Doi:10.1016/s0037-6337(08)70794-0

Practice Trends
S K I N & A L L E R G Y N E W S • O c t o b e r 2 0 0 8 Midlevel Practitioners Help Drive Bottom Line B Y R O B E R T F I N N
the things dermatologists should consider mal risk before plunging in with a ful -time when hiring a physician assistant (PA) or S A N F R A N C I S C O — Physician assis- tants and nurse practitioners can enhance “This is a way to enhance profitability,” rect staff to monitor all new-patient calls, see once these individuals are hired is not tice, but it is important to take a hard look gists are about as busy as they can be, so each day? Are prospective patients making profitability,” Ms. McLaughlin said. “It’s the solution is not simply to see more pa- not all about the profit, but certainly you where because they couldn’t get appoint- day. Aside from the financial issues, many ments within a reasonable period of time? Doing this is not as straightforward as it might seem. It’s not a matter of simply lin, a certified health care business consul- perhaps 2 full days or 4 half-days—can be subtracting the practitioner’s salary and benefits from his or her gross receipts. To The following table summarizes the highest scores of local cutaneous signs and symptoms of irritation that wereworse than baseline: must also subtract a realistic share of the Metronidazole Gel, 1%
Gel Vehicle
For topical use only. Not for oral, ophthalmic or intravaginal use.
INDICATIONS AND USAGE
Sign/Symptom
METROGEL® (metronidazole gel), 1% is indicated for the topical treatment of inflammatory lesions of rosacea.
138 (25.4)
63 (34.2)
CONTRAINDICATIONS
METROGEL® (metronidazole gel), 1% is contraindicated in those patients with a history of hypersensitivity to metro-
nidazole or to any other ingredient in this formulation.
Midlevel
PRECAUTIONS
General: Topical metronidazole has been reported to cause tearing of the eyes. Therefore, contact with the eyes
should be avoided. If a reaction suggesting local skin irritation occurs, patients should be directed to use the medica- practitioners
tion less often or discontinue use. Metronidazole is a nitroimidazole and should be used with care in patients with 134 (24.6)
60 (32.6)
evidence of, or history of, blood dyscrasia.
should ‘never see
Information for Patients: Patients using METROGEL® (metronidazole gel), 1% should receive the following informa-
1. This medication is to be used as directed.
a new patient,
3. Avoid contact with the eyes.
4. Cleanse affected area(s) before applying METROGEL® (metronidazole gel), 1%.
Pruritus
86 (15.8)
35 (19.0)
because I think
5. This medication should not be used for any other condition than that for which it is prescribed.
6. Patients should report any adverse reaction to their physicians.
the biggest
Drug Interaction: Oral metronidazole has been reported to potentiate the anticoagulant effect of coumarin and war-
farin, resulting in a prolongation of prothrombin time. Drug interactions should be kept in mind when METROGEL® (metronidazole gel), 1% is prescribed for patients who are receiving anticoagulant treatment, although they are less danger we all
likely to occur with topical metronidazole administration because of low absorption.
Stinging/burning
56 (10.3)
28 (15.2)
Carcinogenesis, Mutagenesis and Impairment of Fertility: Metronidazole has shown evidence of carcinogenic activ-
have is missing a
ity in a number of studies involving chronic, oral administration in mice and rats, but not in studies involving ham- In several long-term studies in mice, oral doses of approximately 225 mg/m2/day or greater (approximately 37 times melanoma or
the human topical dose on a mg/m2 basis) were associated with an increase in pulmonary tumors and lymphomas.
Several long-term oral studies in the rat have shown statistically significant increases in mammary and hepatic tumors at doses >885 mg/m2/day (144 times the human dose).
something.’
The following additional adverse experiences have been reported with the topical use of metronidazole: skin irritation, Metronidazole has shown evidence of mutagenic activity in several in vitro bacterial assay systems. In addition, a transient redness, metallic taste, tingling or numbness of extremities, and nausea.
dose-related increase in the frequency of micronuclei was observed in mice after intraperitoneal injections. An OVERDOSAGE: There are no reported human experiences with overdosage of METROGEL® (metronidazole gel), 1%.
increase in chromosomal aberrations in peripheral blood lymphocytes was reported in patients with Crohn’s disease Topically applied metronidazole can be absorbed in sufficient amount to produce systemic effects.
who were treated with 200 to1200 mg/day of metronidazole for 1 to 24 months. However, in another study, no DOSAGE AND ADMINISTRATION: Areas to be treated should be cleansed before application of METROGEL® (metro-
increase in chromosomal aberrations in circulating lymphocytes was observed in patients with Crohn’s disease treat- nidazole gel), 1%. Apply and rub in a thin film of METROGEL® (metronidazole gel), 1% once daily to entire affected area(s). Patients may use cosmetics after application of METROGEL® (metronidazole gel), 1%.
In one published study, using albino hairless mice, intraperitoneal administration of metronidazole at a dose of 45 HOW SUPPLIED: METROGEL® (metronidazole gel), 1% is supplied as follows:
mg/m2/day (approximately 7 times the human topical dose on a mg/m2 basis) was associated with an increase in 60 gram tube – NDC 0299-3820-60
ultraviolet radiation-induced skin carcinogenesis. Neither dermal carcinogenicity nor photocarcinogenicity studies 60 gram tube with complimentary 4 oz Cetaphil® Gentle Skin Cleanser – NDC 0299-3820-04
have been performed with METROGEL® (metronidazole gel), 1% or any marketed metronidazole formulations.
pointed and might well leave after a short Pregnancy: Teratogenic Effects: Pregnancy Category B. There are no adequate and well-controlled studies with the
Storage Conditions: Store at controlled room temperature: 20˚ to 25˚C (68˚ to 77˚F), excursions permitted between
use of METROGEL® (metronidazole gel), 1% in pregnant women.
time if reality doesn’t match expectations.
Metronidazole crosses the placental barrier and enters the fetal circulation rapidly. No fetotoxicity was observed after Prescribing Information as of February 2007.
oral administration of metronidazole in rats or mice at 200 and 20 times, respectively, the expected clinical dose.
However, oral metronidazole has shown carcinogenic activity in rodents. Because animal reproduction studies are so whether switching to an incentive pro- not always predictive of human response, METROGEL® (metronidazole gel), 1% should be used during pregnancyonly if clearly needed.
gram will work, but employees shouldn’t Nursing Mothers: After oral administration, metronidazole is secreted in breast milk in concentrations similar to
those found in the plasma. Even though blood levels taken after topical metronidazole application are significantly
be switched unless it’s clear that they will lower than those achieved after oral metronidazole, a decision should be made whether to discontinue nursing or todiscontinue the drug, taking into account the importance of the drug to the mother and the risk to the infant.
Pediatric Use: Safety and effectiveness in pediatric patients have not been established.
Geriatric Use: While specific clinical trials in the geriatric population have not been conducted, sixty-six patients
aged 65 years and older treated with METROGEL® (metronidazole gel), 1% over ten weeks showed comparable safe- ty and efficacy as compared to the general study population.
ADVERSE REACTIONS
it on the practice’s gross revenues or on de- In a controlled clinical trial, 557 patients used METROGEL® (metronidazole gel), 1% and 189 patients used the gelvehicle once daily. The following table summarizes adverse reactions that occur at a rate of ≥ 1% in the clinical trials: System Organ Class/Preferred Term
Metronidazole Gel, 1%
Gel Vehicle
pressed a strong preference for using gross Patients with at least one AE Number (%) of Patients
186 (33.4)
51 (27.0)
Infections and infestations
76 (13.6)
28 (14.8)
PAs some responsibility for keeping oper- penses that they cannot control. “You can chase a piece of equipment and they think, ‘This is going to cut into my take, so I’m not so interested in doing it,’ ” she said. Manufactured by:
Musculoskeletal and connective tissue disorders
tioner’s billings with patients’ medical Baie d’Urfé, QC, H9X 3S4 CanadaMade in Canada.
Neoplasms
Marketed by:
practitioners are rarely trained in the art Galderma Laboratories, L.P.
Fort Worth, Texas 76177 USA of third-party compensation, and there is Nervous system disorders
References: 1. Wolters Kluwer, PHast Database, January 2008. 2. Data
Respiratory, thoracic and mediastinal disorders
on file. A multi-center clinical study of metronidazole 1% compared to vehicle for 10 weeks (n=552). 3. Data on file. HSA-3. Galderma
Laboratories, L.P. 4. Odom RB. The subtypes of rosacea: implications for
Skin and subcutaneous tissue disorders
treatment. Cutis. 2004;73:9-14.
matologist in private practice in Los An- Vascular disorders
tation, he always compensates his midlevel www.metrogel.com www.cetaphil.com
practitioners with a straight salary.
with these practitioners: “They [should] the biggest danger we all have is missing

Source: http://www.consultpmc.com/docs/SkinAllergy1008.pdf