Assessment of the pharmaceutical quality of omeprazole capsule brands marketed in Egypt.

The pharmaceutical quality of 7 local omeprazole capsule brands in Egypt was assessed relative to the proprietary product (Losec). Drug content, content uniformity, drug release (using USP test for enteric coated articles and a modified release test) were determined. Products were subjected to a 3-month stability study. Of the 7 brands, 6 had satisfactory drug content and content uniformity. All brands passed the USP drug release test. The modified release test proved to be more discriminative. After 3 months storage, drug content of 3 brands remained > 90% and 2 of these brands maintained drug release above 75%. Changes in pellet appearance during storage were indicative of omeprazole chemical degradation.

A therapeutic substitution policy for proton pump inhibitors: clinical and economic consequences.

OBJECTIVE: With the growing need to provide prescription drug benefits to older patients and to contain costs, it will be necessary to direct that coverage so as to make expenditures as efficient as possible. We evaluated the clinical and economic consequences of coverage restriction for 3 leading proton pump inhibitors (PPIs) in a large-scale natural experiment. METHODS: The study design was a time-trend analysis in the setting of a provincial drug benefits program in British Columbia, Canada. We studied all British Columbia residents aged 66 or older (N = 501,104) using linked data on all prescription drug dispensings, physician services, and hospitalizations between January 2002 and June 2004. The new policy restricted coverage to rabeprazole and required treatment failure with a histamine H2 blocker. More widely used PPIs (omeprazole, pantoprazole, and lansoprazole) had to be paid for out of pocket, unless the physician requested an exemption. The main outcome measures were utilization of PPIs, drug discontinuation rates, gastrointestinal hemorrhage rates, and drug expenditures. RESULTS: Utilization of the restricted PPIs declined sharply after the policy change (-14,850 daily doses per month per 10,000 residents, P < .0001), whereas use of the covered PPI increased sharply (+19,300, P < .0001), with 45% of all PPI users switching to the covered agent within 6 months. We found no increased use of H2 blockers or stopping of gastroprotective drugs. There was no increase in the monthly rate of hospitalization for gastrointestinal hemorrhage after the PPI restriction (P = .35) even though the study had the power to detect increases of 24 events per 10,000 residents with 95% confidence. There was a slight increase in physician visits 3 months after the policy change (P = .01) for a 2-month period when 9% of new rabeprazole users were switched back to a restricted PPI. In the first 6 months of the policy change, the provincial health plan saved at least 2.9 million Canadian dollars as a result of the policy change. CONCLUSIONS: Coverage restriction of 3 leading PPIs led to substantial utilization changes and savings, without increased noncompliance or clinical complication.

Initiatives in South Africa to enhance the prescribing of generic proton pump inhibitors: findings and implications.

BACKGROUND: There have been multiple reforms in South Africa to conserve resources including policies to enhance generic use, such as compulsory generic substitution and copayments. However, there are concerns with the limited knowledge of their impact. OBJECTIVE: The objective was to determine utilization and expenditure of different proton pump inhibitors (PPIs). METHODOLOGY: A retrospective drug utilization study was conducted on a prescription database of a medical aid administrator in 2010. RESULTS: The limited prescribing of single-sourced PPIs accounted for 21.5% of total prescriptions. The limited use of originators omeprazole and lansoprazole accounted for 1.8 and 1.4% of total prescriptions for the molecule, respectively. Generic prices accounted for 36-68% of the originator in 2010. Patients received on average 2.91 PPI prescriptions during the year. CONCLUSION: Policies to enhance prescribing of generics appear working. Opportunities exist to further lower generic prices given low prices in some European countries.