Are acute infusion reactions after rituximab underreported?

Background: Rigorous premarketing trials may fail to capture safety issues associated with new drugs. This is more likely to happen in case of biopharmaceuticals. We take the case of rituximab, and anti CD20 monoclonal antibody, which was the first monoclonal antibody to get approval. This open label observational study was done with the objective of estimating the incidence of acute infusion reaction associated with rituximab infusion.Methods: The study population consisted of patients hospitalized for receiving rituximab, in day care centre(s) of a tertiary care hospital. Number and type of acute infusion reactions (AIR) were recorded on a case record form along with patient characteristics and medical history.Results: A total of 50 infusions were observed and all infusions were followed by at least one AIR. Total 71 AIRs were recorded among these 50 infusions (1.4 AIR per infusion). Non-Hodgkin’s lymphoma was the commonest indication for which patients were receiving rituximab. In a subset analysis, incidence of AIR was statistically lower in patients having received corticosteroids as premedication. However, brand of rituximab, gender of the patient and first or second cycle had no bearing on incidence of AIRs.Conclusions: AIRs are more common in real time clinical settings than what is reported. There is a need to formulate appropriate risk management plan depending on post marketing clinical data. Use of corticosteroids as premedication may be one such strategy. New drugs, esp biopharmaceuticals, may have unidentified/under reported safety issues and there is a need to undertake focussed pharmacovigilance endeavours to unravel them.

Objective assessment of handwriting in outpatient prescriptions of a tertiary care hospital

Background: Poor physician handwriting may lead to wrong comprehension and dispensing errors. This study was planned to objectively assess the quality of handwriting of doctors and their readability by physician, pharmacist and patient and to explore the impact of experience and familiarity of pharmacist on prescription readability.Methods: A 100 prescriptions were selected and were given to a pharmacist, a doctor and an educated lay person. They rated the readability of prescriptions on a scale of 1-10 and an average readability score was calculated. Prescriptions with average score 4 or less were subjected to analysis by a pharmacist working at the hospital dispensary (P1) and another pharmacist not working at hospital pharmacy (P2).Results: Average score of pharmacist, physician and lay person was 6.14, 5.2 and 3.14 respectively. A total of 28 prescriptions, containing 93 medicines, had an average readability score of 4 or less. P1 was not able to comprehend one medicine while P2 could not comprehend 19 medicines out of these 93. The performance of both pharmacists was compared by diagnostic tests (EPI 6.04D). The sensitivity of P2 was 80% (95% CI 70.6-87.7), specificity and positive predictive value were 100, and negative predictive value was 5.3 (0.3-28.1).Conclusions: Familiarity of the pharmacist with the prescribing physicians’ handwriting is an important factor in comprehension of poorly legible prescriptions. This could limit the patients to pharmacists around the prescribers. Implementation of appropriate steps need to be assured to minimize the prescription errors.

Netarsudil: a novel intra-ocular pressure lowering agent

Optic disc health is an important indicator of visual functions. The first line of management to prevent/halt the damage to optic disc is to control responsible pathological condition, if identified. In absence of identifiable cause, the most validated approach is lowering of intra-ocular pressure (IOP). Individually, as well as combinations of currently available drugs are not fully effective in all patients of glaucoma in achieving desired IOP control. Hence, there is a need of newer alternatives which address this unmet need. Recently, a newer IOP lowering agent with a novel mechanism of action, netarsudil, has been approved by United States Food and Drug Administration (US-FDA) in December 2017. Netarsudil acts by inhibiting Rho-associated protein kinase resulting in lowering of overall tone of the contractible cells in trabecular meshwork thereby improving drainage of aqueous humor outflow and lowering of IOP. Though in its early days, this drug gives an armamentarium to ophthalmologists and physicians to control IOP in patients of open-angle glaucoma and ocular hypertension.