Responsible self-medication: perceived risks and benefits of over-the-counter analgesic use

Objectives This study examines awareness of the potential risks associated with over‐the‐counter (OTC) use of paracetamol and non‐steroidal anti‐inflammatory drugs (NSAIDs) among Australian consumers to better understand patterns of usage of these products. Methods We employed two self‐reported cross‐sectional surveys (conducted in 2001 and 2009) using computer‐aided telephone interviewing. Both survey samples were weighted to match national population proportions; data were collected for 3702 respondents (study 1, 2001, n = 1901; study 2, 2009, n = 1801). The inclusion criteria were age over 18 years and willingness to participate in the survey. Key findings Self‐reported regular use (once or more per month) of OTC analgesics declined between 2001 (67.5%) and 2009 (55.0%; P < 0.05). In 2009 42.0% of regular OTC analgesic users were purchasing NSAIDs outside the pharmacy setting (compared with none in 2001). Stated awareness of potential risks has increased slightly among regular paracetamol users (from 49.0% in 2001 to 52.0% in 2009) and regular NSAID users (from 25.0% in 2001 to 41.0% in 2009). Regular OTC analgesic users were considered to be using the product appropriately if there were no contraindications, warnings, precautions or potential drug interactions to the analgesic that they had used. In 2001, significantly more people were using paracetamol appropriately than were using NSAIDs appropriately (98.3 compared with 79.3%; P < 0.05). Corresponding figures for 2009 were 96.4 and 69.1% (P < 0.5). Conclusions Increasing consumer awareness of the need to consider potential risks prior to taking OTC analgesics is a positive sign. However, this has not translated to an increase in appropriate use of OTC NSAIDs; since ibuprofen has become available outside the pharmacy setting in Australia fewer people are using NSAIDs appropriately according to the label. The quality use of medicines, in particular OTC NSAIDs, is becoming increasingly reliant on product labelling and the ability of consumers to understand and self‐assess risk.     

Children's over‐the‐counter medicines pharmacoepidemiological (COPE) study

Objective To quantify the extent and types of minor ailments in children that were presented at community pharmacies and the types of over‐the‐counter (OTC) medicines purchased in response to these ailments. Method Data on all requests and sales of OTC medicines for children (aged 16 years and under) and consultations for minor ailments in children were recorded in eight community pharmacies for one week every month over a 12‐month period. Participants were members of the public who consulted the pharmacists or other pharmacy staff in the community pharmacies. Key findings A total of 976 consultations was recorded with 61.5% requesting an OTC medicine by name and 38.5% by symptom presentation. An average of 10.2 consultations was made per pharmacy per week. Requests for treatment were usually made within five days of symptom occurrence (86%). Most of the consultations were made by mothers (75%), although 17% were by fathers. The most commonly purchased OTC medicine was paracetamol. There were five requests for aspirin and one was for a 2‐year old child. A total of 62 cases (6%) was referred back to the child's primary care physician (general practitioner). Conclusions Symptoms related to cough and cold were the most common problems in children presenting to community pharmacies for treatment. Paracetamol was the most widely used OTC medicine in children. Pharmacy staff do question the request for OTC medicines such as aspirin, to ensure its safe use. Community pharmacies play an important role as the first port of call for advice on minor ailments in children and have an opportunity to provide health promotion to carers of children.     

Reasons for the use of mild analgesics among English students

Objective Mild analgesics such as paracetamol and ibuprofen are amongst the most commonly used over-the-counter (OTC) drugs. However, little is known about what beliefs people hold about them. The present paper examines: (a) the patterns of mild analgesic usage in a sample of university students, (b) their beliefs about the associated risks and the necessity of taking mild analgesics, and (c) the association between beliefs about analgesics and self-reports of their use. Setting A convenience sample of 333 students studying at a large English University were approached on the University campus. Of these, 291 agreed to participate, yielding an 87% response rate. Method This study employed a cross-sectional design, with all participants completing the same questionnaire concerning their use of mild painkillers, such as paracetamol and ibuprofen, and beliefs about their use. Main outcome measure Four questions asked about their patterns of mild analgesic use in the past month, specifically (a) have they taken analgesics, (b) how often did they take analgesics when they had symptoms, (c) did they take more than a single dose of 1–2 tablets at one time, and (d) did they exceed the maximum dose. Results Almost all of the 291 participants reported symptoms in the past month, with over two thirds treating with mild analgesics, and one sixth exceeding the maximum dose. Only 17% indicated that there were short-term risks of using mild analgesics, although half indicated that there were long-term risks. The risks that were identified generally did not conform with current medical thinking. Perceptions of risks were not generally associated with self-reports of analgesic usage. Rather, respondents who thought analgesics were more necessary were more likely to report taking analgesics, report taking more analgesics, and report exceeding the maximum dose. Conclusion These results indicate the need for caution in current moves to encourage self-medication. If people are unaware of the risks of drugs such as paracetamol or ibuprofen, then they may only contact health professionals after they experience adverse effects     

A large simple clinical trial prototype for assessment of OTC drug effects using patient-reported data

PURPOSE: Innovative methods are needed to assess risks related to treatment for common medical conditions, where therapy is usually patient-directed or over-the-counter (OTC), and where tolerability, i.e. patient experienced events, may affect patterns of use. A large-scale, blinded, randomised trial was conducted to compare the tolerability of paracetamol (acetaminophen), aspirin and ibuprofen at OTC doses, with patient-reported adverse event (AE) data as the primary outcome. METHODS: Patients with mild to moderate pain were randomised to either: paracetamol up to 3 g/d, aspirin up to 3 g/d or ibuprofen up to 1200 mg/d for 7 days. Patients recorded AE and severity in a diary as the primary data source. After inclusion, contact with patients by general practitioner (GP) investigators was by telephone after 24 hours and 7-9 days, and unscheduled visits, when GPs recorded AE. The study outcome was the frequency of significant adverse event (SGAE) (serious, severe, moderate or undefined intensity, or resulting in withdrawal or an investigator visit). RESULTS: Of 8677 patients included, 44 patients were non-evaluable, leaving 8633 evaluable patients; 1347 patients reported SGAE (paracetamol: 14.5%, aspirin: 18.7%, ibuprofen: 13.7%). Completed diaries were returned by 98.5% of patients, and only 49 cases were lost to follow-up (0.6%). Almost all patients were contacted by telephone, 99.3% at the first call, and 98.5% at the second. Most SGAE were reported by patients; only 27 patients (2%) had a SGAE reported only by the GP. The tolerability rankings by treatment were consistent for all categories of SGAE: aspirin had the highest incidence of SGAE, and ibuprofen and paracetamol, lower, comparable incidences. CONCLUSIONS: A large, simple, randomised trial with patient-generated data can provide a sensitive source of information on AE, particularly in comparative safety assessments of OTC medications and other short-term therapies. This suggests reconsideration of the view that investigators are the most valid source for identifying and reporting AE.     

A comparison of four analgesics in post-episiotomy pain

This study was conducted to compare the analgesic efficacy of four commonly used analgesics namely ibuprofen, analgin, paracetamol and aspirin in post-episiotomy pain. The subjects were healthy postpartum women on the obstetric service of Goa Medical College, each of whom received only one experimental medication. Subjective reports were used as indices of pain intensity or relief. Ibuprofen was found to be the most effective analgesic in post-episiotomy pain followed by analgin and paracetamol in that order. Surprisingly, aspirin was found to be no better than placebo.     

Factors that influence how adults select oral over-the-counter analgesics: A systematic review

BackgroundOral over-the-counter (OTC) analgesics such as acetaminophen, aspirin, ibuprofen, and naproxen sodium are widely used to treat pain. Although generally considered safe, inappropriate use can lead to injury.ObjectiveThis study aimed to explore patient attitudes, beliefs, and perceptions about the efficacy and potential risks of oral OTC analgesics and to identify factors that adult patients use to make decisions about these medications.MethodsWe searched MEDLINE, CINAHL, Scopus, and Embase to identify studies published in English between January 2000 and June 2019. We included randomized controlled trials, controlled trials, observational studies, systematic reviews, and meta-analyses that included OTC analgesics. Authors worked independently during study selection, data extraction, and analysis and then compared their findings and discussed discrepancies until consensus was reached. We evaluated study quality using the Study Quality Assessment Tool and Critical Appraisal of a Cross-Sectional Study.ResultsWe identified 10,898 unique articles, of which 53 were included in this systematic review. A total of 36 studies included acetaminophen, 25 included nonsteroidal anti-inflammatory drugs (NSAIDs), and 19 did not specify a product. Adults had mixed perceptions about the effectiveness of analgesics. Knowledge of the risks of high doses of acetaminophen (liver toxicity) and NSAIDs (gastrointestinal bleeding or nephrotoxicity) was generally low and declined with less formal education. Individuals with severe or recurrent pain were more likely to exceed the maximum recommended dose of the medication. Although participants reported considering a variety of factors when deciding between different OTC analgesics, there was no clear medication that was generally preferred. Our review was comprehensive; however, the quality of the studies was generally good to fair.ConclusionAdults frequently use oral OTC analgesics and possess a diverse set of beliefs about the efficacy and safety of the products. Pharmacists are well positioned to provide guidance to support the effective and safe use of these products.     

The Onset of Action and the Analgesic Efficacy of Saridon®* (a Propyphenazone/Paracetamol/Caffeine Combination) in Comparison with Paracetamol,Ibuprofen, Aspirin and Placebo (Pooled Statistical Analysis)

Summary

The objective was to evaluate the onset of action, analgesic efficacy and tolerability of Saridon, a propyphenazone 150?mg/paracetamol 250?mg/caffeine 50?mg combination, in comparison with paracetamol 500?mg, aspirin 500?mg, ibuprofen 200?mg and placebo, by a pooled statistical analysis of eight studies. Out of 500 generally healthy patients (55.2% men, 44.8% women), average age 43.5 years, 329 (65.8%) had moderate and 171 (34.2%) severe acute dentoalveolar pain. More Saridon-treated patients reported ‘pain gone/partly gone’ and less ‘pain unchanged or worse’ compared with paracetamol, aspirin and placebo 30?min (p?=?0.009, p?<?0.001, p?=?0.001, respectively) and 60?min after dosing (p?<?0.0001 for all). The difference with ibuprofen was observed 60?min after dosing (p?<?0.01). Pain intensity differences 30?min and 60?min after dosing infer that Saridon has a faster onset of action than all of the other medications that it was compared with (ibuprofen at only 60?min after dosing). Total pain relief scores four hours after dosing were higher in the Saridon group compared with the paracetamol, ibuprofen, placebo (p?<?0.0001 for all) and aspirin groups (p?<?0.01). At the end of the study, patients assessed Saridon as more efficacious than the other study medications (p?<?0.0001 for all). No serious adverse events were observed with any of the drugs studied. All medications were well tolerated. Twenty patients (4.0%) reported adverse events with no significant differences between groups. The most common adverse events were gastrointestinal disorders, followed by nervous system, skin, subcutaneous tissue, respiratory, cardiac and general disorders. Saridon is an effective analgesic that combines the advantage of fast onset and effective analgesia as compared with paracetamol alone, ibuprofen, aspirin or placebo. The results of this pooled analysis of eight studies should be confirmed in a double-blind study, since seven of the studies included in this analysis were single blind.     

Comparison of the Pharmacokinetic Profiles of Soluble Aspirin and Solid Paracetamol Tablets in Fed and Fasted Volunteers

Summary

The aim of this study was to investigate the absorption of popular preparations of two common analgesics – soluble aspirin and solid paracetamol tablets. An open, randomised, crossover study design was used to compare the pharmacokinetic parameters of soluble aspirin and solid paracetamol tablets in 16 healthy, male volunteers from the University of the Witwatersrand, South Africa, in both fed and fasted states. Plasma concentrations of paracetamol, aspirin and salicylic acid were measured. It was found that the rate of absorption was significantly faster for soluble aspirin than for solid paracetamol, regardless of fed or fasting state, considering time to maximum concentration (p < 0.01), time to first quantifiable concentrations (p < 0.05) and absorption rate (p < 0.01). Absorption rate was significantly affected by food for both soluble aspirin (p = 0.028) and for solid paracetamol (p = 0.0003). Time to maximum concentration was not significantly affected by food for soluble aspirin (p = 0.17) but significantly lengthened for solid paracetamol (p = 0.0003). The extent of absorption was affected by food in terms of maximum concentration for both drugs (p = 0.0001), with a reduction of 49% in the fed state for solid paracetamol compared to 18% for soluble aspirin, the difference between the drugs being statistically significant (p = 0.0024). The overall bioavailability of soluble aspirin was unaffected by food and the bioavailability of salicylic acid was increased in the fed state, whereas that of solid paracetamol was lowered in the fed state. Greater inter-individual variation was seen in paracetamol concentrations compared with aspirin or salicylic acid levels. In conclusion, these results show that the absorption of soluble aspirin is largely unaffected by food, whereas, in the same volunteers, the absorption of solid paracetamol tablets is greatly affected. In some volunteers, maximum plasma concentrations of paracetamol following food did not reach levels previously reported to be required for effective analgesia, and this may have implications for pain relief in some individuals. The practice in some individuals of taking aspirin tablets after food to minimise potential gastric disturbance should not affect the level of analgesia.     

The characteristics of acute non‐fatal medication‐related events attended by ambulance services in the Melbourne Metropolitan Area 1998–2002

Introduction and Aims. To describe the characteristics of non‐fatal medication‐related ambulance attendances in Melbourne. Design and Methods. A retrospective analysis of 16 705 patient care records completed by ambulance paramedics in Melbourne where medications had a causal role in the attendance. Results. A single medication only was implicated in 11 765 cases (70% of the total). Of these, 85% involved one of six types of medication: benzodiazepines (52%), paracetamol (15%), selective serotonin re‐uptake inhibitors (6.5%), combination paracetamol and opioids (4%), phenothiazines (3.4%) and tricyclic antidepressants (TCA) (3.7%). Cases involving benzodiazepines were significantly (P < 0.001) older (Average = 37 years) than those involving paracetamol (Average = 30 years). Thirty‐four per cent of cases involved concurrent alcohol use, and this varied according to drug type (paracetamol 26%, benzodiazepines 40%, selective serotonin re‐uptake inhibitors 35%, paracetamol and opioids 35%). An abnormal Glasgow Coma Scale score was found in 19% of cases, again varying according to drug type (paracetamol 10%, TCA 39%, benzodiazepines 21%, paracetamol and opioids 17%, phenothiazines 15%). Ten per cent of cases were not transported to hospital ranging from 3% for TCA to 13% for benzodiazepines. Discussion and Conclusions. The majority of non‐fatal medication events attended by ambulance paramedics involve one of six substances. Benzodiazepines were most commonly implicated and, as management may require only simple supportive treatment, significant numbers are not transported to hospital. The unique clinical population is identified in this study and the ongoing medical and psychiatric treatment of these patients not transported to hospital in the study period needs to be considered. [Hutton J, Dent A, Buykx P, Burgess S, Flander L, Dietze P. The characteristics of acute non‐fatal medication‐related events attended by ambulance services in the Melbourne Metropolitan Area 1998–2002. Drug Alcohol Rev 2009]     

Systematic review and meta-analysis of the clinical safety and tolerability of ibuprofen compared with paracetamol in paediatric pain and fever

ABSTRACT

Objective: The main aim of this review was to compare the tolerability and safety between ibuprofen and paracetamol when used as anti-pyretic and analgesic agents in children up to 18 years of age.

Methods: MEDLINE (1950 to November 2008), EMBASE (1980 to November 2008), The Cochrane Library (2007, Issue 3), ACP Journal Club (1991 to November 2007) and Pascal (1987 to November 2007) were searched for randomised controlled trails (RCTs) (comparing ibuprofen and/or paracetamol with placebo), controlled observational studies and large case series comprised more than 1000 participants.

Main outcome measures: Adverse events (AEs) requiring discontinuation of medication; systemic reactions related to ibuprofen or paracetamol; serious AEs that are fatal, life-threatening or require hospitalisation; and serious AEs not requiring hospitalisation.

Results: A total of 24 RCTs examined either ibuprofen and/or paracetamol versus placebo for AE data. Twelve other studies meeting our criteria were also included for AE data. Meta-analysis of systemic reactions demonstrated that tolerability and safety of ibuprofen was similar to placebo, as was paracetamol: ibuprofen versus placebo relative risk (RR) 1.39 (95% CI: 0.92, 2.10); paracetamol versus placebo RR 1.57 (95% CI 0.74, 3.33). A total of 2937 systemic AEs occurred in 21?305 patients taking ibuprofen compared with 1466 systemic AEs in 11?164 patients taking paracetamol: RR 1.03 (95% CI 0.98, 1.10). There was no significant difference between the two groups. Narrative analysis of AE data identified conflicting evidence regarding hepatic injury with paracetamol and group A streptococcal infections with ibuprofen or paracetamol treatment.

Conclusions: Ibuprofen, paracetamol and placebo have similar tolerability and safety profiles in terms of gastrointestinal symptoms, asthma and renal adverse effects. While the study data investigated here may not reflect over-the-counter use, these results are still relevant in the context of any safety concerns relating to general ibuprofen or paracetamol treatment in children.     

Acetaminophen Protection Against Estramustine-Induced Cytotoxicity on Cultured Fibroblasts

Abstract: Two commonly used analgesics, ibuprofen and acetaminophen (paracetamol) were investigated for possible influence on Chinese hamster fibroblast (V-79) cytotoxicity (measured by cells cloning ability and ⁸⁶Rb accumulation) of the antineoplastic drugs estramustine and bleomycin in vitro. Fibroblast exposure to estramustine (80 mg/1) or bleomycin (50 mg/1), for 1 or 24 hr, reduced the number of surviving clones to approximately 35% and 50% respectively. Acetaminophen (10 or 100 mg/1), but not ibuprofen, significantly increased the number of surviving clones with estramustine. The analgesics had no effect on bleomycin cytotoxicity. The uptake of ⁸⁶Rb⁺ (K⁺ analogue) by V-79 cells was reduced after incubation with 80 mg/1 estramustine phosphate. Acetaminophen (30 mg/1) but not 10 mg/1 acetaminophen or ibuprofen (30 or 100 mg/1), significantly protected against estramustine reduction of ⁸⁶Rb accumulation. Acetaminophen inhibition of estramustine cytotoxicity is suggested to be due to reversal of estramustinc-induced inhibition of cellular potassium channel ion transport.     

Suprofen. A review of its pharmacodynamic and pharmacokinetic properties, and analgesic efficacy

Suprofen (sutoprofen) is a non-steroidal anti-inflammatory analgesic, closely related structurally to drugs such as ibuprofen, ketoprofen and naproxen. In patients with acute pain, single oral doses of suprofen are at least as effective as: usual therapeutic doses of aspirin; codeine alone or combined with aspirin; dextropropoxyphene alone or in various combinations; oxycodone combined with aspirin; dipyrone; pentazocine; paracetamol (acetaminophen); diflunisal; ibuprofen; indomethacin; or mefenamic acid. In chronic pain due to osteoarthritis, suprofen is as effective as usual dosages of aspirin or dextropropoxyphene during long term therapy, and as effective as diclofenac, ibuprofen, indomethacin and naproxen during short term treatment. As with other non-steroidal anti-inflammatory drugs, gastrointestinal complaints are the most frequently reported side effects, although discontinuation due to gastrointestinal effects may be necessary less frequently with suprofen than with aspirin, dextropropoxyphene or combinations of the two. Suprofen appears to be a useful alternative to mild analgesics, analgesic combinations or the older more established non-steroidal anti-inflammatory drugs in the treatment of patients with acute or chronic pain. However, further definition of its efficacy and tolerability is required, especially in comparison with newer non-steroidal anti-inflammatory analgesics.