Prescription Quality and Safety

Prescription safety is our highest priority at CVS Caremark. Every day, our pharmacists and pharmacy staff fill nearly two million prescriptions that help patients treat and manage their illnesses and maintain healthy lifestyles. Our processes for prescription and patient safety are continually being strengthened and improved upon through our focus on:

• Quality assurance
• The right resources
• The right technology
• Effective management of prescription recalls, returns and disposal

Quality Assurance

All of our pharmacy operations, including mail order services and in-store pharmacies, follow comprehensive quality assurance processes for prescription safety and accuracy.

Dispensing Process – Mail Service Pharmacy

The dispensing process employed in our prescription mail order service operations includes the following quality assurance measures:

• Enhanced quality control—Bar-coded numbers are assigned to all order forms and prescriptions for automated tracking and to ensure that the proper medications are dispensed.
• Electronic imaging—High-resolution scanned images are made of all hard-copy prescriptions, which eliminates lost correspondence and makes the dispensing process more efficient.
• Quality procedures for compounded prescription items—We follow the highest standards of good pharmacy practice, including compounding medications one prescription at a time.
• Integrated system for eligibility verification and drug utilization review—When orders are received, the plan participant’s identity is checked against our integrated retail and mail service system to confirm eligibility status and the claim is adjudicated according to the client’s plan.
• Final quality assurance check—A separate registered pharmacist verifies all components of each plan participant’s order prior to packaging. This includes comparing a high-resolution image of the contents in the container to a file image of the prescribed drug, as well as physically examining the container’s contents.

Dispensing Process – Retail

Our in-store pharmacies have well-defined processes in place to ensure accurate dispensing, including the following quality assurance dispensing measures:

• Accuracy scanning—The National Drug Code (NDC) must be scanned on both the pharmacy bottle and the prescription label to ensure a match.
• Pharmacist verification screen—Computer displays show the image of the pill being dispensed, identify pediatric and infant patients, and display the patient’s age (not just date of birth).
• Drug Utilization Review—Performed by the pharmacist to evaluate the appropriateness of therapy and check for drug interactions.
• High Alert Medication Program—Combining on-screen messaging with pharmacy shelf awareness stickers, in order to differentiate between look-alike and sound-alike medications.
• Refrigerated prescription bookmarks—Refrigerated medications are stored with the patient’s prescription and can be pulled together, while a “bookmark” is put in the waiting bin.
• Echo Check Box—Enhanced entry screen provides a reminder to “echo” back and verify the drug, strength, prescription and indication for prescriptions that have been called in by a physician.
• Comprehensive quality assurance check—A registered pharmacist verifies the accuracy of key patient, drug, and medication information prior to dispensing to the patient.

At our specialty pharmacies, we employ an additional, comprehensive review process to ensure medication appropriateness and conduct a complete plan participant assessment to ensure that no safety, administration or efficacy issues with the prescribed medication will arise.

Our effective systems and processes enable us to accurately fill hundreds of millions of prescriptions every year. In the rare event that a prescription error does occur through any of our prescription operations, it receives immediate attention by a pharmacy supervisor for follow-up, which typically includes:

• Contacting appropriate individuals affected by the event, such as patients, caregivers and prescribers.
• Submitting an incident report for analysis and investigating the incident to determine how it occurred.
• Taking necessary corrective measures to prevent future occurrences; potentially including re-training staff and, where needed, modifying our operating procedures.
• Tracking and reporting errors internally and adhering to reporting requirements of state pharmacy boards.

While the total number of prescriptions we fill has steadily increased, our overall number of prescription errors has declined. We continually improve our quality assurance measures to minimize the risk of errors, which now amount to a small fraction of one percent of total prescriptions filled.

Pharmaceutical Supply Chain

The National Association of Boards of Pharmacy accredited the CVS Caremark distribution center in Indiana as the first U.S. retail pharmacy to be a Verified Accredited Wholesale Distributor (VAWD) in 2006. Today, all nine of
CVS Caremark’s pharmacy distribution centers have been VAWD accredited. The VAWD program is designed to preserve the safety and integrity of the pharmaceutical supply chain by providing assurances that wholesale distribution facilities operate legitimately, and employ appropriate security and best practices for the distribution of prescription drugs.

CVS Caremark only purchases drugs from pharmaceutical manufacturers or their authorized distributors. These suppliers must pass our stringent evaluation and approval process and adhere to our Vendor Quality Assurance Policy. In addition, CVS Caremark participates in a number of industry groups and initiatives that focus on improving the safety and security of the pharmaceutical supply chain. In 2008, we participated in both the global and U.S. health care teams for GS1 and the National Association of Chain Drug Stores Supply Chain Council.

The Right Resources

Proper pharmacy staffing is an important factor in ensuring patient safety and prescription accuracy. Our retail pharmacy workflow system is designed to have the flexibility to safely accommodate a range of pharmacist-to-technician ratios. We use a variety of factors to determine the appropriate staffing ratios for each of our pharmacies, including prescription volume, types of prescriptions to be filled, levels of automation that exist, and state board of pharmacy regulations. If a state does not provide ratio guides, we typically maintain a 3:1 technician-to-pharmacist ratio. At least one pharmacist is required to staff the pharmacy counter in our stores at all times.

The role of our 25,000 pharmacists is to provide counseling to patients, oversee pharmacy technicians and dispense medicines safely, accurately and efficiently. While pharmacy technicians do not fill prescriptions, they do support pharmacists by entering data, managing the cash register, resolving insurance issues and managing inventory, all under the direct supervision of a pharmacist. In some states, pharmacy technicians must be registered or certified by the state pharmacy board. Our training program involves a rigorous curriculum that meets or exceeds the standards of state pharmacy boards. We require technicians to pass internal training at three levels as they advance their responsibilities and we encourage them to obtain national certification through the Pharmacy Technician Certification Board.

The Right Technology

CVS Caremark continuously invests in innovative, state-of-the-art technology and automation solutions that are integrated into our organized workflows, helping to ensure safety and accuracy in filling prescriptions.

e-Prescribing

CVS Caremark is a leading advocate for the adoption and use of e-prescribing technology, because we believe the direct transmission from prescriber to pharmacy leads to improved prescription quality, safety, and ultimately, improved health outcomes. All of our facilities are equipped to accept electronically generated prescriptions. We are the only PBM with its own e-prescribing solution (iScribe®) and the first national pharmacy chain to have all retail pharmacies e-enabled.

Effective Management of Prescription Recalls, Returns and Disposal

We have effective processes in place for immediately managing pharmaceutical recalls and safely handling the return and disposal of medication.

Prescription Recalls/Alerts

To help ensure prescription safety and quality, we fully comply with all product alerts and recalls.

In 2008, the FDA issued an import alert for drugs from two Ranbaxy facilities in India that manufacture some of our products. We immediately informed our pharmacists about the FDA announcement, and in keeping with the direction of the FDA recommended consumers continue taking medication manufactured by Ranbaxy so as not to disrupt their drug therapy. While a recall was never issued, we continue to monitor the situation carefully and will follow the direction of the FDA in regard to any further action that needs to be taken.

Handling Returns and Disposal of Pharmaceuticals

We have clear policies and procedures in place for all of our operations and adhere to all federal and state regulations regarding the handling of pharmaceutical and over-the-counter medicines returned for any reason by the customer.

Returned medication is kept in a quarantined area until it is picked up, processed and sent to a third party to be destroyed. A similar process is used for expired pharmaceuticals. Colleagues who are responsible for handling returned and expired drugs are trained on our policies and procedures as part of their orientation.

Safe Consumer Disposal of Prescription Drugs

Proper consumer disposal of unused, unneeded and expired prescription drugs is a complex issue and an industry-wide concern. The pharmacy industry is starting to explore the feasibility of a take-back pharmaceutical program. Among the many complex factors to be sorted out are how to eliminate the risk of contamination and infection when drugs are returned from extremely sick patients, and how to store returned drugs in a secure location within the pharmacy. CVS Caremark is committed to working with our peers to develop an industry-wide solution.

In the meantime, we recommend that customers and patients follow the 2007 guidelines for the safe disposal of prescription drugs, which were issued by the White House Office of National Drug Control Policy, the Department of Health and Human Services, and the Environmental Protection Agency. Our specialty pharmacies also provide patients with instructions and kits for proper and safe disposal of their injectable medicines and related supplies.