CVS Caremark-sponsored research finds FDA drug warnings can fuel medication nonadherence
WOONSOCKET, R.I. — Food and Drug Administration drug warnings can have an immediate negative impact on medication adherence among patients, even if the warnings are not safety related, according to new research sponsored by CVS Caremark.
The research found that immediately following a high-profile FDA communication questioning the efficacy for a cholesterol-lowering drug, the monthly level of patients who stopped filling their prescription increased by nearly 6%. In addition, of those patients who stopped taking the drug after the FDA warning, only 16.5% switched to another clinically appropriate therapy.
The study, entitled "Warnings without guidance: Patient responses to an FDA warning about ezetimibe," was conducted by researchers at Harvard University, Brigham and Women’s Hospital and CVS Caremark, and was published in the June 2012 issue of the journal Medical Care.
"These findings suggest that when an FDA communication about a prescription drug is widely reported in the news media and is not related to a safety issue or accompanied by clear guidelines about how to apply this information, the resulting confusion can bluntly reduce overall rates of treatment," stated study co-author Niteesh Choudhry, who is with Brigham and Women’s Hospital. "Furthermore, if patients respond to this information by stopping therapy altogether and do not switch to another clinically appropriate medication, there could be a negative impact on health outcomes, which runs contrary to the intent of the initial communication."
Researchers from Harvard University, Brigham and Women’s Hospital and CVS Caremark reviewed the impact of an FDA communication made on Jan. 25, 2008, regarding the cholesterol-lowering medication ezetimibe. The FDA issued an early communication after results from the ENHANCE trial indicated that adding ezetimibe (known as either Zetia or the ezetimibe-simvastatin combination Vytorin) to a treatment regimen including simvastatin did not appear to improve patient outcomes. The FDA raised questions about the effectiveness of the drug in its communication, but did not advise healthcare professionals to discontinue prescribing these products. The communication received substantial media attention.
"This study provides an interesting perspective on how information made available to both healthcare practitioners and patients about the effectiveness of a drug can impact patient behavior and result in nonadherence," added Troyen A. Brennan, EVP and chief medical officer of CVS Caremark. "The results suggest that a more robust understanding of how and why patients respond to drug information could lead to even more effective public health warnings regarding new data about medications."
The researchers reviewed de-identified claims data for more than 860,000 patients identified as new users of ezetimibe between January 2006 and August 2008. The researchers estimated trends in discontinuation rates of ezetimibe during three time periods: before the FDA communication (January 2006 to December 2007), during the transition period when the FDA communication was issued (December 2007 to January 2008) and after the communication (January 2008 to July 2008).
In addition to the key findings related to drug discontinuation and low levels of drug switching to a clinically appropriate alternative, the researchers found that several patient characteristics were associated with discontinuation rates after the FDA warning had been issued. Overall, patients who resided in lower-income areas had a 12.9% lower rate of discontinuation compared with patients living in the highest income areas; female patients had a 6.9% lower rate of discontinuation compared with male patients; and younger patients had lower rates of discontinuation, with patients ages 18 to 34 years old having a 32.4% lower rate of discontinuation compared with patients older than 65 years of age.
This study is a product of a research collaboration between CVS Caremark, Harvard, and Brigham and Women’s Hospital that is focused on understanding why many consumers do not take their prescriptions as directed, and developing solutions to assist patients in using their medications effectively. Excess healthcare costs due to medication nonadherence in the United States are estimated to be as much as $300 billion annually.
Nurse practitioner and physician assistant perceptions on administration of flu vaccine in the retail clinic
Today, injectable vaccines are packaged in two types of containers: (1) vials, either a multi-dose or single-dose; or (2) pre-filled syringes, those filled by the vaccine manufacturer. Vials require manipulation or transfer of the vaccine into an injection device while a pre-filled syringe is supplied as a unit-dose, ready-to-administer syringe. Vials have a total of 12 preparation steps, whereas a pre-filled syringe has a total of four preparation steps. The reduction in number of preparation steps has numerous efficiency and potential worker and patient safety implications.
Additionally, the setting for immunizations in the United States is rapidly changing, as evidenced by more people being immunized in nontraditional settings, most notably in retail-based environments. In the 2010-2011 influenza immunization campaign, approximately 18.5% of adults ages 18 years and older were vaccinated in a retail setting.1
The impact of vaccine packaging has recently been studied in traditional immunization venues.
During the 2009-2010 flu immunization campaign, a time and motion study by Pereira and Bishai of The Johns Hopkins University Bloomberg School of Public Health concluded the choice of vaccine packaging will have an impact on the efficiency of the immunization process.2 More specifically, by measuring the difference in preparation time, the study estimated that for every 100 vaccine doses prepared for injection, about one hour of clinician time could be saved by using pre-filled syringes as opposed to multi-dose vials. The economic implication of this efficiency saved about $1.10/dose, excluding the acquisition cost of the vaccine.2 A complete cost analysis would need to factor in not only acquisition costs of the vaccines, but also the opportunity cost of lost clinician or pharmacist time and, in the unlikely event of a safety mishap, any potential costs related to those events. Finally, the study also concluded that when using multi-dose vials there is an increase in potential for problems. The problems cited in the study are also consistent with those indicated by the National Center for Immunization and Respiratory Disease and include, but are not limited to vaccine waste, bacterial contamination, administration errors, storage under inappropriate conditions and reduced vaccine potency.3
In 2011, the Convenient Care Association was interested in studying the impact of vaccine packaging in a retail clinic setting and conducted a pilot program. The pilot program looked at the perceptions of nurse practitioners and physician assistants working in 31 retail health clinics operated by The Little Clinic regarding the preparation and administration of flu vaccine via pre-filled syringes versus multi-dose vials. By assessing providers’ perceptions only, this study differs from Pereira and Bishai’s time-motion study, which recorded actual time and use differences between pre-filled syringes and vials. Below is a discussion of how NPs and PAs perceive providing flu vaccine with pre-filled syringes versus multi-dose vials.
Twenty qualitative phone interviews were conducted with nurse practitioners and physician assistants at The Little Clinic convenient care clinics after they had administered at least ten injections with pre-filled syringes. The normal method of administration is multi-dose vials. The qualitative interviews elicited the following themes:
- Pre-filled syringes were more efficient because they were quicker, simpler, and more convenient to use and involved fewer steps;
- Having a fine gauge needle already attached to the pre-filled syringe would increase efficiency;
- Providers liked the ease of recording vaccine administration with pre-printed pull-off labels with lot numbers; and
- Multi-dose vials take up much less storage space.
- Pre-filled syringes are safer, ensuring correct dose and correct vaccine;
- Provider needle sticks can happen with both methods of delivering vaccine. Withdrawing from a multi-dose vial increases the risk of provider needle sticks, as ideally the needle is changed between withdrawing from the multi-dose vial and injecting the vaccine, with a needle being uncapped twice and disposed of twice;
- With multi-dose vials, there is an opportunity to contaminate the vaccine; and
- Some patients request pre-filled syringes for the added assurance of the correct medication and the correct dose.
- Pain is not impacted by presentation of flu vaccine administration;
- Pain is impacted by gauge of needle used to administer vaccine;
- Patients have reported vaccines hurt or burn with both methods of administration;
- Patients, especially children, appeared less stressed, anxious or apprehensive with pre-filled syringes, than when vaccine is withdrawn from a multi-dose vial in front of them; and
- Most providers prefer pre-filled syringes over multi-dose vials, although some providers that had more experience using the syringes associated with multi-dose vials reported greater familiarity and comfort with these syringes.
Fifty-eight written surveys were completed by providers at The Little Clinic convenient care clinics who administer flu vaccine to the public, after they had administered at least 10 injections with pre-filled syringes versus their normal method of administration using multi-dose vials. The survey questions were answered by placing an X on a visual analog scale that consisted of a 10-cm horizontal line. “Pre-filled syringe” was written at the far left side of the 10-cm horizontal line and “multi-dose vial” at the far right side of the line. The mid-point of the line was marked as neutral. When scored, the Xs were given numbers of 5, 4, 3, 2 or 1, defined by where they fell within the line, which was divided into five equal sections. The Xs were scored as 5 or 4, if on the first or second section of the line on the left (indicating pre-filled syringes). The Xs were scored as 3 or neutral if they were in the middle or third section of the line, and 2 or 1 if on the fourth or fifth section of the line (indicating multi-dose vials). The percent, the mean (the average) and the mode (most frequent) follow for each of the questions:
The first three questions on the survey addressed operations:
- Eighty-four percent indicated pre-filled syringes are more efficient with a mean of 4.4 and a mode of 5.
- Sixty-two percent indicated pre-filled syringes provide a better likelihood of accuracy and reduce the possibility of recording incorrect information with a mean of 4.1 and a mode of 5.
- Eighty-nine percent indicated multi-dose vials use less storage space with a mean of 1.6 and a mode of 1.
The next three survey questions addressed safety:
- Seventy-six percent indicated pre-filled syringes were safer for the patient, ensuring correct dose and correct vaccine with a mean of 4.3 and a mode of 5.
- Sixty-four percent indicated pre-filled syringes reduced the chance of needle sticks to the provider with a mean of 4.1 and a mode of 5.
- Ninety-five percent indicated pre-filled syringes have a lower probability of contamination with a mean of 4.7 and mode of 5.
The last three questions on the survey addressed preference/experience:
- Ninety-three percent perceived neither method as more painful with a mean of 3.1 and a mode of 3.
- Forty-seven percent indicated multi-dose vials were more stressful, and 33% were neutral, indicating neither method was more stressful with a mean of 2.5 and a mode of 3.
- Seventy-six percent preferred pre-filled syringes with a mean of 4.2 and a mode of 5.
The perceptions of nurse practitioners and physician assistants as gathered in this study can help guide best clinical practices for delivering immunizations and/or injections in the retail clinic. If new best practices are adopted, external environmental controls are needed to increase adherence. Accreditation organizations should create standards requiring storing and dispensing medications in ready-to-use units. Adoption of pre-filled units will remove the risks inherent in using multi-dose vials, as noted in both this study and The Johns Hopkins University Bloomberg School of Public Health study. New standards would provide justification and additional incentive for pharmaceutical companies to redesign their existing offerings — e.g., packaging changes or other necessary designs — in order to meet the standards.
- Only providing flu vaccine in pre-filled syringes would reduce the chance of contamination of vaccine and dramatically lower the chance of giving the wrong vaccine or dose.
- The industry (vaccine manufacturers, distributors, device manufacturers and retail clinics) should partner and collaborate to identify solutions that address storage considerations for pre-filled units.
1 2010-2011 Influenza Vaccine Production and Distribution Market Brief, HIDA, September 2011.
2 Pereira, C.C. and Bishai, D. (2010).Vaccine presentation in the USA: Economics of Pre-filled Syringes Versus Multi-dose Vials for Influenza Vaccination. Expert Reviews 9(11): 1343-1349.
3 National Center for Immunization and Respiratory Diseases (NCIRD). Influenza 2008–2009: ACIP recommendations. www2a.cdc.gov/podcasts/player.asp?f=11041#transcript
This study was funded by a grant from Becton, Dickinson & Co. to the Convenient Care Association. The authors of this study have no other relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or material discussed in this manuscript. An Institutional Review Board was not needed as this was a survey of providers with no identifiers attached to their responses. Special thanks to The Little Clinic and their clinicians for completing the qualitative and written surveys.
About The Little Clinic
Founded in 2003 and headquartered in Brentwood, Tenn., The Little Clinic is a pioneer in customer-focused healthcare with a mission to provide convenient, affordable healthcare and wellness education. A wholly owned subsidiary of The Kroger Co., The Little Clinic healthcare clinics are currently located inside select Kroger stores in Georgia, Kentucky, Tennessee and Ohio; King Soopers in Colorado and Fry’s Food Stores in Arizona. The Little Clinic was awarded The Joint Commission Gold Seal of Approval in 2009 and obtained reaccreditation in 2012. Visit The Little Clinic online at www.thelittleclinic.com, www.facebook.com/thelittleclinic and www.thelittleclinic.blogspot.com.
CVS/pharmacy announces return of its ‘free gas’ promotion
WOONSOCKET, R.I. — Just in time for the kick off of this year’s Memorial Day weekend, CVS/pharmacy is bringing back its "Earn Free Gas" promotion, which allows ExtraCare members to earn free gas cards throughout the spring and summer by shopping for household essentials, health and beauty products, and snacks at store locations nationwide.
Last year, more than 1 million free gas cards were issued to shoppers who took advantage of the summer-long deal. This year, members of the CVS/pharmacy ExtraCare program can earn up to five $10 gift cards to Exxon/Mobil or Shell during select weeks from May through August by spending $30 on specially marked items found in the weekly CVS/pharmacy circular.
"At CVS/pharmacy, we are committed to finding ways to provide our customers with personalized value each time they shop. This year’s earn free gas promotion delivers on that promise and builds on the success and popularity of our program last year by giving customers an easy way to earn up to $50 in free gas while shopping for select essential items in our stores this summer," stated Judy Sansone, SVP merchandising for CVS/pharmacy.
Customers can find the qualifying products on the front and back pages of the weekly CVS/pharmacy circular beginning May 20, available in-store, online and on Facebook. All qualifying products will be specially marked with a "gas!" symbol to make them easily identifiable.
Once ExtraCare customers reach the $30 required purchase threshold, a special coupon will print on their receipt that can be redeemed immediately in store for a $10 gas card. If customers prefer to wait to redeem their coupon, they have up to 30 days to do so. There is a limit of five redemptions per week for each ExtraCare cardholder. The promotion will take place throughout the summer.
This is the latest example of how CVS/pharmacy is making it easy for customers to gain ExtraSavings and earn ExtraBucks Rewards through the ExtraCare program all year long. Most recently, CVS/pharmacy has given customers the option of sending their earned quarterly ExtraBucks Rewards and personalized ExtraCare email coupons to their cards directly for digital redemption, eliminating the need for any printing.
In addition, CVS/pharmacy introduced an updated mobile app — available as a free download from Apple’s App Store or through Google Play — that allows shoppers to store their ExtraCare card digitally in their smartphone, eliminating the need to carry a physical rewards card when shopping.
The CVS/pharmacy ExtraCare program is the largest retail savings and rewards program, with more than 69 million active cardholder households.