Trends in Non-prescription Drug Recalls in Japan.

Recalls of non-prescription drugs can contribute to preventing harm to human health, however, they also interrupt the supply of medicines to the market. The aim of the present study was to investigate the trends in non-prescription drug recalls in Japan. Class I, II, and III recalls reported from April 2009 to March 2014 were obtained from the websites of the Ministry of Health, Labour and Welfare and the Pharmaceuticals and Medical Devices Agency. Each drug recall was classified according to year, dosage form, therapeutic category, and reasons for the recall. The trends over the 5 year period were assessed for each class. A total of 220 recalls were reported in the 5-year study period. The numbers of drug recalls were 21, 16, 80, 58, and 45 in 2009, 2010, 2011, 2012, and 2013, respectively. The drugs recalled consisted of 177 internal medications, 35 topical agents, and 8 others. Drug recalls were observed in 12 therapeutic categories of drug effects. The largest number of recalls was for Chinese herbal medicines and crude drugs. Of all the drug recalls in 2011, Chinese herbal medicines and crude drugs produced by one manufacturer accounted for 84%. Slightly more than half (54%) of drug recalls were due to a violation of the regulations. One manufacturer recalled many drugs because of non-compliance with the standard regulations for manufacturing drugs after 2011. In conclusion, non-prescription drug recalls can occur for any drug regardless of the dosage form and therapeutic category.

Assessment of Osgood-Schlatter Disease and the Skeletal Maturation of the Distal Attachment of the Patellar Tendon in Preadolescent Males.

BACKGROUND: Osgood-Schlatter disease (OSD) is a traction apophysitis of the tibial tuberosity. Ultrasonography (US) is able to detect pathologic changes, such as cartilage swelling and fragmentation of the tibial tubercle ossification center. PURPOSE: To compare the US stages of tibial tuberosity development and the physical features and prevalence of OSD in this patient cohort. STUDY DESIGN: Cross-sectional study; Level of evidence, 3. METHODS: Subjects included 238 males (n = 476 joints) with a mean age of 11.4 ± 1.6 years (range, 7-14 years). The tibial tuberosity development on US was divided into 3 stages: the cartilaginous stage (stage C), apophyseal stage (stage A), and epiphyseal stage (stage E). It was then investigated whether the subjects had pain in the tibial tuberosity on application of pressure. Age, height, body weight, body mass index (BMI), heel-buttock distance (HBD, cm), and straight-leg raise angle (SLRA) were evaluated. To confirm the diagnosis of OSD, the participant had to fulfill the following clinical criteria: pain with direct pressure on the tibial apophysis, fragmentation of the bone, and irregularity of the ossification center detected by US. RESULTS: The tibial tuberosity was stage C in 195 knees, stage A in 105 knees, and stage E in 176 knees. The subjects' heights, weights, and BMIs significantly increased with advancing development of the tibial tuberosity. The HBD increased in stage E (P < .01). The SLRA was not significantly different among groups. There was fragmentation of the bone and irregularity of the ossification center in 32 knees (6.8%): 0 in stage C, 21 (4.3%) in stage A, and 11 (2.3%) in stage E. Fragmentation of the bone and irregularity were observed significantly more often in stage A (P < .01). On the other hand, there were 10 joints with OSD (2.1%): 0 in stage C, 3 (0.6%) in stage A, and 7 (1.5%) in stage E. OSD was observed significantly more often in stage E than in the other stages (P < .05). CONCLUSION: The present study showed that the HBD increased from stage A to stage E. The prevalence of OSD was highest in stage E.