FDA Initiative for Drug Facts Label for Over-the-Counter Naloxone

Cohen, Barbara R.; Mahoney, Karen; Baro, Elande; Squire, Claudia; Beck, Melissa J.; Travis, Sara; Pike-McCrudden, Amanda; Izem, Rima; Woodcock, Janet

doi:10.1056/nejmsa1912403

Cited by 23 publications

(28 citation statements)

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“…In a study conducted in the USA with 400 participants to evaluate their knowledge of OTC anti-inflammatory drugs, the authors found that almost a third of the them were unaware of the contraindication of the medication, that more than 50% denied having any discussion of OTC medications with their providers and that two-thirds of the respondents reported seeing only the medication packaging for determining the dose (Arain et al , 2019). However, direct-to-consumer (DTC) advertising usually does not provide enough information about therapeutic alternatives, efficacy, costs and risks, and the OTC drug label is the primary means through which instructions for safe and effective use are conveyed to consumers (Cohen et al , 2020). In this context, the instructions on the label and package insert are of great importance, as well as the knowledge, skills and abilities of the consumers to understand the instructions provided (Cohen et al , 2020; Kripalani et al , 2007).…”

Section: Introductionmentioning

confidence: 99%

“…However, direct-to-consumer (DTC) advertising usually does not provide enough information about therapeutic alternatives, efficacy, costs and risks, and the OTC drug label is the primary means through which instructions for safe and effective use are conveyed to consumers (Cohen et al , 2020). In this context, the instructions on the label and package insert are of great importance, as well as the knowledge, skills and abilities of the consumers to understand the instructions provided (Cohen et al , 2020; Kripalani et al , 2007).…”

Section: Introductionmentioning

confidence: 99%

“…Label understanding refers to the ability of the consumer to read and interpret the information present and to use the medication safely, follow instructions correctly and to know when to seek help from a health professional (Guo et al , 2020). Understanding the instructions given on labels and package inserts relates not only to reading skills, but also to health literacy (Cohen et al , 2020; Guo et al , 2020; Berkman et al , 2014) defined as the ability of consumers to obtain, process and understand the information and services necessary to make appropriate health-related decisions (Sørensen et al , 2012; Berkman et al , 2014). According to Paakkari and Okan (2020), poor health literacy in a population is an underestimated public health problem globally.…”

Section: Introductionmentioning

confidence: 99%

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Vulnerability of poorly literate adult consumers regarding over-the-counter drugs

Bernardes

Mattoso

Bouzada

et al. 2020

IJPHM

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Purpose This study aims at verifying the impact of literacy on over-the-counter (OTC) drug consumer vulnerability as evaluated by health literacy and label comprehension. Design/methodology/approach The item response theory (IRT) was used to estimate the health literacy of two groups and the two-way analysis of variance tests was used to test the hypotheses for the existence of mean differences between the two populations. The convenience sample involved 188 OTC consumers: 94 (50%) poorly literate and 94 (50%) university students/graduates. Findings University consumers/graduates have a level of health literacy and label comprehension that is superior to those presented by poor literate consumers. Also, age does not influence the level of health literacy by OTC drug users but has a significant impact on the understanding of OTC drug labels. Finally, the level of schooling and the “age group,” simultaneously, does not impact the understanding of OTC drug labels or health literacy. Research limitations/implications This study has added in the field of knowledge by investigating the behavior of poor literate consumers in Brazil, a developing country. The results may be relevant to Marketing professionals, especially those in the pharmaceutical industry, and to police makers, as they help identify the main problems faced by poorly literate consumers. Practical implications It is necessary to raise awareness of the dangers of self-medication and wrong use of medications, mainly focused on people with low literacy. As a suggestion, a simple glossary presented along with the label could provide explanations of scientific terms, thus increasing health literacy and reducing the vulnerability of the consumers. Social implications This study showed that when using common words such as gastritis to define a health problem, there is a higher degree of correctness. These results suggest the adoption of a more straightforward language and more precise explanations. By doing that, the pharmaceutical industry and policymakers will improve their social impact by increasing consumer power and taking care of the health of the most vulnerable population: the illiterate people. Originality/value This study contributes to the international literature, as it enhances and clarifies the knowledge about the customers’ power and vulnerability in developing countries. It fills a gap by evaluating label comprehension and heath literacy at the same time, giving an academic contribution for pharmaceutical consumers’ studies.

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Section: Introductionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

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Vulnerability of poorly literate adult consumers regarding over-the-counter drugs

Bernardes

Mattoso

Bouzada

et al. 2020

IJPHM

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“…The FDA efforts to reduce overdose deaths in communities across the country affected in recent years by the opioid crisis have focused on optimizing access to naloxone, a critical tool for individuals, families, and first responders. The FDA has approved injectable, auto‐injector, and nasal spray naloxone formulations and has, through product labeling efforts, led the way for such products to be used effectively and broadly to save the lives of victims who are overexposed to opioids 5 . The FDA has placed emphasis on the development and appropriate instruction of non‐specialists in the use of naloxone products, so that bystanders as well as first responders can effectively administer naloxone to individuals exposed to dangerous opioid levels.…”

mentioning

confidence: 99%

“…The FDA has approved injectable, auto-injector, and nasal spray naloxone formulations and has, through product labeling efforts, led the way for such products to be used effectively and broadly to save the lives of victims who are overexposed to opioids. 5 The FDA has placed emphasis on the development and appropriate instruction of non-specialists in the use of naloxone products, so that bystanders as well as first responders can effectively administer naloxone to individuals exposed to dangerous opioid levels. As a part of this work, the FDA has supported research on the labeling of naloxone products, including use by the general public.…”

mentioning

confidence: 99%

Multi‐Agency Development of Medical Countermeasures Against Opioid‐Induced Respiratory Depression

Throckmorton

Volkow

Platoff

et al. 2020

Clin Pharma and Therapeutics

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The development of medical countermeasures (MCMs) and therapies to treat opioid-induced respiratory depression (OIRD) in the context of public health emergencies requires expertise from diverse governmental agencies. As government representatives working to advance MCMs within the OIRD space, we describe here our particular institutional missions and outline the various populations we are committed to serve.

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Intranasal Naloxone Repeat Dosing Strategies and Fentanyl Overdose

Strauss,

Li,

Chaturbedi

et al. 2024

JAMA Netw Open

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ImportanceQuestions have emerged as to whether standard intranasal naloxone dosing recommendations (ie, 1 dose with readministration every 2-3 minutes if needed) are adequate in the era of illicitly manufactured fentanyl and its derivatives (hereinafter, fentanyl).ObjectiveTo compare naloxone plasma concentrations between different intranasal naloxone repeat dosing strategies and to estimate their effect on fentanyl overdose.Design, Setting, and ParticipantsThis unblinded crossover randomized clinical trial was conducted with healthy participants in a clinical pharmacology unit (Spaulding Clinical Research, West Bend, Wisconsin) in March 2021. Inclusion criteria included age 18 to 55 years, nonsmoking status, and negative test results for the presence of alcohol or drugs of abuse. Data analysis was performed from October 2021 to May 2023.InterventionNaloxone administered as 1 dose (4 mg/0.1 mL) at 0, 2.5, 5, and 7.5 minutes (test), 2 doses at 0 and 2.5 minutes (test), and 1 dose at 0 and 2.5 minutes (reference).Main Outcomes and MeasuresThe primary outcome was the first prespecified time with higher naloxone plasma concentration. The secondary outcome was estimated brain hypoxia time following simulated fentanyl overdoses using a physiologic pharmacokinetic-pharmacodynamic model. Naloxone concentrations were compared using paired tests at 3 prespecified times across the 3 groups, and simulation results were summarized using descriptive statistics.ResultsThis study included 21 participants, and 18 (86%) completed the trial. The median participant age was 34 years (IQR, 27-50 years), and slightly more than half of participants were men (11 [52%]). Compared with 1 naloxone dose at 0 and 2.5 minutes, 1 dose at 0, 2.5, 5, and 7.5 minutes significantly increased naloxone plasma concentration at 10 minutes (7.95 vs 4.42 ng/mL; geometric mean ratio, 1.95 [1-sided 97.8% CI, 1.28-∞]), whereas 2 doses at 0 and 2.5 minutes significantly increased the plasma concentration at 4.5 minutes (2.24 vs 1.23 ng/mL; geometric mean ratio, 1.98 [1-sided 97.8% CI, 1.03-∞]). No drug-related serious adverse events were reported. The median brain hypoxia time after a simulated fentanyl 2.97-mg intravenous bolus was 4.5 minutes (IQR, 2.1-∞ minutes) with 1 naloxone dose at 0 and 2.5 minutes, 4.5 minutes (IQR, 2.1-∞ minutes) with 1 naloxone dose at 0, 2.5, 5, and 7.5 minutes, and 3.7 minutes (IQR, 1.5-∞ minutes) with 2 naloxone doses at 0 and 2.5 minutes.Conclusions and RelevanceIn this clinical trial with healthy participants, compared with 1 intranasal naloxone dose administered at 0 and 2.5 minutes, 1 dose at 0, 2.5, 5, and 7.5 minutes significantly increased naloxone plasma concentration at 10 minutes, whereas 2 doses at 0 and 2.5 minutes significantly increased naloxone plasma concentration at 4.5 minutes. Additional research is needed to determine optimal naloxone dosing in the community setting.Trial RegistrationClinicalTrials.gov Identifier: NCT04764630

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FDA Initiative for Drug Facts Label for Over-the-Counter Naloxone

Cited by 23 publications

References 4 publications

Vulnerability of poorly literate adult consumers regarding over-the-counter drugs

Vulnerability of poorly literate adult consumers regarding over-the-counter drugs

Multi‐Agency Development of Medical Countermeasures Against Opioid‐Induced Respiratory Depression

Intranasal Naloxone Repeat Dosing Strategies and Fentanyl Overdose

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