November 3, 2003

Division of Dockets Management (HFA-305)

Food and Drug Administration

5630 Fishers Lane, Room 1061

Rockville, MD 20852

Docket No. 2003N-0361

Dear Sir/Madam:

The American Pharmacists Association (APhA) is pleased to submit
comments on the Food and Drug Administration's (FDA) Anti-Counterfeit
Drug Initiative as published in the September 5, 2003 *Federal
Register*. APhA, founded in 1852 as the American Pharmaceutical
Association, is the largest national professional society of pharmacists
in the nation, representing more than 53,000 practicing pharmacists,
pharmaceutical scientists, student pharmacists, and pharmacy
technicians.

The protection of our medication supply is obviously of vital interest
to pharmacists, including efforts to prevent the introduction of
counterfeit products into the system and the quick identification and
elimination of such products from the system if the medication supply is
infiltrated. Pharmacists rely upon a safe and pure medication supply to
help patients make the best use of their medications. APhA applauds the
efforts by the FDA to stem these illegal activities which are straining
our regulatory system and are putting American patients at risk. The
FDA's report that since the year 2000 counterfeit drug investigations
have increased to an average of over 20 per year indicates a need to
strengthen our regulatory system.

These comments address questions raised in the September 5, 2003 Notice
of Public Hearing as well as those questions raised in the FDA
Counterfeit Task Force Interim Report in four basic areas: the
advantages and disadvantages of various anti-counterfeit technologies;
regulatory and legislative challenges; public education needs and
strategies; and the role that pharmacists will play in implementing new
anti-counterfeit activities. APhA sees value in enhancing our efforts to
combat counterfeiting through advanced technologies and coordination of
efforts by all interested parties including manufacturers, wholesalers,
pharmacists, and patients. APhA's support is only tempered by the
reality that we are working with limited resources and therefore must
look at both the costs and benefits of any new activity prior to its
implementation.

**Technology**

*Cost-Benefit Analysis*

Technology advances present an opportunity to strengthen the safety of
our drug supply. However, it is important to recognize that these
advances do not come without a cost. As some of these technologies will
be implemented at the pharmacy level, pharmacists and pharmacies will
bear some of the additional costs necessary to employ new
anti-counterfeit technologies. Depending on the technology and the
necessary equipment, this may involve a substantial financial
contribution. While providing an anti-counterfeit benefit, the burdens
associated with infrastructure upgrades must be taken into account as
the Agency develops its policies around anti-counterfeit technologies.
The benefits of anti-counterfeit technologies should not become overly
burdensome, financially or administratively, for the health care
practitioners providing patient care.

*Numbers & Types of Technology*

In determining the number and types of anti-counterfeiting technologies
that should be used on packaging and labeling, one overriding
consideration is involved: are the technologies sufficient to protect
against counterfeiting? Anti-counterfeiting initiatives must be
continuously reviewed and updated to keep ahead of counterfeiters.
However, we recognize the resource limitations of the Agency and
interested parties. In an ideal world with unlimited resources, we would
have a sophisticated anti-counterfeit system for every drug --- but
resources are limited. We recommend that the Agency focus its efforts on
those drugs most likely to be counterfeited. We recognize that this list
of drugs may change, given the activities of the counterfeiters, and
recommend that the Agency equip itself with mechanisms that will allow
it to rapidly respond to new counterfeit efforts.

To assist in the identification of these priority products, APhA
recommends that the Agency develop criteria for determining what drugs
are most likely to be counterfeited. Ideally, that list of criteria
would include anything that would stimulate a counterfeiter to
counterfeit. We agree that at a minimum, that list should include the
following criteria from the Interim Report: potential impact on public
health if the product was counterfeited; any history of or potential for
counterfeiting, tampering, or diversion of the product; volume of the
product sold; the dosage form of the product; approved and unapproved
uses of the product; current and potential misuse or abuse of the
product; and other products in the class with a history of being
counterfeited. It is also important to consider a product's cost when
developing this list. But considering drug cost has its limitations.
Cost becomes a much less important factor when a counterfeiter is
focused on harming a patient population. In that circumstance, they
might counterfeit a less expensive medication with a higher potential to
cause harm to a broad population.

When considering covert and overt technologies, APhA recommends using a
combination of these technologies. Counterfeiters have proven themselves
sophisticated and adaptable to advances in technology and changes in
anti-counterfeiting efforts. While overt technologies, such as specific
colors and fonts for labels, can provide pharmacists helpful clues about
the validity of the drug they are dispensing, instituting only overt
technologies could provide the counterfeiter a "blue print" on how to
circumvent the system. While each type of anti-counterfeit technology,
alone, provides a benefit, creating a system builds upon the strength of
each technology and helps create a less penetrable system, because
advantages and disadvantages exist with each type of technology. For
example, bar codes, a type of track and trace technology, are often
discussed as an anti-counterfeiting technology that should be adopted
industry-wide. Incorporating bar codes may provide many benefits beyond
simply assisting in anti-counterfeit efforts, such as inventory control,
reducing medication errors, identifying theft and diversion, and
implementing recalls. The value of bar codes to anti-counterfeiting
initiatives, however, must consider the ease of copying bar codes and
circumventing the protections by creating fake bar codes. While still an
important option for a base-line anti-counterfeit strategy, no single
technology will prevent counterfeiters. Sophisticated criminal
activities require sophisticated countermeasures.

*Unit-of-Use Packaging*

Many of the Report's technology-related questions focused on unit-of-use
packaging. APhA supports adoption of unit-of-use packaging as the
industry standard[^1]. Unit-of-use packaging may enhance patient safety,
patient compliance, and efficiencies in drug distribution. While most
other groups will focus on the manufacturers' and re-packagers' role in
unit-of-use packaging, it is important to consider the role of the
pharmacist, and the accompanying revisions to state law that may be
necessary to fully implement the concept. In current practice,
pharmacists receive prescriptions for many different quantities --- for
28-, 30- or 31-day supplies --- supplies that may not match unit-of-use
packaging. For effective implementation of unit-of-use packaging,
pharmacists must be permitted to modify prescribed quantities to
correspond with commercially available unit-of-use packages. Without
such authority, pharmacists will bear the burden of contacting
prescribers to amend the prescription, not for clinical concerns but to
comply with available packaging.

Establishing standards for unit-of-use packaging is another necessary
element to successful implementation. Expanding the scope of unit-of-use
packaging provides an opportunity to create more consumer-friendly
packaging and help pharmacists and patients improve medication use.
Allowing for a number of different unit-of-use formats, however, could
actually stimulate patient and pharmacist confusion. For example, one
drug's unit-of-use packaging could be designed in a circle, requiring a
patient to take tablets in a clockwise fashion, and another drug's
unit-of-use packaging could be designed in a rectangle, with the patient
taking pills from left to right, moving from the top row to the bottom.
While arguably self-evident to a patient using just one medication, a
patient using multiple medications must then also master multiple types
of packaging and presentation of the medication.

Setting standards for unit-of-use packaging could also help address some
of the shelf space issues at the pharmacy. Pharmacies are challenged
with stocking a multitude of drug products in a limited space.
Efficiencies in space are created when product boxes are similar in
size. Without standards, manufacturers could greatly vary the box sizes
of their products, creating inefficiencies and impacting the ability of
pharmacies to stock all products. Standards could preclude great
variations in box sizes and therefore could assist pharmacies as they
work to appropriately stock pharmacy shelves.

*Direct Shipment to End-Users*

While an interesting option to solving the challenges created by having
too many intermediaries in the supply system, direct shipments to
pharmacies and other end-users may pose additional problems. In current
practice, multiple pharmaceutical manufacturers deal with a relatively
small number of wholesalers and large purchasers, and the wholesalers
and large purchasers then distribute products to pharmacies. This system
provides efficiencies to both the manufacturer and the pharmacy by
allowing each end of the distribution system to work with a smaller
number of distributors. A direct-shipment-to-end-user system that
removes the wholesaler function would require pharmacies to work with
multiple manufacturers, and manufacturers to work with tens of thousands
of pharmacists and pharmacies, creating administrative challenges for
all participants in the distribution system.

In an effort to limit those administrative burdens, manufacturers could
choose to ship their products only to large pharmacy operators and leave
smaller pharmacies and their patients without access to medications. All
pharmacies must have access to all medications to ensure that patients
may conveniently receive their medications from their pharmacist of
choice and in doing so, take advantage of the pharmacist-provided
consumer protections against drug interactions, adverse events, etc.
Additionally, an end-user distribution system assumes that the pharmacy
is the last stop in the medication distribution system. In some
circumstances, a pharmacy may provide medications to another pharmacy,
such as when there is a shortage of a particular medication. This is an
important element of providing patients timely access to necessary
medication. Although it is impossible to predict the impact of such a
dramatic change in our drug distribution system, it is clear that
current efficiencies in the central wholesaler system would be lost, or
at least compromised, with a direct-to-end-user system.

*Managing the System*

The FDA must play a strong role in reviewing the use of various
anti-counterfeiting technologies, whether in the form of special
packaging, taggants incorporated into the product, or track and trace
technologies. To better ensure an effective security system, the FDA
should be a leader in managing the system. We would support having some
anti-counterfeiting technologies identifiable only by the manufacturer
and/or the FDA, as well as efforts to limit the number of
persons/entities with access to any anti-counterfeiting-related data.
Entities other than the FDA who desire access to this data must
demonstrate clear need. As such, the FDA should, at a minimum, set a
baseline for industry to meet for all anti-counterfeit activities.

In addition to setting a baseline, the FDA should play a strong role in
guiding the industry through this process. In particular, the FDA could
help the process of establishing this new system by clarifying the role
of each interested party within the new system. One often misunderstood
area is the intersection of authority between the FDA and state
regulators, such as the state Boards of Pharmacy. State Boards of
Pharmacy play a significant role in regulating pharmacies, pharmacists,
and wholesale distributors. The new system would benefit from a
coordinated, consistent approach from the FDA and other regulators, and
including this type of information as part of the industry guidance
document.

**Regulatory and Legislative Issues**

*Prescription Drug Marketing Act*

In our June 30, 2000, comments on the Agency's final rule implementing
the Prescription Drug Marketing Act of 1987 (PDMA) as amended, APhA
expressed concerns that the changes to the wholesale distribution of
prescription medications would erect barriers adversely impacting
pharmacists' ability to obtain prescription drugs. APhA's concerns
included creating two categories of drug distributors (authorized and
unauthorized), each with their own regulatory requirements, and
requiring unauthorized wholesale distributors to provide a drug origin
statement or paper "pedigree" detailing each previous transaction of the
drug upon each subsequent sale or trade of the drug.

APhA recognizes the value of requiring a trail of transactions for a
prescription drug and agrees that pedigrees, in concept, may be an
appropriate tool to track prescription drugs from manufacturer, to
wholesaler/distributor, to pharmacist. However, our concerns with a
paper-based system have not dissipated since our 2000 comments, although
our confidence in the distribution system has changed dramatically. A
paper pedigree system could negatively impact the security of our drug
distribution system by creating a false sense of security when the mere
presence of a paper pedigree could be proof of little. The value of a
paper-based system is reduced by the ease of counterfeiting paper
pedigrees. A paper-based pedigree system may provide a track record of
the product movement, or simply provide a counterfeit record of the
product movement---a trail as fake as the product it accompanies. If an
entity is sophisticated enough to counterfeit the product, the same
entity would be equally capable of counterfeiting a paper pedigree.

Proposals to issue an electronic, universal pedigree address our
concerns regarding PDMA's affect on drug availability. Early iterations
of PDMA implementation created a two-tiered system by developing a
system of authorized and unauthorized distributors. It is highly
unlikely that a manufacturer would provide an unauthorized distributor
with a pedigree when it is not required to --- and forcing unauthorized
distributors to construct a pedigree is an insurmountable burden that
would likely reduce the number of legitimate distributors in the system.
Fewer legitimate distributors could lead to a decrease in competition,
an increase in prescription drug prices, and a disruption in drug
distribution. Because of these concerns, APhA supports a carefully
constructed, electronic universal pedigree.

We continue to support a pedigree requirement in concept and recommend
that the Agency consider alternative formats, such as an electronic
pedigree system or other approaches less likely to be falsely produced
by counterfeiters. As with any new system, such steps should be
implemented after a cost-benefit analysis has been conducted.

*Access to Quality, Regulated Drugs*

APhA firmly believes that one of the greatest risks to patients
receiving counterfeit drugs is personal importation of medications from
outside the U.S. Importation, particularly personal importation, raises
patients' risk of receiving a substandard or fake medication
substantially by making the world a patient's pharmacy --- a drug
provider that is often unregulated or at least regulated very
differently. Members of Congress and state policymakers, in an effort to
increase access to medications for their constituents, have begun
efforts to facilitate and/or legalize this unsafe practice. Simply
strengthening existing regulatory enforcement to address importation
would reduce the risk of patients receiving a counterfeit medication.

Over the last year, so-called storefront operations have popped up
around the country to facilitate personal importation of
pharmaceuticals. These facilities are clearly participating in the
delivery of medications to patients. State Boards of Pharmacy, with whom
enforcement of the practice of pharmacy lies, find themselves struggling
with jurisdictional issues when trying to close down these storefront
operations. Often walking the fine line of "practicing pharmacy", these
storefronts occasionally fall in a regulatory vacuum. Any changes
necessary to directly address these entities --- thereby providing
either federal or state regulators the authority to shut down these
operations --- must be made. In addition, APhA supports the proposal to
increase penalties for counterfeiting medications. Such action would
send a strong message to counterfeiters that we do not condone this
illegal, unsafe, and unscrupulous practice.

*State Pharmacy Practice Acts*

As stated previously, personal importation is the greatest risk to
patients receiving counterfeit drugs and State Boards of Pharmacy are
struggling with jurisdictional issues when trying to regulate
"storefront" operations. Therefore, APhA would support efforts to
enhance the ability of state Boards of Pharmacy to regulate all entities
engaging in pharmacy practice, including so-called storefronts.
Additionally, APhA supports strengthening wholesaler regulations, such
as requiring a site visit to a wholesaler before issuing a license. This
step would enhance regulators' efforts to ascertain that the wholesalers
seeking licensure are legitimate businesses.

**Education & Communication**

*Role of the Public*

Patients play a very important role in identifying and reporting
suspected counterfeit drugs. Occasionally, counterfeit drugs may be
identified only through patient experience with medications --- only
after the drug interacts with a human body. But for patients to fulfill
this role of reporter, they first need to be aware of the importance of
reporting. Second, patients must know where to report --- that they
should tell their pharmacist when a drug looks, smells, feels, or tastes
different than what they had previously experienced or expected. Even if
the change in appearance or effect is not related to a counterfeit
medication, this conversation may help limit adverse drug events or side
effects, it may help improve medication use and advance patient care.
Third, patients also need to understand how easily drugs can be
counterfeited and how difficult it is to detect counterfeit drugs.
Without such education, patient may not consider an odd effect the
result of a counterfeit drug and may assume that the pharmacist would
have "seen" (with the naked eye) whether a drug was counterfeit. Neither
assumption is true and should be clarified. A call to action and
consumer tips on what to watch for will help patient reporting of
suspected counterfeit medications. APhA consumer tips are posted on our
website (http://www.pharmacyandyou.org/InternetPharmacy.html) and are
attached for your information.

*Messaging*

Effective and efficient notification of counterfeit medication requires
a consistent message in a consistent format. Inconsistent, conflicting
messages will only perpetuate unnecessary chaos. Notification should
take place in priority order as well, with an optimal situation
notifying the pharmacy community first, with immediate subsequent
notification of the public and the rest of the health care system. By
communicating first with the pharmacy community --- both pharmacies and
pharmacists ---the Agency helps prepare the community most likely to
receive questions about the situation, and the community most likely to
have the information necessary to proactively contact affected patients.
Organizations such as APhA can play an integral role in these emergency
communications.

Messages to pharmacists should focus on information the pharmacist needs
to address their patient population, such as: name of the product, lot
number, specifics about identifying the counterfeit product, and
information on the risks to patients. This type of information will
allow the pharmacist to determine the likelihood that their drug supply
was infiltrated by the particular product in question and to immediately
notify the affected patients.

*Collaboration\
*APhA recommends that the Agency collaborate with private stakeholders
in designing communication strategies among stakeholders. This
public/private partnership could facilitate efforts to standardize
anti-counterfeit communications and to augment and coordinate
communication systems. APhA specifically recommends utilizing our
website of resources for pharmacy professionals, www.Pharmacist.com, to
deliver FDA messages about counterfeiting. Pharmacist.com is the
single-source site for the professional resources that are vital to the
continuous professional development needs of pharmacists, student
pharmacists, and pharmacy technicians. Pharmacist.com, a collaborative
effort of APhA and the National Association of Boards of Pharmacy,
assembles in one place the resources pharmacists need. As a medium
developed by pharmacy for pharmacy, Pharmacist.com provides information
in a useful format. Pharmacist.com could be used to link to MedWatch to
facilitate pharmacists reporting suspected counterfeits. In addition to
Pharmacist.com, APhA has another internet-based communication tool that
could be used to send information about counterfeit medication events.
Pharmacist.com Focus is a weekly publication that is emailed to more
than 65,000 pharmacists and student pharmacists and could be easily used
to focus the attention of this audience on anti-counterfeit activities.
However, Pharmacist.com Focus is not restricted to a weekly distribution
schedule. In a crisis, APhA has the ability to send special alerts to
Pharmacist.com Focus subscribers --- an invaluable tool during an
emergency situation. An advantage of these systems is that they already
exist, and it is more efficient to augment a currently existing system
than to create a net new one that must be introduced to pharmacists.
Pharmacists are already familiar with these systems and will be
responsive to their information as they are seen as fair and unbiased
resources for information.

Creating efficient and effective public/private collaborations is a
challenge when trying to meet the needs of a wide spectrum of interested
parties. Involving interested parties early in the process can assist in
these efforts. A common understanding of how systems will work will
better prepare everyone to handle an emergency situation, and the
creation of templates supports efforts to ensure that messages stay
consistent. Having as much of a "system" in place prior to an event is
an effective way to manage a situation. Creating consistency before an
emergency helps prevent unnecessary mishaps.

**Industry and Health Professional Issues**

*Role of the Pharmacist*

As the medication experts on the health care team and the health care
practitioners with the most comprehensive set of drug information for
the patients they serve, pharmacists should take a leadership role in
identifying counterfeits, preventing their introduction into the
distribution chain, and educating consumers about counterfeits and how
to address a suspected counterfeit medication.

Pharmacists have the responsibility of partnering with patients to share
information about medication use, to ask patients to report anything
different about their medication. Patients need to know, for example,
that a drug that stings when injected could, in a rare situation, be
counterfeit, or, more commonly, that they could be suffering an adverse
reaction. Pharmacists are essential in efforts to help patients make the
best use of their medications.

Pharmacists must also play a reporting role, and need education to focus
them on the most efficient reporting procedures. While pharmacists
better understand the ease of counterfeiting medications, many have not
dealt directly with the situation. Pharmacists need information about
how and to whom they should report suspected counterfeit medications:
reporting to FDA and the pharmaceutical manufacturers. APhA supports
efforts to increase the understanding by pharmacists of the role that
they play in preventing counterfeit medications from reaching patients,
and has published a continuing education piece on protecting the
integrity of the prescription medication supply, which will be
distributed to more than 120,000 pharmacists in the November, 2003 issue
of *Pharmacy Today*.

In addition, the profession can address the practice of safe drug
distribution by developing best business practices for buying
medications. These guidelines could then be widely distributed to
pharmacists to assist them in preventing the introduction of counterfeit
medications in their pharmacy and to facilitate the identification of
counterfeit drugs.

Finally, APhA commends the Task Force for recognizing that this effort
must go beyond our own borders and must include the international
pharmacist community. In devising international activities, APhA
recommends that the Task Force work with the International
Pharmaceutical Federation (FIP), a world-wide federation of national
pharmaceutical (professional and scientific) associations. FIP has
expressed concerns regarding the proliferation of counterfeit
medications. At its 2003 World Congress in Sydney, Australia, the FIP
Council adopted a *Statement of Policy on Counterfeit Medicines,* which
can be accessed at http://www.fip.org/pdf/counterfeitmedicines2003.pdf

APhA is pleased that the FDA is addressing this important issue. This
review of current policies and systems is timely, given recent increases
in counterfeit medications and importation by individual patients. As
the FDA considers the steps to limit drug counterfeiting, the analysis
must consider the costs associated with the recommendations -- costs in
terms of both time and money. Pharmacists and other members of the
pharmaceutical supply system are ready to invest in appropriate
measures, but we should invest wisely in those strategies that will
provide the best value for the cost. APhA urges the FDA to consider our
recommendations as they finalize their anti-counterfeit drug initiative.
Thank you for the opportunity to share our thoughts on this issue. If
you need additional information, please contact Susan Bishop, APhA\'s
Senior Manager of Regulatory Affairs and Political Action, at
202-429-7538 or sbishop@aphanet.org.

Sincerely,

![](media/image1.png)John A. Gans, PharmD

Executive Vice President

cc: Susan C. Winckler, RPh, JD, Vice President, Policy and
Communications & Staff Counsel

Kristina E. Lunner, Director, Federal Government Affairs

Susan K. Bishop, MA, Senior Manager, Regulatory Affairs and Political
Action

 

## About Importing Medications and Internet Pharmacies

![](media/image2.png){width="4.145833333333333in"
height="5.2083333333333336e-2in"}

[About Importing
Medications](http://www.pharmacyandyou.org/InternetPharmacy.html#Import%23Import)\
[About Internet
Pharmacies](http://www.pharmacyandyou.org/InternetPharmacy.html#Internet%23Internet)

**\
****Importing Medications: Getting Your Questions Answered**

 The American Pharmaceutical Association (APhA), the national
professional society of pharmacists, addresses consumer questions
regarding the importation of medications and offers helpful advice on
the risky practice.

**What does "importation" refer to?**\
Importation refers to patients obtaining medications outside of the
United States . It is the practice of bringing medications from one
country to another.  

**Why would a person engage in the practice?**\
Consumers---feeling the financial pressures of expensive prescription
drugs---look for alternative ways of obtaining the medication they need.
However, importing medications only offers short-term cost savings,
because if the medication is wrong or used incorrectly it can cause
greater harm to the patient, thus resulting in higher long-term costs.

**Importing drugs sounds illegal. Can just anyone bring drugs from one
country to another?**\
Just as bringing fruit from a foreign country into the U.S. is illegal,
importing medications is also illegal. Under federal law, only the
manufacturer of a drug may import prescription medications, because the
federal government regulates the manufacturing of prescription and
nonprescription medications. The federal government has processes to
ensure the safety of products manufactured according to its rules---but
not an imported product brought in from another country by an
individual.

In using the fruit analogy, the U.S. prohibits a person from bringing
fruit from a foreign country into the U.S. because the fruit may be
contaminated and potentially bring disease and devastation to our
nation's harvest. In similar terms, neither the pharmacist nor the
public has assurance that imported products are effective, safe, or have
been produced under U.S. quality control requirements. Imported products
may be subpotent (contain too little active ingredient) or superpotent
(contain too much active ingredient). In the worst cases, imported
medications may be contaminated, which can harm or permanently damage
the body, causing paralysis, organ malfunction, or even death.

**Safeguard Yourself with Knowledge & Consider this Advice:**

**1.     Are you getting what you ordered?** Once a product leaves the
U.S. regulatory system, the product is at risk of becoming contaminated.
Understand that other distributors are not held to certain storage
standards or product labeling. You could be consuming a product that has
become faulty due to temperature conditions or one that is simply the
wrong product.  

**2.     Do your local doctors and pharmacists know what you are
taking?** Drug interactions with other medications are something doctors
and pharmacists consider before prescribing and dispensing prescription
medications to patients. You may be taking a medication that will become
ineffective or cause harm when taken in conjunction with another
medication.\
\
Patients often see different doctors for different examinations,
creating the potential for drug interactions. To protect against this
risk, patients should use ONE pharmacy for their medication needs.
Pharmacists ensure that a patient receives the right medication in the
right dose. Pharmacists also check for interactions by maintaining a
patient's medication history, thus protecting the patient from receiving
the wrong medication. If you choose to import your medications, be sure
to discuss those medications with your doctor and pharmacist.\
\
In addition, some web sites offer medications for sale without the
patient receiving a physical examination. Bypassing direct contact with
a doctor or pharmacist puts the patient at higher risk to receive
inappropriate medications. 

**3.     Are you getting the most from your medication?** Medications
are powerful technology and are only safe when used appropriately.
Appropriate medication use involves more than just getting the product;
it also requires understanding how to use the medication, including
monitoring for unwanted side effects and potential interactions with
other medications. Pharmacists are the patient's partner in making the
best use of medications.

**What You Should Know About Internet Pharmacies:**

There is a portion of our population for whom Internet Pharmacies offer
valuable benefits. Some patients may feel more comfortable communicating
personally sensitive health information to a pharmacist via the
Internet. There are *two important points* patients must be aware of
when selecting any pharmacy:

**MEDICATIONS ARE SAFE -- WHEN USED CORRECTLY.**

As part of that correct use of medications, patients should keep the
following things in mind when choosing a pharmacy whether a local
pharmacy, mail order pharmacy, or an Internet pharmacy.

Preferably, patients should use only *ONE* pharmacy source. Using just
one pharmacy decreases the possibility of patients suffering a harmful
drug interaction because they've gotten their medications from multiple
sources such as an Internet pharmacy *and* their community pharmacy.

If getting acute prescription medications (like an antibiotic) from a
local pharmacy, the patient should alert the local pharmacist about
other medications they are already taking.

Patients should always have access to a pharmacist. All patients should
have a telephone number to contact their pharmacist, whether they use a
local pharmacy, mail order pharmacy, or Internet pharmacy. This is
particularly significant for patients using a mail order pharmacy or an
Internet pharmacy. They do not have the option of visiting the
pharmacist to ask questions about their medications in person.

**Some Services Provided by Your Local Pharmacist Cannot be Transmitted
over a Modem**

Patients choosing to use an Internet Pharmacy should consider the
following:

**1.      With current technology, an Internet pharmacist cannot check
the patient's blood pressure or blood cholesterol level to help the
patient monitor his drug therapy.** Unless the Internet Pharmacy and
consumer both have video teleconferencing capabilities, allowing the
patient and pharmacist to see one another as they interact, pharmacists
will not be able to observe signs or behaviors that may be important
indicators of symptoms and potential adverse responses to drug therapy.

**2.      Are Internet pharmacies licensed to serve patients in my
State?** Assuming the internet pharmacy is located in the United States
, individual state boards of pharmacy license pharmacists and pharmacies
and establish the regulatory framework for protecting the public
health.\
\
The National Association of Boards of Pharmacy (NABP) developed a system
to verify licensure of Internet Pharmacies---the Verified Internet
Pharmacy Practice Site^TM^ (VIPPS) certification. NABP is located in
Park Ridge , Illinois . The organization can be reached by telephone at
(847) 698-6227. Their Internet Site URL is
[http://www.nabp.net](http://www.nabp.net/).

**3. **   **Will I have access to a pharmacist to answer my questions
about medication use?** Regardless of the type of pharmacy, patients
should select a pharmacy that has a pharmacist available to answer
questions. In order to help make the best use of their medications,
patients should consult a pharmacist to make sure that they receive the
RIGHT medication, in the RIGHT dose, with the RIGHT information. \
\
:

![](media/image2.png){width="4.145833333333333in"
height="5.0694444444444445e-2in"}

[![](media/image3.png){width="1.3527777777777779in"
height="0.42569444444444443in"}\<\>](http://www.pharmacyandyou.org/main.html)

[^1]: The following policy statement was adopted in 2003 by the APhA
    House of Delegates: ***Unit-of-Use Packaging:*** APhA advocates for
    the adoption of "unit of use" packaging as the industry standard to
    enhance patient safety, patient compliance, and efficiencies in drug
    distribution. APhA shall collaborate with the pharmaceutical
    industry, third party payors, and appropriate federal agencies to
    affect the changes necessary for the adoption of "unit of use"
    packaging as the industry standard. APhA encourages the enactment of
    legislation and regulations to permit pharmacists to modify
    prescribed quantities to correspond with commercially available
    "unit of use" packages.