2021 Volume 23 Issue 8 Published: 31 August 2021
  

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  • Medication without harm, much work remains to be done
    Xiao Mingzhao
    2021, 23(8): 393-395. https://doi.org/10.3760/cma.j.cn114015-20210615-00677
    Abstract ( ) PDF ( )
    Patient safety is a serious global public health problem. In March 2017, World Health Organization (WHO) released the 3rd global patient safety challenge: Medication Without Harm, called for reducing serious and avoidable drug-related injuries in all countries by 50% in the next 5 years, and formulated a strategic action framework for medication safety at the same time. In June 2019, WHO released 3 technical reports, including medication safety in high-risk situations, medication safety in polypharmacy, and medication safety in transitions of care, so as to promote countries to take effective planning and actions as soon as possible to solve problems in the field of medication safety. In April 2021, WHO held a " Medication Without Harm" network conference, emphasizing that it′s an arduous and long-term work to achieve the goal. In May 2021, WHO issued the global patient safety action plan 2021—2030, which took medication safety as the most important task in the 3rd strategic goal, and put forward 4 actions for this task: actions for governments, actions for health care facilities and services, actions for stakeholder, and actions for the WHO. China′s National Health Commission issued the notice on further strengthening patient safety manage- ment in April 2018, focusing on promoting patient medication safety. The realization of the 3rd global patient safety challenge requires the joint efforts of all countries in the world.
  • Guidelines for prevention of medication errors in operating rooms of medical institutions
    Medication Safety Panel in China Core Group of International Network for the Rational Use of Drugs, Chinese Pharmacological Society Professional Committee of Drug-induced Diseases, et al
    2021, 23(8): 396-402. https://doi.org/10.3760/cma.j.cn114015-20210712-00785
    Abstract ( ) PDF ( )
    There are risks of medication error in the whole process of drug use and management in the operating room. The types of medication errors in operating room include prescription issuing/doctor′s order giving error, prescription/doctor′s order delivery error, drug dispensing error, labeling error, preparation error, drug application technology error, drug monitoring error, drug storage error, essential drug setting error, etc. The risk factors of medication errors in the operation room mainly exist in the links of prescription issuing and delivery, drug dispensing and distribution, drug administration and monitoring, drug management, etc. The prevention strategies of medication errors in operating room include technical strategies (mandatory and constraint strategies, implementation of automation and computerization, development of standardized identifiers and processes, establishment of audit project lists) and management strategies (recommending the management mode of operation pharmacy, increasing the support of clinical pharmacy, storing drugs in different areas in operation room, allocating human resources reasonably, standardizing management of drug maintenance, advocating safe drug use culture, and strengthening professional skills training based on post competency). This guideline is applicable to all personnel involved in the use and management of drugs in the operating room.
  • Construction and analysis on the implementation effect of an intelligent control system for narcotic drugs in hospital wards
    Qiu Tingting, Kong Xianwei, Yan Yingying, Cheng Yinchu, Liu Bin, Zhou Xinghan, Yang Yiheng
    2021, 23(8): 403-407. https://doi.org/10.3760/cma.j.cn114015-20210204-00154
    Abstract ( ) PDF ( )
    Objective To construct an intelligent control system for narcotic drugs in the wards of Peking University Third Hospital and evaluate its implementation effect.　Methods Based on the introduction of intelligent medicine cabinet, relevant software was developed to establish an intelligent control system for narcotic drugs, which connected with the intelligent medicine cabinet and hospital information system, and then formed an intelligent control system for narcotic drugs. In the control system, a remote database for essential narcotic drugs (essential drug database) in the wards was established and 2 closed-loop pathways for locking the batch number of narcotic drugs were designed according to whether the choice was essential drugs in the ward or drugs in the inpatient pharmacy. Based on the functional system of intelligent medicine cabinet, an intelligent management process for narcotic drugs was established, and process remode- ling was carried out in prescribing, prescription checking, drugs dispensing and distributing, and account registration, etc. The work efficiencies in remodeled processes before and after the implementation of the control system were compared.　Results The intelligent control system for narcotic drugs was successfully constructed. The essential drug database was deployed in all wards of the hospital and the remote management in the whole hospital was realized. Two closed-loop pathways that could lock the drug batch number effectively controlled the first-in-first-out of narcotic drugs and solved the problem in batch number tracing of narcotic drugs. Thus the fine control of closed-loop batch number tracing, real-time counting, and accurate searching of narcotic drugs in the whole process from entering the drug storage to being used in patients was realized. Because of the establishment of intelligent management process, the manual procedures of doctors in prescribing and drug dispensing and distribution were avoided and the prescription checking procedure of pharmacist were simplified, thus the accuracy in prescribing, prescription checking, and drug dispensing and distribution was improved. The time consumptions for doctors in issuing orders and prescribing, nurses in handling problematic prescriptions, pharmacists in prescription checking and drug dispensing and distribution, and pharmacy inventory and booklet registration etc. were significantly less after the implementation of the control system than before (all P<0.001), and the work efficiency was obviously improved.　Conclusion By constructing the intelligent management system for narcotic drugs in the hospital wards, the full-process closed-loop traceable management for narcotic drugs with traceable sources and whereabouts and accoun- tability in the whole hospital has been preliminarily realized, and the work efficiency has been obviously improved.
  • Role of medication safety self-assessment in improving the medication safety level in hospitals
    Ni Qian, Qi Wei, Tan Lin, Chen Lulu，Zhou Mofei, Hu Xin, Tan Ling
    2021, 23(8): 408-415. https://doi.org/10.3760/cma.j.cn114015-20210125-00107
    Abstract ( ) PDF ( )
    Objective To explore the role of medication safety self-assessment according to        “2011 ISMP Medication Safety Self Assessment for Hospitals (Chinese version)”(Chinese version of ISMP) in improving the level of medication safety in hospitals.　Methods The main results of medication safety self-assessment conducted by Beijing hospital using the Chinese version of ISMP in 2018 and 2020 were compared and analyzed. The assessment was organized by The Drug Risk Management Group of The Professional Committee of Therapeutic Drug Monitoring in The Chinese Pharmacological Society and the content  included in the comparative analysis was 10 key elements, 20 core characteristics, and 161 evaluation items in the Chinese version of ISMP. Each item was scored referring to the Likert′s Five-Level Scoring and the corresponding score of choices A-E was 0, 0, 2, 3, and 4 respectively. The actual scores of the items and the percentage scores of 10 key elements in the 2 self-assessment activities were compared. Items with the greatest improvement (0 score in 2018 and 4 score in 2020) and those with no improvement (the score in 2020 was not higher than that in 2018) were found.　Results The median actual score of 161 items in 2020 were higher than that in 2018 and the difference was statistically significant ［4(3, 4) vs. 3(2, 4) scores， P<0.001］. The median percentage scores of items under key elements Ⅰ (patient information), Ⅱ (drug information), Ⅴ (drug standardization, storage, and distribution) were significantly higher than those in 2018 [75.5%(50.0%，100%) vs. 100%(100%,100%)，P=0.002；25.0%(0,75.0%) vs.100%(75.0%,100%)，P<0.001；50.0%(50.0%,100%) vs. 100%(100%,100%)， P=0.003）]. In 2020, the percentage score of key element Ⅳ (drug labeling, packaging, and nomenclature) was 100%, the same as that in 2018; the percentage scores of the other 9 key elements were higher than those in 2018. Among them, the percentage score of key element Ⅶ (environmental factors, workflow, and staffing patterns) increased to 100% (94.2% in 2018) and those of the other 8 key elements were from 73.4% to 97.2%. There were 14 items with the greatest improvement and 1, 7, 3, 2, and 1 item of them was under key elements Ⅰ, Ⅱ, Ⅴ, Ⅵ (medication device acquisition, use, and monitoring), and Ⅷ (staff competency and education), respectively. However, there were 24 items that had not been improved and 2, 4, 2, 4, 1, and 11 items of them were under key elements Ⅰ, Ⅱ, Ⅴ, Ⅷ, Ⅸ (patient education), and Ⅹ (quality process and risk management), respectively.　Conclusion Using the Chinese version of ISMP in self-assessment of medication safety in hospital will help improve the level of hospital medication safety.
  • Study on clinical and pathological characteristics of Polygonum multiflorum-associated liver injury
    Zhao Hong, Liu Ligai, Sun Lei, Xie Wen
    2021, 23(8): 416-423. https://doi.org/10.3760/cma.j.cn114015-20210514-00562
    Abstract ( ) PDF ( )
    Objective To explore the clinical and pathological characteristics of Polygonum multiflorum-associated liver injury.　Methods Medical record data of inpatients with Polygonum multiflorum-associated liver injury diagnosed by histopathological examination between January 2009 and December 2018 in Beijing Ditan Hospital, Capital Medical University were collected and analyzed retrospectively. According to the different processing methods of Polygonum multiflorum, the patients were divided into raw Polygonum multiflorum group and prepared Polygonum multiflorum group. The clinical and pathological characteristics in patients in the 2 groups were compared.　Results A total of 22 patients entered the study. Of them, 8 patients were in the raw Polygonum multiflorum group, including 4 males and 4 females with a median age of 32 (25, 37) years; 14 patients were in the prepared Polygonum multiflorum group, including 2 males and 12 females with a median age of 51 (38, 58) years. Twenty one patients were clinically identified as hepatocellular injury type and one patient (raw Polygonum multiflorum group) was identified as mixed type, which all had varying degrees of acute hepatitis related symptoms. The median peak levels of alanine aminotransferase, aspartate aminotransferase, and total bilirubin in the raw Polygonum multiflorum group were significantly higher than those in the prepared Polygonum multiflorum group ［1-832 (1-134, 2-301) U/L vs. 900 (456, 1-102) U/L, P=0.001; 1-135 (475, 1-408) U/L vs. 466 (240, 662) U/L, P=0.017; 212.1 (102.5, 363.4) μmol/L vs. 59.7 (17.7, 117.3) μmol/L, P=0.012］. The main pathological manifestation of liver injury in patients in the 2 groups was acute lobular hepatitis. After the occurrence of liver injury, all 22 patients discontinued Polygonum multiflorum preparation and were given symptomatic treatment, and all were improved and discharged after 9-37 d of hospitalization. After discharge, one patient lost the follow-up and the other 21 patients′ liver function recovered, with a median time to recovery of 3 (2, 6) months. Three patients′ abnormal liver function lasted more than 6 months and they were diagnosed with chronic hepatitis.　Conclusions Polygonum multiflorum-associated liver injury is mainly hepatocellular injury type and the pathological feature is acute lobular hepatitis. The degree of liver injury caused by raw Polygonum multiflorum is more serious than that caused by prepared Polygonum multiflorum. After stopping Polygonum multiflorum and giving symptomatic treatment, most patients had a good prognosis.
  • Clinical and literature case analysis on cyclophosphamide-associated severe hyponatremia
    He Fei, Liang Xin, Mei Zhihong, Li Guohui
    2021, 23(8): 424-432. https://doi.org/10.3760/cma.j.cn114015-20210201-00141
    Abstract ( ) PDF ( )
    Objective To explore the clinical characteristics of hyponatremia associated with cyclophosphamide (CTX).　Methods The diagnosis and management of a breast cancer patient with severe hyponatremia after CTX treatment in Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College was reported. The main clinical data of this patient and the relevant cases collected by searching PubMed, Embase, CNKI, and Wanfang database (as of January 26, 2021), including gender, age, indications of CTX, usage and dosage of CTX, time from the application of CTX to the occurrence of hyponatremia (latency), and clinical manifestations, treatment and outcome of severe hyponatremia, etc., was descriptively analyzed.　Results A total of 34 patients were included in the analysis, including 4 males and 30 females, aged from 27 to 87 years with the median age of 56 years. The primary disease were malignant tumor in 22 cases (17 cases of breast cancer), systemic lupus erythematosus in 6 cases, glomerulonephritis in 3 cases, scleroderma in 2 cases, and monoclonal gamma globulinosis in 1 case. Among the 34 patients, 22, 8 and 1 of 31 patients who received CTX intravenously developed severe hyponatremia after the first, second and seventh dose of treatments, respectively. Among them, 27 cases had latency records, which were 3-96-h (median time 24-h) and 25 cases had latency ≤48-h. The latency of severe hyponatremia induced by oral CTX was 1 d, 21 d and 30 d, respectively. The lowest value of blood sodium in 34 patients was 102-124-mmol/L, and in 30 patients (88.2%) were less than 120-mmol/L. The main clinical manifestations were disturbance of consciousness (20 cases), nausea and vomiting (17 cases), and epileptic seizures (15 cases). Twenty-two cases (64.7%) underwent hydration rehydration in a short time before and after CTX treatment, 1 case did not undergo hydration rehydration, and 11 cases had no relevant descriptions. After severe hyponatremia occurrence, CTX treatment was discontinued in all 34 patients. After sodium supplementation and water restriction, blood sodium returned to normal 8 h ~ 24 d (median time 48-h) after drug withdrawal, and returned to normal within 5 d in 27 cases (79.4%). Of them, one patient was still in coma after blood sodium returned to normal, and was diagnosed with central pontine myelinolysis one week later.　Conclusions CTX-associated severe hyponatremia mostly occurs within 48-h of intravenous administration and the latency of oral administration is longer. It occurs usually in patients with large amount of hydration and rehydration in a short time before and after medication. The prognosis in most patients is good when CTX is stopped, sodium is supplemented and water is limited.
  • Practice of clinical pharmacists participating in perioperative pharmaceutical management
    Xie Han, Xue Min, Ma Zhengliang, Qiu Yudong, Ge Weihong
    2021, 23(8): 433-435. https://doi.org/10.3760/cma.j.cn114015-20201111-01130
    Abstract ( ) PDF ( )
    In the past, clinical pharmacists were less involved in the perioperative pharmaceutical management for surgical patients, mainly related to the analgesic management of postoperative pain. In recent 2 years, clinical pharmacists have found that the perioperative patients often suffer from other underlying diseases and need long-term medication. The lack of perioperative pharmaceutical management and evaluation may increase the risk of intraoperative accidents or postoperative complications in some patients. In May 2020, a female patient with rheumatoid arthritis in Nanjing Drum Tower Hospital Affiliated to Medical College of Nanjing University failed to fully evaluate the risk of difficult airway caused by long-term use of prednisolone tablets before operation developed difficulty with facemask ventilation and tracheal intubation after anesthesia, and the operation was forced to be terminated. This incident attracted great attention from pharmacists, so they began to implement comprehensive pharmaceutical management for perioperative patients, including formulating a number of management specifications for common perioperative drugs, opening a perioperative pharmaceutical care clinic for daytime surgical patients, and implementing comprehensive perioperative pharmaceutical management for surgical inpatients. Half a year after clinical pharmacists strengthened the perioperative pharmaceutical management, the satisfaction of surgeons, nurses, and patients with their works were 98.2%, 99.1%, and 93.9%, respectively.
  • Fulminant type 1 diabetes mellitus caused by nivolumab
    Wang Suhong, Cheng Yan, Yang Maoguang, He Yangfang, Shen Hong, Cai Hanqing
    2021, 23(8): 436-438. https://doi.org/10.3760/cma.j.cn114015-20201202-01203
    Abstract ( ) PDF ( )
    -An 82-year-old female patient received monotherapy with nivolumab (240-mg by an IV infusion on the firsr day, 14 days as a cycle) because of multiple metastases of central adenocarcinoma in the right upper lobe of the lung. After 8 cycles of immunotherapy (about 4 months), the patient developed severe nausea and vomiting. Laboratory tests showed random blood glucose 43.2-mmol/L and β-hydroxybutyric acid 5.3-mmol/L. Blood gas analysis showed pH 7.01, bicarbonate root 4.0-mmol/L, alkali residual -22.4-mmol/L, serum potassium 6.1-mmol/L, and lactic acid 2.9-mmol/L. The patient had no previous history of diabetes mellitus. Fulminant type 1 diabetes mellitus due to nivolimab was considered. Nivolumab was stopped and rehydration, hypoglycemia, acidosis correction, and other symptomatic treatments were given. Two days later, her symptoms were improved obviously. Laboratory tests showed fasting plasma glucose 15.8-mmol/L and β-hydroxybutyric acid 0.2-mmol/L. Blood gas analysis showed pH 7.39, bicarbonate root 21.2-mmol/L, alkali residual -3.8-mmol/L, serum potassium 4.3-mmol/L, and lactic acid 1.0-mmol/L.
  • Severe hepatic injury due to Xiaojin capsules (小金胶囊)
    Deng Xiaoqin, Chen Qiong, Shen Dongfang, Hu Yin, Tan Helang
    2021, 23(8): 438-440. https://doi.org/10.3760/cma.j.cn114015-20201222-01268
    Abstract ( ) PDF ( )
    A 32-year-old male patient with hyperplasia of mammary glands took 5 Rupishu tablets (乳癖舒片) orally thrice daily by himself for about 2 years. Due to the poor treatment effect, he received additional 7 Xiaojin capsules orally twice daily according to the doctor′s advice. The patient′s liver function was normal during the monotherapy with Rupishu tablets. After 50 days of medication with the 2 drugs, the patient developed dark urine and yellowish skin and pruritus. Twelve days later, laboratory tests showed alanine aminotransferase (ALT) 1-068-U/L, aspartate aminotransferase (AST) 562-U/L, total bilirubin (TBil) 106.9-μmol/L, direct bilirubin (DBil) 84-μmol/L, and alkaline phosphatase (ALP) 175-U/L. He was diagnosed as having severe drug-induced liver injury, which was considered to be associated with Xiaojin capsules. Then both drugs were discontinued. Magnesium isoglycyrrhizinate injection and adenosylmethionine for injection were given for liver protection. Twelve days later, laboratory tests showed ALT 163-U/L, AST 52-U/L, TBil 36.1μmol/L, DBil 21.7μmol/L, and ALP 142-U/L. After that, the patient took the above 2 drugs by himself again. Twenty days later, the symptoms above-mentioned and abnormal liver function recurred. Xiaojin capsules were stopped and anti-inflammatory and liver-protective treatments were given. Twenty-three days later, laboratory tests showed ALT 25-U/L, AST 19-U/L, TBil 14.3-μmol/L, DBil 3.6-μmol/L, and ALP 76-U/L.
  • Pancytopenia induced by overdose of ganciclovir
    Li Zuojun, Yang Xinliang, Chen Yejun, Wang Li, Zuo Wenjian, Liu Xiaohong, Wang Chunjiang
    2021, 23(8): 440-442. https://doi.org/10.3760/cma.j.cn114015-20201209-0122
    Abstract ( ) PDF ( )
     A 42-year-old female patient who had a fever for 10 days and was suspected of cytomegalovirus infection received IV infusions of ganciclovir 150-mg dissolved in 0.9% sodium chloride injection 100-ml and cefoperazone sodium and tazobactam sodium 2.25 g dissolved in 0.9% sodium chloride injection 100-ml twice daily. Before medication, the patient′s white blood cell count (WBC) was 12.71×109/L, platelet count (PLT) was 262×109/L, ren blood cell count (RBC) was 2.99×1012/L, and hemoglobin (Hb) was 84-g/L. Because the patient developed edema 2 days later, the drugs were adjusted to IV infusions of ganciclovir 150-mg dissolved in 0.9% sodium chloride injection 50-ml once daily and piperacillin sodium tazobactam sodium 2.25 g dissolved in 0.9% sodium chloride injection 50-ml twice daily. On day 11 of medication, laboratory tests showed WBC 3.01×109/L, 2.32×109/L, PLT 92×109/L, RBC 2.39×1012/L and Hb 68-g/L; on day 13 of medication, her WBC was 1.98×109/L, PLT was 86×109/L, RBC was 2.44×1012/L，and Hb was 69-g/L. After tracing the patient′s previous medical records, it was learned that the patient had previously experienced mild myelosuppression due to ganciclovir treatment. Then ganciclovir-induced pancytopenia was considered. Ganciclovir was stopped and subcutaneous injections of recombinant human granulocyte stimulating factor injection 200-μg once daily and recombinant human erythropoietin injection 10-000 U once a week were given. Five days later, laboratory tests showed WBC 3.82×109/L, PLT 197×109/L, RBC 3.12×1012/L， and Hb 92-g/L. The patient had renal transplantion 3 years ago. According to the level of creatinine clearance rate, overdose of ganciclovir was used in the patient.
  • Immediate-type hypersensitivity induced by omeprazole enteric coated capsules
    Feng Bo, Liu Peng, Zhang Yajun, Hu Peng
    2021, 23(8): 443-444. https://doi.org/10.3760/cma.j.cn114015-20210111-00041
    Abstract ( ) PDF ( )
    A 39-year-old female patient took omeprazole enteric-coated capsules 40-mg orally for stomachache. About 2.5-hours after the medication, the patient developed generalized itching, followed by urticaria like rash all over the body, dyspnea, and palpitations. Anaphylaxis due to omeprazole enteric coated capsules was considered. Anti-allergic drugs such as dexamethasone, calcium gluconate, and vitamin C were given immediately. Two hours later, dyspnea, palpitations, and pruritus were relieved and the rash completely subsided 3.5-hours later.
  • Anaphylactic shock caused by biosynthetic human insulin injection
    Li Jun, Shen Jianghua, Xu Jingyi, Mu Hong
    2021, 23(8): 445-446. https://doi.org/10.3760/cma.j.cn114015-20210222-00190
    Abstract ( ) PDF ( )
    A 75-year-old female patient with diabetes mellitus was scheduled for surgery due to right distal radius fracture. She was given an IV infusion of 5% glucose and sodium chloride injection 500 ml + biosynthetic human insulin injection (Novolin R) 6 U during fasting before operation, and no other drugs were concomitantly used. Her fingerstick glucose was 10.6-mmol/L before the IV infusion. At about 3-minutes of fluid infusion (infused fluid was about 8-ml), the patient suddenly developed chills all over the body and nausea, followed by consciousness loss, no response to verbal stimuli, foam at mouth, convulsions of both upper limbs, and incontinence of urine. Finger-stick glucose was 9.6-mmol/L and hypoglycemic reaction could be ruled out. Electrocardiogram monitoring showed the lowest blood pressure 37/27-mmHg and oxygen saturation 0.40. Anaphylactic shock due to biosynthetic human insulin was considered. Anti-anaphylactic and anti-shock treatments such as intravenous pumping of dopamine and norepinephrine, subcutaneous injection of epinephrine, and intravenous infusion of dexamethasone were given successively. Three hours later, the patient returned to normal.
  • Immune-related skeletal muscle and myocardium injury induced by camrelizumab
    Li Lin,Liu Wenhui, Liu Yiping, Luo Zhiying
    2021, 23(8): 447-448. https://doi.org/10.3760/cma.j.cn114015-20201210-01229
    Abstract ( ) PDF ( )

    A 76-year-old male patient with small cell lung cancer received EC (etoposide and carboplatin) chemotherapy combined with camrelizumab. On the 22th day of medication, the patient deve- loped chest tightness, shortness of breath, dyspnea, limb weakness, walking difficulty, etc. Laboratory tests revealed creatine kinase (CK) 1-210-U/L and CK-MB 63 U/L. The chemotherapy and immunotherapy were stopped, but the patient′s symptoms continued to worsen. Laboratory tests showed troponin T (TnT) 336-ng/L, CK 1-025-U/L, CK-MB 74-U/L, and N-terminal pro brain natriuretic peptide (NT-proBNP) 648-ng/L. The muscle magnetic resonance imaging (MRI) and electromyogram showed muscle injury and cardiac MRI showed left ventricular fibrosis. Then immune-related skeletal muscle and myocardial injury caused by camrelizumab was considered. The patient received an IV infusion of methylprednisolone sodium succinate for injection 100-mg once daily for 13 days. Then the patient′s fatigue symptoms were improved, the levels of CK and NT-proBNP decreased to the reference range, but the levels of TnT and CK-MB were 491-ng/L and 113-U/L, respectively. Therefore, an intravenous infusion of immunoglobulin 20 g once daily was given. Five days later, his dyspnea was improved, and TNT and CK-MB decreased to 201-ng/L and 59-U/L, respectively.

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