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© Geriatric Times. All rights reserved.

The Reality of Drug Regimen Reviews

by Gary Snodgrass, Pharm.D.

Geriatric Times September/October 2000 Vol. I Issue 3


Not long ago, I was reading an article on Resident Assessment Protocol (RAP) Utilization Guidelines (Consultant Pharmacist 2000;15[3]) by Nancy Losben, R.Ph. The guidelines contain 18 categories or potential problems that can diminish a long-term care facility resident's quality of life. These potential problem areas or conditions include delirium, cognitive loss, visual function deficits, communication deficits and a host of other conditions for which pharmacists need to rule out medication as the etiology. Losben does a good job explaining the purpose for which the RAP Utilization Guidelines were designed:

  • Ensure that a full range of causal factors is considered;
  • Help describe the nature of a condition;
  • Identify complications and risk factors;
  • Reveal the need for further investigation; and
  • Formulate individualized care plan goals and approaches.

As I continued to read the article, I struggled to maintain a mental diagram of how the 18 RAP categories-interrelated with the Health Care Financing Administration's (HCFA) 24 quality indicators-meshed with HCFA domains, F-tags, interpretive guidelines and the Minimum Data Set (MDS) 2.0.

Just then the phone rang, my mental picture scrambled and my brain read: "Unusable signal." This is the message from my satellite dish when I am trying to change a TV channel after a teenager has played with all four remote controls.

This experience reminded me that, at my age, I am beginning to have difficulty tackling complex issues with the same organization and clarity presented in the article. As a corollary to this, my consulting practice often diverges from the clear decision-tree analysis the Omnibus Budget Reconciliation Act (OBRA) advocates. Therefore, in this issue I will present a case study of a resident referred to me for drug regimen review. The goal is to share with you some of the challenges I think most consultants face in melding what we should do with what reality allows us to do.

One of my clients is a 99-bed skilled nursing facility (SNF) in Northern California. It has an active Medicare wing and several private-pay residents. About 70% of the other patients fall under MediCal. Like similar facilities, it has weathered the storm of reimbursement pressures, unrealistic expectations from residents' families, aggressive surveyors and less-than-timely physician visits. By any measure of quality of care, however, this client is the best SNF within the geographic area. It is important to frame the following case study within that context. Overall, this is a very good facility, and it is chosen by most of the community leaders within the area when they are seeking long-term care for their loved ones.

"GS" (not his real initials) is a 91-year-old white male, admitted to the SNF from an acute care hospital four years ago. His discharge diagnoses from acute care included: left hemispheric cerebrovascular accident (CVA) with left hemiplegia; Wernicke's aphasia; possible right homonymous hemianopsia versus right neglect; oral motor apraxia and cognitive defects; atrial fibrillation; osteoarthritis; history of prostatic cancer (treated with Lupron and flutamide); possible congestive heart failure (previously used Dyazide); and impaired mobility. He had a past history of CVA with transient right-sided weakness, for which he did not seek medical attention, one year prior to the acute care admission. Prior to admission he lived at home with his wife, who is very attentive and visits him at the SNF daily.

The resident was admitted to the SNF on Coumadin (warfarin) 4 mg qd, Procardia (nefedipine) XL 30 mg qd, Colace 100 mg bid, Propine (dipiverine hydrochloride) 0.1% ophth. soln. 1 gtt ou qd, Tylenol (acetaminophen) prn, MOM and Dulcolax supps. prn. He began working with an occupational therapist to assist with upper extremity strengthening and coordination, neuromuscular re-education, and assessment and training in basic activities of daily living. A speech therapist worked with him on speech, language, swallowing and cognition. Recreational therapists began to work on community mobility and community re-entry.

When I first saw GS in December 1998, he was lethargic but could communicate partially by grunting. He was accepting about 70% of his diet and weighed 186 pounds (up from his admission weight of 170 lbs), but he still had dysphagia. He had been placed on a mechanical soft diet, with close supervision at meals.

The physician progress note read, "Unfortunately, there is little to do except continue supportive care. Will have PT & OT re-eval in light of new CVA. Will use Haldol (haloperidol) for extreme agitation." The list of admission diagnoses had been amended to include: CVA (onset 11/98), increased agitation and cortical blindness. The nursing staff reported multiple behavior tallies of thrashing about in bed, severe yelling, inability to calm self and angry outbursts. He had an order for "May use pelvic restraint in wheelchair for safety" and another for "R. leg elevated & secured to W/C leg rest to keep flaccid leg from injury."

From a medication standpoint, he continued with ophthalmic medications, various prn orders for laxative cascade, Ascriptin 1 qd, Tylenol ES 1000 mg bid, acetaminophen 650 mg po q4hrs prn general pain, Vicodin (hydrocodone) 1 q4hrs prn moderate general pain. He also had orders for haloperidol 5 mg po q4hrs prn extreme agitation, along with an order for haloperidol 5 mg IM if po refused.

At this point, his compliance was poor, with medication refusals making it difficult to assess the efficacy of any particular medication.

He had no acute cardiac or gastrointestinal distress, but the nursing staff was concerned that he would yell constantly for about an hour in the early morning. They would medicate him with haloperidol and hydrocodone prns, but then his wife would become upset that he was lethargic when she came in to feed him lunch. I discussed with the staff the need to minimize lethargy by limiting administration of haloperidol to combative behavior and danger to self/others. Since he appeared to c/o right arm pain, we set a goal of trying to rule out pain as the cause of his behavioral outbursts.

By avoiding haloperidol prns and documenting better his response to prn analgesics, perhaps we could disentangle his drug regimen. I was also hoping to adjust the hydrocodone dose or find an optional analgesic (e.g., trial of nonsteroidal anti-inflammatory drugs or Celebrex [celecoxib]/Vioxx[rofecoxib]) to limit the total daily dose of acetaminophen. In addition to clinical concerns, I also expressed the need for better documentation of medical necessity for the antipsychotics. GS's physician was less than interested in OBRA compliance.

On my next visit to the facility, I found that GS's wife had lectured the physician on the evils of haloperidol. Therefore, Haloperidol was discontinued, and Ativan (lorazepam) 0.5 mg po q12hrs routinely was started for anxiety manifested by angry outbursts. In addition, lorazepam 1 mg IM q8hrs prn loud yelling was ordered. The nursing staff had been unable to establish any pattern of analgesic response, but GS continued to grimace, yell most of the morning and receive hydrocodone prns two to three times daily. Compliance with oral meds had worsened, and GS alternated between screaming and lethargy. Most of the hydrocodone prns and lorazepam IM prns were given before noon, so his wife was less than pleased with the staff for making it difficult for her to feed GS at lunch.

I met with the wife to discuss the significant differences in GS's behavior in the morning versus the afternoon, and I explained the pattern of alternating agitation and sedation with multiple prns. I again negotiated with the nursing staff, giving options for increased doses of routine meds versus prns, a possible trial of low-dose Risperdal (risperidone) if we could get better compliance and the need to enlist the wife as an ally. I reviewed non-drug behavioral interventions, pain versus dementia and the necessity of detailed documentation.

On a subsequent visit, I could see we were going backward. Compliance with routine meds was almost zero. Nursing was able to get him to accept more prns, and lorazepam 1 mg po q8hrs prn had been added to routine lorazepam po and Ativan IM prns. The resident had become more combative and had struck out at several members of the staff and other residents.

I voiced my opinion that GS was declining and was becoming an inappropriate placement and, unfortunately, the next step might be transfer to a secured facility or dementia unit. The staff had become fearful of GS, his wife felt helpless and GS had little if any "quality-of-life." It took me almost two more months to convince the physician to try low-dose haloperidol decanoate. Brusque progress notes were traded, we had some heated discussions, more education with the wife (no other family was available), and impromptu inservice programs on regulatory noncompliance and legal liability were held with the administrator.

We started haloperidol decanoate 12.5 mg IM q4weeks and obtained some positive response. Nursing staff was able to track a pattern of the medication wearing off in about 10 days. We increased the frequency of haloperidol decanoate to q2weeks, and the staff experienced the same pattern. GS still had some yelling episodes, but no combativeness. He was occasionally sedated, but had an easier time with meals. (He still received lorazepam prns, but not frequently.) The physician, however, did not grant me any newfound credibility for my recommendation. Therefore, my further recommendations for trying optional analgesics went unheeded. This is from the "leave-well-enough-alone" school of pharmacology.

Finally I was pleased we had done some good for GS. At least he could eat his lunch, was mobile in his wheelchair and was 100% compliant with po meds. I had visions of being able to taper the haloperidol decanoate and starting a very low dose of one of the newer atypical antipsychotics, as the literature suggests we should. As long as I was being this optimistic, maybe we could even revisit his hydrocodone prn/high-dose acetaminophen regimen for osteoarthritis.

I wish that had been the end of the case study. On my next visit, however, I received a dose of "political" pharmacology. Mrs. GS apparently had the administrator on the carpet because the nursing staff had "given him two shots." Obviously the administrator wanted me to confirm or disprove the medication error. I met with both Mrs. GS and the administrator to hear their concerns and to reassure them.

After interviewing the staff and reviewing the chart, I found that his wife wanted to take GS home over the holiday. Concerned about potential sedation, she had talked a nurse into holding the haloperidol decanoate. Three days later he decompensated and became very combative. He was returned to the SNF, and the nursing staff gave him lorazepam 1 mg IM prn. The haloperidol decanoate was also given, although three days late. This is what his wife had misinterpreted as an error of haloperidol double-dosing. I again met with Mrs. GS and the administrator and explained what had happened. The wife said she understood and that she was not upset.

My progress note read, "Met with Mrs. GS and administrator to review her concern about lethargy and 'they gave him two shots.' It turns out that she requested holding the haloperidol on 4/22, which was delayed until 4/25. This extended his 10-day cycle, as per his previous pattern he became combative, and he received lorazepam 1 mg IM x 1 on 4/26, before the haloperidol decanoate injection could take effect. The lorazepam resulted in increased sedation, and difficulty in accepting meals. Options for the future include: re-enforcing with family the importance of being consistent with the haloperidol decanoate cycle, and considering d/c of early morning lorazepam 0.5 mg po, and changing lorazepam 1 mg prn to hs only." In addition to my written note, I asked the nursing staff to contact the physician by phone and update me.

Following-up a few days later, I had to write the following note: "Drug Consult follow-up: Apparently, above recommendations not shared with t

he physician. Staff reported some drooling on 5/6 and the physician ordered Haldol decanoate d/c'd. Wife now reports alternating episodes of morning yelling and sedation. Observed today at 12:45 and he is sedated, probably secondary to Ativan prn severe yelling for 90 minutes this morning.

If the above trial off Haldol is not effective, consider re-instituting Haldol decanoate at a dose of 25 mg q14days, or Risperdal 0.5 mg q hs if still po med compliant."

In conclusion-and in my defense-I have oversimplified this case, and I have left out a lot of detail and descriptions of attempted interventions. With the mixture of anger, frustration and disappointment, and the nagging feeling of maybe I could have done something else, it is difficult to bare failure in a column. It is small solace that we did GS some good temporarily. Mostly I hope this case sparks some ideas for improved consulting effectiveness. Best wishes.

P.S. I will be back to that facility next week to try again.

Dr. Snodgrass is an independent consultant and president of Triad Management Group. His firm assists health care managers in pharmacy systems analysis, vendor evaluation, medication utilization and quality assurance in long-term care, residential care and psychiatric facilities.