Drug Regimen Review: Bane or Boon?

by Duncan S. MacLean, MD, CMD

One of the annoyances a doctor first notices when starting into nursing home practice is the monthly note from the pharmacist about drug "irregularities." Pharmacists in other practice settings rarely admonish doctors. But in nursing homes, they dispense suggestions to us regularly.

Most doctors admit, however grudgingly, that some pharmacist advice is helpful, such as reminders about essential lab monitoring. However, other advice appears unimportant or irrelevant. Sometimes, the pharmacist has overlooked existing lab results or documentation, requiring us to duplicate our previous efforts. In other cases, pharmacist recommendations may be inappropriate to the overall plan of care and may strike us as intrusive.

"Doctor, please consider a trial of an ACE inhibitor--indicated for CHF," read the pharmacist's monthly note. I had to admit that I had never tried an ACE inhibitor for this 75-year-old man, who had resided in my facility for more than three years. His diagnoses included proven coronary artery disease, CHF with an ejection fraction of 30%, and dementia.

Previously, he had frequent complaints of chest pain, raising the possibility of impending cardiac death. More recently, however, the team recognized that many of his pains were not cardiac (responding to hugs and cookies). His rare true angina episodes responded easily to nitroglycerin. He could walk short distances without any cardiac symptoms.

Thus, I now considered him generally medically stable with a fair prognosis in the short term. Perhaps he might live long enough, after all, to benefit from ACE inhibitors.

"Recommend low dose, because of creatinine of 1.6 and calculated clearance of 30 cc/min," added the pharmacist, because of the resident's age and mild renal impairment. I reviewed the theoretical benefit of reduced morbidity and mortality, along with the medication's risk for renal toxicity, with the resident's cardiologist and daughter.

With their agreement, I started a low-dose ACE inhibitor. Weekly monitoring of renal functions not unexpectedly showed an abrupt rise in creatinine. I stopped the ACE inhibitor, and fortunately the creatinine returned to baseline.

Was this an instance of pharmacist meddling? Or was the pharmacist's ACE inhibitor recommendation a constructive suggestion for this patient's management? Either way, this case shows that the pharmacist can play an active role in nursing home care.

What do the regulations require from consultant pharmacists? How can medical directors help facilities and physicians get the most appropriate support from their pharmacist? This column will discuss drug regimen review (DRR) and a medical policy highlighting the physician's responsibility.

Regulations

The Centers for Medicare and Medicaid Services' State Operations Manual (SOM) contains four sections that regulate drug use in nursing homes (also see Resources).

Appendix PP: Tags F428-F430, Drug Regimen Review. This section requires monthly DDRs by a licensed pharmacist for every resident. The pharmacist must report irregularities to the attending physician and director of nursing (DON). These tags require the attending physician and DON to "act on" reported irregularities relevant to their respective disciplines. They do not require attending physicians to agree with the pharmacist or even to explain why they do not agree. The interpretive guidelines for tag F429 "encourage" the medical director to intervene if the attending physician does not act, by failing either to write the suggested order or to document rejection of the pharmacist's recommendation.

The other three sections of the SOM contain standards to be used by consultant pharmacists for DRR.

Appendix PP: Tag F329, Unnecessary drugs. Most medical directors are familiar with this section, which defines an unnecessary drug as one used:

• in excessive dose
• for excessive duration
• without adequate monitoring
• without indications
• in the presence of adverse consequences necessitating dose reduction or discontinuation.

This section lists both psychotropic drugs and other drugs with a high risk of severe adverse drug reactions (ADRs). This policy column previously reviewed psychotropic drugs in the February 2001 issue of Caring. The companion policy is referenced in the Resources section.

Appendix P: Investigative Protocol: Adverse Drug Reactions. CMS added this section to the SOM in July 1999. This policy column previously reviewed the ADR Investigative Protocol in the October 2000 issue of Caring. The companion policy is referenced in the Resources section. The Protocol guides surveyors to identify possible ADRs and drug-disease interactions using criteria published by Beers et al. in 1997. The Investigative Protocol cross-references the four groups of high- and moderate-ADR-risk drugs listed in Appendix PP (see Resources).

Appendix N: Surveyor Procedures for Pharmaceutical Service Requirements in Long-Term Care Facilities. This section gives detailed instructions to surveyors and facilities about drug use, including duplicate therapy, duration of therapy, dosing, and monitoring. This Appendix applies to both long-term care facilities and intermediate-care facilities for the mentally retarded. It covers 21 drug categories (see box at right). It also addresses inappropriately crushed medications and unheeded histories of drug allergy.

Getting the Most from the Consultant Pharmacist

Consultant pharmacists should audit compliance with these four sets of standards as a regulatory minimum. They may also routinely check for drug-drug interactions, physician prescribing mistakes, and nursing administration errors (tags F332 and F333).

Increasingly, consultant pharmacists are called upon to help control drug costs. They can recommend generic substitutions. They can also recommend therapeutic substitutions, such as a generic ACE inhibitor instead of a proprietary drug still under patent. They can recommend dose simplification to avoid wasting split tablets.

Some consultant pharmacists collaborate with the medical director to devise protocols requiring a trial of less expensive traditional therapies before prescribing more expensive newer drugs. For example, some facilities ask physicians to try sulfonylureas before prescribing the more expensive glitazones or metformin.

One potential area for pharmacist drug-regimen review is polypharmacy reduction. This, however, raises several concerns. First, combination therapy is now recommended for some medical conditions such as diabetes, hypertension, coronary artery disease, renal failure, and congestive heart failure. It may not be appropriate for the consultant pharmacist to challenge such regimens.

Secondly, interventions to reduce the number of medications prescribed should be done in conjunction with the medical staff. Gerety et al reported one example of a successful polypharmacy intervention jointly conducted by the clinical pharmacist and admitting geriatrician at the Audie Murphy VA nursing home in San Antonio, TX (Gerety ML, Cornell JE, et al. J Am Geriatr Soc 1993;41:1326). Residents in this study reduced their average number of drugs taken from 7.0 on admission to 5.9 at 6 months. The biggest reductions occurred for digoxin, H2 blockers, furosemide, and potassium.

Effective drugs are now available for secondary prevention of the complications of osteoporosis, hyperlipidemia, and congestive heart failure, among others. Nursing home clinicians should recognize that the benefits of treatment might not become statistically--much less clinically--significant until after completing three years of therapy. Since the average nursing home patient survives fewer than three years after admission, such preventive regimens may not be warranted for patients without good enough prognoses to benefit from the treatment.

I have found the consultant pharmacist to be most helpful when integrated into the facility's interdisciplinary care plan (ICP) team. Ideally, the pharmacist should attend ICP team meetings. Even if the pharmacist is not able to attend ICP team meetings, he or she can still coordinate drug regimen reviews with the team by telephone before or afterwards. Pharmacists can routinely advise the team about drug side effects, costs, polypharmacy, and treatment of active conditions.

The medical director should also ensure that the consultant pharmacist reviews a patient carefully with the nursing staff, attending physician, or medical director before recommending new medications or increased doses of existing medications based on the presence of a diagnosis. Often, patients do not need treatment for an existing diagnosis or the risk of treatment outweighs the potential benefits.

A consultant pharmacist can also help in other special circumstances. Some recent examples in my facility included proposed use of erythropoietin for severe anemia of chronic disease, review of continued use of a multi-drug anti-retroviral regimen in terminal AIDS, and use of interferon for multiple sclerosis. In each case, we included the pharmacist in a special team meeting to make decisions regarding drug therapy in the context of the overall management plan.

Medical Policy

Two versions of medical policies on drug regimen review are posted in AMDA's Online Model Policy Manual. The policy should contain three key elements.

First, it should indicate that drug-regimen review is a regulatory requirement, not simply capricious interference by a presumptuous pharmacist.

Second, it should require the attending physician to respond to pharmacist recommendations. It should make clear that the attending physician does not have to accept the recommendation. Although the regulation does not require the attending physician to justify rejecting the recommendation, I suggest requiring an explanation as a good risk-management strategy.

Third, the medical policy should cross-reference both the psychotropic drug policy and ADR policy. These policies describe the extra analysis and documentation needed from physicians for psychotropics and targeted high-ADR-risk drugs.

A reasonable policy can help turn drug-regimen review from a bane for physicians into a boon for good nursing home care.

Dr. MacLean is Medical Director of Delaware's state-operated system of nursing homes. He was founding President of the Pennsylvania Medical Directors Association and served as an Issue Expert on Long-Term Care for the 1995 White House Conference on Aging. He has directed a private non-profit nursing home, a hospital-based subacute unit, and a private personal care facility. He has served on AMDA committees, presented at the AMDA Annual Symposium, and conducted Symposium discussion groups.

The opinions expressed by Dr. MacLean are his own and not necessarily those of the American Medical Directors Association.

back to top