Therapeutically equivalent groupings

There are three levels of equivalence for classifying products, each submitted to an identical maximum level of public financing chemical equivalence, pharmacological equivalence and therapeutic equivalence. The first level entails establishing groups for the same active ingredient, which at the same time include both generics and brand-name pharmaceuticals whose patent has expired. This is the system applied in Sweden, Denmark, Norway and Spain. It encompasses bio-equivalent products with identical qualitative or quantitative composition, pharmaceutical form, dose, administration method and presentation . 

The same name is also being used for some vaccines that differ in potency. As shown in Table 1.4, the two approved vaccines against hepatitis B, Recombivax HB and Engerix-B, both known as Hepatitis B Vaccine (Recombinant), when used as directed, are therapeutically equivalent in terms of their ability to induce antibodies that protect vaccinated individuals from hepatitis B virus infection. However, the dose and volume required to produce a satisfactory immune response are different for each product and for each age group. 

Nair NP, Reiter-Schmitt B, Ronovsky K, Vyssoki D, Baeke J, Desseilles M, Kindts P, Mesotten F, Peuskens J, Addington D, et alThe Risperidone Study Group. Therapeutic equivalence of risperidone given once daily and twice daily in patients with schizophrenia. J Clin Psychopharmacol 1998 18(2) 103—10. 

Both the Brand Price Premium and Therapeutic Group Premium policies are aimed at establishing benchmark prices within equivalent groups of medicines and promoting use of the cheapest of the options available. 

Schnitzer T, Bone HG, Crepaldi G, et al. Therapeutic equivalence of alendronate 70 mg once-weekly and alendronate 10 mg daily in the treatment of osteoporosis. Alendronate Once-Weekly Study Group. Aging (Milano) 2000 12 1-12. 

Please compare the definition of therapeutic equivalence with the definition of bioequivalence and examine the differences, if any, between these two definitions. Would you consider them to be the same Would bioequivalent products guarantee or assure therapeutic effectiveness Please discuss these issues in a study group. 

Australia (1998) Coverage six therapeutic groups, especially coronary diseases and ulcers (pharmacological equivalence) RP the lowest in each group Reviewal every four months... 

Pharmaceutical Comparison. At least 8 studies to date have examined the effectiveness of hypericum compared to the pharmaceutical antidepressants imipramine, amitriptyline, and maprotiline. Preliminary results indicate that hypericum is equivalent to standard antidepressants in effectiveness (Linde et al. 1996 Vorbach 1997). Similar to the pharmaceutical antidepressants, there is a 10-14 day lag for therapeutic effects of hypericum (Harrer et al. 1994). Indeed, the differences seen between hypericum and placebo groups becomes apparent between 2 and 4 weeks (Sommer and Harrer 1994). Hypericum has been reported to have a more favorable side-effect profile than several pharmaceutical antidepressants as well (Vorbach et al. 1994 Harrer et al. 1994). In double-blind studies, subjects have reported fewer and less-severe side effects. Although these initial results are promising, Linde and colleagues (1996) have concluded that the present evidence is inadequate to establish... 

Prilosec, Rapinex, Zegerid) and its S-isomer, esomeprazole (Nexium), lansoprazole (Prevacid), rabeprazole (Aciphex), and pantoprazole (Protonix). These drugs have different substitutions on their pyridine and/or benzimidazole groups but are remarkably similar in their pharmacological properties. Omeprazole is a racemic mixture of R- and S-isomers the S-isomer, esomeprazole (S-omeprazole), is eliminated less rapidly than R-omeprazole, which theoretically provides a therapeutic advantage because of the increased half-life. Despite claims to the contrary, all proton-pump inhibitors have equivalent efficacy at comparable doses. 

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