Failure Mode, Effect, and Criticality Analysis of the Parenteral Nutrition Process in a Mother-Child Hospital: The AMELIORE Study.

BACKGROUND: The parenteral nutrition (PN) process is complex and involves multiple steps and substeps, especially in pediatrics and neonatology, given the particular needs of these patients. The objective of this study was to perform a critical analysis of the PN process at the Centre Hospitalier Universitaire Sainte-Justine to determine which potential pitfalls are related to this process and which should be prioritized when implementing corrective measures. METHODS: This is a Failure Mode, Effect, and Criticality Analysis (FMECA) study. A multidisciplinary team assessed each step of the PN process and identified associated failure modes. Adapted rating scales were used to determine severity, frequency, and detectability of the failure modes. Ratings were established through multidisplinary consensus, and a criticality index (CI) was calculated for each failure mode. RESULTS: A total of 265 failure modes were identified in the 5 major steps of the PN process. The failure mode with the highest CI was the inscription of an inaccurate weight at prescription, with a CI of 800. The step with the highest cumulative CIs was administration to patients, with a CI sum of 7691. Various recommendations aimed at minimizing the risks associated with the PN process were made following this FMECA. Additional interventions are expected to emanate from this project because data will be presented throughout the departments involved. CONCLUSION: This study is a successful example for other hospitals interested in carrying out the same kind of healthcare improvement initiative.

Infant Exposure to Methylphenidate and Duloxetine During Lactation.

BACKGROUND: Duloxetine and methylphenidate are commonly prescribed for the management of depression and attention-deficit/hyperactivity disorder (ADHD), respectively. However, little information is available concerning their safety during lactation. The purpose of this case series was to provide additional information to the medical literature concerning infant exposure to methylphenidate and duloxetine through breast milk. METHOD: Bioanalytical method (liquid chromatography coupled to mass spectrometry) was developed and validated before its use to determine the concentrations of both medications in breast milk samples. CASES: Case 1: A 30-year-old woman with depression and ADHD took duloxetine 90 mg daily and methylphenidate 36 mg daily during pregnancy and breastfeeding. The newborn was found to have a congenital pulmonary airway malformation. The breastfeeding status was nonexclusive. At week 4 postpartum, the concentration found in the milk was 32.8 ng/mL of duloxetine and 7.9 ng/mL of methylphenidate (estimated relative infant dose [RID] of 0.3% and 0.2%, respectively). Case 2: A 41-year-old women with depression took duloxetine 60 mg daily during pregnancy and lactation. She gave birth to a healthy child. The breastfeeding status was nonexclusive. Cord to maternal plasma concentration ratio was 0.4. At day 6 postpartum, the concentration of duloxetine was 23.6 ng/mL in the foremilk and 14.3 ng/mL in the hindmilk (RID of 0.4% and 0.2%, respectively). At week 6 postpartum, the concentration was 25.2 ng/mL in the foremilk and 29.3 ng/mL in the hindmilk (RID of 0.4% and 0.4%, respectively). CONCLUSION: In accordance with previously published data, this case series suggests a minimal exposure to duloxetine and methylphenidate through breast milk. Thus, these drugs are likely compatible with lactation. However, large cohort studies are necessary to evaluate their long-term impact on the exposed infants.

Analyse des modes de défaillance, de leurs effets et de leur criticité dans le circuit du médicament: revue de littérature.

BACKGROUND: Failure mode, effects, and criticality analysis (FMECA) is a systematic and proactive risk analysis method to determine major failures in complex processes. OBJECTIVE: To identify all articles involving the use of failure mode and effects analysis (FMEA), FMECA, or FMECA in health care within the medication use system. DATA SOURCES STUDY SELECTION AND DATA EXTRACTION: The MEDLINE database was searched, for the period January 1990 to January 2017. The search included studies using the FMECA method, in part or in full, and dealing with one or several components of the medication use system. The reference lists of articles identified in the initial search were checked manually for additional pertinent references. DATA SYNTHESIS: The researchers identified 171 articles, and retained 39 for analysis: 32 describing use of the FMEA or FMECA approach and 7 describing use of the FMECA in health care approach. They identified between 4 to 378 failure modes, according to the published studies. Among the 39 articles, 10 reported a pre- and post-implementation analysis of corrective measures. In 4 of those 10 articles, the analysis was conducted on a theoretical basis, that is, before the corrective measures were actually implemented. Using the articles retained for analysis, a summary table was developed with the following elements: publication year, main author, country, primary objective, secondary objectives, descriptions of both method and results, and comments. The summary table gave the opportunity to comment on the use of the FMECA-type analysis within the medication use system. CONCLUSIONS: This literature review included 39 published articles using an FMEA, FMECA, or FMECA in health care approach within the medication use system. Most studies used either the FMEA or the FMECA approach, whereas the FMECA in health care approach was used only rarely. Only a minority of studies assessed the effects of corrective measures that were implemented. This overall approach allows for mapping of a care process, determination of failure modes, and prioritization of corrective measures. Its use for the assessment of the medication use system should be promoted.