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Conceived and designed the experiments: Thus, monitoring of serum creatinine and potassium is recommended when a first dispensing of NSAID occur in patients treated with these drugs.
We conducted a pharmacoepidemiological retrospective cohort study using data from the French Health Insurance Reimbursement Database to evaluate the proportion of serum creatinine and potassium laboratory monitoring in patients treated with ACEI, ARB or diuretic and receiving a first dispensing of NSAID. We described the first dispensing of NSAID among 3, patients of a 4-year cohort 6, patients treated with antihypertensive drugs and analyzed serum creatinine and potassium laboratory monitoring within the 3 weeks after the first NSAID dispensing.
Serum creatinine and potassium monitoring was Overall, monitoring was more frequently performed to women aged over 60, treated with digoxin or glucose lowering drugs, but not to patients treated with ACEIs, ARBs or diuretics.
Monitoring of serum creatinine and potassium of patients treated with ACEIs, ARBs or diuretics and receiving a first NSAID dispensing is insufficiently performed and needs to be reinforced through specific interventions.
NSAIDs association with these drugs can increase arterial blood pressure. Moreover, the risk of significant renal impairment is associated with the number of these drugs, when they are associated . In France, two drug interaction compendia are available. The concise information provided in this guideline is used by the main drug databases especially the French National Formulary: The second one is the annual supplement of the French independent drug information bulletin La Revue Prescrire .
However, prescribers' compliance to these recommendations had not been fully evaluated. Thus, we performed a pharmacoepidemiological cohort study investigating if these laboratory monitoring are currently followed by practitioners.
All the French population is covered by a publicly funded health system. Four kinds of data are computerized in this database: Concerning drug dispensing, the database contains information on the date of dispensing, quantity dispensed, and prescriber. Drugs are classified according to the Anatomical Therapeutic Chemical system . We extracted a random sample of patients sample rate: Inclusion in the study was on 1 April for all patients and the maximal follow-up was 4 years until 31 March , because of database size limitations.
Patients were considered lost-to-follow-up if having no drug dispensing for more than 3 months. All data were anonymous in conformity with the French Law of Privacy 8. Antihypertensive drugs included beta-blocking agents, ACEI, ARBs, diuretics except eplerenone , calcium channel blockers except bepridil , alpha-blocking agents or other drugs centrally acting antihypertensive drugs, minoxidil and dihydralazine.
Renin inhibitors were not available in France during the period of study and thus were not included in the analysis. We took into account fixed combinations of antihypertensive drugs as separate drugs. For chronically used drugs, data were extracted between 6 months before and 6 months after the first NSAID dispensing.
Patients were considered exposed between the first and the last dispensing of these drugs in this one-year time frame. Laboratory monitoring of serum creatinine and potassium were considered relevant if occurring within 3 weeks after the start of NSAID. This time frame is pharmacologically relevant and already used in monitoring of initiation or intensification of Renin Angiotensin System Inhibitors RASIs .
We performed an observational study on anonymous data. Thus, considering the French legislation, it does not need to be approved by an ethic committee. Descriptive statistics were computed to characterize patients, drug dispensing, and laboratory monitoring. Characteristics considered in univariate models included age, gender, level of renal failure and hyperkalemia risk caused by DDIs with antihypertensive drugs, digoxin, potassium supplements, glucose lowering drugs, platelet anti-aggregating agents, hospitalizations in the three months previous first dispensing of NSAIDs.
Over the 6, patients of the cohort, 3, had a first dispensing of NSAIDs during the follow-up incidence rate: Among them, were not treated with antihypertensive drug anymore when the first dispensing of NSAIDs occurred and were thus excluded from the analysis figure 1. Among the 3, remaining patients, 22 had a first dispensing of two different NSAIDs, always prescribed by the same physician.
Dentists preferentially prescribed ibuprofen Cardiologists and anesthesiologists mainly prescribed flurbiprofen Baseline complete monitoring was performed in This monitoring occurred by mean on the 8 th day 8. Table 3 shows the different rates of monitoring according to DDIs risks. Univariate analysis showed that all the characteristics selected were associated to serum creatinine and potassium monitoring table 4.
Multivariate analysis performed with these variables table 5 , showed that being aged over 60 60— Monitoring occurred at day 8 and was more frequently performed to women aged over 60, treated with potassium supplements or glucose lowering drugs, but not to patients treated with ACEI, ARBs or diuretics.
The characteristics of NSAID prescriptions are close to the ones found in a monthly prevalence descriptive study leaded in the same area in . Among GPs, the rate of piroxicam prescriptions remains high, but is decreasing compared to previous studies performed in the same area . We also found that dentists' prescriptions were preferentially ibuprofen, the NSAID commonly prescribed for its anti-inflammatory and analgesic effect in acute dental pain .
This information is reassuring, as low dose ibuprofen is believed to be with naproxen the least harmful NSAID regarding cardiovascular events .
Furthermore, in our study the level of DDIs risk is not associated with a greater control. In Bootsma et al. As an explanation to this phenomenon, two approaches can be considered focusing on guideline-related factors and GPs-related factors . Concerning the quality of the interaction compedia, one should underline that the main one, provided by the French Drug Agency, is available online .
The main limitation of the recommendations could be the absence of explicit time frame in which the monitoring should be performed. The impact of this lack of precision remains uncertain. Moreover, the recommendations are different in other compendia. This lack of consistency between drug interaction compendia has already been raised  and underlines the necessity for their standardization.
Regarding GPs-related factors for the non-implementation of drug prescribing guidelines, GPs may consider guidelines as too stringent in general. They consider laboratory monitoring as time-consuming, especially when they are uncertain that monitoring was already performed by another provider . GPs also raise concerns about the real impact of computerized clinical decision support to increase implementation of guidelines, as a phenomenon of alert fatigue could occur.
In the present study, cardiologists and anesthesiologists prescribed more frequently adequate monitoring. This phenomenon can be explained by an increased prescription of flurbiprofen within these two medical specialties. Flurbiprofen is marketed in France for prevention of reinfarction and reocclusion after successful thrombolysis or angioplasty in acute myocardial infarction, in patients for whom aspirin is not recommended . Thus, these patients could have more frequent monitoring because of their condition.
Another explanation could be that these medical specialties are more aware of the risk evaluated in the present study. The use of the French Health Insurance Reimbursement Database in pharmacoepidemiological studies has already been fully described  , but it implies some limitations. As for many administrative databases, we did not have access to medical characteristics of the patients. This involves using medications as proxies of morbidities e.
We were not able to extract some characteristics associated to serum creatinine and potassium monitoring in a previous study  , because of database limitations. In this study of Raebel et al. Furthermore, the disease necessitating NSAID prescription could alone be a condition implying a monitoring of serum creatinine and potassium e. Moreover, the database only records monitoring that have been performed and not all the ones that have been prescribed.
A lot of patients-related situations reluctance to blood test, doctor shopping, excessive self-confidence towards adverse drug reactions… could have an impact on the realization of monitoring in a reasonable time frame. Finally, the low prevalence of complete monitoring could have been underestimated.
In our study, we only have access to ambulatory biochemical monitoring and thus could have missed the ones realized during hospitalizations. On the other hand, one could have underestimated the prevalence of ibuprofen and aspirin consumption, as these specific NSAIDs can be sold out-of-the-counter and thus not recorded in the French Health Insurance Reimbursement Database.
The low prevalence of serum creatinine and potassium monitoring shows a very poor implementation of guidelines. Further studies are required to correlate this low prevalence with a potential increased risk of severe adverse drug reactions. Moreover, intervention studies are required to improve the knowledge of this specific risk, especially among GPs.
The authors have declared that no competing interests exist. The authors have no support or funding to report. National Center for Biotechnology Information , U. Published online Mar Received Jan 12; Accepted Feb Copyright Fournier et al. This is an open-access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are properly credited.
This article has been cited by other articles in PMC. Methods All the French population is covered by a publicly funded health system. Study population We extracted a random sample of patients sample rate: Open in a separate window. Statistic analysis Descriptive statistics were computed to characterize patients, drug dispensing, and laboratory monitoring.
Serum creatinine and potassium monitoring Baseline complete monitoring was performed in Limitations The use of the French Health Insurance Reimbursement Database in pharmacoepidemiological studies has already been fully described  , but it implies some limitations. Conclusion The low prevalence of serum creatinine and potassium monitoring shows a very poor implementation of guidelines. DOCX Click here for additional data file. Renal injury from drugs and chemicals, 3rd ed.
Accessed 15 Dec Pharmacoepidemiological research using French reimbursement databases: Accessed Dec Adherence to biochemical monitoring recommendations in patients starting with Renin Angiotensin system inhibitors: