Over-the-counter Nonsteroidal Anti-inflammatory Drugs Research Articles

Racial Differences in Over-the-Counter Non-steroidal Anti-inflammatory Drug Use Among Individuals at Risk of Adverse Cardiovascular Events.

Black Americans are disproportionately affected by adverse cardiovascular events (ACEs). Over-the-counter (OTC) non-steroidal anti-inflammatory drugs (NSAIDs) confer increased risk for ACEs, yet racial differences in the use of these products remain understudied. This study sought to determine racial differences in OTC NSAID and high-potency powdered NSAID (HPP-NSAID) use. This retrospective analysis examined participants at risk of ACEs (defined as those with self-reported hypertension, diabetes, heart disease, or smoking history ≥ 20years) from the North Carolina Colon Cancer Study, a population-based case-control study. We used multivariable logistic regression models to assess the independent associations of race with any OTC NSAID use, HPP-NSAID use, and regular use of these products. Of the 1286 participants, 585 (45%) reported Black race and 701 (55%) reported non-Black race. Overall, 665 (52%) reported any OTC NSAID use and 204 (16%) reported HPP-NSAID use. Compared to non-Black individuals, Black individuals were more likely to report both any OTC NSAID use (57% versus 48%) and HPP-NSAID use (22% versus 11%). In multivariable analyses, Black (versus non-Black) race was independently associated with higher odds of both NSAID use (OR 1.4, 95% CI (1.1, 1.8)) and HPP-NSAID use (OR 1.8 (1.3, 2.5)). Black individuals at risk of ACEs had higher odds of any OTC NSAID and HPP-NSAID use than non-Black individuals, after controlling for pain and socio-economic status. Further research is necessary to identify potential mechanisms driving this increased use.

Identifying Non-Steroidal Anti-Inflammatory Drug (NSAID) Users Among People with Osteoarthritis Through Administrative and Clinician-Reported Data - A Validation Study of 116,162 Patients.

(i) To report the prevalence of participants to a first-line intervention for OA in Sweden using over-the-counter (OTC) and/or prescribed NSAIDs; (ii) To estimate the accuracy of dispensed prescriptions of NSAIDs recorded in a Swedish health-care register to capture the use of NSAID considering clinician-report as reference standard. Register-based study. We used data from OA individuals who participated in the Swedish first-line intervention recorded in the Swedish Osteoarthritis Register (SOAR). SOAR includes clinician-reported use of NSAIDs in the three months preceding the intervention. We used the Prescribed Drug Register to retrieve data on NSAID prescriptions dispensed in the same period. We estimated the prevalence of OTC users (individuals with clinicians-reported use of NSAID but no prescription dispensed), prescription users (individuals with clinicians-reported use of NSAID and a prescription dispensed) and non-users (neither of the previous). We calculated sensitivity, specificity, positive predictive value, and negative predictive value of dispensed prescriptions of NSAIDs vs clinician-report. We included 116,162 individuals (mean age [Standard Deviation]: 66 [9.6] years, 79% women, 77% knee OA). Overall, 24.7% (95% Confidence Intervals [CI] 24.5%; 25.0%) used OTC NSAIDs only, 18.2% (18.0%; 18.5%) used prescribed NSAIDs, 6.6% (6-4%; 6.7%) reported not using NSAIDs while having an NSAID prescription dispensed. Of the 49,913 individuals with clinician-reported use of NSAIDs, 21,190 had a prescription dispensed (sensitivity: 42.5% [95% CI 42.0%, 42.9%]; positive predictive value: 73.5% [73.0%, 74.0%]). Of the 66,249 individuals reporting not using NSAIDs, 58,617 did not have a prescription dispensed (specificity: 88.5% [88.2%, 88.7%]; negative predictive value: 67.1% [66.8%, 67.4%]). Overall, 24.7% of participants in a first-line intervention for OA used OTC NSAIDs only while 18.2% used prescribed NSAIDs. Dispensed prescriptions of NSAIDs have high specificity but low sensitivity and can correctly identify about 70% of both the non-users and users in this population.

OTC Analgesics vs Opioids for Pain Management.

The use of opioids in acute pain may be appropriate in some situations, but there are opportunities to reduce exposure to opioids with equally effective monotherapy and combination therapy over-thecounter (OTC) medications. There are a number of OTC analgesics that are readily accessible and costeffective options to treat pain. The American College of Rheumatology Osteoarthritis Guideline "strongly" recommends the use of topical nonsteroidal antiinflammatory drugs (NSAIDs) and oral NSAIDs to treat arthritis pain, and it conditionally recommends against the use of opioids (other than tramadol). The American Headache Society suggests that OTC NSAIDs and combination medications such as acetaminophen, aspirin, and caffeine are Level A recommendations for reducing migraine pain and other symptoms. Nonopioid OTC analgesics, such as NSAIDs and the NSAID/acetaminophen combination, are safe and effective firstline options for managing acute dental pain according to the American Dental Association. The American College of Physicians supports the use of NSAIDs as first-line therapy for the treatment of low back pain.

Abstract EP66: Racial Differences In The Use Of Over-the-counter Non-steroidal Anti-inflammatory Drugs Among Individuals At Risk Of Adverse Cardiovascular Events

Introduction: Over-the-counter (OTC) non-steroidal anti-inflammatory drugs (NSAIDs) are commonly used despite conferring risk for adverse cardiovascular events (ACEs). ACEs disproportionately affect Black individuals, yet patterns of OTC NSAID and high-potency powder NSAID (HPP-NSAID) use among different racial groups remains understudied. Hypothesis: We hypothesized that use of OTC NSAIDs and HPP-NSAIDs is higher among Black individuals. Methods: We analyzed data from the North Carolina Colon Cancer study, a population-based case-control study in 1996-2000. Participants at risk of ACEs, defined as self-reported hypertension, diabetes, heart disease, or smoking history ≥ 20 years, were included in our analysis. Primary outcomes were any OTC NSAID use and HPP-NSAID use. Secondary outcomes included regular use of the primary outcome variables. Using multivariable logistic regression, we quantified the independent association of the outcomes with race after adjusting for age, sex, education, poverty, and pain interfering with daily activities. We investigated the effect modifications of poverty status and educational attainment separately on the noted associations. Results: Of the 1286 participants at risk for ACEs, 583 (45%) reported Black, 695 (54%) White, and 8 (<1%) Other race. Overall, 665 (52%) reported any NSAID use and 204 (16%) reported HPP-NSAID use. Any NSAID use was reported by 329 (57%) Black participants compared to 332 (48%) White participants. HPP-NSAID use was reported by 126 (22%) Black participants compared to 76 (11%) White participants. Of users, 174 (26%) reported regular NSAID use and 37 (18%) reported regular HPP-NSAID use; this pattern was similar across race. In multivariable analysis, Black (versus White) race was independently associated with higher odds of NSAID use (odds ratio [OR] 1.4 95% confidence interval [1.1, 1.8]). Pain interfering with daily activities (OR 1.4 [1.1, 1.8]) was also associated with NSAID use and older age was negatively associated with NSAID use (OR 0.96 [0.95, 0.97]). After adjustment, Black race was associated with HPP-NSAID use (OR 1.8 [1.3, 2.6]). Male sex (OR 1.6 [1.2, 2.3]) and being in or near poverty (OR 1.6 [1.0, 2.3]) were also independently associated with HPP-NSAID use and older age (OR 0.96 [0.94, 0.97]) and educational attainment of some college or greater (OR 0.5 [0.3, 0.7]) were negatively associated with HPP-NSAID use. The associations between race and either outcome were not significantly moderated by educational attainment nor poverty status. Conclusions: In this population-based study, Black individuals at risk of ACEs had higher odds of any NSAID and HPP-NSAID use than White participants, even after controlling for pain and socio-economic status. Further research is necessary to determine the impact of this differential use on established inequities in cardiovascular outcomes.

Factors Influencing Pain Management of Patients with Osteoarthritis: A Cross-Sectional Study.

Background: Osteoarthritis (OA) is a complex disease associated with chronic pain. Many patients treat their joint pain at a symptomatic level with over-the-counter (OTC) pain medications, often without the knowledge of their physicians. The aim of this study was to provide physicians with data about osteoarthritic patients’ habits of pain management and to examine the explanatory factors of various ways of self-treatment. Methods: A cross-sectional study involving 189 patients with hip or knee OA and scheduled for joint replacement surgery was carried out. Participants filled out a self-administered questionnaire consisting of the Western Ontario and McMaster Universities Osteoarthritis Index and questions about their methods of alleviating pain. Results: 2.6% of patients did not use anything to alleviate their pain, while 63% practiced a non-pharmacological method. Diclofenac was the most frequently used drug, followed by ibuprofen. Profession had the greatest impact on medication habits; patients doing manual work were significantly more likely to take OTC non-steroidal anti-inflammatory drugs and use topical analgesics. Conclusions: Patients utilized a wide variety of pain management techniques. They seemed to use well-known painkillers, even if their side effects were less desirable. Such patients require comprehensive pain management, including educational and behavioural interventions, complemented by topical and oral medication.

The patient journey in knee osteoarthritis-variations in diagnosis, patient characteristics, and treatment by physician specialty

The patient journey in knee osteoarthritis-variations in diagnosis, patient characteristics, and treatment by physician specialty

The Role of Knowledge and Attitudes About Nonsteroidal Anti-inflammatory Drugs in Determining Treatment Use.

ObjectiveThe objective of this study was to evaluate how patient knowledge and beliefs regarding nonsteroidal anti‐inflammatory drugs (NSAIDs) may influence the use of NSAIDs for osteoarthritis (OA).MethodsSurveys of 334 adults with knee and/or hip OA were analyzed in this cross‐sectional study. Familiarity with and perceptions of benefits/risks of NSAID use were measured to assess associations with the use of prescription and nonprescription oral NSAIDs. Multinomial logistic regression models were adjusted for sociodemographic and clinical variables.ResultsIn this sample, 35.9% and 35.6% reported use of oral prescription and nonprescription‐only NSAIDs, respectively. Hispanic participants, compared with non‐Hispanic White participants, had lower perceived benefit (P = 0.005) and risk (P = 0.001) of prescription NSAIDs. The following were associated with prescription NSAID use instead of no NSAID use: having family/friends who used prescription (relative risk ratio [RRR] 3.91; 95% confidence interval [CI] 2.05‐7.47) and over‐the‐counter (OTC) (RRR 3.10; 95% CI 1.65‐5.83) NSAIDs for OA, understanding the consequences of using both prescription (RRR 3.50; 95% CI 1.79‐6.86) and OTC (RRR 2.80; 95% CI 1.39‐5.65) NSAIDs, higher perceived benefit of both prescription (RRR 2.51; 95% CI 1.71‐3.66) and OTC (RRR 1.44; 95% CI 1.01‐2.06) NSAIDs, and lower perceived risk of both types of NSAIDs (prescription: RRR 0.63 [95% CI 0.46‐0.87]; OTC: RRR 0.53 [95% CI 0.37‐0.75]). Similar results were found when we assessed the relationship between these variables and OTC NSAID use versus no oral NSAID use.ConclusionAdults with knee and/or hip OA were more likely to use NSAIDs if they were more familiar with, had an increased perceived benefit of, and had a decreased perceived risk of these drugs. Patients’ perceptions and beliefs about NSAIDs should be evaluated when considering them for treatment.

Potential for Detection of Safety Signals for Over-the-Counter Medicines Using National ADR Spontaneous Reporting Data: The Example of OTC NSAID-Associated Gastrointestinal Bleeding

One post-marketing surveillance challenge for many regulatory authorities is access to information regarding the safety of over-the-counter (OTC) medicines. National spontaneous adverse drug reaction (ADR) report data represent a rich potential data source for the detection of safety signals associated with OTC medicines, yet little is known regarding the possibility of detecting safety signals for OTC medicines within these datasets. The aim of this study was to evaluate the potential for detecting safety signals for OTC medicines in National ADR spontaneous reporting data, using OTC non-steroidal anti-inflammatory drugs (NSAIDs) and gastrointestinal bleeding as an example. Data from the Australian Adverse Drug Reactions System (ADRS) dataset (1971–2008) and the Canadian Vigilance Adverse Reaction Online Database (VAROD) (1965–2013) were used to explore the feasibility of using spontaneous reporting data, exploring the association between gastrointestinal bleeding and the use of OTC NSAIDs. Safety signals were examined using disproportionality analyses and reporting odds ratios calculated. After adjusting for age, gender, medications known to increase the risk of bleeding, and medications used for the management of conditions associated with an increased risk of bleeding, a two-fold increase in the risk of gastrointestinal (GI) bleeding with OTC NSAID was observed within each dataset. This study demonstrates that spontaneous ADR reporting data can be used in pharmacovigilance to monitor the safety of OTC medicines.

Association between NSAID Exposure and Kidney Function Decline in Primary Care Patients

There are limited data evaluating chronic nonsteroidal anti-inflammatory drug (NSAID) exposure and decline in kidney function in primary care practice where rates of NSAID prescribing are high (1,2). The majority of published observational studies have evaluated the association of prescription NSAID use with AKI using claims data in focused geographic areas outside of the United States (1). It is estimated that >36 million Americans use over-the-counter (OTC) NSAIDs and data suggest that many users, regardless of age, exceed the recommended dose (1,3,4). Education materials for prescription ( e.g ., Food and Drug Administration Medication Guide) and OTC (label) NSAIDs have also been noted to have content that is not aligned with the universal precautions for health literacy. Poor literacy around NSAID education materials has been documented among primary care patients with CKD (5). This study sought to evaluate eGFR changes associated with chronic NSAID exposure in a large, geographically vast, primary care cohort using data from the DARTNet Practice Performance Registry receiving prescription and OTC NSAIDs (6). This project was determined to not require oversight by the University of Michigan Institutional Review Board. This determination was based on the fact that the data set analyzed had no protected health information. Eligible patients were ≥18 years old and had at least two eGFR measurements (between 29 ml/min per 1.73 m2) at least 3 months apart. Baseline was defined as the first qualifying eGFR during the study period of January 1, …

Nonsteroidal Anti-Inflammatory Drug Use in Chronic Arthritis Pain: Variations by Ethnicity

Our objective was to determine if there are ethnic differences in the use of over-the-counter (OTC) and prescription oral nonsteroidal anti-inflammatory drugs (NSAIDs) and if observed ethnic differences persist after adjustment for sociodemographic and clinical factors. Knee and hip osteoarthritis study participants were identified. Surveys were administered to collect sociodemographics, clinical information, and oral treatment methods for arthritis. Multivariable logistic regression models were created using a fully conditional method. Hispanics (n=130), compared to non-Hispanic whites (n=204), were less likely to have a high school education (26.9% vs 63.2%, P <0.001), less likely to have private medical insurance (P <0.001), and more likely to have worse health (P=0.004). OTC oral NSAID use was less common (52.9% vs 66.3%, P=0.019), whereas prescription oral NSAID use was more common (43.4% vs 31.7%, P=0.042) among Hispanics than non-Hispanic whites in the last 6 months. The ethnic difference in using an OTC NSAID instead of not using any oral NSAID was attenuated and no longer significant when adjusted for age, sex, education, and medical insurance (odds ratio [OR] 0.54 [95% confidence interval [CI]: 0.28-1.02]). The odds of using a prescription instead of an OTC NSAID remained significantly higher among Hispanics than non-Hispanic whites when adjusted for the same variables (odds ratio 2.17 [95% confidence interval: 1.16-4.05]). Among patients with osteoarthritis, OTC NSAIDs were less commonly used but prescription NSAIDs were more commonly used by Hispanics than non-Hispanic whites. Sociodemographic factors partially mediate ethnic differences in the use of oral NSAIDs.

Risk of myocardial infarction associated with non-steroidal anti-inflammatory drugs: Impact of additional confounding control for variables collected from self-reported data.

SummaryWhat is known and objectiveImportant risk factors and over‐the‐counter (OTC) dispensing of non‐steroidal anti‐inflammatory drugs (NSAIDs) are often not routinely recorded in electronic health records. This study aimed to assess the impact of patient's reports on these factors on the risk of acute myocardial infarction (AMI) for NSAID use.MethodsA nested case‐control study was conducted among adults in the Utrecht Cardiovascular Pharmacogenetics study. Cases were patients with a first diagnosis of AMI as a hospital discharge diagnosis and controls were those without AMI. NSAID exposure was either current use of selective COX‐2 inhibitors or conventional NSAIDs. Information was collected from The Dutch PHARMO Database Network (pharmacy records of drug dispensing linked to hospitalization records) and the patient's questionnaire (lifestyle factors, body mass index and history of cardiovascular diseases). Unconditional logistic regression analysis was used to calculate odds ratios (ORs) and to control for confounding factors.ResultsWe identified 970 AMI cases and 2974 controls. Among cases, 11 (1.1%) and 185 (19.1%) were exposed to selective COX‐2 inhibitors and conventional NSAIDs, respectively. Compared to non‐use, none of these drug classes were associated with an increased risk of AMI (adjusted OR 1.07, 95% CI: 0.52‐2.18 and 0.93, 95% CI: 0.77‐1.12, respectively). Additional adjustment for potential confounders from patient's reports did not change the risk estimates (adjusted OR 1.08, 95% CI: 0.53‐2.22 and 0.89, 95% CI: 0.73‐1.09, respectively).What is new and conclusionAdditional confounding control for variables from self‐reported data or considering self‐reported OTC NSAID use did not change the risk estimates for the association between NSAIDs and AMI.

Prevalence and Pharmaceutical Treatment of Plantar Fasciitis in United States Adults

This study provides prevalence estimates of plantar fasciitis in U.S. adults, as well as the types and frequencies of pharmaceutical treatment specifically for this pain. Data are from the 2013 National Health and Wellness Survey, a large (n = 75,000) internet panel survey designed to approximate the adult U.S. population. Strengths of associations are determined using multivariable logistic regression. It was estimated that .85% (95% confidence interval [CI] = .77–.92) of the sample reported diagnosed plantar fasciitis with pain in the past month. Higher prevalence of plantar fasciitis was seen in women (1.19%; referent) versus men (.47%), in those aged 45 to 64 (1.33%) versus those aged 18 to 44 (.53%; referent) years, and in the obese (1.48%) versus those with a body mass <25 (.29%; referent). Prescription medications for pain were used by 41.04% of plantar fasciitis respondents, but only 6.31% attributed this use specifically to plantar fasciitis pain. Nonsteroidal anti-inflammatory drugs (4.01%) and opioids (2.21%) were the most prevalent prescription drugs used specifically for plantar fasciitis pain. Almost 70% of individuals with plantar fasciitis used over the counter (OTC) analgesics for general pain management, with OTC nonsteroidal anti-inflammatory drugs being used by 49.47% and acetaminophen by 26.93% of respondents. Individuals diagnosed by medical specialists had twice the odds of using prescription drugs as those diagnosed by other providers (odds ratio = 2.12; 95% CI = 1.01–4.46). Non-Hispanic black individuals were more likely to use prescription pain medications specifically for plantar fasciitis pain than non-Hispanic white individuals (odds ratio = 3.02; 95% CI = 1.05–8.70). PerspectiveThe current study provides additional insights into the pain and disability associated with plantar fasciitis, as well as the pharmaceutical treatments being used for its management. Prescription as well as OTC medications are used to manage plantar fasciitis symptoms despite limited, if any, clinical trial data supporting their use.

Nonsteroidal Anti-Inflammatory Drugs and Analgesics Use by Kidney Transplant Recipients

BackgroundNonsteroidal anti-inflammatory drugs (NSAIDs) and analgesics are the most commonly used drugs and are increasingly available over-the-counter (OTC). In certain groups of patients, including kidney transplant recipients, their use may be complicated by adverse effects or drug interactions. The aim of our study was to assess the causes and frequency of OTC NSAIDs or analgesics use, as well as the awareness of related side effects.Material/MethodsWe enrolled 94 randomly selected kidney transplant recipients, who represented 5% of all kidney transplant recipients at our center. An anonymous survey consisting of 23 multiple-choice questions was administered voluntarily and anonymously.ResultsIn all, 63% of study patients confirmed taking the OTC painkillers; 22% of these patients took these drugs at least several times a week, and 4% took these drugs daily. For 38% of the study kidney transplant recipients, NSAIDs or analgesics were reported to be the only way to manage their pain. In addition, 30% of study patients were unaware of the risks associated with these drugs, despite the fact that 89% of the study patients consider physicians the best source of information.ConclusionsOur study found that 63% of kidney transplant recipients regularly took OTC painkillers and 30% were unaware of the potential adverse effects. This necessitates continuous, ongoing education of kidney transplant recipients about the risks of OTC NSAIDs or analgesics use.

Factors Associated With Potentially Inappropriate Medication Use in Rural, Community-Dwelling Older Adults.

Potentially inappropriate medication (PIM) use is a serious public health problem in older adults because it may lead to adverse events. The purpose of the current study was to explore PIM use in rural, community-dwelling older adults. Participants (N = 138) underwent one-on-one medication reviews. Approximately one half (49%) of the sample used prescribed and over-the-counter (OTC) PIM. Prescribed and OTC nonsteroidal anti-inflammatory drugs (33%) and anticholinergic medications (28%) were the most frequently used PIM. Use of PIM was associated with a higher number of medications (r = 0.331, p < 0.01), more medical providers (r = 0.223, p < 0.001), and poor physical health (r = -0.193, p < 0.05). Higher number of medications increased the probability of PIM use by 85% (odds ratio: 1.8; 95% confidence interval [1.19, 2.84]). Findings highlight the importance of re-evaluating the monitoring of medications in rural, community-dwelling older adults and the need for sustainable interventions to reduce prescribing and OTC PIM use. [Journal of Gerontological Nursing, 43(9), 21-30.].

IL-10 Gene Polymorphisms and Self-Medication With Over-the-Counter Nonsteroidal Anti-Inflammatory Drugs.

Genetic influences on self-medication with over-the-counter (OTC) drugs merit investigation. For example, patients frequently use OTC nonsteroidal anti-inflammatory drugs (NSAIDs) to treat inflammation, but the inflammatory response is also affected by endogenous cytokines whose production varies across polymorphisms of their encoding genes. In the case of interleukin 10 (IL-10), literature suggests that a single nucleotide polymorphism (SNP) in the promoter region of the cytokine's gene (-1082 A > G [rs1800896]) influences production with higher levels associated with G variant alleles. To demonstrate the feasibility of researching the role of genetics in self-medication by using existing national survey data to evaluate a possible association between OTC NSAID use and genotype at the -1082 SNP of the IL-10 gene. Statistical analyses were performed using data from 6,309 participants in the Third National Health and Nutrition Examination Survey (NHANES III). OTC NSAID use (aspirin or ibuprofen) in the previous month was significantly more common among persons with AG or GG genotypes at the -1082 SNP. Odds of use consistently increased relative to the number of G alleles. This trend remained statistically significant (odds ratio = 1.14 per additional G allele, p = .02, 95% confidence interval [1.02, 1.27]) after adjustment for confounding. Analysis of population-based genetic data suggests an association between a common self-medication behavior and a specific genetic polymorphism. These findings broadly demonstrate that NHANES data provide opportunities to investigate such associations and specifically imply that potential interrelationships among OTC NSAID use, IL-10 genotype, and IL-10 cytokine levels deserve further study.

Rates of Nonsteroidal Anti-Inflammatory Drug Use in Patients with Established Cardiovascular Disease: A Retrospective, Cross-Sectional Study from NHANES 2009-2010.

Nonsteroidal anti-inflammatory drugs (NSAIDs) are commonly used to treat pain, inflammation, and fever in the USA. Unfortunately, NSAIDs have been associated with an increased risk of adverse cardiovascular events, especially among NSAID users with established cardiovascular disease (CVD). In 2005, the Food and Drug Administration (FDA) released an initial warning regarding NSAID use and CVD risk, and recently, in July 2015, released an updated statement strengthening this initial warning. The purpose of this study is to evaluate the rates of NSAID use among patients with CVD following the 2005 FDA warning regarding NSAID use and increased CVD risk. This was a retrospective, cross-sectional study of participants from the National Health and Nutrition Examination Survey, 2009-2010. Participants' CVD status was determined by self-reported diagnosis. Current use of over the counter (OTC) NSAIDs was defined by self-reported use of ibuprofen or naproxen, and we identified the current use of prescription NSAIDs in the database of prescription medication. Respondents with CVD were 2.1 times more likely to use OTC NSAIDs or prescription NSAIDs than respondents without CVD. Among CVD patients, respondents with angina and myocardial infarction were 60% more likely to use any form of NSAID, and respondents with congestive heart failure were less likely to use any form of NSAID than those with other forms of CVD. Our results indicate that there is still a large proportion of CVD patients using NSAIDs. It is now crucial to determine the reasons why prescribers are still prescribing NSAIDs despite the FDA warning.

The use of nonsteroidal anti-inflammatory drugs and analgesics by liver transplant recipients.

This study aimed to assess the reasons and the frequency of the use of over-the-counter (OTC) nonsteroidal anti-inflammatory drugs (NSAIDs) or analgesics by liver transplant recipients (LTR). Patient awareness of possible drug-related side-effects was also assessed. NSAIDs and analgesics available without prescription belong to the most commonly used class of drugs. However, use of these drugs might be complicated by toxic adverse effects (AEs). Patients at risk for AEs include the transplant recipients. This was a descriptive study. An anonymous survey was carried out in 73 randomly selected LTR, who represented 10% of all LTR at our centre. There were 64% of the patients who confirmed taking NSAIDs or analgesics; 16% of these patients took these drugs at least several times a week and 10% took them daily. For 39% of patients, the only way to manage their pain were OTC NSAIDs or analgesics. As many as 36% of patients were unaware of the risks associated with the use of these drugs. Ninety per cent of LTR consider physicians the most trusted source of drugs information. Our study shows that two-thirds of LTR take OTC NSAIDs or analgesics and one-third are unaware of the AEs associated with these drugs. Therefore, both transplant nurses and doctors should educate their patients about the use and possible AE of these drugs. Considering the high NSAIDs consumption rates, the side effects of these drugs should always be suspected. Especially in patients taking these drugs and referring to medical advisors with specific symptoms, such as: abdominal pain, anaemia, elevated serum creatinine concentration or liver enzymes activity. Awareness of the scale of the problem enables health professionals to cooperate in educating patients. Such practices may reduce uncontrolled abuse of these drugs and related health care costs.

Adverse drug reactions and drug-drug interactions with over-the-counter NSAIDs.

Nonsteroidal anti-inflammatory drugs (NSAIDs) such as ibuprofen have a long history of safe and effective use as both prescription and over-the-counter (OTC) analgesics/antipyretics. The mechanism of action of all NSAIDs is through reversible inhibition of cyclooxygenase enzymes. Adverse drug reactions (ADRs) including gastrointestinal bleeding as well as cardiovascular and renal effects have been reported with NSAID use. In many cases, ADRs may occur because of drug–drug interactions (DDIs) between the NSAID and a concomitant medication. For example, DDIs have been reported when NSAIDs are coadministered with aspirin, alcohol, some antihypertensives, antidepressants, and other commonly used medications. Because of the pharmacologic nature of these interactions, there is a continuum of risk in that the potential for an ADR is dependent on total drug exposure. Therefore, consideration of dose and duration of NSAID use, as well as the type or class of comedication administered, is important when assessing potential risk for ADRs. Safety findings from clinical studies evaluating prescription-strength NSAIDs may not be directly applicable to OTC dosing. Health care providers can be instrumental in educating patients that using OTC NSAIDs at the lowest effective dose for the shortest required duration is vital to balancing efficacy and safety. This review discusses some of the most clinically relevant DDIs reported with NSAIDs based on major sites of ADRs and classes of medication, with a focus on OTC ibuprofen, for which the most data are available.

Usage patterns of ‘over‐the‐counter’ vs. prescription‐strength nonsteroidal anti‐inflammatory drugs in France

Most risks of nonsteroidal anti-inflammatory drugs (NSAIDs) are pharmacological, dose and duration dependent. Usage patterns of prescription-only (POM) or 'over-the-counter (OTC)' NSAIDs may influence risks, but are not commonly described. The Echantillon Généraliste de Bénéficiaires database, the permanent 1/97 representative sample from the French national healthcare insurance systems, was queried over 2009-2010 to identify usage patterns, concomitant chronic diseases and cardiovascular medication in OTC and POM NSAID users. Over 2 years, 229 477 of 526 108 patients had at least one NSAID dispensation; 44 484 patients (19%) were dispensed only OTC NSAIDs (93% ibuprofen) and 121 208 (53%) only POM NSAIDs. The OTC users were younger (39.9 vs. 47.4 years old) and more often female (57 vs. 53%); 69% of OTC users and 49% of POM users had only one dispensation. A mean of 14.6 defined daily doses (DDD) were dispensed over 2 years for OTC vs. 53 for POM; 93% OTC vs. 60% POM patients bought ≤ 30 DDD over 2 years, and 1.5 vs. 12% bought ≥ 90 DDD. Chronic comorbidities were found in 19% of OTC users vs. 28% of POM users; 24 vs. 37% had at least one dispensation of a cardiovascular drug over the 2 years. Most of the use of NSAIDs appears to be short term, especially for OTC-type NSAIDs, such as ibuprofen. The validity of risk estimates for NSAIDs extrapolated from clinical trials or from observational studies not including OTC-type usage may need to be revised.

High-risk use of over-the-counter non-steroidal anti-inflammatory drugs: a population-based cross-sectional study.

The use of non-steroidal anti-inflammatory drugs (NSAIDs) is associated with serious adverse drug events (ADEs). To determine the prevalence of over-the-counter (OTC) NSAID use in the general population and in patients with a high risk of developing a serious NSAID-related ADE. Cross-sectional study in four general practices in the Netherlands. Two patient samples were selected: a random sample of adults (general population sample); and adult patients with a high risk of developing a serious ADE in case of NSAID use (high-risk sample). All included patients were sent a questionnaire regarding their use of OTC NSAIDs in the 4 weeks prior to participation. In the general population sample, 118 of 456 (26%) invited patients completed the questionnaire. Of these, 35 (30%) had used an OTC NSAID. In the high-risk sample, 264 of 713 (37%) invited patients completed the questionnaire, and of these high-risk patients 33 (13%) had used an OTC NSAID. Over 20% of OTC NSAID users in the general population sample and over 30% in the high-risk sample had used the OTC NSAID for >7 days. OTC NSAIDs were used in a dosage exceeding the recommended daily maximum by 9% and 3% of OTC NSAID users in the general population and the high-risk sample respectively. OTC NSAIDs are used by almost one-third of the general population. In the high-risk patients selected, one in eight patients used an OTC NSAID. Continued efforts by health authorities and healthcare professionals to inform patients of the risks of these drugs are warranted.