In the case of Health Product Recalls and PW, the action is to re

In the case of Health Product Recalls and PW, the action is to remove the defective medicine from the dispensary shelves and contact the manufacturer for return. Whereas, with other risk communication documents where there is no recall required, healthcare professionals and the public are given selleck inhibitor advice on how to deal with defective medicines and to alert the public to be aware of expected risks. Two types of drugs can be distinguished from risk communication documents: substandard drugs and falsified drugs. The decision on which incident was falsified or substandard is that published by Health Canada. The type

of defects were then classified using the same classification as used in our previous study.7 The quality defects were classified as contamination, minor or major packaging defect, delivery (eg, leaking bags) defect, stability failure, potency issues, active ingredient defect and other issues (such as other deviations concerning non-compliance with

good manufacturing practice at manufacturing site). The WHO Anatomical Therapeutic Chemical (ATC) Classification System was used to classify defective medicines.15 The first level of this classification categorises medicines according to the organ or system in which they act and the second level classifies medicines according to their main therapeutic group. This was performed to highlight the most frequent therapeutic classes affected by these recalls. Method of analysis Minitab

(V.16) software was used to store and analyse the data. Descriptive statistics were used to summarise the results. Marketing authorisation holders of recalled medicines were either licensed manufacturers or distributors. A comparison between the manufacturers and distributors in the number of substandard medicines reported under each type of quality defect was carried out using Fisher’s exact test. A significant difference was defined at a p value <0.05. The comparison was conducted to investigate if there are certain types of quality defects (eg, stability or packaging issues) that were more likely to be reported with distributors, as this may indicate non-compliance with Good Distribution Practices. Results A total of 653 defective medicines were identified in the Canadian supply chain (figure 1). Among these defective medicines, 649 were found Batimastat to be substandard medicines, and only four were found to be falsified medicines in the 9 years studied. The rate of reporting defective medicines has increased each year over the past 6 years (figure 2). Figure 1 Flow diagram of search and resulting incidents. Figure 2 Number of incidents of defective medicines reported by Health Canada. Substandard medicines Substandard medicines represent the bulk of defective medicines (n=649, 99%) reported by Health Canada.

Leave a Reply

Your email address will not be published. Required fields are marked *

*

You may use these HTML tags and attributes: <a href="" title=""> <abbr title=""> <acronym title=""> <b> <blockquote cite=""> <cite> <code> <del datetime=""> <em> <i> <q cite=""> <strike> <strong>