When is protonix going generic

Most recently, the US Food and Drug Administration approved a generic version of rabeprazole, which should only continue the trend seen in Figure 1. There is little data to support efficacy differences between PPI formulations and there are cost differences between brand name and generic formulations of the same class of drugs. Generic omeprazole was available during our entire study period, yet, only in and did PPIs with an available generic formulation account for a greater proportion of visits than brand name only PPIs.

Much of the effort to reduce national drug costs has been through direct generic substitution, whereby a brand name drug is replaced with its less costly generic equivalent, when available. Loss of patent protection for several brand name drugs and the increasing use of tiered pricing strategies that encourage patients to select lower-cost generic drugs have led this approach to be relatively successful [ 18 , 19 ]. Duru et al. We found that, from to , the generic share of total PPI prescriptions increased from The increasing generic share of PPIs in our study is in line with studies of all outpatient drugs.

Aitken et al. However, Variations in care point to opportunities to improve quality. Our study identified practice ownership as the greatest predictor of brand name PPI prescribing. The researchers also found that the probability of a veto of generic substitution increased as patients' copayments decreased [ 21 ].

We also found that academic medical practices were also associated with higher rates of brand name PPI prescribing. Physicians and trainees in the US are often unaware of the costs of medical care, and numerous factors make acquiring cost information difficult. Okike et al.

Studies by Epstein et al. A national survey of United States physician trainees showed an association between positive attitudes toward industry-physician interactions, less knowledge about evidence-based prescribing, and greater inclination to recommend brand name drugs [ 25 ]. Recent policy changes seek to reduce undue influence of pharmaceutical marketing on physicians.

Particular attention has been paid to trainees because the medical school and residency learning environment may influence subsequent professional development and behavior [ 25 ]. The impact on these policies and on brand name versus generic prescribing remains to be determined.

A variety of other factors may also influence generic substitution [ 5 ]. Generic substitution is regulated by state laws and many states allow pharmacists to substitute a generic unless explicitly directed by the physician or patient. However, few states mandate that a pharmacist substitute a generic unless overridden by a physician's order [ 26 ].

Second, payment structure may encourage or discourage generic substitution by assigning lower or higher out-of-pocket costs to generic formulations. Prior studies show inconsistent results on patients' perspectives on the perceived efficacy or safety of generic versus brand name drugs [ 27 — 29 ]. This was a retrospective analysis using NAMCS data, which uses a robust survey design to help ensure that trends identified are reflective of all outpatient physician visits.

Study limitations include the possibility of sampling and misclassification bias. Our data reflect PPIs that have available generic formulations, and it is possible that many prescriptions provided by physicians did not actually result in generic substitution. NAMCS physician visit records only list up to 8 medications per visit. It is possible that patients with greater than eight medications could be taking medications not listed, including PPIs.

This would lead to an underestimation of PPI prescriptions. We were unable to control for state or local variables that could provide more granular regional detail of prescribing practices. NAMCS data also do not provide patient level data on severity or chronicity of patient symptoms. Diagnoses are listed in the NAMCS data; however, discrete diagnoses are not linked to each medication and we were unable to account for the specific diagnoses or symptoms that could be driving PPI prescriptions with only brand name formulations.

For example, initial clinical cohort studies in reported an increased risk for adverse cardiovascular events, when under simultaneous clopidogrel and PPI treatment due to CYP2C19 inhibition.

Pharmacokinetic and pharmacodynamic data have suggested varying inhibition by different PPIs of the enzyme systems necessary to convert clopidogrel to its active form, but there is no high level evidence that differences on surrogate markers translate into meaningful differences in outcomes [ 31 ].

Although use of PPIs with generic formulation availability is increasing, there still appears to be opportunity for significant improvement. A portion of the work was conducted while Dr. Gawron and Dr. Gawron, Feinglass, Tan, Bove, and Smith have no disclosures or outside interests to declare.

Pandolfino has served as a consultant and educational speaker for Given Imaging. Andrew J. Gawron, Joseph Feinglass, Bruce K. Tan, Michiel J. Bove, and Stephanie Shintani-Smith have no conflict of interests. John E. Gawron contributed to study design, data analysis, interpretation of results, writing and revising of paper, and final approval of paper.

Joseph Feinglass contiributed to study design, statistical support, interpretation of results, revising of paper, final approval of paper. Pandolfino contributed to study design, interpretation of results, writing and revising of paper, and final approval of paper. Bruce K. Tan contributed to study design, interpretation of results, writing and revising of paper, and final approval of paper. Michiel J. Bove contributed to study design, interpretation of results, writing and revising of paper, and final approval of paper.

Stephanie Shintani-Smith contributed to study design, data analysis, interpretation of results, writing and revising of paper, and final approval of paper.

National Center for Biotechnology Information , U. Journal List Gastroenterol Res Pract v. Gastroenterol Res Pract. Published online Feb 5. Gawron , 1 , 2 Joseph Feinglass , 3 John E. Pandolfino , 4 Bruce K. Tan , 5 Michiel J.

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