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Pharmaceutical Technology Regulatory Sourcebook October 2020 51 Smalley criticizes the industry's pervasive "train- ing by PowerPoint" approach, advocating more of a 'tell me, show me, watch me' approach. "Trade unions are very good at this. If someone starts off in a union as an apprentice, he or she must dem- onstrate competence in performing a procedure in order to be qualified to do this independently. They're not learning via slide shows," he says. Without improved training, the wrong practices can easily take root. "If a bad driver is stopped by the police and argues 'But I've been driving for 20 years,' he or she may have been driving badly for 20 years. Similarly, some compounders may be experienced, but doing things the wrong way. Schools are not providing the materials and state boards are not requiring basic classes and train- ing in compounding," says Smalley. "You can't create new laws for driving without making any drivers ed courses available," he adds. Pandemic adds new challenges The COVID-19 pandemic has challenged more compounders to take over the manufacturing of key workhorse drugs as well as hand sanitiz- ers. However, Dana sees the need for pharmacy personnel to be aware of the risk of coronavirus contamination. "Environmental monitoring won't detect coronavirus. Compounders need formal programs that address the suitability of person- nel engaged in compounding operations. There needs to be a screening program in place, to test staffers to ensure that they were not exposed to the virus. Basic health issues are the starting point," he says. Given increased demand for their services, some larger compounders are investing in more mod- ern, efficient equipment to keep pace. A growing number of B compounders are sourcing advanced equipment just as any drug manufacturer would. "Larger compounders are approaching both en- gineering companies and vendors, as well as the occasional consultant. Some of the smaller ones have also tripped over to the big pharma world, although others still may not know much outside of what they've always done," says James Agalloco, a consultant who specializes in aseptic processing. And a number of companies are adding com- pounding capacity. SCA Pharma, for example, is expanding its sterile pharmaceutical manufactur- ing facility in Windsor, CT by 40 percent through 2021, after what the company's CEO Milton Boyer describes as five years of continued growth. FDA's temporary COVID-19 guidance has allowed the company to be more f lexible in responding to customer needs, he says, but challenges remain, notably hospitals' inability to forecast require- ments, based on their changing patient census. In response, the company is "focusing on optimizing safety for its essential employees and improving supply chain efficiency to deliver critical medi- cines to front-line hospitals," Boyer told Pharma- ceutical Technology. References 1. USP General Chapter <797>, Compounding for Sterile Prepara- tions, usp.org, 2008. 2. USP General Chapter <800>, Hazardous Drugs and Their Han- dling, usp.org, 2016. 3. United States Senate, The Case for Clarifying FDA Authority: Large-Scale Drug Compounding and the Ongoing Risk to Public Health, ussenate.gov, May 22, 2013 4. FDA, Press Release, "Compounding Pharmacy Owner Sentenced to Five Years in Prison for $10.5 Million Health Care Fraud," fda. gov, March 27, 2018. 5. United States Government Accountability Off ice, Report to Congressional Committees, FDA Has Taken Steps to Implement Compounding Law, but Some States and Stakeholders Reported Challenges, gao.gov, November 2016. 6. FDA, Draft Guidance, Insanitary Conditions at Compounding Facilities, fda.gov, September 2018. 7. ICH Q9, Quality Risk Management (ICH, 2006). 8. PDA, Technical Report 54, Implementation of Quality Risk Man- agement at Pharmaceutical and Biopharmaceutical Facilities, pda. org. (PDA, 2012). PT