Protecting Patients

Advancing Patient Safety

Each year, more than 50 million errors occur during the filling of some three billion prescriptions in the United States alone, many of them as a result of misread labels.* Building on our commitment to patient safety, we reviewed and redesigned product labels for all of our pharmaceutical products to make it easier for pharmacists to dispense our medicines properly.

As part of the process, we studied literature on dispensing errors and human factors, observed dispensing in pharmacies, and interviewed and sought feedback from pharmacists, physicians and patients. Our findings led to a new standardization process that highlights critical product identification information such as brand name, generic name, dosage strength, quantity and dosage form on the front panel of a label. Additionally, the size of the label text corresponds with the importance of the information it represents. Color also is used to highlight critical information about product strength and special warnings. In certain cases, product images may be included to provide a safety check that the correct product has been selected.

Beginning in 2006, all new Abbott products filed for approval with regulatory agencies included the new label format. We will continue our efforts to convert labels, both domestically and internationally, to the new standard format in accordance with all local regulatory requirements.

*	Flynn, Elizabeth A., Kenneth N. Barker, Brian J. Carnahan. National observational study of prescription dispensing accuracy and safety in 50 pharmacies. Journal of the American Pharmaceutical Association; 43(2):191–200.

Product Quality

Developing quality products that are safe and effective is a process that spans our entire organization – from research and development to manufacturing, marketing and communications – to ensure that we go beyond simply complying with regulatory requirements to earning trust from customers who depend on our innovative products.

Our product quality efforts are led by our Corporate Regulatory and Quality Science organization, which reports to our chairman and CEO. This group also is accountable to the Public Policy Committee of our board of directors.

Our approach to developing quality products includes:

• Standardizing, implementing and improving key quality systems; Continually improving our products and processes;
• Acting quickly and effectively to resolve issues;
• Achieving a high rate of regulatory inspections without observations; Listening to our customers;
• Maintaining a positive relationship with regulators;
• Establishing broad and effective communication across the company;
• Proactively engaging key external stakeholders to gain their perspectives and counsel; and
• Acting globally.

Product Safety

Patient safety is paramount. We have a number of processes in place to make sure that we meet the highest safety and quality standards during the design and development, manufacture, delivery and labeling of our products. In 2007, we made a number of enhancements to our quality and regulatory systems, including:

Working to harmonize basic quality and compliance of all product requirements on a worldwide basis is a significant challenge in a global market where each individual country also has its own regulations.

Simplifying, on a company-wide basis, our quality policies so they are easier for employees to understand and apply. These policies are clearly stated global requirements.

Employing a "quality by design" approach, focusing on improving manufacturing efficiencies and consistent delivery of product that fulfills our customers needs.

Serious Adverse Events Consortium

Partnering at the intersection of science and public health

Because of individual differences in biology and genetics, the very drugs intended to alleviate illness may instead trigger a serious adverse event (SAE) for a handful of patients. In 2007, Abbott helped form the Serious Adverse Events Consortium to share medical data and develop solutions to make treatment with medication even safer for patients. Comprising industry and academic research partners, as well as the FDA, this consortium will help reduce SAEs by identifying genetic markers – certain patterns in a person's DNA – that may contribute to his or her risk for these events.

Collaboration is vital to the project's success. Each individual partner in the coalition, including Abbott, has its own data on serious adverse events. Because SAEs are so rare, answers can be found only by pooling data and expertise. By having a universal resource, we will be even better able to identify and address potential safety issues before new drugs become available to the public, identify which medicines certain patients should avoid, and provide doctors and patients with high-quality safety and warning information.