**Department of Veterans Affairs VHA DIRECTIVE 97-056**

## Veterans Health Administration

**Washington, DC 20420 November 12, 1997**

**Administration of Aerosolized Pentamidine to**

**HUMAN IMMUNODEFICIENCY VIRUS (HIV) POSITIVE PATIENTS**

**1. [PURPOSE:]{.underline}** This Veterans Health Administration (VHA)
Directive outlines the policy of Department of Veterans Affairs (VA) for
administering aerosolized pentamidine to Human Immunodeficiency Virus
(HIV) positive patients with special consideration to the healthcare
workers providing this medication. This directive will not be included
in a manual.

**2. [BACKGROUND]{.underline}**

a\. [Pneumocystis]{.underline} [carinii]{.underline} pneumonia (PCP),
the most common presenting manifestation of Acquired Immunodeficiency
Syndrome (AIDS), is a major and recurring cause of morbidity and
mortality for persons infected with the HIV. In recent years, important
advances have been made in understanding which of the HIV infected
patients are at highest risk for developing PCP and in establishing the
safety and efficacy of chemotherapeutic regimens that can reduce the
frequency of this illness.

b\. Prophylaxis should be initiated for all HIV infected patients with a
history of prior PCP and for those with CD4 counts less than 200 per
milliliter (mm.) or CD4 cells less than 20 percent of the lymphocyte
total. Several approaches (including use of oral sulfamethoxazole and
trimethoprim (Bactrim, Septra, co-trimoxazole), oral dapsone with or
without trimethoprim and aerosolized pentamidine are currently deemed to
be relatively safe and effective. The comparative monthly cost of the
various drug regimens (given daily) are as follows: sulfamethoxazole and
trimethoprim DS = \$1.20, trimethoprim 100 milligrams (mg.) = \$2.70,
and dapsone 50 - 100 mg. = \$1.55 - \$3.10. Aerosolized pentamidine 300
mg., given once per month, is \$19.00. Many experts consider
sulfamethoxazole and trimethoprim to be the agent of choice for PCP
prophylaxis because of proven efficiency, ease of administration, and
low cost. Not all individuals are candidates for this form of
prophylaxis. The choice for each patient must be individualized after
careful consideration of the patient\'s history of allergy, compliance
with medications, other medical problems, drug interactions and the
relative expense of the prophylactic regimens.

c\. When aerosolized pentamidine is administered, certain precautions
must be taken because of the possibility that HIV infected individuals
may also be infected with [Mycobacterium]{.underline}
[tuberculosis]{.underline}. The transmission of tuberculosis (TB) is a
recognized risk in healthcare settings. Guidelines for the prevention of
transmission in this setting have been published by Centers for Disease
Control and Prevention (CDC). The most recent CDC guidelines should be
followed in all VA facilities.

d\. Concern about the potential health effects of aerosolized
pentamidine to healthcare workers exposed in the work setting has also
been expressed. To date, no new guidelines have been issued by either
CDC or the Food and Drug Administration (FDA) based on extensive
follow-up by the manufacturer on all reported adverse effects. These
adverse effects include coughing, tearing in those who wear contact
lenses and a lead-like taste. Occupational Safety and Health
Administration (OSHA) Field Information Manual, Section V, Chapter 3 has
a discussion concerning pentamidine in which they state the drug should
be administered in a well-ventilated area and/or room with healthcare
workers using respiratory equipment to guard against TB. Because it
appears that some individuals experience adverse effects from
aerosolized pentamidine, it is important to minimize exposure of
healthcare workers and to be responsive to those who report symptoms
related to administration of the drug. If special sensitivity is
documented by the Employee Health Unit, examination of the environmental
conditions under which the drug is administered should first be
conducted. In cases where

**THIS VHA DIRECTIVE EXPIRES NOVEMBER 12, 2002**

bronchospasm or severe sensitivity reactions occur, employees may be
excused from administering aerosolized pentamidine. Each facility will
develop local policies for excusing personnel.

**3.** **[POLICY:]{.underline}** Each VA facility providing care to HIV
infected individuals should develop procedures for administering
aerosolized pentamidine when medically indicated for HIV infected
patients when other forms of PCP prophylaxis are not appropriate.

**4. [ACTION:]{.underline}** Each VA facility providing care to HIV
infected individuals requiring PCP prophylaxis should develop guidelines
for the administration of aerosolized pentamidine based on the
following:

a\. Each patient should be screened for TB with a history, tuberculin
skin test and baseline chest X-ray before routinely beginning
aerosolized pentamidine. However, in areas where tuberculosis is
prevalent, the use of sputum smear and culture should be considered
because tuberculosis may not be readily recognized by these screening
tests and many AIDS patients have symptoms which may mimic those of
tuberculosis.

b\. Before each subsequent treatment, a review of symptoms suggestive of
tuberculosis (productive cough, hemoptysis, night sweats or persistent
cough and fever) should be done. If such symptoms are elicited, further
diagnostic evaluation should be initiated before proceeding with
treatment.

c\. If active tuberculosis is suspected or documented, appropriate
anti-tuberculosis therapy should be initiated. If aerosolized
pentamidine is deemed medically necessary for a patient with active
tuberculosis who is not yet smear negative it should be provided in a
room or booth appropriate for sputum induction (see [Morbidity and
Mortality Weekly Report (MMWR]{.underline}) October 28, 1994, or the
most recent guidelines published by CDC, or other valid oversight or
regulatory agencies such as OSHA).

d\. Aerosolized pentamidine should be administered in a well-ventilated
room as described later in this paragraph. Decisions on engineering
controls to be used in rooms where aerosolized pentamidine is used
should be based on the number and frequency of treatments administered,
the prevalence of tuberculosis in the community and the characteristics
of population served, such as a large homeless population or conversely,
a stable urban and/or rural population. In facilities where several
patients may be receiving therapy at one time or over the course of a
day, located in areas where there is high risk of TB, treatment rooms
should be directly vented to the outside and be under negative pressure
relative to adjacent rooms. The time interval between patient treatments
should allow for 99 percent removal of contaminants. ***NOTE:** Table
S3, \"Air changes per hour and time in minutes required for removal
efficiencies \...,\" [MMWR]{.underline} October 28, 1994, page 72,
should be consulted for the appropriate time interval required for 99
percent removal efficiency at the varying number of room air exchanges
per hour.*

e\. Current policies of the CDC and OSHA as applicable to the individual
VA facility should be followed with respect to screening new and current
employees for tuberculosis.

f\. When aerosolized pentamidine is administered to patients who have or
are at high risk for tuberculosis, healthcare workers should wear
appropriate respirators as defined in the most recent guidelines
published by CDC or other valid oversight or regulatory agencies such as
OSHA. Surgical masks should not be worn as substitutes.

g\. Patients who cough should be considered candidates for an inhaled
bronchodilator prior to therapy. This has been shown to reduce coughing.
Patients should not return to a common waiting room until coughing
subsides.

h\. Healthcare workers who request other tasks due to adverse reactions
to pentamidine should be referred to the Employee Health physician for
evaluation prior to assignment away from the aerosolized treatment area.

i\. If High Efficiency Particulate Air (HEPA) filters and/or ultraviolet
lights are used on room exhaust, it is necessary to have these items
certified for use in a healthcare facility. If this certification
service is not provided within your facility, it should be provided
under contract. An ongoing maintenance and monitoring program for these
items is necessary.

j\. Clinical management should be aware of new equipment coming to
market that is designed to reduce irritation to the patients during
aerosolization (i.e., some new nebulizer systems allow patients to stop
medication delivery prior to coughing).

**5. [REFERENCES]{.underline}**

a\. CDC Guidelines for Preventing the Transmission of Mycobacterium
Tuberculosis in the Healthcare Facilities. [MMWR]{.underline} October
28, 1994, 43: (R-13); 1-132.

b\. Healthcare Worker Respirator Protection Training, VA Video Training
Package, Office of Occupational Safety and Health, April 23, 1997.

**6. [FOLLOW-UP RESPONSIBILITY]{.underline}** Director, Acquired Immuno
Deficiency Syndrome (AIDS) Service (132) is responsible for the contents
of this Directive.

**7. [RESCISSION]{.underline}** This VHA Directive expires November 12,
2002.

S/ by Thomas Garthwaite, M.D. for

Kenneth W. Kizer, M.D., M.P.H.

Under Secretary for Health

DISTRIBUTION: CO: E-mailed 11/12/97

FLD: VISN, MA, DO, OC, OCRO and 200 - FAX 11/12/97

EX: Boxes 104, 88, 63, 60, 54, 52, 47 and 44 - FAX 11/12/97