The New Food and Drug Administration Drug Package Insert: Implications for Patient Safety and Clinical Care

2009 ◽  
Vol 108 (1) ◽  
pp. 211-218 ◽  
Author(s):  
Kelley Teed Watson ◽  
Paul G. Barash
Keyword(s):  
Patient Safety ◽  
Drug Administration ◽  
Food And Drug Administration ◽  
Clinical Care ◽  
Package Insert

scholarly journals Sponsors’ and investigative staffs' perceptions of the current investigational new drug safety reporting process in oncology trials

2017 ◽  
Vol 14 (3) ◽  
pp. 225-233 ◽  
Author(s):  
Raymond Perez ◽  
Patrick Archdeacon ◽  
Nancy Roach ◽  
Robert Goodwin ◽  
Jonathan Jarow ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Patient Safety ◽  
Drug Administration ◽  
Drug Safety ◽  
Food And Drug Administration ◽  
Educational Materials ◽  
Research Staff ◽  
Safety Reporting ◽  
New Drug ◽  
Final Rule

Background/aims: The Food and Drug Administration’s final rule on investigational new drug application safety reporting, effective from 28 March 2011, clarified the reporting requirements for serious and unexpected suspected adverse reactions occurring in clinical trials. The Clinical Trials Transformation Initiative released recommendations in 2013 to assist implementation of the final rule; however, anecdotal reports and data from a Food and Drug Administration audit indicated that a majority of reports being submitted were still uninformative and did not result in actionable changes. Clinical Trials Transformation Initiative investigated remaining barriers and potential solutions to full implementation of the final rule by polling and interviewing investigators, clinical research staff, and sponsors. Methods: In an opinion-gathering effort, two discrete online surveys designed to assess challenges and motivations related to management of expedited (7- to 15-day) investigational new drug safety reporting processes in oncology trials were developed and distributed to two populations: investigators/clinical research staff and sponsors. Data were collected for approximately 1 year. Twenty-hour-long interviews were also conducted with Clinical Trials Transformation Initiative–nominated interview participants who were considered as having extensive knowledge of and experience with the topic. Interviewees included 13 principal investigators/study managers/research team members and 7 directors/vice presidents of pharmacovigilance operations from 5 large global pharmaceutical companies. Results: The investigative site’s responses indicate that too many individual reports are still being submitted, which are time-consuming to process and provide little value for patient safety assessments or for informing actionable changes. Fewer but higher quality reports would be more useful, and the investigator and staff would benefit from sponsors’“filtering” of reports and increased sponsor communication. Sponsors replied that their greatest challenges include (1) lack of global harmonization in reporting rules, (2) determining causality, and (3) fear of regulatory repercussions. Interaction with the Food and Drug Administration has helped improve sponsors’ adherence to the final rule, and sponsors would benefit from increased communication with the Food and Drug Administration and educational materials. Conclusion: The goal of the final rule is to minimize uninformative safety reports so that important safety signals can be captured and communicated early enough in a clinical program to make changes that help ensure patient safety. Investigative staff and sponsors acknowledge that the rule has not been fully implemented although they agree with the intention. Clinical Trials Transformation Initiative will use the results from the surveys and interviews to develop new recommendations and educational materials that will be available to sponsors to increase compliance with the final rule and facilitate discussion between sponsors, investigators, and Food and Drug Administration representatives.

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.

Alternate dosage formulations of oral targeted anticancer agents

2021 ◽  
pp. 107815522110379
Author(s):  
Charlotte Wagner ◽  
Val Adams ◽  
Colleen Overley
Keyword(s):  
Drug Administration ◽  
Anticancer Agents ◽  
Clinical Judgment ◽  
Medical Information ◽  
Food And Drug Administration ◽  
Package Insert ◽  
Drug Manufacturer ◽  
Anticancer Compounds ◽  
Disease States ◽  
Primary Literature

Objective Oral anticancer therapies have demonstrated superior outcomes compared to traditional cytotoxic chemotherapy in many disease states. However, certain patients may not be candidates for these agents due to odynphagia or dysphagia. The purpose of this review is to summarize the data for extemporaneous compounding of oral anticancer agents. Data sources Food and drug administration approvals of oncology agents were reviewed to identify oral anticancer therapies. In order to find alternative administration options: the package inserts of each of these agents were reviewed, each medication was searched in a tertiary drug information resource, the medical information teams of each drug manufacturer were contacted to inquire about proprietary data, sites with pediatric trials were contacted, a primary literature search was performed, and listservs for national pharmacy and oncology organizations were reviewed. Data summary Eighty-five food and drug administration-approved oral anticancer therapies were identified to be included. Of those agents, nine (11%), had information in the package insert related to alternative administration. After further research, 46 (54%) of the agents had some information related to alternate formulations for administration. The recipes and stability of each of these compounds is included. Conclusions The majority of agents do not have Phase I or II trials that assess safety or pharmacokinetics of alternative formulations. Clinicians should exercise caution when recommending or administering these agents outside of food and drug administration-approved indicated use and utilize clinical judgment in assessing the risks and benefits of altering anticancer compounds. However, the alternative administration considerations presented can increase access to oncology patients who have difficulty swallowing.

Unapproved Uses of Approved Drugs: The Physician, the Package Insert, and the Food and Drug Administration: Subject Review

PEDIATRICS ◽  
1996 ◽  
Vol 98 (1) ◽  
pp. 143-145 ◽  
Author(s):  
Keyword(s):  
Drug Administration ◽  
Food And Drug Administration ◽  
Age Groups ◽  
Package Insert ◽  
Age Group ◽  
Off Label Use ◽  
Off Label ◽  
Fda Approval ◽  
Approved Drugs

Physicians who prescribe a new drug that has not been approved for a specific indication or a specific age group frequently find themselves in a quandary. Physicians who prescribe "old," time-honored drugs usually do not consult the package insert or search for US Food and Drug Administration (FDA) approval. This statement was written to clarify the legal and informational status of the package insert and the role of the FDA in approving or not approving drugs for specific indications or specific age groups. The unapproved use of approved drugs, or so-called "off-label" use, is extremely prevalent among physicians who care for children. It is important that such use of compounds be brought up to date with current FDA policies and to emphasize the responsibility of the prescribing physician in the use of these compounds.

The Ethical Health Lawyer

2005 ◽  
Vol 33 (1) ◽  
pp. 160-162 ◽  
Author(s):  
Leslie Griffin
Keyword(s):  
Patient Safety ◽  
Side Effects ◽  
Drug Administration ◽  
Food And Drug Administration ◽  
National Institutes Of Health ◽  
Public Attention ◽  
Institutional Misconduct ◽  
Heart Attacks ◽  
The Public

“There's a new whistleblower in Washington,” according to CNN News. He is Food and Drug Administration scientist David Graham, who claims that the FDA failed to warn the public about certain drugs' dangerous side effects and pressured him to change his research's conclusion that the arthritis drug Vioxx caused heart attacks. Another Washington whistleblower, Dr. Jonathan Fishbein of the National Institutes of Health, alleged that he was fired because “he had raised concerns about sloppy practices that might endanger patient safety” in a study of the AIDS drug nevirapine.Graham and Fishbein thus joined the ranks of whistleblowers who have gained some prominence in recent years for their reporting of corporate or institutional misconduct. The best-known whistleblowers—the FBI's Coleen Rowley, Enron's Sherron Watkins, and WorldCom's Cynthia Cooper, who together received Time magazine's Whistleblower Person of the Year Award in 20024 - focused public attention on the reform of corporate accounting and legal practices.

scholarly journals Case series of reports of pruritus and sipuleucel-T submitted to the Food and Drug Administration Adverse Event Reporting System

2019 ◽  
Vol 5 (1) ◽  
Author(s):  
Graça M. Dores ◽  
Silvia Perez-Vilar ◽  
Manette T. Niu
Keyword(s):  
Adverse Event ◽  
Drug Administration ◽  
Reporting System ◽  
Food And Drug Administration ◽  
Adverse Event Reporting System ◽  
Package Insert ◽  
Case Series ◽  
Adverse Event Reporting ◽  
Cellular Immunotherapy ◽  
Event Reporting

AbstractSipuleucel-T, an autologous active cellular immunotherapy, is indicated for the treatment of asymptomatic or minimally symptomatic castration-resistant prostate cancer. The U.S. Food and Drug Administration Adverse Event Reporting System (FAERS) received a report of pruritus without rash following the second dose of sipuleucel-T in a patient who had otherwise not started any new medications concurrent with the first and second doses of sipuleucel-T. No further sipuleucel-T was administered, but symptoms persisted for at least 6 weeks despite treatment with several medications aimed at symptomatic relief of pruritus. Rash is the only dermatologic adverse event included in the sipuleucel-T U.S. package insert. A search of the FAERS database yielded seven additional U.S. reports of pruritus and sipuleucel-T identified as the primary suspect medication; two of these occurred prior to the administration of sipuleucel-T (following leukapheresis). In data mining analyses, pruritus following sipuleucel-T was not reported more frequently than expected when compared to all other adverse event-drug/biologic combinations in FAERS. Thus, pruritus following sipuleucel-T administration was rarely, but not disproportionately, reported to FAERS. Although we cannot exclude the possibility that diabetes, malignancy, or other conditions may have contributed to pruritus in our index patient, in view of the timing of sipuleucel-T therapy and onset of symptoms, a drug/biologic-related reaction is plausible. In the appropriate clinical scenario, sipuleucel-T (or its components) should not be overlooked as a potential etiological agent in pruritus.

Sign in / Sign up

Export Citation Format

Share Document