1.National competent authority regulation and practice of drug benefit-risk communication in the United States,European Union and China
Yinan ZHANG ; Tingxi WU ; Zhigang ZHAO
Chinese Journal of Pharmacoepidemiology 2024;33(1):19-27
Safer drug use relies on the sustained vigilance and continual awareness of all individuals,and drug benefit-risk communication plays a pivotal role in facilitating this process.Foreign exploration on drug benefit-risk communication started relatively earlier.Upon scrutinizing the websites of drug regulatory authorities in the United States and Europe Union,it appears that these regions have established comprehensive communication regulation and practice systems,developed strategic plans and guidance,and communicated with healthcare professionals,patients and the public via various tools and channels,mainly including drug statutory information,new safety information,potential safety signals,etc.In China,drug benefit-risk communication is involved in the legislation,but the relevant guidelines and specific implementation rules are still lacking,and the evidence-based communication research and communication tools are relatively insufficient.We could learn from the experience of other countries,which involves enhancing regulatory implementation,establishing a communication framework,developing scientific evidence,assessing communication effectiveness,refining communication tools,and diminishing information barriers,in order to ultimately support patient and health care professionals to make informed decisions about medication.
2.Medication Evaluation of Elderly Inpatients Receiving Multiple Medication and Effect Evaluation of Clinical Pharmacist ’s Intervention
Tingxi WU ; Yunli XING ; Feng HUANG ; Chang XU ; Junxian YU
China Pharmacy 2019;30(22):3150-3154
OBJECTIVE: To evaluate the medication of elderly inpatients receiving multiple medication, to evaluate the effects of pharmaceutical care provided by clinical pharmacists, and to provide reference for clinical drug use of elderly patients. METHODS: The elderly inpatients receiving multiple medication were selected from Beijing Friendship Hospital Affiliated to Capital Medical University during Oct. 2018 to Feb. 2019. The process of pharmaceutical care for elderly inpatients was established and developed through the CGA team of the elderly. PCNE classification system was used to analyze drug-related problems; Bayliff tool was used to evaluate the harmfulness of drug-related problems; Morisky questionnaire was used to analyze medication compliance. Drug use was followed up 3 months after discharge to evaluate the effect of clinical pharmacist’s intervention. RESULTS: A total of 71 elderly inpatients with multiple medication were included, 73.24% of them (52 patients) suffered from 54 drug-related problems, 32 of which were related to therapeutic effects (59.26%), 13 (24.07%) drug adverse events (possible), 9 unnecessary drug therapy problems (16.67%). There were 69 causes of pharmaceutical related problems, of which 58 (84.06%) were doctor’s orders. The main causes were drug selection (36.23%), drug dosage (24.64%) and drug dosage form (20.29%). Totally 143 interventions were conducted by clinical pharmacists, including 102 successful interventions, with success rate of 71.33%. The highest acceptance of intervention was adverse drug events reporting(100%), followed by patient level (97.56%), doctor level (65.12%) and drug level (52.83%). Among 54 pharmaceutical-related problems, the most potential hazards were grade 1 hazards, involving 35 problems (64.81%). The score of medication compliance in patients who received medication education from clinical pharmacists was (6.19±0.58), which was significantly higher than (4.13±1.62) at the initial stage of admission (P<0.05). Follow-up results showed that 6 patients discontinued drugs by themselves, and 13 patients took drugs additionally by themselves. CONCLUSIONS: Drug related problems were common in elderly inpatients receiving multiple medication. Clinical pharmacists can establish a feasible pharmaceutical care process suitable for clinical needs according to the actual clinical situation. With the help of relevant evaluation tools such as relevant drug criteria, drug instructions and drug software, and at the same time, according to the physiological and pathological conditions of patients, they can cooperate with clinicians to select suitable therapeutic drugs for elderly patients to reduce the phenomenon of unreasonable medication and multiple medication, so as to improve the effectiveness and safety of drug use in the elderly.
3.Platelet antibody positive rate and influencing factors in common related diseases of platelet transfusion: A retrospective study
Yan WU ; Huan TU ; Tingxi ZHAN ; Xin LI ; Zebo YU
Chinese Journal of Blood Transfusion 2021;34(7):735-738
【Objective】 To explore platelet antibody production and its influencing factors in common platelet transfusion diseases. 【Methods】 From January 2018 to June 2020, patients who applied for platelet transfusion in the First Affiliated Hospital of Chongqing Medical University were enrolled. The solid phase agglutination method was used to detect the platelet antibodies of the patients. The platelet antibody positive rate of common platelet transfusion diseases and the types of diseases with higher platelet antibody-positive rates were analyzed. 【Results】 The overall positive rate of platelet antibodies in transfusion candidates was 15.0%. The 21~40 years old age patients(21.5%), females(18%) had a significantly higher platelet antibody positive rate than other ages and males(12.1%) (P<0.05). Besides, patients with a history of blood transfusion and pregnancy also had a higher platelet antibody positive rate. Tumors, blood and hematopoietic organ diseases, and digestive system diseases have higher platelet antibody-positive rates, which were 24.0%, 18.3%, and 16.6%, respectively. The platelet antibody positive rate varies significantly in common platelet transfusion diseases. As to transfused patients stratified by diseases, the platelet antibody positive rate of myeloid leukemia(48.7%)was higher than that of other diseases(P<0.05). In comparison, the platelet antibody positive rate of non-transfusion patients with liver failure and miscellaneous diseases(46.7%)was higher than that of others (P<0.05). 【Conclusion】 The positive rate of platelet antibody is somewhat higher in female, 21~40 years old patients. History of blood transfusion is a key risk factor for the production of platelet antibodies.