Author's addendum to the article: Fingolimod: Assay analysis of US generic capsule products reveals variation in fingolimod content beyond the recommended acceptance criteria.

Our article "Fingolimod: Assay analysis of US generic capsule products reveals variation in fingolimod content beyond the recommended acceptance criteria" highlighted the variation of active ingredient in generic fingolimod capsule products. This analysis was prompted by reports of clinical adverse events and/or multiple sclerosis relapse in patients following transition from Gilenya® fingolimod capsules (Novartis) to generic fingolimod capsule products. Further assay analysis functioned to both confirm previous out-of-specification findings, and to identify an additional generic product that failed to comply with United States Pharmacopeia (USP) recommendations.

Fingolimod: Assay analysis of US generic capsule products reveals variation in fingolimod content beyond the recommended acceptance criteria.

The immunomodulating agent fingolimod is a sphingosine-1-phosphate receptor modulator used in the treatment of multiple sclerosis (MS). We analyzed three FDA approved fingolimod 0.5 mg generic capsule products for fingolimod content. Assay results demonstrated a wide variation in fingolimod content between manufacturers, with one product demonstrating a fingolimod content of 76.8 % of the approved dose. This falls significantly below the FDA acceptance criteria of 90.0-110.0 % of label claim.

Comparison of oral and video debriefing and its effect on knowledge acquisition following simulation-based learning.

Introduction: Learning from simulation takes place to a large extent in debriefing; however, there is still sparse knowledge about the advantages and disadvantages of debriefing methods. 2 common forms are video-assisted and oral only debriefing. We set out to determine if there is increased knowledge acquisition for candidates undergoing video, rather than oral debriefing. Methods: Second year doctors were randomised to a training day with oral or video feedback. Candidates underwent an emergency clinical scenario followed by feedback. The candidates completed 30 multiple choice questions related to managing common clinical emergencies presimulation and postsimulation training. Results: There was no significant difference in the postscore mean for the oral debriefing (128.3, SD 5.16) and video-assisted debriefing group (127.1, SD=5.96). There was significant interaction between precourse and postcourse scores with superior knowledge acquisition for candidates with lower precourse scores (p=0.008). The candidates with lowest precourse score showed significant improvement in the orally debriefed group in comparison to video debriefed group. Discussion: Our results showed that video debriefing has equivocal effect to oral debriefing. Oral debriefing provides superior knowledge acquisition to learners with lower precourse test scores.

Judging whether a patient is actually improving: more pitfalls from the science of human perception.

Fallible human judgment may lead clinicians to make mistakes when assessing whether a patient is improving following treatment. This article provides a narrative review of selected studies in psychology that describe errors that potentially apply when a physician assesses a patient's response to treatment. Comprehension may be distorted by subjective preconceptions (lack of double blinding). Recall may fail through memory lapses (unwanted forgetfulness) and tacit assumptions (automatic imputation). Evaluations may be further compromised due to the effects of random chance (regression to the mean). Expression may be swayed by unjustified overconfidence following conformist groupthink (group polarization). An awareness of these five pitfalls may help clinicians avoid some errors in medical care when determining whether a patient is improving.

Determining whether a patient is feeling better: pitfalls from the science of human perception.

Human perception is fallible and may lead patients to be inaccurate when judging whether their symptoms are improving with treatment. This article provides a narrative review of studies in psychology that describe misconceptions related to a patient's comprehension, recall, evaluation and expression. The specific misconceptions include the power of suggestion (placebo effects), desire for peace-of-mind (cognitive dissonance reduction), inconsistent standards (loss aversion), a flawed sense of time (duration neglect), limited perception (measurement error), declining sensitivity (Weber's law), an eagerness to please (social desirability bias), and subtle affirmation (personal control). An awareness of specific pitfalls might help clinicians avoid some mistakes when providing follow-up and interpreting changes in patient symptoms.

Ultrasound provides a reliable test of local anesthetic spread.

BACKGROUND AND OBJECTIVES: We predicted that practitioners could identify injectate spread in a model of ultrasound-guided peripheral nerve block. METHODS: Both novices and experts in ultrasound-guided peripheral nerve block were asked to recognize the spread of local anesthetic in a gelatin ultrasound phantom. In a blinded and randomized fashion, these participants were observed to either successfully or unsuccessfully state whether an injection had been made. RESULTS: Twelve novices and 8 experts each completed the trials. Accuracy, Sensitivity and specificity were calculated for all trials. Users attained a very high accuracy and sensitivity (> 85%) as well as specificity (> 90%) with ultrasound in this model. CONCLUSIONS: This study shows that ultrasound is a reliable method of detecting injectate spread in a gelatin phantom model.