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Fulltext A quantitative insight of the interactions of prescribers with pharmaceutical organization's representatives in clinical settings of Karachi

Shakeel S, Nesar S, Iffat W, Fatima B, Maqbool T, Jamshed S

Integr Pharm Res Pract, 2019;8:75-83.
PMID: 31309080 DOI: 10.2147/IPRP.S196318

Objectives: The study was conducted with the aim to evaluate the prescribers' approach of interaction with medical representatives for drug promotion. Methods: An explanatory, cross-sectional design was used to evaluate prescribers' interactions with the medical sales representatives (MSRs) through an anonymous, self-filled questionnaire from June to December 2017. Data presented as means±SEM or as percentages and statistically analyzed by one way ANOVA, using significance level of 0.05. Results: A response rate of 82.8% was achieved. More than 70% agreed that knowledge obtained from MSRs is reliable and useful. A large proportion of respondents acknowledged that MSRs are a key link between pharmaceutical companies and health care professionals, and their interactions are beneficial as MSRs perform an important teaching function. More than 45% agreed that gifts are influential; however, physicians cannot be compromised with very expensive gifts. The majority of the respondents (76%) considered that promotional items are ethically appropriate; however, 66.21% thought that promotional items influence the practice of prescribing. More than half (52.18%) deemed a promotional material more reliable than a printed advertisement. More than 80% of the respondents opined that medication samples are considered appropriate; however, they should only be given to those patients who cannot financially afford them. Around 69% thought that company-sponsored meetings promote their own drugs under the disguise of CME programs. Conclusion: The present study emphasizes the importance of employing scientifically sound prescribing decision by prescribers in their day to day practice without being influenced by pharmaceutical company's promotional activities. There is a need for restricting unprincipled practices by the concerned regulatory authorities to evade preventable harm to the patient's well-being.
Exploratory Findings of Prescribing Unlicensed and Off-Label Medicines Among Children and Neonates

Shakeel S, Iffat W, Nesar S, Zaidi H, Jamshed S

Integr Pharm Res Pract, 2020;9:33-39.
PMID: 32104664 DOI: 10.2147/IPRP.S231134

Objective: A cross-sectional study was carried out to evaluate the practice of unlicensed and off-label drug prescribing/dispensing in children and neonates by physicians and clinical pharmacists in the metropolitan city of Karachi.
Methods: The study was conducted for the duration of 5 months - November 2018 to March 2019 - in different clinics and tertiary care hospitals of Karachi, Pakistan. Respondents were interviewed by our researchers using 30 items questionnaire. Descriptive statistics were used to evaluate the answers of respondents to survey items. Pearson correlation and independent sample t-test were employed to recognize the association between the responses of participants and independent variables. P values less than 0.05 were considered statistically significant.
Results: A total of 421 questionnaires were completed by physicians and clinical pharmacists. The mean age of the study participants was 49.5 years. Around 98% of pharmacists and 93.5% of physicians were well conversant with the definition of unlicensed and off-label drugs. Around 68% of physicians and 77% of pharmacists reported that they were more concerned about the efficacy of such drugs as compared to that of licensed medicines in children. The most frequent off-label categories observed in the study were dose (65.21%) and indication (17.52%). A vast majority (>80%) thought that approving new drugs by regulatory authorities will drop the occurrence of medication errors due to incorrect dosing. The British National Formulary (BNF) for children was used as the best reliable source of information among respondents.
Conclusion: The present study highlighted the common practice of unlicensed and off-label drug prescribing in pediatrics; however, respondents showed their concern towards decreasing such practice and are likely to welcome initiatives intended to assure medication safety in children.
Fulltext Utilization and Impact of Electronic and Print Media on the Patients' Health Status: Physicians' Perspectives

Shakeel S, Nesar S, Rahim N, Iffat W, Ahmed HF, Rizvi M, et al.

J Pharm Bioallied Sci, 2017 Oct-Dec;9(4):266-271.
PMID: 29456378 DOI: 10.4103/jpbs.JPBS_327_16

Aims: Despite an increased popularity of print and electronic media applications, there is a paucity of data reflecting doctors' opinions regarding efficient utilization of these resources for the betterment of public health. Hence, this study aimed to investigate the perception of physicians toward the effect of electronic and print media on the health status of patients.
Setting and Design: The current research is a cross-sectional study conducted from January 2015 to July 2015. The study population comprised physicians rendering their services in different hospitals of Karachi, Pakistan, selected by the nonprobability convenience sampling technique. In this study, 500 questionnaires were distributed through email or direct correspondence.
Methods and Materials: Physicians' perception toward the impact of electronic and print media on the health status of patients was assessed with a 20-item questionnaire. Different demographic characteristics, such as age, gender, institution, position, and experience of respondents, were recorded. Quantitative data were analyzed with the use of Statistical Package for Social Sciences, version 20.0 (SPSS, Chicago, IL). The association of the demographic characteristics of the responses of physicians was determined by one-way ANOVA using 0.05 level of significance.
Results: In this study, 254 physicians provided consent to show their responses for research purposes. A response rate of 50.8% was obtained. Nearly one-third of the respondents negated that patients get health benefit using electronic and print media. The majority did not consider electronic and print media as lifestyle-modifying factors. Physicians thought that patients particularly do not rely on mass media for acquiring health information and consider healthcare professionals as unswerving information resource.
Conclusions: Mass media can be productive resources to augment awareness among patients, although physicians seem unconvinced about the extended usage of print/electronic media.
Fulltext Development and Validation of a Novel General Medication Adherence Scale (GMAS) for Chronic Illness Patients in Pakistan

Naqvi AA, Hassali MA, Rizvi M, Zehra A, Iffat W, Haseeb A, et al.

Front Pharmacol, 2018;9:1124.
PMID: 30356775 DOI: 10.3389/fphar.2018.01124

Objective: This study aimed to develop and validate a self-reporting adherence tool termed as General Medication Adherence Scale (GMAS) in Urdu language for measuring adherence toward medication use among Pakistani patients with a chronic disease. Methods: A month-long study (December 2017) was conducted in three tertiary health care settings of Karachi, Pakistan. The tool underwent content and face validity as well as factor analyses, i.e., exploratory, partial confirmatory and confirmatory factor analyses. Random sampling was conducted, and sample size was calculated using item response theory. The item-to-respondent ratio was 1:15. Fit indices namely normed fit index (NFI), Tucker Lewis index (TLI), comparative fit index (CFI), goodness of fit index (GFI), absolute goodness of fit (AGFI), parsimony goodness of fit index (PGFI), root mean square error of approximation (RMSEA), and standard root mean square residual (SRMR) were calculated. Additionally, estimation of the convergent, discriminant and known group validities, was conducted. Internal consistency was analyzed by test-retest reliability, McDonald's and Pearson correlation coefficient. The factor analyses were conducted using IBM SPSS version 22 and IBM SPSS AMOS version 25. Results: Content validity index (CVI) was reported at 0.8 (SD 0.147) and the tool was content validated with three hypothetical constructs. Factor analyses highlighted a 3-factor structure. The fit indices were calculated with satisfactory results, i.e., PGFI, GFI, AGFI, NFI, TLI, and CFI were greater than 0.9 and PGFI > 0.5. The values of RMSEA and SRMR were less than 0.07. A Cronbach's alpha value of 0.84 was obtained in reliability analysis. The test-retest Pearson's correlation coefficient value was reported at 0.996 (p-value < 0.01). Convergent and discriminant validities for all constructs and, known group validity for two constructs, were established. A high response rate of 91% was achieved in respondents. Patients without insurance coverage appeared to be low adherent compared to those with insurance coverage (p-value < 0.05). Non-comorbid patients were more likely to be highly adherent as compared to comorbid patients (p-value < 0.01). Conclusion: A novel tool GMAS was developed in Urdu language and was subsequently validated in patients with chronic diseases.
Fulltext Perspectives about Pandemic Influenza and Its Prophylactic Measures among Final Year Pharmacy Students in Karachi, Pakistan

Rahim N, Iffat W, Shakeel S, Naeem MI, Qazi F, Rizvi M, et al.

J Pharm Bioallied Sci, 2017 Apr-Jun;9(2):144-151.
PMID: 28717338 DOI: 10.4103/jpbs.JPBS_328_16

AIMS: In flu pandemics, pharmacy students' knowledge, attitudes, and practices are critical to save patients life. The objective of study was to determine the knowledge of and attitude toward the pandemic influenza among the pharmacy students of Karachi, Pakistan.
SETTINGS AND DESIGNS: The cross-sectional study was conducted from September to December 2014 by adopting a prevalidated questionnaire distributed to senior pharmacy students (final year) in seven private and public sector universities of Karachi.
MATERIALS AND METHODS: A total of 443 pharmacy students responded the survey. Data regarding sociodemographic characteristics of the students, perceptions, level of knowledge and attitudes toward influenza, and prophylactic measures were collected.
STATISTICAL ANALYSIS: To compute the correlation between different variables, data were analyzed using Pearson's Chi-square statistic method. P < 0.05 was considered statistical significance for all analysis.
RESULTS: Influenza was identified as a viral disease (n = 423; 95.48%) and 282 (71.2%) students correctly identified it as disease affecting humans and pigs. Textbooks reported as most common source of knowledge (n = 282; 64%). Most common symptoms identified were fever (81.94%), sore throat (64.1%), and nonproductive cough (43.34%). The most common preventive measures were covering nose and mouth (268; 60.5%) and wearing protective coverings (254; 57.3%). Only half of the students correctly reported about the route of administration (180; 40.6%) and strains in vaccine (186; 41.98%). The best time for administration of such vaccine was known by only 156 pharmacy students (35.34%). The majority of the students (82.6%) had no idea about the manifestation of influenza pandemic. Knowledge regarding influenza differed according to gender and institutions differing in their affiliation with tertiary care hospitals.
CONCLUSION: It was observed that knowledge about disease progression, transmission, vaccination, and treatment in pharmacy students, especially those who are not getting clinical training in tertiary care hospitals was limited. There is an urgent need to develop awareness programs to increase knowledge of influenza among clinical pharmacists as they are more susceptible to infections and community as a whole.
Fulltext Development and validation of the General Rehabilitation Adherence Scale (GRAS) in patients attending physical therapy clinics for musculoskeletal disorders

Naqvi AA, Hassali MA, Naqvi SBS, Shakeel S, Zia M, Fatima M, et al.

BMC Musculoskelet Disord, 2020 Feb 01;21(1):65.
PMID: 32007095 DOI: 10.1186/s12891-020-3078-y

BACKGROUND: Non-adherence to physical therapy ranges from 14 to 70%. This could adversely affect physical functioning and requires careful monitoring. Studies that describe designing and validation of adherence measuring scales are scant. There is a growing need to formulate adherence measures for this population. The aim was to develop and validate a novel tool named as the General Rehabilitation Adherence Scale (GRAS) to measure adherence to physical therapy treatment in Pakistani patients attending rehabilitation clinics for musculoskeletal disorders.
METHODS: A month-long study was conducted in patients attending physical therapy sessions at clinics in two tertiary care hospitals in Karachi, Pakistan. It was done using block randomization technique. Sample size was calculated based on item-to-respondent ratio of 1:20. The GRAS was developed and validated using content validity, factor analyses, known group validity, and sensitivity analysis. Receiver operator curve analysis was used to determine cut-off value. Reliability and internal consistency were measured using test-retest method. Data was analyzed through IBM SPSS version 23. The study was ethically approved (IRB-NOV:15).
RESULTS: A total of 300 responses were gathered. The response rate was 92%. The final version of GRAS contained 8 items and had a content validity index of 0.89. Sampling adequacy was satisfactory, (KMO 0.7, Bartlett's test p-value 0.95 while absolute fit index of root mean square of error of approximation was
Optimization of empagliflozin immediate release tablets (10 mg) using central composite rotatable design with response surface methodology

M Hanif A, Bushra R, Iffat W, Ghayas S, Perveen S, Riaz H, et al.

Pak J Pharm Sci, 2021 Jul;34(4(Supplementary)):1519-1525.
PMID: 34799327

Empagliflozin is a selective inhibitor of sodium glucose co-transporter II, given as mono therapy or an add-on treatment to reduce the glycated hemoglobin levels in type 2 diabetes. This work deals with designing, formulating and optimizing empagliflozin (10mg) immediate release (IR) tablets by direct compression technique using different excipients. Through central composite rotatable design (CCRD), total nine formulations (EF1-EF9) were generated by changing the composition of binder avicel PH 102® (X1) and superdisintegrant acdisol⌖ (X2). Formulation runs with in suitable weight range and powder properties were subjected to compression. The influence of interaction of excipients on friability (Y1), hardness (Y2) and disintegration (Y3) were analyzed by fitting the polynomial quadratic model with response surface methodology (RSM). Trials EF2, EF7, EF8 and EF9 exhibited acceptable tablet attributes upon physico-chemical testing. Different dissolution models were applied to observe the in vitro drug release pattern in phosphate buffer of pH 6.8. The cumulative drug release of IR tablet batches followed the Weibull kinetics with regression coefficient (r2) values of 0.983-0.992. Empagliflozin trials were exposed to accelerated storage conditions (40±2°C/ 75±5% RH) for stability testing. Shelf life period of exposed formulations were computed in range of 22 to 25 months. Keeping in view of the results, it is concluded that the employed technique of preparation and optimization are observed to be excellent for developing immediate release empagliflozin (10mg) tablets.
Development and validation of a novel rheumatoid arthritis knowledge assessment scale in Pakistani patients with rheumatoid arthritis

Naqvi AA, Hassali MA, Iffat W, Zia M, Fatima M, Shakeel S, et al.

Int J Rheum Dis, 2019 Nov;22(11):2031-2044.
PMID: 31595667 DOI: 10.1111/1756-185X.13721

AIM: Rheumatoid arthritis (RA) is a chronic progressive disabling disease that mainly affects joints. Studies documenting Pakistani patients' knowledge regarding RA disease are lacking and there is a need for such endeavor. The purpose of this study was to develop and validate a novel research tool to document patient knowledge about RA disease.
METHODS: A novel research instrument known as the rheumatoid arthritis knowledge assessment scale (RAKAS) which consisted of 13 items, was formulated by a rheumatology panel and used for this study. This study was conducted in rheumatology clinics of three tertiary care hospitals in Karachi, Pakistan. The study was conducted in March-April 2018. Patients were recruited using a randomized computer-generated list of appointments. Sample size was calculated based on item-to-respondent ratio of 1:15. The validities, factor structure, sensitivity, reliability and internal consistency of RAKAS were assessed. The study was approved by the institutional Ethics Committee.
RESULTS: A total of 263 patients responded to the study. Content validity was 0.93 and response rate was 89.6%. Factor analysis revealed a 3-factor structure. Fit indices, namely normed fit index (NFI), Tucker Lewis index (TLI), comparative fit index (CFI) and root mean square of error approximation (RMSEA) were calculated with satisfactory results, that is, NFI, TLI and CFI > 0.9, and RMSEA 19 and difficulty index <0.95. Sensitivity and specificity of RAKAS were above 90%. The tool established construct and known group validities.
CONCLUSION: A novel tool to document disease knowledge in patients with RA was formulated and validated.
Cross-culture adaptation and validation of English version of Rheumatoid Arthritis Knowledge Assessment Scale (RAKAS) in patients with rheumatoid arthritis

Naqvi AA, Hassali MA, Iffat W, Shakeel S, Zia M, Fatima M, et al.

Int J Rheum Dis, 2020 Jul;23(7):918-927.
PMID: 32525287 DOI: 10.1111/1756-185X.13860

AIM: To carry out cross-culture adaptation and validation of the English version of Rheumatoid Arthritis Knowledge Assessment Scale (RAKAS) in patients with rheumatoid arthritis (RA).
METHODS: A cross-sectional study was conducted for 2 months in 2 tertiary care hospitals in Karachi, Pakistan. Sample size was calculated based on item-subject ratio. The translation was carried out using standard procedures for translation and cross-culture adaptation. The validation process included estimation of discrimination power, item difficulty index, factorial, convergent, construct and known group validities and reliability. Reliability of the scale was estimated using Kuder-Richardson Formula 20 and a value of σ2 ≥ 0.6 was acceptable. SPSS v23, Remark Classic OMR v6 software and MedCalc Statistical Software v16.4.3, were used to analyze the data. The study was approved by the relevant ethics committee (IRB#NOV:15).
RESULTS: The mean score was 7.68 ± 2.52 (95% CI: 7.31-8.05) for 177 patients. The σ2 = 0.601, that is, >0.6, test-retest reliability ρ = .753, P
Fulltext Assessment of quality of work life (QWL) among healthcare staff of intensive care unit (ICU) and emergency unit during COVID-19 outbreak using WHOQoL-BREF

Bilal Maqsood M, Ashraful Islam M, Zeb-Un-Nisa, Abbas Naqvi A, Al Qarni A, Fuad Al-Karasneh A, et al.

Saudi Pharm J, 2021 Sep 20.
PMID: 34566456 DOI: 10.1016/j.jsps.2021.09.002

Objective: The study aimed to document the quality of work life (QWL) among healthcare staff of intensive care unit (ICU) and emergency unit during COVID-19 outbreak using WHOQoL-BREF.
Methods: A multicenter cross-sectional study was conducted for two months (May - June 2020) among healthcare staff working in intensive care units (ICUs) and emergency units of the hospitals under National Guard Health Authority (NGHA) across five cities of Saudi Arabia. The study used the WHOQoL-BREF instrument to document the QWL through an electronic institutional survey. The data was analyzed through IBM SPSS version 23. The study was approved by an ethics committee.
Results: A total of 290 healthcare professionals responded to the survey. The mean overall quality of life score was 3.37 ± 0.97, general health = 3.66 ± 0.88, domains, i.e., physical = 11.67 ± 2.16, psychological = 13.08 ± 2.14, social = 13.22 ± 3.31 and environment = 12.38 ± 2.59. Respondents aged > 40 years, male gender, married status, being a physician and, having a work experience > 15 years and no extra working hours, had higher mean scores for several domains of Quality of life (QoL), overall QoL and general health (p < 0.05).
Conclusion: The QWL among healthcare staff during COVID-19 pandemic was low. Demographic factors were mainly the determinants for a higher QWL while extra working hours was determinant of lower QWL. Despite the pandemic, no COVID-19 related variable affected the work life of healthcare staff.

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