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OBJECTIVE: To establish the pharmaceutical care pathways of nanoparticle albumin bound paclitaxel ( nab-PTX), so as to provide reference for clinical rational drug use. METHODS: Data of patients who used nab-PTX from Jan. 2020 to Jun. 2023 in the hospital were retrospectively analyzed and evaluated. The pharmaceutical care pathways of rational use of nab-PTX was established based on the instructions of nab-PTX, evidence-based medicine, and the real-world data of nab-PTX use in the hospital. RESULTS: Data analysis of 279 patients included in this study showed that 42 cases of metastatic breast were in line with the drug indications of nab-PTX, and 237 cases (84. 9%) were off-label. There were 209 off-label cases with evidence-based medical evidence (including cervical cancer, pancreatic cancer, stomach cancer, non-small cell lung cancer, nasopharyngeal cancer, ovarian cancer or fallopian tube cancer, esophageal cancer, endometrial cancer, and cholangiocarcinoma), which were evaluated as rational drug use. However, some off-label cases (oral cancer, mediastinal tumor, bone carcinoma, soft-tissue carcinoma, prostatic cancer, and malignant duodenal neoplasm) were evaluated as irrational due to insufficient evidence-based medical evidence. The most common adverse drug reactions of nab-PTX were myelosuppression and peripheral neuropathy, which were consistent with the drug instructions. The pharmaceutical care pathways of nab-PTX were established from various aspects, including pre-chemotherapy, chemotherapy, post-chemotherapy and follow-up. CONCLUSIONS: Offlabel drug use of nab-PTX is common, and the management for application of nab-PTX should be strengthened. The development of pharmaceutical care pathways of nab-PTX can improve the work efficiency of pharmacists and ensure the safe and rational drug use of cancer patients. [ABSTRACT FROM AUTHOR]

OBJECTIVE: To investigate the management status of off-label drug use in 146 medical institutions, so as to provide reference for improving the management level of off-label drug use. METHODS: Off-label drug use management in 146 medical institutions was investigated by questionnaire survey, including 104 tertiary hospitals and 42 secondary hospitals. Basic situation, management status, existing problems and successful experience were statistically analyzed. RESULTS: There were different degrees of off-label drug use in 146 medical institutions, of which 125 (85. 62%) carried out off-label drug use management. The management measures included establishment of management system (125 / 125, 100. 00%), formulation of off-label drug use catalogue (106 / 125, 84. 80%), and supervision for rationality of use process ( 112 / 125, 89. 60%). Totally 97. 26% ( 142 cases) of the respondents believed that sufficient evidence-based basis was the premise of off-label drug use. The proportion of medical institutions with sufficient evidence of off-label drug use was “about 50%” in 33. 56% (49 institutions), “almost all” in 34. 25% (50 institutions), and “few” in 30. 14% (44 institutions). Off-label drug use management had problems such as clinicians’ lack of cooperation / attention, non-use in accordance with prescribed procedures ( 116 / 146, 79. 45%), widespread off-label phenomenon, and difficulty in comprehensive management ( 73 / 146, 50. 00%). Management of off-label drug use can be improved by multi-department cooperation, clear responsibilities, hierarchical management according to the level of evidence or risk, and the introduction of information management. CONCLUSIONS: The phenomenon of off-label drug use is widespread, and medical institutions have made some success in the management of off-label drug use, yet there are also difficulties. Successful experience should be promoted to improve the management level of off-label drug use in medical institutions, so as to standardize the behavior of off-label drug use. [ABSTRACT FROM AUTHOR]

OBJECTIVE: To investigate the clinical application characteristics of ulinastatin, so as to provide reference and basis for standardizing its clinical application and updating drug instructions. METHODS: Clinical data of 3 032 inpatients with ulinastatin from Jan. 2021 to Jun. 2022 in the hospital information system of Yantai Yuhuangding Hospital was retrospectively collected, the basic data and clinical medication information were statistically analyzed. RESULTS: The majority of 3 032 patients with ulinastatin were male, accounting for 59. 96% ( 1 818 cases), with an average age of ( 60. 92 ± 14. 28) years. The top three departments ranked by case number of ulinastatin were cardiac surgery, gastroenterology and hepatobiliary surgery. A total of 742 cases (24. 47%) met the indications of drug instructions, the rest were off-label drug use, and there were 1 977 cases (65. 20%) of off-label drug use with higher level evidence-based evidence. The single dose, solvent and frequency of ulinastatin were rational, and no related adverse drug reactions occurred. The average drug utilization index of ulinastatin in the hospital was 0. 59 (<1), the overall dosage was rational. CONCLUSIONS: The off-label use of ulinastatin is common, and relevant measures should be taken to standardize the clinical application. For application with sufficient evidencebased evidence and common clinical use, it is recommended that drug manufacturers update and revise the drug inserts in a timely manner. [ABSTRACT FROM AUTHOR]

OBJECTIVE: To perform clinical comprehensive evaluation of total glucosides of paeony capsules in the treatment of recurrent oral ulcer based on evidence-based evidence, so as to provide reference for clinical rational drug use. METHODS: Wangfang Data, CNKI, CBM, PubMed, Embase, the Cochrane Library, the International Health Technology Assessment Network, the International Health Technology Assessment Association and other websites were systematically retrieved to collect clinical research, pharmacoeconomic research, safety evaluation and other data of total glucosides of paeony capsules in the treatment of recurrent oral ulcer (the search deadline was from database establishment to Nov. 30th, 2022). The quality of literature and its methodology were evaluated and analyzed. RESULTS: A total of 15 articles were included, including 12 clinical studies and 3 safety evaluations, pharmacoeconomics studies were not included. The total glucoside of paeony capsules has certain advantages in the treatment of recurrent oral ulcer in improving the total effective rate, shortening the ulcer healing time, reducing pain score, improving the level of inflammatory factors, improving immune function, and promoting the long-term curative effect. The safety study results showed that the total glucoside of paeony capsules had higher safety and lower incidence of adverse drug reactions in clinical use, and combined treatment with other western drugs could effectively reduce the occurrence of adverse drug reactions and enhance patient compliance. Results of drug accessibility evaluation showed that total glucosides of paeony capsules had good availability, affordability, convenience and acceptability in the treatment of recurrent oral ulcer. CONCLUSIONS: Total glucosides of paeony capsules can significantly improve the total effective rate, improve the quality of life of patients, relieve pain, and has higher safety in the treatment of recurrent oral ulcer, yet there is a lack of literature on pharmacoeconomics. In the future, more standardized clinical observation and related pharmacoeconomics research should be further carried out to supplement evidence of higher quality. [ABSTRACT FROM AUTHOR]

OBJECTIVE: To summarize the situation of new antineoplastic prescription special review in the hospital, so as to promote rational use of drugs. METHODS: Retrospective analysis was performed on the special review of new antineoplastic prescription in the hospital from 2018 to 2021, and the review results were analyzed and summarized. RESULTS: From 2018 to 2021, there were 48 reviews on new antineoplastic drugs. A total of 4 800 prescriptions were selected, and 4 578 prescriptions were rational, with rational rate of 95. 38%. Of the 222 irrational prescriptions, 197 prescriptions were non-standard prescriptions (88. 74%), and the irrational types were “prescribing without clinical diagnosis or incomplete clinical diagnosis”; there were 25 inappropriate prescriptions (11. 26%). A total of 276 prescriptions were involved in off-label drug use, all about indications;among the drugs involved, apatinib had the largest number of off-label drug use prescriptions ( 166 prescriptions, 60. 14%), followed by antirotinib (49 prescriptions, 17. 75%). CONCLUSIONS: According to the current regulations, clinical guidelines and other evidence, constantly improving the review rules and procedures of new antineoplastic drugs will make the prescription more standardized and clinical use more reasonable. [ABSTRACT FROM AUTHOR]

OBJECTIVE: To investigate the status of off-label drug use in outpatient department of a stomatological hospital（ hereinafter referred to as "the hospital"), so as to provide reference for improving the level of rational drug use in stomatological hospital. METHODS: Off-label drug use information in outpatient prescriptions of the hospital from Jul. 2019 to Jun. 2020 was collected. PASSPA2 system was used to randomly select outpatient prescriptions according to the rate of 3%. Pareto chart and related rules were used to retrospectively analyze the prescriptions of off-label drug. RESULTS: Totally 5 153 outpatient prescriptions were selected, including 9 444 medical orders. There were 1 393 prescriptions with off-label drug use, and the incidence of off-label drug use was 27. 03%. There were3 174 medical orders for off-label drug use, and the incidence was 33. 61%. The main factors of off-label drug use were off-label indications. The secondary factors were the administration routes. The general factors were off-label population, off-label usage and dosage, and off-label precautions. CONCLUSIONS: Analysis of off-label drug use in the outpatient department of the hospital by Pareto chart is helpful to identify the main and secondary factors of off-label drug use in the outpatient department of the hospital. In response to these factors, medical institutions should continue to strengthen the management of off-label drug use and improve the level of rational drug use in hospitals. [ABSTRACT FROM AUTHOR]

OBJECTIVE: To investigate the off-label use of antiepileptic drugs in outpatient children with epilepsy, and to explore its influencing factors, so as to provide reference for rational use of antiepileptic drugs in children. METHODS: The cases of children with epilepsy in pediatric outpatient department of Chinese PLA General Hospital from Jan.2019 to Nov.2020 were summarized, and whether there was off-label drug use in the prescription of antiepileptic drugs was judged according to the contents of drug instructions.The types of off-label drug use and the offlabel use of various antiepileptic drugs were analyzed statistically, and the influencing factors of off-label drug use were discussed by univariate analysis. RESULTS: A total of 193 children with epilepsy were enrolled, of which 166 children were treated with antiepileptic drugs, totally 249 case-times of antiepileptic drugs.The three main types of off-label drug use were off-label age administration (85 case-times, 34. 1%), over single drug/additive administration (49 casetimes, 19. 7%), and off-label attack types (41 case-times, 16. 5%). Among various antiepileptic drugs, Topiramate tablets (78. 4%, 40/51) and Leveethracetam tablets (58. 8%, 30/51) accounted for a higher proportion of drugs with off-label age administration. Levetiracetam tablets (9. 8%, 5/51) accounted for the highest proportion of over-dose administration, and Clonazepam tablets (13. 6%, 3/22) accounted for the highest proportion of over-frequency administration.Levetiracetam tablets (51. 0%, 26/51) took the lead of off-label attack types, and Levetiracetam tablets (62. 7%, 32/51) accounted for the highest proportion of over single drug/additive administration. CONCLUSIONS: Off-label use of antiepileptic drugs is common in pediatric outpatient department, especially off-label age administration, among which Levetiracetam tablets and Topiramate are the most prominent. Age and basic drugs affect the use of pediatric antiepileptic drugs in our hospital. [ABSTRACT FROM AUTHOR]

OBJECTIVE: To investigate the current status of off-label drug use of immunosuppressants prescriptions in a grade III level A hospital(hereinafter referred to as "the hospital"), so as to probe into the risk of off-label drug use and promote the rational drug use. METHODS: Immunosuppressants prescriptions from the outpatient department of the hospital from Jul. 2016 to Jun. 2018 were selected, and all off-label drug use prescriptions were screened for statistical analysis. The basis of off-label drug use was analyzed according to domestic and foreign literature reports, guidelines and Micromedex tools. Risk matrix method was used to evaluate the risk level of adverse drug reactions of off-label drug use. RESULTS: Within the statistical interval, there were 1 128 off-label drug use of immunosuppressants prescriptions in the hospital, and the main types were drugs with off-label indications. Evidence types were respectively foreign guidelines(94 prescriptions, 8.3%), domestic guidelines(396 prescriptions, 35.1%), expert consensus(596 prescriptions, 52.8%) and other literature(42 prescriptions, 3.7%). Among the 25 off-label drug use of immunosuppressants, 11(44.0%) off-label drug use had been included by Micromedex. The risk of renal toxicity of cyclosporine, respiratory disorders of mycophenolate mofetil, renal toxicity of lymphoma, non-melanoma and tacrolimus, respiratory distress syndrome and other adverse drug reactions were rated as grade E, which was considered as the severe risk. CONCLUSIONS: The off-label use of immunosuppressants in the outpatient department of the hospital is supported by relevant evidence, but the quality of the evidence is different and there is a risk of severe adverse drug reactions. In clinical practice, it is suggested that the hospital should establish the off-label drug use evaluation group to form consensus among experts in the hospital as soon as possible,so as to avoid medical risks as far as possible and promote the rational drug use. [ABSTRACT FROM AUTHOR]

OBJECTIVE: To investigate the status of off-label use of probiotics in children, and to explore the causes, so as to provide reference for the rational use of probiotics in children. METHODS: Through the hospital information system, the outpatient and emergency prescriptions containing probiotics were searched in Children’s Hospital of Fujian Fuzhou from Jul. to Dec. 2017. The general information, drug use and off-label drug use of the children were statistically analyzed by referring to the drug instructions. RESULTS: A total of 24 992 prescriptions for children’s probiotics were collected, involving Bifidobacterium bifidum triple live bacteria tablets(golden bifid), Clostridium butyricum enterococci triple live bacteria tablets(Shiyi), Bifidobacterium triple live viables(Peifeikang), Bacillus subtilis Enterococcus granules(medilac-vita) and Bacillus licheniformis capsules, among which the number of prescriptions of Bifidobacterium bifidum triple live bacteria tablets(golden bifid) took the lead(10 263 prescriptions, accounting for 41.07% of the total number of prescriptions). Off-label probiotics were mainly used for off-age patients(14 prescriptions, 0.06%) and off-label indications(12 363 prescriptions, accounting for 49.47% of the total number of prescriptions), among which 10 112 prescriptions were used for the prevention of antibacteria-related diarrhea(accounting for 81.79% of the total number of prescriptions for off-label indications). CONCLUSIONS: Probiotics have a higher incidence of off-label drug use in children, most of which are based on evidence-based medicine. The effect on probiotics is still under study, so the prescription behavior should be standardized as far as possible to promote the rational drug use. [ABSTRACT FROM AUTHOR]

OBJECTIVE: To investigate the off-label drug use situation of alprostsadil injections in inpatients from the First People’s Hospital of Dali ( hereinafter referred to as “our hospital” ) and security classification was conducted，so as to provide reference for the rational drug use in clinic. METHODS： 1 476 inpatient medical orders during 2014-2016 were randomly selected， the off-label drug use were judged in accordance with the instructions. Statistical analysis was conducted on drug use in various departments and diseases， and security classification and rationality of drug use were analyzed. RESULTS： There were four kinds of off-label drug use in our hospital，including over indications，improper route of administration and cirrational administration times and improper solvent，etc. And a total of 11 departments were involved in over indications， including the most used for orthopaedic department， endocrinology and Chinese and western medicine and urinary surgery， mainly in treatment of type 2 diabetes complications，tendon from broken，hand thumb injury，lumbar disease，kidney disease，cardiovascular disease and severe fracture，etc. CONCLUSIONS： The off-label drug use of alprostsadil injections in our hospital is common，and some has medical evidence; yet there are still some irrational phenomenon， which needs the close attention by the clinic. [ABSTRACT FROM AUTHOR]

OBJECTIVE: To investigate and analyze the off-label drug use record in the Second Affiliated Hospital of Chongqing Medical University (hereinafter referred to as “our hospital”), so as to promote the standardized management of off-label drug use. METHODS: The off-label drug use record application form submitted by each clinical department of our hospital to the pharmacy department and the general table of off-label drug use list approved by the Pharmacy Administration and Drug Therapy Committee of our hospital (hereinafter referred to as “ the pharmaceutical affairs committee”) during 2012-2017 were summarized, and statistical analysis was conducted by using Excel software. RESULTS: During 2012-2017, a total of 14 clinical departments in our hospital submitted 124 applications for off-label drug use record, and 106 were approved, with a pass rale of 85.48%. 59 applications were submitted and approved by the rheumatology and immunology department, which too the first place, with a pass rale of 100%, accounting for 55.66% of the total number of approved applications. The quality of evidence-based medicine attached to the off-label drug use record application submitted by each clinical department was relatively high. Among the 106 approved applications for off-label drug use, the main one was over-indications (100 cases, 94.34%), followed by over-dosage (5 cases, 4.72%), which should be the focus of off-label drug use supervision. CONCLUSIONS: There are still some irrational problems in the management of off-label drug use in our hospital, which need to be further improved, meanwhile, it is urgent for the stale to issue relevant laws and regulations or documents to guide off-label drug use, implement more standardized management, avoid the risk of practice, and ensure the safe medication for patients. [ABSTRACT FROM AUTHOR]

OBJECTIVE: To realize the application status of off-label drug use in psychiatry department, and to provide reference for the formulation of management for off-label drug use in psychiatry department. METHODS: The rationality and necessity of off-label drug use in psychiatry department of Beijing Huilongguan Hospital (hereinafter referred to as "our hospital") were analyzed, and then countermeasures and suggestions on off-label drug use were put forward. RESULTS: The application of off-label drug use in clinical cases was rational and necessary to some extent,yet the inspection to the clinical use of psychotic drugs should be implemented. CONCLUSIONS: It is necessary to establish effective regulatory measures by supervision department, adopt effective mechanism of communication between medical staff and patients by medical institutions, and strengthen the supervision and guidance of pharmacists, so as to reduce irrational drug use and risk of off-label drug use. [ABSTRACT FROM AUTHOR]

OBJECTIVE: To investigate the status of off-label drug use in outpatient department of gastroenterology of the Sixth Affiliated Hospital of Sun Yat-sen University (hereinafter referred to as "our hospital"), and to provide reference for the formulation of administrative regulation of off-label drug use. METHODS: Clinical decision support software (Version number 1. 2. 03) was adopted. 1 000 prescriptions were randomly selected from 9 390 prescriptions of gastroenterological outpatient department issued from Sept. 2014 to Nov. 2014 in our hospital, statistical analysis was conducted by referring to the drug instructions, and off-label drug use prescriptions were those which did not meet the criteria of drug instructions. RESULTS: 127 prescriptions were off-label drug use, accounting for 12. 70% of the selected prescriptions. Assorted by types, the aspects were mainly over usage and dosage (51. 91%) and over indications (42. 75%). Assorted by medicine classification, off-label drug use mainly were proton pump inhibitors (32. 38%), central nervous system drugs (23. 62%), immunosuppressive and cytotoxic drugs (16. 54%). CONCLUSIONS: Although most of the off-label drug use accorded with evidence-based medicine theory,and has support of literature report and evidence, there are still some potential safety risks. The hospital should establish off-label drug use regulations, ensure the legitimate rights of patients and doctors, so as to reduce the risk of medication. [ABSTRACT FROM AUTHOR]

OBJECTIVE: To investigate the off-label drug use in outpatient prescriptions of internal hematology in the Second Affiliated Hospital of Kunming Medical University (hereinafter referred to as "our hospital "), so as to provide reference for the rational standard drug use in clinic. METHODS: 3 033 outpatient prescriptions of internal hematology from Jun. 2014 to Jun. 2015 were extracted, and prescriptions for indications, administration frequency, administration doses, age, contraindications and route of administration were analyzed one by one about off-label drug use according to drug instructions. RESULTS: Of the 3 033 prescriptions,a total of 3 229 drug prescriptions in the outpatient prescriptions of internal hematology were selected, among which off-label drug use was 2 012 cases (62. 31%). Of the off-label drug use cases, off-label drug use indications was the most common, accounting for 98. 61% (1 984 cases) of the total off-label drug use outpatient prescriptions, followed by medication for overfrequency and over-dosage. CONCLUSIONS: Off-label drug use in outpatient prescriptions is a common phenomenon our hospital; therefore, it is necessary to attach more importance to the phenomenon by the close monitoring and proper intervention, so as to promote the standardization of drug use. [ABSTRACT FROM AUTHOR]

OBJECTIVE: To investigate the situations of off-label drug use prescriptions in outpatients with oral mucosal diseases, so as to provide reference for the rational use and management of off-label drug use. METHODS: Retrospective method was adopted to analyze the off-label drug use prescriptions in outpatients with oral mucosal diseases admitted into Peking University School of Stomatology (hereinafter referred to as "our hospital") from Jan. 2015 to Mar. 2015. RESULTS: There were 66 categories of drugs used by patients with oral mucosal diseases, with 21 123 medical orders, of which 21.21% were off-label drug use prescriptions and 19.62% were medical orders. Types of off-label drug use prescriptions were off-label indications, the pharmacological effects of off-label drug use were in accordance with the treatment of oral mucosal diseases; 6 drugs were used in off-label route of administration for the indications recorded by drug instructions were insufficient. The top 5 off-label drugs in medication orders were sodium Bicarbonate tablet, ethacridine solution, total Glucosides of paeony capsule, Nystatin tablet, and tacrolimus ointment, respectively accounting for 23.74%, 20.97%, 15.85%, 11.05%, and 6.54% of total off-label medication orders. CONCLUSIONS: Off-label drug use were common and indispensable in treatment of oral mucosal diseases. Pharmaceutical companies should pay more attention to the development of oral mucosal disease drugs. [ABSTRACT FROM AUTHOR]

OBJECTIVE: To provide reference for standardizing management of off-label drug use in our hospital. METHODS: Through analyzing off-label drug use and the hidden danger for clinical drug use, causes of the existing problems and corespondent countermeasures and suggestions for risks prevention were investigated. RESULTS: The phenomenon of off-label drug use was objective reality, for the drug instruction had its loophole and inadequacy, and the update of information were falling behind. Meanwhile, off-label drug use could increase the medication risks in patients and the professional risks in doctors, which should be strengthened in respect of clinical standardization and institutionalized management. The pre-existing management experience in international were stipulate evidence-based basis on off-label drug use, encourage drug companies to update instructions in time and establish independent drug information organization, etc. CONCLUSIONS: Off-label drug use had its rationality and necessity. Related regulations should be formulated as soon as possible and off-label drug use should follow certain principles. It is necessary to strengthen the supervision, guidance, publicity and education by clinical pharmacists so as to promote the clinical rational drug use. [ABSTRACT FROM AUTHOR]

OBJECTIVE: To investigate the off-label drug use conditions in pediatric outpatient department of Jingzhou Maternal and Child Health Hospital (hereinafter referred to as "our hospital"), and to provide reference for the ration drug use in children. METHODS: Prescriptions from pediatric outpatient department of our hospital in 2014 were randomly selected, to judge the medical orders by the drug instruction, and statistical analysis was conducted on the incidence and types of off-label drug use, incidence of off-label drug use in children at different age stages and the drugs categories, etc. RESULTS: Of the 1 200 sampled prescriptions, 3 258 cases involved in medical orders, the incidence rate of off-label drug use were 43. 83%. The top 3 types of off-label drug use were respectively over optimal application groups (53. 81%), over times of administration (20. 30%), over dosage of administration (13. 20%). Infancy (45. 26%), toddler age (45. 15%) and preschool age (44. 03%) dominated the top 3 places. Meanwhile, the top 3 drugs of off-label drug use were microbe and mineral drugs (55. 87%), Chinese patent medicine (50. 29%) and anti-infectious agents (46. 40%). CONCLUSIONS: Off-label drug use is a widely existing phenomena, which needs the clinical physicians to have a good knowledge of drug introductions, and to carry out off-label drug use only with the permission of the patients' parents; at the same time, the Health Administration should formulate the related management system on off-label drug use,so as to ensure the safe and effective medication in children. [ABSTRACT FROM AUTHOR]