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Assessment of the Current State of Pharmacovigilance System in Pakistan Using Indicator-Based Assessment Tool.

ABSTRACT: Objectives: Pakistan felt the need for an effective and robust pharmacovigilance (PV) system after one of the deadliest drug-related tragedies causing more than 300 deaths in 2012. The country set up its national PV center in 2015 and joined WHO's Program for International Drug Monitoring (PIDM) in 2018 as a full member. The current study was aimed to evaluate the PV system's functionality, identify the gaps, areas of improvement, and a strategy to lead a functional PV system in Pakistan. Methods: The descriptive cross-sectional study was conducted by providing an interviewer-administered questionnaire of the PV system across Pakistan by utilizing the Indicator based Pharmacovigilance assessment tool (IPAT). By a convenience sampling method 36 study participants were selected from the Drug Regulatory Authority of Pakistan (DRAP), drug administration of provincial health departments of 4 provinces and federally affiliated areas, 5 national public health programs, and 23 public and private hospitals. The assessment includes document review, interviews of the key informants by structured open-ended questions, and a review of websites of relevant organizations. Results: Drug Regulatory Authority of Pakistan (DRAP) with a national PV center received a 75% overall performance score on IPAT. To be regarded as "minimally functioning," a country's PV and drug safety system must meet all core indicators. DRAP scored 80.76% on the core indicators so cannot be deemed functional at this time. The only province with a regional PV center, Punjab, had scored 72.13% on relevant parameters. Despite receiving funding from the Global Fund, none of the National Public Health Programs (PHPs) have PV centers or associated activities. All hospitals except two private hospitals could not qualify the minimum requirements for functional PV. The absence of a legal framework for mandatory ADR reporting, lack of drug information center, budgetary constraints, no active surveillance activities, the nonexistence of pharmacovigilance risk assessment expert committee, and insufficient coordination among stakeholders were identified as major gaps. Conclusion: The results of the study reveal that Pakistan's PV system is not fully functional at all levels. A two-phased strategy encompassing the non-financial and financial interventions is proposed to improve the PV systems at the national, provincial, PHPs, and hospitals levels.

SUBMITTER: Khan MAA

PROVIDER: S-EPMC8795784 | biostudies-literature |

REPOSITORIES: biostudies-literature

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Project description:PurposeAs the number of cancer survivors grows, the responsibility for addressing their unique physical and emotional needs also increases. Survivorship care services vary by geography, health system, and insurance coverage. We aimed to understand the state of survivorship care services in Wisconsin's cancer facilities.MethodsThe selection of cancer treatment facilities sought to provide a geographically representative sample. An adapted Patient-Centered Survivorship Care Index was comprised of questions regarding different aspects of survivorship practices. Areas of interest included disciplines incorporated, services provided, standards of care, and discussion of late-term effects, among others.ResultsOut of 90 sites invited, 40 responded (44.4%). Oncologists, physician assistants, and nurse practitioners were the most common follow-up care disciplines. Risk reduction services, dietary services, access to physical activity, and behavioral health specialist referral were described as standards of care in less than half of sites. All sites reported working with community partners, 92.5% of which worked with YMCA-related programs. Discussion of long-term effects was a standard of care for all sites. Effects such as emotional distress and health practice changes were frequently discussed with almost all patients, while sexual functioning and fertility were not.ConclusionsServices and specialties related to behavioral health, fertility/sexual health, and rehabilitation and physical activity varied between sites. Such services may be offered less often due to variable insurance coverage.Implications for cancer survivorsPolicy solutions should be explored to increase insurance coverage and provision rates of necessary survivorship services to keep up with the projected increase in demand. Given imperfect and evolving measurement tools to assess needs for cancer survivorship care services, cancer survivors should feel empowered to voice when they have unmet needs and request referrals.

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Project description:BackgroundIn response to the COVID-19 pandemic, concerted efforts were made by provincial and federal governments to invest in critical care infrastructure and medical equipment to bridge the gap of resource-limitation in intensive care units (ICUs) across Pakistan. An initial step in creating a plan toward strengthening Pakistan's baseline critical care capacity was to carry out a needs-assessment within the country to assess gaps and devise strategies for improving the quality of critical care facilities.MethodsTo assess the baseline critical care capacity of Pakistan, we conducted a series of cross-sectional surveys of hospitals providing COVID-19 care across the country. These hospitals were pre-identified by the Health Services Academy (HSA), Pakistan. Surveys were administered via telephonic and on-site interviews and based on a unique checklist for assessing critical care units which was created from the Partners in Health 4S Framework, which is: Space, Staff, Stuff, and Systems. These components were scored, weighted equally, and then ranked into quartiles.ResultsA total of 106 hospitals were surveyed, with the majority being in the public sector (71.7%) and in the metropolitan setting (56.6%). We found infrastructure, staffing, and systems lacking as only 19.8% of hospitals had negative pressure rooms and 44.4% had quarantine facilities for staff. Merely 36.8% of hospitals employed accredited intensivists and 54.8% of hospitals maintained an ideal nurse-to-patient ratio. 31.1% of hospitals did not have a staffing model, while 37.7% of hospitals did not have surge policies. On Chi-square analysis, statistically significant differences (p < 0.05) were noted between public and private sectors along with metropolitan versus rural settings in various elements. Almost all ranks showed significant disparity between public-private and metropolitan-rural settings, with private and metropolitan hospitals having a greater proportion in the 1st rank, while public and rural hospitals had a greater proportion in the lower ranks.ConclusionPakistan has an underdeveloped critical care network with significant inequity between public-private and metropolitan-rural strata. We hope for future resource allocation and capacity development projects for critical care in order to reduce these disparities.

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Assessment of the Current State of Pharmacovigilance System in Pakistan Using Indicator-Based Assessment Tool.

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