Scholars@Duke
Hugh Hanna Tilson

Hugh Hanna Tilson

Adjunct Professor in the Department of Family Medicine and Community Health
Family Medicine and Community Health, Community Health
Box 104425 Med Ctr, Durham, NC 27710
Community Health Division, Box 104425 DUMC, Durham, NC 27710

Scholarly Works

Summary of Research: Pregnancy and Infant Outcomes in Multiple Sclerosis: Findings from the Global MAPLE-MS Pharmacovigilance Program.

Journal article Neurol Ther · April 2026 Information on pregnancy and infant outcomes after cladribine tablets exposure is limited, as its use is not recommended during pregnancy. This is a summary of the original published article 'Pregnancy and infant outcomes in multiple sclerosis: findings fr ... Full text Link to item Cite

Pregnancy and Infant Outcomes in Multiple Sclerosis: Findings From the Global MAPLE-MS Pharmacovigilance Program.

Journal article Neurol Neuroimmunol Neuroinflamm · September 2025 BACKGROUND AND OBJECTIVES: With its use being contradicted during pregnancy, limited information exists concerning pregnancy and infant outcomes on exposure to cladribine tablets before or during pregnancy in women with multiple sclerosis (MS). In this stu ... Full text Link to item Cite

The Antiretroviral Pregnancy Registry: Three decades of prospective monitoring for birth defects.

Journal article Pharmacoepidemiol Drug Saf · June 2024 PURPOSE: Antiretrovirals (ARVs) are life-saving drugs used for the treatment and prevention of HIV infection and antiviral drugs (AVs) for the treatment of chronic HBV infection. ARVs have proven highly effective in reducing perinatal HIV transmission, how ... Full text Link to item Cite

Belimumab use during pregnancy: a summary of birth defects and pregnancy loss from belimumab clinical trials, a pregnancy registry and postmarketing reports.

Journal article Ann Rheum Dis · February 2023 OBJECTIVE: Describe available data on birth defects and pregnancy loss in women with systemic lupus erythematosus (SLE) exposed to belimumab. METHODS: Data collected from belimumab clinical trials, the Belimumab Pregnancy Registry (BPR), and postmarketing/ ... Full text Link to item Cite

Belimumab use during pregnancy: Interim results of the belimumab pregnancy registry.

Journal article Birth Defects Res · January 15, 2023 BACKGROUND: Belimumab is approved for active, autoantibody-positive systemic lupus erythematosus (SLE) and lupus nephritis, but limited data exist regarding its use in pregnancy. The Belimumab Pregnancy Registry (BPR, GSK Study BEL114256; NCT01532310) was ... Full text Link to item Cite

Outcomes in Pregnant Persons Immunized with a Cell-Based Quadrivalent Inactivated Influenza Vaccine: A Prospective Observational Cohort Study

Journal article Vaccines · October 1, 2022 Objective: To evaluate pregnancy and infant outcomes among persons immunized with a cell-based quadrivalent inactivated influenza vaccine (IIV4c) during routine pregnancy care. Design: Prospective observational cohort. Setting: US-based obstetrics/gynecolo ... Full text Cite

A Prospective Cohort Study on Pregnancy Outcomes of Persons Immunized with a Seasonal Quadrivalent Inactivated Influenza Vaccine during Pregnancy

Journal article Vaccines · October 1, 2022 This US-based, prospective observational cohort study evaluated the safety of a quadrivalent inactivated influenza vaccine (IIV4; Afluria Quadrivalent) in pregnant persons immunized over four influenza seasons between 2017 and 2021. Pregnancy outcomes incl ... Full text Cite

Building A Strong and Inclusive Workforce for Health: In Conversation with North Carolina Commerce Secretary Machelle Baker Sanders and Health Secretary Kody Kinsley.

Journal article N C Med J · 2022 North Carolina faces a significant health workforce shortage exacerbated by the COVID-19 pandemic. To meet this challenge, the Department of Commerce and the Department of Health and Human Services are prioritizing equity, creativity, and collaboration. ... Full text Link to item Cite

Building a Workforce for Health in North Carolina.

Journal article N C Med J · 2022 COVID-19 exposed and exacerbated the historical shortages and maldistribution of the health workforce in North Carolina. This edition of the North Carolina Medical Journal highlights the work being done in our state to address these needs, and calls for an ... Full text Link to item Cite

Long-term safety and effectiveness of canakinumab therapy in patients with cryopyrin-associated periodic syndrome: results from the β-Confident Registry.

Journal article RMD Open · May 2021 OBJECTIVE: To report the long-term safety and effectiveness of canakinumab, a fully human anti-interleukin 1β monoclonal antibody, in patients with cryopyrin-associated periodic syndromes (CAPS), including familial cold autoinflammatory syndrome (FCAS), Mu ... Full text Link to item Cite

State Health Official Career Advancement and Sustainability Evaluation-Description of the Methods Used in the SHO-CASE Study.

Journal article J Public Health Manag Pract · 2020 State health officials (SHOs) lead state governmental public health agencies, playing an important role in their states. However, little comprehensive research has examined SHOs or characteristics of these leaders, limiting evidence about ways to improve S ... Full text Link to item Cite

State Health Officials: Backgrounds and Qualifications.

Journal article J Public Health Manag Pract · 2020 CONTEXT: State health officials (SHOs), the executive and administrative leaders of state public health, play a key role in policy development, must be versed in the relevant/current evidence, and provide expertise about health issues to the legislature an ... Full text Link to item Cite

Public Health Senior Deputy's Perceptions of State Health Officials' Success Factors: Professional Characteristics, Personal Attributes, and Signs of Derailment.

Journal article J Public Health Manag Pract · 2020 CONTEXT: Senior deputies work closely with state health officials (SHOs) in state public health agencies and are a valuable resource for understanding their roles, responsibilities, and characteristics. OBJECTIVE: Examine senior deputies' perceptions of SH ... Full text Link to item Cite

Evaluation of pregnancy outcomes in patients with multiple sclerosis after fingolimod exposure

Journal article Therapeutic Advances in Neurological Disorders · January 1, 2018 Background and Methods: Limited data are available on the safety of fingolimod in pregnant women. We estimated the risk of adverse pregnancy outcomes in women with multiple sclerosis (MS) exposed to fingolimod either shortly before or during pregnancy in p ... Full text Cite

Safety of vaccinations in patients with cryopyrin-associated periodic syndromes: a prospective registry based study.

Journal article Rheumatology (Oxford) · September 1, 2017 OBJECTIVES: Pneumococcal, tetanus and influenza vaccinations are recommended for patients with cryopyrin-associated periodic syndromes (CAPS) when treated with immunosuppressive medication. The aim of this publication is to report the safety of pneumococca ... Full text Link to item Cite

High Turnover Among State Health Officials/Public Health Directors: Implications for the Public's Health.

Journal article J Public Health Manag Pract · 2017 CONTEXT: State health officials (SHOs) serve a critical role as the leaders of state public health systems. Despite their many responsibilities, there is no formal process for preparation to become an SHO, and few requirements influence the selection of an ... Full text Link to item Cite

Association between in utero zidovudine exposure and nondefect adverse birth outcomes: analysis of prospectively collected data from the Antiretroviral Pregnancy Registry.

Journal article BJOG · May 2016 OBJECTIVE: To examine the association between nondefect adverse birth outcomes and in utero exposure to zidovudine (ZDV)-containing regimens versus non-ZDV antiretroviral (ARV) regimens. DESIGN: Analysis of prospectively-collected data. SETTING: Global. PO ... Full text Link to item Cite

Recommendations for selecting drug-drug interactions for clinical decision support.

Journal article Am J Health Syst Pharm · April 15, 2016 PURPOSE: Recommendations for including drug-drug interactions (DDIs) in clinical decision support (CDS) are presented. SUMMARY: A conference series was conducted to improve CDS for DDIs. A work group consisting of 20 experts in pharmacology, drug informati ... Full text Link to item Cite

Prenatal exposure to zidovudine and risk for ventricular septal defects and congenital heart defects: data from the Antiretroviral Pregnancy Registry.

Journal article Eur J Obstet Gynecol Reprod Biol · February 2016 OBJECTIVE: To assess the risk for ventricular septal defects and congenital heart defects following zidovudine exposure during pregnancy using data from the Antiretroviral Pregnancy Registry. STUDY DESIGN: Data on 16,304 prospectively reported pregnancies ... Full text Link to item Cite

Mortality and comorbidities in patients with multiple sclerosis compared with a population without multiple sclerosis: An observational study using the US Department of Defense administrative claims database.

Journal article Mult Scler Relat Disord · November 2015 BACKGROUND: Data are limited for mortality and comorbidities in patients with multiple sclerosis (MS). OBJECTIVES: Compare mortality rates and event rates for comorbidities in MS (n=15,684) and non-MS (n=78,420) cohorts from the US Department of Defense (D ... Full text Link to item Cite

New opportunities of real-world data from clinical routine settings in life-cycle management of drugs: example of an integrative approach in multiple sclerosis.

Journal article Curr Med Res Opin · May 2015 The assessment and demonstration of a positive benefit-risk balance of a drug is a life-long process and includes specific data from preclinical, clinical development and post-launch experience. However, new integrative approaches are needed to enrich evid ... Full text Link to item Cite

Abacavir and lamivudine exposures during pregnancy and non-defect adverse pregnancy outcomes: data from the antiretroviral pregnancy registry.

Journal article J Acquir Immune Defic Syndr · March 1, 2015 BACKGROUND: The antiretroviral (ARV) pregnancy registry, an international voluntary registry, provides information on teratogenicity and non-defect adverse pregnancy outcomes. METHODS: We analyzed ARV pregnancy registry prospective singleton pregnancies, e ... Full text Link to item Cite

When We Have Data We Can Count on, Everyone WINS.

Journal article J Public Health Manag Pract · 2015 Full text Link to item Cite

Public health accreditation addresses issues facing the public health workforce.

Journal article Am J Prev Med · November 2014 As the Public Health Accreditation Board (PHAB) launched the nation's only accreditation program for state, local, tribal, and territorial health departments in September 2011, attention to the issues facing the public health workforce in these health depa ... Full text Link to item Cite

Public health workforce taxonomy.

Journal article Am J Prev Med · November 2014 Thoroughly characterizing and continuously monitoring the public health workforce is necessary for ensuring capacity to deliver public health services. A prerequisite for this is to develop a standardized methodology for classifying public health workers, ... Full text Link to item Cite

No evident association between efavirenz use and suicidality was identified from a disproportionality analysis using the FAERS database.

Journal article J Int AIDS Soc · 2014 OBJECTIVE: To assess the potential association of selected antiretrovirals (ARVs), including efavirenz, with suicidality. DESIGN: Retrospective analysis of the Food and Drug Administration Adverse Event Reporting System (FAERS), by performing a Multi-Item ... Full text Link to item Cite

Methodological challenges in monitoring new treatments for rare diseases: lessons from the cryopyrin-associated periodic syndrome registry.

Journal article Orphanet J Rare Dis · September 10, 2013 BACKGROUND: The Cryopyrin-Associated Periodic Syndromes (CAPS) are a group of rare hereditary autoinflammatory diseases and encompass Familial Cold Autoinflammatory Syndrome (FCAS), Muckle-Wells Syndrome (MWS), and Neonatal Onset Multisystem Inflammatory D ... Full text Link to item Cite

Teaching population health: a competency map approach to education.

Journal article Acad Med · May 2013 A 2012 Institute of Medicine report is the latest in the growing number of calls to incorporate a population health approach in health professionals' training. Over the last decade, Duke University, particularly its Department of Community and Family Medic ... Full text Open Access Link to item Cite

Hepatitis B virus and human immunodeficiency virus drugs in pregnancy: findings from the Antiretroviral Pregnancy Registry.

Journal article J Hepatol · November 2012 BACKGROUND & AIMS: Fetal safety of antiviral therapies is important given the long-term treatment of women with chronic hepatitis B (CHB) infection who may become pregnant. We analyzed neonatal safety data from the Antiretroviral Pregnancy Registry (APR), ... Full text Link to item Cite

Pitfalls in meta-analyses on adverse events reported from clinical trials.

Journal article Pharmacoepidemiol Drug Saf · October 2011 In recent years, comparative effectiveness research has been more aggressively pursued as a means to improve health care, including systematic reviews and meta-analyses to inform health policy decision making. Because most clinical trials have pre-specifie ... Full text Link to item Cite

Wanted: the workforce to work on the workforce agenda.

Journal article J Public Health Manag Pract · November 2009 Full text Link to item Cite

Moving forward with workforce development research in public health.

Journal article J Public Health Manag Pract · November 2009 Full text Link to item Cite

Active drug safety surveillance: a tool to improve public health.

Journal article Pharmacoepidemiol Drug Saf · December 2008 PURPOSE: Ensuring that drugs have an acceptable safety profile and are used safely is a major public health priority. The Centers for Education and Research on Therapeutics (CERTs) convened experts from academia, government, and industry to assess strategi ... Full text Link to item Cite

Education for the public health profession: a new look at the Roemer proposal.

Journal article Public Health Rep · 2008 Demands for a high level of professionalism in public health practice, and concomitant strengthening of public health education to match 21st-century community challenges provide an opportunity to reconsider the current paradigm for professional degrees in ... Full text Link to item Cite

Role of the centers for education and research on therapeutics (CERTs) in pharmacovigilance and proper use of therapeutics.

Journal article Clin Pharmacol Ther · August 2007 According to the Institute of Medicine (IOM) Committee on the Assessment of the U.S. Drug Safety System, "The recent highly publicized controversies surrounding the safety of some drugs have contributed to a public perception that the drug safety system is ... Full text Link to item Cite

Aspirin use among adults aged 40 and older in the United States: results of a national survey.

Journal article Am J Prev Med · May 2007 BACKGROUND: Aspirin is effective for the primary and secondary prevention of cardiovascular events, but its use has been suboptimal. METHODS: Investigators performed a nationally representative Internet-based survey of U.S. consumers aged 40 and older usin ... Full text Link to item Cite

The antiretrovirals in pregnancy registry: a fifteenth anniversary celebration.

Journal article Obstet Gynecol Surv · February 2007 UNLABELLED: The year 2007 marks the fifteenth anniversary year of the founding of a landmark effort in drug safety risk management, the formation of the first monitoring effort of an antiretroviral (ARV) drug in pregnancy which has become the Antiretrovira ... Full text Link to item Cite

Use of national public health performance standards to assess Maine's diabetes system.

Journal article J Public Health Manag Pract · 2007 In the fall of 2003, Maine underwent a rigorous assessment of the diabetes public health system using a modified version of the State Public Health System Performance Instrument developed by the Centers for Disease Control and Prevention's National Public ... Full text Link to item Cite

Literacy and misunderstanding prescription drug labels.

Journal article Ann Intern Med · December 19, 2006 BACKGROUND: Health literacy has increasingly been viewed as a patient safety issue and may contribute to medication errors. OBJECTIVE: To examine patients' abilities to understand and demonstrate instructions found on container labels of common prescriptio ... Full text Link to item Cite

Misunderstanding of prescription drug warning labels among patients with low literacy.

Journal article Am J Health Syst Pharm · June 1, 2006 PURPOSE: The common causes for misunderstanding prescription drug warning labels (PWLs) among adults with low literacy were studied. METHODS: A total of 74 patients reading at or below the sixth-grade level and receiving care at the primary care clinic at ... Full text Link to item Cite

Defining the competencies of those conducting pharmacovigilance.

Journal article Pharmacoepidemiol Drug Saf · March 2006 PURPOSE: The absence of agreed competencies in pharmacovigilance and patient risk management is a key factor hindering the development of training and a curriculum in these interrelated disciplines. If competencies were to be developed, they could be tailo ... Full text Link to item Cite

Growing the field of health impact assessment in the United States: an agenda for research and practice.

Journal article Am J Public Health · February 2006 Health impact assessment (HIA) methods are used to evaluate the impact on health of policies and projects in community design, transportation planning, and other areas outside traditional public health concerns. At an October 2004 workshop, domestic and in ... Full text Link to item Cite

Linking town and gown.

Journal article Am J Prev Med · January 2006 Full text Link to item Cite

Spending on postapproval drug safety.

Journal article Health Aff (Millwood) · 2006 Withdrawals of high-profile pharmaceuticals have focused attention on post-approval safety surveillance. There have been no systematic assessments of spending on postapproval safety. We surveyed drug manufacturers regarding safety efforts. Mean spending on ... Full text Open Access Link to item Cite

Breaking the translational barriers: the value of integrating biomedical informatics and translational research.

Journal article J Investig Med · May 2005 The conduct of translational health research has become a vital national enterprise. However, multiple barriers prevent the effective translation of basic science discoveries into clinical and community practice. New information technology (IT) application ... Full text Link to item Cite

Assessing the risk of birth defects associated with antiretroviral exposure during pregnancy.

Conference Am J Obstet Gynecol · September 2004 OBJECTIVE: The purpose of this study was to examine teratogenic risk of antiretroviral (ARV) drugs. STUDY DESIGN: The Antiretroviral Pregnancy Registry (APR) monitors prenatal exposures to ARV drugs and pregnancy outcome through a prospective exposure-regi ... Full text Link to item Cite

Assessing teratogenicity of antiretroviral drugs: monitoring and analysis plan of the Antiretroviral Pregnancy Registry.

Journal article Pharmacoepidemiol Drug Saf · August 2004 This paper describes the Antiretroviral Pregnancy Registry's (APR) monitoring and analysis plan. APR is overseen by a committee of experts in obstetrics, pediatrics, teratology, infectious diseases, epidemiology and biostatistics from academia, government ... Full text Link to item Cite

Clinical research in the United States at a crossroads: proposal for a novel public-private partnership to establish a national clinical research enterprise.

Journal article JAMA · March 3, 2004 The clinical research infrastructure of the United States is currently at a critical crossroads. To leverage the enormous biomedical research gains made in the past century efficiently, a drastic need exists to reengineer this system into a coordinated, sa ... Full text Link to item Cite

The price of value.

Journal article J Public Health Manag Pract · 2004 Full text Link to item Cite

Adherence or compliance? Changes in terminology.

Journal article Ann Pharmacother · January 2004 Full text Link to item Cite

The public health workforce.

Journal article Annu Rev Public Health · 2004 The development of a fully-competent public health workforce as a key component of the nation's public health infrastructure has become the focus of increasing attention. The subject is included in one, and is the major topic of a second, report from the I ... Full text Link to item Cite

A research agenda for public health workforce development.

Journal article J Public Health Manag Pract · 2004 In the past decades, public health research has focused on categorical rather than cross-cutting or systems issues. Little research has been carried out on the infrastructure required to support public health programs. This article describes the results of ... Full text Link to item Cite

The impact of community design and land-use choices on public health: a scientific research agenda.

Journal article Am J Public Health · September 2003 The design of a community's built environment influences the physical and mental health of its residents. Because few studies have investigated this relationship, the Centers for Disease Control and Prevention hosted a workshop in May 2002 to help develop ... Full text Link to item Cite

Improving the US health care system: action plan to enhance efficiency, reduce errors, and improve quality.

Journal article J Investig Med · March 2003 The decisions made by stakeholders in the nation's health care system that affect the quality of care experienced by patients are too often made without the benefit of scientific evidence. A multidisciplinary set of investigators conducting health services ... Full text Link to item Cite

Birth defect classification by organ system: a novel approach to heighten teratogenic signalling in a pregnancy registry.

Journal article Pharmacoepidemiol Drug Saf · September 2002 The Antiretroviral Pregnancy Registry (APR) is an ongoing international prospective exposure-registration cohort study that monitors outcomes of pregnancies exposed to marketed antiretroviral medications. The population of women exposed to antiretrovirals ... Full text Link to item Cite

The public health workforce.

Journal article Health Aff (Millwood) · 2002 Defining the public health workforce and specifying its performance requirements present equal challenges as the nation anticipates public health needs for the twenty-first century. The core group of professionals employed by government public health agenc ... Full text Link to item Cite

Annals of Pharmacotherapy: An introduction

Journal article Annals of Pharmacotherapy · January 1, 2002 Cite

The potential impact of measuring healthcare quality on pharmaceutical-related costs and outcomes

Journal article Disease Management and Health Outcomes · January 1, 2002 Quality measurement has achieved a powerful momentum across the spectrum of healthcare, driven primarily by the search for strategies to contain rapidly rising healthcare costs without sacrificing quality of care. Because pharmaceutical care is involved in ... Full text Cite

Public health physicians: an endangered species.

Journal article Am J Prev Med · October 2001 BACKGROUND: Questions have arisen regarding the competency levels of the various professions within the public health sector, including those of physicians. Protection of the nation's health requires that physicians on the public health team be competent p ... Full text Link to item Cite

Partnership for front-line success: a call for a national action agenda on workforce development.

Journal article J Public Health Manag Pract · July 2001 Despite more than a decade of dialogue on the critical needs and challenges in public health workforce development, progress remains slow in implementing recommended actions. A life-long learning system for public health remains elusive. The Centers for Di ... Full text Link to item Cite

Proactive safety surveillance.

Journal article Pharmacoepidemiol Drug Saf · May 2001 Growth in health information systems presents opportunities to enhance postmarketing safety surveillance of medical products. Spontaneous suspected side effect reports provide the foundation, but we need to 'proactively' improve their quality and our strat ... Full text Link to item Cite

From the IOM's clinical research roundtable

Other Journal of Investigative Medicine · January 1, 2001 Cite

Heralding a change: field action reports.

Journal article Am J Public Health · May 2000 Full text Link to item Cite

Session C: The role of patient databases in assessing treatment safety.

Journal article J Acquir Immune Defic Syndr Hum Retrovirol · 1998 Full text Link to item Cite

Self-treatment patterns among clients attending sexually transmitted disease clinics and the effects of self-treatment on STD symptom duration. The Study Group.

Journal article Sex Transm Dis · July 1997 OBJECTIVE: To assess patterns of self-treatment and its effects on the duration of sexually transmitted disease (STD) symptoms before medical care. METHODS: A cross-sectional interview survey in public STD clinics (7 U.S. cities). Patients, seeking treatme ... Full text Link to item Cite

Zidovudine therapy in pediatric patients: Report on the zidovudine pediatric treatment IND program

Journal article Journal of Clinical Research and Drug Development · December 1, 1994 Under a Treatment Investigational New Drug (IND) program, zidovudine was made available to HIV-infected children prior to general pediatric use of zidovudine. A total of 623 children ages 3 months to 12 years received zidovudine therapy between October 198 ... Cite

Risk for adverse events among patients receiving intravenous histamine2-receptor antagonists.

Journal article Ann Pharmacother · December 1993 OBJECTIVE: To identify risk factors for adverse drug reactions (ADRs) in patients receiving intravenous histamine2-receptor antagonists (H2-RAs). DESIGN: The study hypothesis was evaluated by performing a logistic regression procedure with a backward elimi ... Full text Link to item Cite

Record linkage to conduct an epidemiologic study on the association of rheumatoid arthritis and lymphoma in the Province of Saskatchewan, Canada.

Journal article J Clin Epidemiol · July 1993 The objective of this effort was to assess the utility of the large automated database in Saskatchewan as a resource for pharmacoepidemiologic studies. To this end a study was undertaken to test the hypothesis that rheumatoid arthritis (RA) increases the r ... Full text Link to item Cite

Safety of acyclovir: a summary of the first 10 years experience.

Journal article J Med Virol · 1993 The era of pharmacoepidemiology has introduced profound changes in the ability of the sector to monitor the post-marketing safety of new products. We report on the population-based assessment by Wellcome of the safety of Zovirax reflected in a program of u ... Full text Link to item Cite

An international comparison of case definition of severe adverse cutaneous reactions to medicines.

Journal article Drug Saf · January 1993 There is substantial intercountry variation in the proportion of cases of toxic epidermal necrolysis (TEN) and Stevens-Johnson syndrome (SJS) which are attributed to specific drugs. This study was undertaken to determine whether these differences might ref ... Full text Link to item Cite

The use of observational data to study drug efficacy

Journal article P and T · December 1, 1992 Cite

Incidence and natural history of cytomegalovirus disease in patients with advanced human immunodeficiency virus disease treated with zidovudine. The Zidovudine Epidemiology Study Group.

Journal article J Infect Dis · December 1992 Data were analyzed from a multicenter observational cohort study of 1002 persons with AIDS or AIDS-related complex (ARC) and total CD4 cell count < 0.25 x 10(9)/L treated with zidovudine between April 1987 and April 1988. Cytomegalovirus (CMV) disease deve ... Full text Link to item Cite

Postmarketing surveillance study of permethrin creme rinse.

Journal article Am J Public Health · June 1992 BACKGROUND: An observational, epidemiological study was undertaken to evaluate the safety of permethrin 1% creme rinse (Nix) for treatment of head lice infestations. METHODS: Thirty-seven local public health departments enrolled a total of 38,160 patients ... Full text Link to item Cite

Adverse drug events and the Freedom of Information Act: an apple in Eden.

Journal article Ann Pharmacother · February 1992 OBJECTIVE: To review some of the abuses and proper uses of the Food and Drug Administration's (FDA's) spontaneous adverse-reaction reporting system, as a way of educating the reader to its strengths and limitations. DATA SOURCE: Published literature and re ... Full text Link to item Cite

Method of examining oral acyclovir use for adverse events

Journal article Journal of Clinical Research and Pharmacoepidemiology · December 1, 1991 The safety profile of acyclovir has been unremarkable in controlled research populations but has not been examined in general medical practice. This report describes the development and testing of an epidemiologic method to examine oral acyclovir use for p ... Cite

A population-based study of Stevens-Johnson syndrome. Incidence and antecedent drug exposures.

Journal article Arch Dermatol · June 1991 To determine the incidence of Stevens-Johnson syndrome, a descriptive epidemiology study was performed using computerized Medicaid billing data from 1980 to 1984 from the states of Michigan, Minnesota, and Florida. The ratio of persons hospitalized with a ... Link to item Cite

Occurrence of neoplasia in patients with rheumatoid arthritis enrolled in a DMARD Registry. Rheumatoid Arthritis Azathioprine Registry Steering Committee.

Journal article J Rheumatol · June 1991 The Rheumatoid Arthritis Azathioprine Registry (RAAR) was established in 1982 to examine the safety of azathioprine (AZA) and other disease modifying agents (DMARD) in the treatment of RA. In yearly followup over the past 7 years, 20 malignant conditions h ... Link to item Cite

Using a claims database to investigate drug-induced Stevens-Johnson syndrome.

Journal article Stat Med · April 1991 In order to explore a priori hypotheses about drug-induced Stevens-Johnson Syndrome (SJS), a case-control study was initiated using data from COMPASS, a computerized data base consisting of Medicaid claims data. The records of 3.8 million patients in five ... Full text Link to item Cite

Use of estrogens among middle-aged Massachusetts women.

Journal article DICP · April 1991 This study describes estrogen use among 45- to 55-year-old white women in Massachusetts from 1981 to 1987. In a 1981 cross-sectional survey, 7705 white women (77 percent response rate) returned a questionnaire or were interviewed by phone. Premenopausal wo ... Full text Link to item Cite

Digoxin Immune Fab therapy in the management of digitalis intoxication: safety and efficacy results of an observational surveillance study.

Journal article J Am Coll Cardiol · March 1, 1991 An observational surveillance study was conducted to monitor the safety and effectiveness of treatment with Digoxin Immune Fab (Ovine) (Digibind) in patients with digitalis intoxication. Before April 1986, a relatively limited number of patients received t ... Full text Link to item Cite

Psychotropic medication prescription in U.S. ambulatory medical care.

Journal article DICP · January 1991 Because of the pharmacologic power of psychotropic medications, the potential for adverse effects, and the changing popularity of particular psychotropic drugs, it is vital for pharmacoepidemiologists to monitor the prescribing patterns of these medication ... Full text Link to item Cite

Major advances in international pharmacoepidemiology.

Journal article Ann Epidemiol · December 1990 Pharmacoepidemiology applies the principles of epidemiology to the problems of pharmacotherapy--particularly addressing society's need to know more about drug safety issues than the highly structured pre-approval clinical trials programs can provide. Thus, ... Full text Link to item Cite

Quality of life bibliography and indexes.

Journal article Med Care · December 1990 Link to item Cite

Guidelines for decision making in postmarketing surveillance of drugs

Journal article Journal of Clinical Research and Pharmacoepidemiology · December 1, 1990 At the time a drug is marketed, its full safety profile has not yet been elucidated. Currently, the FDA's informal spontaneous reporting system (SRS) monitors adverse experiences in the general population. The passive SRS, however, detects but does not eva ... Cite

Acyclovir use and its surveillance in a general population.

Journal article DICP · June 1990 This study examined the extent and patterns of use of acyclovir in a health maintenance organization (HMO) population. The development and implementation of a system to survey acyclovir users for possible acute adverse effects is also described. Acyclovir ... Full text Link to item Cite

Medication monitoring in the workplace: toward improving our system of epidemiologic intelligence.

Journal article J Occup Med · April 1990 There is a great deal we do not know about the safety of pharmaceutical agents, especially regarding their safe use in the workplace. Economic and scientific imperatives can lead to a new drug's approval and marketing even though testing is limited; theref ... Full text Link to item Cite

A working group on epidemiology in the pharmaceutical industry (EPI). A new force for the field

Journal article Journal of Clinical Research and Pharmacoepidemiology · January 1, 1990 Collaboration among research based pharmaceutical companies in the field of drug safety has a long-standing tradition in many countries. Building the capacity, science, policy, and personnel needed to protect the health of people taking the medicines we di ... Cite

Guest editorial

Journal article Medical Care · January 1, 1990 Full text Cite

Prescription drug use patterns of human immunodeficiency virus-infected patients taking zidovudine. Walter Reed Retrovirus Research Group.

Journal article DICP · September 1989 Prescription drug profiles of 116 human immunodeficiency virus (HIV)-infected patients taking zidovudine in 1988 were surveyed. Patients received the drug an average of 236 days. About one-third (32 percent) required reduced dosage presumably because of he ... Full text Link to item Cite

Expanding roles of hospital epidemiology: pharmacoepidemiology.

Journal article Infect Control Hosp Epidemiol · June 1989 Full text Link to item Cite

Atracurium--a post-marketing surveillance study: methods and U.S. experience.

Journal article Br J Anaesth · June 1989 Two companion post-marketing studies have evaluated the frequency of adverse events amongst patients receiving atracurium. In this first report, we describe the study methods used in both centres and the findings of the study conducted at the Group Health ... Full text Link to item Cite

Atracurium--a post-marketing surveillance study: U.K. study and discussion.

Journal article Br J Anaesth · June 1989 Two companion post-marketing studies have evaluated the frequency of adverse events amongst patients receiving atracurium. In this second report, we describe the Scottish study and discuss findings in both centres. In this study we compare the frequency of ... Full text Link to item Cite

A proactive approach to monitoring for adverse drug reactions. Structured pharmacoepidemiologic studies

Journal article Journal of Clinical Research and Drug Development · January 1, 1989 Cite

Public health in the field--the rescue is at hand.

Journal article Am J Public Health · December 1988 Full text Link to item Cite

Survival experience among patients with AIDS receiving zidovudine. Follow-up of patients in a compassionate plea program.

Journal article JAMA · November 25, 1988 Through a compassionate plea program (Treatment Investigational New Drug), 4805 patients with acquired immunodeficiency syndrome who previously had experienced Pneumocystis carinii pneumonia (PCP) received zidovudine (Retrovir, formerly azidothymidine). Ov ... Link to item Cite

Pharmacoepidemiology: the industry's perspective.

Journal article J Rheumatol Suppl · October 1988 The pharmaceutical industry has a vital interest in, and plays a central role regarding, the issues of safety of the medicines it produces. Not only does industry have the basic and broadest expertise and "ownership" in drugs, it also is in an ideal positi ... Link to item Cite

Acyclovir in Pregnancy Registry. An observational epidemiologic approach.

Journal article Am J Med · August 29, 1988 Observational epidemiologic methods are being used to evaluate the safety of acyclovir in pregnancy. An essential component of this research is the establishment of a baseline expectation of pregnancy outcomes among women with herpes not receiving acyclovi ... Link to item Cite

Monitoring the safety of antivirals. The example of the acyclovir experience.

Journal article Am J Med · August 29, 1988 The obligation to monitor the safety of newly introduced medicines is as old as the medical epidemiologic obligations of medicine itself. But society's expectations, the resources and methodologies for such monitoring, and the practices of the pharmacologi ... Link to item Cite

Pharmacoepidemiology: the future.

Journal article Drug Intell Clin Pharm · May 1988 Like all other futures, the future of pharmacoepidemiology is not entirely clear. Major forces exist that are driving the agenda for pharmacoepidemiology. This article reviews and weighs these factors and the roles of the major related actors. Like all hea ... Full text Link to item Cite

A giant step for pharmacoepidemiology

Journal article Journal of Clinical Research and Drug Development · January 1, 1988 Cite

Electronic drug safety surveillance in North America

Journal article Pharmaceutical Medicine · January 1, 1988 Electronic drug safety surveillance is a broad but cryptic title for the use of large, pre-existing, computer data files of health-related information in carrying out studies in pharmacoepidemiology. What, you may ask, is pharmacoepidemiology? Well, there ... Cite

Adverse drug experiences. Postmarketing surveillance of tracrium, 1983-1986

Journal article Journal of Clinical Research and Drug Development · January 1, 1988 The only true model for drug safety is the human experience. the only true sentinel for the unusual but important adverse reaction is the experience in large numbers of people treated over long periods of time. This paper presents the experience with postm ... Cite

Introduction to pharmacoepidemiology.

Journal article Drug Intell Clin Pharm · September 1987 Full text Link to item Cite

Pharmaco-epidemiology--an operational model (translating the vision into realistic plans and objectives).

Journal article Drugs Exp Clin Res · 1987 The author, previously the State Public Health Officer of the State of North Carolina, and subsequently building the pharmaco-epidemiological programme of the Wellcome Foundation, describes the programme using a number of illustrative examples in tracing d ... Link to item Cite

Clinical trials are not enough: drug development and pharmacoepidemiology

Journal article Journal of Clinical Research and Drug Development · January 1, 1987 Pharmacoepidemiology is an essential tool for proper drug development. Despite their limitations, the techniques of epidemiology, including surveillance, structured case-control, and cohort observational studies, have a direct application to risk-benefit c ... Cite

Social policy and drug safety.

Journal article Clin Geriatr Med · February 1986 Drug safety policy for the elderly says more by its relative silence and ambiguity than it could by any single affirmative set of rules and principles. The difficulties in developing such social policies embody the interaction of the complexities of each o ... Link to item Cite

Use of Adverse Reaction Data Bases and Making Risk Assessments of Proposed Switch Candidates

Journal article Drug Information Journal · April 1, 1985 We are as never before at a point in our science that we are able to begin to evaluate the truth about drug risks. It is hoped that we will couple what we know about our evolving epidemiologic science with what we know about the medical arts. As this era o ... Full text Cite

Pharmaco-epidemiology--drugs, arthritis, and neoplasms: industry contribution to the data.

Journal article Am J Med · January 21, 1985 The real possibility that exogenous chemicals, including pharmaceuticals, increase risk of cancer is not a surprise. Epidemiologic systems to monitor exposure, as well as risk with or without such exposure, have been very hard to develop and very expensive ... Full text Link to item Cite

Methodologic Issues in Post-Marketing Surveillance: Pharmaceutical Industry's View—Burroughs Wellcome

Journal article Therapeutic Innovation Regulatory Science · January 1, 1985 The program in pharmaco-epidemiology has been developed at Burroughs Wellcome Company coupling into a single department the monitoring of spontaneously reported adverse experiences (“epidemiologic intelligence”) with the design and conduct of epidemiologic ... Full text Cite

Standards--a model for the nation.

Journal article Am J Public Health · November 1982 Full text Link to item Cite

Inter-governmental relationships: More different, or more the same?

Journal article American Journal of Public Health · January 1, 1981 Full text Cite

A ray of hope.

Journal article Am J Public Health · January 1977 Full text Link to item Cite

Community mental health services and the poor

Journal article Abstracts of Hospital Management Studies · January 1, 1974 This paper presents several points of view concerning objectives of a mental health care system for the treatment of the poor and describes system considerations and expected outcomes of the various approaches presented. It is contended that the ambiguity ... Cite