![](media/image1.png){width="1.3319444444444444in" height="6.525in"}June
21, 2002

Dockets Management Branch

HFA-305

Food and Drug Administration

5630 Fishers Lane, Room 1061

Rockville, MD 20852

#### RE: Docket number 02N-0115

Dear Sir or Madam:

The National Community Pharmacists Association (NCPA) respectfully
submits the following comments to the Food and Drug Administration (FDA)
regarding the agency's approach to risk management of prescription
drugs.

Since 1898, NCPA has represented the pharmacist owners, managers, and
employees of independent community pharmacies. The nation's independent
pharmacies, independent pharmacy franchises, and independent chains
total approximately 25,000 independent community retail pharmacy sites
or approximately half of the retail pharmacies in the U.S. and dispense
nearly half of the nation's three billion retail prescription medicines
resulting in \$53 billion in prescription drug sales each year.
Independent community retail pharmacies employ nearly 60,000
pharmacists.

The NCPA would like to provide the FDA with perspective on the following
five areas:

1.  Need for community pharmacists participation

2.  Need for "open" drug distribution versus restricted drug
    distribution

3.  Need for a standardized approach to risk management

4.  Need for compensation for risk management services

5.  Need to contain liability

# 1. Need for community pharmacists participation

Community pharmacies are the primary point of distribution for
outpatient prescription drugs in the United States. As medication
experts, pharmacists help assure the safe and effective use of
medications in their patients. For this reason, it is important that any
risk management system developed will integrate the systems and
procedures and already in place at community pharmacies for the safe use
of prescription drugs.

Community pharmacists are ideally positioned and accessible to patients
and their families. Given the availability and convenience of community
pharmacies, community pharmacists are the most accessible health care
professional in many neighborhoods and locales. Oftentimes, they are the
first professional approached when an individual needs medical attention
and information. Patients with chronic conditions typically see
community pharmacists six to eight times more frequently than
physicians.

Increasingly, community pharmacies are providing expanded disease
management services relative to chronic conditions (e.g., comprehensive
diabetes care, arthritis care, and care for cholesterol and
hypertension) and handling specialty drug products for complicated
therapies. As a result, community pharmacists are very experienced at
working with both patients and health care providers and in dealing with
many different types of therapies including complex, high risk
medications.

Additionally, technology is currently available in all community
pharmacies today to support pharmacists' computerized drug utilization
review (DUR). Automated DUR involves systematic real-time screening of
drugs for clinically significant potential drug therapy problems so that
pharmacists can solve potential drug therapy problems before a
prescription is dispensed to a patient. Such systems can be used to
support the delivery of medication risk management.

Hence, involving community pharmacists in playing a key role in
medication risk management is appropriate.

# 2. Need for "open" drug distribution versus restricted drug distribution

As a broad principle, NCPA supports the concept that, once a high risk
drug is approved for marketing by the FDA, the drug should be available
through any community pharmacy outlet that chooses to stock the product
and help assure its appropriate use through pharmacist monitoring,
educational programs, counseling, and other appropriate interventions.

It is important for the pharmacist that already has an established
relationship with the patient, and who knows the patient\'s medical
condition, to coordinate and integrate the "risk-managed" drug into the
patient's existing prescription medication regimen. That is, if the
patient is already taking multiple medications, it is important for the
patient's regular pharmacy provider to help assure that the new "risk
managed" drug does not present any potential problems for the patient.

NCPA is opposed to limiting distribution of outpatient drugs to a
restricted network of pharmacies, and total circumvention of community
pharmacists. Patients should be able to obtain high-risk drugs from
their community pharmacist that they currently use to obtain their other
medications and health care services.

**[3. Need for a standardized approach to risk management]{.underline}**

While we recognize that each drug product is unique, a different risk
management approach has been developed for each current "risk-managed"
drug. We believe that the continuation of unique drug-specific risk
management programs that require pharmacists to understand multiple sets
of distinct requirements is counterproductive to minimizing risk. A
standardized, seamless, computer-based system is needed that can be
easily accessed by practitioners to deliver risk management services to
patients. Community pharmacies currently have access to "real-time"
information systems that will allow easy communication with patients,
physicians, third-party payers, the FDA, and manufacturers.

**[4. Need for compensation for risk management services]{.underline}**

Providing additional risk management services to patients results in
additional costs to providers. The FDA traditionally has not become
involved in economic issues relating to the financing of prescription
drugs. However, if the agency is going to require that health
professionals perform certain additional activities relating to the
management of a drug product, then these services must be paid for by
the manufacturer or health plan as part of the cost of providing the
drug product. Respectfully, we ask that the agency explore these
economic issues, since providing risk management services come at a
cost.

## 5. Need to contain liability

Community pharmacies are willing to participate in risk management
programs, however, many are concerned about additional liability that
they might incur by participating in these risk management programs. To
encourage participation, the FDA should take steps to contain liability.

Thank you for the opportunity to provide these comments. Please contact
me if NCPA can provide any additional clarification of assistance.

Sincerely,

![](media/image2.png){width="2.4722222222222223in" height="0.41875in"}

Kathryn F. Kuhn, R.Ph.

Vice President, Pharmacy Programs