International Journal of Risk & Safety in Medicine - Volume 27, issue 3
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The International Journal of Risk and Safety in Medicine is concerned with rendering the practice of medicine as safe as it can be; that involves promoting the highest possible quality of care, but also examining how those risks which are inevitable can be contained and managed.
This is not exclusively a drugs journal. Recently it was decided to include in the subtitle of the journal three items to better indicate the scope of the journal, i.e. patient safety, pharmacovigilance and liability and the Editorial Board was adjusted accordingly. For each of these sections an Associate Editor was invited. We especially want to emphasize patient safety. Our journal wants to publish high quality interdisciplinary papers related to patient safety, not the ones for domain specialists. For quite some time we have also been devoting some pages in every issue to what we simply call WHO news. This affinity with WHO underlines both the International character of the journal and the subject matter we want to cover. Basic research, reports of clinical experience and overviews will all be considered for publication, but since major reviews of the literature are often written at the invitation of the Editorial Board it is generally advisable to consult with the Editor in advance. Submission of news items will be appreciated, as will be the contribution of letters on topics which have been dealt with in the journal.
Abstract: BACKGROUND: There is paucity of data regarding the use of off-label (OL) and unlicensed drug (UL) use in children admitted to the Pediatric Intensive Care Units (PICUs). OBJECTIVE: To determine prevalence of OL- and UL-drug use in children admitted to PICU. DESIGN: Prospective observational study. SETTING: PICU in Mumbai (formerly Bombay), India. PARTICIPANTS: Consecutive patients aged 28 d-12 yr admitted over 12-mo period. METHODS: Prescriptions issued to PICU patients were surveyed and demographic data, diagnosis and details of drugs used (dose, frequency, route…of administration, indication, and UL use) were noted. Descriptive statistics was used for providing prevalence of OL drug (including category) and UL use. Fisher-Pearson test was used to determine the significance of age, mechanical ventilation and number of systems involved with reference to OL- and UL-drug use. RESULTS: 482 participants received 1789 [OL: 738(41.25%) and UL: 376(21.01%)] drug prescriptions; OL-drug use was highest in infants (56.52%) with indication outside the license (32.37%) being the commonest category of OL-drug use across all age-groups. Unlicensed drug use was entirely due to extemporaneously-prepared drug (EPD) use. The OL drug- and EPD-use were significantly associated with infancy and ventilation therapy. CONCLUSIONS: The high prevalence of OL- and UL-drug use in children admitted in the PICU significantly compromises their right to safe drugs. As most of the OL drug use is related to drugs used in children for several years; legislative and regulatory initiatives are required to ensure that accumulated evidence and experience gets incorporated in the license.
Keywords: Drug approval, drug labeling, intensive care units
Abstract: OBJECTIVE: To investigate the incidence of off-label (OL) and unlicensed (UL) prescribing to children in primary care in Malta. METHODS: A prospective pharmaco-epidemiological review of 1507 medicines recommended to 924 children by both paediatricians and general practitioners was conducted. OL medicines were defined as medicines that were not prescribed in accordance with their Summary of Product Characteristics (SmPC) with respect to age, dose and indication as well as frequency, duration and route of administration. UL medicines were defined as medicines that did not have a marketing authorisation, as well as medicines whose formulation was modified.…RESULTS: 721 from 1507 medicines (47.8% ) were prescribed in an OL/UL manner, the highest incidence in the 1 month –2 years age range (210 from 345 medicines; 60.9% ). More paediatricians rather than family doctors prescribed in an UL (11.6% vs 3.6% , p < 0.001) and OL manner for age (25.7% vs 19.6% , p < 0.001). Conversely, more family doctors rather than paediatricians prescribed in an OL manner for dose (33.5% vs 21.4% , p < 0.001). CONCLUSION: Contributing factors for the high rates of OL and UL prescribing include failure by prescribers to follow recommendations detailed in the product literature and a lack of licensed paediatric medicines.
Keywords: Children, general practice, off-label medicines, unlicensed medicines
Abstract: BACKGROUND: Drugs are approved for formulary listing based on limited knowledge of their safety. Serious safety issues are often identified after a drug is marketed. OBJECTIVE: To determine whether the listing status of drugs on the Ontario Drug Benefit (ODB) Formulary changes following the identification of safety concerns by Health Canada and whether the results of reviews by people responsible for the ODB Formulary are made public. METHODS: All new active substances (NAS) approved by Health Canada from January 1, 2002 to March 31, 2012 that subsequently had a warning issued about…a serious safety concern were identified. Editions of the ODB Formulary were searched to find which of these drugs were listed on the Formulary before the safety warning was issued. RESULTS: A total of 263 NAS were approved of which 42 subsequently acquired one or more serious safety warnings and 15 of these were listed on the ODB Formulary before the safety warning was issued. The listing status of 14 of the 15 drugs was unchanged after the release of the safety warning. No information is available about whether the listing status of these 14 drugs was reassessed. CONCLUSIONS: The ODB Formulary should develop a set of criteria to determine whether the listing status of drugs should be reviewed after Health Canada issues a serious safety warning. The results of any reconsiderations should made public so that prescribers and patients alike know that the ODB Formulary officials still regard the drugs as having a positive benefit to harm ratio.
Keywords: Drug formulary, drug safety, formulary management, Ontario
Abstract: Excessive use of over-the-counter (OTC) medications has been a growing public health problem. We present the case of a patient with avoidant personality disorder, social phobia, and dull normal intelligence, with dependence to pheniramine maleate. His anxiety symptoms, initially unresponsive to conventional treatment, reduced only after stopping pheniramine during inpatient care. This case emphasizes the need for awareness and regular monitoring of the use of OTC medications in vulnerable patient populations.