Brand and generic medications: are they interchangeable?
Background and Objectives: Generic substitution has become a common practice since the late 1970s in the United States. At that time, many of these generics caused bioavailability problems, which fueled suspicions about their efficacy and safety, and the Food and Drug Administration (FDA) standards...
| Publicado en: | Annals of Saudi Medicine Vol. 28; no. 1; pp. 33 - 42 |
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| Autores principales: | , , , , , , , |
| Formato: | tables/charts Journal Article |
| Publicado: |
Association of Arab Universities
Jan-Feb2008
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| Acceso en línea: | Ver este registro en EBSCOhost |
| fields | @attributes: recordID: 1 pdfLink: plink: https://search.ebscohost.com/login.aspx?direct=true&db=ccm&AN=105757735&site=ehost-live header: @attributes: shortDbName: ccm uiTerm: 105757735 longDbName: CINAHL Complete uiTag: AN controlInfo: bkinfo: dissinfo: jinfo: jid: 02564947 IKW jtl: Annals of Saudi Medicine issn: 02564947 maglogo: N pubinfo: dt: Jan-Feb2008 vid: 28 iid: 1 pid: 55627 pub: Association of Arab Universities place: Great Neck, New York artinfo: ui: 105757735 105757735 NLM18299655 2009914092 NLM18299655 105757735 ppf: 33 ppct: 9 formats: tig: atl: Brand and generic medications: are they interchangeable? aug: au: Al-Jazairi AS Blhareth S Eqtefan IS Al-Suwayeh SA Al-Jazairi, Abdulrazaq S Bhareth, Sakra Eqtefan, Iyad S Al-Suwayeh, Saleh A affil: Department of Pharmacy Services, King Faisal Specialist Hospital & Research Center, Saudi Pharmaceutical Industries & Medical Appliances Corporation and the cCollege of Pharmacy, King Saud University, Riyadh, Saudi Arabia sug: subj: Drugs, Generic Therapeutic Use Drugs, Prescription Therapeutic Use Treatment Outcomes United States United States Food and Drug Administration ab: Background and Objectives: Generic substitution has become a common practice since the late 1970s in the United States. At that time, many of these generics caused bioavailability problems, which fueled suspicions about their efficacy and safety, and the Food and Drug Administration (FDA) standards for bioequivalence. In Saudi Arabia, the increasing number of local products raised several concerns with regard to switching from brands to generics. Our objective was to review and examine the basis of the controversy surrounding brand and generic interchangeability and to explore a practical approach in pursuing a switch.Data Sources: Articles indexed initially under terms such as generic medications, generic substitution, bioequivalence and bioinequivalence were identified. These terms were used to search the indexing service, MEDLINE (1966-2006). References from the extracted articles, and additional data sources, including the Code of Federal Regulations and Regulatory Guidance from the FDA Center for Drug Evaluation and Research were also reviewed.Data Synthesis: For most drugs, bioequivalence testing generally should enable clinicians to routinely substitute generic for innovator products. However, for narrow therapeutic, critical dose drugs, or for highly variable drugs, safe switching between products cannot be assured. These drugs need special precautions and blood level monitoring upon switching. FDA firmly believes that approved generic and brand drugs can be dispensed with the full expectation that the consumer will receive the same clinical benefit.Conclusion: Performing the switch process is an advisable practice to reduce health care costs in countries with strong post-marketing surveillance program, but caution is to be exercised when narrow therapeutic index drugs or highly variable drugs are prescribed. pubtype: Academic Journal doctype: tables/charts Journal Article ougenre: Article language: English refInfo: holdings: @attributes: islocal: N |
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