Adherence to label and device recommendations for over-the-counter pediatric liquid medications.
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ABSTRACT:
SUBMITTER: Budnitz DS
PROVIDER: S-EPMC4651167 | biostudies-literature | 2014 Feb
REPOSITORIES: biostudies-literature
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Adherence to label and device recommendations for over-the-counter pediatric liquid medications.
Budnitz Daniel S DS Lovegrove Maribeth C MC Rose Kathleen O KO
Pediatrics 20140106 2
<h4>Objective</h4>To reduce dosing errors when administering orally ingested over-the-counter liquid medications, the US Food and Drug Administration (FDA) and the Consumer Healthcare Products Association released voluntary recommendations for dosing directions and dosing devices. This study assessed recommendation adherence for national brand name orally ingested over-the-counter liquid pediatric analgesics/antipyretics and cough, cold, and allergy medications available after the FDA guidance w ...[more]
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Project description:Importance:Inaccurate medication records and poor medication adherence result in incomplete knowledge of therapy for patients. Objective:To study accuracy of medical records and patient adherence by measuring blood concentrations of medications. Design, Setting, and Participants:This cross-sectional study validated a serum-based liquid chromatography-tandem mass spectrometry assay to simultaneously quantify 263 medications used for acute and chronic conditions. The assay panel was applied to 3 clinical patient cohorts: residual serum from 1000 randomly selected samples sent for routine clinical chemistry testing between April 8 and October 6, 2015 (residuals cohort), 50 prospectively enrolled patients in a gastroenterology clinic between March 1 and March 15, 2016, who were prescribed more than 5 medications (gastroenterology care cohort), and a convenience cohort of 296 patients with hypertension who sought care in an emergency department (ED care cohort) between July 1, 2012, and April 25, 2013. Integrated data analysis of the cohorts was performed from August 22 to November 29, 2017. Main Outcomes and Measures:Medication serum concentrations, electronic health record medication lists, and predicted drug interactions. Results:Of the 1346 total samples, 1000 came from the residuals cohort (640 women and 360 men; median age, 60 years [interquartile range (IQR), 44-71 years]), 50 from the gastroenterology care cohort (30 women and 20 men; median age, 66 years [IQR, 62-70 years]), and 296 from the ED care cohort (160 women and 136 men; median age, 59 years [IQR, 52-66 years]). Median medication adherence, defined as the subset of detected medications from the prescription record, was 83% (IQR, 50%-100%) in the residuals cohort, 100% (IQR, 84%-100%) in the gastroenterology care cohort, and 78% (IQR, 57%-100%) in the ED care cohort. Patients adherent to 1 medication were more often adherent to other medications. Among patients prescribed 3 medications or more, there were no significant associations between medication adherence and sex or number of prescribed medications, and there was a modest association between adherence and age. By comparing detected vs prescribed medications, we detected a median of 0 (IQR, 0-2) medications per patient that were not listed in the electronic health record in the residuals cohort, 1 (IQR, 0-2) medication per patient that was not listed in the electronic health record in the gastroenterology care cohort, and 1 (IQR, 0-2) medication per patient that was not listed in the electronic health record in the ED care cohort. A total of 435 patients (43.5%) in the residuals cohort had no discrepancy between the electronic health record and detected medication lists, 22 patients (44.0%) in the gastroenterology care cohort had no discrepancy between the electronic health record and detected medication lists, and 41 patients (13.9%) in the ED care cohort had no discrepancy between the electronic health record and detected medication lists. Half of adverse drug reaction alerts occurred among medications detected without prescription. Conclusions and Relevance:Comprehensive medication monitoring offers promise to improve adherence, the accuracy of medical records, and the safety for patients with polypharmacy.
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Project description:IntroductionUnintentional medication ingestions by young children lead to nearly 60,000 emergency department visits annually; 15% involve oral liquid medications. Safety packaging improvements have been shown to limit liquid medication ingestions. Estimated rates of emergency department visits for pediatric ingestions by product were calculated to help target interventions.MethodsFrequencies and rates of emergency department visits for unintentional pediatric ingestions were estimated using adverse event data from the National Electronic Injury Surveillance System-Cooperative Adverse Drug Event Surveillance project and retail sales/pharmacy dispensing data from Information Resources, Inc. and QuintilesIMS (collected 2012-2015; analyzed 2017). Rates of emergency department visits for ingestions of over-the-counter liquid medications were compared with those for prescription solid medications.ResultsFrom the results of 568 cases, an estimated 6,427 emergency department visits (95% CI=4,907, 7,948) were made annually after a child aged <6 years accessed one of the four most commonly implicated over-the-counter liquid medications without caregiver oversight. Nearly two thirds (63.8%) of these visits were made by children aged ≤2 years and 9.0% resulted in hospitalization. Acetaminophen was the most commonly implicated over-the-counter liquid medication (2,515 estimated emergency department visits annually). Rates of emergency department visits for liquid diphenhydramine and acetaminophen ingestions (8.1 and 7.4 emergency department visits per 100,000 bottles sold) were higher than rates for other common over-the-counter liquids and comparable to high-rate prescription solid medications (clonidine and buprenorphine/naloxone: 11.1 and 10.5 emergency department visits per 100,000 dispensed prescriptions, respectively).ConclusionsProduct-specific rates of emergency department visits for unintentional ingestions can help prioritize preventive interventions, such as enhancing safety packaging with flow restrictors.
| S-EPMC6714556 | biostudies-literature
Project description:IntroductionChronic idiopathic constipation (CIC) is a prevalent functional gastrointestinal disorder diagnosed based on patient-reported symptoms and the absence of structural gastrointestinal abnormalities. Individuals with CIC typically institute dietary changes and use stool softeners or over-the-counter (OTC) laxatives, possibly at the direction of a healthcare provider, before prescription medications for CIC are initiated. Although highly prevalent, there is limited information regarding CIC patient experiences with OTC medications.MethodsThis post-hoc analysis used patient-reported data from a questionnaire administered during patient screening for a prospective linaclotide Phase 3b clinical trial in patients with CIC (N = 1482 screened). The questionnaire asked patients to report their experiences with OTC CIC medications over the preceding 6 months.ResultsAmong patients with screening responses (N = 1423), most were female (85%) and white (66%), with a mean age of 48.9 years. A high proportion of patients had used one or more OTC medications (70% had ≥1 OTC; 19% had ≥3 OTCs), with the majority being bisacodyl (33%) and polyethylene glycol (30%). The most commonly cited reason for stopping an OTC medication was insufficient symptom relief (17-40%). The majority of patients taking OTC medications reported no or little satisfaction with the medication's effect on their constipation (62%) and CIC-specific abdominal symptoms (78%). Many patients had little to no confidence in bowel movement (BM) frequency after taking OTC medications and their confidence in their ability to predict BM timing was also low (49-81% not at all confident).ConclusionsTreatment effects on individual CIC symptoms, predictability of bowel habits, and satisfaction with treatment are all important factors for healthcare providers and patients to consider when establishing an effective treatment regimen for CIC.Trial registration numberNCT01642914.
| S-EPMC7799845 | biostudies-literature
Project description:Background: The safety of pharmacotherapy for geriatric patients is an essential aspect of the demographic perspective in view of the increasing size of this population. Non-opioid analgesics (NOAs) are among the most popular and often overused over-the-counter medications (OTC). The reasons for drug abuse are common in the geriatric population: musculoskeletal disorders, colds, inflammation and pain of various origins. The popularity of self-medication and the ability to easily access OTC drugs outside the pharmacy creates the danger of their misuse and the incidence of adverse drug reactions (ADRs). The survey included 142 respondents aged 50–90 years. The relationship between the prevalence of ADRs and the NOAs used, age, presence of chronic diseases, and place of purchasing and obtaining information about the mentioned drugs were evaluated. The results of the observations were statistically analyzed using Statistica 13.3. The most commonly used NOAs among the elderly included paracetamol, acetylsalicylic acid (ASA) and ibuprofen. Patients consumed the medications for intractable headaches, toothaches, fevers, colds and joint disorders. Respondents indicated the pharmacy as the main location for purchasing medications, and the physician as the source of information for selecting the therapy. ADRs were reported most frequently to the physician, and less frequently to the pharmacist and nurse. More than one-third of respondents indicated that the physician during the consultation did not take a medical history and did not ask about concomitant diseases. It is necessary to extend pharmaceutical care to geriatric patients that includes advice on adverse drug reactions, especially drug interactions. Due to the popularity of self-medication, and the availability of NOAs, long-term measures should be taken to increase the role of pharmacists in providing effective, safe health care to seniors. We are targeting pharmacists with this survey to draw attention to the problem of the prevalence of selling NOAs to geriatric patients. Pharmacists should educate seniors about the possibility of ADRs and approach patients with polypragmasy and polypharmacy with caution. Pharmaceutical care is an essential aspect in the treatment of geriatric patients, which can contribute to better results in their existing treatment and increase the safety of medication intake. Therefore, it is important to improve the development of pharmaceutical care in Poland in order to enhance patient outcomes.
| S-EPMC10001525 | biostudies-literature
Project description:Objective: To systematically analyze the supporting evidence, drug information, and the type of off-label drug use in recommendations on off-label drug use in pediatric guidelines. Methods: A cross-sectional study was performed by systematic search through MEDLINE (via PubMed) and Embase databases to identify literature published from 1 January 2018, to 31 December 2020. Only pediatric clinical practice guidelines that included recommendations on off-label use of drugs were included. We present descriptive information on the sources of the included guidelines, country, publication year, evidence grading system used, details on the types of off-label drug use, and the types of studies used as references to support the recommendations. Results: A total of 66 pediatric guidelines with 605 recommendations were included. Eighty-seven (14.4%) recommendations did not cite any references; and the remaining 518 recommendations were supported by 2,240 references (mean 4.3 references/recommendation). The most common types of studies cited were pediatric RCTs (n = 314, 14.0%), pediatric case series studies (n = 260, 11.6%), and reviews (n = 255, 11.4%). Twenty-one percent (n = 470) of the references were studies on adults. One hundred and forty (23.1%) recommendations were graded using the Grading of Recommendations, Assessments, Development, and Evaluations (GRADE) system, of which 37 (26.4%) were graded as strong but supported with only C or D level of evidence. The most commonly reported type of information in the recommendations was indication (n = 499, 82.5%). The most commonly addressed type of off-label drug use in the 523 positive recommendations was unapproved population (n = 255, 48.8%). Sixty-nine (11.4%) recommendations explicitly reported the drug use as off-label. Conclusion: Children may be exposed to medical risks due to gaps in reporting and evidence of off-label drug use recommendations in pediatric guidelines.
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Project description:Background The unintentional misuse of over-the-counter sleep aids among older adults is an important public health problem and a focus of Healthy People 2020. Accordingly, the 2015 Beers Criteria for Potentially Inappropriate Medication Use in Older Adults recommends that individuals 65 years or older avoid use of diphenhydramine and doxylamine; however, many over-the-counter sleep products contain these active ingredients. Objective To identify the proportion of older adults using an over-the-counter medication containing diphenhydramine or doxylamine, and compare their characteristics with older adults using an over-the-counter medication that does not contain these ingredients. Setting Study participants were recruited from the Community Registry of the Pittsburgh Claude D. Pepper Older Americans Independence Center. Method The study sample was taken from a larger survey of 1025 participants on sleep health and over-the-counter sleep medication use conducted from February to April 2015. A subset of 169 participants aged 65 and older reporting taking at least one over-the-counter product to improve sleep within the past 30 days (16.5%) were selected for our analysis on associations between participant characteristics and potentially inappropriate use of over-the-counter sleep medications. Main outcome measure The proportion and characteristics of older adults taking at least one over-the-counter medication containing diphenhydramine or doxylamine. Results Of the 223 over-the-counter sleep medications listed by participants, 115 (52%) contained diphenhydramine or doxylamine. Using the Beers Criteria, we found that more than half of participants (59%) had used a potentially inappropriate over-the-counter medication containing diphenhydramine or doxylamine to improve sleep within the past 30 days. Participants taking at least one diphenhydramine or doxylamine containing medication were less likely to be aware of any safety risks in taking over-the-counter sleep medications than participants not taking these products (38 vs 49%, p = 0.016). Conclusion A majority of older adults in a limited sample from the United States taking an over-the-counter medication to improve sleep are taking a product containing diphenhydramine or doxylamine, both of which are classified as potentially inappropriate for older adults. Awareness of the safety risks of over-the-counter medications and addressing conditions that impact sleep quality could be facilitated through consultation with pharmacists and other healthcare providers.
| S-EPMC5541127 | biostudies-literature
Project description:BACKGROUND: Chronically ill children and adolescents comprise a vulnerable population that requires specific considerations in order to positively impact their treatment outcome. Pediatric renal patients can be non-compliant and also forgetful in taking their medications. OBJECTIVE: The objectives of the study were to (a) assess medication adherence and (b) to identify emotionality and variables that influence non-adherence by use of "The Child & Adolescent Adherence to Medication Questionnaire" (CAAMQ), which was constructed at Texas Tech University Health Sciences Center. METHODS: Pediatric renal patients from 10 to 21 years-of-age, taking three or more medications, for longer than a three-month period, were eligible to complete the CAAMQ. RESULTS: Thirty-four patients participated in the study. Many of the respondents had problems remembering to take their medications on weekends (P = 0.021). The majority of the patients stated that they were not bothered about having to take their medications (70.6%); and that taking pills did not interfere with their daily activities (85.3%). Open-ended questions in the CAAMQ identified patients' feelings of sadness, distress, and the importance of strong family support systems. The study participants reported that they preferred to take their medications at school, in the nurses' office or in a place where privacy was assured. The results indicated that Prednisone was the most disliked of all of the medications. Female patients were more reactive and secretive than males regarding peers knowing about their disease and medication schedules (P<0.017). CONCLUSIONS: Non-adherence in pediatric patients is a complex and serious problem, which ultimately affects the patients' health. Privacy and daily routine were found to impact the patients' adherence to medications. Creative and individualized reminders for teenagers need to be developed and validated. Further studies that take into consideration developmental and motivational factors may help researchers identify modifiable psychosocial predictors that will lead to improved medication adherence.
| S-EPMC3715481 | biostudies-other
Project description:Background and purposeCharacterization of emergency department (ED) visits for acute harms related to use of over-the-counter cough and cold medications (CCMs) by patient demographics, intent of CCM use, concurrent substance use, and clinical manifestations can help guide prevention of medication harms.MethodsPublic health surveillance data from the National Electronic Injury Surveillance System-Cooperative Adverse Drug Event Surveillance project were used to estimate numbers and population rates of ED visits from 2017 to 2019.ResultsBased on 1396 surveillance cases, there were an estimated 26 735 (95% CI, 21 679-31 791) US ED visits for CCM-related harms annually, accounting for 1.3% (95% CI, 1.2-1.5%) of all ED visits for medication adverse events. Three fifths (61.4%, 95% CI, 55.6-67.2%) of these visits were attributed to non-therapeutic CCM use (nonmedical use, self-harm, unsupervised pediatric exposures). Most visits by children aged <4 years (74.0%, 95% CI, 59.7-88.3%) were for unsupervised CCM exposures. Proportion hospitalized was higher for visits for self-harm (76.5%, 95% CI, 68.9-84.2%) than for visits for nonmedical use (30.3%, 95% CI, 21.1-39.6%) and therapeutic use (8.8%, 95% CI, 5.9-11.8%). Overall, estimated population rates of ED visits for CCM-related harms were higher for patients aged 12-34 years (16.5 per 100 000, 95% CI, 13.0-20.0) compared with patients aged <12 years (5.1 per 100 000, 95% CI, 3.6-6.5) and ≥ 35 years (4.3 per 100 000, 95% CI, 3.4-5.1). Concurrent use of other medications, illicit drugs, or alcohol was frequent in ED visits for nonmedical use (61.3%) and self-harm (75.9%).ConclusionsContinued national surveillance of CCM-related harms can assess progress toward safer use.
| S-EPMC10917081 | biostudies-literature
Project description:ObjectiveDespite the positive attitudes pharmacists have toward evidence-based practices (EBPs), its application in community pharmacies in Saudi Arabia is lacking. Therefore, this study aimed to explore and assess EBPs by community pharmacists in Saudi Arabia when they dispense over-the-counter (OTC) medications for three minor ailments: diarrhea, cough, and the common cold.Research design and methodsWe used a mixed-methods approach consisting of two study parts. The first was a quantitative investigation that used mystery shoppers. Four researchers, posing as mystery shoppers, visited 214 randomly selected pharmacies in the Riyadh region of Saudi Arabia. They used 14 questions from a standardized checklist to examine EBPs by community pharmacists. The qualitative part of the study entailed three focus-group discussions with 13 pharmacists from different community practice settings and explored factors that affected the application of EBPs when supplying OTC medications from the pharmacists' point of view.ResultsThe analysis indicated that 40% of pharmacists dispensed OTC medications according to EBPs. Logistic regression analysis showed that one question, "Describe your symptoms", predicted the correct supply of OTC medications (p = 0.021). The qualitative section of the study identified nine factors that affected EBP. Some of these factors facilitated EBP, such as established patient-pharmacist relationships, some acted as barriers such as conflicts between available evidence, while other factors could either facilitate or hinder EBPs, such as the health literacy of the patient.ConclusionGiven that dispensing OTC medication is a core function of pharmacists, this study uncovered low adherence to EBPs by community pharmacists in Saudi Arabia when dispensing OTC medication for three minor ailments: diarrhea, cough, and the common cold. Furthermore, this study identified a number of explanatory factors for this low adherence. Targeting these factors could help change the behavior of pharmacists and decrease undesirable outcomes.
| S-EPMC7676695 | biostudies-literature
Project description:BackgroundCommon cold is a frequent illness in northern hemisphere between late autumn and early spring. Patients suffering from it frequently turn to pharmacists instead of physicians in order to receive medical advice and treatment. We studied its treatment advised by pharmacists in Poland, as well as evidence for the efficacy of their recommendations by utilizing a self-developed questionnaire and a study of existing literature.MethodsThe data were collected by 27 pharmacists who worked in four large network community pharmacies in Lodz, Poland. The study took place from December 2019 to February 2020. Data were recorded only if the patient asked for pharmacy counselling for over-the counter (OTC) products due to common cold self-diagnosis and a product was sold. Pharmacists' recommendations were compared with the results of a literature review of best evidence to determine appropriateness of the pharmacists' decisions.ResultsIn four out of five cases the pharmacists recommended products contained paracetamol. In addition, in one out of three patient encounters they advised nasal decongestant, inosines and/or OTC mucolytics. There was a significant relationship between fever and recommendation frequency of some analgesics, inosines, mucolytics and sore throat products (OR > 1, p < 0.05); rhinorrhea and recommendation frequency of paracetamol, inosines, anti-histamines and alpha-mimetics (OR > 1, p < 0.05); cough and recommendation frequency of paracetamol, inosines, mucolytics and sore throat products (OR > 1, p < 0.05); and fatigue and recommendation frequency of paracetamol, acetylsalicylic acid, inosines and sore throat products (OR > 1, p < 0.05). The pharmacist recommendations were based on patients' symptoms, product price, pharmaceutical company promotion and the financial incentive. In many cases their recommendations were not in line with current best practice recommendations.ConclusionsOur study suggests that the most common rationale for pharmacist recommendation on anti-common cold treatment was to take a "shotgun" approach. Pharmacists commonly made recommendations for products that lack strong evidence for efficacy (i.e. anti-viral agents) and are potentially unnecessary, based on presentation of the symptom. Reasons for this situation include lack of training, lack of time to evaluate the patient, lack of awareness of evidence as well as drug company marketing and financial incentives (i.e. fulfilling sale plans and target sale bonuses).Trial registrationThe study was a non-interventional, observational research trial. The study registration was not required.
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