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At least 73 records · Page 4Linked to original sources
PubMed1998

A generic drug primer: regulatory aspects and scientific concepts.

The regulatory aspects of generic drug substitution and the scientific concepts that serve as the basis for generic drug approval are discussed, with emphasis on the source of therapeutic equivalence information compiled by the Food and Drug Administration in Approved Drug Products with Therapeutic Equivalence Evaluations. The Food and Drug Administration's determination of bioequivalence for immediate-release and extended-release dosage forms is summarized, with a discussion of the underlying assumptions and current issues regarding bioequivalence testing. Medical practitioners must comply with the regulations stated in each state's Pharmacy Practice Act when allowing generic substitution and should ensure that the substituted product is therapeutically equivalent to the prescribed product.

Drugs, Generic↗
PubMed2006

[Generic drug substitution].

The rapidly rising health care expenditures, attributed mainly to the high cost of prescription drugs, have led governments around the world to look to generics as a means of containing costs in the pharmaceutical market. Generic drugs provide a less expensive alternative to brand name drugs due to the elimination of the need to perform lengthy and costly clinical trials, as required for innovative drugs. Essentially, generic substitution of drugs may be performed only after showing unequivocally that the generic formulation is identical in its active ingredients, strength, and route of administration as its innovative counterpart, and that they are bioequivalent to each other. Although the two are in essence the same, generic substitution is occasionally a controversial matter.

Costs and Cost Analysis↗
PubMed2004

[Generic drugs in a district hospital. Intervention strategies].

OBJECTIVE: To know the prescription of generic drugs in specialized attention and the impact of two different intervention strategies: MATERIAL AND METHODS: Intervention trial with evaluation and later comparison. The data on the use of generic drugs are obtained from the medical reports. After an informative note of general character we repeated the taking of data one month later. In the service of Medicine we also analysed each doctor's profile prescriptions and a personalized informative note was edited and accompanied by a brief verbal explication of the campaign. Then repeated the collection of data to the week and the month. RESULTS: 1545 reports were revised (3460 prescribed drugs). 42% of the medication could be prescribed as generic but it was only made in 10% (21% in Internal Medicine). After the informative note no significant variations were observed. Only in Internal Medicine an initial increment was obtained (21 to 56%, RR 0.38, IC 0.26-0.55) that it disappeared at month. COMMENTS: The utility of the intervention to generic promotion is limited and transitory. Besides improve the information, seems necessary the implication of the physician in the promotion campaigns.

Drug Utilization↗
PubMed2003

Generic drug utilisation on the General Medical Services (GMS) scheme in 2001.

Expenditure on medicines under the Community Drug Schemes was Euro 674.8 million in 2001, a 27% increase as compared with the year 2000. Prescribing less expensive generic drugs is one method of reducing costs whilst maintaining therapeutic efficacy. In this study the cost and quantity of generic drugs dispensed and the potential savings for GMS prescribing in 2001 that could be made by increasing utilisation of generic drugs was investigated. Twenty two per cent of prescription items were dispensed generically (branded generics (17%) and non-branded generics (5%)) in 2001. This represented approximately 13% of the total ingredient cost of drugs dispensed in that period. Eighteen per cent of prescription items were dispensed as proprietary preparations when a generic equivalent was available. Eleven of the top 30 drugs, of highest cost to the GMS scheme, had a generic equivalent which if substituted could produce savings in the region of Euro 5.65 million. The results of this study highlight the potential for cost savings to be made by generic substitution, facilitating the most efficient use of the limited drugs budget.

Drug Prescriptions↗