Lack of guidelines and recommendations on use, ill-defined value of care, patient preference, and physiciansâ€™ lack of awareness are among the factors that can prevent widespread adoption of new medications.
Ultimately, the discoveries and achievements of clinical research do not matter if physicians do not implement the guidelines created from those results. Paul Heidenreich, MD, MS, professor of medicine (cardiovascular) and professor by courtesy of health research and policy at the VA Palo Alto Health Care System, examined the limiting factors controlling widespread guideline implementation. In a presentation at HFSA 2016, he described the historical implementation time frames â€‘â€‘ initial guideline recommendation to widespread practice. In the end, he noted that electronic records can be expected to shorten this timeframe.
Heidenreich pointed out that it routinely takes about 18 years before a novel drug is accepted and commonly used in practice. With the threshold for widespread implementation defined as use by 90% of polled physicians, the “Get-With-the-Guidelines” program implemented in hospitals by the AHA took 18 years before ACE inhibitors were commonly implemented, as had been recommended for treating left ventricular systolic dysfunction (LVSD). In the case of evidence-based recommendations on the use of beta blockers, it was not until 2011 that the guideline-recommended drug was commonly implemented. This included metoprolol succinate and carvedilol, but not the short-acting metoprolol. Again, it was about 18 years from initial recommendation time to widespread implementation. Aldosterone candidates for LVSD face similar timeframes.
Heidenreich identified several factors that he said control implementation of new medications into common practice. First, each new therapy will have its own distinct barriers. In the US especially, guidelines are needed before most physicians (and payers) will adopt new remedies. The value of care delivered is getting more and more attention, as it can dramatically affect implementation. “I don’t think one can assume that just because the drug has a benefit you are going to get things implemented,” Heidenreich said.
Historically, the big players have introduced 34 new drugs or 27 new devices, with each costing roughly $450 million or $300 million, respectively. However, when the product’s price is elevated 10-fold (as with the new hepatitis C drugs), many payers just flatly respond that they cannot pay that.
Available analysis presented by Heidenreich was focused more on general healthcare, not only cardiovascular disease. The most common cause of failure to implement general healthcare guideline treatments was that physicians were not aware of recommendation specifics. This occurred approximately 50% of the time. Heidenreich presented several useful strategies for addressing this problem, including: distribution of guidelines/summary guidelines, staff meetings, pocket cards, and grand rounds. Other causes of failure to implement guideline-recommended practices (20-25%) included patient preference, disagreements with the recommendation, physician finding the recommendation confusing, or the physician assumed the patient would not comply/be able to afford the new treatment.
Interventions that have been used to implement heart failure guidelines have included providing a summary guideline, staff meetings, pocket cards, local champions, and grand rounds.
Now, with electronic medical records, Heidenreich said we have a new opportunity to identify who is not following guidelines and promote adherence through the use of computerized reminders.
In conclusion, guideline recommendations are necessary to drive uptake. All therapies must show cost-value and budget impact before implementation can be expected to be successful. Each therapy will have distinct barriers to implementation. Electronic records will provide much quicker analysis to identify barriers to implementation going forward.
During the ensuing discussion, one physician expressed concern that a primary care physician may have 50 patients, each with different conditions. How can he or she be expected to know what to do for all of them? Heidenreich expressed sympathy and understanding for this real-world concern, especially when physicians in that setting may only have 10 minutes for each patient. He emphasized that one approach that has been helpful is to integrate pharmacists more fully into the care team.