Measuring medicine prices in Peru: validation of key aspects of WHO/HAI survey methodology.

OBJECTIVES: To assess the possibility of bias due to the limited target list and geographic sampling of the World Health Organization (WHO)/Health Action International (HAI) Medicine Prices and Availability survey used in more than 70 rapid sample surveys since 2001. METHODS: A survey was conducted in Peru in 2005 using an expanded sample of medicine outlets, including remote areas. Comprehensive data were gathered on medicines in three therapeutic classes to assess the adequacy of WHO/HAI's target medicines list and the focus on only two product versions. WHO/HAI median retail prices were compared with average wholesale prices from global pharmaceutical sales data supplier IMS Health. RESULTS: No significant differences were found in overall availability or prices of target list medicines by retail location. The comprehensive survey of angiotensin-converting enzyme inhibitor, anti-diabetic, and anti-ulcer products revealed that some treatments not on the target list were costlier for patients and more likely to be unavailable, particularly in remote areas. WHO/HAI retail prices and IMS wholesale prices were strongly correlated for higher priced products, and weakly correlated for lower priced products (which had higher estimated retailer markups). CONCLUSIONS: The WHO/HAI survey approach strikes an appropriate balance between modest research costs and optimal information for policy. Focusing on commonly used medicines yields sufficient and valid results. Surveyors elsewhere should consider the limits of the survey data as well as any local circumstances, such as scarcity, that may call for extra field efforts.

Measuring medicine prices in Peru: validation of key aspects of WHO/HAI survey methodology / Determinación de los precios de los medicamentos en Perú: validación de aspectos fundamentales del método de encuesta de la OMS/HAI

Objectives: To assess the possibility of bias due to the limited target list and geographic sampling of the World Health Organization (WHO)/Health Action International (HAI) Medicine Prices and Availability survey used in more than 70 rapid sample surveys since 2001. Methods: A survey was conducted in Peru in 2005 using an expanded sample of medicine outlets, including remote areas. Comprehensive data were gathered on medicines in three therapeutic classes to assess the adequacy of WHO/HAI's target medicines list and the focus on only two product versions. WHO/HAI median retail prices were compared with average wholesale prices from global pharmaceutical sales data supplier IMS Health. Results: No significant differences were found in overall availability or prices of target list medicines by retail location. The comprehensive survey of angiotensin-converting enzyme inhibitor, anti-diabetic, and anti-ulcer products revealed that some treatments not on the target list were costlier for patients and more likely to be unavailable, particularly in remote areas. WHO/HAI retail prices and IMS wholesale prices were strongly correlated for higher priced products, and weakly correlated for lower priced products (which had higher estimated retailer markups). Conclusions: The WHO/HAI survey approach strikes an appropriate balance between modest research costs and optimal information for policy. Focusing on commonly used medicines yields sufficient and valid results. Surveyors elsewhere should consider the limits of the survey data as well as any local circumstances, such as scarcity, that may call for extra field efforts.

Objetivos: Evaluar la posibilidad de sesgo debido a la limitación de la lista de referencia y del muestreo geográfico de la encuesta de precios y disponibilidad de medicamentos de la Organización Mundial de la Salud/Health Action International (OMS/HAI) usada en más de 70 muestras de encuestas rápidas desde el 2001. Métodos: En el año 2005, se realizó una encuesta en Perú, con una muestra ampliada de puntos de venta de medicamento, incluso en zonas remotas. Se recogieron datos integrales acerca de los medicamentos de tres clases terapéuticas, con el fin de evaluar la idoneidad de la lista de referencia de medicamentos de la OMS/HAI y el énfasis únicamente en dos versiones del producto. Las medianas de los precios al por menor de la OMS/HAI se compararon con el promedio de precios al por mayor del proveedor de datos mundiales de ventas farmacéuticas IMS Health. Resultados: No se observó ninguna diferencia significativa en la disponibilidad general ni en los precios de los medicamentos de la lista de referencia por localización de venta al por menor. La encuesta integral de los inhibidores de la enzima convertidora de la angiotensina, los antidiabéticos y los productos antiulcerosos reveló que algunos tratamientos que no están en la lista destinataria eran más caros para los pacientes y era más probable que no estuvieran a la venta, sobre todo en las regiones remotas. Los precios al por menor de la OMS/HAI y los precios al por mayor de IMS presentaron una correlación intensa en el caso de los productos de precio más alto, y la correlación fue débil en el caso de los productos de precio más bajo (que tuvieron márgenes de beneficio calculados más altos para el minorista). Conclusiones: El método de la encuesta de la OMS/HAI logra un equilibrio adecuado entre los costos de investigación moderados y la información óptima para la política. El énfasis en los medicamentos de uso frecuente produce unos resultados válidos y suficientes. Los encuestadores de otros...

Increased health costs from mandated Therapeutic Substitution of proton pump inhibitors in British Columbia.

BACKGROUND: In 2003, British Columbia's PharmaCare programme implemented a drug reimbursement policy called Therapeutic Substitution, which required patients with acid-related diseases, primarily gastro-oesophageal reflux disease (GERD), to make a medically unnecessary switch from their prescribed proton pump inhibitor (PPI) to the cheapest available brand name PPI (Pariet, rabeprazole sodium), comprising a different (nongeneric) chemical. AIM: To evaluate the independent effects of PPI Therapeutic Substitution on individual healthcare utilization among those complying with the policy. METHODS: We used the BC Ministry of Health Services' individual-level linked data, allowing isolation of healthcare utilization for the entire population of PPI consumers from 2002 to 2005. RESULTS: After controlling for individual case variation in age, gender and a proxy for pre-existing health status, regression analysis revealed statistically significant greater overall use of PPIs, physician services and hospital services independently associated with patients who complied with Therapeutic Substitution. Over the 3-year period 2003-2005, this represented net healthcare expenditures totalling approximately C$43.51 million (C$9.11 million in total PPI drug expenditures, C$24.65 million for physician services and C$9.75 million for hospital services). CONCLUSION: Medically unnecessary drug switching caused by compliance with Therapeutic Substitution policy appears to be independently associated with higher overall healthcare utilization.

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.

Use of intravenous proton pump inhibitors in community practice: an explanation for the shortage?

BACKGROUND: Since 2001, one intravenous proton pump inhibitor (pantoprazole) has been available in the United States. A drug shortage bulletin was issued for this agent in 2003. AIM: To evaluate the patterns of use of intravenous proton pump inhibitors (IV PPIs) in routine clinical practice. METHODS: Prospective evaluation of IV PPI use in two community-based teaching hospitals. A computerized pharmacy ordering system was used to identify all patients for whom an IV PPI was ordered. Trained investigators obtained clinical data from patient records and these data were mapped to establish clinical criteria for the use of IV PPIs. RESULTS: Intravenous PPIs were prescribed in 238 patients over a 30-day period and a total of 1,631 doses were prescribed. Primary care providers prescribed 46% of prescriptions. Fifty-six percent of patients who received IV PPIs had no acceptable indication for their use. Of the 126 (81%) patients who were started on PPIs for the first time during their hospital stay, 102 were discharged on a PPI. CONCLUSIONS: Intravenous PPIs are widely used for poor indications, which may contribute to the shortage of these agents.

How Zantac became the best-selling drug in history.

Glaxo's Zantac began its dominance of the acid/peptic marketplace with a launch strategy, taking advantage of the established Roche sales force to rapidly promote the product. Educational symposia for physicians were instrumental in disseminating both disease and product information to primary care physicians and specialists. This technique not only pleased physicians (more referrals), but also increased public awareness of gastrointestinal disease, further expanding the patient market. Several novel marketing strategies contributed to Zantac's success, including the public-service announcements, celebrity media tours, and consumer-awareness bulletins, which brought the drug to the lay public and encouraged individuals to seek advice from their physicians.

Misoprostol: a prostaglandin E1 analogue.

The pharmacology, pharmacokinetics, clinical efficacy, contraindications and precautions, adverse effects, dosage, and cost of misoprostol are reviewed. Misoprostol is a synthetic analogue of natural prostaglandin E1. It produces a dose-related inhibition of gastric acid and pepsin secretion and enhances mucosal resistance to injury. Misoprostol is extensively absorbed from the stomach and undergoes rapid de-esterification to its biologically active metabolite, misoprostol acid. The average absorption after an oral dose is 88%; peak plasma concentrations of misoprostol acid are achieved in less than 30 minutes. Clinical trials have demonstrated ulcer healing rates of approximately 60-80% in patients with duodenal ulcers who received misoprostol 800 micrograms daily for four weeks. Misoprostol was generally no more efficacious than conventional therapy with the H2-receptor antagonists cimetidine and ranitidine. The healing rate observed for gastric ulcers was less than that observed for duodenal ulcers. In trials involving healthy volunteers and patients with arthritis receiving aspirin, naproxen, tolmetin, ibuprofen, or piroxicam, misoprostol was consistently superior to placebo, cimetidine, and sucralfate in the prevention of nonsteroidal anti-inflammatory drug (NSAID)-induced gastropathy. The majority of these studies have been of short duration; however, long-term studies (up to three months) have corroborated superiority over placebo. Misoprostol is an abortifacient and is contraindicated in pregnant women and women of childbearing potential not using effective contraception. The most common adverse effect of misoprostol therapy is diarrhea, which is often mild and self-limiting and can be minimized by administration of misoprostol after meals and at bedtime. The cost (based on retail price) of four weeks of therapy with misoprostol is comparable to that of other antiulcer agents. Misoprostol has been shown to be an effective agent for the prevention of NSAID-induced gastric ulcers. However, there is no evidence that it offers any clinical advantage over H2-receptor antagonists for the treatment of gastric or duodenal ulcer disease.