Is there a gold standard in medication counselling?


Bottom-Line

  • The Indian Health Service technique has demonstrated  –  in a single moderate quality (pragmatic, non-randomized, unblinded, multicenter prospective trial) of 500 participants  –  to be superior to traditional lecture-style technique in ambulatory non-pregnant adults being able to immediately recall medical information after a single counseling session from a pharmacist
  • Outcomes
    • 71% of the IHS method group successfully recalled medication information vs 33% for the traditional method group
    • Odds of patients knowing when to take their medication and its side-effects profile were about 4 times more likely to happen in the IHS vs the traditional group
    • IHS pharmacists were bringing up side-effects approximately 3 times more often in their counseling.
    • The time required for both groups were 128 and 75 seconds for IHS and traditional, respectively
  • Although promising, the IHS method should be further studied to assess whether it can improve other measures such as long-term adherence, clinical targets; as well as medication-related mortality, morbidity, and health system expenditures

 

Introduction

Believe it or not: the American Pharmacist Association’s code of Ethics prohibited pharmacists from counselling patients about their medications in the 1950s, and only since the OMBRA act passed in 1990 are American pharmacists legally required to counsel on new prescriptions. During the last few decades pharmacists working for the Indian Health Service (IHS) pioneered a new method of pharmaceutical education, with the use of private counseling rooms, to Native American patients across the US. To understand how this method could be beneficial, we have to understand how pharmacists typically educate patients about their prescriptions.

Why a standardized medication counselling technique is needed

A mistake pharmacists commonly make is starting their counselling by saying information the patient already knows.  A more efficient approach to medication education could simply entail that  all pharmacists need to do is to verify the patients’ understanding and fill in the information gaps that they have(PDF). Generally, laws mandate that pharmacists have a professional duty to provide, or at least offer, counselling on new prescriptions to everyone. There does not, however, seem to have unanimous legal definitions detailing which information must be relayed due to various practical reasons (PDF).

Patients who are being prescribed a new treatment want to be educated on basic information regarding their medication(s), specifically: directions of use, drug interactions, and especially information about side-effects.  While this education is a shared responsibility of the prescriber – generally a physician or nurse practitioner – and the dispensing pharmacist, studies indicate that we don’t always counsel patients on directions of use or side-effects. If patients are not counselled adequately on the importance of taking their medications as prescribed, this may lead to dangerous outcomes – due to poor treatment adherence – which cost the American healthcare system at least 100 billion US dollars and is the most important cause of preventable medication-related hospital admissions.

Medication education (also referred to as counselling) is taught in all accredited pharmacy schools but no specific process has universally been established beyond the traditional method. This method is defined as a lecture-style process where the pharmacist talks and the patient listens without any verification of comprehension. However, it is becoming apparent that this traditional method is sub-optimal since studies show that patients retain only half or less of what is being said. There has recently been much effort by pharmacy schools to improve this education gap by using open-ended questions and “show-and-tell” techniques, which are the basis of a relatively new counselling process called the Indian Health Service (IHS) method.

The Indian Health Service method

The method developed by IHS pharmacists is described by Lam et al. in a recent study  which is the subject of this article (fig:1) :

“The second method is the Indian Health Service (IHS) technique, which uses three open-ended questions (prime questions) to verify patient understanding of the name and purpose of the medication, directions for use and storage, what to expect if the medication works, what to do if it does not, and what type of potential adverse effects to look out for, as well as what to do if they should occur. Any gaps in understanding are corrected before moving on to the next prime question. After completing the prime questions, patients are asked to verbally confirm their understanding of the information discussed during the three prime questions (Figure 1). When patients verbalize their understanding by answering the three prime questions and during final verification, the information is placed in longer term or gist memory and is retained longer than the information patients hear in the traditional counseling method.”

indian_health_method

Since the IHS has potential in improving long term patient adherence, some investigators have done a few small studies – most of which are unpublished – and found promising results. Lam and his colleagues are the first to have looked at how effective this method is by comparing the immediate post-counseling retention rates between IHS and lecture-style techniques, and how much time is needed for each counselling method.  They undertook a prospective, nonrandomized observational study at four pharmacies where half would utilize the IHS method and the other half would use the traditional lecture approach of medication counseling.

Non-pregnant adults were asked to participate in the study by a pharmacy technician and were led to a private room where the pharmacist consultation would take place. There was an investigator in the room present to accurately measure the counseling time and the pharmacist in the room did not know which patient were included in the study, nor which question the patient would be asked immediately afterwards in an interview. In the control group (traditional method), the pharmacist would present verbal information containing the name of the drug, how to take it, and possible adverse effects; while the intervention group (IHS method) were trained to provide structured and open-ended questions to verify patient understanding of the proper use of the new prescription medication (see Fig.1).

Results and limitations

In total, 500 participants were included in the study. It is noted that the IHS group were generally younger, had been using the study pharmacy for a shorter amount of time, and had been prescribed more contraceptives and less cardiovascular medications than the control group.  The main outcome was correct recall answers for all three questions concerning their new prescription  –  the Indian Health Service intervention group yielded a 71% accuracy compared to 33% for the traditional method.  Also, the odds of knowing when to take their medication and its side-effects profile were about 4 times more likely to happen in the IHS than the traditional group. Even the IHS pharmacists were bringing up side-effects approximately 3 times more often in their counselling.  Lastly, the time required for both groups were 128 and 75 seconds for IHS and traditional, respectively.

A few limitations in the study’s methodology affects their findings: it was not a randomized sample of participants; blinding was mostly impossible, especially of the counselling pharmacist; no surrogate (like blood pressure) or adherence (pill-count devices) outcomes were assessed; and no later-recall (e.g.: 24-hour or 1 month post-counselling) was measured. This last limitation is important because counselling techniques need to show that patient education can reliably be improved upon in terms of long-term adherence since many medication-related hospitalizations are due to chronic medications (e.g.: anticoagulants, digoxin, insulin). Hopefully, the end result of would be that improving the patient’s long-term adherence by the IHS technique could subsequently increase the efficacy of treatments prescribed while reducing mortality, morbidity, and overall health-care expenditures caused by poor adherence.

The other issues seen with this study mostly are attributed to disadvantages of using convenience sampling (or non-probability sampling) which limits the generalizability of the study. If the study participants are chosen from a convenient sample, and not from the total population, there is a risk of selection bias and sampling error  –  specifically the intervention group may differ largely in certain characteristics from the control group which may confound the results.  For example, we must take into consideration that the intervention group were on average 10 years younger and may have better recall ability or otherwise test better than the control group.

Conclusion

Considering that both groups were relatively similar and the magnitude of the effect seen, we can conclude that the results of Lam et al. are valid and certainly make the case for further studies using other outcomes to determine if the Indian Health Service method is truly a counselling gold standard.

Main reference

  1. Lam N, et al., A comparison of the Indian Health Service counseling technique with traditional, lecture-style counseling,J Am Pharm Assoc. 2015;55:503–510 doi: 10.1331/JAPhA.2015.14093