Objective To investigate the current status of adverse drug reaction(ADR)monitoring in medical institu-tions under China's pharmacovigilance framework in Guangdong Province,and to propose evidence-based strategies for enhancing institutional monitoring capabilities.Methods A cross-sectional survey was conducted using a structured questionnaire devel-oped in alignment with national regulatory requirements and expert consensus.Data were collected from 65 medical institutions,including general hospitals,traditional Chinese medicine hospitals,and maternal/children's hospitals,across 21 prefecture-level cities in Guangdong.Descriptive and comparative analyses were performed to evaluate institutional practices.Results All 65 in-stitutions submitted valid responses.Among them,63(96.9％)had established standardized ADR reporting protocols,with 93.8％(61/65)delegating oversight to pharmacy departments.ADR data were predominantly collected via institutional informa-tion systems(67.7％,44/65),though these systems focused on passive reporting and basic data aggregation,lacking functional-ities for active signal detection or risk alert mechanisms.Significant disparities(P＜0.05)were observed across hospitals of dif-ferent tiers in reporting modalities,system sophistication,analytical frequency,and early warning implementation.Notably,mo-nitoring practices for conditionally approved drugs(e.g.,emergency-authorized therapeutics)exhibited systemic deficiencies.Conclusions To address these gaps,the following measures are recommended:Accelerating the adoption of intelligent monito-ring systems to enable real-time ADR detection and predictive analytics;Implementing tiered resource allocation policies to ensure equitable capability development;Establishing specialized protocols for high-risk pharmaceuticals,particularly conditionally ap-proved and fast-tracked drugs;Strengthening interdisciplinary training programs to improve pharmacovigilance literacy among healthcare practitioners.These interventions aim to foster a proactive risk management culture and advance patient safety within China's evolving healthcare landscape.

Objective To investigate the current status of adverse drug reaction(ADR)monitoring in medical institu-tions under China's pharmacovigilance framework in Guangdong Province,and to propose evidence-based strategies for enhancing institutional monitoring capabilities.Methods A cross-sectional survey was conducted using a structured questionnaire devel-oped in alignment with national regulatory requirements and expert consensus.Data were collected from 65 medical institutions,including general hospitals,traditional Chinese medicine hospitals,and maternal/children's hospitals,across 21 prefecture-level cities in Guangdong.Descriptive and comparative analyses were performed to evaluate institutional practices.Results All 65 in-stitutions submitted valid responses.Among them,63(96.9％)had established standardized ADR reporting protocols,with 93.8％(61/65)delegating oversight to pharmacy departments.ADR data were predominantly collected via institutional informa-tion systems(67.7％,44/65),though these systems focused on passive reporting and basic data aggregation,lacking functional-ities for active signal detection or risk alert mechanisms.Significant disparities(P＜0.05)were observed across hospitals of dif-ferent tiers in reporting modalities,system sophistication,analytical frequency,and early warning implementation.Notably,mo-nitoring practices for conditionally approved drugs(e.g.,emergency-authorized therapeutics)exhibited systemic deficiencies.Conclusions To address these gaps,the following measures are recommended:Accelerating the adoption of intelligent monito-ring systems to enable real-time ADR detection and predictive analytics;Implementing tiered resource allocation policies to ensure equitable capability development;Establishing specialized protocols for high-risk pharmaceuticals,particularly conditionally ap-proved and fast-tracked drugs;Strengthening interdisciplinary training programs to improve pharmacovigilance literacy among healthcare practitioners.These interventions aim to foster a proactive risk management culture and advance patient safety within China's evolving healthcare landscape.

A 93-year-old patient with Parkinson′s disease and Alzheimer disease received oral levodopa and benserazide hydrochlo-ride 375 mg/d,benzhexol hydrochloride 2 mg/d,donepezil hydro-chloride 5 mg/d,olanzapine 2.5-5.0 mg/d. The patient occasionally felt lower extremities weakness during the medication period. After having olanzapine two and a half years,laboratory examination showed the following levels:lactate dehydrogenase 351 U/L,creatine kinase 1 425 U/L,serum creatine 259 μmol/L. Rhabdomyolysis induced by olanzapine could not be excluded. Olanzapine was stopped. The treatments with an IV infusion of vitamin B650 mg dissolved in 0.9% sodium chloride injection 500 ml once daily and oral sodium bicarbonate 0.5 g thrice daily were given. On day 8,the patient′s lactate dehydrogenase level was 326 U/L,creatine kinase level was 355 U/L,serum creatine level was 63 μmol/L.

A 93-year-old patient with Parkinson′s disease and Alzheimer disease received oral levodopa and benserazide hydrochlo-ride 375 mg/d,benzhexol hydrochloride 2 mg/d,donepezil hydro-chloride 5 mg/d,olanzapine 2.5-5.0 mg/d. The patient occasionally felt lower extremities weakness during the medication period. After having olanzapine two and a half years,laboratory examination showed the following levels:lactate dehydrogenase 351 U/L,creatine kinase 1 425 U/L,serum creatine 259 μmol/L. Rhabdomyolysis induced by olanzapine could not be excluded. Olanzapine was stopped. The treatments with an IV infusion of vitamin B650 mg dissolved in 0.9% sodium chloride injection 500 ml once daily and oral sodium bicarbonate 0.5 g thrice daily were given. On day 8,the patient′s lactate dehydrogenase level was 326 U/L,creatine kinase level was 355 U/L,serum creatine level was 63 μmol/L.