Amamentação e utilização de medicamentos: qual a orientação presente nas bulas de anticoncepcionais e anti-infecciosos? / Breastfeeding and drug use: what is the orientation found in drug package inserts of contraceptives and anti-infective agents?

Resumo O objetivo deste artigo é avaliar a concordância entre bulas e fontes bibliográficas baseadas em evidências científicas quanto à presença de contraindicação do uso de anticoncepcionais e anti-infecciosos durante a amamentação. Foram selecionados medicamentos anticoncepcionais e anti-infecciosos, segundo a ATC, com registro na ANVISA e presentes nas fontes bibliográficas: Manual Amamentação e Uso de Medicamentos e Outras Substâncias, Medications and Mother's Milk, LactMed®, Micromedex® e UpToDate®. As informações foram extraídas das seções "Contraindicações" e "Advertências e precauções" das bulas e comparadas com as informações das fontes. Foi avaliada a presença de informação contraindicando o uso do medicamento durante a amamentação. Em cinco (55,5%) dos nove anticoncepcionais foi verificada contraindicação na bula. Entre as fontes bibliográficas, o percentual variou de 0% a 55,5%, dependendo da fonte. Para os anti-infecciosos, o percentual de contraindicação foi de 46,3% na bula, variando de 0% a 12,9% nas fontes. Existe concordância entre as bulas e as fontes bibliográficas com relação aos anticoncepcionais; no caso dos anti-infecciosos, as bulas apresentam contraindicação para o uso durante a amamentação com mais frequência.

Abstract This article aims to evaluate the conformity between drug package inserts (DPIs) and evidence-based bibliographic sources regarding the presence of contraindications to the use of contraceptives and anti-infective agents during breastfeeding. Contraceptive and anti-infectives were selected, according to ATC, with the updated record in the ANVISA and present in the bibliographic sources Breastfeeding and Use of Medicines and Other Substances, Medications and Mother's Milk, LactMed®, Micromedex® and UpToDate®. Information was extracted from the DPI "Contraindications" and "Warnings and precautions" sections and compared with the information in the bibliographic sources. The contraindication of the drug during breastfeeding was evaluated. Contraindications were found in the DPIs of five (55.5%) of the nine contraceptives. The contraindication percentage ranged from 0 to 55.5% among the bibliographic sources, depending on the source. The percentage was 46.3% in the DPIs, ranging from 0 to 12.9% in the bibliographic sources for anti-infectives. There is an agreement between the DPIs and the bibliographic sources regarding contraceptives; regarding anti-infectives, the DPIs are more often contraindicated for use during breastfeeding.

Analysis of Pediatric Medication Information Labelling in 46 Pieces of Package Inserts for Skin External Drugs in Our Hospital / 中国药房

OBJECTIVE： To investigate the labelling problems of pediatric medication in the package inserts of skin external drugs in our hospital， and to put forward the suggestions. METHODS： A total of 46 package inserts for skin external medicine were collected from outpatient pharmacy of our hospital during Jan.-Dec. in 2018. Information on pediatric medication， precautions for pediatric medication， pediatric usage and dosage， and pediatric pharmacokinetic labelling in those package inserts was analyzed and summarized according to the types of domestic， imported and joint enterprises， classification of western medicine and Chinese patent medicine and labelling clarity， etc. RESULTS： Among 46 package inserts， 37 western medicines and 9 Chinese patent medicines were included； 31 domestic enterprises， 9 import enterprises and 6 joint ventures were involved. The ratio of pediatric medication， precautions （for pediatric medication）， pediatric usage and dosage， and pediatric pharmacokinetics labelling were 38.7％， 58.1％，  29.0％ and 0 for domestic drugs； 88.9％， 55.6％， 44.4％ and 33.3％ for imported drugs； 33.3％， 83.3％， 16.7％ and 0 for joint venture drugs； 59.5％， 62.2％， 32.4％ and 8.1％ for western medicine； 0， 55.6％， 22.2％ and 0 for Chinese patent medicine. 5 （10.9％） drug package inserts clearly indicated the usage and dosage of children； 12 （26.1％） drug package inserts were clearly labeled for the usage and dosage involving children； 12 （26.1％） drug package inserts were clearly marked to remind children to use under the supervision of doctors and adults； 11 （23.9％） drug package inserts clearly indicated that pediatric medication was not clear and the safety of pediatric medication was not yet established； 1 （2.2％） package insert clearly indicated that children should be cautious and forbidden； 3 （6.5％） package inserts did not involve package insert for pediatric medication； 2 （4.3％） package inserts clearly indicated that the drugs were stored in places not accessible to children. CONCLUSIONS： There are some problems in the package inserts of skin external drugs in our hospital， such as the marked rate of pediatric medication is quite different； the contents of the labels of pediatric medication are ambiguous and pharmacokinetic data is absent； the contents of the package inserts are inconsistent and the patients are not easy to understand professional terms. The standardization， strictness and guidance of drug package inserts for children can be improved by strengthening the supervision and management of drug package inserts by drug regulatory authorities， increasing the research and development of children’s special drugs， increasing the attention of pharmaceutical enterprises to pediatric medication， paying the attention to the revision of standard package inserts， advancing the clinical trials of children， and raising the awareness of safe drug use of patients and users.

Status of Responses to Foreign Language Inquiries When Selling OTC Drug / 医薬品情報学

Objective: Along with the increase in the number of foreign visitors to Japan, the number of inquiries in foreign languages at the time of OTC drug sales has increased.　To clarify the current status of responses to foreign language inquiries when selling OTC drug, we surveyed the frequency of foreign language response, languages used, trouble experienced, and preparation useful in responding to foreign language inquiries when selling OTC drug.Methods: Our survey was conducted with 694 registered salesclerks of drugs at an external training seminar in Tokyo, Japan.Results: Of the 649 respondents, 337 (51.9%) had experience in responding to inquiries in a foreign language when selling OTC drug.　The languages used were as follows: ”English,” 86.4%; ”Chinese,” 70.0%; ”Korean,” 25.8%.　Of the respondents who had experience in responding to inquiries in a foreign language when selling OTC drug, 107 (31.8%) responded ”I experienced trouble because I could not understand what was being said,” and 228 (67.7%) responded ”I could not respond and experienced trouble.”　When asked about preparation/tools useful for selling OTC drug, 434 (66.9%) responded ”multilingual written correspondence table,” 359 (55.3%) responded ”smartphone or tablet‐based correspondence multilingual table,” 299 (46.1%) responded ”marks and illustrations,” and 253 (39.0%) responded ”I would like to be taught how to respond in a foreign language (simple conversation).”Conclusions: Our results revealed that when selling OTC drug, response to inquiries in a foreign language occurred frequently and trouble was experienced in listening comprehension and speaking a foreign language.　Therefore, urgent countermeasures such as preparing a multilingual correspondence table of symptoms, usage, and dosage, and lectures on methods of responding through simple foreign language conversations are necessary.　In addition, efforts such as creation of multilingual drug package inserts by pharmaceutical companies were considered to be an effective measure.

Analysis of the Situation of the Minimum Sales Package Unit / 中国药房

OBJECTIVE:To analyze the situation of the minimum sales package unit,and to provide reference for standardiz-ing package. METHODS:According to related regulations of New Edited Materia Medica(17th edition)and package inserts,373 kinds of oral drugs,57 kinds of oral drugs for lowering blood glucose,blood lipid and blood pressure,6 kinds of second kind psy-chotropic oral drugs were analyzed statistically in respect of minimum sales package unit and medication duration. RESULTS:There were 30 kinds of minimum sale package unit for 373 oral drugs,among which common capacity were 20,10,100 grain/tab-let/pill,accounting for 14.21%,14.21%,12.33% respectively,and 57.11% were used within 7 d. There were 13 kinds of mini-mum sale package unit for 57 oral drugs for lowering blood glucose,blood lipid and blood pressure,among which the common ca-pacity were 7,30,14,10 grain/tablet/pill,accounting for 33.34%,14.04%,14.04%,14.04% respectively,and 85.97% were used within 14 d,indicating sales package unit often based on weekly dosage. Among 6 kinds of type Ⅱ psychotropic oral drugs, minimum sales package unit capacity of 3 kinds were all 20 grain/tablet/pill,and those of other 3 kinds were 10,7,6 grain/tablet/pill;one of them were used more than 7 d. CONCLUSIONS:Minimum sales package unit is confirmed discretionarily. It is sug-gested that minimum sale package unit of oral drugs for lowering blood glucose,blood lipid and blood pressure should be packaged according to the dosage of 2 weeks to one nonth;the capacity of type Ⅱ psychotropic oral drugs is lower than the dosage of 7 days,and daily dose package is the best.

Analytical evaluation of drug package inserts in India.

Background: A drug package insert or prescribing information is a document provided along with a prescription medication to provide additional information about that drug. Drug package inserts are approved by the administrative licensing authority. A package insert is intended to provide information for the safe and effective use of the respective drug. Product information provided by pharmaceutical companies has been determined to be far from adequate and not conforming with requirement of Indian regulatory. Hence, it was decided to conduct a study to assess the presentation and completeness of clinically important information provided in the currently available package inserts in India. Methods: Package inserts were provided by five pharmacies on request. The package inserts were collected in 10 weeks’ period and then they were analyzed for presentation and completeness of clinical information according to heading mentioned in Section 6.2 and 6.3 of schedule D of Drug and Cosmetic Rule, 1945. If the information was present under relevant heading, it was scored as one. Otherwise as score of zero was assigned. Total score for each heading was calculated by adding the score from the individual package inserts. Results: 70 package inserts were included in the study. None of the reviewed package inserts contained all the sections as required by the Drugs and Cosmetics Act. Total 15 headings were evaluated under both Section 6.2 and 6.3, highest value for the presence of heading were 12 out of 15 heading evaluated. That shows the best value of compliance was 80%. Conclusion: Accurate drug product information is important for the safe and effective use of medicines. Hence, pharmaceutical companies and regulators should ensure that accurate and up to date product information is provided in the package inserts.

Cross-sectional Survey on the Drug Off-label Use in A Primary Hospital / 中国药房

OBJECTIVE:To provide reference for the clinical rational drug use. METHODS:Cross-sectional survey was adopt-ed to statistically analyze the off-label use of inpatient(489 prescriptions)and outpatient prescriptions(466 prescriptions)in our hos-pital in Jun. 19,2014. RESULTS:The prescription items and ratios of off-label use in inpatients and outpatients in our hospital were 240,14.1%(240/1 704)and 149,17.4%(149/852),respectively. The top 4 types of drug off-label use included changing ad-ministration frequency,indications,compatibility concentrations of injections and dosage. CONCLUSIONS:Some of off-label use are rational,supporting by kinds of guidelines,expert consensus and literature reporting;while some are irrational,clinic should avoid this kind of irrational use and be strictly controlled by pharmacists. Meanwhile,it is suggested that the drug manufacturers up-date the instructions timely to provide reference for ensuring safety drug use of patients.

A alta prevalência de prescrições de medicamentos off-label e não licenciados em unidade de terapia intensiva pediátrica brasileira / High prevalence of off-label and unlicensed drug prescribing in a Brazilian intensive care unit

OBJETIVO: Descrever o uso e determinar a prevalência de medicamentos de uso off-label enão licenciados em prescrições na unidade de terapia intensiva pediátrica de um hospital no sudeste do Brasil. MÉTODOS: Estudo transversal envolvendo os pacientes internados na unidade de terapia intensiva pediátrica durante o período de maio de 2008 a janeiro de 2009. A classificação quanto aos critérios de aprovação da Agência de Vigilância Sanitária (Anvisa) foi baseada em seu bulário eletrônico e no Dicionário de Especialidades Farmacêuticas e as análises realizadas no software R. RESULTADOS: Foram analisados 1.054 itens de prescrição de 73 pacientes. O gênero feminino foi o mais frequente (52 por cento) e a idade dos pacientes variou de zero a 16 anos. Observou-se que 23,4 por cento dos medicamentos foram prescritos de modo off-label, 12,6 por cento não licenciados e 1,4 por cento foram classificados em ambas as razões; 86 por cento receberam ao menos um item de uso off-label e 67 por cento ao menos um item de uso não licenciado. Os grupos terapêuticos mais prescritos foram os antibacterianos de uso sistêmico, os analgésicos, psicolépticos e antiasmáticos. CONCLUSÃO: Os resultados do presente trabalho confirmam a alta prevalência do uso off-label e não licenciados dos medicamentos em unidade de terapia intensiva pediátrica.

OBJECTIVE: To describe the use and determine the prevalence of off-label and unlicensed drug use prescribing in a pediatric intensive care unit in a Southeastern Brazilian hospital METHODS: Cross-sectional study of inpatients in a pediatric intensive care unit from May 2008 through January 2009. The classification according to the Brazilian regulatory agency (Agência de Vigilância Sanitária - Anvisa) approval criteria was based on the Anvisa electronic package insert list, Pharmaceuticals Dictionary, and the analysis was conducted through R software. RESULTS: We analysed 1,054 prescription items for 73 patients. Females predominated (52 percent), and the patients' age ranged from 0 to 16 years. Among the prescribed items, 23.4 percent were off-label, 12.6 percent were unlicensed, 1.4 percent were both off-label and unlicensed, 86 percent had at least one item off-label, and 67 percent had at least one unlicensed drug. The most frequently prescribed therapeutic groups were systemic anti-bacterial, analgesic, psycholeptic, and antiasmathic agents. CONCLUSION: The current study results confirm the high prevalence of unlicensed and off-label drug use in a pediatric intensive care unit.

Investigation and Analysis of Dose-Related Items in Drug Package Inserts / 中国药房

OBJECTIVE:To provide reference for standardization of drug package.METHODS:5 dose-related items stated in a total of 426 package inserts of chemical drugs collected from the drug storeroom in our hospital were investigated and analyzed.RESULTS:Only 32.39% of the package inserts were with complete labeling.The labeling rate for special group was low and only 40% labeled the maximal dose.Less than 2% of child dose stated the doses according to body surface area,and the problem of over-dose was common.Only 27.46% had the item of "under supervision of a physician".CONCLUSION:It is necessary to strengthen supervision on drug package inserts and improve cognition on the importance of drug package inserts.

Survey and Analysis of Drug Use that Goes Beyond the Scope of Package Inserts in Pediatrics / 中国药房

OBJECTIVE:To probe into the situation of drug use that goes beyond the scope of package inserts in pediatrics of our hospital and to promote clinical rational drug use.METHODS:A total of 3 142 prescriptions between Mar.and Apr.2006 collected from the pediatric out-patient department of our hospital were analyzed in accordance with the contents of the related drug package inserts.RESULTS:Of the total 3 142 prescriptions,345(11.0%) involved drug use that goes beyond the scope of package inserts,leading the list were prescriptions of infants,accounting for 71.3% of the total.The problems such as age(52.2%) and indication(36.5%) were the main type;respiration system drugs(48.4%) and the antibiotics(40.6%) were the main drug kinds involved.CONCLUSIONS:It's widespread for drug use that goes beyond the package inserts in the pe-diatrics,which conforms to evidence-based medicine and the spirit of philosophy and ethics,but against the principle of law,which thus should be given fully attention in the clinic.