Study on the value of pharmaceutical service related to risdiplam based on follow-up data of DTP pharmacy / 中国药房

OBJECTIVE To explore the value of providing pharmaceutical service related to risdiplam in direct-to-patient （DTP） pharmacies. METHODS The follow-up data of spinal muscular atrophy （SMA） patients who purchased and used risdiplam from Shangyao Yunjiankang Yiyao Pharmacy （Shanghai） Co.， Ltd. from May 2021 to January 2023 were collected. The medication information， therapeutic efficacy and the occurrence of adverse events were retrospectively analyzed. RESULTS A total of 42 prescriptions were checked by pharmacists in the DTP pharmacies， and 7 prescriptions were found to be unreasonable （16.7%， 7/42）， which were corrected after the timely intervention. During the follow-up management， pharmacists replied to 4 patients （9.5%， 4/42） regarding medication consultation about medication requirements and adverse events. Two patients with type Ⅰ SMA experienced adverse events： one of them presented with fever and the other presented with skin dryness with darkening. Both of them were grade Ⅰ toxic reactions and generally did not require clinical treatment. Considering that the patient sustained low-grade fever for a long time， the pharmacist suggested symptomatic treatment under the guidance of the doctor. CONCLUSIONS Pharmacists in DTP pharmacies conducting follow-up management of risdiplam use for rare disease SMA patients can help promote rational， standardized medication for patients.

Status quo and problem analysis of market operation and management of DTP pharmacies in Guizhou province / 中国药房

OBJECTIVE To in vestigate the existing problems about store construction and market operation and management of DTP （direct-to-patient）pharmacies in Guizhou province ，and to provide countermeasures and suggestions for the improvement and development of professional operation of DTP pharmacies in Guizhou province. METHODS According to the literature review ， the questionnaire was designed. Then the field survey of 11 DTP pharmacies and questionnaire survey for the person in charge （or store managers ） in Guizhou province were conducted from April to May 2021. The questionnaire mainly included the basic information，online sales channel construction ，pharmaceutical logistics distribution ，pharmaceutical care ，vocational training ， construction of pharmacy management system and application of drug management information system etc. ，in order to analyze the inadequacies of market operation and management of DTP pharmacies in Guizhou province and put forward suggestions. RESULTS Totally 11 questionnaires were delivered and 9 valid questionnaires were retrieved ，the effective response rate of questionnaires was 81.82％ . The sample pharmacies were all from Guiyang ，most of them （77.78％）were established by local pharmaceutical enterprises in Guizhou province ，and only 22.22％ of the sample pharmacies had opened online drug purchase channels. In terms of pharmaceutical care ，55.56％ of the sample pharmacies provided basic testing and life style interventions respectively ，44.44％ of the sample pharmacies provided adverse drug reaction monitoring ，and 33.33％ of the sample pharmacies implemented health education presentations and chronic disease rehabilitation program respectively. In term of personnel training ，only 11.11％ of the sample pharmacies implemented weekly business training ，and 66.67％ of the sample pharmacies received innovative and academic pharmacy information training. The construction of DTP pharmacy management systems in Guizhou province was completed basically ， but in terms of application of drug management information system ， 22.22％ of the sample pharmacies conducted drug application analysis and monitoring. CONCLUSIONS The development of DTP pharmacies in Guizhou province is still in initial stage currently. The convenience and accessibility of medicines for patients and the construction of online sales channel need to be improved ；the internet channel construction is slow ；an effective selection and evaluation mechanisms for pharmaceutical logistics enterprises need to be created ；pharmaceutical care ability and pharmacy service personnel training system need to be strengthened ；informatization management and industrial recognition of DTP pharmacies in Guizhou province need to be promoted. Therefore ，the enterprises ， government， universities and associations should work together and strengthen the professionalization ， informatization， institutionalization and standardization of DTP pharmacies in Guizhou province ，in order to provide patients with a convenient drug sales channels and high-quality personalized pharmaceutical care platforms eventually.

Status Investigation on Antitumor Pharmaceutical Care Ability of DTP Pharmacy in China / 中国药房

OBJECTIVE：To investigate antitumor pharmaceutical care ability a nd the current status of direct to patient （DTP） pharmacy in China ，and to provide reference for building a quality evaluation system of DTP pharmacy which focuses on the pharmaceutical care. METHODS ：From Sept. to Dec. 2019， an electronic questionnaire survey was conducted amongpharmacists of all of 126 listed DTP pharmacies and involved wang_star@163.com education background ，professional knowledge sources andpharmaceutical care ability （such as prescription checking and E-mail：dujoan-88@163.com dispensing，medication consultation and guidance ，medication management，follow-up），pharmaceutical knowledge of antitumor medicine ，etc. DTP pharmacies in C hina were inspected on site ， and their pharmaceutical care management were evaluated ，and impression of on-site inspection were discribed with questionnaire survey. The current situation of oncology pharmaceutical care ability of DTP pharmacy in China was evaluated and corresponding suggestions were put forward. RESULTS ：A total of 400 questionnaires were sent out ，and 392 valid questionnaires were collected with recovery rate of 98.0％. The cancer pharmacists in DTP pharmacy were mainly from East China ，mainly in Jiangxi （73 persons，18.62％），Anhui（68 persons，17.35％）. The pharmacists were mainly junior college or below （229 persons，58.42％）， followed by undergraduate （158 persons，40.31％）. The working years were more than 5 years（241 persons，61.48％）. The majors were mostly pharmaceutics （123 persons，31.38％），followed by pharmacy （including pharmacology ）（81 persons， 20.66％）. The regular knowledge sources of pharmacists in DTP pharmacy included learning materials （302 person times ， 77.04％），textbooks（250 person times ，63.78％）and Wechat push （206 person times ，52.55％）；the latest knowledge sources included training courses （347 person times ，88.52％），Wechat push （211 person times ，56.38％）and academic conferences （162 person times ，41.33％）. The expected training methods included online video courses （344 person times ，87.76％）and offline courses（248 person times ，63.27％）. In terms of prescription checking and dispensing ，there were mainly problems such as incomplete medical documents and materials ；82.91％ and 64.54％ of pharmacists needed routine medical records and discharge summary，and 91.58％ of pharmacists took the doctor ’s handwritten prescription as the basis for dispensing new anti-tumor drugs ； pharmacists paid less attention to allergy history ，genetic history and ADR in the field of drug consultation and guidance. According to DTP pharmacists ，the difficulties in the process of drug treatment management included patient ’s ADR monitoring （239 person times，60.97％），evaluating the rationality of drug use （222 person times ，56.63％），making a complete drug use record （219 person times ，55.87％）. The main follow-up visits of pharmacists were telephone （334 person times ，85.20％）and dispensing site （313 person times ，79.85％）. And 333 pharmacists（84.95％）thought it was necessary to make an appointment for dispensing ；the score rates of professional knowledge examination of antitumor pharmacy for the respondents were 40.56％-84.69％. In the aspect of pharmaceutical care management ，the main points of deduction were drug evaluation ，content and process of drug treatment management，drug follow-up and record ，and the proportion of deduction was 93％，86％ and 64％ respectively. In the on-site inspection，it was found that the pharmacist had a single source of working knowledge ，did not fully grasp the contents of the evaluation forms such as ADR classification standard ，and prescription checking did not meet the requirements. CONCLUSIONS ： DTP pharmacy in China develops rapidly under the guidance of relevant policies ，but its pharmaceutical care is still in the basic stage，which is far behind the requirements of providing whole-course pharmaceutical care for patients. It is necessary to improve the professional service ability of DTP pharma

Analysis and follow-up of dTP value in patients with coronary heart disease complicating diabetes / 重庆医学

Objective To analyze the dTP value in the patients with coronary heart disease (CHD) complicating diabetes mellitus (DM) and its relationship with major adverse cardiovascular events (MACE) and rehospitalization.Methods Two hundreds and seventy CHD patients were selected as the research subjects,including 136 cases of non-MD and 134 cases of DM.Their clinical condition was recorded.The indicators such as height,body mass,blood pressure and heart rate were measured.ECG,echocardiography,coronary angiography and other examiantions were carried out.The various indicators were detected.11-dh-TXB2 and 6-k-PGF1a levels were detected in the two groups and then dTP value was calculated.The 1-year follow-up was performed,MACE and rehospitalization were recorded.Epdate software was used for building a database and SPSS 17.0 software was applied for conducting the statistical analysis.Results The dTP level in the f non-DM and DM patients were 1.8 ± 0.6 and 2.0 ± 0.7 respectively,the difference was statistically significant (P＜ 0.05).For the non-DM CHD group,hs-CRP,systolic blood pressure,diastolic pressure,lesions number and severe lesions number were correlated with dTP level(P＜0.05).For the complicating DM CHD group,hs CRP,blood glucose,CHO level,lesions number and severe lesions number were correlated with dTP level(P＜0.05).After 1-year follow-up,MACE had 33 cases (24.3％) in the non-DM group and 44 cases (32.8％) in the DM group respectively,the difference was not statistically significant (P＞0.05).The rehospitalized cases had 12 cases (8.8％) in the non-DM group and 24 cases (17.9 ％).in the DM group respectively,the difference was statistically significant (P＜ 0.05).The dTP levels of MACE occurrence and non-MACE occurrence were 2.3 ± 0.8 and 1.8 ± 0.6 respectively,the difference was statistically significant (P＜0.05).The dTP levels of rehospitalized patients and non-rehospitalized patients were 2.4 ± 1.0 and 1.9 ±-0.6 respectively,the difference was statistically significant(P＜0.05).Conclusion The dTP level in the patients with CHD complicating DM is significantly increased,suggesting that platelet is obviously activated,moreover higher dTP level increases the risk of MACE and rehospitalization.So the anti-platelet therapy should be strengthened.

A Case of Pilomatricoma Arising at a Diphtheria-tetanus-pertussis Vaccination Site / 대한피부과학회지

No abstract available.

A Case of Pilomatricoma Arising at a Diphtheria-tetanus-pertussis Vaccination Site / 대한피부과학회지

No abstract available.

Comparative analysis of the intracerebral mouse protection test and serological method for potency assays of pertussis component in DTP vaccine

The aim of this study was to compare the PSPT standardized in-house as an alternative to MPT for potency assays of pertussis component. Statistical analyses have showed similar pertussis potency values when PSPT was compared to MPT. Significant correlation between the potency results obtained by in vivo and in vitro assays was also been observed. Results by PSPT have demonstrated reproducibility and accuracy for potency pertussis control and this approach has been considered promising for use at least during the steps of production.

A situação vacinal das crianças que apresentaram eventos adversos com vacina tetravalente no município de Belém-PA, 2008 / The immunization status of children experiencing adverse events with tetravalent vaccine in Belem, PA, 2008

Alguns estudos que tem acompanhado a utilização da vacina tetravalente na rotina do PNI desde 2002 observaram uma incidência maior de eventos adversos associados à mesma em comparação com as demais vacinas do calendário vacinal. Este estudo teve como objetivo conhecer a situação vacinal das crianças que apresentaram eventos adversos após vacinação de tetravalente na rede pública do município de Belém no ano de 2008. Foi realizado um estudo transversal. A população estudada foi a de menores de um ano que apresentaram eventos adversos após vacinação tetravalente. Foram analisadas variáveis relacionadas às características sócio-econômicas dos responsáveis, à situação vacinal das crianças participantes e aos eventos adversos após a vacina. Verificou-se que 33,3 por cento das crianças participantes apresentaram algum atraso no esquema vacinal, e os principais motivos do atraso foram o esquecimento por parte da mãe (22,8por cento) e a falta de orientação dos profissionais de saúde (13,7 por cento). Concluiu-se que tais motivos podem indicar falhas na atenção primária em saúde no que se refere ao controle de doenças que, atualmente, são preveníveis por vacinação, assim, presume-se que tenham ocorrido oportunidades perdidas de vacinar estas crianças.

Pattern of functional antibody activity against Haemophilus influenzae type b (Hib) in infants immunized with diphtheria-tetanus-pertussis/Hib Brazilian combination vaccine

We evaluated the functional activity of Haemophilus influenzae B (Hib) antibodies elicited in a group of infants immunized with the diphtheria-tetanus-pertussis vaccine combined with an Hib vaccine produced totally in Brazil after technological transfer of Hib vaccine production from Glaxo SmithKline, Belgium. Blood samples from immunized infants (N = 985) were collected for the determination of Hib antibodies. Total Ig and IgM and IgG subclasses of antibodies against polyribosyl ribitol phosphate (PRP) were analyzed by ELISA. Almost all vaccinees (97.56 percent, 961/985) developed a strong anti-PRP IgG antibody response (¡Ý1.0 ¦Ìg/mL), while an anti-PRP IgM response was observed in 64.24 percent (634/985) of them (¡Ý0.15 ¦Ìg/mL). Only 18.88 percent (186/985) of the infants in the group with high PRP antibody IgG concentrations (¡Ý1.0 ¦Ìg/mL) developed a high IgM antibody response. Anti-PRP IgG antibody levels were significantly higher than anti-PRP IgM. These results demonstrate the predominance of IgG antibodies over IgM antibodies in response to PRP, with a ratio of 17:1. IgG antibodies were predominantly of the IgG1 subclass. An increase in IgG avidity was also observed during the course of immunization.

Análise da temperatura axilar e da febre verificadas em um ensaio clínico com vacinas / Analysis of axillary temperature and fever observed in a clinical trial of vaccines

Objetivos: Analisar a temperatura axilar no estudo da vacina contra difteria, tétano, o componente pertussis e hemófilo (DTP/Hib), a frequência de febre e a associação dos eventos adversos. Analisar a metodologia para verificação da temperatura corpórea e febre utilizada em diferentes estudos clínicos com a vacina DTP/Hib. Materiais e métodos: Este trabalho é baseado em dados obtidos do “Estudo de imunogenicidade e reatogenicidade de vacina combinada contra difteria, tétano, pertussis e hemófilo tipo b: validação clínica de produto produzido totalmente no Brasil”, com 1000 lactentes, realizado no município do Rio de Janeiro, no ano de 2006. Foi analisada a temperatura axilar nos tempos 3, 6, 12, 24, 48 e 72 horas após a vacinação. Foram analisadas as associações entre os eventos adversos locais e eventos adversos sistêmicos. Resultados: A freqüência de febre foi de 53,4 % após a primeira dose, 39,9 % após a segunda dose e 31,5 % após a terceira dose nas 24 horas após a vacinação. A freqüência de febre foi diminuindo com a aplicação das doses. Não houve padrão de associação entre os eventos adversos locais e sistêmicos. A mediana da distribuição da temperatura axilar foi maior nos tempos 6 e 12 horas após a vacinação. Conclusões: A definição de febre e as metodologias utilizadas nos estudos clínicos para verificar a temperatura corpórea ainda são heterogêneas, o que dificulta a comparabilidade entre eles.

Objectives: To analyze the axillary temperature in the study of the vaccine DTP/Hib (Martins et al., 2008), the frequency of fever and the association of the adverse events. To analyze themethodology for checking of the corporal temperature and fever used in different clinical trial with the vaccine DTP/Hib. Materials and methods: This work is based on obtained data of the “Study of immunogenicity and reactogenicity of vaccine combined against diphtheria, tetanus, pertussisand haemophylus type b: clinical validation of product produced totally in Brazil ”, with 1000 infants, carried out in the local authority of the Rio of January, in the year of 2006. The axillary temperature was analyzed in the times 3, 6, 12, 24, 48 and 72 hours after the vaccination. The associations were analyzed between the adverse local events and adverse systemic events. Results: The frequency of fever was 53.4 % after the first dose, 39.9 % after the second dose and 31.5 % after the third dose in 24 hours after the vaccination. The frequency of feverwas lessening with the application of the doses. There was no standard of association between the adverse local events and systemic adverse events. The medium one of the distribution ofthe axillary temperature was bigger in the times 6 and 12 hours after the vaccination. Conclusions: The definition of fever and the methodologies used in the clinical studies to check the corporal temperature they are still heterogeneous what makes difficult thecomparability between them.

Immunogenicity, reactogenicity and consistency of production of a Brazilian combined vaccine against diphtheria, tetanus, pertussis and Haemophilus influenzae type b

A randomized, double-blinded study evaluating the immunogenicity, safety and consistency of production of a combined diphtheria-tetanus-pertussis-Haemophilus influenzae type b vaccine entirely produced in Brazil by Bio-Manguinhos and Instituto Butantan (DTP/Hib-BM) was undertaken. The reference vaccine had the same DTP vaccine but the Hib component was produced using purified materials supplied by GlaxoSmithKline (DTP/Hib-GSK), which is registered and has supplied the Brazilian National Immunization Program for over more than five years. One thousand infants were recruited for the study and received vaccinations at two, four and six months of age. With respect to immunogenicity, the vaccination protocol was followed in 95.6 percent and 98.4 percent of infants in the DTP/Hib-BM and DTP/Hib-GSK groups, respectively. For the Hib component of the study, there was 100 percent seroprotection (>0.15 µg/mL) with all three lots of DTP/Hib-BM and DTP/Hib-GSK. The geometric mean titer (GMT) was 9.3 µg/mL, 10.3 µg/mL and 10.3 µg/mL for lots 1, 2 and 3 of DTP/Hib-BM, respectively, and the GMT was 11.3 g/mL for DTP/Hib-GSK. For diphtheria, tetanus and pertussis, seroprotection was 99.7 percent, 100 percent and 99.9 percent, respectively, for DTP/Hib-BM, three lots altogether and 99.2 percent, 100 percent and 100 percent for DTP/Hib-GSK. GMTs were similar across all lots and vaccines. Adverse events rates were comparable among the vaccine groups. The Brazilian DTP/Hib vaccine demonstrated an immunogenicity and reactogenicity profile similar to that of the reference vaccine.

Incidência de episódios hipotônicos-hiporresponsivos associados à vacina combinada DTP/Hib usada no Programa Nacional de Imunizações / Incidence of hypotonic-hyporesponsive episodes associated to the combined DTP/Hib vaccine used in Brazilian National Immunizations Program

OBJETIVO: Avaliar a segurança da vacina combinada de difteria-tétano-coqueluche de células inteiras e Haemophilus influenzae tipo b usada no Programa Nacional de Imunizações, e em especial a incidência de episódios hipotônicos-hiporresponsivos. MÉTODO: Acompanhamento de uma coorte de 21.064 lactentes (20.925 ou 99,7 por cento aderiram ao protocolo de estudo), nas 48 horas após a aplicação da vacina de difteria, tétano, coqueluche de células inteiras e Haemophilus influenzae tipo b em centros de saúde na cidade do Rio de Janeiro, para determinar e investigar eventos adversos graves, espontâneos e solicitados. Cada criança foi monitorada durante somente uma dose. RESULTADOS: A incidência de episódios hipotônicos-hiporresponsivos foi de 1:1.744 doses (casos confirmados) e de 1:1.495 doses (casos confirmados mais casos suspeitos). A taxa de incidência de convulsões foi de 1:5.231 doses. Não foram detectados casos de apnéia. Esses resultados são comparáveis àqueles relatados na literatura para a vacina contra difteria-tétano-coqueluche de células inteiras. CONCLUSÃO: A vacina contra difteria, tétano, coqueluche de células inteiras e Haemophilus influenzae tipo b em estudo pode ser usada com segurança no Programa Nacional de Imunizações, de acordo com as precauções e contra-indicações correntes.

OBJECTIVE:To evaluate the safety of a combined diphtheria-tetanus-whole cell pertussis-Haemophilus influenzae type b vaccine used on the Brazilian National Immunizations Program, chiefly the incidence of hypotonic-hyporesponsive episodes. METHOD: Follow-up of a cohort of 21,064 infants (20,925 or 99.7 percent adhered to the study protocol), within 48 hours of vaccination with diphtheria-tetanus-whole cell pertussis-Haemophilus influenzae type b vaccine in health care units in the City of Rio de Janeiro, to ascertain and investigate spontaneous and solicited severe adverse events. Each child was followed-up for one dose only. RESULTS: The rate of hypotonic-hyporesponsive episodes was 1/1,744 doses (confirmed cases) and 1/1,495 doses (confirmed plus suspect cases). The rate of convulsions was 1/5,231 doses. No cases of apnea were detected. These results are comparable to those found in the literature with diphtheria-tetanus-whole cell pertussis vaccine. CONCLUSION: The diphtheria-tetanus-whole cell pertussis-Haemophilus influenzae type b vaccine under study can be safely used in the National Immunizations Program, according to the current precautions and contraindications.

Using physical method to determine the previous freezing of absorbed DTP vaccine

Absorbed DTP vaccines in the same Lot (produced by IVAC, Nha Trang) were kept at 4°C, -5 +/-10oC, -20°C on 2, 3 and 6 hours. After being thawed completely, the vaccine containers were vigorously shaken and the contents were examined for physical changes. The results showed that the containers kept at 4oC had no physical changes; the containers kept at -5 +/-10oC, 20°C for 6 hours had significant changes such as agglomeration, floccules or granular matter, and sedimented rapidly. It is suggested that structure of aluminum adjuvant in DTP vaccine is changed. The containers kept at -5 +/-10oC, -20°C for 6 hours can be considered as the positive control and the shaking test can be used to determine the previous freezing of adsorbed DTP vaccines.