The Influence of the Food and Drug Administration Pregnancy and Lactation Labeling Rule on Drug Information Resources

2020 ◽  
pp. 106002802095665
Author(s):  
John Brock Harris ◽  
Amy P. Holmes ◽  
Lea S. Eiland
Keyword(s):  
Drug Administration ◽  
Health Care Providers ◽  
Drug Information ◽  
Food And Drug Administration ◽  
The United States ◽  
Primary Objective ◽  
Information Resources ◽  
Care Providers ◽  
Pregnancy And Lactation ◽  
In Pregnancy

Background Drug information resources are commonly used by health-care providers answering pregnancy-related medication questions. In 2015, the United States Food and Drug Administration approved a new pregnancy and lactation medication labeling content and format, removing the pregnancy category, and using a narrative. Despite labeling requirements changing, it is unknown if drug information resources updated monographs to reflect these changes. Objective The primary objective was to evaluate if commonly used drug information resources provide pregnancy information listed similar to the requirements of the Pregnancy and Lactation Labeling Rule (PLLR). Secondary analyses included evaluating the references and inclusion of the pregnancy category rating. Methods Pregnancy recommendations for 23 medications were evaluated in 9 drug information resources (Clinical Pharmacology, Drugs in Pregnancy and Lactation, Epocrates®, First Databank, LexiComp® Online, LexiComp® Online Pregnancy & Lactation, In-Depth, Medi-Span®, Micromedex®, and Multum®). The number of references per drug monograph and most recent reference publication year was obtained. Results LexiComp® Online Pregnancy & Lactation, In-Depth mimics the new PLLR structure and consistently had the highest number of and most recent references when the medication was included. Drugs in Pregnancy and Lactation was the next most similar in content with the PLLR and second in most references per monograph; however, the most recent reference was the textbook publication year. Conclusion and Relevance LexiComp® Online Pregnancy & Lactation, In-Depth and Drugs in Pregnancy and Lactation provided pregnancy information in a format most similar to the PLLR. However, several drug information resources contained pregnancy categories ratings that were to be removed from medication labeling per the PLLR.

Adverse Drug Reactions and the Food and Drug Administration

1989 ◽  
Vol 2 (4) ◽  
pp. 209-213 ◽  
Author(s):  
Kay C. Pearson ◽  
Dianne L. Kennedy
Keyword(s):  
Adverse Drug Reactions ◽  
Drug Administration ◽  
Health Care Providers ◽  
Food And Drug Administration ◽  
Improve Patient Care ◽  
The United States ◽  
Care Providers ◽  
Drug Reactions ◽  
Us Government ◽  
Government Work

The monitoring of adverse drug reactions (ADRs) after a drug is marketed is an important mission for the US Food and Drug Administration (FDA). Currently, the FDA receives and computerizes nearly 60,000 ADR reports each year. The FDA has an active postmarketing surveillance system in place to effectively triage, tabulate, analyze, and evaluate these reports. Of highest priority to FDA are the discovery of serious reactions that were not observed before a drug was marketed and the detection of increased occurrence of serious reactions that are known to occur with the drug. All reactions for new moieties marketed in the United States during their first 3 years are of interest. Pharmacists are in a unique position to be aware of adverse reactions because of their knowledge of drugs, their close working relationships with other health care providers, and their direct interactions with patients. By participating in FDA's ADR reporting system, pharmacists can actively contribute to drug safety and help improve patient care. This is a US government work. There are no restrictions on its use.

scholarly journals A Comparison of Tertiary Drug Resources’ Consistency Regarding Drug-Drug Interactions of Adjunctive Analgesics

2020 ◽  
pp. 875512252095133
Author(s):  
Andrew Lang ◽  
Michael A. Veronin ◽  
Justin P. Reinert
Keyword(s):  
Health Care ◽  
Drug Interaction ◽  
Drug Interactions ◽  
Patient Care ◽  
Health Care Providers ◽  
Drug Information ◽  
Interaction Analysis ◽  
Information Resources ◽  
Care Providers ◽  
Drug Drug Interaction

Background: Health care providers routinely rely on tertiary drug information resources to affirm knowledge or proactively verify the safety and efficacy of medications. Though all patient care areas are affected, the reliability of these resources is perhaps nowhere as poignant as it is in high-acuity settings, including the emergency department and the intensive care unit. As providers seek to identify adjunctive analgesics for acute pain in these areas, they must be able to rely on the integrity to whichever resource their institution has granted access. Objective: To determine the congruency of drug-drug interaction information found on 3 tertiary drug resources. Methods: A drug-drug interaction analysis was conducted on Micromedex, Lexicomp, and Medscape. Adjunctive analgesics included dexmedetomidine and ketamine, which were compared with the intravenous opioid products morphine, fentanyl, and hydromorphone. Results: Significant discrepancies were appreciated with regard to the severity of drug-drug interactions. In addition, the heterogeneity in which reaction severity and likelihood are described by each respective resource makes direct comparisons difficult. Interaction warnings for dexmedetomidine and fentanyl included a “major interaction” from Micromedex, whereas Lexicomp did not identify a risk and Medscape only recommended increased monitoring on the grounds of respiratory and central nervous system depression. Conclusions: Health care providers must remain vigilant when reviewing tertiary drug information resources. Pharmacists possess the training and skills necessary to assist interdisciplinary medical teams in providing optimal patient care through evaluating and applying the information gleaned from these resources.

scholarly journals Dietary Supplements: Knowledge and Adverse Event Reporting Practices of Department of Defense Health Care Providers

2020 ◽  
Vol 185 (11-12) ◽  
pp. 2076-2081
Author(s):  
Melissa Rittenhouse ◽  
Jonathan Scott ◽  
Patricia Deuster
Keyword(s):  
Health Care ◽  
Adverse Event ◽  
Dietary Supplements ◽  
Drug Administration ◽  
Health Care Providers ◽  
Department Of Defense ◽  
Food And Drug Administration ◽  
Clinical Care ◽  
Care Providers ◽  
Reporting Practices

Abstract Introduction The purpose of the study was to assess the knowledge of dietary supplements (DS) and adverse event (AE) reporting practices of the Department of Defense health care providers. AEs related to use of DS are not uncommon. However, it is estimated that less than 2% of AEs are reported. This is problematic given the Food and Drug Administration relies on AE reports to identify and ultimately remove unsafe products from the market. Inadequate reporting of AE puts all DS users at risk. Materials and Methods Cross-sectional design was used. Electronic surveys were sent to the Department of Defense health care professionals (HCPs) and Emergency Medicine (EM) physicians asking questions about practices regarding DS and AE knowledge and reporting behaviors. The surveys were open for 5 months. During this period of time, HCPs received three email reminders following the initial email to enhance participation. The computer package IBM SPSS version 25 software (IBM Corp. Released 2017. IBM SPSS Statistics for Windows, Version 21.0, Armonk, New York) was used for statistical analysis. Frequency distributions of the responses were analyzed. Results Of the 1,700 surveyed, 270 HCPs and 68 EM physicians completed the surveys. At least 39% of HCPs reported never receiving formal DS training. Seventy-two percent of HCPs reported asking their patients about the use of DS. However, when asked if they knew where to report an AE, only 40% of HCPs knew where to report an AE and only 38% knew how to report an AE. Of the EM physicians, only 38% asked their patients about DS. However, a majority (78%) reported that they had encountered an AE. EM physicians also reported they lacked knowledge regarding where (87%) and how (87%) to report AE. Conclusions It is clear that physician and nonphysician HCPs would benefit from additional training about DS and how and where to report suspected AE. Providing regular training on risks, common AE, and how and where to report an AE would help fill the knowledge gap in the ever-changing DS industry. Addressing these issues and coming up with a solution to integrating AE reporting into clinical care could improve health care practices and increase AE reporting to the Food and Drug Administration, which would have a beneficial impact on patient care, public safety, and mission readiness.

scholarly journals Evaluating Medication Use in Pregnancy and Lactation: What Every Pharmacist Should Know

2013 ◽  
Vol 18 (3) ◽  
pp. 247-258 ◽  
Author(s):  
Betsy Walters Burkey ◽  
Amy P. Holmes
Keyword(s):  
Breast Milk ◽  
Drug Administration ◽  
Rating Scales ◽  
Food And Drug Administration ◽  
Medication Use ◽  
Drug Transfer ◽  
Drug Classes ◽  
Pregnancy And Lactation ◽  
In Pregnancy

As a pharmacist, being asked to give advice about medication use during pregnancy or lactation can be daunting. This article reviews the principles of drug transfer across the placenta, into breast milk, and reviews the rating scales and different resources available. The Food and Drug Administration classification scale is reviewed and the upcoming changes are explained, along with recent labeling changes for specific medications or drug classes when appropriate. This article provides the pharmacist with a practical set of tools to review the information available and assess the risks of treating or withholding a medication for mother and infant.

scholarly journals Malaria in Pregnancy

2005 ◽  
Vol 13 (4) ◽  
pp. 229-236 ◽  
Author(s):  
Jesus R. Alvarez ◽  
Abdulla Al-Khan ◽  
Joseph J. Apuzzio
Keyword(s):  
United States ◽  
Health Care ◽  
Health Care Providers ◽  
Environmental Changes ◽  
The United States ◽  
Human Migration ◽  
Care Providers ◽  
Control Vector ◽  
Underdeveloped Countries ◽  
In Pregnancy

Recently, there has been a resurgence of malaria in densely populated areas of the United States secondary to human migration from endemic areas where factors such as cessation of vector control, vector resistance to insecticides, disease resistance to drugs, environmental changes, political instability, and indifference, have played a role for malaria becoming an overwhelming infection of these tropical underdeveloped countries. It is important for health care providers of gravida to be alert of the disease and its effects on pregnancy.

The Effect of Experience Levels on Injury Rates in Collegiate Rugby Players

2021 ◽  
pp. 1-5
Author(s):  
Francesca A. Harvey ◽  
Eric Schussler
Keyword(s):  
Health Care Providers ◽  
Injury Rate ◽  
The United States ◽  
Primary Objective ◽  
Care Providers ◽  
Injury Rates ◽  
Factors Affecting ◽  
Experience Levels ◽  
Experienced Male ◽  
Rugby Players

Due to increasing rugby participation in the United States, understanding the factors affecting injury rate during participation have gained in importance. The primary objective of this research is to determine the effect of experience on injury rate in collegiate union rugby. Forty-three participants (23 men and 20 women) from the club rugby team participated over the course of one season. Injury data were analyzed by high (3+) and low (<3) seasons of experience. Twenty-four unique injuries were identified for an overall rate of 36.14 injuries per 1,000 exposures. Females with low experience (n = 14) had a rate of 47.34/1,000 exposures; females with high experience (n = 19) had a rate of 34.38/1,000 exposures. Males with low experience (n = 10) had a rate of 28.57/1,000 exposures; males with high experience (n = 13) had a rate of 42.06/1,000 exposures. Inexperienced female participants and experienced male participants showed higher rate of injury during rugby play. Identifying this at-risk group can aid coaches and responsible health care providers in making safer training and game play decisions.

Revisiting the Fetal Assault Law in Tennessee: Implications and the Way Forward

2021 ◽  
pp. 152715442198999
Author(s):  
Caroline K. Darlington ◽  
Peggy A. Compton ◽  
Sadie P. Hutson
Keyword(s):  
United States ◽  
Health Care ◽  
Drug Use ◽  
Health Care Providers ◽  
Well Being ◽  
The United States ◽  
Care Providers ◽  
Opioid Use ◽  
The Impact ◽  
In Pregnancy

The rising prevalence of opioid use disorder (OUD) among those living in the United States has demanded a collaborative response from health care and policy spheres. Addressing OUD among pregnant women is especially difficult, given the controversies surrounding the medical and ethical balance between meeting maternal versus fetal/newborn needs. Most medical organizations discourage the criminalization of drug use in pregnancy due to the adverse public health outcomes of such an approach. Despite this recommendation, many states continue to use punitive law to address drug use in pregnancy. In 2014, the Fetal Assault Law in Tennessee (TN) became the first law in the United States to directly allow women to be prosecuted for drug use in pregnancy. Since its expiration in 2016, this law has been re-introduced several times to the TN legislature in support of permanent implementation. This article outlines the impact of the initial Fetal Assault Law on maternal/newborn health in TN and provides alternative immediate, short-term, and long-term health policy strategies through which health care providers and legislators can better advocate for the well-being of both mothers with OUD and their infants.

The Special Perils of Being Old and Sick in Prison

2020 ◽  
Vol 32 (5) ◽  
pp. 276-284
Author(s):  
William J. Jefferson
Keyword(s):  
United States ◽  
Health Care ◽  
Medical Care ◽  
Health Care Providers ◽  
The United States ◽  
United States Constitution ◽  
Care Providers ◽  
Medical Practitioners ◽  
Medical Needs ◽  
Access To Medical Care

The United States Supreme Court declared in 1976 that deliberate indifference to the serious medical needs of prisoners constitutes the unnecessary and wanton infliction of pain…proscribed by the Eighth Amendment. It matters not whether the indifference is manifested by prison doctors in their response to the prisoner’s needs or by prison guards intentionally denying or delaying access to medical care or intentionally interfering with treatment once prescribed—adequate prisoner medical care is required by the United States Constitution. My incarceration for four years at the Oakdale Satellite Prison Camp, a chronic health care level camp, gives me the perspective to challenge the generally promoted claim of the Bureau of Federal Prisons that it provides decent medical care by competent and caring medical practitioners to chronically unhealthy elderly prisoners. The same observation, to a slightly lesser extent, could be made with respect to deficiencies in the delivery of health care to prisoners of all ages, as it is all significantly deficient in access, competencies, courtesies and treatments extended by prison health care providers at every level of care, without regard to age. However, the frailer the prisoner, the more dangerous these health care deficiencies are to his health and, therefore, I believe, warrant separate attention. This paper uses first-hand experiences of elderly prisoners to dismantle the tale that prisoner healthcare meets constitutional standards.

A survey of Instagram users with asthma to evaluate the acceptability of a planned clinical trial intervention (Preprint)

2020 ◽  
Author(s):  
Kerry Spitzer ◽  
Brent Heineman ◽  
Marcella Jewell ◽  
Michael Moran ◽  
Peter Lindenauer
Keyword(s):  
United States ◽  
Social Media ◽  
Health Care Providers ◽  
College Education ◽  
The United States ◽  
Survey Study ◽  
Care Providers ◽  
Healthy Behaviors ◽  
Social Media Platforms ◽  
Hispanic White

BACKGROUND Asthma is a chronic lung disease that affects nearly 25 million individuals in the United States. There is a need for more research into the potential for health care providers to leverage existing social media platforms to improve healthy behaviors and support individuals living with chronic health conditions. OBJECTIVE In this study, we assess the willingness of Instagram users with poorly controlled asthma to participate in a pilot study that uses Instagram as a means of providing social and informational support. In addition, we explore the potential for adapting photovoice and digital storytelling to social media. METHODS A survey study of Instagram users living with asthma in the United States, between the ages of 18 to 40. RESULTS Over 3 weeks of recruitment, 457 individuals completed the pre-survey screener; 347 were excluded. Of the 110 people who were eligible and agreed to participate in the study, 82 completed the study survey. Respondents mean age was 21(SD = 5.3). Respondents were 56% female (n=46), 65% (n=53) non-Hispanic white, and 72% (n=59) had at least some college education. The majority of respondents (n = 66, 81%) indicated that they would be willing to participate in the study. CONCLUSIONS Among young-adult Instagram users with asthma there is substantial interest in participating in a study that uses Instagram to connect participants with peers and a health coach in order to share information about self-management of asthma and build social connection.

Effects of Cardiovascular Disease and Related Risk Factors on Neurocognition

2019 ◽  
pp. 83-116
Author(s):  
Spencer W. Liebel ◽  
Lawrence H. Sweet
Keyword(s):  
Cardiovascular Disease ◽  
Older Adults ◽  
Cognitive Processing ◽  
Health Care Providers ◽  
The United States ◽  
Research Literature ◽  
Neurocognitive Functioning ◽  
Care Providers ◽  
Cardiac Events ◽  
Related Risk

Cardiovascular disease (CVD) affects approximately 44 million American adults older than age 60 years and remains the leading cause of death in the United States, with approximately 610,000 each year. With improved survival from acute cardiac events, older adults are often faced with the prospect of living with CVD, which causes significant psychological, social, and economic hardship. The various disease processes that constitute CVD also exert a deleterious effect on neurocognitive functioning. Although existing knowledge of neurocognitive functioning in CVD and its subtypes is substantial, a review of these findings by CVD type and neurocognitive domain does not exist, despite the potential impact of this information for patients, health care providers, and clinical researchers. This chapter provides a resource for clinicians and researchers on the epidemiology, mechanisms, and neurocognitive effects of CVDs. This chapter includes a discussion of neurocognitive consequences of CVD subtypes by neuropsychological domain and recommendations for assessment. Overall, the CVD subtypes that have the most findings available on specific neurocognitive domains are heart failure, hypertension, and atrial fibrillation. Despite a large discrepancy between the number of available studies across CVD subtypes, existing literature on neurocognitive effects by domain is consistent with the literature on the neurocognitive sequelae of unspecified CVD. Specifically, the research literature suggests that cognitive processing speed, attention, executive functioning, and memory are the domains most frequently affected. Given the prevalence of CVDs, neuropsychological assessment of older adults should include instruments that allow consideration of these potential neurocognitive consequences of CVD.

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