The Consultant Pharmacist is published by the
American Society of Consultant Pharmacists.

Research and Reports

Effect of Consultant Pharmacist Interventions Upon Unnecessary Use of Histamine H2-Receptor Antagonists in Skilled Nursing Facilities

 

James Joyner
David Schack
Judy Burgio

 


Objective: To assess the economic impact of consultant pharmacists’ interventions in reducing unnecessary or inappropriate histamine H2-receptor antagonist therapy in skilled nursing facilities.

Design: A set of criteria was developed to identify skilled facility residents who were receiving unnecessary or inappropriate H2 antagonist therapy. Consultant pharmacists evaluated resident health records and included in the study residents who met the criteria. Written recommendations were made to the attending physicians to reduce H2 antagonist doses or to discontinue therapy. Reduced medication costs directly resulting from the pharmacist’s interventions were evaluated. Residents were assessed for recurrence of symptoms for up to six months after the intervention.

Setting and Participants: Approximately 7,000 residents’ health records from facilities throughout northern California were evaluated against the criteria. Of those evaluated, 181 met the criteria for unnecessary or inappropriate H2 antagonist therapy. Thirteen residents were discharged from the facilities prior to the attending physician’s response to the pharmacist’s written recommendations, leaving a total of 168 residents who finished the study.

Interventions: Consultant pharmacist interventions were in the form of a computer-generated memo recommending dosage reduction or discontinuation, which was placed in the resident’s health record for physician review and response.

Main Outcome Measures: Number of residents whose symptoms recurred, actual drug costs, and estimated value of nursing time saved as a result of the pharmacist’s intervention.

Results: Only 7 of the 129 residents observed had symptoms recur, resulting in the need for resumption of H2 antagonist therapy.

Conclusions: This study demonstrates that the consultant pharmacist can have a positive impact on reducing drug-related costs in the skilled nursing facility by identifying unnecessary drug use and facilitating appropriate action to correct it.

Key Words: Cost-benefit analysis, Histamine H2-receptor antagonist, Skilled nursing facility.

Abbreviations: H2 = histamine 2.


Therapy with histamine H2-receptor antagonists (hereafter referred to as H2 antagonists) is common in the skilled nursing facility setting because of their high degree of therapeutic efficacy and relatively low incidence of adverse effects. Currently, experts recommend use of H2 antagonists for 4—8 weeks for most indications (gastric ulcer, duodenal ulcer); other conditions such as gastroesophageal reflux or pathological hypersecretory conditions may require long-term therapy. In our experience as consultant pharmacists, we have observed many cases in which these drugs are not used in appropriate doses and are continued much longer than necessary. Short-course therapy is rarely used in the skilled nursing setting; most residents who are prescribed these drugs continue to receive them over several months or years. Often physicians have not attempted trials with lower maintenance doses; however, a lack of appropriate dosage adjustments in residents with low creatinine clearances indicates that the potential for accumulation in residents with renal impairment has not been fully appreciated.

These observations suggest a pattern of unnecessary use of this category of drugs in the skilled nursing setting. Because of the high cost and widespread use of these drugs, unnecessary use represents a substantial misappropriation of health care dollars. The consultant pharmacist is in a unique position to identify unnecessary drug use and to initiate action to reduce drug-related costs.

Purpose

The purpose of this study was to assess the economic impact of consultant pharmacists’ recommendations to physicians to reduce unnecessary or inappropriate H2 antagonist therapy for skilled nursing facility residents. The impact of these recommendations upon direct costs and nursing time was assessed. It was beyond the scope of this study to include the effect on other costs, including the cost associated with the treatment of adverse drug reactions.

Methodology

Consultant pharmacists identified residents for this study during routine monthly drug regimen reviews at various skilled nursing facilities throughout northern California. Criteria were established to define residents who were receiving unnecessary H2 antagonists, specifically screening out residents from the study who had recurrent ulcer disease, gastroesophageal reflux disease, or pathological hypersecretory conditions for which a discontinuation of H2 antagonist therapy may have resulted in a negative resident outcome. Written recommendations were made to the attending physicians to discontinue or reduce the dosage of the H2 antagonist. This study focused strictly on H2 antagonist medications; proton-pump inhibitors were not studied because their overall use at the time of the study was very small in our population. There were no distinctions made with regard to the cause of peptic ulcer disease in residents admitted to the study. Specifically, Helicobacter pylori testing and use of non-steroidal anti-inflammatories were not assessed. Of approximately 7,000 charts reviewed, 181 met the inclusion criteria.

The criteria for unnecessary or inappropriate use of H2 antagonists are shown below. (All of these criteria had to be met before a pharmacist intervention was made.)

  1. Resident has been receiving an H2 antagonist for at least eight weeks in a full therapeutic (non-maintenance) dose

    OR

    Resident is receiving H2 antagonist in a full therapeutic dose and has significant renal impairment (see Residents with Reduced Renal Function, below).

  2. Resident does not have one of the following conditions documented in the health record as the indication for H2 antagonist therapy:

    • Zollinger-Ellison syndrome
    • Systemic mastocytosis
    • Multiple endocrine adenoma
    • Gastroesophageal reflux disease.

  3. Resident does not demonstrate gastrointestinal signs or symptoms at present (gastric pain, nausea, vomiting, evidence of blood in stool, recent complete blood cell count indicative of blood loss, hemoglobin < 11 g/dl).

  4. Resident’s health record does not show any previous unsuccessful attempt at dose reduction.

Pharmacist Interventions

For residents who met the study criteria, pharmacists recommended discontinuation of the H2 antagonist therapy or reduction in dose to a maintenance dose.

Maintenance doses:
  Famotidine 20 mg q.h.s.
  Ranitidine 150 mg q.h.s.
  Cimetidine 400 mg q.h.s.
  Nizatidine 150 mg q.h.s.

Residents with Reduced Renal Function. For residents whose calculated creatinine clearance values (using the Cocroft and Gault equation) were below the threshold values on the following chart, pharmacists recommended a 50% dose reduction or administration of doses on an every-other-day schedule:1

  Cimetidine <50 ml/min
  Ranitidine <50 ml/min
  Nizatidine <50 ml/min
  Famotidine <10 ml/min

Results

Responses to Consultant Pharmacist Interventions. Recommendations were made to reduce dosage or to discontinue H2 antagonist drug therapy in 181 residents. Table 1 shows the attending physicians’ responses to recommendations. The table also reflects the resident outcome rate and relapse rate.

Resident Outcomes. All residents who received a dose reduction or discontinuation of H2 antagonist therapy were assessed for recurrence of symptoms by consultant pharmacists monthly for up to six months after the intervention. Residents were considered to have relapsed if the H2 antagonist was reintroduced or the dosage was increased. Positive resident outcome, defined as the elimination of the drug or a reduction in the dose, was observed in 94.6% of residents (122 of 129 positive physician responses). Negative outcomes, as noted in Table 1, were observed in 5.4% of residents. It seems most likely that the very low incidence of resident relapse was due to use of narrow criteria in defining unnecessary H2 antagonist use. None of the residents who relapsed required hospitalization. Although some residents (151) were not present in the facilities for a full six months after pharmacist interventions were completed, most residents were followed for at least three months.

Table 1. Physicians’ Responses to Recommendations by Consultant Pharmacist

Total recommendations to physicians181
Residents discharged prior to physician response13
Total qualifying recommendations168
Residents whose dose was reduced because of renal insufficiency10 (5.9%)
Residents whose drug was discontinued32 (19.0%)
Residents whose dose was reduced to a maintenance dose80 (47.6%)
Residents who relapsed (dose initially reduced but increased within six months because of return of symptoms)7 (5.4%)
Total positive responses from physicians129 (76.8%)

Economic Benefit Directly Resulting from Consultant Pharmacist Interventions. These results show that consultant pharmacist interventions can have a dramatic effect on physicians’ prescribing practices, leading to dose reduction or discontinuation of unnecessary H2 antagonist therapy or both. In turn, changes in prescribing practice can affect health care costs.

We assessed the total economic result of these interventions (Table 2), including both the actual drug costs and an estimated value of nursing time saved, which could be reallocated to other areas of patient care. Although there is some controversy about the exact value of nursing time saved, we believe that these interventions did save time. Using an administration estimate of one minute per dose and an average salary of $15 per hour, we estimated that 73.5 hours of nursing time was saved per month, which is equivalent to approximately $1,102. This is a small but important savings compared with actual drug costs saved ($7,874 per month). This figure was simply an estimate to help us quantify to management the value of the interventions.

Table 2. Estimated Savings Resulting from Consultant Pharmacist Intervention in H2 Antagonist Therapy

Monthly drug cost savings
(Based on monthly pharmacy charges to private patient)
$7,874
Monthly nursing time saved
(Based on saving one minute per dose)
73.5 hours
Value of nursing labor made available for other areas of patient care
(Based on average $15/hour salary)

$1,102
(73.5 hours x $15/hour)
Total monthly savings


$8,976
(drug cost savings +
nursing labor savings)
Total savings during study
(3-month period)
$26,928

Conclusion

This study demonstrated that the consultant pharmacist can have a positive effect in the skilled nursing setting by identifying unnecessary H2 antagonist therapy, facilitating appropriate action to correct it, and ultimately preventing misapplication of substantial health care dollars. In our limited time of three to six months for follow-up observation, we observed high positive outcomes (almost 95%) and only 7 relapses.

This study had some limitations, however. One limitation was the fact that some of the study participants were discharged between three and six months after interventions were made. We would have preferred to have been able to follow all the participants for at least six months and preferably for one year after the interventions.

In the future, we would like to further study the importance of testing for or treating H. pylori, which is closely associated with peptic ulcer disease. Potential study topics include the cost-effectiveness of testing for H. pylori with use of the new ammonia breathalyzer or whole blood or serology tests, and cost-effectiveness and potential resistance of empiric treatment of H. pylori.

Reference
1. Drug Facts and Comparisons, 49th ed, St. Louis: Facts and Comparisons.


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The Consultant Pharmacist is published by the
American Society of Consultant Pharmacists.