Are there times when it’s better to dispense a brand drug instead of its generic equivalent?
Before answering that it would be good to briefly review some basic information regarding the differences between brand name and generic medications.
食物及药物管理局(食品及药物管理局美国药品监督管理局(fda)负责药品在美国的审批.S. 在新药的例子中 过程 通常以“发现”开头.” The drug will then typically proceed into a “Preclinical Research” phase where animal testing is applied. The drug manufacturer can then apply for an “Investigational New Drug” (IND) application. If approved, the IND would allow the drug manufacturer to proceed to “Clinical Studies.” All the while, the drug manufacturer is gathering data about safety (副作用特定患者群体的耐受性等.)和功效. 一旦制造商掌握了足够的信息, 将提交“新药申请”(NDA), 如果药物被批准, 它可以在美国生产并提供使用.S.
When a new drug is produced the drug manufacturers typically give it a brand name, and the 食品及药物管理局 grants a period of exclusivity during which time the drug maker has exclusive marketing rights to that drug. 一旦某种药物的专卖权到期, generic manufacturers may begin making their versions of the brand name drug.
The generic manufacturer submits an “Abbreviated New Drug Application” (ANDA), which in essence allows them to request approval of the drug without having to include the Preclinical and Clinical Study data that the original manufacturer must supply. 而不是, the generic manufacturer must prove to the 食品及药物管理局 that the generic drug is comparable to the brand name drug in quality, 纯度, 强度, 剂型, 给药途径, 功效, 和预期用途(又名, bioequivalent). 话虽如此, the generic form will always have some differences as they cannot be exact copies of the brand, but these differences are not considered medically important in a bioequivalent drug. This abbreviated approval 过程 allows the generic manufacturer to provide the drug at a significantly lower cost than the brand name counterpart.
为了解决品牌使用问题， 药房福利经理 (PBMs) require medications be dispensed at the pharmacy as generics where possible and when substitution is not restricted by the prescriber or market conditions. 解决错失的通用机会, outreach programs and detailed reporting can also notify the claims examiner if a brand drug with a generic available was dispensed. 而 十分之九 美国的处方.S. 都是仿制药吗, there can be reasons a pharmacist or doctor chooses to dispense a brand over its generic equivalent, 从临床到财务.
The most common clinical scenario for use of brands over generics is for a group of drugs called “Narrow Therapeutic Index” drugs. The medications in this classification include anticonvulsants, which are used for treatment of seizure disorder but not pain, 和血液稀释剂，如香豆素. These medications are monitored via blood tests where a small change in blood concentration can affect the management of the disease. 例如, 如果病人服用5mg香豆素情况稳定, switching to a generic warfarin may cause a small fluctuation in blood concentration and result in lower effectiveness and an increase in clotting.
Another possible scenario where a brand might be substituted for a generic, 尽管罕见的, 是在药品短缺的情况下. 例如, if there are limited generics available of a specific drug or there is a recall or interruption in the supply chain, the pharmacist may choose to substitute the brand in order to fill the prescription with an available medication. An even less common scenario could involve a patient being allergic to an inactive ingredient in the generic product, as the generic may contain different ingredients including additives, 着色, 等.
To find out more about brand and generic medications, visit the Food and Drug Administration (食品及药物管理局) 仿制药概况 网站.
This information is meant to serve as a general overview, and any specific questions or concerns should be more fully reviewed with your health care professional such as the prescribing doctor or dispensing pharmacist.
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