scholarly journals Generic drugs in Brazil: known by many, used by few

2005 ◽  
Vol 21 (6) ◽  
pp. 1808-1815 ◽  
Author(s):  
Andréa D. Bertoldi ◽  
Aluísio J. D. Barros ◽  
Pedro C. Hallal

This study evaluated knowledge and use of generic drugs in a population-based sample of adults from a southern Brazilian city. The outcomes were: the proportion of generics in total medicines used; theoretical and practical knowledge about generics; and strategies used to buy medicines on medical prescriptions. The recall period for drug utilization was 15 days. The proportion of generics in total medicines was 3.9%. While 86.0% knew that generics cost less and 70.0% that the quality is similar to brand name medicines, only 57.0% knew any packaging characteristics that distinguish generics from other medicines. The highest proportion of generic drug utilization was in the antimicrobial pharmacological group. A brand name medicine (with a brand similar to the generic name) was mistakenly classified as a generic through photos by 48.0% of the interviewees. Among subjects who bought medicines in the 15-day period, 18.9% reported buying a generic, but this result should be interpreted with caution, because the population frequently fails to differentiate between generics and other medicines.

2009 ◽  
Vol 37 (4) ◽  
pp. 624-629 ◽  
Author(s):  
D. E. P. Bramley

The recent proliferation of brand names for prescription medications has made the clinician's task of identifying the corresponding generic drug substances more difficult. A survey of 86 anaesthetists and anaesthetic trainees at two Melbourne hospitals was conducted to measure the extent to which this was perceived to be a clinical problem. In addition, a theoretical test was administered to examine the ability of these anaesthetists to correctly identify generic drugs and therapeutic groups when only the brand name is provided. The results indicated this is perceived to be a genuine clinical problem, with more than 80% of respondents encountering unfamiliar trade names ‘often’ or ‘always’ and the test revealing that fewer than one third of commonly prescribed brand names were identified correctly.


2014 ◽  
Vol 3 (9) ◽  
pp. 318-321
Author(s):  
Seheli Sejuti Bithi ◽  
Md. Minhazur Rahman Khan ◽  
Ahsan Ullah Khan

Antibiotics are generally prescribed for both as prophylactically (before orthopaedics surgery etc.) or to treat ongoing infection (like septic arthritis, osteomyelitis etc.) in the orthopaedics department. But if antibiotics are not use rationally then there will be increase chances of resistance of bacteria as also as deteriorate the patients’ disease condition which ultimately increase the total cost of treatment. The goal of this study was to see the antibiotics utilization pattern. A prospective cross-sectional, multicentre drug utilization study was conducted for a period of 3 months to evaluate the pattern of antibiotics use in orthopaedic unit of various hospitals of Dhaka City, Bangladesh. A total of 498 prescriptions were studied; in which 160 prescriptions contained mono-antibiotic therapy (51.79%) and 147 prescriptions contained poly-antibiotics therapy (48.21%) and the beta-lactam antibiotics were most commonly prescribed (81.68%). Mono-antibiotics prescriptions were the common pattern than combination and brand name has been prescribed frequently than generic. To minimize cost, it is advisable to promote prescription of generic drugs. Also justifying efforts are needed to improve appropriateness of antimicrobial therapy and minimize the development of antimicrobial resistance. Hence the results of the study showed that there is a considerable scope for improvement in the prescription pattern.DOI: http://dx.doi.org/10.3329/icpj.v3i9.19896 International Current Pharmaceutical Journal, August 2014, 3(9): 318-321


CNS Spectrums ◽  
2009 ◽  
Vol 14 (9) ◽  
pp. 1-7 ◽  
Author(s):  
Pierre Blier

Most antidepressants and other psychotropics in clinical use are available as generic formulations (Table). The availability of lower-priced, generic drugs can benefit patients and third-party payers, but it should not be assumed that all generic drugs are equally beneficial. There are numerous reports in the literature of unexpected and untoward consequences that occur when a generic drug is substituted for the original brand-name drug. A previously stable clinical response may suddenly deteriorate, or the patient may experience new or more severe adverse events (AEs). The United States Food and Drug Administration requires that manufacturers of generic drugs demonstrate that their formulation has pharmacokinetic properties similar (or bioequivalent) to the brand-name drug. Bioequivalency studies are conducted in healthy volunteers, not in patients who would be treated with that drug. Moreover, bioequivalency studies are conducted on a current lot of the branded drug and do not account for variability between lots of the generic formulation. The manufacturer is only required to submit bioequivalency data that support the Abbreviated New Drug Application (ANDA); the FDA does not require disclosure of failed bioequivalence studies. Unlike brand-name drugs, lengthy and costly clinical studies are not required to show that the generic drug is effective and safe.Although the FDA has taken the position that bioequivalence and therapeutic equivalence are equal, many questions related to the use of generic drugs remain unanswered. The following question-and-answer session is an excerpt of an interview with Pierre Blier, MD, PhD, conducted by Diane Sloan, PharmD, which addresses the issue of generic substitution of psychotropic drugs.


2012 ◽  
Vol 40 (1) ◽  
pp. 165-170
Author(s):  
Brenna Jenny

When the Supreme Court in PLIVA v. Mensing determined that certain state tort law failure-to-warn claims against generic drug companies were pre-empted by federal drug regulations, the pronouncement was met with substantial criticism. In light of the Court's decision two years earlier in Wyeth v. Levine, where the Court allowed a similar claim against a brand-name drug manufacturer to proceed, many complained the resulting Levine-Mensing dichotomy created an arbitrary distinction between brand-name and generic drugs, allowing an injured patient's ability to recover to hinge solely on the happenstance of whether the individual had taken the brand-name or generic version. But, although Mensing cut back significantly on the ability of plaintiffs to make state law failure-to-warn claims against generic drug manufacturers, the case did not completely prohibit such claims. Instead, the Court banned only failure-to-warn claims premised on an argument that the generic drug company needed to change its label in order to meet state tort law duties. If plaintiffs can advance other theories independent of a formal label change, such as a failure to adequately warn a physician about a recent change to the drug's label, then they may still be able to proceed against generic drug manufacturers.


2016 ◽  
Vol 23 (5) ◽  
pp. 891-898 ◽  
Author(s):  
Sameer Malhotra ◽  
Adam D Cheriff ◽  
J Travis Gossey ◽  
Curtis L Cole ◽  
Rainu Kaushal ◽  
...  

Abstract Objective Increasing the use of generic medications could help control medical costs. However, educational interventions have limited impact on prescriber behavior, and e-prescribing alerts are associated with high override rates and alert fatigue. Our objective was to evaluate the effect of a less intrusive intervention, a redesign of an e-prescribing interface that provides default options intended to “nudge” prescribers towards prescribing generic drugs. Methods This retrospective cohort study in an academic ambulatory multispecialty practice assessed the effects of customizing an e-prescribing interface to substitute generic equivalents for brand-name medications during order entry and allow a one-click override to order the brand-name medication. Results Among drugs with generic equivalents, the proportion of generic drugs prescribed more than doubled after the interface redesign, rising abruptly from 39.7% to 95.9% (a 56.2% increase; 95% confidence interval, 56.0–56.4%; P  < .001). Before the redesign, generic drug prescribing rates varied by therapeutic class, with rates as low as 8.6% for genitourinary products and 15.7% for neuromuscular drugs. After the redesign, generic drug prescribing rates for all but four therapeutic classes were above 90%: endocrine drugs, neuromuscular drugs, nutritional products, and miscellaneous products. Discussion Changing the default option in an e-prescribing interface in an ambulatory care setting was followed by large and sustained increases in the proportion of generic drugs prescribed at the practice. Conclusions Default options in health information technology exert a powerful effect on user behavior, an effect that can be leveraged to optimize decision making.


Author(s):  
Mosab Arafat ◽  
Zahaa Ahmed ◽  
Osama Arafat

The belief that generic drugs are inferior to brand name drugs has been always under debate. Especially since the price of generic drugs is generally far cheaper than brand-name drugs. Although, this is because of waiving the preclinical studies and clinical trials for the generic drug, the quality, and purity of materials used for generic drug preparation is still arguable. Thus, the objective of this overview was to find out the tolerable deviations between generic and brand name drugs which should not alter the pharmacology. Using inactive additives in the generic drug different than in the brand name drug, such as binders, glidants, diluents, anti-adherents, disintegrants or polymer carrier material and filler should not change the drug bioavailability and pharmacokinetic parameters as long as both products using the identical active ingredient(s) in equivalent amounts. Even if both drug products are bioequivalent to each other in terms of active ingredient, they are not in terms of inactive ingredients. Hence, the probability of unexpected adverse drug reaction and allergies from the generic formulation are possible, especially, when people react sensitive toward specific component. Therefore, the occasional negative response occurring upon the switch from brand-name drug to the generic drug can be attributed to intra-and inter-patient variations toward inactive ingredients. Variations toward inactive ingredients can be obtained experimentally by utilizing a proper thermoanalytical technique. As a result, thermoequivalence of generic drugs to brand name drugs can be determined based on thermal information obtained from both products. In conclusion, thermoequivalence study can be a useful tool to demonstrate any possible variation between the inactive ingredients of both products.


Author(s):  
Henry Grabowski ◽  
Genia Long ◽  
Richard Mortimer ◽  
Mehmet Bilginsoy
Keyword(s):  

2020 ◽  
Vol 30 (Supplement_5) ◽  
Author(s):  
D Menezes ◽  
D Lewer ◽  
A Yavlinsky ◽  
M Tinelli ◽  
R Aldridge

Abstract Introduction The number of people experiencing homelessness in England has increased since 2010 and a recent systematic review and meta-analysis demonstrated high levels of mortality in this group across high-income countries. In this study we examine the death rates in people experiencing homelessness after discharge from hospital. Methods This is a study of linked hospital admission records and mortality data for two groups. First, a “Homeless group”: people seen by 17 specialist homeless discharge schemes between 1 November 2013 and 30 November 2016. Second, an “IMD5 group”: A matched group of patients who live in deprived areas and have the same age and sex, and were discharged from the same hospital in the same year as the homeless patient. Our analysis entailed calculating mortality rates across each group and by the number of comorbidities. Results The mortality rate for the IMD5 group was 1,935 deaths per 100,000 person years, compared with 5,691 for the homeless group, giving a rate ratio of 2.9 (95% CI 2.5-3.5). The mortality risk increased with the number of comorbidities. Individuals in the IMD5 group with zero comorbidities had a death rate of 831 per 100,000 person-years, compared with the homeless group for which the corresponding figure was 2,598 and or those with 4+ comorbidities were 7,324 (IMD5) and 12,714 (homeless). This suggests a 'super-additive' interaction in which the effect of morbidity on mortality risk after discharge is greater for homeless patients. Survival at 5 years for the homelessness group was for men 80% (95% CI 77-85) and women 85 (95% CI 81-87). Conclusions This study shows that the well-established inequity in mortality for people experiencing homelessness exists after discharge from hospital and is greatest for the most unwell patients. Our results suggest a need for greater emphasis on prevention of homelessness, early healthcare interventions and improved hospital discharge arrangements for this population. Key messages The well-established inequity in mortality for people experiencing homelessness exists after discharge from hospital and is greatest for the most unwell patients. Our results suggest a need for greater emphasis on prevention of homelessness, early healthcare interventions and improved hospital discharge arrangements for this population.


2017 ◽  
Vol 20 (2) ◽  
pp. 324-334 ◽  
Author(s):  
Cassia Garcia Moraes ◽  
Sotero Serrate Mengue ◽  
Tatiane da Silva Dal Pizzol

ABSTRACT: Objective: To assess the agreement between three recall periods for self-reported drug use using a 24-hour recall period as reference. Methods: Participants were allocated into three groups with different recall periods of 7, 14 and 30 days and were interviewed at two different times. A 24-hour recall questionnaire was answered during the first interview, and a questionnaire on drug use over the different recall periods tested was answered during the second interview. The agreement between the questionnaires was evaluated using percent agreement and kappa. Results: For continuous drugs, percent agreement varied between 92 and 99% and kappa varied between 0.71 and 0.97 for three periods tested. For drugs of occasional use, percent agreement varied between 63 and 81% and kappa varied between 0.27 and 0.52. The prevalence of drugs, particularly those of occasional use, increases with time. Conclusions: The high level of agreement between the three recall periods suggests that all of them are valid for the investigation of drugs of continuous use.


2016 ◽  
Vol 25 (4) ◽  
pp. 417-429
Author(s):  
Kaoru Ito ◽  
Shunya Ikeda ◽  
Masaki Muto

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