Corporate Social Responsibility: Product Quality and Patient Safety

It's crucial to deliver the safest medical and pharmaceutical products to the patients who count on us.

We deliver one-third of prescription medicine in North America, and we serve more than 2.1 million customers every day across 13 European countries. And it’s crucial to deliver the safest products to all of these patients, because both the people making the medicine and the people taking it count on us.

Responding to the opioid epidemic in the U.S.

Each day, our distribution team delivers life-saving medicines to pharmacies, hospitals and clinics that serve millions of patients. We take to heart that at the end of each and every item delivered – every pill bottle, every vial, every ointment – there is a patient in need. We know that it’s not just a package, it’s a patient.

Over the past decade, as the opioid epidemic evolved rapidly, we enhanced our teams, processes and technologies dedicated to preventing diversion. We are committed to maintaining – and continuously enhancing – strong programs designed to detect and prevent opioid diversion within the pharmaceutical supply chain, while also protecting the availability of appropriate treatments for patients with serious illnesses and injuries.

This complicated, multi-faceted public health crisis must be addressed through a comprehensive and collaborative approach. Each participant in the pharmaceutical supply chain can play an important role.

We are advancing a series of company initiatives focused on helping to address the opioid epidemic, including launching a foundation dedicated to combating the crisis, offer thoughtful public policy recommendations – including the Prescription Safety-Alert System (RxSAS) technology proposal – and supporting innovative programs and partnerships that we believe can have a meaningful impact on this challenging issue. We are committed to engaging with all who share our dedication to acting with urgency to address this epidemic and working together to end this crisis.

McKesson Supply Chain infographic: Manuracturer to Transportation to Distribution Center to Transportation to Hospital/Pharmacy to Customer/PatientEnsuring the integrity of the supply chain

Our quality management system is based on international procedures to ensure that products we handle and distribute, as well as the products we manufacture in our private-label line of business, follow applicable regulations.

  • Compliance: We comply with applicable laws and regulations concerning product quality in the countries where we do business. These include the Drug Supply Chain Security Act in the U.S., the Food and Drugs Act in Canada, and the Good Distribution Practice and the Good Manufacturing Practice guidelines in the European market. These laws and regulations commit us to keeping our products traceable, handling hazardous products appropriately and continuing to work with authorized trading partners.

    McKesson takes all compliance concerns very seriously. In 2018, the U.S. Food and Drug Administration (FDA) identified concerns with our DSCSA compliance, and we are committed – at the highest levels of the Company – to addressing the issues the government raised and further enhancing our DSCSA compliance program. This enhancement effort has been and will continue to be, multi-faceted, and in ways that will help our policies and procedures stay contemporary as further regulatory guidance and best practices emerge. Most importantly, our enhanced procedures, dedicated review team, and a systematic approach are intended to ensure that we remain an important and reliable partner to the FDA in securing the integrity of the pharmaceutical supply chain in this country. Read a summary of McKesson’s response to the FDA’s February 2019 warning letter (PDF, 175 KB).
  • Product integrity: In addition, our supply chain security, safety and security training programs focus on the integrity of product packaging and containers. Here’s how:

    When receiving products, we verify the quantity, supplier name and product name through the purchase order. We also make sure that the product is not set to expire soon. Our tracking system also automatically lets us know if a supply is affected by a recall.

    When shipping products, we use containers that keep quality and safety in check. That means caring for everything from packaging to temperature control. To manage cold chain products, we use sophisticated technology for environmental controls and temperature monitoring. Refrigeration experts ensure we select shipping containers that comply with manufacturers’ product specifications. When we use passive cold chain solutions, we require containers to pass a qualification process. This helps guarantee product integrity and help prevent any quality issues.

    When potential incidents happen, we work to respond promptly. We follow a CAPA (Corrective Action – Preventive Action) process, with the goal of reducing any problems. To prevent falsified products from entering the legal distribution network, we follow a supplier qualification procedure for vendors. As part of this process, we perform regular audits and checks around authorizations and certifications.

    During product recalls, we reach out to pharmacies and other customers with details on the recall and how products can be returned to McKesson. We continuously train our customer service employees so they are up-to-date on current recalls.
  • Traceability: In Europe, we’ll be following the Falsified Medicines Directive (PDF, 822 KB), which requires batch tracking of medicinal products. When products enter the warehouse, we record the product code, expiration date and batch number. Using handheld terminals, we track the product at every stage of its journey in the warehouse – from replenishment, to picking, to returns. Employees can either scan the information or enter it manually. If an inaccuracy occurs, the tracking system generates an alert. Our quality coordinators monitor the alerts and resolve any inconsistencies.
  • Supplier requirements: Just as we hold ourselves accountable, we also hold our suppliers accountable for the quality of their products and services. In areas where we outsource distribution, this includes contracted carriers and couriers.

    In the U.S., Canada and Europe, suppliers meet our requirements through compliance with regional, national and international legislation. Outside these regions, our private-label suppliers must agree to McKesson’s Sustainable Supply Chain Principles (MSSP). These cover compliance with appropriate laws along with adherence to our strict policies on protecting workers, preparing for emergencies, identifying and managing environmental risk, and protecting the environment.
  • When we manage quality, our guide is not only laws and regulations but also best practices and international standardsManufacturer requirements: We comply with manufacturer requirements for handling and distributing products. In some cases, we have contracts with manufacturers that restrict the sale of certain medicines to certain customers, such as prison systems and others, for lethal injections. McKesson is committed to helping manufacturers implement their policies in this area. The needs and requirements of manufacturers vary. As a result, our contractual commitments, controls and processes vary by manufacturer. McKesson has processes and systems to enable manufacturers to validate McKesson's performance against our contractual arrangements.

    When we manage quality, our guide isn’t only laws and regulations but also best practices and international standards. As an example, eleven of our businesses in Europe are certified by ISO 9001, an international standard for quality management systems.

Quality improvement through Six Sigma

Across McKesson, we strive to continuously improve by using Six Sigma. Six Sigma helps us work better by using data to drive decision-making and by promoting continuous quality improvement across our company. Using problem-solving tools, Six Sigma reduces defects and minimizes variances.

By improving processes, we can see fewer errors, faster cycle time and less waste.

In FY18, McKesson completed 441 Six Sigma projects, which had more than $130 million in fiscal impact across our company, suppliers and customers.

Here are a few of our Six Sigma projects:

  • Keeping patients safer by reducing errors: A few years ago, medication dispensing errors made headlines in the U.K. While we weren’t involved, we knew we wanted to double down on our commitment to safety. The result was the SaferCare program. It works like this: each pharmacy nominates a SaferCare Champion, who is responsible for making sure staff complete a safety checklist. Every four weeks, the staff meets as a team to discuss issues and review a case study. Errors (which were already extremely low) have dropped by half since the program started.
  • Restocking faster, so pharmacists have more time with patients: Several of our LloydsApotek pharmacies in Sweden turned to Six Sigma to improve replenishment. Patients were waiting longer to have their prescriptions filled, which reduced the quality of their experience and increased costs. After visiting pharmacies, our Six Sigma experts realized the stockrooms needed a new layout with separate scanning and sorting stations, and that staff needed new training. With that plan in place, the pharmacies have seen faster restocking and cost savings of around 70%.
  • Tracking to better control precursor returns: Precursors are products with active pharmaceutical ingredients that can be used to make illegal drugs, such as methamphetamine. As part of McKesson Canada’s commitment to Health Canada, Six Sigma led a team to create an automated tracking system. It provides visibility along each step of a precursor return—from when the product is created and shipped to the customer to when the physical return comes back into the McKesson building for processing. Already, government auditors have been impressed by the visibility and control in product handling of precursor returns.

These are just a few of our Six Sigma successes. Whether it’s reducing defects or streamlining processes, we look forward to tackling additional projects in FY19 and beyond.

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