vitro.
Tenofovir disoproxil fumarate (TDF) and emtricitabine (FTC) are nucleoside reverse transcriptase ... more Tenofovir disoproxil fumarate (TDF) and emtricitabine (FTC) are nucleoside reverse transcriptase inhibitors approved as pre-exposure prophylaxis (PrEP) against human immunodeficiency virus (HIV). Prophylactic TDF-based regimens have been shown to reduce the risk of HIV infection by 74 to 92% among participants with detectable drug levels. Adverse events observed in clinical trials include nausea, elevated creatinine and liver enzymes, and decreased bone mineral density. This article reviews the pharmacology, pharmacokinetics, and the safety profile of TDF and FTC used as PrEP for HIV infection. TDF-FTC can have a large impact in preventing HIV infections among high risk individuals when taken daily. Although TDF-FTC is associated with adverse events, they can be minimized with clinician-guided monitoring.
Journal of the American Pharmacists Association : JAPhA, Jan 8, 2017
To describe the first community pharmacy-based hepatitis C antibody (HCV-Ab) point-of-care (POC) ... more To describe the first community pharmacy-based hepatitis C antibody (HCV-Ab) point-of-care (POC) screening program and its outcomes in California. Community pharmacy. Community pharmacists perform HCV-Ab POC testing, counsel patients about HCV transmission and prevention, and provide linkage to care. Pharmacists implement an HCV-Ab POC screening program in collaboration with the local public health department. Descriptive data of the demographics of the persons receiving HCV-Ab POC screening and qualitative assessment of the attitudes and knowledge of the trained pharmacists involved in its implementation. During the 3-month pilot, 6 community pharmacists performed 83 HCV-Ab rapid POC tests with 1 positive result (1.2%). Risk factors for the positive result included injection drug use, crack cocaine or methamphetamine use, and being in the high-risk birth cohort. Although some expressed reservations, pharmacists attested to the feasibility of incorporating HCV screening into their r...
Human immunodeficiency virus (HIV) infection has become a treatable chronic disease with near-nor... more Human immunodeficiency virus (HIV) infection has become a treatable chronic disease with near-normal life expectancy when patients receive antiretroviral therapy (ART). Family physicians and other primary care clinicians commonly provide long-term comprehensive care for persons with HIV infection. This article describes the scope of initial care, including obtaining a thorough history; physical examination for HIV-associated manifestations; attention to HIV-specific immunization schedules; routine and HIV-specific laboratory evaluation; and ensuring standard health care maintenance to prevent HIV- and non-HIV-related morbidity and mortality. Clinicians should encourage combination ART as early as possible, although careful assessment of patient readiness and ability to sustain lifelong treatment must be weighed. After ART initiation, monitoring viral load and CD4 lymphocyte response is essential to ensure viral suppression and evaluate immune system restoration. Opportunistic infect...
California has an estimated 175,000 State Prisoners. The prevalence of HIV in the incarcerated po... more California has an estimated 175,000 State Prisoners. The prevalence of HIV in the incarcerated population ranges from 2-5% or an estimated 4000 HIV-infected inmates in State prisons. Complicating the issue of caring for this number of patients, is the fact that California has 33 prisons over a wide, mostly rural geographical area. The University of California, San Francisco's Correctional Medicine Consultation Network (CMCN) has developed a model of care that combines periodic on site consultation with weekly telemedicine clinics. We have established Primary Care HIV Consultative Clinics at various institutions throughout the state where we are able to provide a more cohesive approach to the care of the HIV-infected patient by developing and operating within interdisciplinary collaborative teams that bridge the CMCN clinical staff with local prison staff. Interest by Students, Residents, and Health Care Educators in Correctional Medicine and in Increasing Access to the Underserv...
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Papers by Betty Dong