Availability of drug at convenient stores is not associated with an increased incidence of their poisoning.

PURPOSE: In late 2012, South Korea revised the Pharmaceutical Affairs Act to make selected medications including acetaminophen, ibuprofen, and cold medications available in nonpharmacy outlets, including the 24-hour convenient stores (CVS). The objective of this study was to identify whether the characteristics and trend of self-poisonings associated with these medications were altered after the legislative change. METHODS: A retrospective study was performed using national data from the Emergency Department (ED)-based Injury In-depth Surveillance database. The patients diagnosed with poisoning were sorted from 2011 to 2016 and included in the study. As the Act was implemented from 2013, the demographic characteristics and clinical outcomes were compared before and after January 2013. A piecewise regression analysis was performed to determine the association between the monthly use of acetaminophen, medication for cold, and nonsteroidal anti-inflammatory drugs (NSAIDs) and the incidence of total poisonings before and after the January 2013. RESULTS: Among 1 536 277 patients included in the database, 17 523 patients diagnosed with poisoning were enrolled. After the legislative change, the etiology of poisoning did not change, although the frequency of hospitalization from ED was significantly increased. The monthly trend for poisoning due to acetaminophen, cold medications, and NSAIDs showed no significant slope change between before and after the legislative change. The proportional use of acetaminophen and cold medications was significantly decreased, while that of NSAIDs was unchanged before and after the legislative change. CONCLUSIONS: The change in the Pharmaceutical Affairs Act was not associated with any change in the monthly frequency of medication-related poisoning.

Trends of non-union and prescriptions for non-steroidal anti-inflammatory drugs in the United States, 1993-2012.

BACKGROUND AND PURPOSE: Surgical care and pain management for patients with fractures have evolved over the years. We wanted to ascertain if there were any changes in the incidence of non-unions and, if so, whether the use of non-steroidal anti-inflammatory drugs (NSAIDs), including COX-2 selective inhibitors, might have an effect. PATIENTS AND METHODS: We used the National Inpatient Sample (NIS) to estimate the annual number of patients hospitalized for surgical treatment of a non-union between 1993 and 2012, and calculated age-adjusted rates of non-union. We estimated the prevalence of prescriptions for NSAIDs from 1996 through 2012 using the Medical Expenditure Panel Survey (MEPS). The interrupted time-series analysis was used to relate quarterly rates of non-union to changes in prescriptions for NSAIDs between 1996 and 2009. RESULTS: The annual estimate of non-unions in the USA declined 30% from 25,634 in 1993 to 17,815 in 2012 (p < 0.001). Specifically, the age-adjusted rate of non-unions decreased by 44% from 8.6 per 10(5) persons in 1996 to 4.8 per 10(5) persons in 2012 (p < 0.001). However, there was an 8% increase in the incidence rate of non-unions (p = 0.003) between 2000 and 2004, when certain COX-2 selective inhibitors were on the market and their prescriptions were prevalent at around 6% among those with fractures. A drop in non-union estimates from 22,321 in 2010 to 18,789 in 2011 (p = 0.04) also coincided with a marked decrease in prescriptions for NSAIDs in patients with fractures, from 22% to 14% (p = 0.02). INTERPRETATION: Non-unions in the USA declined substantially between 1993 and 2012, but this was interrupted by changes in prescriptions for NSAIDs, with sustained increases between 2000 and 2004 followed by transient decreases in 2005 and 2011.

Ibuprofen: a journey from prescription to over-the-counter use.

Ibuprofen was the first non-aspirin non-steroidal antiinflammatory drug (NSAID) to be approved for over-the-counter (OTC) use and is widely considered to be the best tolerated drug of its class. Low-dose, OTC ibuprofen has been used for pain relief for over 30 years without any obvious major health issues. However, there is no clear differentiation between the OTC and prescription doses of ibuprofen, and their respective effects. Adverse reactions to ibuprofen appear to be dose and duration dependent, and this may be the reason for the observed tolerability of the drug at OTC doses. OTC ibuprofen is at least as effective as aspirin and more effective than paracetamol. The tolerability concerns associated with higher dose NSAIDs currently do not apply to low-dose, short-term use of ibuprofen for common pain. Ibuprofen is associated with the least risk of GI complications compared with other NSAIDs and is considered relatively benign in overdose. This review will aim to distinguish the safety of OTC or non-prescription use of ibuprofen from its prescription use.

Paracetamol availability and recent changes in paracetamol poisoning: is the 1998 legislation limiting availability of paracetamol being followed?

OBJECTIVE: To determine the degree of adherence to legislation introduced in 1998 restricting the availability of over the counter paracetamol. DESIGN: A prospective observational study. SETTING: An emergency department in an inner city London teaching hospital. Pharmacy and non-pharmacy outlets in south London. MAIN OUTCOME MEASURES: (1) The source of paracetamol ingested by 107 patients presenting with an acute paracetamol overdose (2001-2003) and (2) the ability to purchase paracetamol from pharmacy and non-pharmacy outlets in a manner contravening paracetamol pack size legislation (2004). RESULTS: Potentially toxic amounts of paracetamol in excess of pack size restrictions were purchased in 70% (17 of 24) of outlets. Forty six per cent of patients who had ingested a potentially toxic dose of paracetamol obtained the tablets in a manner contravening the 1998 legislation. CONCLUSION: Legislation limiting the availability of over the counter paracetamol is not being adhered to in south London. A significant number of patients ingesting a potentially toxic dose of paracetamol report purchasing the tablets in a manner contravening the legislation. Studies that attempt to assess the impact of the legislation need to be interpreted in the context of these results. Measures to enforce current legislation may help to reduce the severity of paracetamol poisoning in the UK.

How well are national guidelines relating to the general sales of aspirin and paracetamol, adhered to by retail stores: a mystery shopper study.

OBJECTIVE: To determine whether non-pharmaceutical retail outlets are aboding to the current Medicines and Healthcare products Regulatory Agency (MHRA) national guidelines for over-the-counter (OTC) sales of aspirin and paracetamol. METHODS: Stages 1 and 2 of the study deployed eight and four medical students, respectively, to undertake a mystery shopper style investigation. Stage 1: eight medical students attempted to buy ≥ 96 tablets/capsules aspirin or paracetamol in one transaction in 62 shops. Stage 2: four medical students attempted to purchase 32 paracetamol 500 mg along with a 'flu remedy preparation also containing paracetamol, in 54 shops. RESULTS: Stage 1 data revealed that 58% and 57% retailers sold more than the MHRA guidelines recommended for paracetamol and aspirin, respectively. We observed that 23% and 28% retailers were willing to sell ≥ 96 tablets of paracetamol or aspirin with no questions asked. Stage 2 results showed that 57% retailers sold 32 × 500 mg paracetamol in conjunction with a paracetamol-containing 'flu preparation; while 98% shops sold 16 × paracetamol 500 mg along with a paracetamol-containing 'flu remedy, with no questions asked of the shopper or advice given. DISCUSSION: MHRA national guidelines for OTC medicines sales appear to be poorly adhered to in non-pharmacy shops. Sales of aspirin and paracetamol OTC must be better regulated in the UK to ultimately reduce morbidity and mortality rates of deliberate and accidental overdoses.

Availability of over-the-counter drugs for arthritis in Sao Paulo, Brazil.

Seventy pharmacies located in Sao Paulo were randomly selected and visited. Seven researchers posed as ordinary clients presenting with a standardized complaint of symptoms according to a scenario previously defined. The client asked for medicines to relieve his/her pain or discomfort. After the seller's suggestion the client asked for 2 drugs randomly selected from a drug list containing 30 trademarked drugs commonly prescribed to arthritis patients. These drugs should be available only on prescription. In only 12.8% of the pharmacies did the seller initially suggest the client see a physician. The sellers "prescribed' non-steroid anti-inflammatory drugs (NSAID), vitamins, analgesics (AN) and corticosteroids (CO) in respectively 42.8, 20.0, 14.3 and 5.7% of the visits. From the drug list, the client secured 67.7% of the NSAID, 65.0% of the CO and 20.0% of the sedatives without presenting a prescription. Pharmacy sellers usually comply with the clients demands. Future studies should aim at the evaluation of interventions to reduce the availability of the over-the-counter drugs for arthritis.

Effects of legislation restricting pack sizes of paracetamol and salicylate on self poisoning in the United Kingdom: before and after study.

OBJECTIVE: To evaluate the effects on suicidal behaviour of legislation limiting the size of packs of paracetamol and salicylates sold over the counter. DESIGN: Before and after study. SETTING: UK population, with detailed monitoring of data from five liver units and seven general hospitals, between September 1996 and September 1999. SUBJECTS: People who died by suicidal or accidental overdose with paracetamol or salicylates or who died of undetermined causes; patients admitted to liver units with hepatic paracetamol poisoning; patients presenting to general hospitals with self poisoning after taking paracetamol or salicylates. MAIN OUTCOME MEASURES: Mortality from paracetamol or salicylate overdose; numbers of patients referred to liver units or listed for liver transplant; numbers of transplantations; numbers of overdoses and tablets taken; blood concentrations of the drugs; prothrombin times; sales to pharmacies and other outlets of paracetamol and salicylates. RESULTS: Numbers of tablets per pack of paracetamol and salicylates decreased markedly in the year after the change in legislation on 16 September 1998. The annual number of deaths from paracetamol poisoning decreased by 21% (95% confidence interval 5% to 34%) and the number from salicylates decreased by 48% (11% to 70%). Liver transplant rates after paracetamol poisoning decreased by 66% (55% to 74%). The rate of non-fatal self poisoning with paracetamol in any form decreased by 11% (5% to 16%), mainly because of a 15% (8% to 21%) reduction in overdoses of paracetamol in non-compound form. The average number of tablets taken in paracetamol overdoses decreased by 7% (0% to 12%), and the proportion involving >32 tablets decreased by 17% (4% to 28%). The average number of tablets taken in salicylate overdoses did not decrease, but 34% fewer (2% to 56%) salicylate overdoses involved >32 tablets. After the legislation mean blood concentrations of salicylates after overdose decreased, as did prothrombin times; mean blood concentrations of paracetamol did not change. CONCLUSION: Legislation restricting pack sizes of paracetamol and salicylates in the United Kingdom has had substantial beneficial effects on mortality and morbidity associated with self poisoning using these drugs.

[COX-2 inhibitor non-steroidal anti-inflammatory drugs, myth or reality?]. / Les AINS anti-Cox-2 sélectifs, mythe ou réalité?

The discovery of two isoforms of cyclooxygenase, Cox-1 constitutive and Cox-2 inducible, has prompted the development of new molecules with high Cox-2 selectivity. These new NSAIDs belong to the coxib class and have theoretically a better digestive tolerability than classical NSAID have. In Belgium, rofecoxib ((Vioxx) and celecoxib (Celebrex) are commercialized. Rofecoxib is indicated in the symptomatic treatment of osteoarthritis (12.5 to 25 mg/d) and celecoxib is indicated in osteoarthritis (200 mg/d) and in rheumatoid arthritis (200 to 400 mg/d). Several studies have demonstrated their efficacy, similarly to classical NSAID as diclofenac (Voltaren), naproxen (Naprosyne), ibuprofen (Brufen) and their superiority compared to placebo. Their safety profile for gastrointestinal events is proven in patients without ulcer history compared to classical NSAID. However, the concomitant use of aspirin decreases the benefit as demonstrated for celecoxib at 400 mg/d but not investigated for rofecoxib. The selective inhibition of Cox-2 with no effect on Cox-1 favors cardiovascular events in patients at risk. Other side effects are similar to classical NSAID. Thus Cox-2 inhibitors NSAID are interesting molecules for their sparing gastrointestinal activity. They must be used with caution in patients with ulcer history, in the elderly and in patients requiring aspirin for cardiovascular prophylaxis.

Trends in gastrointestinal bleeding in the Region of Valencia (2000-2005). Relationship to sales of nonsteroidal anti-inflammatory drugs and acid suppression medication.

OBJECTIVE: To describe 2000-2005 time trends of prescription for NSAIDs, proton pump inhibitors (PPIs) and hospital admissions for gastrointestinal (GI) bleeding. METHODS: Time series analysis of gastrointestinal (GI) bleeding admission and drugs' Defined Daily Dose per 1000 people per day (DDD/1000/day) in the Region of Valencia, Spain, from January 2000 to December 2005. RESULTS: Dispensation of NSAIDs went from 42.7 DDD/1000 people/day in 2000 to 58.3 DDD/1000 people/day in 2005. During the same period, dispensation of PPIs went from 26.3 DDD/1000 people/day to 68.5 DDD/1000 people/day (both are statistically significant). The rate of hospitalisations for gastrointestinal bleeding during this period oscillated between 142 and 126 admission per 100 000 inhabitants/year. No year showed significant differences compared to 2000. CONCLUSION: A substantial increase in the NSAID use from 2000 to 2005 was not accompanied by changes in GI bleeding hospitalisation rates in Valencia, but GI bleeding rates continued to be high, suggesting a need to improve NSAIDs use.

"Take your medicine": nonadherence issues in patients with ulcerative colitis.

Ulcerative colitis is a lifelong disease causing inflammation and ulceration of the colon. Symptoms of ulcerative colitis include abdominal pain, bloody diarrhea, bloating, and fecal urgency. The current standard therapy for mild to moderate ulcerative colitis is the use of 5-aminosalicylates, with patients requiring continuous treatment to maintain remission. A substantial proportion of patients, however, are nonadherent to prescribed 5-aminosalicylate treatment regimens, resulting in a greater chance of disease relapse with severe associated symptoms. There are many reasons why a patient with ulcerative colitis may be nonadherent including the patient's perception of the condition or a lack of understanding about the disease or treatment. Multiple daily dosing or rectal administration of 5-aminosalicylate medications also can adversely affect adherence rates. Because gastrointestinal nurses often are the primary points of contact for patients with ulcerative colitis, they are in a unique position to take simple steps that will improve adherence rates and thus increase the efficacy of prescribed therapy. This article highlights important aspects of education and patient care for patients with ulcerative colitis.

Acetylsalicylic-acid-containing drugs and nonsteroidal anti-inflammatory drugs available in Canada.

A large number of drugs containing acetylsalicylic acid (ASA) and nonsteroidal anti-inflammatory drugs (NSAIDs) are available by prescription and over the counter in Canada. The possibility of serious side effects and drug interactions is therefore high. The authors have compiled a comprehensive list of products containing these drugs from information supplied by pharmaceutical databases, independent marketing researchers and Health Canada's Drug Directorate. Physicians should ensure that additional ASA-containing drugs or NSAIDs are not inadvertently taken by patients, especially those receiving oral anticoagulant therapy or those with a qualitative platelet defect. Patients at risk should be cautioned to check with their physician before taking any new medication, even over-the-counter products.

Intolerancia a antiinflamatorios no esteroideos con reacción respiratoria: aspectos clínicos y diagnósticos / Intolerance to non-steroidal anti-inflammatory drugs with respiratory reaction: clinical and diagnostic features

Fundamento: La prevalencia de la intolerancia a antiinflamatorios no esteroideo (AJ­NEs) es en adultos con asma del LO al 30%. El mecanismo e desconocido aunque se cree que e debe a una inhibición de la ciclooxigenasa con aumento de los leucotrie-nos. Clínicamente se caracteriza por rinoconjuntivitis y asma. El diagnóstico de sospecha se basa en la historia clínica y el definitivo, en el test de provocación oral (TPO). El objetivo del presente estudio es analizar los diferentes aspecto relacionado con el diagnóstico de la intolerancia a AINEs (lA) en pacientes que presentaron clínica respiratoria tras la ingesta de un AINE, y comparar los datos recogido en la historia clínica con los resultados obtenidos con un protocolo de estudio. Métodos: Se ha estudiado a 150 pacientes con sospecha de intolerancia a AINEs con reacción respiratoria. El TPO se consideró positivo cuando el descenso del pico de flujo fue 2:15% respecto al basal y/o aparecían síntomas nasooculares y/o bronquiales. El diagnóstico se estableció por anarnnesis si el cuadro clínico era considerado grave, o por TPO cuando dos AINEs di tintos estructuralmente provocaban idéntica reacción. La intolerancia a AINEs se descartó cuando e toleró 1 g de ácido acetil alicílico (AAS). A un subgrupo de 20 pacientes diagnosticados de intolerancia a AINEs se les realizó una provocación con paracetamol para comprobar su tolerancia. Resultados: El 32% se diagnosticó de intolerancia a AJNEs (el 74% por protocolo de estudio y el resto, por historia clínica). Los fármaco responsables de las reaccione fueron: AAS (95%), pirazolonas (36%), arilpropiónicos (10%). oxicam (2%), fenamato (2%) y paracetamol (2%). Con el TPO se observó: rinitis (9%), asma (12%) rinitis con de censo del pico de flujo de entre el 15 y el 25o/c (7%) y rinoconjuntiviti y asma (72%). Se detectó una asociación estadísticamente significativa (x2) entre lo dato de la historia clínica y el TPO (p<Ü.05). El 40% de los pacientes intolerantes tuvieron una reacción positiva con el paracetamol. el 25% con dosis superiores a l g. Conclusiones: La significativa reproductibilidad entre los datos de la historia clínica y el TPO confirma la necesidad de valorar cada caso individualmente, con el fin de utilizar las pruebas diagnósticas que menor riesgo conlleve para el paciente (AU)

Background: In adult asthma. non­steroidal anti­inflammatory drug ( SAID) prevalence is about 10­30%. The causative mechanism is thought to be due to cyclooxigenase inhibition, which cause an increase of leukotrienes. Clinical finding are rhinoconjuctivitis and a thma. Diagnosis is based on clínical history and oral challenge tests (OCT). To analize different features in the diagnosis of SAIDs intolerance in patient with respiratory symptoms after NSAID ingestion and to compare data from clínica] history with our protocols results. Methods: One hundred and fifty patients uspected of respiratory reaction by ( SAIDs) were studied. OCT wa positive if PEFR fell >?5% from the basal values with bronchial symptoms and/or nasoocular symptoms appeared. Diagnosis was establi hed by clinical history if the clinical features are considered hazard for patients life or by OCT when two structurally different SA!Ds caused the same reaction. Intolerance was ruled out if patient tolerated up to 1 g of ASA. 20 patients diagnosed of lA were challenged with paracetamol up to 2 g in order to establih the tolerance to this SAID. Results: Thirty­two percent patient were intolerant: 74% based on study protocol. Causative drugs were: ASA (95%). yrazole (36% ). Aril propionics ( 10%), Oxicam (2~ ), Fenamics (2%), and paracetamol (2%). Along OCTs. rhinitis was een in 9%. asthma in 12%. rhinitis with PEFR fall of about 15­25% in 7% and rhinoconjuntivitis and asthma in 72%. A statistical association (X2) between clínica! finding and OCTs (p<0.05) was found. Forty percent of intolerant patients suffered a positive reaction with paracetamol. Twenty­five percent with do es > 1 g. Conclusions: The significant reproducibility between data from clínical history and OCT confirm that it is necesary to value each ca e individually for using diagnostic test with low risk for patients (AU)