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New Jersey Division of Consumer Affairs Announces Agreement with CVS

 Addressing Errors That Led to Prescriptions Being Filled With the Wrong Pills at Five New Jersey Pharmacies spacer spacer spacer spacer spacer

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February 25, 2013 NEWARK – Attorney General Jeffrey S. Chiesa and the New Jersey Division of Consumer Affairs today announced an agreement with CVS-Caremark, resolving incidents at five separate CVS pharmacies in Camden, Morris and Union counties.

The pharmacies mistakenly commingled various types of pills that had very different medical effects. As a result of those mistakes, some patients received pill bottles containing the wrong medication. The pharmacies in question are located in Budd Lake, Chatham, Cherry Hill, Rahway, and Scotch Plains.

“The Division of Consumer Affairs launched an immediate inquiry to ascertain the facts, and potential harm to consumers, of a pill dispensing error at the CVS in Chatham – and soon learned about similar incidents at a total of five CVS pharmacies across New Jersey, all within a short span of time,” Attorney General Chiesa said. “In order to protect the public and prevent these errors from happening again, the Division pushed CVS to work with us on an effective solution. As a result, CVS has already begun to enhance its quality and safety assurance measures, and has agreed to contribute $650,000 toward a Division of Consumer Affairs education and enforcement campaign on prescription drug safety and abuse.”

Attorney General Chiesa noted that, throughout the Division of Consumer Affairs inquiry, CVS displayed a commitment to develop and implement enhanced strategies to prevent the errors that led to these incidents, from happening again.

Under the agreement, CVS has retrained its staff members and enhanced the oversight and quality assurance measures at its New Jersey pharmacies. These enhanced measures include closer monitoring to ensure prescriptions are filled accurately, before they are dispensed. The company will also give consumers additional resources to check the accuracy of their own medication. For example, the CVS website will provide color images of medications and will offer a personalized prescription profile for each customer. CVS will also pay the Division of Consumer Affairs a total of $650,000 in part to fund a public education campaign, to advise New Jersey’s consumers of the need to carefully check their medication, ask their pharmacist or physician when they have questions about medications, check available resources to learn about their prescriptions, and to make the public aware of the dangers of prescription drug abuse.

“This agreement includes a significant payment from CVS to help us educate the public about the importance of ensuring that individuals receive the correct medications,” said Acting Director of the State Division of Consumer Affairs Eric T. Kanefsky. “The prescriptions that pharmacies dispense include Controlled Dangerous Substances. The fight against the abuse and diversion of dangerous medications, including CDS, has been a priority of the Division in recent years. Our efforts must include steps like those CVS has now put in place, to ensure the integrity of the process by which CDS and all medications are dispensed.”

The Division of Consumer Affairs began investigating CVS in response to an incident that took place between December 2011 and January 2012 at the CVS pharmacy at 471 Main Street, Chatham. Patients came to the pharmacy with prescriptions for tablets of children’s chewable fluoride. On a total of 15 occasions, pill bottles that were supposed to contain fluoride tablets also included tablets of tamoxifen, a breast cancer treatment drug. The pills are similar in size, shape, and color, but can be distinguished by their imprint codes. Fluoride tablets are stamped “SCI” on one side and “1007” on the other, while tamoxifen pills have “M” on one side and “274” on the other.

Upon learning of the incident, the Division ordered CVS to produce extensive documentation, and provide corporate representatives to come in and answer questions under oath at the Division’s headquarters in Newark, about the Chatham pharmacy’s operations and about any other incidents in which pills may have been inappropriately commingled.

During the subsequent inquiry, CVS provided information about the following incidents, all of which occurred during 2012:

  • On or about March 3, the CVS pharmacy at 600 North Kings Highway, Cherry Hill, mistakenly commingled metoprolol, a high blood pressure drug, with risperidone, which treats schizophrenia. Three commingled containers were dispensed to consumers who had prescriptions for the blood pressure drug. Other containers, containing the wrong medication, were detected and corrected before leaving the pharmacy.
  • On or about March 7, the CVS pharmacy at 255 Route 46, Budd Lake, had a single dispensing error in which a patient was meant to receive metformin, a diabetes medication, but instead received pravastatin, a cholesterol drug. The patient was concerned she may have consumed the wrong medication, and visited an emergency room.
  • On or about March 11, a CVS in Rahway filled a prescription calling for tablets of Coreg, a blood pressure drug, at 20 milligrams per tablet. The pill container included the correct medication as well as more powerful 80 milligram tablets of Coreg. There is no indication that the patient took the wrong medication.
  • On or before March 24, the CVS pharmacy at 415 Park Avenue, Scotch Plains, dispensed approximately 30 prescriptions from an automated filling machine in which pills for atorvastatin, a cholesterol drug, were accidentally commingled with pills for losartan, a blood pressure drug. There is no indication that patients took the wrong medication.

In response to these incidents, CVS reached out to all potentially affected consumers, directed them to appropriate medical resources, and took steps to replace the mistaken products with the correct medications. CVS also notified the Division of Consumer Affairs and the State Board of Pharmacy.

The Division’s inquiry included extensive, detailed discussions with CVS personnel and counsel, and review of the CVS internal investigations. It also included on-site pharmacy inspections by the Division’s Enforcement Bureau, as well as consultation with the State Board of Pharmacy which has independent jurisdiction to license and oversee pharmacists, and register and oversee pharmacy technicians.

The Division’s inquiry revealed that the errors likely arose when staff members deviated from CVS policies and mechanisms intended to ensure accuracy in dispensing. For example, when returning unclaimed prescriptions back to store inventory, employees may have poured the pills into the wrong stock bottles even though CVS policy dictated that unclaimed prescriptions should not be returned to stock bottles at all. Additionally, some errors involved the use of automated filling machines, which had been loaded by staff with bins of improperly commingled pills.

Under its agreement with the Division of Consumer Affairs, CVS admits no liability for the medication errors, but agrees to take the following steps at all of its New Jersey pharmacies:

Retraining and enhanced procedures.

  • CVS has retrained the staff at all of its New Jersey pharmacies in procedures to be followed when unclaimed prescriptions are returned to pharmacy stock. Some of the errors arose when employees overlooked or circumvented the company’s longstanding procedures.
  • CVS has retrained all specialists assigned to stock and dispense medications from automated filling machines. CVS stopped use of the automated filling machines in its New Jersey locations until staff responsible for filling the machines had been retrained.
  • CVS has established enhanced procedures regarding the use of automated filling machines. A pharmacist will visually inspect every pill before loading the machines. Routine refilling of all machines will be scheduled to occur only during specific “down time,” enabling this critical function to take place during less-pressured business hours.
  • CVS will continue to adhere to its various policies intended to ensure accurate and safe dispensing. Pharmacy supervisors will advise CVS employees throughout New Jersey that noncompliance with company policy and procedure will result in employment consequences proportionate to the conduct.

Inspection and oversight.

  • The pharmacist-in-charge at each New Jersey CVS pharmacy will conduct quality assurance reviews at least once every month, with a particular focus on medication safeguards.
  • District supervisors will conduct store visits at least once every month. They will look for any indicators that CVS procedures need reinforcement or that specific individuals need retraining.
  • CVS will notify the Division of Consumer Affairs and State Board of Pharmacy within three days after CVS’s quality assurance department learns that a commingling error has occurred. Within 10 days of learning about an incident, CVS will provide the Division and the Board of Pharmacy with a full report that will include a summary of its investigation and an assessment of the source of the error.

Public awareness.

  • CVS will pay $650,000 to the Division in order to fund a public awareness campaign about the dangers of prescription drug abuse, as well as various concerns associated with the proper use of prescription drugs. The payment will also reimburse the Division for attorneys’ fees and investigative costs incurred during its inquiry into CVS’s activities.
  • CVS will use its website to make pill images and clinical information about medications available to the public. In addition, each CVS customer will be able to view a personalized prescription profile online, with color images of medications and clinical information. This will give the public an additional resource to check the accuracy of medication.
  • CVS will provide posters and single-page pamphlets or similar notices to its New Jersey pharmacies, reminding patients to compare the written description on their prescription labels to the actual contents of the prescription vials.

Prescription Monitoring Program.

  • CVS is now providing its New Jersey pharmacists with direct computer access to the New Jersey Prescription Monitoring Program (NJPMP). The NJPMP is a powerful database, maintained by the Division of Consumer Affairs, which tracks prescriptions for Controlled Dangerous Substances and Human Growth Hormone throughout New Jersey. NJPMP data is provided to registered prescribers and pharmacists, and made available to law enforcement, in order to help root out the illegal diversion and abuse of prescription drugs.
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