Prescribed Guidance

Oversight of long-term care (LTC) prescribing is getting a little more difficult because, on top of the restrictions on access imposed on prescribers as a result of Medicare Part D, there are now additional pressures being applied by LTC state surveyors. These new surveyor pressures are the results of the revised survey guidelines concerning pharmacy services and unnecessary medications that were introduced on December 18, 2006. In addition to these factors, it appears likely that legislative changes planned for Medicare Part D may place even greater restrictions on prescribing.

The Need for Prescribing Guidance

The perceived need for restrictions on prescribing comes from our current clinical, economic, and political environment. On the clinical side, there continue to be reports of failure to follow evidence-based guidelines such as the Beers Criteria.¹ Dr. Steven Handler in The American Journal of Geriatric Pharmacotherapy concluded that medication-related adverse events are common in the nursing home setting.² A recent study published in The New England Journal of Medicine caught national headlines in concluding that adverse effects of atypical antipsychotic drugs overall offset any advantages in their efficacy in the treatment of psychosis, aggression, or agitation in patients with Alzheimer’s disease.³

On the economic side, with increasing demand for prescription drugs for a growing number of elderly persons, as well as enhanced availability of innovative products, payors are looking to apply greater guidance to assure that utilization is controlled. This is especially severe in LTC, where nursing home residents take an average of 8.8 medications per day, and 32% take 9 or more medications.⁴ But of course it is not only the direct cost of the medications that is an issue but also the costs associated with medication-related adverse events, which was estimated to be $4 billion per year in a 1997 study.⁵

These economic pressures are especially acute given that the federal government is now the primary payor for the vast majority of medications for the elderly. These forces are coming together to cause regulations and other restrictions to guide prescription access to what is considered appropriate. All too often, however, the determination of appropriate access may be directed by non-clinicians.

Medication Therapy Management

One way that the prescription guidance has historically been applied in LTC is through medication regimen review. The State Operating Manual (SOM) F428—Medication Regimen Review (MRR) requires that the drug regimen of each resident must be reviewed at least once per month by a licensed pharmacist. The pharmacist must report any irregularities to the attending physician and the director of nursing; these reports must then be acted upon. This is not to say that this report must be accepted, but attending physicians are obligated to acknowledge recommendations. The acknowledgement of these recommendations must include clear documentation of acceptance or clinical reasoning as to why the recommendations were not followed.

The goal of MRR is to promote positive outcomes and minimize adverse consequences associated with medications. This review includes preventing, identifying, reporting, and resolving medication-related problems, medication errors, or other irregularities and collaborating with other members of the interdisciplinary team. The consultant pharmacist reviews are targeted to eliminate medication-related problems that arise from the use of a medication without adequate indication for use, or identifiable evidence that safer alternatives or more clinically appropriate medications have been considered. Some of the other objectives of MRR, as identified by the American Society of Consultant Pharmacists (ASCP), include:

• Use of an appropriate medication that is not reaching treatment goals for reasons such as timing or techniques of administration, dosing intervals, etc.
• Use of a medication in an excessive dose (including duplicate therapy) or for excessive duration
• Presence of an adverse consequence associated with medication(s)
• Use of a medication without adequate monitoring
• Presence of a clinical condition that might warrant initiation of medication

This last bullet is important because it relates to potential underutilization of medication. In this situation, the target of MRR is to take aim at prescribing guidance to assure that, in the presence of a clinical condition that might warrant initiation of medication, appropriate treatments are considered.

Physicians have an important role to play with regard to MRR, which includes documentation of the clinical reasoning behind prescribing; this includes documentation of objective findings, diagnoses, symptoms to support the chosen medication, and dosing. With regard to dosing, the frequency, route, and duration must be consistent with an LTC resident’s condition, manufacturer’s recommendations, and applicable standards of practice. Once the medication is ordered, the work is not finished for physicians; the prescribers’ role includes monitoring and acting on lab results, diagnostic studies, or other measurements on a continuous basis. When faced with consultant pharmacists’ MRR recommendations, physicians can either accept the recommendation and provide orders, or reject the recommendation and provide a brief explanation, such as in a dated progress note.

Unfortunately, under the Medicare Part D rules, prescription plans must implement their own medication management, which all too often will be duplication to the efforts of LTC consultant pharmacists. Under Medicare Part D, these services are provided through plans under their medication therapy management (MTM) programs. MTM programs are services targeting those seniors who are taking multiple medications with costs over $4000 annually to treat multiple chronic illnesses. The $4000 financial threshold for medications used annually remains the same for 2007. The Centers for Medicare & Medicaid Services (CMS) believes strongly that MTM programs will evolve and become a cornerstone of the Medicare Prescription Drug Benefit.

The stated objective of CMS in developing MTM programs is to ensure that prescribed Medicare Part D medications are appropriately used to optimize therapeutic outcomes through improved medication use, as well as to reduce the risk of adverse events, including adverse drug interactions for targeted beneficiaries. CMS believes that MTM programs should include enhanced enrollee understanding through beneficiary education counseling, and other means that promote the appropriate use of medications and reduce the risk of potentially adverse events associated with their use. Another component could be increased enrollee adherence to prescription medication regimens (eg, through medication refill reminders, special packaging, compliance programs, and other appropriate means). MTM programs could also include detection of adverse drug events and patterns of overuse and underuse of prescription drugs to ensure that the appropriate medications are prescribed.

The difference with regard to MTM programs and MRR is that MRR applies to every resident of the LTC provided on at least a monthly basis by a consultant pharmacist, whereas MTM programs are only available to targeted beneficiaries and are delivered at a frequency and by a provider determined by the prescription plan. This means that MTM programs do not have to be provided to every LTC resident, nor done on a monthly basis, nor delivered by a consultant pharmacist. So, within LTC, conflict and redundancies will arise because of these overlapping programs. And it will be up to the attending physician to continue to translate the recommendations from both programs into what is best for the LTC resident served by Medicare Part D.

F-Tags

ASCP has said that new guidelines take a holistic approach to medication management, stressing the importance of the care process as a whole. Nowhere is this attempted more than in F-tag 329—Unnecessary Medications. Under this F-tag, each resident’s medication regimen must be free from unnecessary medications. Some of the definitions that apply to an unnecessary medication include any medication when used:

• in excessive doses (including duplicate therapy); or
• for excessive duration; or • without adequate monitoring; or
• without adequate indications for its use; or
• in the presence of adverse consequences which indicate the dose should be reduced or discontinued; or
• without recommended gradual dose reduction (GDR).

Surveyors will be especially watchful of utilizing this F-tag when it comes to the use of the psychiatric medications. Within this large class of medications, surveyors are to monitor to ensure that gradual dose reduction (GDR) takes place in a very regimented manner to achieve the lowest dose of these medications. For example, residents who use antipsychotic drugs must receive gradual dose reductions and behavioral interventions, unless clinically contraindicated, in an effort to discontinue these drugs. This is especially true within the first year after admission on antipsychotic or after initiation:

• GDR in two separate quarters, with at least 1 month between attempts
• After first year, GDR annually

The guidelines do outline the limited times when GDR would be considered clinically contraindicated if, for example, the resident’s target symptoms returned or worsened after the most recent GDR attempt within the facility, and the physician has documented clinical rationale. A new change under the F-tags is the fact that GDR and behavior monitoring now applies to antipsychotics no matter what the indication, which now include behavioral symptoms related to dementia or other psychiatric disorders.

There are also specific tapering guidelines for sedatives/hypnotics, as well as psychopharmacological medications that are now grouped together, so as to include more than just benzodiazepines. This definition has been expanded to include any medication used for managing behavior, stabilizing mood, or treating psychiatric disorders, which could apply to anticonvulsants and antidepressants, as well as to antidementia agents, despite the fact that there is no standard to attempt tapering of these agents. To ensure continued appropriate use of these agents, physicians and pharmacists will need to work together to document appropriate medication use and any contraindications against GDR, as well as to educate surveyors regarding the clinical appropriateness of treatment.

Managing Pharmaceutical Access

Of course, at the end of the day, all professionals involved in the care of LTC residents have the same objective of improving health outcomes through appropriate medication management. In order to accomplish this, physicians will need to make adjustments in their clinical practice, especially with regard to documentation, in order to be in compliance with the new SOM. Many of these adjustments should lead to improved outcomes to older persons, but some may result in the elimination of needed medications that could become dropped because of the increased barriers in accessing medications, and especially psychopharmacological drugs.

Physicians’ responsibilities need to go beyond the bedside and should include providing the clinical education and guidance to state surveyors to ensure that regulations are applied in a consistent and clinically astute manner. In addition, physicians will need to continue to apply pressure through such organizations as the American Geriatrics Society (AGS), American Medical Directors Association (AMDA), American Society of Consultant Pharmacists (ASCP), and others to ensure that future guidance being applied to the prescribing of medications utilizes the best clinical evidence available rather than reliance upon arbitrary measures. This is the only path that will lead to achieving the objective of improved health outcomes through appropriate medication management.

Please send any questions or experiences about Medicare Part D you would like to share with readers to: BSpivack@Waveny.org