Ensuring Quality and Safety

Product quality and patient safety are top priorities for CVS Caremark. We are committed to ensuring the prescription medications and products we sell are safe, high-quality and cost-effective.

Pharmacy Operations

All of our pharmacy operations, including mail services, specialty pharmacies and retail pharmacies, follow comprehensive quality assurance processes for prescription safety and accuracy. The dispensing process employed in our prescription mail service operations includes extensive quality assurance measures, such as enhanced quality control, electronic imaging, quality procedures for compounded prescription items, an integrated system for eligibility verification and drug utilization review and final quality assurance checks.

At our specialty pharmacies, we employ an additional comprehensive review process for medication appropriateness and conduct a complete patient assessment to help prevent safety, administration or efficacy issues with the prescribed medication.

Our retail pharmacies also have well-defined processes in place to ensure accurate dispensing, including on-screen computer messaging, bar-coded prescription labels, electronic prescribing, automated prescription filling technology, electronic pill imaging, electronic scanning of prescription orders, upgraded prescription verification computer screens, enhanced telephone order prescription blanks and quality assurance training for all pharmacy personnel. We also have a relationship with the PSO Advisory, a patient safety organization based in Providence, RI, to provide feedback on safety improvements.

To ensure patient safety, we provide information on all prescription labels to describe what the medication looks like and we advise patients to check their medication to make sure that it matches the label information that notes color, shape and markings. Labeling information also includes side effects as well as instructions on how best to take the medication. A comprehensive drug description slip is also provided with every prescription and contains helpful information about side effects, drug interactions and what to do if a patient misses a dose. Prescription medications account for approximately 70 percent of revenues at CVS/pharmacy stores and more than 80 percent of CVS Caremark’s total revenues. Our labeling practices apply to all prescription medications dispensed by the company.

In addition, our pharmacists are trained to exercise their professional judgment to meet potentially conflicting challenges posed by the regulatory imperative to prevent drug diversion and inappropriate drug use.

Product Quality Assurance, Safety and Testing Process

CVS/pharmacy follows a standardized process to ensure consumer product quality and safety and our suppliers must comply with our product quality and safety standards and requirements. We utilize a third-party company to provide the technical expertise to support day-to-day operations of our quality assurance testing program at all levels – from production to use.

CVS Brand Products

Our goal when developing a CVS Brand product is to meet or exceed national brand performance. The manufacturing of CVS Brand products is contracted through third-party vendors who are required to comply with all applicable laws and regulations. All CVS Brand products are evaluated at least annually and reviewed for their adherence to specifications and performance. We are continuously improving our products based on ongoing market surveillance and customer feedback.

Prior to acceptance as a CVS Brand product, potential new store products must demonstrate compliance through rigorous testing with all quality standard requirements as detailed in our Test Requirements protocol. This protocol specifically states animal testing is prohibited. In addition to testing, the supplier must have on file the documentation to substantiate their products are not tested on animals and do not use adulterated materials.

A Technically Advanced Quality Assurance program was developed with the assistance of a third party to ensure CVS Brand products meet regulatory requirements as to safety, identity, strength, quality and purity characteristics. We employ a pre-clearance, supplier qualification and ongoing quality monitoring program to assure compliance and continuous improvement.

Imported Products

All imported consumer products, in the form of final production samples, are tested for quality, safety and performance. We are also committed to working with suppliers who meet our standards as responsible corporate citizens. 

Effective Management of Product Recalls

We have effective processes in place for managing pharmaceutical and product recalls, including many which are taken as a 
precautionary approach:

• Notifying internal and external stakeholders
• Removing products from the shelves at all of our stores, distribution centers and our website
• Ensuring that technological solutions are activated to block accidental sales
• Educating colleagues on recalls
• Posting retail recall posters, when appropriate
• Returning recalled items for proper disposal

In 2011, we also focused additional resources on post-marketing surveillance – monitoring the performance of products once they are in the hands of consumers. Our efforts are focused on customer safety and satisfaction. This resulted in fewer CVS Brand product recalls and improvement in manufacturing facilities’ regulatory compliance and good manufacturing practices.

A number of recalls in 2011 affected national-branded products and a smaller number of store brand products. Our recall process is effective in removing products from the store shelves and changes implemented in 2011 have reduced replenishment time.

Cosmetic Safety

Our cosmetics supplier partners are actively engaged in ingredient and product safety and provide industry-wide thought leadership on these issues. We require our cosmetics vendors to supply CVS/pharmacy with products that comply with our Cosmetic Safety Policy and applicable regulations in regard to banned substances and packaging requirements. In evaluating vendor compliance to ensure cosmetics safety, products must be formulated to ensure they present no risk of contamination and each production batch must be tested to meet FDA requirements and CVS/pharmacy specifications. In addition, product ingredients are identified and each ingredient is evaluated based on available safety information before it is considered for sale. Colorants are confirmed to ensure they are acceptable for use by FDA requirements. Testing is performed to assess and confirm skin compatibility as well as to confirm the absence of lead, bisphenol A and phthalates as required by regulation.

To further ensure safety and promote education across the retail industry, our Product Development Managers participate in professional organizations and consult with third-party experts on specific questions related to ingredient and product safety facing the industry. Our Government Affairs team and third-party quality assurance labs keep us apprised of current and potential legislation that would impact our protocols, as well as developments around the world that may eventually impact U.S. standards. We are also monitoring the Food Safety Modernization Act and Reasonable Testing program to understand what impact that will have on us and our suppliers.

CVS/pharmacy Cosmetic Safety Policy

Our company is dedicated to improving the lives of those we serve through innovative and high-quality health and pharmacy services. That is why we are dedicated to staying abreast of new conclusive research related to cosmetic safety, to assessing findings that demonstrate a linkage between certain health and environmental risks and specific chemical ingredients used in beauty and personal care products, and to evaluating how these findings impact the products we sell.

We are commited to:

• Providing our customers with innovative products from around the world that have been hand-selected and tested to meet or exceed regulatory standards.
• Building relationships with partners who educate us on scientific research and developments related to ingredients of concern in cosmetic products.
• Continuously evaluating our CVS Brand and private label products based on new research findings.
• Partnering with our cosmetic suppliers to ensure proper protocols are used to ensure cosmetic safety.
• Developing action plans to replace ingredients of concern in our branded and private label products when safer alternatives are available and prompting similar action by our supplier partners.
• Educating consumers on our cosmetic safety standards and on product evaluation tools that will enable them to take an active role in maintaining good health.