Clinical pharmacology in developing countries.
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AIMS: Prescribing drugs is a key responsibility of a doctor and requires a solid grounding in the relevant scientific disciplines of pharmacology and therapeutics (PT). The move away from basic science disciplines towards a more system-based and integrated undergraduate curriculum has created difficulties in the delivery of PT teaching in some medical schools. We aimed to develop a web-based strategy to overcome these problems and improve the PT learning experience. METHODS: We designed and introduced 'eDrug', a dynamic interactive web-based student formulary, as an aid to teaching and learning of PT throughout a 5-year integrated medical curriculum in a UK medical school of 1300 students. This was followed by a prospective observational study of student-reported views about its impact on their PT learning experience. RESULTS: eDrug was rated highly by students and staff, with the main benefits being increased visibility of PT in the curriculum, clear identification of core drugs, regular sourcing of drug information via direct links to accredited sources including the British National Formulary, prioritization of learning, immediate access and responsiveness. It has also served as a focus of discussion concerning core PT learning objectives amongst staff and students. CONCLUSIONS: Web-based delivery of PT learning objectives actively supports learning within an integrated curriculum.
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BACKGROUND: Nurse prescribing has advanced rapidly over the previous decade and is clearly on the agenda for the future. Previous research considers nurse prescribing from the patient's perspective, the medical professions' stance and the legal and ethical implications. However, there is a paucity of literature that explores the experiences of nurse prescribers' within their current role. These experiences need investigating to ensure nurse prescribing is able to advance in ways that provide benefit to nurses and thus provides the impetus for the study. AIM: To explore and review nurse prescribers' experiences of prescribing. DESIGN METHODS: A purposeful sample of seven nurse prescribers currently prescribing within a West Midlands Community Trust underwent minimally structured interviews in this qualitative study. Transcribed interviews were analyzed using thematic analysis. FINDINGS: Four themes were generated from analysis of the interviews, 'patient centred care', 'benefits of nurse prescribing', 'support and role satisfaction' and finally 'prescribing difficulties'. CONCLUSIONS: Nurse prescribers' perceive prescribing as a predominantly positive experience, frequently asserting the advantages that prescribing saves the patient and nurse time, is more convenient for the patient and increases the nurses' autonomy and role satisfaction. However, negative experiences of restrictions to practice as a result of nurse prescribers' formulary limitations and duplication of documentation were also described. RELEVANCE TO CLINICAL PRACTICE: Nurse prescribing is a rapidly evolving area of practice with the potential to advance nursing roles. This research aims to provide an insight into the experiences of current nurse prescribers that may then be disseminated and applied to future practice.
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A joint drug formulary covering both hospital and general practice prescribing has been in existence in Grampian since 1990. The aims of this study were to measure adherence to this formulary in general practice and to identify who had initiated non-formulary drugs. The drug therapy of elderly patients on presentation to hospital was compared to the formulary. Of the 449 drugs prescribed 377 (84%) were recommended in the formulary. The main areas of non-formulary prescribing were antidepressants, hypnotics, nitrates and diuretics, with some non-formulary drugs being initiated by hospital prescribers. The method described was found to be extremely simple and had the advantage that it reflected actual prescribing at the time of the study.
The pharmacokinetic properties of four erythromycin formulations were compared in six adult horses after administration of single and multiple oral doses. Formulations of erythromycin administered were estolate and phosphate given 37.5 mg/kg every 12 h and 25 mg/kg every 8 h, and stearate and ethylsuccinate given 25 mg/kg every 8 h. Areas under the curve (AUC) and maximum plasma erythromycin concentrations (Cmax) were equal or greater (P > or = 0.05) following administration of erythromycin phosphate and stearate compared with those values following administration of erythromycin estolate or ethylsuccinate. In comparing an 8 h vs. a 12 h dosage interval for multiple doses of erythromycin phosphate or estolate, there were no significant differences observed in AUC(24-28 h), peak-trough plasma concentrations or duration that plasma concentrations exceeded the minimal inhibitory concentration (MIC) for Rhodococcus equi. Comparisons of pharmacokinetic parameters between single and multiple doses were made for each formulation. Differences in Cmax, tmax, or t1/2 beta between single and multiple doses were demonstrated for erythromycin ethylsuccinate and estolate. Based on equivalent plasma antibiotic concentrations, erythromycin phosphate or stearate could be substituted for estolate in the treatment of Rhodococcus equi pneumonia. Furthermore, there was no advantage of an 8-h interval, compared with an interval of 12 h.
OBJECTIVES: This randomized, open-label trial was designed to help inform antipsychotic treatment policies. It compared the 1-year cost-effectiveness of initial treatment with olanzapine (OLZ) (n = 229) versus a "fail-first" algorithm on conventional antipsychotics (then olanzapine if indicated) (CON) (n = 214); and versus initial treatment with risperidone (RIS) (n = 221). METHODS: Individuals with schizophrenia or schizoaffective disorder were recruited from May 1998 to September 2001. Clinical, functioning, and resource utilization data were collected at baseline and five postbaseline visits. Brief Psychiatric Rating Scale scores defined "clinical effectiveness;" Lehman Quality of Life Scale social relations scores defined "social effectiveness." RESULTS: Requiring failure on less expensive antipsychotics before use of olanzapine did not result in total cost savings, despite significantly higher antipsychotic costs with OLZ. Total 1-year mean costs were 21,283 dollars for CON; 20,891 dollars for OLZ; and 21,347 dollars for RIS (pair-wise comparisons nonsignificant). Intent-to-treat effectiveness comparisons (nonsignificant) were augmented by analyses that adjusted for duration on initial antipsychotic treatment, and by comparisons of patients remaining on initial antipsychotic treatment versus those who required switching. When accounting for differential switching rates (OLZ 0.14 vs. CON 0.53, P < 0.0001; vs. RIS 0.31, P < 0.0001), OLZ was significantly more effective than CON on clinical (P = 0.025) and social (P = 0.043) measures, and significantly more effective than RIS on the social (P = 0.002) measure. Further, patients initiated on an antipsychotic from which they needed to switch required additional resources for hospitalization (P = 0.036) and crisis services (P = 0.029). CONCLUSIONS: Approaches that integrate costs, effectiveness, and treatment patterns are important for providing optimal information regarding the value of first-line antipsychotic options for schizophrenia.
OBJECTIVE: Timely access to necessary medicines that Australians need is one of the four pillars of the Australian Government's National Medicines Policy. We were interested to determine whether there was a change in the time taken for medicines to be listed once recommended by the Pharmaceutical Benefits Advisory Committee (PBAC). METHODS: Descriptive statistics were used to show the pattern of recommendations for PBAC meetings from 1999 to 2003. For successful recommendations, we developed a linear regression model to analyze the time to list from the PBAC meeting to date of listing (time to list). The model determined whether this time had changed over the 4-year period, and the reasons for any changes. RESULTS: The PBAC made 307 positive recommendations at its 17 meetings over the study period. Ninety percent resulted in a Pharmaceutical Benefits Scheme (PBS) listing on or before April 1, 2005. Eighty-two percent of the recommendations made in 1999 and 2000 resulted in early or on-time listings. In 2001, 2002, and 2003, the comparable proportions were 67%, 68%, and 75%. Mean times to list for the years from 1999 to 2003 were similar (approximately 23 weeks), except in 2001 where it was 30 weeks. CONCLUSIONS: Over the study period, 90% of all PBAC recommendations resulted in a PBS listing. In 2001 there was a statistically significant increase in the mean time to list. In addition, it appears that recommendations for new listings and new indications (medicines that are likely to result in substantial Government expenditure) were associated with a longer time to list.
OBJECTIVES: The principal aim of this study was to illustrate applying discrete-choice methods for eliciting preferences for technology adoption criteria, including threshold values for cost-effectiveness ratios. A secondary objective was to compare the criteria weights of a sample of industry stakeholders with the results obtained from a study of National Institute for Health and Clinical Excellence (NICE) recommendations. METHODS: We administered a two-stage stated-preference (SP) question format to a sample of respondents who have expertise in applying economic analysis to technology adoption decisions. We elicited paired comparisons and recommendation judgments for similar criteria from a sample of International Society for Pharmacoeconomics and Outcomes Research members. Respondents evaluated nine pairs of hypothetical drugs, first indicating which drug was "better," then indicating what they would recommend to a reimbursement authority such as the National Health Service. Stated-choice studies often obtain only paired-comparison judgments. RESULTS: Parameter estimates from the initial paired-comparison question indicate only incremental cost-effectiveness ratio and number of affected patients influence evaluations. These two factors have identical weights in the second recommendation question, but all four factors were considered in determining the recommendation threshold. Our sample was more willing than NICE to accept trade-offs between cost-effectiveness and other drug features and was less concerned about cost-effectiveness ratios and information uncertainty. Nevertheless, our sample was in agreement with NICE about the importance of the number of patients who would benefit as a criterion for influencing adoption recommendations. CONCLUSION: This study demonstrates that including a question allowing respondents the opportunity to reject both alternatives in a forced-choice paired comparison can be important for obtaining accurate preference estimates. Our results demonstrate that SP methods offer a feasible means of quantifying a broad set of valuations that incorporate the preferences of patient, citizen, payer, and other stakeholder groups.
OBJECTIVE: To determine factors that influence patient willingness to accept a medication change to a unified, restrictive formulary. DESIGN: Prospective cohort study. SETTING: University-affiliated hospital-based primary care internal medicine practice. PATIENTS/PARTICIPANTS: Two hundred ninety-seven members of a managed care plan who had received a prescription for a nonformulary medication in the previous 4 months and whose primary care physician approved a conversion to a formulary medication. INTERVENTIONS: Clinical nurses invited patients to change to a formulary medication at the time of a telephone refill request based on a standard script. MEASUREMENTS AND MAIN RESULTS: The overall conversion rate to the formulary medication was 59.8%. Seventy-four percent of patients who requested a refill by telephone converted to the formulary (odds ratio [OR], 2.24; 95% confidence interval [CI], 1.02 to 4.72). Patient age (OR, 1.03; CI, 1.01 to 1.05) and male gender (OR, 2.00; CI, 1.09 to 3.67) were each significant correlates of conversion. After adjustment in a multivariable model, only telephone refill request (adjusted OR, 2.31; CI, 1.07 to 4.97) and age (adjusted OR, 1.03; CI, 1.01 to 1.06) remained significant. Among the patients who made a telephone refill request, those who converted were more likely to completely trust their physician's judgment (P=.04) and to trust their physician to put their health over cost concerns (P=.05). Formulary conversion reduced costs beginning 3 months after the conversion date. CONCLUSIONS: A protocol for encouraging conversion to a unified formulary at the point of a telephone refill request increases formulary compliance rates and reduces medication costs. Patients who decline to convert medications are less likely to trust their physician.
During congressional debate over the Medicare Part D prescription drug benefit, much attention was focused on nominal benefit design. Relatively little attention was paid to details about how plans would operate, such as the design of drug formularies. Yet, formularies will be important tools for controlling costs, and may be as important as nominal benefit design in determining enrollees' access to medications and out-of-pocket costs. We describe Part D plan incentives and how they may influence formulary design, and then provide recommendations for Part D formulary implementation. We encourage the Centers for Medicare & Medicaid Services (CMS) to develop standardized tools to provide physicians and patients with up-to-date and easily accessible information about covered drugs on each plan's formulary (perhaps via a central website) and a national set of easy-to-follow procedures for reconsideration and appeals. Such efforts should reduce administrative burden and better allow physicians to help patients obtain needed medications.
BACKGROUND: Incentive-based formularies have been widely instituted to control the rising costs of prescription drugs. To work properly, such formularies depend on patients to be aware of financial incentives and communicate their cost preferences with prescribing physicians. The impact of financial incentives on patient awareness of and communication about those costs is unknown. OBJECTIVE: To evaluate the relationship between enrollment in incentive-based pharmacy benefit plans and awareness of out-of-pocket costs and rates of communication about out-of-pocket costs. DESIGN: A matched telephone survey of patients and their primary care physicians. SETTING: Los Angeles County. PARTICIPANTS: One thousand nine hundred and seventeen patients aged 53 to 82 (73% response rate). MEASUREMENTS: Patient-reported pharmacy benefit design, knowledge of out-of-pocket costs, and discussion of out-of-pocket costs with physicians. RESULTS: Sixty-two percent of patients who had prescription drug coverage and were aware of their pharmacy benefit design reported being enrolled in incentive-based plans. The majority of these (54%) were "never" or only "sometimes" aware of their out-of-pocket cost requirements at the time of the physician visit. After controlling for numerous physician and patient level variables, we found that patients enrolled in pharmacy benefit designs requiring no copayments were more likely to report they "never" discuss out-of-pocket costs with physicians compared with patients enrolled in incentive-based pharmacy benefit designs (81% vs 67%, P=.001) and patients with no prescription drug insurance (57%, P<.001). CONCLUSIONS: Incentive-based pharmacy benefit plans and lack of insurance are associated with increased rates of discussions about out-of-pocket costs. Nonetheless, most incentive-based enrollees are unaware of out-of-pocket costs when prescriptions are written and never discuss out-of-pocket costs with their physicians, likely mitigating the effectiveness of financial incentives to guide decision making. Considering that out-of-pocket costs are associated with adherence to medical therapy, interventions to improve patient access to out-of-pocket cost information and the frequency of patient-physician discussions about costs are needed.
The prevalence of diabetes in the U.S. Medicare population is growing at an alarming rate. From 1980 to 2004, the number of people aged 65 or older with diagnosed diabetes increased from 2.3 million to 5.8 million. According to the Centers for Medicare and Medicaid (CMS), 32% of Medicare spending is attributed to the diabetes population. Since its inception, Medicare has expanded medical coverage of monitoring devices, screening tests and visits, educational efforts, and preventive medical services for its diabetic enrollees. However, oral antidiabetic agents and insulin were excluded from reimbursement. In 2003, Congress passed the Medicare Modernization Act that includes a drug benefit to be administered either through Medicare Advantage drug plans or privately sponsored prescription drug plans for implementation in January 2006. In this article we highlight key patient and drug plan characteristics and resources that providers may focus upon to assist their patients choose a coverage plan. Using a case example, we illustrate the variable financial impact the adoption of Medicare part D may have on beneficiaries with diabetes due to their economic status. We further discuss the potential consequences the legislation will have on diabetic patients enrolled in Medicare, their providers, prescribing strategies, and the diabetes market.
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The recent publication of drug formularies by third-party payers has serious implications for the practice of medicine. These formularies list the medications for which the consumer can be reimbursed by the third-party payer. The most restrictive of the five formularies I have received lists only two agents for the treatment of migraine headaches: Cafergot (at an incorrect dose of 1/100 mg) and Ergotrate which is no longer available. The most liberal of the formularies lists analgesics, Cafergot, Midrin, and Imitrex for the treatment of acute attacks, and as prophylactic agents, Inderal, Sansert, and analgesics (known to cause rebound headaches when used in this fashion in migraine patients). Abortive agents of proven value, such as DHE-45 and NSAIDs, and preventative medications, such as calcium channel blockers, tricyclic antidepressants, serotonin reuptake inhibitors, methylergonovine, and divalproex sodium, are not available. No one could quarrel with a goal of developing a cost-effective formulary. However, the authors of these formularies have clearly demonstrated their inability to provide even a current, accurate, and adequate formulary by existent standards of care in the treatment of migraine headache. While it is easy to criticize these formularies, it is more difficult to develop a comprehensive list that would satisfy the practitioners' need to provide relief for their patients with a minimum of side effects, and the needs of third-party payers (presumed) to provide quality care at the most economical level.