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At least 19 recordsLinked to original sources
PubMed1976

The cost of upper respiratory tract infections in Canadian children.

We reviewed reports of the incidence, duration, causative organism, sequelae, and cost of upper respiratory tract infections (URI). Using these data, we projected the extent and cost of URI in Canadian children from birth to age 14. We estimated that in 1973, some 6.2 million Canadian children suffered between 23.8 and 42.3 million episodes of URI, of which 5.6 million needed medical attention; approximately 215,300 children were admitted to hospital for treatment of URI-related diseases and utilized 742,800 hospital days. Some direct costs were estimated, including physicians' fees, hospitalization, antibiotics, "cold remedies", and pharmacists' prescription fees; in 1973 these ranged from $141 million to $211 million. The common cold is as common as its name implies, and we need to intensify the search for a solution. Until this is found, both medical profession and the public should be warned of the uselessness, and possible hazards of some of the "remedies" for colds, and made aware of the vast amounts of money expended upon them.

Adolescent↗
PubMedDate not supplied

The prescription Drug User Fee Act of 1992 and the new drug development process.

The Prescription Drug User Fee Act of 1992 (PDUFA) authorizes the US Food and Drug Administration (FDA) to levy user fees on manufacturers who submit applications to the agency. Revenues are dedicated to the achievement of a set of specific performance goals, documented by the FDA Commissioner and referenced in the Act. The FDA currently credits PDUFA with the agency's success in reducing new drug review times and eliminating the formidable new drug application (NDA) backlog. To provide an independent assessment of PDUFA's impact on the new drug development process, the Tufts Center for the Study of Drug Development established an annual user fee survey of over 50 major pharmaceutical and biotechnology firms with operations in the United States. As of December 31, 1996, survey data have been collected for fiscal years 1994, 1995, and 1996. Data from a cohort of user fee drugs approved in 1993-1996 were compared with data from all non-user fee drugs approved in 1990-1992. Whereas the mean approval phase (NDA submission to approval) for the user fee drugs was considerably shorter than that for the non-user fee drugs (14.5 versus 31.0 months, respectively), the mean clinical phase (investigational new drug application filing to NDA submission) was somewhat longer (88.0 versus 81.1 months, respectively). As a result, the total time from the start of clinical testing to drug approval (total phase) was only marginally shorter for the user fee drugs (102.0 versus 112.1 months, respectively). These results highlight the need for efforts to reduce lengthy drug development times.

Biotechnology↗
PubMed1996

The Prescription Drug User Fee Act of 1992. A 5-year experiment for industry and the FDA.

The Prescription Drug User Fee Act of 1992 authorises the US Food and Drug Administration (FDA) to collect in excess of $US332 million in user fee revenues over a 5-year period. Not only did Congress determine that the revenues would be dedicated to expediting the FDA's review of human drug applications, the FDA articulated formidable time-specific performance goals to be achieved by fiscal year 1997. At the mid-point in the 5-year programme, the FDA reported that it had met or exceeded its performance goals. In this article, we review the history of the user fee scheme in the US, outline the details of the legislative provisions, and discuss the challenges confronting the agency as it works to simultaneously meet the user fee goals and respond to political forces calling for substantive FDA reform. User fees loom large for the global pharmaceutical and biotechnology industries as economic pressures force a number of countries to consider shifting a portion of the cost of regulatory review to the regulated industry. This article provides a reference on the US framework and may be useful in future international comparisons as the user fee phenomenon spreads.

Drug Industry↗
PubMed1994

Community financing of drug supplies in rural Nepal: evaluating a 'fee per item' drug scheme.

A new programme in rural Nepal was evaluated in which users partly fund the supply of additional drugs needed at health posts. Patients are charged a fee per item prescribed (FPI scheme). The scheme is administered by the District Public Health Office (DPHO). This scheme is compared with two established schemes: one charges patients a fee per prescription ('fee-per-script' or FPS scheme) and is administered by independently paid NGO (non-governmental organization) staff; the other uses local shops as a means of supplying drugs. The new scheme was associated with a rise in average daily attendance from nine to thirty-two patients a day (a 240% increase) when compared to a similar period the previous year. Fewer drugs were prescribed in the FPI scheme (average per patient 1.8 vs. 2.4, Chi square P <0.001). The average cost of a drug from the user's perspective was approximately 12% lower in the FPI scheme. These factors combined to make the average cost to the patient of a prescription half that of one in the FPS scheme. The new scheme was 24% cheaper to run on a 'cost per patient' basis when compared with the FPS scheme. However, the overall subsidy needed for the scheme to operate was higher because of the big increase in attendance. One-off stocktakes of ten essential drugs were used to assess the availability of drugs for patient use. The proportion of these drugs that were in low supply or absent was 24% in the FPI scheme. This was similar in the other two schemes. The government DPHO did not perform all the administrative tasks required. These tasks need to be simplified and different methods for involving DPHO staff in drug scheme management need to be explored. The rapid turnover of senior staff, however, will remain a major impediment. This preliminary evaluation shows that an FPI scheme promotes a more rational use of resources, compared to an FPS scheme. Administration of the scheme may, however, prove to be more difficult. A simple field-based comparative assessment of drug supply schemes can give a valuable insight into the strengths and weaknesses of a new programme.

Financing, Government↗
PubMed2002

Cost effectiveness of adding leflunomide to a 5-year strategy of conventional disease-modifying antirheumatic drugs in patients with rheumatoid arthritis.

OBJECTIVE: To estimate, from a public payer's perspective, the 5-year cost effectiveness of adding leflunomide (LEF) to a sequence of disease-modifying antirheumatic drugs (DMARDs) representative of a typical rheumatoid arthritis (RA) management approach adopted by Canadian rheumatologists. METHODS: A DMARD sequence including LEF was compared with one excluding it, using a 5-year simulation model where patients with RA cycle through different treatment regimens. Data were obtained through a systematic literature search (drug withdrawal rates, number and type of adverse events, American College of Rheumatology 20% responder status) and separately conducted surveys (choice of DMARD sequence, management of adverse events). Costs for adverse event management were calculated using the Ontario Schedule of Benefits, and monitoring costs were calculated according to official Canadian product monograph recommendations. Wholesale prices of all drugs were adjusted by the allowable markup and prescription fees. Utilities (as measured by the standard gamble [SG] and rating scale [RS] techniques) were obtained from 482 patients who participated in a 1-year randomized controlled trial that compared LEF, methotrexate, and placebo. Costs and utilities were discounted by 3%. Probabilistic sensitivity analysis was performed. RESULTS: Adding LEF to a conventional strategy of DMARDs increased the 5-year management costs by $1,231 compared with the strategy without LEF, which results in a cost-effectiveness ratio of $13,096 per additional year of response to treatment, and cost-utility ratios of $54,229 (RS) and $71,988 (SG) per quality-adjusted life-year gained. CONCLUSION: Adding LEF as a new option to a conventional sequence of DMARDs extends the time patients may benefit from DMARD therapy at a reasonable cost effectiveness and cost utility. LEF data are limited to clinical trials; data from observational studies would be needed to corroborate these findings.

Anti-Inflammatory Agents, Non-Steroidal↗
PubMed1996

Clinical skill development for community pharmacists.

The importance of establishing clinical pharmacy services in the community cannot be understated in light of current challenges to the traditional dispensing role as the primary service of the community pharmacist. Advancements in automated dispensing technology and declining prescription fee reimbursement are rapidly forcing pharmacists to seek alternative sources of revenue. Providing pharmaceutical care is a viable option to increase customer loyalty job satisfaction, and reimbursement. To support the development of clinical services, academic institutions are forming partnerships with individual community practitioners to overcome perceived educational and training barriers. The authors describe the design and development of two unique clinical skill development programs at the University of Illinois at Chicago. This paper also outlines the patient focused services that the participants have established upon completing the training. These programs successfully enhanced participants' therapeutic knowledge base and facilitated development of the clinical skills necessary for direct patient care.

Clinical Competence↗
PubMed2002

Do pharmaceutical prices respond to potential patient out-of-pocket expenses?

Despite the importance of patient insurance in the market for prescription pharmaceuticals, little is known about the impact of patient reimbursement on the pricing behavior of pharmaceutical firms. I examine the link between potential patient out-of-pocket expenses and pharmaceutical pricing using a unique policy experiment from Germany. Starting in 1989, a maximum reimbursement for a given medicine replaced a flat prescription fee. This change in reimbursement exposes the patient to the price of a prescribed product. Using a product-level panel data set covering several therapeutic categories before and after the policy change, I find that producers significantly decrease prices after the change in potential patient out-of-pocket expenses. Price declines are most pronounced for brand-name products. Moreover, branded products that face more generic competitors reduce prices more.

Drug Costs↗
PubMed1994

The cost of schizophrenia.

In 1988, the management of mental illness in the United States cost an estimated $129.3 billion which comprises direct costs (hospital/institution costs, health care provider fees, prescription drugs), indirect costs (reduced/lost productivity due to morbidity or mortality) and other costs including productivity of family caregivers. The largest mental health care expenditure is for schizophrenia due to the high prevalence of this illness, early age of onset, and pattern of chronicity. This paper reviews three aspects of the care of schizophrenia that have an impact on cost: 1. prevention of relapse; 2. provision of community care; and 3. use of new antipsychotic medications. Better compliance, community-based care incorporating clinical case management and improved treatments can be expected to lower costs while improving the quality of life and social functioning of patients.

Antipsychotic Agents↗
PubMed2004

Effects of prescription drug user fees on drug and health services use and on health status in vulnerable populations: a systematic review of the evidence.

Rising pharmaceutical expenditures have led to the use of cost-sharing measures. The authors undertook a systematic review of the effects of cost sharing on vulnerable populations (the poor and those with chronic illnesses). Virtually every article reviewed supports the view that cost sharing decreases the use of prescription drugs in these populations. Copayments or a cap on the monthly number of subsidized prescriptions lower drug costs for the payer, but any savings may be offset by increases in other health care areas. Cost sharing also leads to patients foregoing essential medications and to a decline in health care status.

Chronic Disease↗
PubMed1984

Prescription pricing across Canada (Part II).

The first of a two part article entitled "Prescription Pricing Across Canada" appeared in the June issue of CPJ. The article was prompted by recent press reports of a prescription drug study commissioned by the Saskatchewan government, and the consequent attention-getting headlines. The first article dealt with the Western provinces. The second part discusses prescription pricing in Ontario, Québec, New Brunswick, Nova Scotia, Prince Edward Island, Newfoundland, and the Northwest Territories.

Canada↗
PubMed2001

The effects of different kinds of user fee on prescribing costs in rural Nepal.

OBJECTIVES: (1) To estimate the cost of irrational prescribing, and (2) to compare the effect of three different kinds of user fee on prescribing costs, in rural Nepal. METHODS: A controlled before-after study was conducted in 33 government primary health care facilities in rural eastern Nepal during 1992-95. A fee per prescription (covering all drugs in whatever amounts) was regarded as the control against which two types of fee per drug item (covering a full course of treatment for each item) were compared. The average total cost to the patient for two drug items was the same in all fee systems. Total cost, expected cost (according to standard treatment guidelines) and wastage costs (total minus expected cost) per prescription were calculated from an average of 400 prescribing episodes per facility per year. The proportion of prescriptions conforming to standard treatment guidelines was calculated from 30 prescriptions per facility per year. RESULTS: 20-52% of total drug costs were due to inappropriate drug prescription. A fee per drug item, as compared with a fee per prescription, was associated with (1) significantly fewer drug items prescribed per patient, (2) significantly lower drug costs per prescription, (3) significantly lower wastage due to inappropriate drug prescription, and (4) a significantly greater proportion of prescriptions conforming to standard treatment guidelines. Average drug cost per prescription (which was 24-33 Nepali rupees [NRs] across districts and time) was 5.7 NRs (95% confidence interval 1.0 to 10.4) and 9.3 NRs (95% confidence interval 4.8 to 13.8) less with the two different item fees, respectively, than with the fee per prescription. CONCLUSION: The economic consequences of irrational prescribing are severe, particularly in association with charging a fee per prescription. Item fees in the public sector reduce irrational prescribing and associated costs.

Drug Costs↗