Medication Errors in Pediatrics: Proposals to Improve the Quality and Safety of Care Through Clinical Risk Management

Medication errors represent one of the most common causes of adverse events in pediatrics and are widely reported in the literature. Despite the awareness that children are at increased risk for medication errors, little is known about the real incidence of the phenomenon. Most studies have focused on prescription, although medication errors also include transcription, dispensing, dosage, administration, and certification errors. Known risk factors for therapeutic errors include parenteral infusions, oral fluid administration, and tablet splitting, as well as the off-label use of drugs with dosages taken from adult literature. Emergency Departments and Intensive Care Units constitute the care areas mainly affected by the phenomenon in the hospital setting. The present paper aims to identify the risk profiles in pediatric therapy to outline adequate preventive strategies. Precisely, through the analysis of the available evidence, solutions such as standardization of recommended doses for children, electronic prescribing, targeted training of healthcare professionals, and implementation of reporting systems will be indicated for the prevention of medication errors.

Prescription Audit and Dispensing Errors in the Outpatient Pharmacy of Tertiary Care Multispecialty Teaching Hospital

Background: Although errors occurring during the process of dispensing may affect the goal of the treatment, they also can be the significant cause of morbidity and mortality. There are only few published evidences which focuses on the errors of dispensing that occurs in the pharmacy. This study focuses on identifying the dispensing errors, impact of brand substitution on cost and DDIs. Objective: To identify the dispensing errors, impact of brand substitution on cost and DDIs. Methodology: Prospective observational study conducted over a period of eight weeks in outpatient hospital pharmacy of tertiary care multispecialty teaching hospital, Tamil Nadu. Prescriptions and medication bills and dispensed medicines are collected from the hospital pharmacy to obtain data required for the study. Prescription containing only medical devices were excluded from the study. Results: Out of 1010 prescriptions, dispensing errors were present in 419 (41.48%) prescriptions which consist of 557 errors. The errors include dispensing multi-pills to make the required dose is 3.77%,tablet splitting is 0.8%, incorrect strength is 1.07%, omission error due to unavailability is 31.4%,dispensing drugs with brands other than prescribed brands is 63.7%. Prescriptions which had more than three drugs were analyzed for drug-drug interactions (n=389). DDIs were present in 156(40.1%) prescriptions which had a total of 281 interactions. Conclusion: The brand substitution and omission errors are the major causes of dispensing errors. Brand substitution is not always recommended as it may have some adverse effects because of salt and excipients variation. Pharmacists are in the position to identify and reduce DDIs by discussing with the physicians.

The effectiveness of split tablet dosing versus alternate-day dosing of warfarin: a randomized control trial

Due to large dosage variation, a variety of warfarin prescription regimens are utilized for specific doses such as tablet splitting, or pill strength alternating. The clinical comparison between the two is lacking. We hypothesize that both approaches result in different times in therapeutic range. We randomized patients with specific warfarin dosage and stable INR for 6 months or longer to receive the whole tablet, alternate-day dosing or the split tablet, same daily-dosing regimen without initial dose change and followed them every 6 weeks for 6 months. The primary outcome was a time in therapeutic range of 2.0–3.0. The secondary outcomes included dosage, compliance, INR, anticoagulant-related events. A total of 66 patients were enrolled, 32 randomly assigned to the split tablet regimen (group S) and 34 to the alternate-day regimen (group A) with two withdrawers. The mean age was 58.6 ± 8.5 years. All baseline characteristics of both groups were similar. The average time in therapeutic range was 72.8 ± 25.4% in group S and 74.9 ± 22.0% in group A (p = 0.72). There were no significant differences in warfarin dosage, compliance, INR and, complications between the two groups. Both warfarin prescription methods, the split tablet and the alternate-day had comparable time in the therapeutic range.

Tablet Splitting in Elderly Patients with Dementia: The Case of Quetiapine

Quetiapine is an atypical antipsychotic approved for treating schizophrenia, bipolar depression, and mania but is frequently used in an off-label manner to control the behavioral and psychological symptoms of dementia in elderly patients with dementia. Due to the need to personalize doses for elderly patients with dementia, quetiapine tablet manipulation is widespread in hospital settings, long-term care facilities, and patient homes. The aim of this study was to assess the impact of the different splitting techniques on quetiapine fumarate tablets by analysing the obtained sub-divided tablets and to discuss compliance with the European Pharmacopoeia limits on whole and split tablets. Quetiapine fumarate tablets of two dose strengths were taken at random (in a number able to assure a power of 0.8 during statistical comparison) and were split with a kitchen knife or tablet cutter. The weight and the drug content were determined for each half tablet. The obtained data were compared to the European Pharmacopoeia limits. The differences between the different splitting techniques were statistically tested. Data showed that split tablets, independently of the dose strength and the technique employed, were not compliant with the European Pharmacopoeia specifications for both entire and subdivided tablets in terms of weight and content uniformity. Thus, such a common practice could have potential effects on treatment efficacy and toxicity, especially when also considering the fragility of the elderly target population in which polypharmacotherapy is very common. These results indicate a compelling need for flexible quetiapine formulations that can assure more accurate dose personalization.

The Effectiveness of Split Tablet Dosing Versus Alternate-Day Dosing of Warfarin: A Randomized Control Trial

Due to large dosage variation, a variety of warfarin prescription regimens are utilized for specific doses such as tablet splitting, or pill strength alternating. The clinical comparison between the two is lacking. We hypothesize that both approaches result in different times in therapeutic range. We randomized patients with specific warfarin dosage and stable INR for 6 months or longer to receive the whole tablet, alternate-day dosing or the split tablet, same daily-dosing regimen without initial dose change and followed them every 6 weeks for 6 months. The primary outcome was a time in therapeutic range of 2.0 to 3.0. The secondary outcomes included dosage, compliance, INR, anticoagulant-related events. A total of 66 patients were enrolled, 32 randomly assigned to the split tablet regimen (group S) and 34 to the alternate-day regimen (group A) with two withdrawals. The mean age was 58.6 ± 8.5 years. All baseline characteristics of both groups were similar. The average time in therapeutic range was 72.8 ± 25.4% in group S and 74.9 ± 22.0% in group A (p = 0.72). There were no significant differences in warfarin dosage, compliance, INR and, complications between the two groups. Both warfarin prescription methods, the split tablet and the alternate-day had comparable time in the therapeutic range.

A Comparison of Effectiveness of Crystalline and Amorphous Atorvastatin

Background: Atorvastatin is a widely used statin, of which there are two available polymorphs: crystalline (original) and amorphous (generic). Pharmacological studies showed the similarity between both forms. However, the lipid-lowering effectiveness of the amorphous form was still uncertain. Objective: To compare the effectiveness of crystalline and amorphous form of atorvastatin. Materials and Methods: The authors conducted an observational cross-sectional analytic study by retrospectively collecting data from January 1, 2016 to December 31, 2017 of the patients at Queen Sirikit Heart Center of the Northeast where the original regimen of crystalline atorvastatin had been replaced by the amorphous atorvastatin at the same dose. Patients must have been prescribed each form of atorvastatin for at least six weeks. The lipid profiles taken at the closest to the switching point (before and after) were used. The primary outcome was changes in low-density lipoprotein (LDL) levels. The secondary outcomes were changes in total cholesterol (TC), triglyceride (TG), and high-density lipoprotein (HDL) levels, as well as a comparison of LDL levels in patients whose tablets were split. Results: Eight hundred twenty-five patients were included in the present study. The mean age was 63.7±9.9 years. Five hundred sixty-eight patients (68.8%) were male, and 736 (89.2%) were treated as secondary prevention. The mean LDL levels during crystalline and amorphous atorvastatin use were 92.4±39.0 and 91.8±41.0 mg/dL, respectively (mean difference –0.6; 95% confidence interval [CI], –2.2 to 1.0; p=0.460). The mean TC, TG, and HDL levels during crystalline and amorphous form use were 153.1±43.3 and 152.0±48.6 mg/dL (p=0.400), 153.4±129.0 and 155.0±148.3 (p=0.740), 43.6±11.9, and 44.4±12.0 (p=0.004), respectively. Among the patients who had tablet splitting, the mean LDL levels during crystalline and amorphous atorvastatin use were 89.2±28.3 and 91.0±30.8 mg/dL, respectively (p=0.279). Side effects were recorded in nine patients, one of which was rhabdomyolysis. Conclusion: The effectiveness of amorphous atorvastatin at lowering lipids was comparable to that of atorvastatin in its crystalline form, and patients were generally able to tolerate amorphous atorvastatin. Keywords: Atorvastatin, Crystalline, Amorphous, Lipid-lowering, Low-density lipoprotein