A global perspective on managed care and pharmacy education.
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Australia↗
Biomedical subjects
Jack E Fincham
Publications and source records attributed to Jack E Fincham.
Professional negligence: when practice goes wrong.
OBJECTIVE: To review the practice and legal principles of negligence law. CASE SUMMARY: An illustrative, fictional case is presented, based in part on facts gleaned from actual case law. A respected pharmacist, faced with the financial loss of his business, decided to engage in 2 creative but unethical schemes to increase his profit margin. In doing so, he violated federal Medicare law and placed a number of the patients who used his services at significant risk for medical complications. DISCUSSION: Negligence law has evolved over the past 30 years in a manner that significantly increases the liability of the practicing pharmacist for both ordinary negligence actions and criminal negligence actions. In addition, the past decade has seen the expansion of Medicare Fraud and Abuse law such that it now represents an increasingly high risk area for every medical service provider, including the pharmacist. CONCLUSIONS: Professional practice in the US is highly regulated, governed by both case law and statutory law. Every practicing pharmacist should be aware of the law that governs his or her behavior to avoid both civil and criminal liability.
Fraud↗
Global public health and the academy.
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Global Health↗
Off-label use of antidepressant, anticonvulsant, and antipsychotic medications among Georgia medicaid enrollees in 2001.
OBJECTIVES: To determine the prevalence of and factors associated with the off-label use of antidepressant, anticonvulsant, and antipsychotic medications. METHOD: A retrospective analysis of Georgia Medicaid recipients was conducted. Recipients prescribed antidepressant, anticonvulsant, or antipsychotic medications were identified. Logistic regression analysis was used to identify factors associated with off-label use. RESULTS: A total of 46,976 (75.42%) antidepressant recipients, 38,497 (80.12%) anticonvulsant recipients, and 21,252 (63.62%) antipsychotic recipients received at least 1 of these medications off-label in 2001. The likelihood of receiving off-label medications increased remarkably with advancing age (>or= 65 vs. < 65 years: antidepressant: OR = 5.15, 95% CI = 4.76 to 5.56; anticonvulsant: OR = 4.54, 95% CI = 4.16 to 4.96; antipsychotic: OR = 5.21, 95% CI = 4.82 to 5.63). Although receiving new anticonvulsants launched after 1993 was the strongest predictor (OR = 7.63, 95% CI = 7.07 to 8.23) of receiving off-label anticonvulsant medications, exposure to newer antidepressants and antipsychotics did not confer a higher chance of receiving off-label medications (selective serotonin reuptake inhibitors vs. tricyclic antidepressants: OR = 0.43, 95% CI = 0.40 to 0.45; atypical vs. conventional antipsychotics: OR = 0.76, 95% CI = 0.72 to 0.80). CONCLUSIONS: The off-label use of antidepressant, anticonvulsant, and antipsychotic medications is highly prevalent. Further research to study the effects of off-label use among this high risk subpopulation may be an important step toward defining the scope of and potential for such use.
Adolescent↗
Phosphodiesterase 5 inhibitors for erectile dysfunction.
OBJECTIVE: To review the pharmacologic and clinical trial data of the Food and Drug Administration-approved phosphodiesterase 5 (PDE5) inhibitors for the treatment of erectile dysfunction (ED). DATA SOURCES: Primary research and review articles were identified through a search of ScienceDirect, PubMed/MEDLINE, and International Pharmaceutical Abstracts (1990-August 2004). The following search terms were used in the Medicine Dentistry and Pharmacology, Toxicology, and Pharmaceutical Sciences subcategories: phosphodiesterase 5 inhibitor, PDE5 inhibitor, erectile dysfunction, sildenafil, vardenafil, tadalafil, prostatectomy, and diabetes. Web of Science (1990-August 2004) was used to search for additional abstracts using the same search terms as above. The package inserts for sildenafil, vardenafil, and tadalafil were also consulted. STUDY SELECTION AND DATA EXTRACTION: All identified research, review articles, and abstracts were assessed for relevance, and all relevant information was included. Priority was given to the primary medical literature and clinical trial reports. DATA SYNTHESIS: ED is a common disorder in males with increased prevalence associated with age and presence of cardiovascular disease, prostatectomy, or diabetes mellitus. Sildenafil, vardenafil, and tadalafil are selective PDE5 inhibitors currently available for treatment of ED. Their pharmacology and pharmacokinetics vary slightly, but with potentially important clinical differences in duration of activity; all have similar clinical efficacy and adverse effect profiles in patients with ED of various causes. CONCLUSIONS: Sildenafil, vardenafil, and tadalafil are safe and effective PDE5 inhibitors for the treatment of ED.
3',5'-Cyclic-GMP Phosphodiesterases↗
Over-the-counter availability of Plan B emergency contraception: further discussion and commentary.
The controversy surrounding the potential switch of the Plan B emergency contraceptive therapy from prescription to over-the-counter status has been unprecedented. Regulatory, professional, and societal aspects of this issue have been discussed recently and will no doubt continue to be debated. In this editorial, members of the Medicine, Law, and Ethics panel of The Annals of Pharmacotherapy's Editorial Board offer a sampling of viewpoints touching on varying aspects of the controversy. Readers may wish to consider the ramifications of their professional decisions in this and similar situations in advance of having to make such decisions.
Contraceptives, Postcoital↗
Patterns of ACE inhibitor use in elderly medicaid patients with heart failure.
The authors identified 321 elderly Kansas Medicaid patients with congestive heart failure and examined angiotensin-converting enzyme (ACE) inhibitor use. Using retrospective claims data, ACE inhibitor use was quantified and daily doses compared to a target enalapril-equivalent dose of 20 mg. The cohort patients averaged 80 years of age, 84% were female, and 70% resided primarily in a nursing home. Only 37.8% received an ACE inhibitor. Users were younger than nonusers (t=2.00; p=0.046), but there was no gender difference (odds ratio [OR], 1.4; 95% confidence interval [CI], 0.73, 2.6). ACE inhibitor users averaged eight prescriptions annually, providing approximately 257 medication days (70% of the study period). The average enalapril-equivalent daily dose was 10.6 mg, and only 22% received the target dose. Nursing home residents were less likely to receive an ACE inhibitor than ambulatory patients (OR, 0.55; 95% CI, 0.34, 0.89) but equally likely to receive target doses (OR, 1.3; 95% CI, 0.34, 4.9). ACE inhibitor use in the Kansas Medicaid congestive heart failure population is not consistent with practice guidelines, particularly among older and/or nursing home patients.
Adult↗