Phytocannabinoids and the individualization of treatment. Why is there no level of evidence? / Fitocanabinoides e a individualização do tratamento. Por que não há nível de evidências?

ABSTRACT BACKGROUND AND OBJECTIVES: The individualization of treatment has been recognized as essential in medical practice, especially due to the demand for different therapeutic approaches for similar situations. However, the complex and variable nature of the phytocannabinoids present in the cannabis plant presents challenges for the application of traditional models for testing the efficacy and safety of new drugs. The objective of the present study was to highlight the particularities of cannabis, including genetic variety, cultivation and production, which make it difficult to comply with traditional drug registration protocols, and the importance of individualizing treatment in the use of cannabis for the control of pain. CONTENTS: Traditional models for testing the efficacy and safety of new drugs are based on a rigid methodology, divided into development and post-market phases. However, the complexity of the cannabis plant, with hundreds of actives that can vary according to the genetic variety, cultivation and production process, makes the application of these models difficult. In addition, international rules do not allow the registration of patents on cannabis products, due to the consideration that they are natural products and the extraction methods are already used in the industry for other plant actives. The individualization of treatment is fundamental in the use of cannabis for pain control, given the complexity of the plant and the limitations of traditional models of testing and drug registration. CONCLUSION: The particularities of cannabis, such as genetic variability and the impossibility of registering patents, make compliance with current protocols difficult. However, the individualization of treatment allows adapting therapies to the needs of each patient, considering effectiveness and tolerance of side effects. Therefore, there is a need to rethink research and registry models to allow for a more flexible and personalized approach in the field of cannabis medicines.

RESUMO JUSTIFICATIVA E OBJETIVOS: A individualização do tratamento tem sido reconhecida como essencial na prática médica, especialmente devido à demanda por diferentes abordagens terapêuticas para situações semelhantes. No entanto, a natureza complexa e variável dos fitocanabinoides presentes na cannabis apresenta desafios para a aplicação dos modelos tradicionais de testes de eficácia e segurança de novos fármacos. O objetivo deste estudo foi destacar as particularidades da cannabis, incluindo a variedade genética, o cultivo e a produção, que dificultam a conformidade com os protocolos tradicionais de registro de medicamentos, e bem como a importância da individualização do tratamento na utilização da cannabis para o controle da dor. CONTEÚDO: Os modelos tradicionais de testes de eficácia e segurança de novos fármacos são baseados em uma metodologia rígida, dividida em fases de desenvolvimento e pós-mercado. No entanto, a complexidade da planta de cannabis, com centenas de ativos que podem variar de acordo com a variedade genética, o cultivo e o processo de produção, torna difícil a aplicação desses modelos. Além disso, as regras internacionais não permitem o registro de patentes de produtos canábicos, devido à consideração de que são produtos naturais e os métodos de extração já são utilizados na indústria para outros ativos vegetais. A individualização do tratamento é fundamental na utilização da cannabis para o controle da dor, dada a complexidade da planta e as limitações dos modelos tradicionais de testes e registro de fármacos. CONCLUSÃO: As particularidades da cannabis, como a variabilidade genética e a impossibilidade de registro de patentes, dificultam a conformidade com os protocolos atuais. No entanto, a individualização do tratamento permite adaptar as terapias às necessidades de cada paciente, considerando a efetividade e a tolerância aos efeitos colaterais. Portanto, é necessário repensar os modelos de pesquisa e registro para permitir uma abordagem mais flexível e personalizada no campo dos fármacos canábicos.

Avaliação do impacto da orientação farmacêutica aos pacientes sobre os medicamentos prescritos / Evaluation of the impact of pharmaceutical orientation given to patients on prescribed drugs

O uso racional de medicamentos é considerado um dos elementos-chave recomendados pela Organização Mundial de Saúde, cuja ausência pode acarretar consequências como reações adversas, diminuição da eficácia do medicamento, perdas de ordem econômica para o governo e/ou indivíduo, interações medicamentosas e agravo do quadro clínico do paciente. O serviço de orientação farmacêutica que envolve esse contexto foi discutido por poucos estudos, considerando-se interessante a utilização de um instrumento validado para demonstrar o impacto do fornecimento de orientação farmacêutica direcionada a pacientes em uso de medicamentos prescritos, o que constitui o objetivo desse trabalho. A metodologia utilizada foi estudo transversal conduzido em uma Unidade Básica de Saúde de Diamantina/ MG. Foi utilizado um questionário para medir o grau do conhecimento do paciente sobre seus medicamentos nos momentos pré e pós a realização de orientação farmacêutica. Após a orientação farmacêutica, observou-se diminuição do percentual de usuários que não conheciam seus medicamentos (73,2%; 93 para 33,9%; 43) e aumento do nível de conhecimento suficiente (14,2%; 18 para 18,9%; 24) e ótimo (11,0%; 14 para 47,2%; 60). Houve aumento do conhecimento dos usuários em todos os itens que compõem o questionário. A orientação farmacêutica apresentou impacto positivo sobre o conhecimento dos pacientes sobre seus medicamentos e constitui uma prática essencial para o Uso Racional dos Medicamentos.

The rational use of drugs is considered one of the key elements recommended by the World Health Organization, the absence of which can lead to consequences such as adverse reactions, decreased drug efficacy, economic losses for the government and/or individual, drug interactions, and worsening of the patient's clinical condition. The pharmaceutical orientation service that involves this context has been discussed by few studies, and the use of a validated instrument to demonstrate the impact of providing pharmaceutical guidance to patients on prescribed drugs is considered interesting and constitutes the objective of this work. The methodology used was a cross-sectional study conducted in a Primary Care Center in Diamantina, MG. A questionnaire was used to measure the patient's level of knowledge about their medications before and after receiving pharmaceutical guidance. After pharmaceutical orientation, there was a decrease in the percentage of users who did not know about their medications (73.2%; n=93 to 33.9%; n=43) and an increase in the level of sufficient knowledge (14.2%; n=18 to 18.9%; n=24) and excellent knowledge (11.0%; n=14 to 47.2%; n=60). There was an increase in users' knowledge of all the items that make up the questionnaire. Pharmaceutical orientation had a positive impact on patients' knowledge about their medications and constitutes an essential practice for the Rational Use of Medications.

Clinical pharmacist participation in the treatment of a pregnancy complicated with Clostridium difficile infection / 药学实践杂志

Objective To explore the clinical pharmacist participation in the treatment of pregnancy complicated with Clostridium difficile infection. Methods From the perspective of medications, clinical pharmacists followed evidence-based medical practice, combined pharmaceutical theory with clinical evidence and provided individualized pharmacy care in drug selection, dose adjustment, medication regime and liver protection treatment. Results Clinical pharmacists integrated into the treatment team to ensure the effectiveness and safety of medication in the patient with pregnancy. Conclusion The individualized pharmacy care improved the effectiveness of drug treatment.

Analysis of Drug Use in a Patient with Rare Camrelizumab-induced Toxic Epidermal Necrolysis by Clinical Pharmacists / 中国药房

OBJECTIVE：To introduce the role of clinical pharmacists in the treatment of camrelizumab-induced toxic epidermal necrolysis （TEN），and to provide reference for the therapy of similar ADR. METHODS：The clinical pharmacist participated in therapy duration of a patient with TEN caused by camrelizumab. The patient was treated with Camrelizumab for injection combined with Apatinib mesylate tablet as anti-tumor therapy，and was admitted to hospital due to extensive skin lesions. After consulting relevant literatures and analyzing the patient’s admission diagnosis [severe epidermolysis bullosa，severe drug eruption（erythema multiforme），abnormal liver function，etc.] and examination results（hypokalemia，etc.），clinical pharmacists suggested to stop above anti-tumor drugs and given Methylprednisolone sodium succinate for injection（160 mg→80 mg→60 mg， qd，ivgtt） for anti-inflammatory treatment，Imiperan cilastatin for injection （1 g，q8 h，ivgtt） for an ti-infection treatment， Potassium chloride injection（1 g，qd，ivgtt）for electrolyte regulation，Compound amino acid injection（3AA）（10.65 g，qd，ivgtt） for nutritional support treatment，Pantoprazole sodium for injection（40 mg，qd，ivgtt）for acid inhibition and stomach protection， Reduced glutathione for injection（2.4 g，qd，ivgtt）for liver protection. Before medication，the patient was given cognitive and behavioral education and medication publicity. The changes of relevant indicators were closely monitored during medication，and the patient was given medication guidance when he was discharged. RESULTS：The doctors adopted the suggestions of clinical pharmacists，and 16 days after treatment，the skin lesions of the trunk and limbs were improved，and the double eyelids were still erosive and exuded a lot of secretions. The patient requested transfer for treatment. CONCLUSIONS：Clinical pharmacists assisted physicians to improve the treatment plan of patients with TEN caused by camrelizumab，and carried out cognitive and behavioral education and medication publicity for patients to ensure the effectiveness and safety of their medication.

Application of statistical process control for spotting compliance to good pharmaceutical practice

ABSTRACT For the release of pharmaceutical products into the drug market; most of the pharmaceutical companies depend on acceptance criteria - that are set internally, regulatory and/or pharmacopeially. However, statistical process control monitoring is underestimated in most quality control in cases; although it is important not only for process stability and efficiency assessment but also for compliance with all appropriate pharmaceutical practices such as good manufacturing practice and good laboratory practice, known collectively as GXP. The current work aims to investigate two tablet inspection characteristics monitored during in-process control viz. tablet average weight and hardness. Both properties were assessed during the compression phase of the tablet and before the coating stage. Data gathering was performed by the Quality Assurance Team and processed by Commercial Statistical Software packages. Screening of collected results of 31 batches of an antibacterial tablet - based on Fluoroquinolone -showed that all the tested lots met the release specifications, although the process mean has been unstable which could be strongly evident in the variable control chart. Accordingly, the two inspected processes were not in the state of control and require strong actions to correct for the non-compliance to GXP. What is not controlled cannot be predicted in the future and thus the capability analysis would be of no value except to show the process capability retrospectively only. Setting the rules for the application of Statistical Process Control (SPC) should be mandated by Regulatory Agencies.

One case study of severe acute pancreatitis in pregnancy with interventions of clin-ical pharmacists in the treatments / 药学实践杂志

Objective To explore the role of clinical pharmacists in pharmaceutical care for a pregnant patient with severe acute pancreatitis .Methods Clinical pharmacists participated in the treatments for one severe case of acute pancreatitis in preg-nancy .Based on the disease states and therapeutic results ,clinical pharmacists adjusted the drug regimen ,selected safer antibi-otics for pregnant patient and provided comprehensive pharmaceutical services for the patient .Results Clinical pharmacists provided individualized pharmaceutical care ,improved the clinical outcomes and reduced the adverse reactions .Conclusion Clinical pharmacists play an important role in improving the drug therapeutic outcome and monitoring the medication safety in specific group of patients .

Exploration of Pharmaceutical Practice for Drug-induced Liver Injury / 中国药师

Objective:To explore a new way of pharmaceutical service mode for disease treatment. Methods:Clinical pharmacists actively participated in the pharmaceutical care for a patient with mixed liver injury, and provided clinical pharmaceutical services through the adverse reaction analysis,etiological mechanisms exploration,therapeutic drugs selection and risk factors prevention. Re-sults:Clinical pharmacists cooperating closely with physicians helped to identify problems in time,and then the medication analysis in the fields of drug selection, dose determination, efficacy evaluation and indicators detection was performed, so that the strategies on medicine treatment could be adjusted timely as the disease progressed. With the gradual recovery of liver function, the patient dis-charged after the conditions were improved. Conclusion:By participating in pharmaceutical practice,clinical pharmacists can provide clinical pharmaceutical service,which is helpful to safety improvement and efficiency of drug administration. It is also an effective way to enhance the learning ability of pharmacists,and cultivate their clinical thinking and practice capacity.

Pharmaceutical Practice for a Patient with Hiatal Hernia Complicating with Venous Catheter-related Infection / 中国药房

OBJECTIVE:To provide reference for clinical desicion,drug use and ADR avoidance. METHODS:Clinical pharmacists participated in the consultations and therapy plan about a patient with hiatal hernia complicating with venous catheter- related infections. Clinical pharmacists suggested pulling out peripherally inserted central catheter(PICC)and placing a catheter again. Anti-infective therapy plan had been adjusted:vancomycin 0.5 g/time,ivgtt,q12 h;fluconazole 0.2 g,ivgtt,qd(0.4 g,ivgtt,qd on the first day),cefoperazone/sulbactam 2 g,ivgtt,q8h. Vancomycin and fluconazole were additionally used for anti- infective therapy. RESULTS:Doctors adopted the suggestions of clinical pharmacist,and pulled out PICC;and then the infection of the patient was controlled effectively. Finally,the infection had been cured. CONCLUSIONS:The participation of clinical pharmacists in the consultation contributes to rational drug use,and assists doctors to make the right clinical decisions and avoid adverse drug events.

Pharmaceutical Practice for a Patient with 5-Fluorouracil Chemotherapy-induced Diarrhea and Neutropenia Associated with Fever / 中国药房

OBJECTIVE:To investigate the way to provide suitable pharmacecaical care for antineophastic drug-induced ADR by clinical pharmacists. METHODS:For one case of 5-FU chemotherapy-induced neutropenia associated with fever and diarrhea, clinical pharmacists provided advices on antibacterial treatment,including imipenem/cilastatin 0.5 g,q6 h,ivgtt;norvancomycin 0.4 g,q6 h,po;levofloxacin 0.4 g,qd,ivgtt;loperamide with initial dose of 4 mg for anti-diarrheal medication,maintaining at 2 mg,q4 h. RESULTS:After 22 days of appropriate antibacterial and anti-diarrheal treatment,the patient's body temperature and he-mogram returned to normal,diarrhea stopped and β-HCG decreased to 61.58 U/L;then the patient was discharged from hospital. CONCLUSIONS:It is beneficial to optimize chemotherapy plan and ADR disposal,and ensure the safety of the treatment that clini-cal pharmacists assist physicans to optimize therapy plan and provide pharmaceutical care.

Validación del cuestionario de medida del conocimiento del paciente sobre su medicamento adaptado al portugués / Validation of the Portuguese version of an instrument to measure the degree of patient knowledge about their medication

Validación de un cuestionario adaptado transculturalmente al portugués en cinco farmacias comunitarias de Portugal. Se determino la capacidad discriminante de los ítems, la validez de contenido y de constructo, análisis factorial de componentes principales, la fiabilidad y su estabilidad. Se observó un elevado grado de equivalencia semántica entre el cuestionario original y el cuestionario adaptado transculturalmente al portugués. Se obtuvo un índice de Kaiser-Meyer-Olkin de 0.550, y el test de esferidad de Bartlett confirmó la adecuación de los datos para la aplicación del análisis factorial (p < 0.0001). Se consideraron 3 factores que explicaron el 52.6% de la variabilidad total. Con respecto a la fiabilidad se obtuvo un á de Cronbach de 0.519, un C.Kappa = 0.89 y CCI = 0.756 (IC = 0.598-0.963). En este trabajo se elabora la primera adaptación para la cultura portuguesa de un cuestionario específico para medir el grado de conocimiento que tienen los pacientes sobre los medicamentos.

The scope of this study was the validation of a cross-culturally adapted questionnaire into Portuguese in five community pharmacies in Portugal. The discriminatory power of items, content and construct validity and factor analysis of the main components and their reliability and stability were determined. A high degree of semantic equivalence between the original questionnaire and the cross-culturally adapted questionnaire into Portuguese was observed. A Kaiser-Meyer-Olkin index of 0.550 was obtained and the Bartlett sphericity test confirmed the adequacy of the data for the application of factor analysis (p <0.0001). Three factors which accounted for 52.6% of the total variability were considered. With respect to reliability the following results were obtained: 0.519 for Cronbach's alpha test; 0.89 for Cohen's kappa coefficient; and 0.756 (IC=0.598-0.963) for the CCI exam. In this work, the first adaptation for the Portuguese culture of a specific questionnaire was produced to measure the degree of knowledge patients have about their medication.

Anti-infection treatment and pharmaceutical care for one patient of liver cirrho-sis complicated with pleural effusion / 药学实践杂志

Objective To investigate the value of clinical pharmacists in clinical treatment through the practice of clinical pharmacists participating in clinical drug treatment and providing pharmaceutical care to patients .Methods Clinical pharmacists were involved in therapeutic scheme making , medication education and drug effect and adverse reaction tracking of one patient of liver cir -rhosis complicated with pleural effusion .Results The effects of drug treatment were improved and the adverse drug reactions were re -duced after the participation of pharmacist in clinical treatment and the implementation of pharmaceutical care for the patient .Conclu-sion The participation of pharmacist in clinical drug therapy could enhance normative and reasonable usage of drugs .This participa-tion is decisive and valuable in clinical treatment .

Diagnosis of the availability and use of drug information sources in drugstores and pharmacies in southern Brazil / Diagnóstico da disponibilidade e da utilização de fontes de informação sobre medicamentos em drogarias e farmácias no sul do Brasil

This research has aimed to estimate the use of drug information sources by pharmacists in drugstores and pharmacies in southern Brazil. It consisted of sending a questionnaire through regular mail, contacting the pharmacist via phone and visiting the drugstores. Four hundred and eight (68.6 percent) of the 595 enrolled establishments answered the questionnaire. The information at pharmacies and drugstores is searched mainly to orient the patient. At drugstores the professionals have an average of 2.3 books, whereas at pharmacies they rely on 6.1. In a pharmacy, the chance to find more than five books is 27 times higher than in a drugstore. The more often available books are pharmaceutical specialties compendiums. There is access to Internet in 87.5 percent of pharmacies and 59 percent of drugstores. The National Agency of Health Surveillance webpage is the most accessed website, and the call centers of Pharmaceutical Companies are the most searched information service. Lack of time is the main alleged difficulty for searching information. The pharmacists working in the studied establishments miss appropriate drug information sources. Taking into consideration how important information is in the pharmaceutical practice, there is a need to emphasize this subject through an educative process, during undergraduate studies and continued education.

A pesquisa teve como objetivo descrever a utilização de fontes de informação em drogarias e farmácias no sul do Brasil. A mesma consistiu do envio do questionário pelo correio, contato com farmacêuticos por telefone e visita aos estabelecimentos. A resposta foi obtida em 408 (68,6 por cento) dos 595 estabelecimentos amostrados. A informação nas farmácias e drogarias é buscada, principalmente, para orientar o paciente. O profissional tem, em média, 2,3 livros nas drogarias e 6,1 nas farmácias. Em uma farmácia, a chance de se encontrar mais de cinco livros corresponde a 27 vezes aquela em uma drogaria. Os bulários são os livros mais frequentemente disponíveis. Há acesso à Internet em 87,5 por cento das farmácias e em 59 por cento das drogarias, sendo a chance de uma farmácia ter este recurso, cinco vezes maior que aquela em uma drogaria. A página da Agência Nacional de Vigilância Sanitária é a mais acessada e o Serviço de Atendimento ao Consumidor das Companhias Farmacêuticas, o serviço de informação mais consultado. A falta de tempo é a principal limitação da busca de informação. O farmacêutico nos estabelecimentos pesquisados é carente de fontes adequadas de informação. Considerando a importância da informação na prática farmacêutica, é necessário enfatizar o tema utilizando um processo educativo no período de formação e em atividades de atualização.

Guide to realize the decree for exercise of private medical and pharmaceutical practice and the enactment No06/CP on January 29th 1994 of the Government for concretization some items of the above decree in the domain of pharmaceutical exercise

The Guide comprises chapters. I. Common regulation (4 items); II. Standard, condition of private medical and pharmaceutical practice facilities (13 items). III. Domain of private medical and pharmaceutical practice categories (3 items). IV Manpower and responsibility of private medical and pharmaceutical practice (1 items). V. Procedures and certification of standard and condition to establish private medical and pharmaceutical practice clinic (9 items). VI. Inspection, control, and dispose violation (2 items). VII. Implement provision (one items).

Some opinions about private pharmaceutical practice

Since Government have been defined the economy of Vietnam is commodity economy with multicomponent under management of Government. The pharmaceutical Branch have been had a firm advance that responded the requisition about drug in task of protection and care of people's health. The attainment such results is to have the great contribution of private pharmaceutical practice system. We hope that the pharmaceutical will have soon a summation about this problem to infer strengths and weaknesses, and valuable lessons, helping the private pharmaceutical practice more and more completely