Kelly Smeltzer loves processes, processes that work and save on waste and money. She has a particular interest in the excess production of pharmaceutical drugs and wastage, with 30 years of experience in supply chain management under her belt.
A survey conducted to understand whether supply issues over amoxicillin have persisted in the US found that an overwhelming majority of pharmacists are still struggling to source the commonly-used antibiotic.
According to the agency, Teva communicated that it would have difficulties supplying immediate release formulations of the drug due to manufacturing delays.
FDA urges manufacturers to ‘sell quality’ to fight drug shortages, releasing a report on the potential introduction of a rating system to reward transparency and investments in quality management.
The US FDA announced a task force has been formed to prevent the shortage of drugs, by addressing the ‘underlying structural concerns’ that allow this to happen.
New US drug shortages this year are running roughly at the same levels as the last two years, and far below the record highs seen earlier this decade, the US FDA told in-Pharmatechnologist.
The International Society for Pharmaceutical Engineering (ISPE) last week offered up a preview to its plan to help manufacturers avoid or mitigate drug shortages due to manufacturing or quality issues.
US drug regulators have claimed recent law changes that enhance communication with pharmaceutical manufacturers helped prevent 140 potential drug shortages in 2013.
Reporting rules designed to prevent drug shortages are likely to be similar in Europe and the US according to the industry group that represents European generic drugmakers.
Payers should keep pharmaceutical firms’ quality records in mind when making purchasing decisions to help prevent drug shortages and stimulate manufacturing innovation according to the US FDA.
Manufacturers’ quality issues were among the most prevalent reasons for drug shortages, according to a survey conducted by the ISPE (International Society for Pharmaceutical Engineering).