International Journal of Risk & Safety in Medicine - Volume 27, issue 3

Authors: Jobanputra, Neha | Save, Sushma U. | Bavdekar, Sandeep B.

Article Type: Research Article

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. Show more

Keywords: Drug approval, drug labeling, intensive care units

DOI: 10.3233/JRS-150653

Citation: International Journal of Risk & Safety in Medicine, vol. 27, no. 3, pp. 113-121, 2015

Authors: Ellul, Ian C. | Grech, Victor | Attard-Montalto, Simon

Article Type: Research Article

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. Show more

Keywords: Children, general practice, off-label medicines, unlicensed medicines

DOI: 10.3233/JRS-150654

Citation: International Journal of Risk & Safety in Medicine, vol. 27, no. 3, pp. 123-134, 2015

Authors: Lexchin, Joel

Article Type: Research Article

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. Show more

Keywords: Drug formulary, drug safety, formulary management, Ontario

DOI: 10.3233/JRS-150655

Citation: International Journal of Risk & Safety in Medicine, vol. 27, no. 3, pp. 135-142, 2015

Article Type: Research Article

DOI: 10.3233/JRS-140652

Citation: International Journal of Risk & Safety in Medicine, vol. 27, no. 3, pp. 143-152, 2015

Authors: Rao, Mukund G. | Varambally, Shivarama | Venkatasubramanian , Ganesan | Gangadhar, Bangalore N.

Article Type: Research Article

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.

Keywords: Antihistamine, abuse, dependence, social anxiety, avoidant personality disorder, anxiety disorder

DOI: 10.3233/JRS-150656

Citation: International Journal of Risk & Safety in Medicine, vol. 27, no. 3, pp. 153-157, 2015

Article Type: Book Review

DOI: 10.3233/JRS-150657

Citation: International Journal of Risk & Safety in Medicine, vol. 27, no. 3, pp. 159-165, 2015

Article Type: Research Article

DOI: 10.3233/JRS-150658

Citation: International Journal of Risk & Safety in Medicine, vol. 27, no. 3, pp. 167-168, 2015