Projecting future drug expenditures--2001.

Drug cost projections for 2001 and factors that are likely to influence drug costs are discussed. The year 2000 introduced many new factors into the decision-making process for drug pricing and raised new considerations regarding drug therapy, distribution, and costs. It is anticipated that drug costs will continue to increase at a rate of 11-15% in 2001. Research and development expenditures for new drugs continue to grow and are estimated to be $26.4 billion in 2000, but the number of new drug approvals, especially for new entities, has not increased significantly. The generic drug industry has been expanding, and sales of generics are expected to increase to $20 billion by 2005. Drug costs also keep rising, and sales may reach $243 billion by 2008; this amounts to 12.6% of total health care spending, compared with 8.1% in 1999. There is a trend toward increasing the rate of conversion of prescription drugs to nonprescription status; this may reduce drug budgets somewhat. 2001 will see new systems of drug distribution and pricing, a federal prospective pricing system for ambulatory care patients covered by Medicare, drug imports from foreign manufacturers, and states taking legal action to reduce prescription drug costs. Drug costs in 2001 are expected to continue to increase at double-digit rates. The increase in costs is due to increased utilization, to new products replacing older products, and to price increases for drugs currently on the market.

Interstitial deletion of 5q33.3q35.1 in a girl with mild mental retardation.

Constitutional interstitial deletions of 5q are uncommon. The corresponding phenotype is not well defined. But severe mental retardation seems to be a consistent manifestation. We describe a 4-year-old girl with a de novo deletion of 5q33.3q35.1 presenting only with mild psychomotor delay, minor facial anomalies, and seizures.

Projecting future drug expenditures--2000.

Drug cost projections for 2000 and factors that are likely to influence drug costs are discussed. The total increase in drug costs in 2000, assuming there are no major unforeseen events (e.g., Medicare coverage of outpatient prescriptions or important new drugs) can be anticipated to be 12-15% above that in 1999. Prescription drug expenditures are projected to increase an average of 11.2% annually between 1999 and 2001. Although there were fewer new drug approvals in the first half of 1999 than in 1998, we can expect that many new, important, and probably expensive agents will be coming to market in 2000. Analysts calculate that pharmaceutical companies invested approximately $24 billion in research and development in 1999, and there are predictions that mergers within the pharmaceutical industry will reduce the number of major pharmaceutical firms to 13. The introduction of pharmacogenomics is of great interest because of its potential to significantly affect drug therapy and the discovery of new agents. Sales of generic drugs are anticipated to increase from $12 billion in 1999 to $14 billion in 2000. Competition between the brand-name and generic drug industries is intensifying, but it remains unclear whether generic drug pricing will offset brand-name price increases. Internet pharmacy has become a reality and is under federal and state scrutiny. The pharmaceutical and drug distribution industries are changing dramatically, and there is concern that many new prescription drugs will not be readily available to patients because of their high cost. Should this occur, action by the federal government is a possibility.

Projecting future drug expenditures--1999.

Drug cost projections for 1999 and factors that are likely to influence drug costs are discussed. The producer price index indicates that the prices of drugs and pharmaceuticals increased sharply, by an average of 10.2%, during the first 10 months of 1998, compared with just 2.1% for all of 1997; the price of pharmaceutical prescription preparations increased by an average of 17.4% in the first 10 months of 1998-an increase of more than six times the average increase for 1997. In the first quarter of 1998, many generic drugs had major price increases. All these increases may be a sign of considerably higher drug costs in 1999. Group purchasing organizations predict price increases in 1999 of 3% for contracted drugs, 5% for noncontracted drugs, and 8% for current and newly marketed drug products. FDA has been able to decrease the time necessary to approve new drugs under the Prescription Drug User Fee Act of 1992 and will be expected to decrease the time even further under the FDA Modernization Act of 1997. Increases of 10-12% or more in managed health care coverage rates are being predicted for 1999, with even larger increases expected for fee-for-service plans. Managed care organizations point to the cost of prescription drugs as the major reason for their rate increases. Last year's prediction that we may be entering a period of smaller increases in drug costs was not fulfilled in 1998; all signs point to even higher drug costs in 1999.

Projecting future drug expenditures--1998.

Drug cost projections for 1998, factors that directly influence drug costs, and tools for projecting drug expenditures are discussed. The producer price index indicates that prices for drugs and pharmaceuticals increased 2.1% between January and June 1997; the increase for prescription preparations was 2.7%. Medi-Span data show an average increase for all drug products of 1.02% during the first six months of 1997; First Data-Bank reports a 1.7% increase for the same period. IMS America data, which take account of weighting for individual drugs or drug classes, show the prices of all drugs increasing 2.3% between the second quarters of 1996 and 1997. Drug industry analysts project the overall price increase in the next 12 months at 2-4%. Group purchasing organizations predict an average increase over the next 12 months of 0.56% for contracted drugs and 3.6% for noncontracted drugs. Various health care provider indexes suggest that increases in drug costs could be smaller over the next few years. The current trend of takeovers and mergers of pharmaceutical companies and health systems is likely to continue into 1998. As a result of generic competition and the loss of patent protection for many pharmaceutical products, the number of drugs to be introduced onto the market and the number of drugs in development are expected to escalate until the year 2000. These and other major changes in the health care environment, including changes in drug distribution and controversies over the use of formularies, will make future forecasting difficult. Compared with previous years, smaller increases in drug costs have been projected for 1998 and beyond, but changes in the health care environment mean that greater knowledge will be required to forecast future drug expenditures.

Projecting future drug expenditures--1997.

Use of the producer price index; data from independent sources, drug industry analyst, group purchasing organizations (GPOs), and health maintenance organizations (HMOs); pharmacoeconomics; and legal developments to project drug expenditures and prepare pharmacy budgets for 1997 is discussed. The producer price index indicates that prices for drugs and pharmaceuticals increased 2.2% during January to May 1996; the increase for prescription preparations was 3.4%. Medi-Span reports an average increase for all drug products of 1.2% for the first six months of 1996. IMS America data show the price of all drugs increasing 1.8% between the second quarters of 1995 and 1996. Drug industry analysts project the overall price increase in the next 12 months at 2.5-5.0%. GPOs predict an average increase over the next 12 months of 2.2% for contracted drugs and 4.3% for non-contracted drugs. HMO pharmacy directors predict pharmacy expenditures will increase by 4.5% per member in 1997. Caution must be applied in using pharmacoeconomics to project drug costs and their impact on health care expenditures. Today's budget must account for the greater integration of drug expenditures into the institution's objectives, possible reductions in other service costs, capitation, competition, shifting of control of the drug budget to specific patient care centers, relocation of services to the ambulatory care setting, and outsourcing. Legal actions in 1996 that may affect price increases and drug budgets included a class-action lawsuit by community and chain pharmacies alleging price discrimination by manufactures and wholesalers. Prices of pharmaceutical products are fairly stable and may remain so in 1997, but projections of future drug expenditures must account for the continuing reshaping of the health care landscape.

Changes in 1994 drug cost for inpatient services.

The healthcare system is undergoing major changes in the manner in which healthcare is being delivered. These changes have affected individual institutions per se, as well as having an affect upon the cost of the drugs being administered. The comparative indices for the years 1993 and 1994 indicate that the utilization and classes of drugs being prescribed are undergoing change. Although drug cost has not increased to the same magnitude as in the past, it continues to show significant growth. Of continuing importance is the changes taking place in the classifications of drugs being used and the affect that these changes have on cost.

1993 changes in drug cost for inpatient services.

This article reviews changes taking place in reference to drug cost during the year 1993. It presents indices used for tracking the changes taking place on a monthly basis, classified by different therapeutic class and overall cost factors.

Prevention of medication errors. Developing a continuous-quality-improvement approach.

Medication errors can be a serious problem that exposes patients to preventable risks. Although medication errors are often considered primarily a nursing issue, every health care provider plays an important role in medication error prevention. A continuous quality improvement philosophy with involvement of a multidisciplinary team is the optimal method for identifying and correcting the causes of medication errors. Careful analysis of the medication distribution system and identification of system flaws is an integral part of the continuous quality improvement process.

Defining excellence.

Excellence in the pharmacy profession, particularly pharmacy management, is defined. Several factors have a significant effect on the ability to reach a given level of excellence. The first is the economic and political climate in which pharmacists practice. Stricter controls, reduced resources, and the velocity of change all necessitate nurturing of values and a work ethic to maintain excellence. Excellence must be measured by the services provided with regard to the resources available; thus, the ability to achieve excellence is a true test of leadership and innovation. Excellence is also time dependent, and today's innovation becomes tomorrow's standard. Programs that raise the level of patient care, not those that aggrandize the profession, are the most important. In addition, basic services must be practiced at a level of excellence. Quality assessment is a way to improve care and bring medical treatment to a higher plane of excellence. For such assessment to be effective and not punitive, the philosophy of the program must be known, and the goal must be clear. Excellence in practice is dependent on factors such as political and social norms, standards of practice, available resources; perceptions, time, the motivation to progress to a higher level, and the continuous innovation required to reshape the profession to meet the needs of society.

Comparative studies on the in vitro drug dissolution profiles for hydroxyzine hydrochloride tablets.

OBJECTIVE: A significant practical problem in the standardization of dissolution testing is addressed. In vitro releasing characteristics of hydroxyzine hydrochloride tablets are presented to further the documentation of bioequivalency criteria. DESIGN: The assessment model compares the official United States Pharmacopeia disintegration approach for dissolution analysis with that of the Food and Drug Administration's recommended rotating paddle technique for inducing aqueous disruption of the solid oral dosage form. RESULTS: The rationale and significance of the study focuses attention on the variation in release of the active ingredient observed relative to the four formulation strengths. With differences in the extent of dissolution noted and official standards in mind, emphasis is placed on the development of an alternate test protocol. CONCLUSIONS: Dissolution data derived via ultraviolet spectrophotometry revealed statistically significant differences in the amount of hydroxyzine hydrochloride being released from its coated structure, the extent of which was found to be dependent on the acid nature of the simulated gastric dissolution medium used and intensity of mixing action employed.

Effect of vehicle ionic strength on sorption of nitroglycerin to a polyvinyl chloride administration set.

The nitroglycerin sorptive properties of a polyvinyl chloride i.v. administration set were studied, and the role played by the admixture vehicle in this process was explored. Admixtures of nitroglycerin 0.4 mg/mL were prepared in sterile water for injection, 5% dextrose injection, Ringer's injection, and 0.25%, 0.9%, and 5% sodium chloride injection. Each admixture was divided into two 500-mL sterile glass containers, and flow through the administration set at 100 mL/hr was begun. Samples of effluent were collected at intervals beginning 10 minutes after the start of the infusion and ending at 180 minutes. Nitroglycerin depletion from solution and uptake by the set was determined by an ultraviolet spectrophotometric assay. Initially, the degree of nitroglycerin loss to the set was greatest for dextrose admixtures, intermediate for water admixtures, and least for sodium chloride admixtures. Losses of about 40% were observed during the first 10 minutes; between 15 and 20 minutes, the stated pattern of drug sorption was reversed, with sodium chloride admixtures now showing the greatest loss of nitroglycerin. The availability of nitroglycerin was an inverse function of increasing ionic strength during the three-hour observation period. Nitroglycerin availability in admixtures in contact with a polyvinyl chloride administration set was dependent on the ionic strength of the vehicle and the time points in the infusion period at which measurements were made.

Medical management of inflammatory bowel disease.

Inflammatory bowel disease is a serious ailment that afflicts nearly one million people in the U.S. alone. The medical management of this disorder currently includes salicylates, corticosteroids, immunosuppressive therapy, and symptomatic treatment with antidiarrheal agents, although several promising new drugs have been developed. The epidemiology, etiology, pathogenesis, and medical management of the disease are discussed in this article.