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"We believe that a drug compendium could be of great value in meeting the drug information needs of pharmacists and registered nurses engaged in medication review, assuming that the document will include relevant information supplemental to that shown in drug labeling. For example, the compendium should include known drug interaction information which FDA considers to be impractical to include in drug labeling. Development of a compendium will be a formidable task which probably will take several years to complete because about 5,000 prescription drugs had FDA marketing approval as of December 1979. About 500 of these drugs are taken by nursing home patients. However, drugs taken by some 16 to 58 percent of these patients are in only 10 classes of drugs. For example, 58 percent of the patients take laxatives; 51 percent take analgesics, pain relievers; and 16 percent take anti-infectives. Criteria on the monitoring and use of some of these drugs has been developed by PSRO's and others. We, therefore, recommended that, pending publication of a drug compendium, HHS issue those criteria which have been developed by PSRO's and others to provide immediate assistance to those pharmacists and nurses making medication reviews in nursing homes.

"HHS generally agreed with our recommendation that PSRO criteria be disseminated, with the stipulation that the criteria be identified as screening criteria and not be inflexible.

"HHS standards require that nursing homes have a pharmacist or registered nurse review the medications of each patient monthly. However, HHS has not adequately defined the scope of these reviews, matters such as reviewing the patient's medical record, interviewing and observing the patient, and determining whether specific types of potential problems exist."

The CHAIRMAN. Excuse me. You recommend there be a pharmacist or registered nurse to review the medication. What about the doctor who originally prescribed the medication?

Dr. GRANT. The doctor routinely would be responsible for reviewing medication. But the pharmacist and registered nurse are required by regulations to be there on the spot to review the activities of the drug procedures and we believe that is a very important part of the program assisting the doctor in his functions.

The CHAIRMAN. It would be their duty, then, to report to the doctor if they had an adverse effect?

Dr. GRANT. Yes, sir.

The CHAIRMAN. From the use of the drug?

Dr. GRANT. Yes, sir.

The CHAIRMAN. If they found the patient was not getting any better or getting worse?

Dr. GRANT. Exactly. They would report to the physician the circumstances of the case so that the physician could take the action that would be warranted.

In this absence of a definition of the scope of medication review, the pharmacists and nurses are left to develop their own interpretations of what should be done. At the nursing homes we visited, the scope of review varied considerably and at many of these homes the scope appeared to be inadequate.

The HHS standards for skilled and intermediate care state as follows regarding medication review:

67-680 0-80--4

Skilled care (42 CFR 405.1127(a)): A pharmacist must review the drug regimen of each patient at least monthly and report any irregularities to the medical director and administrator.

Intermediate care (42 CFR 442.336): A registered nurse must review medications monthly for each resident and notify the physician if changes are appropriate.

Although HHS did not clarify the standards, it did take certain other actions which may have helped to indoctrinate some pharmacists and nurses. About 6 months before the medication review standards were published in 1974, HHS's Public Health Service issued contracts to two organizations to provide training programs and materials on matters relating to nursing home patient medications. The University of Minnesota developed those guidelines and model criteria for conducting drug utilization reviews which we discussed earlier in this statement. However, this information did not receive wide distribution. The American Pharmaceutical Association (APhA), a national society of pharmacists: One, conducted a series of workshops and seminars on institutional pharmaceutical services, including medication review; two, prepared a curriculum for schools of pharmacy to provide similar training to students; three, developed and is promoting a home study course for pharmacists on monitoring drug therapy; and four, developed and is promoting a teaching guide for use by pharmacists in training nursing home staffs in pharmacy services. Neither APhA nor HEW knows how many pharmacists or nurses involved in medication review have been exposed to the training courses or materials.

The APhA medication review training materials include specific review methodology such as procedures for identifying potential problems, check lists, and coordination with nursing home staff. According to APhA, the purpose of this material is to orient pharmacists and others to the medication review process. APhA stated that the set of procedures outlined are neither standardized nor required in all instances, and that there can be many other sets of equally satisfactory review procedures.

While recognizing that the procedures prepared by APhA do not constitute the only acceptable methodology, these training materials imply certain minimum coverage which can reasonably be expected of the reviewer regardless of specific review procedures followed.

The APhA training materials indicated that the scope of medication review made by pharmacists should include: Reviewing the patient's medical records; observing and interviewing the patient, at least in cases where analysis of the medical file indicates a problem possibly caused by a drug or drugs; notifying as appropriate the physician or nursing home staff when medication problems are identified.

The CHAIRMAN. I remember at a previous hearing somebody told us that the nursing homes themselves did not provide a doctor, it was up to the individual patient to get a doctor if he or she wanted one or needed one. Is that true?

Dr. GRANT. That is not always true, Mr. Chairman. It varies with the nursing home concerned. There are nursing homes that employ physicians. There are in other cases individual patients who employ physicians. It depends entirely on the arrangements within that State and within the nursing home, and it varies a good deal.

The CHAIRMAN. Those homes that don't provide a doctor, obviously they just sort of leave it up to the patient to decide whether he or she thinks he needs a doctor or not?

Dr. GRANT. Yes, sir. But the majority, almost all nursing homes today do have a physician required by regulations or by statute, either the State or the Federal Government. There would be very few nursing homes that wouldn't have a physician at least on call. The CHAIRMAN. A great many of those people are in there, their care being paid for under medicaid or medicare?

Dr. GRANT. Yes, sir.

The CHAIRMAN. Those people wouldn't have the independent means ordinarily to pay their own doctor?

Dr. GRANT. That is correct, yes.

The CHAIRMAN. So the doctor would have to be paid. If the ordinary rule prevails, does the 80-percent rule prevail in those cases? In case of medicare, the Government under medicare would only pay 80 percent of the doctor's bill. Isn't that the rule under medicare?

Dr. GRANT. Yes, sir.

The CHAIRMAN. So that 20 percent would be left to the patient who may not have any income except social security payments? Dr. GRANT. Unless it was covered by the medicaid program within that particular State.

The CHAIRMAN. The 20-percent rule does not apply in medicaid? Dr. GRANT. No. It would not apply if the medicaid program within that State stipulated they would cover that 20 percent. In other words, the doctor would bill the medicare program for 80 percent and could receive, if the State permitted, the other 20 percent from the medicaid program.

The CHAIRMAN. Thank you.

Go ahead.

Dr. GRANT. In analyzing each patient's medications, the pharmacist should determine whether:

Each drug is administered as ordered by a physician;

Each drug administered is supported by a diagnosis, condition, or symptom;

The drug being administered for each ailment is the drug of choice;

The dosage strength of each drug being administered is appropriate, given the patient's age, chronic and present disease(s) and current general health;

Duplicate medications are being administered;

Potential causes of adverse effects exist, such as drug-drug, drugfood, or drug-disease interactions or hypersensitivity potential; Evidence of adverse effects is present and, if so, whether these effects are being controlled within tolerable limits;

Appropriate tests have been ordered and made;

Each drug administered is achieving the desired effect.

We interviewed pharmacists having medication review responsibilities at some of the homes visited to determine the scope of their reviews. The scope of review described by about half of those pharmacists was less that that suggested by the APhA training materials to which I have already referred.

For example, some pharmacists were either not reviewing patient medical records or were not doing so routinely, while others reviewed the records but did not consider or did not make recommendations on the need for tests or the physician's choice of drugs. The reasons given by these pharmacists can generally be placed in the following three categories: One, they did not consider themselves to be qualified for various reasons, including lack of clinical training or inadequate information on some drugs; two, their personal concept or interpretations of the scope of medication review was different, including some who believed that certain matters, such as choice of drugs, were the responsibility of the nurse or physician; and three, concern over possible resentment by attending physicians.

We believe that HHS needs to establish minimum standards as to scope of medication review by both pharmacists and registered nurses and to also assure that medication reviewers are apprised of acceptable review methodology. In response to our draft report, both HHS and APhA stated that they are opposed to any standards which would require reviewers to follow a certain system regarding method of review.

APhA agreed, however, that HHS should do more to apprise nursing homes and health care personnel of the many possible but not required elements of a medication review which are available. We concur with HHS and APhA that reviewers should not be required to follow a certain system or method. However, we believe that HHS can define the scope of medication review coverage while still allowing reviewers the latitude to choose specific review methodology to be followed.

We also believe that development and dissemination of drug utilization guidelines and eventually a drug compendium and minimum standards for scope of coverage in medication review should alleviate pharmacists' and nurses' concerns regarding their roles and provide them with a clear understanding of their responsibilities. While issuance of these guidelines and standards will not solve all problems in relationships with physicians, medication reviewers may be less reluctant to make recommendations when they are guided by authoritative drug information and a well-defined role.

At 40 of the 68 nursing homes we visited, the pharmacist reviewing patient medications was also associated with the retail pharmacy providing drugs to many patients residing in that facility. In 37 of the 40 homes, at least one other retail pharmacy was available in the community where either the nursing home or the consultant was located.

While we found no evidence that the pharmacists were not objective in their review, this practice we believe creates the appearance of a potential conflict of interest because the pharmacists making the medication reviews would have a financial disincentive to recommend the discontinuance of or reduction in dosage of the drugs he or she is selling.

The CHAIRMAN. I can well sense the feeling that you have and I share it about the conflict of interest. If the drugstore near the nursing home which does a great deal of business with them is represented by the pharmacist who makes the review of the drugs

given and their effect and the like, his recommendation may very directly affect his business and he may have a personal interest in the recommendation that he makes.

On the other hand, if you use a druggist, a pharmacist who is not related to the nearby drugstore that the nursing home does business with, how is he going to be paid for the service he renders? It is not a very delightful duty, I guess, for a pharmacist to go into a nursing home and go through all the records of the drugs that are prescribed for all the patients and examine as best he can the reaction of the patients to the drugs and make a recommendation about it.

How do you pay the man for doing that and how do you get him? Mr. HOFFMAN. Mr. Chairman, that would be an allowable operating cost of the nursing home. So they would enter into contractual arrangement to provide the service for a fee.

The CHAIRMAN. You mean that would be the duty of the nursing home to provide such a pharmacist?

Mr. HOFFMAN. Yes.

The CHAIRMAN. And to make arrangements for his compensation?

Mr. HOFFMAN. Yes.

The CHAIRMAN. I see. All right. Go ahead. Thank you.

There, again, when you do that, of course, the fellow, the one who is being investigated, in a way is the one that is doing the paying. That is usually not the best way to get an impartial investigation. But to find another way is somewhat difficult, I guess. Go ahead.

Dr. GRANT. In 1977, the Department of Health and Human Services drafted guidelines which encouraged separation of pharmacy consultant services and drug vendor services in those geographic areas where it is possible and feasible. The guidelines, however, have never been issued in final form because of unresolved issues regarding payment for drugs. In our opinion, HHS should issue regulations requiring separation of the medication review component of consultant services from drug vendor services whenever feasible and deal separately with the unresolved payment issues. In commenting on our draft report, HHS said that while it shared our concern about a potential conflict of interest, it believed that regulations should be instituted "only if there is evidence of actual harm to patients." HHS also stated that separation of the two functions would, because of inadequate reimbursement for medication reviews, seriously limit the ability of nursing homes to secure any meaningful review of records. According to HHS, reimbursement for dispensing services are supporting, to a large degree, the medication review activity.

APhA apparently agrees with HHS that reimbursement for medication review is inadequate and while acknowledging that a potential conflict exists, the association believes the best method of preventing an actual conflict from occurring is to adequately compensate pharmacists for nondispensing services.

We do not agree with either HHS or APhA. Our recommendation is addressed to the financial incentive which may contribute to less than adequate medication reviews. We do not believe that the two barriers to effective medication review, lack of drug informa

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