scholarly journals Current landscape of pharmacovigilance in Pakistan

2021 ◽  
Vol 4 (2) ◽  
pp. 75-76
Author(s):  
Zairah Zulfiqar

Drug Regularity Authority of Pakistan came into being in 2012 after multiple casualties were reported due to dispensation of counterfeit & adulterated drugs. The primary purpose was to address any quality & efficacy issues related to medicines and encourage healthcare professionals to play their role in provision of safe medication therapy by practicing pharmacovigilance. Currently, a Medicine Surveillance portal for reporting is available for ADR reporting along with ADR and Drug & Device complaint forms. A new mobile app, MedSafety was recently launched to encourage public to report.

2020 ◽  
Author(s):  
Sooyoung Yoo ◽  
Kahyun Lim ◽  
Se Young Jung ◽  
Keehyuck Lee ◽  
Donghyun Lee ◽  
...  

BACKGROUND The US Health Information Technology for Economic and Clinical Health Act of 2009, which was intended to stimulate the use of electronic health record (EHR) systems, has been amended to cover the behavioral health sector. Consequently, there is an increased need for research on the adoption of behavioral EHR systems by healthcare professionals. Various quantitative studies based on the unified theory of acceptance and use of technology model and technology acceptance model have been conducted in the general medical sectors, but few studies have been conducted in the behavioral sector and they have all been interview-based qualitative studies. OBJECTIVE To evaluate the adoption and implementation of a behavioral EHR system for behavioral clinical professionals through a modified clinical adoption (CA) research model quantitative study. METHODS We modified the existing CA framework to be suitable for evaluating the adoption of the EHR system by behavioral clinical professionals. The existing CA framework did not present questionnaire items. Accordingly, we designed a questionnaire with items that fit into the dimensions of the CA framework and it was verified through the review of behavioral clinical professionals and a pre-survey. The full-scale survey was administered in 5 US behavioral hospitals. The data were analyzed using a structural equation analysis. Additionally, open-ended question responses were qualitatively analyzed. RESULTS We derived a total of 7 dimensions, excluding dimensions that were evaluated as inappropriate for behavioral clinical professionals to respond. In addition, for 2 dimensions, 2 sub-dimensions were classified. A total of 409 behavioral clinical experts from 5 hospitals were surveyed. The ease of use and organizational support significantly influenced the use of the behavioral EHR system. Although the results were not significant, information quality (path coefficient=1.19, P>.05) and service quality (path coefficient=.085, P>.05) tended to influence the ease of use of the system. And Ease of Use (path coefficient=.253, P<.05) and the Organization (path coefficient=.802, P<.05) influenced the use of the system. The qualitative results indicated that the greatest advantage of the adoption of the behavioral EHR system was the ability to search for information quickly, work efficiently, and access patient information even outside of the hospital through the mobile app, resulting in having more time with patients. Conversely, the greatest disadvantage was an overdependence on the EHR system. Many staff members voiced concerns that their work could be paralyzed when the system was unstable. CONCLUSIONS This study designed a model for evaluating behavioral EHR adoption and conducted a quantitative study to derive the factors associated with the successful introduction of an EHR system in a behavioral environment. CLINICALTRIAL The study was approved by the Institutional Review Board of Seoul National University Bundang Hospital (SNUBH) (IRB No.: B-1904-534-301).


Author(s):  
Rabia Hussain ◽  
Mohamed Azmi Hassali ◽  
Anees ur Rehman ◽  
Jaya Muneswarao ◽  
Muhammad Atif ◽  
...  

The contribution of all key healthcare professionals is vital to promote an efficient adverse drug reaction (ADR) reporting system. In this context, nurses are important as they are in a better position to observe a patient’s response regarding the drug therapy and to report an ADR. The aim of the study was to explore the perspectives of nurses about ADR reporting system in Lahore, Pakistan. A total of 21 nurses were interviewed. The thematic content analysis of the qualitative interviews yielded six major themes and eight subthemes. Major themes included: (1) Knowledge about the concept of the medication safety & the ADR; (2) Knowledge regarding pharmacovigilance activities; (3) Willingness to report; (4) Practices related to the ADR reporting; (5) Barriers to the ADR reporting; (6) Facilitators to the ADR reporting. The majority of the nurses were aware of medicine safety and ADRs, but in many cases, they were unable to report these ADRs. The study pointed out considerable concerns regarding the knowledge and practices of nurses about pharmacovigilance activities in their workplace, mainly due to increased workload, due to the absence of a reporting system and legal liability. The main challenges turned out to be the lack of knowledge and training, as well as the implementation of guidelines. Based on the findings, it is suggested that outcome of this study can serve as a guide to design policies that support ADR reporting by nurses in Pakistan.


2020 ◽  
Author(s):  
Jason R. Bobe ◽  
Jessica K. De Freitas ◽  
Benjamin S. Glicksberg

AbstractBackgroundN-of-1 trials are single patient, multiple crossover, comparative effectiveness experiments. Despite their rating as “level 1” evidence, they are not routinely used in clinical medicine to evaluate the effectiveness of treatments.ObjectiveWe explored the potential for implementing a mobile app-based n-of-1 trial platform for collaborative use by clinicians and patients to support data-driven decisions around the treatment of insomnia.MethodsA survey assessing awareness and utilization of n-of-1 trials was administered to healthcare professionals that frequently treat patients with insomnia at the Icahn School of Medicine at Mount Sinai in New York City. 1M electronic health records were analyzed to evaluate evidence for a comorbid relationship between insomnia and dementia or Alzheimer’s disease among a patient population that may benefit from n-of-1 trials for the selection of optimal sleep treatments.ResultsA total of 45 healthcare professionals completed the survey and were included in the analysis. We found that 64% of healthcare professionals surveyed had not heard of n-of-1 trials. After a brief description of these methods, 75% of healthcare professionals reported that they are likely or highly likely to use an app-based n-of-1 trial at least once in the next year if the service were free and easy to offer to their patients.ConclusionsAn app-based n-of-1 trials platform might be a valuable tool for clinicians and patients to identify the best treatments for insomnia. Educational interventions that raise awareness and provide training are also likely necessary. The electronic health record (EHR) may help identify eligible patients.


2020 ◽  
Author(s):  
Ronald Kiguba ◽  
Helen Byomire Ndagije ◽  
Victoria Nambasa ◽  
Leonard Manirakiza ◽  
Elijah Kirabira ◽  
...  

Abstract Background: This study aimed to determine the extent and associated factors of past 6-month reporting of artemisinin-based combination therapy (ACT)-failure by healthcare professionals (HCPs); and difficulties and solutions to the pharmacovigilance (PV) of ACT therapeutic ineffectiveness.Methods: Survey of 685 HCPs from June to July 2018 in purposively selected public and private health facilities in Uganda.Results: One in five [20%, 137/685; 95% confidence intervals (CI) 17% to 23%] HCPs reported ACT-failure to any authority in the previous 6-months. HCPs commonly reported ACT-failure to immediate supervisors (72%, 106/147), mostly verbally only (80%, 109/137); none had ever reported a written ACT-failure to Uganda’s National Pharmacovigilance Centre. Common difficulties to reporting ACT-failure were; unavailability of reporting procedures (31%, 129/421), poor follow-up of treated patients (22%, 93/421) and absence of reporting tools (16%, 68/421). Factors associated with reporting ACT-failure in past 6-months were: hospital-status (vs other; OR = 2.4, 95% CI, 1.41 to 4.21), HCPs aged under 25 years (OR = 2.2, 95% CI, 1.29 to 3.76), suspicion of ACT-failure in past 4-weeks (OR = 2.3, 95% CI, 1.29 to 3.92), receipt of patient-complaint(s) of ACT-failure in past 4-weeks (OR = 2.9, 95% CI, 1.62 to 5.12) and HCPs from northern (vs central; OR = 0.5, 95% CI, 0.28 to 0.93) and western (vs central; OR = 0.4, 95% CI, 0.17 to 0.77) parts of Uganda.Conclusion: One in five HCPs reported ACT-failure, mostly verbally to supervisors. The existing ADR-reporting infrastructure should be leveraged to promote the PV of ACT therapeutic ineffectiveness.


2021 ◽  
Author(s):  
Chao Sun ◽  
Lanbo Zhao ◽  
Lisong He ◽  
Zhihua Ma ◽  
Junkai Zou ◽  
...  

Abstract Objectives: To investigate the medical occupational risk and stress level of workplace violence (WPV) and novel coronavirus 2019 ( 2019-nCoV) pandemic in Chinese healthcare professionals (HPs).Methods: A national questionnaire survey was created to investigate HPs from 21 provinces of China. Seven questions in environment part and eight questions in stress part were used to assess medical occupation risk and stress respectively. Categorical data were statistically analyzed using chi-square tests. Structural equation model was performed to examine the correlations and differences among experiences of WPV, the 2019-nCoVpandemic, and occupational stress.Results:Totally, 1241 HPs completed the online survey from March 1st, 2020 to May 25th, 2020. The majority of the participants thought the current Chinese medical occupation was in inferior circumstance (n = 433, 34.89%), at high risk (n = 1082, 81.19%) and was in middle class (n = 717, 57.78%). Work-related stress ranked first of medical occupational risk (n = 786, 63.34%). When being asked the possility for their children to choose medicine, most HPs were uncertain (n = 542, 43.67%) or opposed (n = 547, 44.08%). More HPs thought there was no stress under 2019-nCoV pandemic (n = 303, 24.42%) than that under WPV (n = 48, 3.87%). WPV (Stress index = 3.23) put more pressure on HPs than the 2019-nCoV pandemic did (Stress index = 2.33) with significant difference (P = 0.006). WPV had a positive relationship with increasing doctor-patient conflicts (E=0.5, P0.000), and a negative correlation with ego-enhancement (E=-0.2, P=0.000) and public concern (E=-0.2, P=0.000). The 2019-nCoV pandemic had a positive correlation with ego-enhancement (E=0.09, P=0.006), the public's concern (E=0.1, P=0.002) and healthcare reform (E=0.1, P=0.000).Conclusions: Most HPs believe that the current environment for Chinese medical occupation is abominable and at high risk. Compared with WPV, the 2019-nCoV pandemic increases personal risks and reduces psychological stress to HPs. WPV weakens enthusiasm and significantly intensifies doctor-patient conflicts.


2021 ◽  
Vol 16 (1) ◽  
pp. 246-255
Author(s):  
Ang Wei Chern ◽  

Healthcare professionals (HCPs) in all healthcare facilities including public hospitals in Malaysia need to cooperate to meet the diverse healthcare demands. To date, there has yet detailed research on this collaboration in Malaysia. This study aimed to explore interdisciplinary collaboration in the Medical Department (wards and clinics) of a state hospital. Four focus group discussions (FGDs) were held. A medical specialist, medical officer, nurse manager/charge nurse, staff nurse, senior and junior clinical pharmacists were all present at each FGD. Purposive sampling was used to recruit participants (nomination by heads of department). FGDs were performed in English, but responses in Malay were accepted and translated into English. All FGDs were audio-recorded, transcribed, and analysed thematically. In the theme of role clarity, most participants opined that the doctors led in patient management, while the nurses were in charge of monitoring, ambulating and drug administration. However, some participants were unfamiliar with the role of pharmacists. The majority believed that effective collaboration did exist, but insufficient. Weak communication skills, lack of communication, personnel and time were obstacles to effective collaboration. Regular discussions between different disciplines can encourage interprofessional collaboration. Despite doctors acknowledging pharmacists' Medication Therapy Adherence Clinic (MTAC) services, and nurses' human immunodeficiency virus (HIV) counselling and diabetic education services, some nurses and pharmacists were unaware of each other's services. To avoid conflicting tasks and human resource wastage, each HCP's services should be actively promoted among other HCPs.


2020 ◽  
pp. 001857872095796
Author(s):  
Theophilus A. Adegbuyi ◽  
Joseph O. Fadare ◽  
Ebisola J. Araromi ◽  
Abayomi O. Sijuade ◽  
Iyanu Bankole ◽  
...  

Background: Adverse drug reactions (ADRs) constitute a significant global healthcare challenge associated with increased morbidity, mortality and healthcare costs; however, there are concerns that ADRs are grossly under-reported by different categories of healthcare professionals (HCPs) in many countries. The main objective of this study was to assess the knowledge, attitude and practice of ADR reporting of HCPs working at the primary, secondary and tertiary levels of care in Ekiti State, Nigeria. Methodology: This was a self-administered questionnaire-based study conducted among HCPs working in Ekiti State, South-west Nigeria. The questionnaire which was adapted from ones used in similar studies was reviewed for content validity by experts in the field. Healthcare professionals (medical doctors, pharmacists, nurses, community health extension workers, and other allied HCPs) working in the 3 tiers of healthcare participated in the study. The questionnaire consisted of sections on the demographics of respondents, their knowledge, attitude and practice of ADR reporting. Data analysis was done using SPSS (version 25) employing t test, ANOVA and chi-square as appropriate with P-value < .05 accepted as being statistically significant. Results: Three hundred HCPs comprising of nurses (112; 37.3%), physicians (75; 25.0%), pharmacists (53; 17.7%), community health extension workers (40; 13.3%) and others (20; 6.7%) completed the questionnaire with 166 (55.3%) of them working in tertiary healthcare facilities. Male respondents (6.3 ± 1.7; P = .003), pharmacists (7.0 ± 1.6; P < .0001), HCPs and those from tertiary centers (6.2 ± 1.7; P = .028) had higher knowledge scores. While 228 (76%) respondents had observed incidents of ADR during their professional practice, only 75 (25%) have ever reported it. Only 113 (37.7%) of respondents had seen the adverse drug reaction reporting form with only 53 (17.7%) ever using it. The reporting methods preferred by respondents were through email/internet (102; 34.0%), phone/SMS (78; 26.0%) and using the hard copy of the forms (95; 31.7%). The attitude of respondents towards ADR reporting was mainly positive. Conclusion: There was significant variation in the knowledge of different categories of HCPs and facility levels about ADR reporting. Encouragingly, the overall attitude of respondents towards ADR reporting was positive. Based on the above, strategies are needed to build capacity of HCPs in the area of on adverse drug reaction and its’ reporting.


2015 ◽  
pp. 1190-1196
Author(s):  
George E. Karagiannis ◽  
Lida Tzachani ◽  
Vasileios G. Stamatopoulos ◽  
Athina Lazakidou ◽  
Dimitra Iliopoulou ◽  
...  

A feasibility study was conducted to evaluate the acceptability and effectiveness of the “Safe medication through pharmacovigilance and compliance monitoring (PharmacoV)” service, an Internet-based interactive information tool that assists physicians in identifying potential Adverse Drug Events (ADEs) or contraindications when they are prescribing medicinal products to patients. The users' perception was assessed by the means of a structured questionnaire containing Likert type responses ranging from 1 to 5. Five hundred eighty nine (n=589) healthcare professionals were enrolled during an eight (8) month trial of the service in London, UK during 2007. The vast majority of the healthcare professionals who participated in the study was very enthusiastic about the PharmacoV concept and perceived clear benefits in terms of accessing drug information. The authors' results suggest that a well-designed intervention study is possible. This will allow the evaluation of the feasibility, acceptability and effectiveness of the intervention in the context of the different European healthcare systems, and may gradually shape an optimal health care system. Their study is limited to the specific extend that the pilot trial of the service could not be implemented as part of the routine clinical practice of the participating physicians mainly because of the need to continuously update the service functionality during the execution of the study.


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