What Compounding Pharmacists Need to Know About Adherence to Statin Treatment

What Compounding Pharmacists Need to Know About Adherence to Statin Treatment

i-pillEven when they’re written for consumers, medical references tend to be dry and ultra clinical. When you look up statins, you’ll usually find something along the lines of, “statins are generally well tolerated, but patients should be monitored for side effects such as muscle pain and weakness.” They could provide a more realistic perspective if a sidebar was included with actual stories from patients. The following example might be more effective in conveying symptoms to look out for: after one individual started taking a statin, his wrists and hands hurt too much to hold onto anything, family members noticed his leg muscles shook when he walked and muscle aches kept him awake at night.

Adverse effects are one of the biggest reasons patients stop taking statins, but they’re not the only reason. To help these patients, compounding pharmacists need to know all the details associated with adherence to statin treatment.

Statin News Includes Pulled FDA Approvals

Several recent studies suggest therapeutic benefits from statins beyond lowering cholesterol, which effectively expands the potential market. But sometimes the news goes in a different direction, such as happened in April 2016, when the FDA withdrew approval for adjunctive use of niacin and fenofibric acid with statins.1 Citing three cardiovascular outcome trials—AIM-HIGH, ACCORD and HPS2-THRIVE—the FDA decided that the benefits of niacin ER tablets and fenofibric acid capsules for co-administration with statins no longer outweigh the risks.

In more positive news, these studies highlight advances in statin research:

  • PCSK9 inhibitors: Results from the Phase 3 GAUSS-3 trial released in April 2016 show that evolocumab is an effective alternative for statin patients with muscle-related side effects.2 After six months of treatment, it significantly reduced LDL cholesterol levels compared with ezetimibe. The study also included a statin rechallenge, which verified reproducible muscle symptoms caused by statins.
  • Age-related macular degeneration: Patients with the dry form of age-related macular degeneration may finally have a treatment that stops progression to neovascular AMD. Researchers at Harvard Medical School reported that 10 out of 23 patients with AMD had significant regression of drusen deposits following treatment with atorvastatin 80 milligrams daily, while eight had nearly complete regression.3

Noncompliance with Statin Medications Needs Attention

The 2013 clinical practice guidelines for high cholesterol changed the game, as they recommended statins for patients aged 40 to 75 with a high risk for a heart attack or stroke within 10 years. Data from the Framingham Heart study affirmed the guidelines, showing they accurately assess those who might benefit from statins.4 A study released in March 2016 goes even further, suggesting the guidelines should be broadened to include patients younger than 40 if they have high cholesterol.5 At the same time, some cardiologists dispute the key indicators used to calculate the 10-year risk and worry it leads to over-prescription of medications.

The hard truth comes down to this: guidelines don’t matter if patients don’t take their prescribed medication—and adherence to statins is low. One review of insurance records estimated that only one out of five patients take their statin medication regularly. Another study noted that half of all patients stop taking statins in the first year and only 36 percent of patients with CAD are adherent.6 Noncompliance is one problem that pharmacists can change by reaching out when patients fill their first statin prescription. Compared to a visit to the doctor, where so much info must be communicated during a short time, statin patients are more likely to listen to your timely and medication-specific advice.

Consider Patient Perspectives to Improve Adherence to Statin Treatment

When you counsel statin patients keep this in the front of your mind—they’re expected to take (and pay for) a medication for a condition that has no symptoms. These patients need to be motivated to stick with the regimen, especially if they’re young enough to figure high cholesterol is an age-related problem. Adverse effects are the number one reason patients stop taking their statins, but here’s an interesting twist: some discontinue meds not because they’ve experienced side effects, but because they read about problems associated with statins. It’s important to consider some counseling considerations:

Ask about symptoms: Muscle pain and weakness are the most common symptoms. The risk is small for other statin side effects, such as liver damage, diabetes and memory loss, but just hearing about serious problems is enough to make patients stop taking meds.

Schedule a medication review: An appointment to review meds is vital because drug interactions with statins are common. Any medication that inhibits isoenzymes, especially CYP3A4, may lead to high statin levels and increase the risk of myalgia and myositis.7

  • Pharmacists need to intervene because about 74 percent of patients don’t tell their physician about all the meds, OTC products and dietary supplements they take.
  • For patients on multiple meds, recommend a compounded solution that simplifies their daily regimen using combination pills—simplification can boost adherence by 11 percent.
  • Double check statin doses for women with chronic heart disease. Prescribed doses are more likely to be inadequate for women than men.8
  • Medication review is especially important for patients using simvastatin, as FDA safety advisories have been updated several times. At present, the dose should not exceed 10 milligrams for patients taking antihypertensives or 20 milligrams for patients taking verapamil or diltiazem. It’s also contraindicated with itraconazole, ketoconazole, erythromycin, HIV protease inhibitors and cyclosporine, to name only a few on the list.

Patient education: Lack of knowledge ranks high on the list of roadblocks to adherence. It doesn’t have anything to do with innate intelligence; it’s all about perceptions and lack of communication. For example:

  • They feel healthy, so they don’t appreciate the need for medication.
  • Patients may not understand the risk of heart attacks and strokes, or that their risk of dying triples if they’re noncompliant.
  • Maybe they still hope to lower cholesterol using diet and exercise, which may not have been part of the discussion with their doctor.
  • Helping patients learn to identify pills and use a system such as a pill box may improve adherence.

You don’t need to give patients all the answers—just ask some key questions to assess their understanding, give them an informative brochure and stress the importance of discussing the issue with their doctor.

Compounding Pharmacists Can Boost Statin Adherence

Much of your effort to improve adherence to statin treatment can take place during medication reviews or through a word of encouragement when patients pick up medications. Simple reinforcement and reminders, even by phone or mail, are estimated to increase adherence by up to 24 percent. Ultimately, patients will recognize your expertise and appreciate the discussion to help them learn about their medications.

Pharmaceutica North America provides the highest quality active ingredients and delivery systems for compounding pharmacists. Whether you need bulk APIs or custom compounding kits, contact us to discuss how we can support your patient’s medication requirements.

Show 8 footnotes

  1. “FDA Pulls Approval of Niacin, Fibrate in Combo with Statins,” April 2016, http://www.medscape.com/viewarticle/862022
  2. “Efficacy and Tolerability of Evolocumab vs Ezetimibe in Patients With Muscle-Related Statin Intolerance,” April 2016, http://jama.jamanetwork.com/article.aspx?articleid=2511043
  3. “Regression of Some High-Risk Features of Age-related Macular Degeneration (AMD) in Patients Receiving Intensive Statin Treatment,” March 2016, http://www.ebiomedicine.com/article/S2352-3964%2816%2930029-9/abstract
  4. “Studies Support Broader Use of Cholesterol-Lowering Statins,” July 2015, http://www.health.harvard.edu/blog/studies-support-broader-use-of-cholesterol-lowering-statins-201507168142
  5. “Individualized Statin Benefit for Determining Statin Eligibility in the Primary Prevention of Cardiovascular Disease,” March 2016, http://circ.ahajournals.org/content/133/16/1574
  6. “How Do We Improve Patient Compliance and Adherence to Long-Term Statin Therapy?” January 2013, http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3534845/
  7. “Optimizing Statin Therapy by Avoiding Clinically Relevant Drug Interactions,” March 2016, http://www.pharmacytimes.com/publications/issue/2016/March2016/R756_March2016
  8. “Gender Differences in Statin Prescription Rates, Adequacy of Dosing, and Association of Statin Therapy with Outcome After Heart Failure Hospitalization: A Retrospective Analysis in a Community Setting,” March 2016, http://www.ncbi.nlm.nih.gov/pubmed/26581760
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