Center for Health Care Strategies, Inc.hpm.umn.edu/ambul_db/db/pdflibrary/DBfile_91011.pdfProviding Pharmacy Services in a Medicaid Long-Term Care Program - 1 ... including monitoring

CHCSCenter for Health Care Strategies, Inc.

RESOURCE PAPER ____________________________

Providing Pharmacy Services in a Medicaid Long-Term Care Program By Steven Christianson, DO, MM Janet Welch, RPh, PhD VNS Choice Funded by the Center for Health Care Strategies, Inc. under The Robert Wood Johnson Foundation’s Medicaid Managed Care Program December 2004 268

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Providing Pharmacy Services in a Medicaid Long-Term Care Program - 1

TABLE OF CONTENTS Abstract________________________________________________________ Executive Summary ______________________________________________ Introduction and Background

What Drove the Need to Change? Development of a Population-Based Approach to Medication Management Development of a Population – Based Medication Management Infrastructure Results of the Nurse Consultant Survey Assessing the Medication Management Program

Interventions

Development of Interventions-Focus Groups Findings Methodology Drug Alert Intervention – Risperdal Quality Intervention – Warfarin Monitoring Safety Intervention – Reduction of Inappropriate Drug Use, Beers’ Criteria Cost/Quality Intervention – Erythropoietin Prospective Pre-Authorization, Oral Iron Supplementation

Conclusion and Next Steps Appendices (view online at www.chcs.org)

Appendix 1: Use of the Medication Database Appendix 2: St. John’s School of Pharmacy Report Appendix 3: Best Practices in Care Management Literature Research Findings Appendix 4: Risperdal Letter to MD Appendix 5:

Warfarin Member Education Warfarin Nurse Education

Appendix 6: Beers Letter to MD Beers Member Education to Staff Beers Nurse Education

Appendix 7: Epogen Pre-Authorization Process Epogen Prior Authorization Criteria Epogen Nurse Education Epogen Member Education


Abstract VNS CHOICE, a partially capitated Medicaid long-term care plan, outgrew its start-up medication management program, and developed a new comprehensive medication management program focusing on population-based pharmaceutical care and preparing and supporting staff nurses to handle individual member medication profiles more effectively. A consultant pharmacist and medication management aids and resources were key components in providing an environment for program change. The process for developing and implementing the initiative included a review of the literature and analysis of medications prescribed in the previous 33 months, followed by individual focus groups of nurse practitioners, nurses, and physicians. Interventions were planned with a goal of improving quality (warfarin monitoring), safety (inappropriate drugs by Beers’ criteria), and cost (prospective pre-authorization of Erythropoietin). The plan learned that interventions that were widely dispersed and educational or informational in nature were not strong enough to improve documentation for warfarin monitoring. We learned that focused interventions with good staff communication and resources, were successful in helping nurses manage complex clinical areas like Beers’ inappropriate medications. The plan also learned that with appropriate communication that was short and concise with patients identified, physicians would cooperate in safe medication practice interventions and change prescribing practices. The plan learned where there are infrequent inappropriate uses of medications, such as in the case of erythropoietin, a retrospective review may be preferable to a prospective pre-authorization process, unless the plan has complete control of all the parties in the process. Necessary components of a medication management program were found to be access to a pharmacist for consultation, resources and educational material tailored to staff and member needs, access to real-time pharmacy claims data, and good physician communication tailored and formatted to their preferences.


Executive Summary VNS CHOICE is a partially capitated Medicaid long-term care (LTC) program that began in 1998 and enrolled several thousand members. A pharmacy program existed from the program outset to administer the Medicaid drug benefit, focusing on individual profile review and retrospective review of data by a Pharmacy Benefit Manager (PBM). With increasing population growth, both management and staff felt that the current pharmacy program no longer met the needs of the population served. A Center for Health Care Strategies (CHCS) grant enabled VNS Choice to move ahead with this process in October 2002. A population-based comprehensive approach was adopted focusing on medication areas for change in the population rather than individuals. All clinical staff was prepared and supported to take a greater part in individual medication profile management. The pharmacist consultant hired for the program change requested access to the online PBM drug database, enabling more timely analysis, action, and response to nurses’ questions. A project manager, initially, and later a pharmacist consultant were hired to coordinate this initiative. To provide an infrastructure within VNS CHOICE, a Pharmacy Committee was formed to review all materials and report to the Quality Assurance/Utilization Review Committee, and periodically to senior management. Focus groups of key stakeholders affected by the program change were an important factor in planning. A number of steps were taken to provide an environment that supported medication management activities and increased staff knowledge of medication management principles. A key component of the program was the availability of a pharmacy consultant for questions about medications, which has been shown effective in many organizational environments. 1,2 Interventions were taken in three main areas to improve quality, safety, and cost. While physician services are not covered under the VNS CHOICE, partial capitation, they are the prescribers for all medications, approve changes to the plan of care, and were included in all interventions where appropriate. Where possible the plan focused on the most important drugs rather than all drugs in each category. Specific focus areas were identified 1based on the retrospective analysis of 33 months of pharmacy drug claims by consultants from St John’s University College of Pharmacy. The quality intervention focused on Warfarin use and monitoring with an emphasis on the most dangerous drug interactions. What the plan learned was that staff was not sure of the monitoring standards, when they did monitor this drug the member’s medical record did not reflect this monitoring. A discussion in the Pharmacy Committee led to a general intervention with a focus on providing a standard documentation process for all nurses. The plan provided medication management resources, and developed a report that identified members with the most dangerous drug-drug interaction with warfarin, which was used to identify members at risk for medical record review during the initiative. After trying this intervention for some time the plan achieved only a modest


improvement in documentation (statistically but not clinically significant), and raises the question of the necessity for a more focused intervention to improve documentation. The safety intervention aimed to reduce the number of inappropriate drugs, by Beers’ criteria, in our population, with a focus on the psychoactive drugs. In focus groups with nurses and doctors, the Beers’ criteria and drugs were little known, indicating a need for education. The nurses were provided with excellent medication management resources. The plan developed a report that identified members using these drugs, and generated a letter to doctors and nurses caring for these specific members. Also member educational material was provided to assist the nurse educating the member. This focused intervention was strong enough to have a marked effect in a relatively short time in reducing these drugs. The cost intervention was focused on Erythropoietin, which is the most frequently used high cost drug in the long-term care population, and has well defined and accepted clinical criteria for use. The authorization process initially implemented for this drug was triggered by dollar threshold not clinical criteria. The plan learned that there was poor documentation to verify its appropriate use, and there was some staff knowledge deficit about this important medication. During the review of this medication the pharmacist identified a lack of oral iron supplementation, so the plan expanded the study to include the proper use of iron supplementation. The plan worked with the PBM to establish a process for clinical authorization for Erythropoietin that would provide the clinical information for the medical record and find inappropriate use. The plan also provided educational material to all staff on its use and the need for iron. The plan communicated with the member’s physicians about the change in authorization process. The prospective pre-authorization process was terminated after six weeks after only one of 24 prescriptions was processed correctly, all meeting the criteria for use. There were many points of confusion and delay at the PBM and the dispensing pharmacy in filling these prescriptions, which led to delay of this essential medication for members. As a result the plan decided to implement its own internal retrospective review of Erythropoietin to obtain the clinical information to justify its use. The plan continues to monitor the use of oral iron supplementation, sending staff reminders when it is not used. To improve the use of iron supplementation, the plan provided educational information to staff, developed a report that identified members not taking iron, and sent memos to staff through the team managers. While the program experienced some sustained improvement in iron supplementation, it never reached a satisfactory clinical level or statistical significance. VNS CHOICE plans to assess iron supplementation in the retrospective review process and address this issue on an individual basis.


Introduction and Background VNS CHOICE, a partially capitated Medicaid long-term care program that began in 1998, has a current membership of more than 3,800 elderly Medicaid and dual-eligible members. Members have an average age of 81 and qualify for nursing home placement on a standard assessment but live in the community. The benefit includes community and home-based care (e.g. home health aide, meals on wheels) but does not cover professional services such as physician services, emergency department, and hospital care. Each member is assigned a nurse consultant on admission who is responsible for coordinating all of the member’s care and benefits, including monitoring medication and providing member education where necessary. The Medicaid covered network services include dental care, vision care, podiatric care, and drugs which are provided through contracted network with a pharmacy benefits manager (PBM). A Medicaid pharmacy benefit administered by the plan has mandatory generic use but few other formulary restrictions that have been identified with poor outcomes in Medicaid programs.3 A contracted pharmacy network and pharmacy benefits manager (PBM) helps administer the drug benefit. Drug cost escalation, and the increasing importance of drug errors and interactions makes the medication management program at VNS CHOICE an important component of the plans’ clinical management. A pharmacy program existed from the inception of VNS CHOICE that included individual profile review by a pharmacist who was not present in the office and who provided written feedback to the nurse consultants identifying potential drug interactions and recommending cost effective drug changes. A PBM contract provided reports with retrospective review of data by cost and therapeutic class, and more recently, reports on PBM interventions to identify members with therapeutic duplication and potential drug interaction (these appear as computer-generated alerts to the dispensing pharmacist at point of sale). Additionally, the PBM provided a report identifying how often prescriptions were filled above the expected level for select drugs, which generated a letter to the prescribing physician from the PBM. What Drove The Need to Change? With the expansion of members and staff VNS CHOICE outgrew the above-outlined medication management program. Table 1 illustrates growth in the past five years. Table 1.

Measure 2001 2002 2003 2004 (Jan-June)

% Change

Average Members/Year 2,388 2,694 3,035 3,605 51.0 % Average # Rx/Member 6.7 7.0 7.4 7.7 15.0 % Average Unit Cost/Rx $41.0 $44.1 $45.5 $48.6 18.5 %

In this population individuals take an average of about seven drugs per member, which also increases the likelihood of adverse drug events.4,5


Number of Rx/Member October 2003

0

100

200

300

400

Number of Rx

Num

ber o

f M

embe

rs

-5%10%25%40%55%70%85%100%

Cum

ulat

ive

Perc

ent

Figure 1. With the introduction of a computerized module for the nurses who identified drug interactions,6 staff dissatisfaction with the content and timeliness of the pharmacist interaction, and the PBM reports, senior management concluded a basic change needed to be made in the medication management program. It was recognized that the plan would have to use the monthly pharmacy claims data spreadsheet reports more effectively as the PBM quality reports are retrospective and too out-of-date to act on, and the report format made it difficult to identify members. This led to the formulation of a population-based approach for VNS CHOICE through a centralized corporate program that includes drug utilization review, and interventions to improve safety, quality, and cost effectiveness for all the members. The plan recognized the need to provide resources and education to manage the individual member medication profiles, which is an important and necessary part of any medication management program. Development of a Population-Based Approach to Pharmaceutical Management The project began with analysis of pharmaceutical claims data7 from January 1999 through September 2001 by consultants from St. John’s University College of Pharmacy in New York, completed in September 2002. The study analyzed the claims by breaking the data into six-month blocks separated into drug classes. Trend analysis was done for volume, cost, and potentially inappropriate drugs. Overall the study showed that prescription trends followed current medication guidelines and popularity of new drugs.8 While there were relatively small numbers of inappropriate drug prescriptions by volume in the St. John’s study, they were spread across all drug categories, and subsequent analysis after receiving the report found 194 members receiving inappropriate drugs by Beers’ criteria.9 The areas of priority selected initially from this data analysis to evaluate for intervention were: • Safety – Beers’ Inappropriate Drugs. • Quality – antidepressants, antipsychotics, warfarin drug interaction. • Cost – Erythropoietin, COX II Inhibitors (68% of NSAIDs), and Proton Pump

Inhibitors.


A grant in October 2002 from CHCS facilitated the development of a comprehensive change in the medication management program. A project team, the Pharmacy Committee, was developed to review and approve project areas and resource development. A PhD pharmacist was recruited as project manager in April 2003, to provide consistent clinical pharmacy expertise and deal directly with large pharmacy data sets. 10 An initial focus group of clinical leaders, VNS CHOICE nurse practitioners, evaluated the St. John’s data in November 2002 and focused priorities on those areas that were the most relevant and where staff had the ability to intervene effectively. The results of that meeting focused the project on: • Inappropriate Beers’ Drugs, which they were not familiar with, and which they

thought that all clinical staff should become aware of as part of the routine evaluation.

• Coumadin drug interactions and monitoring parameters, which they felt was an area where there were knowledge deficits for staff and increased risk for members.

• Erythropoietin, which has an existing, but not effective prospective pre-authorization process based on cost rather than on clinical criteria.

They concluded there were opportunities for cost reduction through practice change, staff knowledge and monitoring deficit, and well-developed national criteria for use. Other important identified areas were under treatment of depression and overuse of antipsychotic drugs, which would require more evaluation, and therefore were not to be included in this study. Several common themes came out of a literature review11 for effective medication management in the outpatient setting. Effective communication with the members tailored to the population using evidence-based data, and education about alternatives are components of medication management in a managed care setting. With members, it is important to focus on the “best therapeutic option available.” For an organization’s employees, it is important to stress that effective medication management programs are a part of the organization’s integrated approach to member safety, quality of care, and better outcomes in care management. It was noted that the pharmacist can play an important part in medication management programs. There is a continuing use of drugs that are deemed inappropriate for the elderly among ambulatory populations.12 In drug interactions warfarin was the leading cause of important and dangerous drug-drug interactions in the elderly. Information on population-based medication management programs also was reviewed. Based on these initial reviews and planning activities, a population-based approach for the interventions was identified. The organization formulated a plan to develop an infrastructure to support an organizational focus on medication management, including the necessary resources to help nurses in becoming more confident and competent in


individual member medication profile management. The basic principles used to formulate interventions were: • The plan will pilot interventions before full deployment if necessary. • The plan will use professionally facilitated focus groups to refine the strategies and

the educational materials used. • Interventions will have components directed at the member, staff, and the physician. • Interventions will be designed to enable the nurses to provide consistent medication

management with the least additional work activity. • Reports and surveys will be developed to evaluate the success of the interventions

and outcomes. Providing an Infrastructure for Population-Based Pharmaceutical Management A multi-pronged medication management program was introduced to support this initiative: • The consultant pharmacist is in the office three days a week and is available via cell

phone at other times. • Drug alerts on new safety issues for medications important to the elderly are now

regularly provided to managers and clinical staff. These drug alerts may identify members and are communicated to physicians when that is deemed necessary (see the intervention section of this report, Drug Alert - Risperdal).

• The Pharmacy Committee initially reported to senior management, and now reports regularly to the Quality Assurance/Utilization Review Committee to integrate the medication management program in the organization’s committee structure.

• It was recognized that the nurse practitioners and the pharmacist would be the clinical and technical content experts respectively for this project in the day-to-day activities and they were provided with online and computer-based authoritative drug information resources including Facts and Comparisons and UpToDate website and CD respectively.

• More recently, clinical management staff in each region has been given access to a website, MD Consult, which includes authoritative drug information.

• The new staff orientation includes an introduction to medication management in the elderly.

• The newly developed Geriatric Curriculum to improve nurse consultants’ knowledge of geriatrics now includes a session by the consultant pharmacist on managing drugs in the elderly.

• The staff newsletter now regularly has a short column on medication management, and the VNS CHOICE Clinical Advisor (for network professionals) will have an issue dedicated to medication management.

• The VNS CHOICE intranet website, which is currently under development, will be accessible by clinical staff and will include a pharmacy section for general dissemination of information and provide a source of drug information.


Results of the Nurse Consultant Survey Assessing the Medication Management Program A survey of nurse consultants was conducted to assess the impact that the medication management program had on them. Sixty-six percent of 161 nurses completed the survey. The survey showed that the efforts to create an infrastructure for medication management were successful. The Educational Materials, Drug Alerts, Geriatric Curriculum, Medication Guide, and Orientation aspects of the program all had positive responses on scoring. The survey also identified the aspects of the program that had significant impact (the scores represent the proportion of nurses positive minus the proportion negative responses, a positive difference is good). The greatest positive impact was in the following:

• Improved knowledge of medication management principles (73.3%). • The ability to educate members about medication (60%). • Confidence dealing with medication related problems (59.1%). • Confidence dealing with physicians about medication problems (43.8%).

The survey also identified the aspects of the medication management program that were found personally most useful. In order of positive responses the results are:

• Nurse consultant education materials (54%). • Drug Alerts (56%). • Geriatric Curriculum (36%). • Availability of a pharmacist (32%). • Member education materials (28%). • New Staff Orientation (27%). • Letters to physicians (16%). • Calls to physicians by the Medical Director (8%).

When asked if VNS CHOICE was doing enough to help nurses in medication management, there was a positive response from the nurse consultants (63.5%). Interventions Interventions were focused in three main areas, quality, safety, and cost. Most of the forms of interventions, which were developed based on focus group analysis, included education and resource material for nurses, member education documents for the nurse to use, and physician communication to facilitate nursing staff taking actions on medication management issues. While physician services are not covered under the partial capitation, physicians prescribe all medications and approve changes to the plan of care and were included in all interventions where appropriate. Where possible we focused on the most important drugs in each category.


Development of Interventions – Focus Group Findings After the initial steps to define the initiatives, the pharmacist consultant developed or identified sets of educational materials for nurses and members, processes for communication internally, and sample communications to physicians. A key part of the project was the use of professionally facilitated focus groups for refinement of the interventions before deployment. Two professionally facilitated focus groups of physicians were held in September 2003, followed by a professionally facilitated group of nurse consultants held at the end of September 2003. These meetings were held to evaluate these materials. There were two physician focus groups, seven physicians in the first and eight in the second, held the same night at a professionally facilitated center, and observed by plan staff behind a double glass mirror. Food was served and $200 honorarium was paid for participation. The results from the physician focus groups were mixed. The plan tried to do the focus group anonymously; however the first group was so violently angry about traditional managed care that the plan identified the characteristics of our program to the second group, in order to re-direct the focus. The general comments from the focus group were:

• There was a lot of skepticism in the initial focus group about motives with

comments that included “only worried about cost” and “switching members’ drugs for economic reasons causes problems sometimes not recognized.” Participants acknowledged that communication that focuses on benefit to the member is best received and they dislike having to justify medically necessary medical practices unless it was related to the members benefit.

• Preferred communication was with pharmacist or nurse practitioner, someone knowledgeable with authority to act. Physicians want to resolve issues in one communication, i.e., if a call is needed conclude what needs to happen at that time.

• For urgent messages or those that need some action taken, phone call is preferred.

• For non-urgent messages physicians preferred short, to the point, member specific communication. “Don't try to educate unless there is something new or novel.”

• A lot of interest in member lists of all medications taken, even/especially those prescribed by others.

• Medication alerts are good and augment manufacturer’s alerts. Including the member’s name and phone number also would be helpful.

• Would like to see the educational information members receive, but selective on important medicines not everything.

• Return fax/mail form with request for information to get data from physician is good if it includes all the member information so it is easy to fill out. Use check boxes where possible.


VNS materials were well received in general, and physicians’ preferred shorter communications confined to one page. “Formatted so that it can be placed in the member’s office chart easily” … “and don’t try to educate me about something I know.” In summary to be effective in communications to physicians you have to be short, to the point, without a lot of unwanted educational material, and identify their affected patients. While this seems common sense, the physicians said they rarely receive this kind of communication from health plans.

The nurse consultant focus group was held on-site at the VNS CHOICE corporate office and was professionally facilitated. Eleven nurses from all regions voluntarily participated, were paid for participation. The nurse consultant focus group was held after the physician focus group to facilitate developing strategies for communication to meet both needs. The major findings from the physician focus group were described at the beginning of the meeting. The comments from the focus groups were:

• Most nurse consultants felt comfortable talking to physicians about medication related issues (the opposite was assumed) except where they feel they must contact the physician unnecessarily, and they said most physicians are receptive to these discussions.

• The most frequently mentioned problem is non-compliance, and their big challenge is uncovering the root causes for the non-compliance. Other challenges, such as inadequate member education, were viewed as contributors to non-compliance.

• They say most physicians are receptive to their discussions about medications. • They find newsletters and reminders about drugs very helpful and would like

more access to in-service education. • The nurse consultants were very positive about member-specific alerts on

medication issues or interventions affecting the member, and they wanted to be notified directly if urgent, and through team leaders for regular communications.

• The nurse consultants liked the idea of communications direct to the physicians before they called. They thought it would make it easier for them to approach the physician and initiate the dialogue.

• The nurses believed the member education tools would make it easier to have discussions with their members. They said member communications should be simple, and easy to understand.

• Reactions to the Medication Guide for the Long-Term Care Nurse13 and the Beers’ OBRA reference book14 and pocket screening card15 were very positive.

• Reactions to the specific intervention program materials were generally positive. The member communications were described as a real improvement over current materials.

• For Beers’ inappropriate drugs, they felt it was better for the nurse to speak directly to the member, rather than a member self-education handout.


This focus group demonstrated that the nurses were more confident in talking to physicians; especially if the physician had been communicated to before they called. It was abundantly clear that more medication management and pharmaceutical resources were needed for them to be more successful at this part of their care management. The materials planned for use after the physician focus group appeared to meet the needs of the nurse consultants. Methodology Pharmacy Monthly Claims Database – Each month the PBM pharmaceutical claims from the previous month are received by the health plan. The data includes a unique member identifier, drug information, dosage information, and cost information. This information is merged with the VNS CHOICE member demographic data to establish a member-specific database for all claims, which is then separated into prescription and non-prescription drugs (although the Medicaid benefit covers over-the-counter drugs, the analysis in this report involved prescription drugs only). St. John’s University College of Pharmacy used these data from January 1999 through September 2001 for the initial retrospective review, breaking the data into six-month groups. Using the GPI codes, they were able to separate the medications into therapeutic classes. In some of the classes specific medications were examined. Classes of medication were evaluated based on several factors: 1) the class made up a high percentage of the prescriptions; 2) the class contained high-cost medications with lower-cost alternatives; or 3) the class contained medications considered potentially inappropriate for use in the elderly. The plan looked for prescribing trends within these classes and the plan looked for potential opportunities for intervention to improve prescribing or achieve cost savings.16 PBM Pharmacy Online Drug Database – The pharmacist consultant requested access to our PBM claims database, which is close to real-time (has a delay of up to 48 hours) and arranged for training in its use. The database can produce ad hoc reports for an individual member or the entire population, for individual or several drugs or drug classes. This database has the same fields as the monthly pharmacy claims and was used for most of the interventions. Statistical Analysis Z-Test for Proportions – Used For the Nurse Consultant Survey: This test is used to compare population proportions. The z-test used was a non-directional or two-tailed z-test in which the alternative hypotheses is that there is no difference between the two groups. Some of the assumptions of this test are that the two samples are selected independently and are selected randomly from their respective populations. The significance testing was conducted at 95 percent confidence with an alpha=0.05. As a result, a p-value less than or equal to 0.05 is considered to be statistically significant.


McNemar's Chi-Square Test – Used In the Interventions: This test is a modified version of the chi-square goodness of fit test that uses one degree of freedom. Some assumptions that this test makes are that the observations are dichotomous; the dichotomous measures are paired observations of the same subjects or matched pairs; and that the dichotomous categories are mutually exclusive. This test is used to determine whether a change has occurred from pre-to post-time periods. The significance testing was conducted at 95 percent confidence with an alpha=0.05. As a result, a p-value less than or equal to 0.05 is considered to be statistically significant. Nurse Consultant Survey: A survey was completed anonymously with nurse consultants in July 2004. There were questions on general topics of medication management and infrastructure (xx) and on each intervention (xx). Most of the questions were on a five-point scale (Disagree=1, Somewhat Disagree=2, Don’t Agree or Disagree=3, Agree=4, Agree Completely=5), with the lower two being negative and the upper two being positive. Statistic analysis using the z-Test was done on each question to see if the difference was statistically significant between proportions of positive and negative responses. Drug Alert Intervention - Risperdal Background: In a letter dated 4/16/03, it was noted by the manufacturer, Janssen, that the prescribing information for risperdal (risperidone) had been changed to include new information regarding cerebrovascular adverse events (e.g., stroke, trans-ischemic attack, including fatalities) reported in elderly members with dementia-related psychosis taking risperdal. Although risperdal does not have an FDA-approved indication for dementia-related psychosis, it is widely prescribed for this diagnosis in elderly persons. Extent of issue: Fifty-six VNS CHOICE members (comprising 1.9 percent of the membership) had a risperdal prescription filled between 5/15/03-7/21/03. Intervention: The online PBM drug database was used to identify all members who took this drug. A memo regarding the alert was sent to team managers for discussion at regularly held staff meetings. A member-specific letter was sent to all physicians caring for the identified members, and a memo was sent to each nurse who had a member under care through the team leader with a copy of the doctor letter.17 A follow-up review of the members was done to assess the impact of the intervention using the online PBM drug database one month later.


Figure 2: Intervention Responses

Risperdal Drug Alert Intervention - 3 Months Follow-up

56 members identified on RisperdalLetters sent to all physicians

Drug alert about the risk ofStroke and CHF in patients taking

higher doses of Risperdal

51 physicians respondedSame Dose23

(45%)

No Drug19

(37%)

Different Drug4

(8%)

Higher Dose2

(4%)

Lower Dose3

(6%)

Analysis of the Results: The results using the McNemar’s Chi-Square Test were statistically significant, p=0.001. A total of 51% of the members had a positive outcome.

• Discontinued antipsychotic drug (37%). • Lower dose or different drug (14%). • Same dose – feedback indicated that they were reviewing the drug use (45%). • Higher dose (4%).

Analysis of the Nurse Consultant Survey: There were no questions on specific drug alerts on the survey. However nurse consultant educational material and the drug alerts were the highest scored response to what the nurse consultants thought was personally most useful in the medication management program, and both were components of this intervention.

Discussion: The results indicate that a drug alert intervention in a managed LTC setting can be successful in affecting practice patterns for drug use with good communication to the physician and nurse care managers in a timely manner. Staff in a medication management program also values drug alerts. Following the guidance gained from the physician and nurse focus groups, the plan framed the physician communication on a significant problem, identified the members affected, and communicated with the nurse caring for the member with the same information on the drug.


Quality Intervention – Warfarin Monitoring Background: Five of the 10 most important dangerous drug interactions in the elderly involve warfarin.18 Many of the dangerous drug-drug interactions among elderly are avoidable.19 Good quality medical practice includes measuring clotting parameters (INR and/or prothrombin time), and documenting the results in the member record. This also is an important quality indicator (see #6 Quality Indicator in “Quality Indicators for Appropriate Medication Use in Vulnerable Elders, in the American College of Physicians (ACP) Assessing Care of Vulnerable Elders (ACOVE)”).20 For safe medical practice, the warfarin dose may need to be adjusted based on lab values. The on line PBM drug database identified all members taking warfarin, and also those on one of the class of drugs with the most danger for interaction (NSAIDS, sulfonamides, quinolones, macrolides, and phenyontin). Results of a survey, using the electronic medical record and discussion with the nurses caring for approximately 35 members taking warfarin and one of the interacting drugs posing the most serious safety risk, demonstrated that the majority of VNS CHOICE nurse consultants are appropriately monitoring the INR, but were not documenting this consistently in the member’s record. There also appeared to be an opportunity for staff education on the standards for interpreting INR value changes. The Pharmacy Committee concluded to focus the intervention on general staff education and measure the results in those members most at risk. It was decided not to develop materials for physicians, as these clinical issues were common and well known, and the focus groups indicated these were the kind of communications they did not want to get. Extent of the issue: There were approximately 200 members (almost 7 percent of the membership) taking warfarin in July and August of 2003, and of those 35 members were identified as concomitantly taking a drug in the class of those thought to have the most risk of a dangerous interaction. Intervention: To improve member safety in the future, consistent documentation of INR and taking appropriate action required while maintaining anticoagulant at a target level for safety consistent with medical guidelines. VNS Choice’s current software does not have a specific field for INR, but a process for consistent anticoagulant documentation within the current electronic medical record system was developed for this intervention, and disseminated to staff in memo form. Educational material was supplied including an educational piece for the nurse consultant and member educational material. A pocket-laminated card from the American Geriatric Society that lists the standards for anticoagulant monitoring and actions needed to be taken was distributed to all nurse consultants.21 Table 2: Record Review Results

Date Member with warfarin and interacting drug

Member with anticoagulant monitoring

in record

% Documented

July-August 2003 35 0 0 May-June 2004 57 8 14%


Analysis of Results: The results using the McNemar’s Chi-Square Test were statistically significant, p=0.0133. While the results are statistically significant, there has been a rather modest clinical improvement in the documentation of anticoagulant use as a result of this intervention. This could be the result of a general rather than focused intervention. An earlier follow-up review could have alerted VNS Choice to the continuing deficiency to take greater action Analysis of the Nurse Consultant Survey: The nurse consultant survey was positive for all questions about the Coumadin intervention. The questions arranged with the most positive response first were:

• The AGS Coumadin Standards Guide and pocket guide (74%). • Member education materials (62.7%). • Able to educate member better (57.3%). • Better able to counsel members about bleeding symptoms and monitoring (57.3). • Documentation guidelines for the electronic record (54.8%). • Feel more confident talking to doctors about this medication (50.9). • Able to identify and act on problems with this medication better with the doctor

(48.1). Discussion: The plan learned from this intervention that you cannot assume good results for simple interventions with general rather than focused actions, unless you monitor early to see improvement. The nurse consultant survey indicates that 61 nurses answered positively and only seven responded negatively about the documentation guidelines. However, the results show that the patients at most risk were not followed. In the discussion in the Pharmacy Committee we all felt that simple actions would lead to large improvements and this may have led to complacency for later follow-up review. General interventions appear to require more vigilant follow-up for good outcomes. Intervention – Reduction of Inappropriate Drug Use, Beers’ Criteria:22 Background: Inappropriate prescribing in the elderly is a widespread problem that has received much attention in recent years. Since the enactment of the Omnibus Budget Reconciliation Act of 1987, the Federal government has placed a regulatory focus on unnecessary medication use among the elderly to due concerns voiced by advocacy and professional groups. By 1991, clinical criteria began to appear in the literature that demonstrated high risks to the elderly of many medication categories, including psychoactive medications. There are valid uses for these drugs in the elderly (e.g. Amitrypiline for pain control). A specific individual’s needs must be assessed when considering potentially inappropriate drugs and information on appropriate use should be provided to the nurse consultants. Dr. Mark Beers published an update to his criteria in 199723 that included 28 criteria identifying medications that should be generally avoided (disease-independent) and another 35 criteria identifying others that should be avoided due to members' pre-


existing disease or condition (disease-dependent). Many of these medications were deemed inappropriate due to their relative ineffectiveness or adverse outcomes and/or the existence of safer or more effective alternatives. The Beers’ criteria were incorporated into the 1999 Guidance to Surveyors, which is used during inspections of nursing homes. Avoidable adverse drug events can be the consequence of inappropriate prescribing. Less serious adverse drug events that frequently are unrecognized may lead to prescriptions for additional agents and decreased quality of life. More serious adverse drug events may result in unnecessary hospitalizations24 and increased morbidity and mortality. A PBM database analysis of the utilization of 11 drugs/drug groups considered to have a “high severity risk” (according to Beers) in the VNS CHOICE population, showed that monthly use during 2003 was approximately 550 prescriptions filled by approximately 500 members (approximately 17% of the membership). Data from April-May 2004 showed that as many as one third of the prescriptions filled fell into the study class of psychoactive drugs. It was decided to focus on three medication groups with CNS depressant properties that had previously been identified as a significant threat:25 Table 3: Medications Identified for Potential Inappropriate Drug Use

MEDICATION CONCERN Anxiolytics/Hypnotics Long-acting benzodiazepines Have a very long half-life in the elderly - may lead to

prolonged sedation and increased risk of falls. Barbiturates Meprobamate

Highly addictive, and have more adverse effects than newer sedative/hypnotics.

Skeletal Muscle Relaxants Various in Class

Most muscle relaxants are poorly tolerated by the elderly; often associated with anticholinergic side effects, sedation, and weakness.

Antidepressants Amitriptyline, Doxepin Have strong anticholinergic and sedative properties; usually

not the antidepressant of choice in the elderly.

Extent of the Issue: From the period April through May 2004, 122 members filled 184 prescriptions for these medications. Intervention: The focus groups for both doctors and nurse consultants demonstrated an opportunity for education on these medications. The consultant pharmacist provided educational materials to all nurse consultants toward the end of 2003. This included general reference on medication management (Medication Guide for the Long-Term Care Nurse), and intervention specific materials. For the Beers’ inappropriate drugs this consisted of “Unnecessary Drugs in the Elderly Including the Psychotropic Utilization


Protocol26; and the “Adverse Drug Reaction (ADR) Screen for Inappropriate Medication 1999.”27

In May 2004, the online PBM drug database was used to identify members on the specified potentially inappropriate drugs April-May 2004. A letter was sent to the physicians of these 122 members to explain the intervention and suggest the physician assess the appropriateness of the medication(s). A copy of the letter was sent to the nurse consultant caring for the member along with a member education piece so that the nurse consultant could follow-up appropriately with the member individually as indicated by the focus group. Results: Of the 122 letters sent, six were returned, leaving 116 members in the study group. A follow-up study was done in June 2004. The following table outlines the results of reviewing the drug claim database. Table 4: Drug Claim Database Review

Date Total Members in

the Study

Members on Inappropriate

Drugs % of Total

April-May 2004 116 116 100% June 2004 116 66 57%

Analysis of the Results: The results using the McNemar’s Chi-Square Test were statistically significant, p=0.001. Because one would not expect that 100 percent of all drug prescriptions identified to be inappropriate, the results may be even more significant. Analysis of the Nurse Consultant Survey: This intervention scored very high on the nurse consultant survey. The questions arranged with the most positive response first were:

• Satisfied with the Obra Guide for Inappropriate Drugs and screening card (76.2%).

• Satisfied with member education materials (66.3%). • Learned a lot that I didn’t know (64.4%). • Better prepared to educate members (54.0%). • Able to identify and act on medication better with the doctor (51.9%). • Feel more confident talking to doctors (42.4).


Discussion: This was a very successful intervention over a relatively short period of time. Several things could account for these results:

• This may have been new interesting information for the physicians as indicated by the focus group, so they acted on it quickly.

• The extensive information provided to the nurse consultants enabled them to be more effective in handling these drugs with the physicians.

• The communication was effective in bringing up an issue that the physician felt they could act on quickly.

• The survey results showed that the nurse consultants liked the educational material, learned a lot about these drugs, and felt more confident and competent in dealing with doctors which could have a positive effect.

• The letter to the doctor contained more than the usual educational material than some of the other interventions that could have had a positive effect.

Cost/Quality Intervention – Erythropoietin Prospective Pre-authorization; Iron Supplementation Background: Erythropoietin is an expensive medication that consistently shows up on the top 10 drugs by cost in our pharmacy data. It is not a benign drug since it can have some serious adverse effects, which requires close monitoring.28 29 30 The current prior-authorization process is activated by dollar threshold rather than clinical criteria, although there are well established Medicare and managed care criteria for its use. A review of the electronic medical record showed little clinical justification for the drug use in most cases other than an appropriate diagnosis. There appeared to be an opportunity for staff education on the standards of care for the medical use of this drug, as learned through staff interviews. An analysis of the data showed that members undergoing dialysis were appropriately receiving this drug through the Medicare ESRD program. However there may be instances where the drug was prescribed for use in the physician’s office, which is billable to Medicare as a professional expense and not covered in our capitation. Also, a substantial number of members were receiving this drug for non-ESRD indication, providing an opportunity in a clinical prospective pre-authorization process to obtain the proper clinical information justifying the use of this medication. There also was the opportunity to find inappropriate use or dosage, or pre-ESRD members who would qualify for the Medicare ESRD program. The consultant pharmacist identified early in the analysis that the plan could not document the use of oral iron supplementation in a substantial number of members, which is necessary for optimal effectiveness. Since the pharmacy benefit included over-the-counter medication and VNS members are indigent, the plan assumed that they were not taking iron supplementation, and extended the study to cover this aspect of care.


Extent of the Issue: There are from 20-45 members in the VNS Choice population taking erythropoietin at any one time. The diagnosis associated with the use varies, and because the plan only captures five diagnoses in its electronic record, there were many cases where there was no appropriate diagnosis in the medical record. A special monthly report was developed by the PBM to identify all the members receiving erythropoietin. In May 2003, 31 members were taking erythropoietin and only nine were on iron supplementation. Intervention: The plan worked with the PBM to establish a process for prospective pre-authorization of erythropoietin using clinical criteria and information supplied by the treating physician to the PBM clinical staff. Clinical information was transmitted to the plan using a standard form, which was to be included in the members chart. The plan retained the final authority for the denial of any prescription with the full access to an appeals process available to the member or the physician on their behalf.31 For the oral iron supplementation intervention, the plan sent e-mails in June 2003 to all team managers for dissemination to nurse consultants explaining the importance of iron supplementation and requesting that the nurse consultants contact physicians for members taking erythropoietin if iron is not being prescribed. Educational materials for the nurse consultants and educational materials for members on erythropoietin were provided.32 Results: After a careful development process the plan worked out a prospective pre-authorization process with the PBM, which was administered centrally by the plan’s consultant pharmacist and medical director. After about two months, 26 requests for erythropoietin had been processed, with only a small number of requests being handled expeditiously. Due to the lack of a streamlined process at the PBM, there were many delays in members receiving this essential medication. Some of the delay was out of the control of the PBM, e.g., when pharmacists ignored the message for prospective pre-authorization at the point of sale. No instances of inappropriate use of erythropoietin were found. It is to be noted that the PBM indicated that they had stopped prospective pre-authorization of this drug with some managed care customers because of the low return of inappropriate use. Discussion at the Pharmacy Committee led to the plan’s decision to terminate the prospective pre-authorization process. The plan decided instead to perform a retrospective review internally to obtain the needed clinical information to justify erythropoietin use. Regarding the evaluation of iron supplementation Table 5 illustrates an analysis, using the on-line claims drug database. Table 5: Iron Supplementation Usage

Date # Members on Erythropoietin

# Members on Iron Supplementation

% Total

May 2003 31 9 29.0% September 2003 27 14 51.9% December 2003 25 11 44.0%

May 2004 41 18 43.9%


Analysis of the Nurse Consultant Survey: While the prospective pre-authorization for erythropoietin was not implemented, there were many beneficial results of the process for staff education and confidence building. The nurse consultant survey shows several areas of positive response, including:

• Learned a lot that I didn’t know (61.2%). • Materials to educate members were good (58.4%). • Education materials for nurse consultants were helpful (55.4%). • I feel more confident talking to physicians about this medication (53.4%).

The survey results were positive for the iron supplementation intervention and do not explain the lack of better clinical results. Responses included:

• The materials help educate members (55.4%). • Feel more confident talking to doctors about this medication (50.9%). • Able to identify and act on problems with this medication with the

doctor (48.1%) • I learned a lot about erythropoietin and iron supplementation that I did not

know (46.3%). Discussion: The results for the iron supplementation intervention, using the McNemar’s Chi-Square Test were not statistically significant, p=0.7237. Despite the results not being statistically significant, there has been a sustained improvement, but not progressive or at the clinical level that is satisfactory. Some of the reasons why iron supplementation was not supplied during the study were: the member was taking iron not recorded in the PBM drug database; the physician refused to prescribe iron; and the member was taking a supplement thought to include iron which was not in the supplement. Iron orally also is notorious for some intolerance. However, while the intervention communicated well with staff, there was only communication with physicians when a problem was determined, and a more widespread communication may have had more effect. For the prospective pre-authorization process the plan learned that even with the best standards, any process requires the cooperation of all those involved, including the dispensing pharmacist for it to be successful. The plan believes that the nurse consultants were not one of the factors that forced a change in strategy, and that they cooperated fully with the development of the prospective review. The plan determined that because erythropoietin is not frequently prescribed inappropriately, and that our retrospective review would catch all new prescriptions in the first month of use, that it was not dangerous for us to use a retrospective authorization process to identify medication problems. This would allow us to have control of the entire process and reduce the barriers for members receiving needed medication in a timely manner.


Conclusions and Next Steps VNS CHOICE developed a program that provided the resources to enable the nurse consultants to effectively manage the individual medication member profile, while building a program for the plan to affect problems in medication management for the entire population. The best way to develop a program for change is to involve those who would be affected in the change process. The plan chose focus groups to guide decisions and methods of communication in developing interventions. In order to be effective, a medication management program must become part of the organizational structure, with dedicated resources necessary to make it effective. An available pharmacist is a valuable part of this structure, as well as a committee of stakeholders that has the potential to effect change. Communication is an important part of any medication management program. The plan did not expect how much administrative support was needed to effectively manage the program. The focus groups indicated that staff and patient educational materials were an important component of improvement, and testing those materials in the focus groups helped to refine materials. To be effective, any intervention needs to reach all stakeholders, including physicians, members, and staff. When the plan did less it was less successful. We also learned that it is important to monitor results early, and modify interventions as necessary to get good outcomes. In final analysis it is possible to effect change in prescribing practices by physicians and more effective medication management practices by staff through effective communication that involves staff, members, and affected physicians; integration of medical management principles in the organizational structure; and providing the resources needed to manage the program. A next step for VNS CHOICE involves developing an automated medication list for all members that will reside in the home, be updated regularly, and be available as a resource for physicians and emergency facilities. Focus group physicians particularly liked this concept. The plan is currently piloting a process to produce such a list for patients using the PBM monthly updated drug database. One potential area for future study because of continued administrative and clinical problems (delays in treatment), are drugs covered by Medicare and supplied in the physicians’ office and not covered under plan capitation. Finally, an important opportunity for future improvement will be to incorporate medication management into a planned clinical system upgrade. Now that the plan has the infrastructure developed, this task will be easier and additional measures to improve the medication access, safety, and quality for members will be possible.


ENDNOTES

1. Hanlon JT, et al. “A Randomized, Controlled Trial of a Clinical Pharmacist Intervention to Improve Inappropriate Prescribing in Elderly Outpatients with Polypharmacy.” American Journal of Medicine, April 1996, 428-37.

2. Hunter KA, et al. “Pharmaceutical Care for Home-Dwelling Elderly Persons: A

Determination of Need and Program Description.” Gerontologist, August 1996, 36(4):543-8.

3. Tamblyn R, et al. “Adverse Events Associated with Prescription Cost-Sharing

among Poor Elderly Persons.” Journal of the American Medical Association, January 2001, 24-31;285(4):421-9.

4. Beyth RJ, Shorr RI. “Epidemology of Adverse Drug Reactions in the Elderly by

Drug Class.” Drugs Aging, March 1999;14(3):231-9.

5. Gurwitz JH, et al. “Incidence and Preventability of Adverse Drug Events among Older Persons in the Ambulatory Setting.” Journal of the American Medical Association, March 2003 5;289(9):11.

6. See Providing Pharmacy Services in a Medicaid Long-Term Care Program online

appendices at www.chcs.org for “Use of the Medication Database.”

7. McKenzie DA, et al. “The Validity of Medicaid Pharmacy Claims for Estimating Drug use Among Elderly Nursing Home Residents: The Oregon Experience.” Journal of Clinical Epidemiology, December 2000;53(12):1248-57.


appendices at www.chcs.org for “St John’s School of Pharmacy Report.”

9. Beers MH et al. “Explicit Criteria for Determining Inappropriate Medication Use in Nursing Home Residents.” Archives of Internal Medicine, 1991, September;151:1825-32.

10. Winslade NE, et al. “Practice Functions Necessary for the Delivery of

Pharmaceutical Care.” Pharmacotherapy, Sep-Oct, 1996;16(5):889-98.

11. See Providing Pharmacy Services in a Medicaid Long-Term Care Program online appendices at www.chcs.org for “Best Practices in Care Management Literature Research Findings.”

12. Golden AG. Inappropriate Medication Prescribing in Homebound Older Adults.

Journal of the American Geriatric Society, 1999, Oct;47(8):948-53.


13. “Medication Guide for the Long Term Care Nurse, 6th Edition,” American Society of Consultant Pharmacist 2003, ISBN: 0-934322-59-7, Phone 703-739-1300.

14. “Unnecessary Drugs in the Elderly Including the Psychotropic Utilization

Protocol; OBRA 1992-99” Revised 2002, Med-Pass Inc, Item# MP5501N, Phone 800-438-8884.

15. “Adverse Drug Reaction (ADR) Screen For Inappropriate Medication 1999,”

Med-Pass Inc, Item# MP5932P, Phone 800-438-8884.

16. See Providing Pharmacy Services in a Medicaid Long-Term Care Program online appendices at www.chcs.org for St. John’s Pharmacy Report.


appendices at www.chcs.org for Risperdal Intervention Materials.

18. American Medical Director Association (AMDA); Multidisciplinary Medication Management Committee, “Top Ten Particularly Dangerous Drug reactions in Long Term Care.” http://www.amda.com/m3/topten.htm

19. Juurlink DN, et al. “Drug-Drug Interactions Among Elderly Patients Hospitalized

for Drug Toxicity.” Journal of the American Medical Association, April 2003, 289(13):1652-58.

20. Knight EL, Avorn J. “Quality Indicators for Appropriate Medication Use in

Vulnerable Elders.” Annals of Internal Medicine, 2001;135:703-10.

21. See Providing Pharmacy Services in a Medicaid Long-Term Care Program online appendices at www.chcs.org for Warfarin Intervention Materials.”

22. Beers MH, op.cit.

23. Beers, et al., 1997.

24. Juurlink DN, et al.

25. Golden AG, et al.

26. “Unnecessary Drugs in the Elderly Including the Psychotropic Utilization

Protocol;” OBRA 1992-99” Revised 2002, Med-Pass Inc. Item# MP5501N, Phone 800-438-8884.

27. “Adverse Drug Reaction (ADR) Screen for Inappropriate Medication 1999,”

Med-Pass Inc., Item #MP5932P, Phone 800-438-8884.


28. Warning: “Unexplained Thrombotic Events and Mortality, Seizures, Not for use with uncontrolled hypertension in ESRD,” Physician Desk Reference for Epoeitin-Alpha (Procrit).

29. Edmund ME, et al. “Seizures in hemodialysis patients treated with recombinant

human erythropoietin,” Nephrology Dialysis Transplantation,1989;4:1065.

30. Abraham PA, Macres MG. “Blood Pressure in Hemodialysis Patients During Amelioration of Anemia with Erythropoietin.” Journal of American Society of Nephrologists, 1991;2:927.


appendices at www.chcs.org for Erythropoietin Pre-Authorization Materials.

32. See Providing Pharmacy Services in a Medicaid Long-Term Care Program online appendices at www.chcs.org for Erythropoietin Intervention Materials.

Documents

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