Drugs dispensing

ethical aspects
Formularies and Drug Distribution
Systems
– One of the great ethical problems of the twenty-first century is the challenge
presented by new drug control and distribution systems. Pharmaceuticals are
becoming increasingly expensive. Presently, the percentage of health care
expenditures spent on prescription drugs is about 12% and is projected to rise
to about 15% by 2014.
latest drugs

– Some drugs currently in use can be eliminated if they can be shown to be

ineffective for the patient’s condition. That should raise few ethical problems.
The controversies will arise when health system planners discover that
sometimes a very expensive drug is only slightly better than a much cheaper
drug. A newly approved agent intended to reduce repeat heart attacks and
costing a thousand dollars per patient might, for example, show a success rate
that is only a tiny bit better than an older agent costing hundreds of dollars.
 Formularies

– Formularies are lists of drugs approved for use by a particular hospital, health plan, or
government. Most hospitals or health organizations have a multidisciplinary committee
called the Pharmacy and Therapeutics (P & T) Committee that is responsible for the
development and operation of a formulary in addition to policy development and sometimes
medication use processes or guidelines.
The formulary system

– it has attempted to outline the scientific data on a medication, including its

toxicities, untoward side effects, safety profile, and beneficial effects—has been
a controversial method of appraising medication therapy. While the
pharmaceutical industry promotes the virtues of a brand name medication, the
formulary system evaluates the virtues and defects of that medication in
comparison with other brands with similar therapeutic uses
 Distributions of drugs

– A number of issues, problems, and opportunities have resulted from systems such as formularies that
attempt to control the distribution of drugs. The following is a partial list:
– (1) the increasing complexity of new drugs, especially biotechnology drugs, is challenging the capabilities of
the P & T Committee staff-support function,

– (2) regulatory agencies, payers, prescribers, members of managed care organizations, and legislative bodies
are questioning and challenging the drug formulary decision making process, and –

– (3) beneficiaries of insurance plans often want everything covered at no additional cost.
– 4 The following cases deal with the ethical implications of formularies and other types of systems to control
drug distribution.
 Eliminating Unproven Therapies

– One of the most troublesome problems with the creation and

administration of drug formularies is the challenge of new therapies.
They are often expensive and many have unknown side effects when they
emerge and come to the attention of prescribers or patients. It is natural
to want to try the newest therapies. Especially when a patient faces a
critical illness these therapies are tempting even if they are unproven.
Not to mention that they are aggressively promoted by the
pharmaceutical industry sales force.
 Case 1
Avastin for Breast Cancer: Eliminating Unproven,
Expensive Therapies
– When the new, targeted cancer drugs came out, Hilde Reagan, Pharm.D., had hoped they would replace
chemotherapy and make cancer treatment easier on her patients in the large oncology unit where she worked.
However, that was not the case with most of the drugs. Many of the new drugs, like bevacizumab, worked only when
combined with traditional chemotherapy. This was particularly troubling since the cost was so high, about $50,000
per year. As a member of the P & T Committee, she knew that the increase in overall survival in fi rst line-treatment
of metastatic colorectal cancer with the addition of bevacizumab was on average about 4.7 months. This made Dr.
Reagan even more concerned about the costs. For these reasons, bevacizumab was not an approved drug on the
hospital formulary. Dr. Reagan had heard about preliminary results of a few studies focusing on the addition of
bevacizumab to standard chemotherapy with breast cancer and non–small cell lung cancer (NSCLC). It appeared that
bevacizumab had acceptable tolerability but extended overall survival by only a little over four months in breast
cancer patients and less than two months in NSCLC. The annual cost would be higher since treatment for breast
cancer and NSCLC require higher doses. Although bevacizumab had not yet been approved by the FDA for use in
breast cancer or NSCLS, Dr. Reagan suspected that one of the oncologists would soon request it for this use. continue
 Case 1

– Sure enough, the next day Dr. Reagan saw orders from Gerald Horchow, MD, for
paclitaxel and bevacizumab for Eugenia Packer, a 44-year-old woman with locally
recurrent breast cancer. Dr. Reagan spoke to Dr. Horchow, “Are you asking that we
consider placing bevacizumab on the formulary? You know that the FDA has
requested more data before making a decision about bevacizumab for breast
cancer. It is just not clear yet if it has any signifi cant impact let alone issues with
the cost. It would cost about $8,000 a month for the bevacizumab.” Dr. Horchow
replied, “If it gives Ms. Packer a few more months, I think we should consider it.
That’s why I ordered it.”
 Eliminating Proven but Marginally
Beneficial Therapie
– Similar questions may arise in other formulary decisions. A drug may be questioned not
because it is unproven or terribly expensive, but because its expected benefi ts are
considered trivial. If the drug were extremely inexpensive, perhaps the modest benefi t
could be ignored, but some drugs are relatively costly when considering the small benefi t
they promise. The following case poses this problem.
 Case 2

– Harvey Silverstone, Pharm.D, noticed the large number of prescriptions the pharmacy was receiving from pediatrician Dr. Linda McAdoo
for the antibiotic Omnicef suspension (Cefdinir) at $55.56 per bottle. He encountered Dr. McAdoo in the lunchroom one day and asked her
about them. Dr. McAdoo told him that many of the prescriptions were for children with otitis media with effusion (OME), a common
infection for which there is a high rate of spontaneous resolution. Before Dr. Silverstone could press her on why she was using an antibiotic
for an infection in which bacteria are involved in less than 50% of the cases, she commented that she knew that antibiotics were not
recommended and that, in any case, medical evidence had accumulated showing that long-term ill effects of OME are rare. She went on to
say that nevertheless the condition can be unpleasant, even if it is a relatively benign infection. Dr. McAdoo explained that parents
bringing their children to her were invariably distraught and desperately wanted her to do something. It is a common problem among
physicians that patients want some action. Dr. McAdoo observed that often that means writing a prescription. Since without a culture she
could not know for sure that the infection was not bacterial and because there was a small chance that the antibiotic would help, she felt
that this, combined with the psychological benefi ts of prescribing something, justifi ed her prescriptions. Extensive use of antibiotics
when they are not necessary can lead to the development of resistant strains of bacteria. This could eventually mean that some child will
develop an infection from the resistant strain and suffer serious consequences because antibiotics had been used too often to attempt to
treat minor infections, especially those that the antibiotic is very unlikely to help. Dr. McAdoo was aware of all of this but commented that
her job as a clinician was to benefi t her patient, not to protect society from some eventual social problem. continue
 Case2

– s to benefit her patient, not to protect society from some eventual social problem. Dr. Silverstone had always accepted the
common wisdom that antibiotics were being overused and should be avoided except in cases in which they are necessary to avoid
serious medical problems. The antibiotics, he believed, should be saved for the truly most needy cases. Still, he acknowledged to
himself that the risks of today’s antibiotics are very low and that there was some small mathematical chance that Dr. McAdoo’s
patients had a bacterial infection that would respond to the antibiotic. He realized that, if he focused solely on the individual
patient, Dr. McAdoo was making a good case, but he knew that collectively such uses of antibiotics were posing a social risk and
were using pharmacy resources for a relatively trivial purpose. The infection would probably not respond to the antibiotic, and the
harms from the condition were not permanent in any case. Dr. Silverstone thought a clinical guideline should be developed to
encourage physicians to use the wait-and-see prescription (WASP) for OME whereby parents are asked not to fi ll the prescription
unless the child is not better or worse in 48 hours. All patients would receive oral ibuprofen suspension and otic analgesic drops.
Research findings indicated that the WASP approach substantially reduced unnecessary use of antibiotics.6 He knew that present
policy permitted the facility’s physicians to prescribe for any purpose they deemed worthwhile as long as a drug was included in
the formulary, but Dr. Silverstone was convinced that this policy made no sense. The mere fact that omnicef suspension was very
beneficial for some uses did not justify letting physicians use it when the drug was almost certainly not going to be effective and
would only offer marginal benefits in any case.
 Eliminating Proven but Cost-
Ineffective Therapies
– Unproven therapies and marginally beneficial ones are not the only kinds of cases facing those responsible for
formularies. Perhaps the most common problems are caused by proven therapies that offer cost-ineffective
benefits. When compared to alternatives they offer significant benefit but benefit that is only marginal
compared with other, much cheaper alternatives. In the era when the platitude was that health professionals
were supposed to do what was best for their patients, these medications were prescribed even though the
benefit at the margin was often very small in comparison to the costs. In an era of cost-conscious medicine,
pharmacists in their role as formulary writers cannot afford the luxury of condoning every such medication. One
example involves the use of an additional agent for preventing nausea that accompanies chemotherapy.
 Case 3

– Jennifer Lavadan, Pharm.D., worked in the oncology department of a large county hospital and clinic in a
major urban center. Because of the location of the hospital, most of the patients were indigent. Therefore,
most of the funding and reimbursement came from county and state welfare programs. The hospital
formulary committee, of which Dr. Lavadan was a member, controlled drug expenditures with a tight hand,
using a blending of cost-effectiveness analysis, peer review, and continuing medical education to evaluate
drug purchases. Recently the American Society of Clinical Oncology (ASCO) had updated its antiemetic
guidelines that previously had been approved in 1999. The 1999 guidelines for preventing high emetic risk
included 2 drugs: 5-HT3 serotonin receptor antagonists, such as dolasetron, granisetron, ondansetron or
palonosetron, and dexamethasone. The 2006 guidelines added aprepitant to the 5-HT3 serotonin receptor
and dexamethasone. The 3-drug combination is recommended for patients receiving chemotherapeutic
agents of high emetic risk. By adding the aprepitant, the cost of the regimen increased by approximately
$329. continue
 Case 3

– At the formulary committee, this change in the ASCO guidelines caused quite a bit of discussion,
particularly among the pharmacists and physicians who worked with oncology patients. Dr. Lavadan
summarized their main concerns, “The primary benefi t of aprepitant, based on data from randomized
controlled trials, is that it increases the complete response rate, which is defi ned as no emetic episode and
no use of rescue therapy in patients receiving highly emetogenic chemotherapy. The absolute benefi t, that
is, no nausea or vomiting, is about 20%, or to put it simply, about 1 in 5 patients will benefit from the
addition of aprepitant. However, because 5-HT3 serotonin antagonist plus dexamethasone remains a very
effective regimen and because of the high cost of the aprepitant, I recommend that the standard of care
here should be to reserve aprepitant for selected patients, those who fail the 5-HT3 serotonin antagonist
plus dexamethasone regimen.” The unspoken message was that the hospital could not afford to offer the
top recommended guideline treatment
 Drug Distribution Systems

– In addition to the use of formularies, a second emerging trend in pharmacy is posing moral problems for
pharmacists, the sociological changes taking place in the way prescription drugs are distributed. In place
of the corner pharmacy or even face-to-face encounters between pharmacists and patients at hospital or
clinic pharmacies, new distribution systems are changing the ways that patients receive their medications
and that pharmacists interact with them. The nature of the pharmacist-patient relationship as well as the
responsibilities of the pharmacist are shifting. Sometimes these changes are as modest as changing the
person in the clinic pharmacy who has face-to-face contact with patients. In place of the pharmacist, a
technician or clerk may be the one who takes in prescriptions and hands medications to patients after the
prescriptions are filled.
 Mail-Order Pharmacies

– Increasingly, patients are choosing to get their prescriptions filled through the mail. In some cases,
prescription benefit plans actually require doing this in order to reduce the costs of prescriptions,
although in the end, the cost reduction may not be that great. In mail-order pharmaceuticals
there is a bigger discount per unit, but it is doubtful that providing increased days supply of drugs
is really cost-effective. The economic benefits of mail-order pharmacy are attractive. There are
efficiencies related to being able to serve much larger groups of patients, thus reducing overhead.
Pharmacists can work more efficiently and avoid slow periods. One of the potential sources of
efficiency, however, is morally controversial. Pharmacists avoid face-to-face meetings with
patients, thus reducing the time spent in patient counseling and the other service-oriented
aspects of pharmaceutical care.
Thank you