Food And Drug Administration Risk Research Articles

A Comprehensive Assessment of Prescription Patterns for Anemia Management in Pregnant Women: A Study From Anand District, India.

Introduction Pregnancy induces various physiological changes, often leading to complications. Physiological anemia of pregnancy, resulting from increased plasma volume and erythropoietin levels, poses significant health risks.Adverse outcomes associated with anemia during pregnancy include maternal and perinatal mortality, premature delivery, and low birth weight. Drug utilization research aims to promote rational drug use for improving health outcomes. The Food and Drug Administration (FDA) categorizes drugs based on teratogenic risk, providing guidance for clinicians. This study aims to analyze prescription trends and FDA risk categories for anemia in pregnant women in the Anand district. Materials and methods The study received institutional ethics approval and involved 816 pregnant women attending antenatal clinics from December 2021 to March 2023. Participants provided informed consent, and data collection included hemoglobin (Hb) levels at each trimester, categorizing participants into anemic (Hb < 11 gm/dL) and non-anemic groups. Prescribed drugs were recorded, and their essentiality was assessed using the WHO Essential Medicines List (WHO-EML) and the National List of Essential Medicines-2022 (NLEM-2022). FDA drug risk categories were utilized for assessing drug safety. Descriptive and statistical analyses were performed. Results Anemia prevalence across trimesters ranged from 62.50% to 65.93%, with an overall average of 64.42%. Iron and folic acid supplementation were significant across trimesters, with varying rates of prescription. Calcium supplementation showed fluctuations, with 100% prescription rates in later trimesters. Ascorbic acid was significantly prescribed in anemic pregnant women throughout pregnancy. Multivitamins were consistently prescribed, emphasizing their importance. The WHO-EML and NLEM-2022 highlighted essential micronutrients, while FDA categories indicated drug safety. Conclusion Anemia prevalence remained high throughout pregnancy, emphasizing the need for consistent supplementation. Prescription patterns aligned with evidence-based guidelines, focusing on iron and folic acid supplementation. Variations in calcium prescription suggest trimester-specific considerations. Prescription trends reflect a responsible approach to managing anemia during pregnancy, emphasizing prophylactic iron and folic acid therapy. The absence of high-risk medications underscores cautious prescribing practices. This study contributes valuable insights into evidence-based pharmacotherapy and maternal health care.

Pragmatic applications of implementation science frameworks to regulatory science: an assessment of FDA Risk Evaluation and Mitigation Strategies (REMS) (2014\u20132018)

BackgroundA Risk Evaluation and Mitigation Strategy (REMS) is a drug safety program for certain medications with serious safety concerns required by the U.S. Food and Drug Administration (FDA) of manufacturers to implement to help ensure the benefits of the medication outweigh its risks. FDA is encouraging “the research community to develop novel methods for assessing REMS,” conveying the unmet need for a standardized evaluation method of these regulatory-mandated healthcare programs. The objective of this research is to evaluate FDA REMS assessment plans using established implementation science frameworks and identify opportunities for strengthening REMS evaluation.MethodsA content analysis was conducted of publicly available assessment plans for all REMS programs (N = 23) approved 1/1/2014–12/31/2018 for new drug applications (NDAs) and biologics license applications (BLAs) requiring FDA-mandated Elements to Assure Safe Use (ETASU). Blinded reviewers critically appraised REMS assessment measures (n = 674) using three established implementation science frameworks: RE-AIM (Reach, Effectiveness, Adoption, Implementation, Maintenance); PRECEDE-PROCEED (Predisposing, Reinforcing, and Enabling Constructs in Educational/Environmental Diagnosis and Evaluation – Policy, Regulatory, and Organizational Constructs in Educational and Environmental Development); and CFIR (Consolidated Framework for Implementation Research). Framework constructs were mapped to REMS Assessment categories as defined by FDA Guidance for Industry to evaluate congruence.ResultsREMS assessment measures demonstrated strong congruence (> 90% mapping rate) with the evaluative constructs of RE-AIM, PRECEDE-PROCEED, and CFIR. Application of the frameworks revealed that REMS assessment measures heavily emphasize implementation and operations, focus less on health outcomes, and do not evaluate program context and design assumptions.ConclusionsImplementation science frameworks have utility for evaluating FDA-mandated drug safety programs including the selection of primary measures to determine whether REMS goals are being met and of secondary measures to evaluate contextual factors affecting REMS effectiveness in varying organizational settings.

Patterns of infections and antimicrobial drugs\u2019 prescribing among pregnant women in Saudi Arabia: a cross sectional study

BackgroundAntimicrobial agents are among the most commonly prescribed drugs in pregnancy due to the increased susceptibility to infections during pregnancy. Antimicrobials can contribute to different maternal complications. Therefore, it is important to study their patterns in prescription and utilization. The data regarding this issue is scarce in Saudi Arabia. Therefore, the aim of this study is to generate data on the antimicrobial agents that are most commonly prescribed during pregnancy as well as their indications and safety.MethodsThis is a retrospective study focusing on pregnant women with a known antimicrobial use at Johns Hopkins Aramco Healthcare (JHAH). The sample included 344 pregnant women with a total of 688 antimicrobial agents prescribed. Data was collected on the proportion of pregnant women who received antimicrobial agents and on the drug safety during pregnancy using the risk categorization system of the U.S. Food and Drug Administration (FDA).ResultsThe results showed that urinary tract infections (UTIs) were the most reported (59%) infectious diseases. Around 48% of pregnant women received antimicrobial medications at some point during pregnancy. The top two antimicrobial agents based on prescription frequency were B-lactams (44.6%) and azole anti-fungals (30%). The prescribed drugs in the study were found to be from classes B, C and D under the FDA risk classification system.ConclusionThe study revealed a high proportion of antimicrobials prescribed during pregnancy that might pose risks to mothers and their fetuses. Future multicenter studies are warranted to evaluate the rational prescription of antimicrobial medications during pregnancy.

Assessment of the FDA Risk Evaluation and Mitigation Strategy for Transmucosal Immediate-Release Fentanyl Products

Transmucosal immediate-release fentanyls (TIRFs), indicated solely for breakthrough cancer pain in opioid-tolerant patients, are subject to a US Food and Drug Administration (FDA) Risk Evaluation and Mitigation Strategy (REMS) to prevent them from being prescribed inappropriately. To evaluate knowledge assessments of pharmacists, prescribers, and patients regarding appropriate TIRF use; to describe sponsor assessments, based on claims data, of whether the REMS program was meeting its goals; and to characterize how the FDA responded to REMS assessments. Qualitative analysis of 4877 pages of FDA documents obtained through a Freedom of Information Act request, including 6 annual REMS assessment reports (2012-2017), FDA evaluations of these reports, and FDA-sponsor correspondence about safety issues. A REMS program to reduce the risk of adverse outcomes, including misuse, abuse, addiction, and overdose, arising from use of TIRFs. (1) Knowledge assessments of pharmacists, prescribers, and patients; (2) survey and claims-based prescribing assessments; (3) FDA and TIRF sponsor communications; (4) modifications to the REMS program; and (5) disenrollment of noncompliant prescribers. Twelve months after initiation of the program, 24 of 302 pharmacists (7.9%), 35 of 302 prescribers (11.6%), and 5 of 192 patients (2.6%) incorrectly reported that TIRFs can be prescribed to opioid-nontolerant patients, with similar levels of misunderstanding maintained in the subsequent reports. At 60 months, product-specific analyses of claims data indicated that between 34.6% and 55.4% of patients prescribed TIRFs were opioid-nontolerant. In the 48-month survey, 106 of 310 prescribers (34.2%) reported prescribing TIRFs for opioid-tolerant patients with chronic, noncancer pain; at 60 months, 54 of 302 prescribers (18.4%) and 148 of 310 patients (47.7%) erroneously reported that TIRFs were FDA-approved for such use. Over the 60-month period examined, there were few substantive changes made to the REMS to address evidence of high rates of off-label TIRF use, and, although the REMS program had a noncompliance plan, there was no report of prescribers being disenrolled for inappropriate prescribing. In this review of FDA documents pertaining to the TIRF REMS, surveys of pharmacists, prescribers, and patients reflected generally high levels of knowledge regarding proper TIRF prescribing, yet some survey items as well as claims-based analyses indicated substantial rates of inappropriate TIRF use. Despite these findings, the FDA did not require substantive changes to the program.

Development of Processes to Ensure Timely Administration of Tocilizumab in the Setting of Cytokine Release Syndrome after Administration of Tisagenlecleucel or Axicabtagene Ciloleucel

Introduction With the commercial approval of tisagenlecleucel and axicabtagene ciloleucel, tocilizumab was concurrently approved by the Food and Drug Administration (FDA) for the management of cytokine release syndrome (CRS).1,2 Per the FDA Risk Evaluation and Mitigation Strategy (REMS) requirements, the pharmacy must stock a minimum of two doses of tocilizumab for each patient, available for administration within two hours.1,2 The complex logistics of the immediate administration of this product in a large academic medical center required coordination of a multidisciplinary team. Objectives/Methods Our multidisciplinary team participated in weekly meetings to develop standard policies and treatment algorithms to treat the acute toxicities seen with tisagenlecleucel and axicabtagene ciloleucel. We also created an annual pharmacy competency outside of the REMS requirements for all inpatient pharmacy staff to ensure awareness and emphasize the need for prompt administration of tocilizumab. Our IT team worked to develop electronic solutions including a PRN entry of tocilizumab that would be released concurrently with the cell infusion order and would be readily available on the patient's medication administration record (MAR) for immediate dispensing. As CRS can occur following the initial admission, we created a “prepare and give now” entry for tocilizumab within our toxicity treatment order set in preparation of potential future admissions. The entry includes help text with the dosing information and is capped at 800 mg. For all scenarios in which tocilizumab administration is necessary, the attending on service is required to call the inpatient pharmacy directly to provide the verbal order to dispense a dose. This safety step ensures that the attending on service is knowledgeable of the patient's symptoms and agrees with use. Results/Conclusion Of the patients that we have treated to date, our median number of tocilizumab doses is 1 dose (range 0-4). Our median time from dispense to administration is 53.5 minutes (range 23-85 minutes) [Table 1]. This demonstrates that our education efforts and available resources have resulted in our ability to properly manage CRS and to dispense and administer tocilizumab well under the 2-hour time frame dictated by the REMs requirements.

Rise in Antidepressant Prescriptions for Youth Raises Questions About Why

Back to table of contents Previous article Next article Clinical and Research NewsFull AccessRise in Antidepressant Prescriptions for Youth Raises Questions About WhyNick ZagorskiNick ZagorskiSearch for more papers by this authorPublished Online:31 Jan 2018https://doi.org/10.1176/appi.pn.2018.2a10AbstractAfter an initial decline in the use of antidepressants by youth following actions taken by the Food and Drug Administration in 2004, one study finds antidepressant use among youth has rebounded.In October 2004, the Food and Drug Administration (FDA) directed pharmaceutical companies to issue a black-box warning about the potential link between the use of antidepressants and increased suicidal ideation among youth. Following this directive, the number of depression diagnoses and antidepressant prescriptions for children and adolescents—which had been on the rise—fell over the next few years.Though there is an extensive body of research exploring this initial decline in prescriptions, fewer studies have looked at long-term prescribing trends. A study published last December in Psychiatric Services in Advance found that following that initial decline, the rate of antidepressant prescribing to children eventually returned to pre-2004 levels. Nilay Kafali, Ph.D., of RTI International and colleagues found that 2.26 percent of children aged 5 to 17 were prescribed antidepressants in 2009, similar to the 2003 level of 2.29 percent. Between 2004 and 2008, that rate had dropped to below 2 percent.The authors calculated these rates using data from the Medical Expenditure Panel Survey (a set of nationally representative surveys of individuals, medical providers, and employers that detail the use and costs of health care services and health insurance coverage). They included available data on children aged 5 to 17 between 2000 and 2011. To estimate how the impact of the black-box warning on antidepressant use among children changed over time, the authors divided the entire sample period into four periods: early prewarning (2000–2001), prewarning (2002–2003), early postwarning (2004–2007), and late postwarning (2008–2011). They found that there was a 0.5 percent statistically significant decline in antidepressant use during the early postwarning years compared with prewarning years, with a particularly strong decrease among children rated as having non-severe psychological impairment. (The authors defined non-severe psychological impairment as a Columbia impairment Scale score of <16). Antidepressant use was 1.1 percent for this group in 2003, dropped to around 0.7 percent between 2004-2007, and rose to 1.09 percent in 2008. Rates of antidepressant use for children with severe psychological impairment showed a gradual decline from 2003 to 2007, but then also rose to pre-2004 levels. “These findings suggest that providers and families of youth may have reacted to the black-box warning in an appropriate manner, weighing the warning with the risks and benefits of the treatment,” Kafali and colleagues wrote. “A return to the rates of antidepressant use before the black-box warning raises concern that this thoughtful accounting of the risks and benefits may have dissipated over time.”A central question for future research is what factors drove this rise in use after 2008. “It is possible that over time physicians have become somewhat inured to the safety warnings,” said Mark Olfson, M.D., M.P.H., a professor of psychiatry and epidemiology at Columbia University Medical Center. “However, it is also possible that increasing prevalence of depression or anxiety among young people during the great recession played a role,” he added.Olfson, who was not involved with this study, noted that other community surveys including the Youth Risk Behavior Survey, the National Survey on Drug Use and Health, and the Monitoring the Future surveys have revealed a recent increase in depressed mood and major depressive episodes among children and adolescents. “An important policy implication of our findings could be that more frequent updates of FDA risk warnings might be necessary to prevent patients and the providers from ‘forgetting’ the potential risks outlined in the original warning,” Kafali and colleagues wrote. ■An abstract of “Long-Run Trends in Antidepressant Use Among Youths After the FDA Black Box Warning” can be accessed here. ISSUES NewArchived

Sharing R&amp;D Risk in Healthcare via FDA Hedges

The high cost of capital for firms conducting medical research and development (R&D) has been partly attributed to the government risk facing investors in medical innovation. This risk slows down medical innovation because investors must be compensated for it. We propose new and simple financial instruments, Food and Drug Administration (FDA) hedges, to allow medical R&D investors to better share the pipeline risk associated with FDA approval with broader capital markets. Using historical FDA approval data, we discuss the pricing of FDA hedges and mechanisms under which they can be traded and estimate issuer returns from offering them. Using various unique data sources, we find that FDA approval risk has a low correlation across drug classes as well as with other assets and the overall market. We argue that this zero-beta property of scientific FDA risk could be a main source of gains from trade between issuers of FDA hedges looking for diversified investments and developers looking to offload the FDA approval risk. We offer proof of concept of the feasibility of trading this type of pipeline risk by examining related securities issued around mergers and acquisitions activity in the drug industry. Overall, our argument is that, by allowing better risk sharing between those investing in medical innovation and capital markets more generally, FDA hedges could ultimately spur medical innovation and improve the health of patients.

Pharmaceutical Risk Control Systems

This paper outlines an initial investigation of the bio-pharmaceutical industry (BPI) and the steps it is taking to meet the new FDA risk mandate. It reviews the industry’s’ current strategy of improving its quality management systems that are central to achieving best practices within its operations. In addition the paper also reviews the strategy for upgrading to the next generation manufacturing execution systems which will control the enterprise facilities through full data integration and actionable intelligence. U.S. PHARMACEUTICAL INDUSTRY The U.S. life science industry is a business sector with high visibility which faces the significant task of developing, testing and manufacturing of pharmaceuticals. Within the complex environments in which bio-pharmaceuticals are developed, there is a strong need for IS systems that monitor, control and manage the production processes. These industrial strength systems (Booch, 1994) can drive each of the steps within the product life cycle and are critical for guaranteeing that quality standards are met. The internal standards are set through quality assurance techniques developed from ‘best practices,’ while the external standards are set by the U.S. Food and Drug Administration (FDA).

Look, Over Here, Some Real LTC-Policy News

Look, Over Here, Some Real LTC-Policy News

Predictors of the use of medications before and during pregnancy

Drug use in pregnancy is often reason of concern for mothers and their physicians. However, only few studies investigated predictors of drug use in pregnancy. To examine maternal characteristics as predictors of medication use in the 6 months before pregnancy and during the first 6 months of pregnancy. To examine whether prescription and over-the-counter (OTC) medication use in the 6 months before pregnancy had an impact on medication use in pregnancy. Six maternity care units and five community pharmacies. Data were collected using a specially designed self-reported questionnaire during the period March 2009-March 2010. Logistic regression was used to identify factors associated with medication use. Adjusted odds ratios (aOR) and 95% confidence intervals (CI) were used as association measures. A total of 236 women were included in the analysis. After controlling for maternal characteristics, parity of more than one was associated with lower prescription medication use in pregnancy (aOR 0.46; 95% CI 0.22-0.93), higher household income with higher OTC medication use before pregnancy (aOR 3.13; 95% CI 1.22-8.00), and miscarriage with higher C and D Food and Drug Administration (FDA) risk category medication use in pregnancy (aOR 3.65; 95% CI 1.30-10.25). Prescription medication use before pregnancy was associated with higher prescription medication use in pregnancy (aOR 2.49; 95% CI 1.12-5.52), OTC medication use before pregnancy with higher OTC medication use in pregnancy (aOR 35.95; 95% CI 7.95-162.49), and C and D FDA risk category medication use before pregnancy with the same category medication use in pregnancy (aOR 3.54; 95% CI 1.23-10.17). Different maternal characteristics were shown as predictors of medication use before and during pregnancy. However, medication use before pregnancy was shown as the most important predicting factor for the medication use in pregnancy.

Drug use before and during pregnancy in Serbia

Observation of drug use patterns during pregnancy is necessary for the recognition of potential bad practices and improvement of safe drug use in pregnancy. To investigate prescription and over the counter drug use among Serbian women in the 6 months before pregnancy and in the first 6 months of pregnancy, and to evaluate the drugs used according to the risk to a fetus. Setting Six maternity care units and five community pharmacies. A multi-center study was performed in Serbia during the period from March 2009-March 2010. A self-reporting questionnaire was used as a data source. Food and Drug Administration (FDA) risk classification system was used to determine the risk of used drugs for the fetus. Differences between subgroups were assessed using McNemar's test on paired proportions. Main outcome measure Proportion of women exposed to drugs or class of drugs. The overall drug exposure was higher in pregnancy (34.7 %) than before pregnancy (29.9 %), p > 0.05, in the cohort of 311 pregnant women. A significantly greater prescription drug use, 19.0 versus 27.3 % of women, p < 0.05, and less selfmedication with over the counter drugs in pregnancy, 15.1 versus 8.7 %, p < 0.05, were observed. Commonly used drugs were musculoskeletal drugs, analgesics/antipyretics and respiratory system drugs before pregnancy (13.8, 12.5, and 6.4 % of women, respectively), and progestogens, analgesics/antipyretics, and antibiotics for the systemic use in pregnancy (9.0, 7.7, and 7.4 %, respectively). A greater exposure to drugs belonging to the FDA risk category A (3.9 vs. 60.8 %, p < 0.05), B (18.0 vs. 19.6 %, p > 0.05), C (10.0 vs. 10.3 %, p > 0.05) and D (2.9 vs. 10.9 %, p < 0.05), as well as less exposure to drugs belonging to category X (0.3 vs. 0 %, p > 0.05) were observed in pregnancy. Folic acid was used by 60.8 % of women in pregnancy, and by only 3.9 % before pregnancy. Besides higher overall drug use in pregnancy than before pregnancy, particularly the use of progestogens, and, subsequently, D category drugs, less selfmedication with over the counter drugs was observed in pregnancy. Insufficient use of folic acid before pregnancy requires public health service activities.

Blueprint for Prescriber Continuing Education Program

EDITOR'S ABSTRACTOn October 25, 2011, the Center for Drug Evaluation and Research (CDER) of the Food and Drug Administration (FDA) posted online this Blueprint for Prescriber Continuing Education, labeled “final,” relating to extended-release and long-acting opioids. The pending FDA Risk Evaluation Management Strategy (REMS) requires prescriber education. This document provides guidance to sponsors of these dosage forms in developing the prescvriber education component of their REMS. This report was posted online by the federal agency on October 25, 2011 at: http://www.fda.gov/downloads/drugs/drugsafety/informationbydrugclass/ucm277916.pdf. It is in the public domain.

Impact of FDA drug risk communications on health care utilization and health behaviors: a systematic review.

To review literature on the impact of The Food and Drug Administration (FDA) drug risk communications on medication utilization, health care services use, and health outcomes. The authors searched MEDLINE and the Web of Science for manuscripts published between January 1990 and November 2010 that included terms related to drug utilization, the FDA, and advisories or warnings. We manually searched bibliographies and works citing selected articles and consulted with experts to guide study selection. Studies were included if they involved an empirical analysis evaluating the impact of an FDA risk communication. We extracted the drug(s) analyzed, relevant FDA communication(s), data source, analytical method, and main outcome(s) assessed. Of the 1432 records screened, 49 studies were included. These studies covered 16 medicines or therapeutic classes; one third examined communications regarding antidepressants. Most used medical or pharmacy claims and a few rigorously examined patient-provider communication, decision making, or risk perceptions. Advisories recommending increased clinical or laboratory monitoring generally led to decreased drug use, but only modest, short-term increases in monitoring. Communications targeting specific subpopulations often spilled over to other groups. Repeated or sequential advisories tended to have larger but delayed effects and decreased incident more than prevalent use. Drug-specific warnings were associated with particularly large decreases in utilization, although the magnitude of substitution within therapeutic classes varied across clinical contexts. Although some FDA drug risk communications had immediate and strong impacts, many had either delayed or had no impact on health care utilization or health behaviors. These data demonstrate the complexity of using risk communication to improve the quality and safety of prescription drug use, and suggest the importance of continued assessments of the effect of future advisories and label changes. Identifying factors that are associated with rapid and sustained responses to risk communications will be important for informing future risk communication efforts.

FDA Risk Assessment of Seafood Contamination after the BP Oil Spill

FDA Risk Assessment of Seafood Contamination after the BP Oil Spill

Farklı Risk Kategorilerine Göre Gebelikte İlaca Maruz Kalımın Değerlendirilmesi: FDA Esaslı Kararlar Daha Fazla Küretaja Neden mi Oluyor?

Objective: The aims of the study were to compare the risk levels of exposed drugs during pregnancy with regard to United States Food and Drug Administration (FDA), Australian Drug Evaluation Committee (ADEC) and Teratogen Information System (TERIS) risk categories, and to determine the outcomes of FDA risk category based decisions on the course of pregnancy in pregnant women who applied to Dokuz Eylul University (DEU) Teratogenity Information Service (TIS). Material and Methods: In this cross-sectional study, 220 pregnant women were enrolled who referred to DEU TIS for a teratogenity risk evaluation due to drug exposure during their pregnancies. Demographics, medical history, time and duration of the exposed drugs were recorded. Drugs exposed during pregnancy were divided into two categories as high or low risk. A drug that was exposed during pregnancy of the highest risk according to FDA was taken into consideration for the evaluation of the outcomes of the pregnancy. Additionally, FDA, TERIS and ADEC risk categories which were classified as

Seafood contamination after the BP Gulf oil spill and risks to vulnerable populations: a critique of the FDA risk assessment.

Background: The BP oil spill of 2010 resulted in contamination of one of the most productive fisheries in the United States by polycyclic aromatic hydrocarbons (PAHs). PAHs, which can accumulate in seafood, are known carcinogens and developmental toxicants. In response to the oil spill, the U.S. Food and Drug Administration (FDA) developed risk criteria and established thresholds for allowable levels [levels of concern (LOCs)] of PAH contaminants in Gulf Coast seafood.Objectives: We evaluated the degree to which the FDA’s risk criteria adequately protect vulnerable Gulf Coast populations from cancer risk associated with PAHs in seafood.Discussion: The FDA LOCs significantly underestimate risk from seafood contaminants among sensitive Gulf Coast populations by failing to a) account for the increased vulnerability of the developing fetus and child; b) use appropriate seafood consumption rates; c) include all relevant health end points; and d) incorporate health-protective estimates of exposure duration and acceptable risk. For benzo[a]pyrene and naphthalene, revised LOCs are between two and four orders of magnitude below the level set by the FDA. Comparison of measured levels of PAHs in Gulf seafood with the revised LOCs revealed that up to 53% of Gulf shrimp samples were above LOCs for pregnant women who are high-end seafood consumers.Conclusions: FDA risk assessment methods should be updated to better reflect current risk assessment practices and to protect vulnerable populations such as pregnant women and children.

New Study Answers Questions About Cardiac Risk of ADHD Drugs

New Study Answers Questions About Cardiac Risk of ADHD Drugs

Understanding the Food and Drug Administration Risk Evaluation and Mitigation Strategies (REMS)

The Director's Forum series is written and edited by Robert Weber and Scott Mark and is designed to guide pharmacy leaders in establishing patient-centered services in hospitals and health systems. As the Food and Drug Administration (FDA) approval process becomes more stringent with regard to postmarketing surveillance for medications, directors of pharmacy will need to understand expectations of inpatient pharmacy services to ensure patient safety and meet requirements. This article provides background information regarding the FDA Risk Evaluation and Mitigation Strategies (REMS) programs and potential implications for hospital pharmacy.

Safety of Long-Acting β-Agonists: Are New Data Really Required?

Safety of Long-Acting β-Agonists: Are New Data Really Required?

Government as Biosecurity Communicator: The 2006 Spinach Advisory

In 2006, after the United States Food and Drug Administration (FDA) traced Escherichia coli O157:H7 cases to spinach, the FDA went beyond communicating with consumers and enlisted the cooperation of the food industry to prevent further spinach consumption. Understanding the factors that increased or frustrated industry participation provides lessons for communicating about accidental contamination and intentional attacks on the American food supply. This qualitative research about FDA's risk communication included interviews with senior representatives of organizations serving a range of roles in the food supply system, including suppliers, distributors, grocery stores, and trade associations. The interviews reveal that when public health concern is no longer warranted, agencies need to develop and disseminate "closure" messages to prevent unintended consequences, including economic impacts. The study also underscores the importance of trade associations and industry networks in protecting consumers, the usefulness of agency flexibility in increasing cooperation with stakeholders, and the need for greater communication among agencies. Outside the geographic epicenter of the contamination, New Jersey government also provided examples of innovative strategies to promote locally grown spinach.