RESUMEN
Generic medications contain the identical active ingredient in the same concentration as their branded counterparts and are administered in the same manner, aiming to deliver comparable efficacy, dosage, and clinical outcomes. Nevertheless, variations in additives and formulation processes, particularly noticeable in topical medications, can influence factors like ease of use and patient adherence. Therefore, in this study, we aimed to compare the rheological attributes of branded and generic injectable ointments, assessing disparities in formulation performance and their impact on patient care. Posterisan® Forte and Hemoporison® ointments were used as the branded and generic versions, respectively, and their viscosity, ductility, and viscoelastic properties were evaluated. Posterisan® Forte showcased enhanced spread ability, maintaining uniform flow characteristics across varying temperatures, whereas Hemoporison® displayed pronounced thixotropic properties and stiffness, suggesting potential benefits for applications necessitating reversible viscosity adjustments and heightened rigidity. Despite sharing identical additives, observable differences in physical characteristics highlight the necessity of understanding formulation traits, which could influence ointment behavior. Alterations in fluidity and viscosity may affect how patients perceive and apply the medication, potentially influencing treatment outcomes and the occurrence of adverse effects.
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Medicamentos Genéricos , Pomadas , Reología , Viscosidad , Medicamentos Genéricos/administración & dosificación , Medicamentos Genéricos/química , Humanos , Inyecciones , Elasticidad , Composición de Medicamentos , Química FarmacéuticaRESUMEN
PURPOSE: To determine the effect of the formulation of topical medications on the healing of corneal epithelial cells after phototherapeutic keratectomy (PTK). STUDY DESIGN: Retrospective cohort study. METHODS: We studied 271 eyes of 189 consecutive patients (aged 67.6 ± 11.8 years) who had undergone PTK for granular corneal dystrophy (n = 140), band keratopathy (n = 47), or lattice corneal dystrophy (n = 2). Postoperatively, generic or brand-named levofloxacin, 0.1% betamethasone, or 0.1% bromfenac sodium hydrate was applied topically. Patients were examined on postoperative days 1, 2, and 5 and weekly thereafter. The time to re-epithelialization was assessed by use of Kaplan-Meier and Cox proportional hazards analyses. RESULTS: The time to re-epithelialization was significantly longer with generic 0.5% levofloxacin, at 8.2 ± 3.5 days, than with 0.5% Cravit (levofloxacin), at 6.7 ± 3.5 days (P = 0.018), or with 1.5% Cravit, at 6.3 ± 2.6 days (P = 0.000). In addition, the time to re-epithelialization was significantly longer with generic 0.1% betamethasone (Sanbetason), at 7.3 ± 3.4 days, than with brand-name 0.1% betamethasone (Rinderon), at 6.1 ± 2.5 days (P = 0.0002). The Cox proportional hazards model indicated that the use of generic formulations for levofloxacin eye drops and 0.1% betamethasone was a significant factor that delayed corneal re-epithelialization (hazard ratio [HR] = 0.72, P = 0.002 and HR = 0.77, P = 0.006, after adjustment for age). Re-epithelialization was significantly shorter in band keratopathy than in corneal dystrophy (HR = 1.56, P = 0.004). No other factors, including age, bandage contact lens, and diabetes mellitus, were significantly associated with time to re-epithelialization. CONCLUSION: Corneal epithelial healing can be significantly affected by different antibacterial or steroid eye drops. Clinicians need to be aware that a generic formulation may affect corneal epithelial healing.
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Distrofias Hereditarias de la Córnea , Queratectomía Fotorrefractiva , Humanos , Estudios Retrospectivos , Composición de Medicamentos , Levofloxacino , Láseres de Excímeros/uso terapéutico , Distrofias Hereditarias de la Córnea/cirugía , Soluciones OftálmicasRESUMEN
BACKGROUND: The aim was: i) to quantify the direct and indirect savings from parallel imports in Sweden during a period when sellers were forbidden from giving discounts to pharmacies, and ii) to study if the effects of competition from parallel imports on list prices became smaller in absolute size when sellers were allowed to give discounts to pharmacies. METHODS: We analyzed the monthly prices for 3068 products during 61 months when discounts were forbidden and for 2504 products during 84 months when discounts were allowed. The price effects were estimated using dynamic models that rendered lagged numbers of competitors into valid and strong instruments for the current values. RESULTS: When discounts were forbidden, parallel imports had a market share of 16% and were on average 9% cheaper than locally sourced drugs, which yielded a direct saving of 231 million Swedish kronor (SEK) (24 million EUR) per year. Also, parallel imports reduced the prices of products with the same substance by, on average, 6% in the long-term, which yielded indirect savings of 421 million SEK (44 million EUR) per year. In total, parallel imports reduced the cost for on-patent pharmaceuticals by 4%. When discounts were allowed, the average gap in list price between parallel imports and locally sourced products was reduced to 0.8%, and the list prices of locally sourced products were no longer significantly affected by competition from parallel imports. CONCLUSION: When discounts were allowed, the savings of parallel imports through lower list prices were replaced by savings of pharmacies through secret discounts.
RESUMEN
OBJECTIVES: Substitution of brand-name drugs with less expensive, equally effective interchangeable generics is an important strategy for promoting adherence and controlling prescription drug spending. US state laws govern generic substitution, but there is variability among states in how these laws are designed. We aimed to determine how different features of state laws regulating generic substitution are associated with use of generic drugs. METHODS: Using national claims databases, we studied individuals with commercial insurance or Medicare Advantage plans who newly initiated one of 34 prescription drugs during the year after new generic competition (2017-2018) to determine any association between generic use and 3 different features of state laws. We used multivariable logistic regression to adjust for demographic and clinical characteristics. RESULTS: Of 502 763 individuals who initiated one of the drugs, 409 856 (81.6%) received a generic version. Those in states requiring patient consent or notification had lower use of generics (81.1% vs 82.9%; adjusted odds ratio 0.89; 95% confidence interval 0.87-0.91; P < .001). By contrast, mandating versus permitting generic substitution and protecting pharmacists from liability did not appear to have significant effects. CONCLUSIONS: In this study of commercially insured and Medicare Advantage patients, patients in states requiring consent or notification for pharmacists to substitute Food and Drug Administration-certified interchangeable generics had lower use of generics. Laws in 39 states plus the District of Columbia could be amended to improve use of inexpensive and equally effective generic drugs.
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Medicamentos Genéricos , Medicamentos bajo Prescripción , Anciano , Sustitución de Medicamentos , Medicamentos Genéricos/uso terapéutico , Humanos , Medicare , Farmacéuticos , Estados UnidosRESUMEN
Recent press reports and other evidence suggest that Medicare Part D plans may be encouraging the use of brand-name drugs instead of generics. However, the scope of such practices is unclear. We examined Medicare Part D formulary coverage and tier placement of matched pairs of brand-name drugs and generics to quantify how often preferred formulary placement of brand-name drugs is occurring within and across Part D plans and to assess the cost implications for Medicare and its beneficiaries. We found that in 2019, 84 percent of 4,176,772 Part D plan-product combinations had generic-only coverage (that is, the brand-name counterparts were not covered). Another 15 percent covered both the brand-name and generic versions of a product. For the small number of products whose brand-name versions were covered preferentially to their generic equivalents, beneficiary and Medicare prices were generally low for both products. Overall, we found that most Part D plan formularies are designed to encourage the use of generics rather than their brand-name counterparts. Policy makers should continue to monitor Part D formulary coverage patterns to ensure consistent and generous coverage for generic drugs, given their important role in reducing prescription drug spending.
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Medicare Part D , Anciano , Costos de los Medicamentos , Medicamentos Genéricos , Humanos , Medicamentos bajo Prescripción , Estados UnidosRESUMEN
BACKGROUND: For a patient, drug switches are not desirable (either between a brand-name drug and a generic drug, or between two generic drugs of the same active substance). Research into the causes of drug switches, and related adverse drug reactions, is hampered by the absence of quantitative data on drug switches. METHODS: We describe the frequency of drug switches in the Netherlands for a selection of active substances. A retrospective cohort study was conducted using the Drug Information System of the National Health Care Institute in the Netherlands. We studied the Dutch patient population from mid-2009 to 2016. The selection of active substances (n = 20) was made based on a report by Lareb, the Netherlands Pharmacovigilance Centre, on adverse drug reactions related to drug switching, and we used qualitative and quantitative descriptive analyses. A drug switch is defined as the replacement of a patient's prescribed drug with a similar drug from a different manufacturer. RESULTS: We identified 23.8 million drug switches on a total of 206 million (11.6%) similar drug dispenses. The frequency of drug switches demonstrated a yearly peak in the period from January to March. In some months, for atorvastatin, losartan, pantoprazole, and irbesartan, more than 60% of similar drug dispenses were drug switches. Most drug switches (80.3%) were between two generic drugs, and 0.12% of these involved a drug from a European parallel import. The proportion of drug switches between two brand-name drugs decreased from 14.5 to 5.53% during our study period, and of these, 86.5% involved a drug from a European parallel import. CONCLUSIONS: Drug switching is common in the Netherlands, and most of the drug switches we studied are between generic drugs. The observed annual peak of drug switches is most likely explained by a specific Dutch reimbursement policy. Not only are the data valuable as is, but they also serve as a first step towards elucidating the reasons for the occurrence of these drug switches. In addition, these data can be used to put into perspective the adverse drug reactions associated with drug switching.
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Sustitución de Medicamentos , Medicamentos Genéricos/administración & dosificación , Estudios de Cohortes , Bases de Datos Factuales , Sustitución de Medicamentos/estadística & datos numéricos , Humanos , Países Bajos , Estudios RetrospectivosRESUMEN
AIMS: Generic medicinal products (GMPs) are low-priced copies of off-patent medicines that reduce healthcare costs and broaden access to healthcare. Thus, healthcare authorities, professionals, and providers recommend their use. In recent years, the US Food and Drug Administration (FDA) and the European Medicines Agency (EMA) approved hundreds of GMPs based on specific bioequivalent trials. The question is whether the brand name drugs and GMPs or the different GMPs similar in purity, efficacy, and safety. METHODS AND RESULTS: We have reviewed the progressive increasing recalls and warning letters of cardiovascular GMPs issued recently by the FDA/EMA. Both Agencies found numerous irregularities in the purity, safety, effectiveness, and current good manufacturing practices in some GMPs widely used in cardiovascular therapy. This evidence and the recent identification of nitrosamine impurities classified as probable human carcinogens in several angiotensin receptor blockers confirm that the presence of low-quality/substandard GMPs represents a serious public health problem with significant impact on national clinical and economic burden. CONCLUSION: A global strategy that unifies the efforts of all the stakeholders, including drug manufacturers, healthcare providers, governments, health professionals, patients, and judicial systems are needed to protect the drug chain supply and ensure that only high-quality GMPs are available for use.
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Fármacos Cardiovasculares/normas , Contaminación de Medicamentos , Medicamentos Genéricos/normas , Control de Calidad , Fármacos Cardiovasculares/efectos adversos , Fármacos Cardiovasculares/farmacocinética , Composición de Medicamentos , Recall de Medicamento , Medicamentos Genéricos/efectos adversos , Medicamentos Genéricos/farmacocinética , Humanos , Seguridad del Paciente , Medición de Riesgo , Equivalencia TerapéuticaRESUMEN
OBJECTIVE: To associate pharmaceutical industry payments to brand-name prescriptions by otolaryngologists. STUDY DESIGN: Retrospective cross-sectional analysis. SETTING: Open Payments Database and the Medicare Part D Participant User File 2013-2016. SUBJECTS AND METHODS: We identified otolaryngologists receiving nonresearch industry payments and prescribing to Medicare Part D recipients. Records were linked by physician name and state. The value of industry payments and the percentage of brand-name drugs prescribed per hospital referral region (HRR) were characterized as medians. Industry payments were correlated to the rate of brand-name prescription by Kendall's τ correlation. This was repeated at the individual physician level and stratified by payment type. RESULTS: In total, 8167 otolaryngologists received a median of $434 (interquartile range, $138-$1278) in industry compensation over 11 (3-26) payments. Brand-name drugs made up a median of 12.9% (8.6%-18-4%) of each physician's drug claims. The number (τ = 0.05, P < .001) and dollar amount (τ = 0.04, P < .001) of industry payments were correlated with the rate of brand-name drug prescription at the individual physician level. The number of industry payments was also associated with the rate of brand-name prescription by HRR (τ = 0.14, P < .001), but the dollar amount was not. By HRR, food and beverage payments received by physicians were associated with the rate of brand-name drug prescription (τ = 0.04, P < .001), but travel and lodging payments were not. CONCLUSIONS: Industry financial transactions are associated with brand-name drug prescriptions in otolaryngologists, and these associations are stronger at the regional level than at the individual physician level. These correlations are of modest strength and should be interpreted cautiously by readers.
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Industria Farmacéutica/economía , Donaciones , Medicare Part D , Otorrinolaringólogos/economía , Pautas de la Práctica en Medicina/economía , Conflicto de Intereses , Estudios Transversales , Costos de los Medicamentos , Humanos , Otorrinolaringólogos/estadística & datos numéricos , Pautas de la Práctica en Medicina/estadística & datos numéricos , Medicamentos bajo Prescripción/economía , Estudios Retrospectivos , Estados UnidosRESUMEN
We study the short- and long-term price effects of the number of competing firms, using panel-data on 1303 distinct pharmaceutical markets for 78 months within a reference-price system. We use actual transaction prices in an institutional setting with little scope for non-price competition and where simultaneity problems can be addressed effectively. In the long term, the price of generics is found to decrease by 81% when the number of firms selling generics with the same strength, form and similar package size is increased from 1 to 10. Nearly only competition at this fine-grained level matters; the effect of firms selling other products with the same active substance, but with different package size, form, or strength, is only a tenths as large. Half of the price reductions take place immediately and 70% within three months. Also, prices of originals are found to react to competition, but far less and much slower.
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Costos de los Medicamentos , Competencia Económica , Costos de los Medicamentos/estadística & datos numéricos , Industria Farmacéutica/economía , Industria Farmacéutica/estadística & datos numéricos , Medicamentos Genéricos/economía , Competencia Económica/economía , Competencia Económica/estadística & datos numéricos , Humanos , Modelos Econométricos , SueciaRESUMEN
It is well known that calcium channel blockers (CCBs) are the first line of therapy for vasospastic angina (VSA). Here, we report two cases of VSA with an increase in the frequency of angina attacks after switching from a brand-name to a generic CCB. In both cases, angina recurred upon switching from a brand-name CCB to a generic CCB during follow-up. The patients' condition improved upon switching back to the original CCB. Both cases involved a high severity of VSA, based on the results of spasm provocation testing. These findings suggest that, in some patients with severe VSA, the frequency of angina attacks increases when switching from a brand-name CCB to a generic CCB. Cardiologists should consider this factor when prescribing drugs for angina.
RESUMEN
OBJECTIVE: We aimed to analyse the effects of age and sex on pain and cost for patients with chronic peripheral neuropathic pain (PNP) who have started treatment with brand name gabapentin versus generic gabapentin (EFG). METHODS: We conducted a retrospective multicentre study using electronic medical records (EMR) for patients of both sexes, older than 18, who began treatment with brand name or generic gabapentin. Adherence (medication possession ratio [MPR]), persistence, use of healthcare resources, cost, and pain reduction were measured for one year. RESULTS: We analysed 1369 EMRs [61.1% women; mean age 64.6 (15.9), 52.4%≥65 years]; 400 used brand name drugs while 969 used generic gabapentin. Persistence and adherence were higher in patients using brand name gabapentin (7.3 vs 6.3 months, P<.001; 86.5% vs 81.3% MPR, P<.001). Lower healthcare costs were observed in patients using brand-name gabapentin in both age groups (<65 and ≥65). Mean difference in cost per patient amounted to 221 (95%CI: 59-382) and 217 (95%CI: 51-382) in the <65 and ≥65 age groups, respectively (P<.01). Mean difference in cost among men amounted to 197 (63-328), while mean difference in cost among women amounted to 239 (96-397) (P=.005 and P=.004, respectively). Compared with EFG, brand treatment showed greater pain relief: 13.5% (10.9-16.2) and 10.8% (8.2-13.5) in <65 and ≥65year patients, respectively (P<.001), and 10.7% (8.2-13.2) and 13.8% (11.0-16.5) in women and men respectively (P<.001). CONCLUSIONS: Regardless of sex and age, patients who started PNP treatment with brand name medication showed greater persistence and adherence to treatment than those taking generic drugs. Brand name treatment also involved lower healthcare costs, and greater pain relief.
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Aminas/uso terapéutico , Analgésicos/uso terapéutico , Ácidos Ciclohexanocarboxílicos/uso terapéutico , Medicamentos Genéricos/economía , Neuralgia/tratamiento farmacológico , Neuralgia/economía , Ácido gamma-Aminobutírico/uso terapéutico , Anciano , Aminas/economía , Ácidos Ciclohexanocarboxílicos/economía , Femenino , Gabapentina , Humanos , Masculino , Persona de Mediana Edad , Estudios Retrospectivos , Ácido gamma-Aminobutírico/economíaRESUMEN
BACKGROUND: Once the patent of a brand-name drug expires, generic drugs are commercialized, and substitution from brand-name to generics may occur. Generic drug equivalence is evaluated through comparative bioavailability studies. Few studies have assessed outcomes after generic drug commercialization at a population level. We evaluated the impact of 3 generic angiotensin II receptor blockers commercialization on adverse events: hospitalizations or emergency room consultations. METHODS AND RESULTS: This is an interrupted time series analysis using the Quebec Integrated Chronic Disease Surveillance System. Rates of adverse events for losartan, valsartan, and candesartan users (N=136 177) aged ≥66 years were calculated monthly, 24 months before and 12 months after generics commercialization. Periods before and after generics commercialization were compared by negative binomial segmented regression models. Sensitivity analyses were also conducted. For all users, there was a monthly mean rate of 100 adverse events for 1000 angiotensin II receptor blocker users before and after generic commercialization. Among generic users of losartan, valsartan, and candesartan, there was an increase in rates of adverse events of 8.0% (difference of proportions versus brand-name, 7.5% [95% confidence interval, -0.9% to 15.9%]; P=0.0643), 11.7% (difference of proportions, 17.1% [95% confidence interval, 9.9%-24.3%]; P<0.0001), and 14.0% (difference of proportions, 16.6% [95% confidence interval, 7.9%-25.3%]; P<0.0001), respectively, the month of generic commercialization. The monthly trend of adverse events was affected for generic versus brand-name losartan users only (difference of proportions, 2.0% [0.7%-3.4%]; P=0.0033) ≤1 year after generics commercialization. Similar results were found in sensitivity analyses. CONCLUSIONS: Among generic users, immediate or delayed differences in adverse events rates were observed right after generic commercialization for 3 antihypertensive drugs. Rates of adverse events remained higher for generic users. Increases were more pronounced for generic candesartan, which is the studied product with the largest difference in comparative bioavailability. Risk and survival analysis studies controlling for several potential confounding factors are required to better characterize generic substitution.
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Antagonistas de Receptores de Angiotensina/uso terapéutico , Antihipertensivos/uso terapéutico , Bencimidazoles/uso terapéutico , Sustitución de Medicamentos , Medicamentos Genéricos/uso terapéutico , Hipertensión/tratamiento farmacológico , Losartán/uso terapéutico , Tetrazoles/uso terapéutico , Valsartán/uso terapéutico , Antagonistas de Receptores de Angiotensina/efectos adversos , Antagonistas de Receptores de Angiotensina/economía , Antihipertensivos/efectos adversos , Antihipertensivos/economía , Bencimidazoles/efectos adversos , Bencimidazoles/economía , Compuestos de Bifenilo , Bases de Datos Factuales , Costos de los Medicamentos , Sustitución de Medicamentos/efectos adversos , Sustitución de Medicamentos/economía , Medicamentos Genéricos/efectos adversos , Medicamentos Genéricos/economía , Servicio de Urgencia en Hospital , Humanos , Hipertensión/diagnóstico , Hipertensión/economía , Hipertensión/mortalidad , Losartán/efectos adversos , Losartán/economía , Admisión del Paciente , Seguridad del Paciente , Vigilancia de la Población , Quebec/epidemiología , Derivación y Consulta , Estudios Retrospectivos , Factores de Riesgo , Tetrazoles/efectos adversos , Tetrazoles/economía , Equivalencia Terapéutica , Factores de Tiempo , Resultado del Tratamiento , Valsartán/efectos adversos , Valsartán/economíaRESUMEN
UNLABELLED: There is a strong impetus to prevent and treat osteoporosis to prevent fractures. $990 million dollars was spent on anti-osteoporosis drugs in 2013. As we shift our focus on primary prevention of fractures, providers are encouraged to find the most cost-effective anti-osteoporosis therapy for patients. PURPOSE: Osteoporosis is a major global problem with osteoporotic fractures posing a potentially avoidable burden on healthcare resources. We studied the utilization and cost of anti-osteoporotic therapy using the 2013 Medicare Part D data. METHODS: Descriptive data were produced from Microsoft Excel and SPSS regarding the anti-osteoporotic drugs of interest. RESULTS: In total, Medicare and its beneficiaries spent approximately $990 million on anti-osteoporotic therapy in 2013. Despite this cost, only one in two adults with osteoporosis aged 65 and older received a prescription for an anti-osteoporosis drug. $756 million (77 %) was attributable to brand name drugs which accounted for 2,459,931 claims (22 %). Generic dispensing rate varied from 57-86 % (mean 77 ± 6) across the different states in the USA. States that mandate substitution with generic equivalents had a higher generic dispensing rate compared to the states that permit generic substitution (92 vs. 90 %; p < 0.05). After adjusting for claim counts, we found that if the states that permit substitution with generic equivalents showed the same generic dispensing rate of 92 % as the states that mandate such substitution, there is a potential for savings of $7.5 million, approximately 9 % of the total expenditure in these states on oral bisphosphonates alone. Thirty-eight percent of the total prescriptions from orthopedic surgeons were for Forteo® or Prolia® compared to 12.5 % from specialists. CONCLUSIONS: These findings highlight the need for ongoing training for physicians who engage in the care of patients with osteoporosis to manage the disease in a cost-effective manner.
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Conservadores de la Densidad Ósea , Costo de Enfermedad , Medicare Part D/estadística & datos numéricos , Osteoporosis , Fracturas Osteoporóticas , Adulto , Anciano , Conservadores de la Densidad Ósea/economía , Conservadores de la Densidad Ósea/uso terapéutico , Análisis Costo-Beneficio , Costos de los Medicamentos , Femenino , Humanos , Masculino , Persona de Mediana Edad , Evaluación de Necesidades , Osteoporosis/complicaciones , Osteoporosis/tratamiento farmacológico , Osteoporosis/economía , Osteoporosis/epidemiología , Fracturas Osteoporóticas/epidemiología , Fracturas Osteoporóticas/prevención & control , Estados Unidos/epidemiologíaRESUMEN
OBJECTIVES: This study aimed to explore the predictors of the selection between brand name drug (BR) and generic drug (GE) and to clarify the quantitative relationship about selection. METHODS: We identified "incident users" who dispensed statins between April 2008 and June 2011 in commercially databases consisted of dispensing claims databases (DCD) of out-of-hospital pharmacies and hospital claims databases (HCD) of in-house pharmacies in Japan. Predictors of the selection between BR and GE, including price difference (PD), the price of BR, their interaction and percent change of the price of GE relative to BR were explored by logistic regression using DCD and HCD separately. RESULTS: We extracted records of 670 patients who have opportunity for selection both BR and GE. Logistic regression analysis demonstrated that PD, the price of BR, interaction between them, and prescriber affiliation were factors significantly associated with the selection in the DCD; logit (p)=9.735-0.251×PD-0.071×the price of BR+0.002×PD×the price of BR-1.816×affiliation+0.220×gender-0.008×age+0.038×monthly medical fee. PD was inversely proportional to BR choice in DCD and lead to the opposite result in HCD. Numerical simulation of selection revealed that the quantitative relationships heavily depend on situations. CONCLUSIONS: PD and the price of BR are predictors of the selection between BR and GE interactively in out-of-hospital pharmacies, but not in in-house pharmacies of medical facilities. Results may support policies which increase the power of out-of-hospital pharmacies for selection.
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Conducta de Elección , Costos y Análisis de Costo/economía , Medicamentos Genéricos/economía , Inhibidores de Hidroximetilglutaril-CoA Reductasas/economía , Medicamentos bajo Prescripción/economía , Costos de los Medicamentos , Competencia Económica , Femenino , Humanos , Seguro de Servicios Farmacéuticos/economía , Japón , Masculino , Persona de Mediana Edad , FarmaciasRESUMEN
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.