Safety and immunogenicity of 2009 pandemic H1N1 influenza vaccination in perinatally HIV-1-infected children, adolescents, and young adults.

BACKGROUND: The safety and immunogenicity of high-dose pandemic H1N1 (pH1N1) vaccination in perinatally human immunodeficiency virus type 1 (HIV-1)-infected children, adolescents, and young adults are unknown. METHODS: Two 30-µg doses of 2009 Novartis pH1N1 monovalent vaccine (Fluvirin) were administered 21-28 days apart to perinatally HIV-1-infected children, adolescents, and young adults. Antibodies were measured by hemagglutination inhibition (HAI) assay at baseline, 21-28 days after first vaccination, 7-13 days after the second vaccination, and 7 months after the first vaccination. RESULTS: Among the 155 participants, 54 were aged 4-8 years, 51 were aged 9-17 years, and 50 were aged 18-24 years. After 2 doses of Fluvirin, seroresponse (≥ 4-fold rise in HAI titers) was demonstrated in 79.6%, 84.8%, and 83% of participants in the aforementioned age groups, respectively, and seroprotection (HAI titers ≥ 40) was shown in 79.6%, 82.6%, and 85.1%, respectively. Of those lacking seroresponse (n = 43) or seroprotection (n = 37) after the first vaccination, 46.5% and 40.5% achieved seroresponse or seroprotection, respectively, after the second vaccination. Among participants who lacked seroprotection at entry, a "complete response" (both seroresponse and seroprotection) after first vaccination was associated with higher baseline log(10) HAI titer and non-Hispanic ethnicity. No serious vaccine-related events occurred. CONCLUSION: Two doses of double-strength pH1N1 vaccine are safe and immunogenic and may provide improved protection against influenza in perinatally HIV-1-infected children and youth. CLINICAL TRIALS REGISTRATION: NCT00992836.

Evaluation of board certification in nutrition support pharmacy.

BACKGROUND: Credentialing of healthcare professionals is a topic that has received increasing attention. The Board of Pharmaceutical Specialties (BPS) has recognized nutrition support pharmacy as a specialty for more than 10 years. There has recently been concern about the decline in the number of pharmacists seeking board certification or recertification as specialists in nutrition support and changes in the job responsibilities of nutrition support pharmacists. These factors have resulted in a need to evaluate the current system of certification of nutrition support pharmacists. METHODS: A national survey was developed and sent to pharmacist members of the American Society for Parenteral and Enteral Nutrition (A.S.P.E.N.) and members of the Home Care Section of the American Society of Health-System Pharmacists (ASHP). The objectives of this study were to describe the activities of nutrition support pharmacists, determine the benefits and barriers to board certification, and assess the current system of certification. RESULTS: Two hundred and fifty-eight of 486 surveys were returned for an overall response rate of 53%. There has been a decrease in the amount of professional time devoted to nutrition support activities. The most highly ranked benefit to certification was peer recognition. The most highly ranked barrier to certification was the examination cost. CONCLUSIONS: There is satisfaction with the current system; however, alternative methods were supported if the current method cannot sustain itself There is a need to evaluate the cost of the examination and increase marketing efforts to candidates for whom the examination is intended.

Clevidipine: a new intravenous option for the management of acute hypertension.

PURPOSE: The pharmacology, pharmacokinetics, efficacy, safety, dosage and administration, and place in therapy of clevidipine are reviewed. SUMMARY: Clevidipine is a new lipophilic, short-acting, third-generation dihydropyridine calcium channel blocker (CCB) approved for use in the management of acute hypertension when oral agents are not feasible. It exerts its hemodynamic effects through selective arterial vasodilation without effects on the venous circulation. Clevidipine has a half-life of approximately two minutes after i.v. administration, resulting in very rapid onset and offset of antihypertensive action. Unlike many current i.v. antihypertensive agents that are metabolized by the kidneys or liver, clevidipine is metabolized in the blood and tissues and does not accumulate in the body. Clevidipine does not appear to inhibit or induce cytochrome P-450 isoenzymes. Several Phase III clinical trials have reported the clinical efficacy and safety of clevidipine in patients with severe hypertension and in cardiac surgical patients with perioperative hypertension. The most frequent adverse events reported in clinical trials of clevidipine were headache, nausea, and vomiting. Risk of rebound hypertension, especially in patients not transitioned from clevidipine to oral antihypertensive therapy after prolonged infusions, should be monitored for at least eight hours after the drug is discontinued. CONCLUSION: Clevidipine, a novel third-generation dihydropyridine CCB, has demonstrated efficacy and safety in patients with acute hypertension and preoperative, perioperative, and postoperative hypertension. While its short duration of action and short half-life are appropriate for use in acute settings, more information on its safety is needed to assess its appropriate use in therapy.