Nevin Manimala

J Am Pharm Assoc (2003). 2023 Jul 4:S1544-3191(23)00237-6. doi: 10.1016/j.japh.2023.06.024. Online ahead of print.

ABSTRACT

BACKGROUND: The growing population demand and the epidemic lead of Coronavirus Disease 2019 (COVID-19) have highlighted the critical importance of patient access to compounded formulations, including for special purposes such as pediatrics, geriatrics, and other uses. However, there are many potential risks, including quality issues and 503A facilities have not received valid prescriptions for individually-identified patients for a portion of the drug products they produce.

OBJECTIVE: The aim is to analyze the (503A facilities) warning letters and identify the problem of compounding medicines not meeting the USP specifications.

METHODS: Content analysis and descriptive statistics methods were used to analyze the violations of compounding warning letters from 2017 to 2021. The content of warning letter violations was analyzed in terms of both the compounding environment and 503A facilities that did not received valid prescriptions for individually-identified patients for a portion of the drug products they produced.

RESULTS: A total of 113 compounding warning letters (503A facilities, N=112) from 2017 to 2021 were analyzed in this study. The percentage of 503A facilities involved in sterile compounding environmental issues was 79.46%, with facility design and environmental controls (73/89, 82.02%), cleaning and disinfecting the compounding area (59/89, 66.29%), and personnel cleansing and garbing (44/89, 49.44%) being the top three issues. Seventy-two (72/112, 64.29%) 503A facilities that did not received valid prescriptions for individually-identified patients for a portion of the drug products they produced. Fifty-one (51/72, 70.83%) of these warning letters were related to sterile environment issues, and 28 warning letters identified specific drugs that did not qualify for Section 503A exemptions.

CONCLUSION: The warning letter of compounding drugs issued by FDA can be used as a learning tool for compounders. Compounders can learn from the experience and lessons, improve compounding operations and reduce mistakes.

PMID:37414280 | DOI:10.1016/j.japh.2023.06.024

Hear Res. 2023 Jun 20;436:108837. doi: 10.1016/j.heares.2023.108837. Online ahead of print.

ABSTRACT

Sensitivity to changes in the stimulus level at one or at both ears and to changes in the interaural level difference (ILD) between the two ears has been studied widely. Several different definitions of threshold and, for one of them, two different ways of averaging single-listener thresholds have been used (i.e., arithmetically and geometrically), but it is unclear which definition and which way of averaging is most suitable. Here, we addressed this issue by examining which of the differently defined thresholds yielded the highest degree of homoscedasticity (homogeneity of the variance). We also examined how closely the differently defined thresholds followed the normal distribution. We measured thresholds from a large number of human listeners as a function of stimulus duration in six experimental conditions, using an adaptive two-alternative forced-choice paradigm. Thresholds defined as the logarithm of the ratio of the intensities or amplitudes of the target and the reference stimulus (i.e., as the difference in their levels or ILDs; the most commonly used definition) were clearly heteroscedastic. Log-transformation of these latter thresholds, as sometimes performed, did not result in homoscedasticity. Thresholds defined as the logarithm of the Weber fraction for stimulus intensity and thresholds defined as the logarithm of the Weber fraction for stimulus amplitude (the most rarely used definition) were consistent with homoscedasticity, but the latter were closer to the ideal case. Thresholds defined as the logarithm of the Weber fraction for stimulus amplitude also followed the normal distribution most closely. The discrimination thresholds should therefore be expressed as the logarithm of the Weber fraction for stimulus amplitude and be averaged arithmetically across listeners. Other implications are discussed, and the obtained differences between the thresholds in different conditions are compared to the literature.

PMID:37413706 | DOI:10.1016/j.heares.2023.108837

Chic Med J. 1875 Aug;32(8):639-640.

NO ABSTRACT

PMID:37413629 | PMC:PMC9812181

Chic Med J. 1875 May;32(5):398-400.

NO ABSTRACT

PMID:37413624 | PMC:PMC9812173

Chic Med J. 1875 Jul;32(7):559-560.

NO ABSTRACT

PMID:37413605 | PMC:PMC9812148

Chic Med J. 1875 Apr;32(4):318-320.

NO ABSTRACT

PMID:37413598 | PMC:PMC9812136

Chic Med J. 1875 Mar;32(3):238-240.

NO ABSTRACT

PMID:37413588 | PMC:PMC9812121

Chic Med J. 1875 Jan;32(1):78-80.

NO ABSTRACT

PMID:37413579 | PMC:PMC9812078

Chic Med J. 1875 Feb;32(2):158-160.

NO ABSTRACT

PMID:37413569 | PMC:PMC9812053