Many factors affect the occurrence of ADRs. Some of these factors can be changed like smoking or alcohol intake others cannot be changed like age, presence of other diseases or genetic factors. Understanding the different effects of these factors on ADRs enables healthcare professionals to choose the most appropriate medication for that particular patient. It also helps the healthcare professionals to give the best advice to patients. Pharmacogenomics is the most recent science which emphasizes the genetic predisposition of ADRs. This innovative science provides a new perspective in dealing with the decision making process of drug selection.

Background: To highlight the importance of spontaneous reporting programs in post marketing surveillance of medicines. Authors also aimed at providing various dimensions of spontaneous programs, including the strengths and weakness, and providing an insight on the future prospects of pharmacovigilance systems. Methods: Various literature related to post marketing surveillance and spontaneous reporting programs were reviewed and the relevant ones highlighting the strengths and weaknesses are summarized. A balance of information on strengths and weaknesses is listed. The health professionals’ awareness regarding existing spontaneous reporting programs is highlighted. Future prospects of pharmacovigilance are discussed. Results: Though beneficial, spontaneous reporting programs encounter several limitations and difficulties in diagnosing adverse drug reaction. Under-reporting and bias are major challenges. Online signal detection tools and innovative methods are needed to strengthen the spontaneous reporting programs. We provide the various issues to be considered while depending on spontaneous reporting programs as a method of post marketing surveillance. Conclusion: To strengthen the spontaneous reporting programs as an effective post marketing surveillance method, more awareness among health professionals and innovative strategies is needed. Integrating pharmacogenetic data can be a potential aspect of future pharmacovigilance. Plain language summary Monitoring adverse effects of marketed medicines through reporting by healthcare professionals and its challenges and way forward Introduction: This article highlights the importance of safety monitoring of medicines after they are launched in the market, mainly through reporting by healthcare professionals. We also highlight the strengths and weaknesses, and provide an insight on the future prospects of pharmacovigilance systems. Methods: Various literature related to the topic were reviewed and the relevant ones highlighting the strengths and weaknesses are summarized. A balance of information on strengths and weaknesses is listed. Health professionals’ awareness regarding existing programs on reporting safety of medicines is highlighted. Results: Though beneficial, reporting of adverse effects by healthcare professionals who deal with patient lacks clarity in diagnosing the adverse effects. Under-reporting and bias are the major challenges. Online software is needed to strengthen reporting by healthcare professionals. We list the various issues to be considered while depending on healthcare professionals’ reporting of adverse effects as a method of post marketing surveillance. Conclusion: To strengthen medicine safety monitoring and reporting by healthcare professionals, more awareness among health professionals and innovative strategies are needed. Integrating the genetic data of patients can be beneficial in predicting adverse effects, therefore avoiding them and enhancing safe prescribing and dispensing by healthcare professionals.

Pharmaceutical care (PC) practice is still limited in the United Arab Emirates. It is crucial to understand pharmacy students’ attitudes and their perceived barriers towards PC provision, to evaluate the effectiveness of theoretical and practical curricula in creating positive attitudes toward PC. This study aims to assess attitudes of final year undergraduate pharmacy students in the United Arab Emirates (UAE), and the barriers perceived by them to practice PC. A cross-sectional survey-based study was conducted in February and March, 2020, involving colleges in UAE offering undergraduate pharmacy programs and having students in their final year. Participants filled a questionnaire covering attitudes’ items, based on the Pharmaceutical Care Attitudes Survey (PCAS), and several perceived barriers. A stratified sample of 193 students participated from six universities, 85% were females, 92.2% and 64.8% completed or engaged in community and hospital pharmacy training respectively, at the time of the study. Attitudes’ items receiving the highest agreement were PC will improve patient health (95.3%), all pharmacists should perform PC (93.3%) and PC would benefit pharmacists (92.7%). However, 44.6% agreed PC is not worth the additional workload. Females showed higher attitudes’ total scores, median (IQR): 55 (51–58) and 52 (49–55.5) for females and males respectively, P = 0.032. Having incomplete courses was also associated with lower scores, median (IQR): 55 (51–58) and 52 (48.5–55.5) for “No” and “Yes” respectively, P = 0.048. Poor image of the pharmacist’s role and lack of private counseling area or inappropriate pharmacy layout were the most perceived barriers, with around 78% agreement. In conclusion, final year undergraduate pharmacy students in the UAE have positive attitudes towards pharmaceutical care. The current curricula may be satisfactory in fostering positive attitudes among students. Poor image of the pharmacist’s role and lack of counseling area or inappropriate pharmacy layout were the main barriers identified, among other barriers.

*Objective: The objective of this study is to assess the performance of community pharmacist towards antidiabetic and antiasthma prescriptions, and also to assess the lack of information provided by community pharmacists regarding patient counseling and missing data, using a simulated patient technique. Methods: A prescription including antidiabetic and antiasthma drugs was used by simulated patient to assess community pharmacist's performance in 194 pharmacies. A performance assessment sheet was used to measure the patient counseling process. A quantitative descriptive and comparative analysis was done for the collected data. Pearson chi-square test (crosstabs) was used with a level of significance 95%). Results: The analysis of the 194 pharmacies visited revealed that most of the pharmacists were male (61%), Arabs (35%) and Indians (55%) with some other nationalities. The dispensing time in the pharmacy ranged between 2 to 10 minutes. Spending time with patients was not affected by gender (p-value 0.087), slightly affected by nationality (p-value 0.04), and highly affected by age (p-value 0.002) leaning towards older pharmacists who spent more time with patients than younger pharmacists. Most pharmacists (90%) started preparing the prescription once they received the prescription with no actual prescription screening. fifty five percent of the pharmacists asked about the duration of the treatment after preparing the prescription. ninety six percent did not counsel patients about diet, exercise and lifestyle changes. Less than 40% asked if the prescription was intended to be used for the same patient. EVALUACIÓN DEL COMPORTAMIENTO DE LOS FARMACEUTICOS COMUNITARIOS ANTE UNA PRESCRIPCIÓN DE ANTIDIABÉTICOS Y ANTIASMÁTICOS RESUMENObjetivo: El objetivo de este estudio es evaluar la actuación de los farmacéuticos comunitarios ante una prescripción de antidiabéticos y antiasmáticos, así como evaluar la falta de información proporcionada por los farmacéuticos comunitarios en relación al consejo a paciente y datos omitidos, utiizando una técnica de paciente simulado. Métodos: Un paciente simulado utilizó una receta que incluía medicamentos antidiabéticos y antiasmáticos para evaluar la actuación de los farmacéuticos comunitarios en 194 farmacias. Para medir el proceso de aconsejamiento del paciente, se utilizó una hoja de control de actuación. Con los datos recogidos se realizó un análisis descriptivo cuantitativo. Se utilizaron pruebas chi-cuadrado de Pearson (crosstabs) con un nivel e significación del 95%. Resultados: El análisis de las 194 farmacias visitadas reveló que la mayoría e los farmacéuticos eran hombres (61%), árabes (35%) e Indios (55%) con algunas otras nacionalidades. El tiempo de dispensación en la farmacia osciló entre 2 y 10 minutos. El tiempo pasado con los pacientes no estuvo afectado por el género (p=0,087), ligeramente afectado por la nacionalidad (p=0,04), y altamente afectado por la edad (p=0,002), aumentando hacia los mayores farmacéuticos, que pasaban más tiempo que los jóvenes. La ...

To evaluate the pharmacist's assessment of patient eligibility for safe use of isotretinoin and the quality of pharmacist's counseling. Patients and Methods: A covert simulated patient (SP) methodology was used in which a trained female researcher, who was 25 years old, played the patient's role through this cross-sectional study by visiting community pharmacies and requesting isotretinoin capsules through a controlled prescription. A data form was used to collect the information following each pharmacy visit by asking about medical/family history and providing comprehensive counseling about the most common adverse effects, proper use instructions, and the importance of adherence to medication. The pharmacists, who did not initiate counseling, were prompted by the SP. Results: The pharmacists in 400 pharmacies who agreed to participate were visited by the SP. Only 7 (2%) pharmacists provided a complete assessment of patient eligibility for using isotretinoin with comprehensive counseling. Most of the pharmacists (84%) provided incomplete assessment as indicated by the overall score. Only 11 (3%) pharmacists asked the six crucial questions for the assessment of patient eligibility. On prompting, only 6 (2%) pharmacists provided complete counseling about the expected adverse effects. The most frequently provided adverse effect was dry skin, specifically dry lips (71.8%). A minority of 108 (27%) pharmacists provided education about the importance of using contraception during isotretinoin therapy. A complete level of counseling was provided by 125 (31.3%) pharmacists regarding the lab tests that the SP needs to undergo during therapy. Female pharmacists were more likely to provide counseling about the pregnancy test (mean=134, p=0.001). Conclusion: Suboptimal level of the patient's assessment was revealed with poor educational counseling by the community pharmacists. New strategies are needed to improve pharmaceutical care services in the UAE.

A BSTRACT Background: Adherence to antiepileptic drugs (AEDs) is an integral component of epilepsy management. There are no previous data in the United Arab Emirates (UAE). Objectives: The aim of this study was to assess the prevalence of AED adherence among patients attending the Neuro Spinal Hospital in UAE and to identify the predictors of nonadherence. Materials and Methods: A cross-sectional study was conducted between April 2018 and May 2019, and included consecutive patients with epileptic who were receiving AEDs for at least 6 months. A validated interviewer-administered questionnaire was used. Adherence was assessed by four-item Morisky’s Medication Adherence Scale with a score between 0 and 4. Patients were considered adherent or nonadherent for a score of zero, or 1 and more, respectively. Chi-square test, binary, and multiple logistic regression analysis were used. Results: The study included 315 respondents, 70.8% ( n = 223) were adherent, the rest were nonadherent. The most common factor affecting adherence was forgetfulness. Lower education level and having a seizure within the last 6 months were significant risk of nonadherence (odds ratio [OR] 95% confidence interval [CI] = 2.6 (1.2–5.8) and 2.5 (1.3–5.2), respectively), whereas levetiracetam intake reduces the risk of nonadherence (OR: 0.5 [0.2–0.9]). Conclusions: The prevalence of AED adherence was 70.8%. Education level and having a seizure in the last 6 months were significant predictors of nonadherence, whereas levetiracetam intake reduces the risk of nonadherence.

Purpose: To review in vitro testing and simulation platforms that are in current use to predict in vivo performances of generic products as well as other situations to provide evidence for biowaiver and support drug formulations development. Methods: Pubmed and Google Scholar databases were used to review published literature over the past 10 years. The terms used were “simulation AND bioequivalence” and “modeling AND bioequivalence” in the title field of databases, followed by screening, and then reviewing. Results: A total of 22 research papers were reviewed. Computer simulation using software such as GastroPlus™, PK-Sim® and SimCyp® find applications in drug modeling. Considering the wide use of optimization for in silico predictions to fit observed data, a careful review of publications is required to validate the reliability of these platforms. For immediate release (IR) drug products belonging to the Biopharmaceutics Classification System (BCS) classes I and III, difference factor (ƒ1) and similarity factor (ƒ2) are calculated from the in vitro dissolution data of drug formulations to support biowaiver; however, this method can be more discriminatory and may not be useful for all dissolution profiles. Conclusions: Computer simulation platforms need to improve their mechanistic physiologically based pharmacokinetic (PBPK) modeling, and if prospectively validated within a small percentage of error from the observed clinical data, they can be valuable tools in bioequivalence (BE) testing and formulation development.

Background: Social media can effectively mediate digital health interventions and thus, overcome barriers associated with face-to-face interaction. Objective: To assess the impact of patient-centered diabetes education program administered through WhatsApp on glycosylated hemoglobin (HbA1c) values, assess the correlation, if any, between health literacy and numeracy on intervention outcomes Methods: During an ‘intervention phase’ spread over six months, target diabetic patients (N=109) received structured education through WhatsApp as per the American Association of Diabetes Educators Self-Care Behaviors recommendations. The control group with an equal number of participants received ‘usual care’ provided by health professionals void of the social media intervention. Changes in HbA1c levels were recorded thrice (at baseline, 3 and 6 months) for the test group and twice (baseline and 6 months) for the control group. Change in HbA1c values were compared and statistical significance was defined at p<0.05. Baseline health literacy and diabetes numeracy were assessed for both groups (N=218) using the Literacy Assessment for Diabetes (LAD), and the Diabetes Numeracy Test (DNT), respectively, and values were correlated with HbA1c change p<0.05. Participants’ satisfaction with the intervention was also assessed. Results: The average age of respondents was 41.98 (SD 15.05) years, with a diabetes history of 10.2 (SD 8.5) years. At baseline, the average HbA1c in the control and test groups were 8.4 (SD 1.06) and 8.5 (SD 1.29), respectively. After six months, a significant drop in HbA1c value was noticed in intervention group (7.7; SD 1.35; p= 0.001); with no significance in the control group (8.4; SD 1.32; p=0.032, paired t-test). Moreover, the reduction in HbA1c was more in the test group (0.7%) than the control group (0.1%) with a difference of 0.6% which is considered clinically significant. There was no significant correlation between LAD score and HbA1c at baseline (r=-0.203, p=0.064), 3 months (r=-0.123, p=0.266) and 6 months (r=-0.106, p= 0.337) Pearson correlation. A similar result was observed with DNT, where DNT score and HbA1c at baseline, 3 months and 6 months showed no correlation (r=0.112, 0.959 and 0.886; respectively) with HbA1c levels. Eighty percent of the respondents found the social media intervention ‘beneficial’ and suggested it be used long term. Conclusions: Diabetes education via WhatsApp showed promising outcomes regardless of the level of patients’ health literacy or numeracy.