ABSTRACT
Background: Healthcare providers are still hesitant in prescribing generic medicines due to several misconceptions about bioequivalence, efficacy, quality, and safety of generic medicines as compared to their branded counterparts. Proper teaching and training help in positive changes in perception as well as the prescribing and dispensing practices of healthcare providers. Aim and Objectives: The aims of this study were to study the knowledge and perception about the generic medicine among 2nd year MBBS and nursing students and to find out the differences between the student’s responses. Materials and Methods: An observational cross-sectional study was conducted involving 83 2nd year MBBS students and 60 2nd year nursing students in Bundelkhand Medical College, Sagar (M.P.), India. Assessment of knowledge and perception about generic medicines using the normal 5-point Likert scale and calculation using the independent-samples Mann–Whitney U-Test and P < 0.05 was considered statistically significant for differences observed among the two groups. Results: Only 33% of MBBS students and 17% of nursing students were select correct answer for bioequivalence limits. Almost 82% of MBBS and 53% of nursing students were agreed toward generic medicines are less expensive than brand name medicines (P = 0.00). Only 45% of MBBS students and 15% of nursing students were disagreed toward generic medicines are of inferior quality to branded drugs (P = 0.001). About 37% of MBBS students and 20% of nursing students were disagreed toward generic medicines are less effective and less safe than brand name medicines (P = 0.01) and only 12% of MBBS students and 7% of nursing students were disagreed toward brand name medicine which are required to meet higher safety standards than generic medicines (P = 0.09). Conclusion: In our study, we found that significant knowledge gap with regard to the regulatory bioequivalence limits for generic medicines and misconceptions about generic drugs is also quite prevalent. Educational interventions are most important tool to improve knowledge and change in perceptions among healthcare students about generic medicines and eventually promote practice of prescribing cost-effective generic drugs.
ABSTRACT
OBJECTIVES@#To study the efficacy and safety of domestic generic levetiracetam in replacement of brand-name levetiracetam in the treatment of children with epilepsy.@*METHODS@#A retrospective analysis was performed on the medical data of 154 children with epilepsy who received domestic generic levetiracetam in the inpatient or outpatient service of Guangdong Provincial People's Hospital from May 2019 to December 2020. Domestic generic levetiracetam and brand-name levetiracetam were compared in terms of efficacy and safety.@*RESULTS@#For these 154 children, the epilepsy control rate was 77.3% (119/154) at baseline. At 6 months after switching to domestic generic levetiracetam, the epilepsy control rate reached 83.8% (129/154), which showed a significant increase (P<0.05). There was no significant change in the frequency of seizures from baseline to 6 months after switching (P>0.05). The incidence of refractory epilepsy in children with no response after switching treatment was significantly higher than that in children with response (P<0.05). Before switching, only 1 child (0.6%) experienced somnolence, while after switching, 3 children (1.9%) experienced mild adverse drug reactions, including dizziness, somnolence, irritability, and bad temper.@*CONCLUSIONS@#Switching from brand-name to generic levetiracetam is safe and effective and holds promise for clinical application, but more prospective randomized controlled trials are required in future.
Subject(s)
Child , Humans , Epilepsy/drug therapy , Levetiracetam , Prospective Studies , Retrospective Studies , SeizuresABSTRACT
Background: The objective of the study was to study the prescribing pattern of the antibiotics in postoperative patients admitted in gynaecology and obstetrics.Methods: Current prospective observational study was conducted in the department of pharmacology, Government Medical College, Kathua in collaboration with department of gynaecology and obstetrics for a period of six months duration from 1st May 2019 to 31st October 2019. The case sheets of all post operated patients above eighteen years of age admitted were studied and analyzed.Results: Total of 1807 case sheets were analyzed and showed that 4245 antibiotics were prescribed with an average of 2.3 antibiotics prescribed. Oral cefuroxime (17.3%) was maximally prescribed in patients who delivered normal presentation with episiotomy and injection ceftriaxone along with tinidazole and gentamycin were prescribed (58.4%) where caesarean section was done. While injection ceftriaxone and sulbactum along with tinidazole and gentamycin (17.09%) was prescribed in patients who were operated for gynaecological diseases. Maximum (80%) of the antibiotics were prescribed under brand name.Conclusions: Cephalosporin’s are commonly prescribed antibiotic and in eighty percent brand names were prescribed. Results underscore that antibiotic in generic name should be encouraged.
ABSTRACT
OBJECTIVE: To figure out the balance mechanism between brand-name drugs and generic drugs in American drug review. METHODS: This paper reviewed FDA laws and regulations, domestic and foreign literature to retrospect the basis of generic development and explore the brand-name drug companies' action to prevent generic competition. RESULTS AND CONCLUSION: The abbreviate new drug application, patent challenge and market exclusivity in the Hatch-Waxman Act were the basis of generic development. Brand-name drug companies prevented competition by occupying the market, refusing to provide samples, submitting citizen petitions to extend generic drug review time and extending the patent term and market exclusivity of brand-name drugs. The United States legislated and amended relevant laws and regulations, adjusted the generic drug user fee to maintain the stability of the balance, which is worthy of further research.
ABSTRACT
<b>Objective: </b>The purpose of this study is to investigate incidents of erroneously dispensed drugs on the assumption that the incidents stem from the similar names of the drugs. The investigation was also conducted to prevent such dispensing incidents in the future, i.e. to search for factors that can prevent future incidents, and finally to propose a prevention plan which takes each of these factors into account.<br><b>Methods: </b>We extracted incident cases related to generic drugs reported by pharmacies in Japan and from those cases examined those that were categorized as cases of erroneously dispensed medicine. We used this data to categorize the difference in relationship between the drugs which were supposed to be prescribed and those which were erroneously dispensed, and to analyze the association between the “Flowchart for Avoiding Confusion Errors between Similarly Named Drugs” and the name similarity index based on this flowchart.<br><b>Results: </b>The types of incident cases due to name similarities of generic drugs were categorized into specification mistakes and brand mistakes. The edit of the name similarity index were especially important factors for dispensing incidents between generic drugs.<br><b>Conclusion: </b>This study focusing on generic drugs revealed the factors that result in dispensing incidents due to name similarity. Further empirical studies investigating the usefulness of interventions that alter the name similarity index is required.
ABSTRACT
OBJECTIVE: To describe the basic concepts of pharmaceutical inter-changeability and to discuss issues involved in the process of medicine substitution as well as the present situation of medicine substitution in our and other countries. METHODS: Collecting literatures on pharmaceutical inter-changeability, generic medicines and brand-name medicines, after analyzing and summarizing the information on pharmaceutical inter-changeability and medicine substitution were reviewed. RESULTS: The substitution of generic medicines with brand-name medicines involves in issues about bioequivalence, therapeutic equivalence, benefit, harm and so on. Our and other countries take appropriate measures to carry out the substitution of generic medicines with brand-name medicines. CONCLUSION: With following certain rules, generic medicines can substitute for brand-name medicines. This can be better to ensure the safety of drug use in clinical practice.
ABSTRACT
OBJECTIVE: To study the principle, feature and impact of the authorized generics strategy in American drug market, thus to provide some references for Chinese scholars who research the authorized generics strategy and for China pharmaceutical companies that would face competition in American pharmaceutical market. METHODS: By case study and policies analysis, the ways how the brand-name companies used the authorized generics in American drug market were summarized. RESULTS and CONCLUSION: Successful authorized generics strategy can maintain a large market share of the brand-name companies products. In American drug market, there are some particularities about the authorize generics strategy due to the features of American drug policies and regulations. China pharmaceutical companies should implement different authorized generics strategy according to their own conditions in American drug market at present.
ABSTRACT
A regulamentação sanitária de medicamentos é uma das oito diretrizes da Política Nacional de Medicamentos. Trata-se da fiscalização e regulamentação de registro de medicamentos e da autorização de funcionamento desde os produtores até o varejo de medicamentos, bem como das restrições àqueles sujeitos a controle especial. A regulamentação sanitária de medicamentos tem como objetivo garantir eficácia, segurança, qualidade e custo aos produtos farmacêuticos. Os estudos clínicos dos medicamentos de Referência, a bioequivalência ou biodisponibilidade relativa e testes de equivalência dos medicamentos similares e genéricos são meios de avaliar a eficácia e a segurança. A qualidade é garantida lote a lote pelas Boas Práticas de Fabricação e Controle dos produtos farmacêuticos e a certificação da empresa pela ANVISA. O custo é avaliado pela câmara técnica de medicamento (CMED), que estabelece os critérios para fixação e ajuste de preços dos produtos farmacêuticos. No pós-registro, a efetividade, segurança e qualidade dos produtos são avaliadas por meio das comprovações exigidas na renovação do registro e, principalmente, pelo programa de farmacovigilância.
The health regulation of drugs is one of eight guidelines issued within the National Drug Policy. It refers to the supervision and regulation of drug registration and the approval of operations, from the manufacturers to the retailers of medicines, as well as the restrictions that apply to drugs under special control. The health regulation of medicines is aimed at controlling the effectiveness, safety, quality and cost of pharmaceutical products. Clinical studies of brand-name (innovator) medicines, bioequivalence or relative bioavailability and the equivalence tests of generic and ?similar? brand-name drugs are means used to assess efficacy and safety. Quality is assured on a batch-to-batch basis by compliance with the Good Manufacturing Practices and Control of pharmaceutical products and by the certification of companies offered by ANVISA. The cost of a medicine is assessed by the Technical Chamber of Medicine (CMED), which establishes the criteria for setting and adjusting the prices of pharmaceutical products. After registration, the effectiveness, safety and quality of products are monitored by means of the tests required on renewal of registration and especially by the pharmacovigilance program.
Subject(s)
Drugs, Generic , Modification of Products Registration , Products Registration , Reference Drugs , Similar DrugsABSTRACT
The government is now operating a pilot project of generic prescription in the National Medical Center and planning to execute it after analyzing the results. The aims of changing Brand Name Prescription (Proprietary Names Prescription) to Generic Prescription (Nonproprietary Names Prescription) are to reduce medical expenses, to increase patient's conveniences and rights, and to strengthen pharmaceutical companies' internal competitiveness. However, we doubt whether these goals can be reached by the execution of the Generic Prescription. More important is that Korea is not well prepared with the medicine bioequivalent experiments, which can be potentially harmful to patients. If the government should carry out this plan just because the pilot project involving some relatively safe medicines does not show problems, it will confront with big damages. Namely, carrying out the Generic Prescription in an unprepared condition will not benefit but will cause a big damage to the patients.
Subject(s)
Humans , Androsterone , Human Rights , Korea , Lifting , Prescriptions , Therapeutic EquivalencyABSTRACT
OBJECTIVE:To provide references for improving the governmental drug pricing,especially for brand-name drugs.METHODS:With the statistical data listed in the governmental drug price catalogs,the price difference rates between brand-name and generic injection were computed.RESULTS:Only 26%of the drugs were in line with the requirement on price difference rate(35%for injections)specified in governmental drug price principle,and the highest price gap between brand-name drug and generic drug was as high as over 500%.CONCLUSIONS:It is advisable for government to adopt mild method of gradual reduction of drug prices,control the preferential degree for the price of the brand- name drugs,establish a dynamic price control system,and promote the balance on the benefits of both brand-name drug manufactures and the generic drug manufacturers.