Harms to competition, and to consumer choice, cost, and privacy cited.

Community Catalyst joined Consumer Union, US Pirg, the National Consumer Federation, and NLARx to ask the FTC to order CVS-Caremark to undo the four year old merger between the CVS pharmacy chain and Caremark, one of the nations largest pharmacy benefits managers.

The letter, covered in today’s New York Times, describes how CVS has used their role as a pharmacy benefit manager (which simply tells a pharmacy whether your health plan covers your prescription or not) to gain customers over other pharmacies.  The letter notes how recent investigations by the FTC and 24 Attorneys General highlight a number of unfair practices designed to switch consumers to CVS pharmacies.

For instance, CVS-Caremark has allegedly charged consumers higher co-payments at  non-CVS pharmacies.  Also, by listing the  organization’s full name “CVS Caremark” on the benefits card provided to beneficiaries of the health plans Caremark serves, some consumers have been deceived into thinking that they can only fill their  prescriptions at  CVS pharmacies. Perhaps the most shocking conduct is the alleged practice of the pbm Caremark providing confidential consumer information to their CVS pharmacy operations, which allows the pharmacists “to solicit non-CVS customers by phone and mail in order to direct them to fill their prescriptions at CVS stores.”

The FTC has been investigating the anti-competitive practices of CVS-Caremark since 2009, and may decide soon how to address these alleged violations of anti-trust and consumer protection laws. The letter urged FTC to order the merger to be undone, and force CVS to sell its pbm business.  If the FTC decides against ordering the break-up of the CVS – Caremark entity, the letter asks FTC to require strong “nondiscrimination” protections for “consumers and pharmacies from programs … which force consumers to use either Caremark-owned mail order or CVS-owned retail pharmacies and ultimately lead to higher prices for consumers.”  The letter also asks FTC to appoint an “independent trustee” to monitor a “stringent firewall between CVS and Caremark” to “protect the confidential information of patients….”

For more info on some lawsuits by pharmacies and consumers concerning these unfair or anti-competitive practices, see Pharmalot’s blog here.

And to learn more about CVS-Caremarks practices that drive up their health plan customer’s costs, visit Change-to-Win’s Alarmed About CVS Caremark website.

As we reported last month, PAL coalition member Change to Win launched a campaign to challenge CVS Caremark’s [NYSE:CVS] sending of a letter to doctors of specific patients, apparently promoting Merck’s [NYSE:MRK] diabetes drug Januvia. Change to Win launched a website for the campaign, Alarmed about CVS Caremark.

This week, Change to Win announced a broader campaign targetting CVS, Cure CVS Now. On Thursday, December 4, Change to Win held press conferences around the country to announce & launch the campaign, and to issue a report on CVS’s practices, Cure CVS: From Low Quality to High Prices, CVS Is Failing Our Communities.

The press conference in Boston featured speakers from a number of community & labor organizations in the Greater Boston area, including the very young:

At the Cure CVS website describes:

CVS’s growth has come at a high price for many of the communities in which CVS operates. The company’s mission is "to improve the lives of those we serve by making innovative and high-quality health and pharmacy services safe, affordable and easy to access." But, according to the results of a 14-month investigation, CVS actually fails to provide equal and fair access to its services, based on analyses of several key measures. And regulators have raised concerns about quality, overcharges, privacy protection and safety related to CVS.

Explore the issues around some of those concerns:

• CVS Fails to Provide Equal Access
• CVS’s Questionable Products and Services
• CVS May Not Offer a Fair Price
• CVS’s Failure to Protect Private Information
• CVS’s Press for Profits May Put Patient Care at Risk

Change to Win’s investigation and report focus primarily on the “retail,” non-pharmacy side of CVS’s business. We hope that they will also investigate practices and quality at the pharmacy counter. We here at PAL and our coalition members work on numerous aspects of how the pharmaceutical supply affects consumers, but we know that the pharmacy counter is “where the rubber meets the road.”

Since CVS is the nation’s largest pharmacy chain, the public should know how CVS is measuring up on things like pricing of drugs to the uninsured, encouraging use of generics, working conditions for pharmacists and pharmacy technicians (which of course affects consumers as well — in terms of quality of service and prevention of errors), protecting the privacy of patient prescription records, ensuring that patients understand how to take their drugs, etc.

We’ll continue to post updates on Change to Win’s campaigns concerning CVS as they become available.

We noted this Newsday story with pleasure: “2 drug chains to provide Rx translation services,” about an agreement between NY Attorney General Andrew Cuomo and the pharmacy chains CVS (NYSE:CVS) & Rite-Aid (NYSE:RAD). Says the article:

CVS and Rite-Aid, will advise pharmacy customers about prescriptions with spoken and written translations in Spanish, Chinese, Italian, Russian, French and Polish, Cuomo said in a news release.

Cuomo’s office launched an undercover investigation after a Brooklyn-based nonprofit, Make the Road by Walking New York, complained that pharmacies “routinely fail to advise non-English-speaking customers in a language that allows them to understand the purpose, dosage and side effects of their medications,” according to the release.

State law requires pharmacists to “personally provide information about prescription drugs to all patients, orally and in writing,” the release said.

This is great news, given that patients whose first language is not English face major obstacles to getting adequate health care. Recognizing this problem, there are state and federal laws requiring that health care providers (and pharmacies, at least in NY) ensure language access for all their patients/customers.

A patient who can’t read or understand the instructions for a prescription drug can’t take it correctly. They may not understand how often to take it, what time of day to take it, whether to take it with food or not, and whether it has any dangerous drug interactions.

Failing to ensure that the millions of such patients can understand how to take their drugs isn’t just important for them individually and their families — it’s important for the health care system as a whole. Patients who can’t comply with their prescription drug regimen because of language barriers are more likely to have their chronic conditions not controlled. This can lead to a worsening of those conditions (e.g. heart disease, high blood pressure, diabetes), putting them at an increased risk of complications and even death. It also puts them at an increased risk of injury caused by their drugs — because of accidental overdosing and drug interactions.

There’s one thing in particular that jumped out while reading the Newsday story:

CVS and Rite-Aid, will advise pharmacy customers about prescriptions with spoken and written translations

[emphasis added]

If this means that CVS and Rite-Aid will be translating a drug’s official FDA-approved label, who is responsible for the content and accuracy of the translated label? Is it the drug store, which translated it? Or the manufacturer, which wrote the original? Manufacturers would argue, understandably, that they’re not responsible for something they didn’t write/translate.

Medical translation is a delicate art, and minor changes in translation can have major consequences for the meaning of the text once it’s translated. Who does the translating is key. There are translators, and then there are translators. Nuances of meaning and idiom are notoriously tricky, yet are key to adequate understanding. PAL’s parent organization, Community Catalyst, learned this while translating its Generics are Powerful Medicine materials into Spanish (those Spanish-language consumer materials about generic drugs are here.

Some other questions came to mind:

• How will these written translations be done? They can’t be done on an as-needed basis – you can’t exactly translate a drug’s label, or even the instructions for taking it, on the spot in the pharmacy. If they’re done prospectively, what drugs will they be done for? There are tens of thousands of prescription medications on the market in the U.S. Yet a huge percentage of dispensed prescriptions are concentrated in a very small number of best-selling drugs. CVS and Rite-Aid aren’t going to translate the label of every drug on the market, so how do they decide which to do?
• What if there are changes to the drug’s label? Is there an ongoing obligation for CVS and Rite-Aid to update the translations? What if, for instance, new risk information is added to a drug’s label and the pharmacy doesn’t add that to the translation? This could present a liability risk to the pharmacy.
• What if there’s a discrepancy between the original label and the translation? Another possible liability risk for the pharmacy
• How do small independent and community pharmacies fulfill this obligation? They don’t have the resources and the staff to do such translations that chains like CVS and Rite Aid do. Does this place them at an even greater competitive disadvantage than they already are?
• If drug manufacturers know that their drugs’ labels have been translated, do they have an obligation to ensure that those translations are accurate? On the one hand, you can’t make a drug maker responsible for every mis-translation of things they write. But on the other hand, if they know a major chain has translated their materials, do they have a responsibility to check the accuracy?
• How do you guard against differing translations? No two translators will translate the same item the same way. Will there be uniformity throughout, say, all of CVS’s stores? What if CVS’s translation differs from Rite-Aid’s? Consumers change pharmacies at times — this can create patient confusion.

The growth of the number of patients in the U.S. who are not fluent or literate in English suggests that translation of prescription drug instructions and labels is going to be an increasing need. The problems above suggest that there’s a need for uniformity. Perhaps drug manfacturers should proactively translate their materials and labels to ensure accuracy and uniformity. The question arises whether a translated label would require the same FDA approval as the original label, and whether FDA has (a) the capacity to review translations and (b) the regulatory or statutory power to do so.

This is an issue that pharmacists, manufacturers, regulators and advocates for improved language access in health care need to address.

We’d be very interested in pharmacists’ take on this issue. How have you dealt with this in your pharmacy? What do you think needs to be done to ensure that non-English speakers understand their medications? How do we take these steps without overburdening pharmacists, particularly those in small independent and community pharmacies?

David Armstrong reports in today’s Wall Street Journal that Change to Win, a member of the Prescription Access Litigation coalition, is launching campaign to challenge CVS Caremark’s [NYSE:CVS] sending of a letter to doctors of specific patients, apparently promoting Merck’s [NYSE:MRK] diabetes drug Januvia. (“Unions Say CVS Pushed Costly Drug to Doctors“)

As the article reports:

A group of labor unions is launching a campaign that accuses CVS Caremark Corp. of violating patient privacy and improperly pushing doctors to prescribe a costly prescription drug.

Change to Win, a group of unions that represents about six million workers, said CVS’s pharmacy benefits management business has been urging doctors via a letter to add Merck & Co. diabetes drug Januvia to specific patients’ treatments. The letter, obtained by the union group, said CVS identified the diabetes patients through a review of prescription-drug claims processed by its Caremark unit.
[on the rise]

A line at the bottom of the letter says Merck paid for the mailing. Neither Merck nor CVS would say how much Merck paid, and the drug maker also declined to say whether the mailing boosted Januvia sales…

Januvia is as much as eight times more expensive than many other diabetes treatments, according to a recent study. Some medical experts say patients may not need the drug and may respond just as well to older, cheaper treatments…

Change to Win says the Januvia letter is an example of CVS putting its interests ahead of the businesses that pay it to manage employee prescription-drug benefits. CVS became a big player in the pharmacy-benefits business when it acquired Caremark, then the nation’s second-largest PBM, for about $27 billion in 2007.

CVS, the nation’s largest retail pharmacy chain, with approximately 6,800 stores across 41 states, acquired Caremark, one the nation’s three largest Pharmacy Benefit Managers (PBMs) in March 2007. Despite concerns that a company comprised of both a pharmacy chain and a PBM (which are supposed to help control health plans’ pharmacy costs) would have untenable conflicts of interest, the Federal Trade Commission (FTC) approved the merger). Change to Win’s campaign suggests that these concerns were not trivial.

We’ll report more on Change to Win’s campaign as we info becomes available…