Assessment of Patient Safety Culture in Primary Health Care Settings in Kuwait

Background Patient safety is critical component of health care quality. We aimed to assess the awareness of primary healthcare staff members about patient safety culture and explore the areas of deficiency and opportunities for improvement concerning this issue. Methods: This descriptive cross sectional study surveyed 369 staff members in four primary healthcare centers in Kuwait using self-administered “Hospital Survey on Patient Safety Culture” adopted questionnaire. The total number of respondents was 276 participants (response rate = 74.79%). Results: Five safety dimensions with lowest positivity (less than 50%) were identified and these are; the non – punitive response to errors, frequency of event reporting, staffing, communication openness, center handoffs and transitions with the following percentages of positivity 24%, 32%, 41%, 45% and 47% respectively. The dimensions of highest positivity were teamwork within the center’s units (82%) and organizational learning (75%). Conclusion: Patient safety culture in primary healthcare settings in Kuwait is not as strong as improvements for the provision of safe health care. Well-designed patient safety initiatives are needed to be integrated with organizational policies, particularly the pressing need to address the bioethical component of medical errors and their disclosure, communication openness and emotional issues related to them and investing the bright areas of skillful organizational learning and strong team working attitudes.   &nbsp

Validated potentiometric method for the determination of sulfacetamide sodium; application to its pharmaceutical formulations and spiked rabbit aqueous humor

Specific, accurate and precise electrochemical method was developed and validated for the determination of sulfacetamide sodium in presence of its co-formulated drug (prednisolone acetate) and its pharmacopoeial impurities. The method was based on fabrication of membrane sensor. The characteristics of electrochemical response were estimated, and the proposed sensor displayed excellent characteristics for the determination of sulfacetamide sodium in bulk powder, laboratory prepared mixtures, dosage forms and in spiked biological fluid (Rabbit aqueous humor). The sensor was constructed through the use of tetradodecylammonium bromide (TDB) as an anion exchanger and 2-nitrophenyl octyl ether (NPOE) as a plasticizer in polyvinyl chloride (PVC) matrix. The performance characteristics, sensitivity and selectivity were evaluated according to IUPAC guidelines. Linearity was achieved over the concentration range of 1 × 10−4.5–1 × 10−2 M with Nernstian slope of 51.086 mV/decade over the pH range of 5–7. The sensor showed a rapid response (10–15 s) and good stability (up to 4 weeks). The obtained results were statistically compared with the official methods and no significant difference was found regarding accuracy and precision. Keywords: Ion selective electrodes, Prednisolone acetate, Rabbit aqueous humor, Sulfacetamide sodium, Tetradodecylammonium bromid

Simultaneous Determination of Aspirin, Dipyridamole and Two of Their Related Impurities in Capsules by Validated TLC-Densitometric and HPLC Methods

Aspirin (ASP) and dipyridamole (DIP) are widely used as a combination in pharmaceutical formulations for treatment of strokes. Many of these formulations are containing tartaric acid as an excipient (in DIP pellets formulation for sustained release), which increases the probability of formation of dipyridamole tartaric acid ester impurity (DIP-I). On the other hand, salicylic acid (SAL) is considered to be one of the synthesis impurities and a degradation product of ASP. In this work, two chromatographic methods, namely, TLC-densitometry and HPLC, have been established and validated for simultaneous determination of ASP, DIP, SAL and DIP-I. Good separation was achieved by using silica gel as stationary phase and toluene–methanol–ethyl acetate (2:3:5, by volume) as mobile phase in the case of TLC-densitometry and Zorbax ODS column with mobile phase consisting of phosphate buffer (pH 3.3)–acetonitrile–triethylamine (40:60:0.03, by volume) for HPLC. Influence of different organic solvents in mobile phase composition has been studied to optimize the separation efficiency in TLC densitometry. Moreover, factors affecting the efficiency of HPLC, like pH of the buffer used, organic solvent ratio in the mobile phase and flow rate, have been carefully studied using one variable at a time approach. Finally, the proposed methods were validated as per ICH guidelines

Stability-indicating methods for the determination of pipazethate HCl in the presence of its alkaline degradation product

Three different accurate, sensitive and reproducible stability-indicating methods for the determination of pipazethate HCl in the presence of its alkaline degradation product are presented. The first method is based on ratio-spectra 1st derivative (RSD1) spectrophotometry of the drug at 305 nm, over a concentration range of 10–70 μg mL−1 with mean percentage recovery of 99.69 ± 1.10. The second method utilises quantitative densitometric evaluation of thin-layer chromatography of pipazethate HCl in the presence of its alkaline degradation product, using methanol: ethyl acetate: ammonia (8:2:0.2, v/v/v) as a mobile phase. Chromatograms are scanned at 251 nm. This method analyses pipazethate HCl in a concentration range of 4–14 μg/spot with mean percentage recovery of 100.19 ± 0.77. The third method is an HPLC method for the simultaneous determination of pipazethate HCl in the presence of its alkaline degradation product. The mobile phase consists of methanol: ammonium sulphate (1%), pH = 5.7, (80:20, v/v). The standard curve of pipazethate HCl shows a good linearity over a concentration range of 5–200 μg mL−1 with mean percentage recovery of 100.67 ± 0.91. These methods were successfully applied to the determination of pipazethate HCl in bulk powder, laboratory-prepared mixtures containing different percentages of the degradation product and pharmaceutical dosage forms. The validity of results was assessed by applying standard addition technique. The results obtained were found to agree statistically with those obtained by a reported method, showing no significant difference with respect to accuracy and precision

Stability-indicating spectrophotometric methods for determination of the anticoagulant drug apixaban in the presence of its hydrolytic degradation product

Apixaban (a novel anticoagulant agent) was subjected to a stress stability study including acid, alkali, oxidative, photolytic, and thermal degradation. The drug was found to be only liable to acidic and alkaline hydrolysis. The degradation product was then isolated and identified by IR and GC–mass spectrometry. Four spectrophotometric methods, namely; first derivative (D1), derivative ratio (DR), ratio difference (RD) and mean centering of ratio spectra (MCR), have been suggested for the determination of apixaban in presence of its hydrolytic degradation product. The proposed methods do not require any preliminary separation step. The accuracy, precision and linearity ranges of the proposed methods were determined, and the methods were validated as per ICH guidelines and the specificity was assessed by analyzing synthetic mixtures containing different percentages of the degradation product with the drug. The developed methods were successfully applied for the determination of apixaban in bulk powder and its tablet dosage form

Stability-indicating chromatographic methods for determination of flecainide acetate in the presence of its degradation products; isolation and identification of two of its impurities

ABSTRACT: In this work, two stability-indicating chromatographic methods have been developed and validated for determination of flecainide acetate (an antiarrhythmic drug) in the presence of its degradation products (flecainide impurities; B and D). Flecainide acetate was subjected to a stress stability study including acid, alkali, oxidative, photolytic and thermal degradation. The suggested chromatographic methods included the use of thin layer chromatography (TLC-densitometry) and highperformance liquid chromatography (HPLC). The TLC method employed aluminum TLC plates precoated with silica gel G.F as the stationary phase and methanol–ethyl acetate–33%ammonia (3:7:0.3, by volume) as the mobile phase. The chromatograms were scanned at 290 nm and visualized in daylight by the aid of iodine vapor. The developed HPLC method used a RP-C column with isocratic elution. Separation was achieved using a mobile phase composed of phosphate buffer pH3.3–acetonitrile– triethylamine (53:47:0.03, by volume) at a flow rate of 1.0 mL/min and UV detection at 292 nm. Factors affecting the efficiency of HPLC method have been studied carefully to reach the optimum conditions for separation. The developed methods were validated according to the International Conference on Harmonization guidelines and were applied for bulk powder and dosage form

Smart chemometrics-assisted spectrophotometric methods for efficient resolution and simultaneous determination of paracetamol, caffeine, drotaverine HCl along with three of their corresponding related impurities

Abstract Three novel, simple and accurate multivariate spectrophotometric assisted mathematical techniques were developed for determination of paracetamol, caffeine, drotaverine HCl and their related impurities. The used multivariate algorithms are principal component regression (PCR), partial least squares (PLS), and synergy intervals partial least squares (siPLS). Linearity of the suggested methods was found to be (1.00–14.60, 1.40–7.00, 1.40–3.80, 1.00–3.00, 1.50–3.50 and 2.50–4.50 µg/mL) for paracetamol, caffeine, drotaverine HCl, and their related impurities; p-aminophenol, theophylline and homoveratric acid, correspondingly. The presented methods were effectively implemented in the determination of the cited compounds in their laboratory prepared mixtures. Commercially available tablet preparation was also analyzed using the applied methods where no impurities were detected and without interference from tablet additives. Moreover, statistical analysis did not reveal any noticeable differences between the obtained results and those acquired from the reported method in terms of accuracy and precision. The developed multivariate algorithms were validated by means of internal and external validation sets. The obtained results showed the siPLS algorithm’s superiority to PCR and PLS according to the values of correlation coefficient values (r) and the lowest root mean square error of prediction (RMSEP). The combination of four subintervals [10, 12, 14, and 17] produced the highest efficiency model. Furthermore, these methods may be an applicable substitute to HPLC ones in quality control laboratories during rush of analyses where several samples have to be analyzed in a short time