Is propranolol compounding from tablet safe for pediatric use? Results from an experimental test.

AIM: Although propranolol is widely used in the treatment of infantile hemangiomas, the standard 40 mg tablet needs to be fractioned to obtain 10 mg parts, with even lower doses (i.e., 2-3 mg/kg/day divided into 2-3 daily doses) required in infants. This study evaluated the weight and dose uniformity in split quarters of propranolol tablets. METHODS: Twenty pharmacy students split 70 propranolol tablets by using a kitchen knife in order to obtain 200 quarters, which were considered integral and adequate for administration. Intact tablets and quarters were weighed. The content of propranolol in tablet quarters was determined on 200 quarters by using high performance liquid chromatography. RESULTS: Overall, 265 parts (94.6%) were integral and 213 (76.1%) were considered as adequate for administration. The mean (± standard deviation) weight of quarters judged as suitable and non-suitable for administration was 49.56 ± 5.27 mg and 46.24 ± 7.53 mg, respectively. Splitting caused a mean weight loss in each tablet of 2.97 ± 2.91 mg (median 2.06 mg). The percentage of quarters with weight lower than theoretical was 55.88%, and the remaining weighted more than expected. The mean propranolol content in quarters was 9.52 ± 0.96 mg (median 9.42 mg, range 7.36-12.23 mg) and 42% of quarters were out of the ± 10% acceptance range. CONCLUSION: The manual splitting of propranolol 40 mg tablets produced a significant proportion of quarters not suitable for administration in children or with a weight and/or an active concentration outside of the required range. The availability of a pediatric oral solution of propranolol will reduce the risk of incorrect dosing.

Costs of therapy with biologics in the treatment of moderate to severe plaque psoriasis in the context of the Italian health-care system.

AIM: Biologics were introduced as innovative and effective therapies for the treatment of moderate-to severe psoriasis. However, in the Italian context there are no comparative cost-effectiveness analyses of all biologics currently approved for psoriasis by the European Medicines Agency (EMA). This study estimates whether the cost of ustekinumab (meant as cost of drug therapies and monitoring) is lower, similar to or higher than that of anti-TNF-α. METHODS: The incremental cost-effectiveness ratio (ICER) and the cost-effectiveness ratio (CER) in terms of cost for patients achieving 75% improvement in PASI (PASI 75) were calculated. The analysis, both during the first 52 weeks, including induction and in maintenance period is based on efficacy data taken from single studies. The costs, based on official source, are calculated in the perspective of National Health Service (SSN). RESULTS: Ustekinumab has the lowest cost for responder, resulting always cost-effective and, in some case, cost saving in the baseline scenario at 52 weeks and in maintenance period. CONCLUSION: Ustekinumab seems to be the most favorable biologic in term of cost per PASI 75 responder for the treatment of psoriasis and it is cost-effective in all scenarios analyzed. Further cost-effectiveness evaluations based on data of use of long-term treatment with biologics in clinical practice, are necessary to support this results.