Download Ativan, Benadryl, and Haldol - International Journal of

This Issue:
◆ Ativan, Benadryl, and Haldol (ABH) Gel and Ativan, Benadryl, Haldol, and
Metoclopramide (ABHM) Gel in the Treatment of Nausea
◆ DermaZinc-Plus with Clobetasol for the Treatment of Psoriasis
◆ Intranasal Fentanyl Citrate and Cancer-Related Breakthrough Pain
◆ Compounding Law Rescinded
March 2001
SAMPLE
Case Reports
Ativan, Benadryl, and
Haldol (ABH) Gel and
Ativan, Benadryl,
Haldol, and
Metoclopramide
(ABHM) Gel in the
Treatment of Nausea
John Herr, RPh
John Farkus, MD
Town and Country Pharmacy,
Ridgewood, New Jersey
In March and April of 2000, we provided
palliative therapy for a 78-year-old woman
who was dying of cancer of the stomach.
The patient was suffering more from nausea than from pain. Her physician had prescribed antiemetic trimethobenzamide
suppositories (Tigan) 200 mg to be used
every 6 to 8 hours as needed, but this medication did not relieve the nausea.
As a pharmacist, I meet weekly with a
hospice care interdisciplinary team for the
purposes of assessing and determining
treatments for terminally ill patients. At
our meeting on March 15, 2000, I suggested that a topical Ativan, Benadryl, and
Haldol (ABH) gel to which pentoxifylline
had been added be prescribed to alleviate
this patient’s nausea, and her physician
agreed. ABH gel is a combination formula
mixed in a Pluronic lecithin organogel in
the following concentrations:
lorazepam (Ativan)
1 mg/mL
diphenhydramine (Benadryl) 25 mg/mL
haloperidol (Haldol)
1 mg/mL
pentoxifylline (Trental)
50 mg/mL
(to enhance absorption)
The patient was instructed to apply 1 mL
of this gel to her wrist every 4 to 6 hours
as needed.
At the time of our interdisciplinary team
meeting on March 29, 2000, the patient
was still experiencing some nausea. I suggested adding metoclopramide (Reglan) in
a 10-mg/mL concentration to the gel; the
dose (a topical application of 1 mL every
4 to 6 hours) was to remain unchanged.
After 2 doses of treatment with this formulation, the patient’s nausea was relieved.
She continued this protocol and experienced relief from nausea until her death in
late April 2000.
We have found this combination of topically applied medication to be very effective in decreasing the anxiety and nausea
produced by some diseases during the endof-life process.
Suggested Reading
1. Carling MA. Hospice and the role of the
compounding pharmacist. IJPC. 2000;4:247249.
2. Allen LV. Hospice care and the pharmacist.
IJPC. 1997;1:10-12.
Der maZinc-Plus with
Clobetasol for the
Treatment of Psoriasis
David Holloway, RPh
Trail Creek Pharmacy, Euless Texas
In late April 2000, a 32-year-old man
became the patient of a physician located
close to our pharmacy. In 1995, the patient had been diagnosed as having psoriasis, for which he had been treated by several physicians. When the patient received
his diagnosis, his family history indicated
that no other relatives had psoriasis, but
the condition was subsequently diagnosed
in his aunt and in his grandfather.
The psoriatic lesions first appeared on
the patient’s elbow as a scaling sore that
did not heal, and in 1997 the lesions appeared on his scalp. He had been treated
with a number of agents, including
betamethasone lotion 0.05% (Diprolene),
calcipotriene topical solution 0.005%
Continued on Reverse.
Literature Summary
Intranasal Fentanyl
Citrate and CancerRelated Breakthrough
Pain
An assessment of the safety,
efficacy, and acceptability of
intranasal fentanyl citrate in the
management of cancer-related
breakthrough pain: A pilot study.
Source: Zeppetella G. J Pain
Symptom Manage 2000;20:253-258.
Breakthrough pain is a common problem,
especially for patients who are undergoing treatment for cancer. This type of pain,
which afflicts patients despite the use of
concomitant analgesic therapy, often occurs frequently and is brief in duration and
severe or excruciating in intensity. According to the author of the study cited
above, an analgesic with the following attributes would be of benefit in treating patients experiencing breakthrough pain:
rapid absorption, an “individual and episodic titration,” a rapid onset of action, and
a short-to-moderate duration. Intranasally
administered medications offer those advantages.
The study described in the article by
Zeppetella consisted of 12 hospice patients (average age, 73 years) who were
experiencing one type of nociceptive cancer-related breakthrough pain (which is
usually responsive to opioids) for which
pain management was required. In nine of
those patients (75%), the site of the break-
the system of delivery.
The author notes that before the study,
the subjects had been receiving oral morphine, which requires approximately 1
hour to achieve maximum concentration
and produces analgesia for a duration of
about 4 hours. Because breakthrough pain
may occur several times per day for short
periods, the effects of short-acting morphine used as a rescue medication may
continue beyond the duration of pain; repeated dosing can result in adverse effects.
Parenterally administered opioids used
when rapid pain relief is required have
many disadvantages for the patient: Their
administration is invasive and uncomfortable. However, INFC can be rapidly, easily, and painlessly absorbed through the
nasal mucosa and, because it has a low
toxic effect on local tissue, it can be used
as long-term therapy. It is delivered as a
bolus dose to the site of absorption and
becomes effective within 10 minutes of
administration. The author suggests that
INFC may have additional applications in
the treatment of neuropathic pain and during painful treatment procedures. Because
INFC was well-tolerated and well-received
by most of the subjects, he recommends
that additional studies be conducted to determine the role of that therapy in the management of cancer-related breakthrough
pain.
E
SA
M
Suggested Reading
1. Fenrich J, Vidaurri V. Psoriasis. IJPC 2000;
4;5:346-348.
2. Allen, LV. Compounding dermatological
products. IJPC 1998; 2;4:260-264.
3. Allen, LV. Environmental sensitivities. IJPC
1998; 2;6:406-408.
through pain was related to the primary
cancer, and the secondary cancer was the
cause of that pain in the remaining subjects.
The average number of daily pain episodes
was five, and 50% of the subjects rated the
pain as being severe or excruciating. In
eight patients (66.6%), the pain lasted 30
minutes or less.
At the time of the study, all subjects had
been receiving morphine in various protocols (listed in Table 2 of the article) as
regular analgesia and were also using
short-acting oral morphine (on average,
twice per day) for breakthrough pain. Relief from breakthrough pain provided by
morphine was rated as “good” by four patients (33%), “fair” by five (42%), and
“poor” by three (25%).
At the initiation of the study, each patient began a protocol of receiving 20 µg
of intranasally administered fentanyl citrate (INFC) from a 10-mL nasal spray
bottle with a 0.2-mL reservoir. Each spray
bottle delivered a 0.2-mL bolus dose with
each spray. This treatment with INFC was
to replace treatment with short-acting oral
morphine, which had been used as the rescue medication before the study. If the
breakthrough pain was completely relieved
by one spray, patients were to continue
with that dosage. If partial relief or no pain
relief resulted, each patient was given a
second bottle to provide sufficient drug to
spray both nostrils. All patients required
two bottles of the preparation. Patients
were asked to use the INFC spray for five
consecutive occurrences of breakthrough
pain. The degree of pain was assessed by
means of a visual analogue scale (VAS)
before treatment with INFC and 3, 5, 10,
15, 30, 45, and 60 minutes after the administration of that medication.
Nonbreakthrough analgesics that were
taken before the trial were continued without change in the dose.
During the study, patients were monitored for adverse events. At the conclusion of the trial, the subjects were asked
whether they had experienced adverse
events and how they rated the pain-management efficacy of INFC. Each subject
was also asked to list the advantages and
disadvantages of taking medication to control pain.
After treatment with INFC, eight patients
(66%) demonstrated a reduction in the VAS
score. Four of those patients noted a reduction in pain 5 minutes after having used
INFC, and seven patients noticed pain relief after 10 minutes. Those eight patients
rated the efficacy of INFC as “good” or
“very good.” Nine patients (75%) indicated that INFC was as effective as or better than morphine, and four (33%) rated
the effectiveness of INFC as “moderate”
or “bad.” According to the author, patients
who had been receiving the lowest daily
doses of morphine showed a decline in the
VAS score after treatment with INFC, and
those who had been receiving a daily morphine equivalent of 120 mg or more did
not. During the study, two patients required
their usual rescue doses of short-acting
morphine in spite of taking INFC, and two
patients suffered from nasal discomfort
and nasal itching when they began to use
INFC, but those symptoms disappeared as
the drug was used repeatedly. No systemic
adverse events as a result of treatment
were noted. At the conclusion of the study,
nine patients (75%) said that they would
continue treatment with INFC, and the remaining subjects were dissatisfied with the
effectiveness of the preparation rather than
PL
(Dovonex), and fluocinolone topical solution (Derma-Smoothe/FS).
The patient’s primary complaint was that
psoriatic lesions covered 25% to 50 % of
his scalp. His physician prescribed a zinc
pyrithione formula with clobetasol propionate 0.05% (DermaZinc-Plus) in a 120mL spray bottle. The medication was to be
applied twice daily. DermaZinc is an overthe-counter preparation used twice a day
to maintain normal skin in patients with
psoriasis. When severe flare-ups occur,
the patient is usually switched to the
DermaZinc-Plus, which must be applied
for approximately 2 weeks or as directed
by a physician. This preparation becomes
a compounded prescription-strength formula when clobetasol is added. Our patient,
like many others with psoriasis, required
multiple therapies in order to restore his
skin back to normal condition.
In addition to treatment with the spray,
ketoconazole shampoo (Nizoral) and an
over-the-counter coal tar shampoo were
prescribed to be alternated in use every
other day, and the patient was to receive
ultraviolet light treatment for 10-to-15
minutes from a tanning bed 2 times a week.
After 5 months of following this regimen,
the patient was doing well and his psoriasis had completely resolved. When he used
a different shampoo, however, the psoriatic lesions recurred within a month. At
the time of this writing, he is continuing
his maintenance therapy with the zinc
pyrithione -clobetasol propionate spray,
the ketoconazole and coal tar shampoos,
and the ultraviolet light therapy and is doing very well.
Legal Update
Compounding Law
Rescinded
In 1997 Congress passed a compounding law as part of the Federal Food and
Drug Administration Modernization Act of
1997 (FDAMA). A section of this compounding law relating to advertising was
challenged for its constitutionality during
the last three years.
On Tuesday, February 6, 2001, the 9th
Circuit Court of Appeals ruled that the
government’s restrictions that prohibit
compounding pharmacists from advertising are unconstitutional.
In Western States Medical Center v.
Shalala, a case brought by a group of licensed pharmacies, the court found that the
advertising provision was not severable
from the compounding section of the law
and therefore declared the entire compounding law invalid.
In its opinion, the Court stated that the
FDA failed to prove that they have a substantial interest in preventing widespread
compounding. They stated that FDA fails
to support the opinion that increased distribution of compounded drugs is dangerous because of the health risks associated
with large numbers of patients taking such
drugs. The decision states that most evidence runs to the contrary noting that compounding is legal under state law and that
most states require pharmacists to know
how to compound. In essence, FDA failed
to prove that compounding is unsafe and
should be limited.
Pharmacists are licensed and regulated
by state boards of pharmacy. Most states
have laws specifically setting forth parameters for pharmacy practice. In addition,
the National Association of Boards of
Pharmacy has published a model act for
states to adopt to regulate compounding
practice and the United States Pharmacopeia has created an entire chapter on
professional compounding practice for
pharmacists to reference.
Although the implication of the court’s
decision is unclear from regulatory standpoint, the practice of compounding as necessary was clearly upheld.
RxTriad-Literature watch of the International Journal of Pharmaceutical Compounding. © 2001 International Journal of Pharmaceutical Compounding. All rights reserved.