Passing inspection: how we ensure medicines are safe for patients By Adele Paterson Tuesday, September 17 was the first World Patient Safety Day (as declared by the World Health Organization). No one should be harmed in healthcare – yet unsafe care in hospitals in low- and middle-income countries means that every year, 134 million adverse events contribute to 2.6 million deaths. Tuesday was a big day for us, too, as we welcomed an inspector from the Medicines and Healthcare products Regulatory Agency (MHRA), part of the UK government’s Department of Health. It was an all-day inspection, and it was all about putting patient safety first. We’re proud to say we passed – giving our donors, partners and patients confidence that the treatments we distribute (4.4 million to 34 countries last year) are safe and effective. So what was Tuesday’s inspection all about? It’s clear no one should be harmed by healthcare, and we all have good intentions. Members of the general public will sometimes contact us, for example, asking if we can pass on their unused medicines. It’s a kind thought, and in an ideal world, it would be great to facilitate this. Unfortunately, we can’t. When medicines leave the regulated supply chain, they may not be safe for others to use. And everyone – no matter where they live – deserves access to safe, effective medicines. In the medical donation space, good intentions must be underpinned by good practice. And IHP is proud to be part of setting international standards around medical product donations. To generate confidence in our work, we maintain rigorous standards. As a licensed wholesaler, for instance, we have a quality management system (QMS), including standard operating procedures (SOPs), ongoing self-inspections, and technical and partner agreements. Monitoring and handling deviations are just as important. Everything is written down and recorded, forming part of our QMS. So, even if our key staff left, we could continue to operate transparently and effectively. Our sector changes fast, and we need to keep up. Recently, to comply with a new piece of EU legislation (the Falsified Medicines Directive) we’ve developed new procedures. As a small team, everyone is responsible: we all have to keep our training folders up to date and maintain knowledge of good distribution practice (GDP). Tuesday’s inspection was helpful in generating practical suggestions and boosting our process of continuous improvement. For us, it’s great to have MHRA oversight. Our work is dependent on strong relationships with donor partners (healthcare companies), receiving partners (NGOs and others) and logistics partners, so a good report is hugely beneficial. It means we can provide donors with the reassurance we operate safely, and give our receiving partners significant benefits, helping them improve practice by sharing our knowledge of quality standards, product recalls, temperature controls, etc. We’re delighted that our recent inspection passed with few comments. As one of our trustees put it: “A nod from the MHRA is no small feat.” It means that we can have confidence, albeit matched by ongoing diligence, that patient safety will not be compromised. In providing access to safe medicines for those in need, many factors are outside our control – but we’re determined that quality management will never be one of them.