newsletterNational Association of Boards of Pharmacy®

aid to governmentthe profession

the public1904 to 2004

In This Issue. . . .Feature News:

October 2004 / Volume 33 Number 9

Fall Conference Speakers Offer Experience, Expertise

(continued on page 171)

150 152 160 162

Curbing Counterfeit Medications

This Month on www.nabp.net:NABP invites manufacturers to free seminar under “Special Items.”

View information and register online for the 2004 Fall Educational Conference under “Special Items” and “Meetings & Events.”

Updated NAPLEX blueprint now available under “Special Items.”

New nomination procedures for open Executive Committee member positions under “Special Items.”

Register for the next FPGEE under “Special Items.”

State board of pharmacy newsletters now contain the National News section under “State Newsletters.”

Upcoming MeetingsThursday-Saturday, October 21-23, 2004 NABP/AACP District II Meeting The Mountaineer Chester, WV

Wednesday-Saturday, October 27-30, 2004 NABP/AACP District VII and VIII Meeting Monte Carlo Hotel Las Vegas, NV

Wednesday-Friday, November 3-5, 2004 NABP/AACP District IV Meeting The Blackwell Inn Columbus, OH

Thursday-Sunday, November 11-14, 2004 NABP’s Fall Educational Conference Renaissance Vinoy Resort and Golf Club St Petersburg, FL

Hey Boo Boo, That’s Some Picnic Basket

Legal Briefs: Fall Conference: Association News: Compounding Pharmacy Accreditation Program Development Under Way

NABP’s plan to launch its new Verified-Accredited Wholesale Distributors™ (VAWD™) program, which accredits wholesale drug distributors, is well under way with the signing of a Memorandum of Understanding (MOU) by BuzzeoPDMA, Inc. The MOU, which was signed on September 7, 2004, outlines BuzzeoPDMA’s agreement to structure with NABP an accreditation and audit process to maintain the integrity of the United States drug distribution system by providing inspection resources for the VAWD program.

NABP began developing VAWD after Food and Drug Administration (FDA) requested that the Association update its Model

Wholesaler Accreditation Program on Track – Inspection Service Established

Rules for the Licensure of Wholesale Distributors, which is part of the Model State Pharmacy Act and Model Rules of the National Association of Boards of Pharmacy. Members of NABP’s resulting Task Force on Counterfeit Drugs and Wholesale Distributors, held in October 2003, revised the Model Rules and proposed the creation of an accreditation program and clearinghouse for wholesale distributors – a plan that was immediately supported by FDA – to further combat counterfeit drugs. NABP has set an aggressive timeline and expects to launch the program in December 2004.

VAWD will help protect the public from the threat of counterfeit drugs affecting the US drug

supply. VAWD accreditation assures stakeholders that wholesalers are legitimate, qualified for state licensure, and employing security and best practices for safely distributing prescription drugs and medical devices, which they also distribute to other wholesalers. Applicants for VAWD accreditation will undergo a criteria compliance review, licensure verification process, an inspection, and screening through NABP’s clearinghouse.

In November 2004, NABP and BuzzeoPDMA will perform pilot inspections of three wholesale distributors representing a cross section of the wholesaler industry. The inspections will enable NABP to fine-tune its processes as well as allow

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The NABP Newsletter (ISSN 8756-4483) is published ten times a year by the National

Association of Boards of Pharmacy (NABP) to educate, to inform, and to communicate the objectives and programs of the Association and its 66 member boards of pharmacy to the profession and the public. The opinions and views expressed in

this publication do not necessarily reflect the official views, opinions, or policies of NABP or any board

unless expressly so stated. The subscription rate is $35 per year.

National Association of Boards of Pharmacy 700 Busse Highway

Park Ridge, IL 60068 847/698-6227 www.nabp.net

custserv@nabp.netCarmen A. Catizone

Executive Director/SecretaryReneeta C. “Rene” Renganathan

Editorial Manager

© 2004 National Association of Boards of Pharmacy. All rights reserved. No part

of this publication may be reproduced in any manner without the written

permission of the executive director/secretary of the National Association of

Boards of Pharmacy.

Executive CommitteeDonna S. Wall Chairperson, District IV

Donna M. Horn President, District I

Dennis K. McAllister President-elect, District VIII

Lawrence H. Mokhiber Treasurer, District II

Charles Curtis Barr Member, District V

Michael A. Moné Member, District III

Richard A. Palombo Member, District II

Oren M. Peacock, Jr Member, District VI

Gary A. Schnabel Member, District VII

Charles R. Young Member, District I

Feature News

NABP’s ProgramsNABP’s wholesaler

accreditation program, Verified-Accredited Wholesale Distributors™ (VAWD™), is based upon the Model Rules for the Licensure of Wholesale Distributors and will be operational by the end of 2004. VAWD accreditation assures stakeholders that wholesalers are legitimate, qualified for state licensure, and employing security and best practices for safely distributing prescription drugs and medical devices they also distribute to other wholesalers. Accreditation, pursuant to the VAWD program, is based upon those standards outlined in NABP’s updated Model State Pharmacy Act and Model Rules of the National Association of Boards of Pharmacy.

Curbing Counterfeit Medications

During the past two years, regulators have seen growing evidence of

counterfeit and adulterated drugs entering the United States medication distribution system. Curbing the counterfeiting problem requires attacking the issue on multiple fronts such as requiring drug pedigrees, updating and enforcing standards for drug product integrity and sound distribution, and utilizing technological advancements in packaging. To maintain the integrity of the distribution supply chain, NABP has recently developed various programs to assist the state boards of pharmacy and regulators.

Just as varying rules among states are more likely to create complications and leave loopholes, varying lists of the drugs at highest risk for counterfeiting would also create difficulties. According to Food and Drug Administration’s (FDA) Counterfeit Drug Task Force report of February 2004, titled “Combating Counterfeit Drugs,” “There was general agreement that the existence of state-specific lists, each with its own regulatory requirements, could inhibit commerce and adversely affect the availability of drugs.”

In order to assist states in developing a uniform list of at-risk drugs, earlier this year NABP proposed, and FDA supported, a National Specified List of Susceptible Products, available at www.nabp.net. The list

was developed by NABP’s National Drug Advisory Coalition in accordance with the Coalition’s primary purpose and will be regularly revisited and revised. Initially, the Coalition will also be charged with drafting the criteria that detail standards and guidance for the revision process. Also, the Coalition will consist of no more than 15 members (including ex-officio members), who will be appointed by NABP’s Executive Committee on an annual basis and will consist of representatives from NABP, the state boards of pharmacy, the American Medical Association, the American Society of Health-System Pharmacists, the Healthcare Distribution Management Association, the National Association of Chain Drug Stores, the Pharmaceutical Distributors Association, the Pharmaceutical Research and Manufacturers of America, United States Pharmacopeia, and any other entity that the NABP Executive Committee deems appropriate. Ex-officio members will serve as a resource for the National Drug Advisory Coalition.

The Counterfeiting Issue

Diversion – an inherent component of counterfeiting – has, of course, long been a problem for the pharmacy profession. “It’s almost endemic in the system,” states Lew Kontnik, a management consultant specializing

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in pharmaceutical anti-counterfeiting. He pointed to the pharmaceutical industry’s multi-tiered pricing system, in which large price differentials exist, as a strong temptation for those who want to illegally “buy low, sell high.”

In a typical diversion scheme, a fraudulent closed-door pharmacy obtains drugs, purportedly for distribution to nursing home patients, at a discounted price from a manufacturer. The diverting pharmacy then sells the drugs at a higher price to a wholesaler who may sell them to a pharmacy or to another wholesaler for further diversion.

Counterfeiters, in order to place the counterfeited drugs into the normal distribution system, use many of the same methods perfected for diverting drugs.

While counterfeiting and diverting drugs are two different crimes, they are also inextricably connected, as Washington Post writers Gilbert M. Gaul and Mary Pat Flaherty noted last fall in their investigative series on the topic. “Counter-feiters … take advantage of criminal channels that have long been used for the illegal diversion of pharmaceuticals,” they wrote. Kontnik agrees: “Prescription drug diversion is the primary channel for counterfeiting. They are intimately related,” he emphasizes.

Feature News

(continued on page 168)

Like diversion, counterfeiting is hardly new, particularly outside the US. Improvements in technology and the growth of the Internet have contributed to criminals’ efforts to slip adulterated drugs into the medication distribution system including everything from label making to communications. “It’s not a brand-new issue, but it has accelerated,” explains Kontnik.

Counterfeit medications clearly pose enormous public health risks. Horror stories abound: a boy receiving injections of insulin instead of a growth hormone; a woman dying of breast cancer taking Procrit® that had been diluted to one-twentieth the strength. Indeed, a Florida grand jury that convened to examine “the safety of prescription drugs in Florida, especially the sale and resale of drugs in the wholesale market” concluded that the percentage of tainted drugs was highest among “the more expensive injectable pharmaceuticals” – often used by some of the most vulnerable patients … such as those in treatment for cancer or AIDS, or those undergoing organ transplants.

The counterfeit medication problem is a complex one, with many contributing factors. The Florida grand jury, for example, pointed to “weak permitting requirements, lax agency oversight of

wholesalers, insufficient criminal penalties, and the failure of wholesalers to use due diligence in their purchasing decisions.”

FDA, in its Task Force report, concluded that an effective anti-counterfeiting strategy would include seven major elements:

� implementation of new authentication and track and trace technologies to protect the integrity of the drug supply,

� adoption and enforcement of strong anti-counterfeiting laws and regulations by the states,

� increased criminal penalties for counterfeiting,

� adoption of secure business practices by all participants in the pharmaceutical supply chain,

� development of an effective system to report counterfeit drugs to FDA,

� education of consumers and health care professionals, and

� collaboration with foreign entities to deter and detect counterfeit drugs on a global basis.

Authentication Technologies

Suggestions to help make prescription drugs more difficult to counterfeit include unit-of-use packaging, tamper-evident packaging, and authentication markers. In its Task Force report, FDA

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Legal Briefs

Hey Boo Boo, That’s Some Picnic BasketBy Dale J. Atkinson

The Medical Board of California issued an administrative subpoena for the medical records of a patient. The impetus behind the subpoena was an ongoing investigation of a physician for alleged indiscriminate prescribing of medicinal-use marijuana. A patient was camping in a state recreational area when two park rangers conducted an inspection upon consent of the patient. The rangers discovered two glass smoking pipes with apparent marijuana residue. The patient claimed ownership of the pipes and admitted he also possessed a small amount of marijuana.

The authority of a regulatory board to efficiently and effectively protect the

public through enforcement of the practice act can be dependent upon its authority to investigate complaints. Investigative authority may include the ability to subpoena documents and records from practitioners to ensure safe, competent practice within the bounds of the scope of practice. Boards of pharmacy must be authorized to issue subpoenas to better enforce the practice act and provide access to much-needed records, some of which may contain sensitive patient information. Questions arise as to when the board can issue a subpoena and how broadly can such a discovery request be tailored. Consider the following.

The patient produced a letter from the physician stating that he was medically certified to use marijuana for migraine headaches and attention deficit disorder.

The ranger sent a copy of the physician letter to the Medical Board seeking “appropriate actions.” Thereafter, the Board sent a letter to the patient stating that the Board was reviewing the physician for quality care and was seeking permission from the patient to release his medical records. Claiming his right to privacy, the patient refused. The Board then subpoenaed the patient’s records from his

physician. The physician refused, stating that release of the records against his client’s wishes would be a breach of physician-patient confidentiality and that the Board had not shown good cause for invading such confidentiality.

The Board petitioned the court to compel compliance with the subpoena. The Superior Court issued its order granting the Board petition and ordering the physician to produce the patient’s records. The Superior Court found that there were sufficient grounds to support the subpoena because the physician letter appeared to prescribe marijuana for the treatment of attention deficit disorder, which is not a listed illness under California law for which marijuana is authorized for prescription. The physician continued to refuse to comply with the subpoena, leading the Board to commence administrative proceedings for failure to comply with the court order compelling compliance with the request. The physician filed a petition with the appellate court seeking a reversal of the lower court order.

In its assessment of the merits of the appeal, the appellate court held that a patient’s right to privacy is founded in the California

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(continued on page 163)

Legal Briefs

Attorney Dale J. Atkinson is a partner in the law firm of Atkinson & Atkinson, counsel for NABP.

Constitution and that the Board must demonstrate through competent evidence that the particular records sought are relevant and material to its inquiry sufficient for a trial court to independently make a finding of good cause to order the materials disclosed. The court also recognized the authority of the physician to assert such a privilege on behalf of the patient.

The court compared an earlier case, Wood v Superior Court, 212 Cal. Rptr 811 (App. Ct. CA 1985), with the facts of the instant matter. In Wood, the Board issued a subpoena for the complete medical records of 52 patients from two different physicians. The Board suspected over-prescribing of Schedule II drugs susceptible for abuse. In its investigation, the Board obtained copies from pharmacies of various Schedule II scripts of physicians. The medical expert for the Board and a pharmacist from one of the pharmacies stated that there was a distinct possibility of over-prescribing controlled substances. In reversing the lower court recognition of the subpoena, the appellate court held that the subpoenas “suffered from a lack of sufficient factual justification to permit the trial court to independently assess the substantiality of the likelihood

of improper prescription practices” because the “root facts upon which an inference of improper prescribing is based must be laid bare.”

In the instant case and following the rationale in Wood, the court similarly found that the Board has facts about certain prescriptions and conclusions by Board personnel, in part based upon expert opinions, that such scripts may be suspicious, but no mediating facts revealing why the conclusion is warranted. The court stated that the Board has made no evidentiary showing what other similarly situated physicians would do and, alternatively, no showing of the likelihood that the prescriptions could have been properly issued, given the circumstances.

Absent this information, the court held that there is no means by which to gauge the likelihood that the records sought will reveal misconduct. Accordingly, there is no independent judicial assessment of good cause. “The judicial function of assessing good cause [citation] cannot be abdicated by deferring to the bare conclusions of board personnel.”

The court rejected the arguments of the Board that good cause was contained in the complaint by the ranger

and that it was necessary for the Board to obtain the records to investigate whether, in fact, violations had occurred. The court also rejected Board arguments that the records could not be obtained through any other means. The court held that the standard created in Wood had not been met. “While the Medical Board may want assurance [the licensee] was not violating the law or providing negligent treatment, that goal, even when accompanied by suspicion, is not enough to invade a patient’s right to privacy unless there are facts from which to make an independent showing of good cause.”

The court also agreed with the amicus curie brief filed by the California Medical Association that the subpoena was overbroad. The Board must limit its requests for records to those essential to a focused inquiry. Because the subpoena sought “all” medical records of the patient from 1999 to the present, such inquiries were beyond the scope of the immediate investigation.

Finally, the court rejected the arguments of the Board that the patient had waived his privacy rights by revealing the letter to

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Feature News

NABP’s members passed Resolution 100-11-04, Sterile Products, at NABP’s

100th Annual Meeting in Chicago, IL, in April 2004. This resolution asks that “NABP communicate to its member boards information concerning the (United States Pharmacopeia) USP General Chapter <797> Pharmaceutical Compounding – Sterile Preparations, and its integration into the Model State Pharmacy Practice Act and Model Rules of the National Association of Boards of Pharmacy.” Appendix C of the NABP Model Act, Good Compounding Practices Applicable to State Licensed Pharmacies, Subpart A – General Provisions, states that “Compounding Pharmacists and Pharmacies shall practice in accordance with these Good Compounding Practices, the Board’s Rules for Sterile Pharmaceuticals, and the current USP – National Formulary (USP–NF) chapters on Compounding and sterile product preparation.”

New Frontiers in Sterile Compounding: USP Chapter 797

On January 1, 2004, USP released USP Tests and Assays Chapter 797, Pharmaceutical Compounding – Sterile Preparations, which represents the organization’s latest efforts to address sterile compounding that occurs not only in hospital pharmacies but also in community pharmacies, physician offices, surgical clinics, and any other setting where sterile preparations are compounded.

One of USP’s primary functions includes serving as the premier authority on standards setting for more than 4,000 prescription and non-prescription drugs, dietary supplements, veterinary drugs, and health care products.

Officially recognized in the federal Food, Drug, and Cosmetic Act (21 U.S.C. § 321 et seq.), the contents of the USP–NF provide the latest Food and Drug Administration (FDA)-

enforceable standards of identity, strength, quality, and purity including tests, analytical procedures, and acceptance criteria. USP–NF also contains chapters addressing topics such as sterility, pyrogen, and antimicrobial effectiveness testing. USP chapters are designated as either “General Chapters” or “Informational Chapters”:

� General chapters, numbered 1-999, are standards and, therefore, enforceable requirements;

� Informational chapters, numbered 1000 and above, are generally not enforceable; and

� USP chapters above 2000 apply to nutritional supplements.

According to the introduction to USP Chapter 797, “[T]he intent of this chapter is to prevent harm and fatality to patients that could result from microbial contamination (nonsterility), excessive bacterial endotoxins, large content errors in the strength of correct ingredients, and incorrect ingredients in CSPs [compounded sterile preparations].” USP Chapter 797 has replaced USP Chapter 1206, Sterile Drug Products for Home Use, an informational chapter that was more

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Feature News

(continued on page 156)

restrictive in its applicability to sterile compounding.

Unfortunately, a number of incidences resulting in significant patient harm and even death have been caused by compounded products that were not appropriately prepared. In August 2002, a 77-year-old woman from North Carolina died from fungal meningitis due to pharmacy compounded methylprednisolone acetate that was administered via lumbar epidural injection.1 The compounded methylprednisolone acetate injection was contaminated with Wangiella dermatitidis, a fungus commonly found in soil. Three other North Carolina residents also developed the life-threatening meningitis from the contaminated compounded product. In December 2003, a two-year-old cancer patient died of a cardiac arrhythmia after receiving an intravenous potassium chloride dose that was fives times the strength of the prescribed dose.2

Traditionally, pharmacists have always engaged in the practice of compounding. In 1938, 50% of prescriptions dispensed in the US were compounded; however, the technologic evolution of mass-produced pharmaceuticals during the 1950s resulted in a significant decrease

in the demand for compounding.3 Recently, the compounding practice has regained momentum due in part to product line discontinuations, shortages of manufactured medicines, and a desire on the part of practitioners to provide individualized pharmacotherapy. At this time, it is estimated that pharmacy compounding accounts for 1% to 10% of all prescriptions dispensed annually, with a total of several billion dollars.

Although many professional pharmacy associations and state pharmacy boards are involved in ongoing initiatives to address quality concerns regarding sterile pharmaceutical compounding, USP Chapter 797 represents the broadest enforceable standards on sterile compounding and preparation.

Overview of USP Chapter 7974

The following sections provide a general overview of the major components of USP Chapter 797. For specific requirements, consult the USP–NF.

‘Compounded Sterile Preparations’ Defined

According to USP Chapter 797, CSPs include:

a. preparations prepared according to the

manufacturer’s labeled instructions and other manipulations when manufacturing sterile products that expose the original contents to potential contamination;

b. Preparations containing nonsterile ingredients or employing nonsterile components and devices that must be sterilized before administration.

c. Biologics, diagnostics, drugs, nutrients, and radiopharmaceuticals that possess either of the above two characteristics, and which include, but are not limited to, baths and soaks for live organs and tissues, implants, inhalations, injections, powders for injection, irrigations, metered sprays, and ophthalmic and otic preparations.

Risk Level ClassificationCSPs are classified

according to three risk levels: low, medium, or high. Low-risk CSPs are those that have the lowest potential for microbial (microbial organisms, spores, and endotoxins), chemical, and physical contamination, while high-risk CSPs are those that have the highest potential for contamination. The risk level assigned to the CSP dictates what conditions

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Table 1: Storage and Beyond-use Dating

Source: USP Tests and Assays Chapter 797, Pharmaceutical Compounding – Sterile Preparations

Risk Level Room Temperature Refrigeration(2°C - 8°C)

Freezer (20°C or less)

Low Risk 48 hours 14 days 45 days

Medium Risk 30 hours 7 days 45 days

High Risk 24 hours 3 days 45 days

Feature News

should be met and what policies and procedures should be implemented to decrease the possibility of contamination while compounding. Refer to Table 2 on page 157 for descriptions and examples of low-, medium-, and high-risk preparations.

Responsibility of Compounding Personnel

Pharmacists and compounding personnel are responsible for the safe preparation, dispensing, and distribution of CSPs. Personnel must maintain a clean compounding environment, which includes hand cleansing, disinfection, and donning procedures. Proper use of equipment and devices such as laminar airflow workbenches (LAFWs) and barrier isolators are essential. Compounding supervisors must develop and maintain polices and procedures that address critical components of all processes. Compounding supervisors must also ensure that compounding ingredients agree with their labeled strengths in accordance with USP monographs or accompanying certificates of analysis from the supplier to assist in the judgment of identity, quality, and purity.

Verification of Compounding Accuracy and Sterilization

Some CSPs, regardless of risk level, may need

terminal sterilization and the compounding facility must correctly design and implement procedures and methods that help determine the appropriate sterilization method that will maintain the strength, purity, and quality of the CSP. Validation testing of the sterilization method chosen should yield a product free of contamination.

Personnel Training and Evaluation in Aseptic Manipulation Skills

The assurance of quality CSPs begins with the compounding personnel. All personnel involved should be adequately educated and trained to demonstrate competencies in the area of aseptic technique. Didactic and experiential forms of education and training should be utilized and this competency should be evaluated using growth media (media fills).

Environmental Quality and Control

The risk of product contamination is largely affected by the duration of product exposure,

the amount of product exposed, and the nature of exposure. Therefore, the consideration of these factors is paramount in maintaining an environment conducive to sterile product preparation.

USP Chapter 797 separates the compounding environment into three general areas:

� the critical area in which compounding occurs (generally referring to the LAFW, barrier isolator, or biological safety cabinet);

� the buffer zone (clean room), which immediately surrounds the critical compounding area; and

� the anteroom, which serves as a donning, cleansing, and storage area for products and supplies.

The critical compounding area must be at least International Organization for Standardization (ISO) Class 5 (Class 100) quality, which means that a maximum of 100 particles sized 0.5 microns are allowed for every cubic foot of air space. The buffer zone must be of ISO Class 8 (Class 100,000) quality. Other requirements

detail how ceilings, walls, floors, fixtures, shelving, counters, and cabinets in the buffer zone should be constructed and maintained to minimize contamination. For example, ceilings and walls should be covered or caulked to avoid crevices where dirt can accumulate. A demarcation line or barrier should identify the separation of the buffer zone and the anteroom. Cleaning and sanitizing of the critical compounding area, buffer zone, and anteroom are detailed in USP Chapter 797, along with explicit gowning procedures that should be adhered to prior to entering the buffer zone, particularly when high-risk CSPs are prepared. Standard operating procedures that address personal cleansing, gowning, storing supplies, operation of LAFWs or barrier isolators, and environmental monitoring and testing are designed to ensure the quality of the environment in

USP 797(continued from page 155)

(continued on page 159)

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Feature News

Source: USP Tests and Assays Chapter 797, Pharmaceutical Compounding – Sterile Preparations

Table 2: USP Chapter 797 Risk Level Classification

Classification Requirements ExampleLow-Risk Compounding � Compounded with aseptic

manipulations in International Organization for Standardization (ISO) Class 5 (Class 100) laminar airflow workbench (LAFW) conditions or better

� Using only sterile ingredients and devices

� Manipulations limited to aseptically opening ampuls; penetrating sterile stoppers; and transfers involving sterile products, syringes, devices, and packages

Preparation of a small-volume paren-teral with sterile solution transferred from a vial

Medium-Risk Compounding � Combining multiple individual or small doses of sterile products that will be administered to multiple patients or for a single patient on multiple administrations

� Involving complex aseptic manipulations other than single-volume transfers

� CSP does not contain a broad-spectrum bacteriostatic agent despite CSP being administered over several days

Compounding of total parenteral nutrition fluids using manual or automated devices characterized by multiple injections, detachments, and attachments of products to the device utilized to deliver all components to a sterile container

High-Risk Compounding � Use of nonsterile ingredients or devices before terminal sterilization

� Sterile ingredients, components, mixtures

� Nonsterile preparations

Preparation consisting of a dissolv-ing nonsterile bulk drug that will be terminally sterilized

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Feature News

The Medicare Prescription Drug, Improvement, and Modernization Act of 2003 affords patients numerous options concerning health care coverage, and portions of the Act offer pharmacists new opportunities for improving medication use and enhancing patient care. One benefit named in the Medicare Act that pharmacists may now extend to a targeted subset of Medicare patients

Coalition of National Pharmacy Organizations Defines MTM Services for Medicare Act

is Medication Therapy Management (MTM); however, specific guidelines and regulations for MTM coverage have yet to be established.

To ensure that the new MTM benefit is effectively implemented, 11 pharmacy organizations including NABP agreed

upon the “Medication Therapy Management

Services Definition and Program Criteria” on July 27, 2004 (see below). NABP’s support noted that the Association

could not involve itself in reimbursement and

economic issues. The definition and criteria were presented to the Centers for Medicare & Medicaid Services (CMS) during its public comment period, which ended October 4, 2004. The Department’s goal is to finalize MTM services guidelines and regulations by the time the Medicare Act takes effect in January 2006.

The coalition of pharmacy organizations developed the definition

Medication Therapy Management Services Definition and Program Criteria

Medication Therapy Management is a distinct service or group of services that optimize therapeutic outcomes for individual patients. Medication Therapy Management Services are independent of, but can occur in conjunction with, the provision of a medication product.

Medication Therapy Management encompasses a broad range of professional activities and responsibilities within the licensed pharmacist’s, or

other qualified health care provider’s, scope of practice. These services include but are not limited to the following, according to the individual needs of the patient:

a. Performing or obtaining necessary assessments of the patient’s health status;

b. Formulating a medication treatment plan;

c. Selecting, initiating, modifying, or administering medication therapy;

d. Monitoring and evaluating the patient’s response

to therapy, including safety and effectiveness;

e. Performing a comprehensive medication review to identify, resolve, and prevent medication-related problems including adverse drug events;

f. Documenting the care delivered and communicating essential information to the patient’s other primary care providers;

g. Providing verbal education and training designed to enhance patient

understanding and appropriate use of his/her medications;

h. Providing information, support services, and resources designed to enhance patient adherence with his/her therapeutic regimens;

i. Coordinating and integrating medication therapy management services within the broader health care management services being provided to the patient.

(continued on page 165)

(continued on page 165)

. . . [Eleven] pharmacy organizations including NABP agreed upon the “Medication Therapy Management Services Definition and Program Criteria” on July 27, 2004.

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Feature News

USP 797(continued from page 156)

(continued on page 170)

which a CSP is prepared are also suggested.

ProcessingA written description

of formal training and the evaluation program for all compounding personnel should cover topic areas such as the employment of appropriate cleanliness techniques including hand cleansing and disinfection of compounding devices and equipment; the selection of appropriate garments, masks, and other donning practices to minimize risk of contamination; demonstration of aseptic technique; and the assurance that CSPs are accurately identified, measured, diluted, sterilized, packaged, labeled, stored, dispensed, and distributed.

Verification of Automated Compounding Devices for Parenteral Nutrition Compounding

The calibration, routine and annual maintenance, and monitoring of the proper function of automated compounding devices (ACDs) used in the preparation of parenteral nutrition formulas are essential. Verification methods for accuracy and precision of ACDs are outlined including the required frequency of verification.

Finished Preparation Release Checks and Tests

Sterility (USP Chapter 71, Sterility Tests) and bacterial endotoxin (USP Chapter 85, Bacterial Endotoxins Test) testing of certain high-risk level CSPs designated for intravenous and central nervous administration are specified. All finished CSPs should be physically inspected for particulates, precipitation, cloudiness, and leakage. Written procedures for compounding accuracy checks such as “double checking” should also be developed.

Storage and Beyond-use Dating

When determining beyond-use dates, compounding personnel should consult the manufacturer’s label for the product used to prepare the CSP, other applicable publications, or by direct testing. “Beyond-use date” refers to the date reached when the finished preparation is no longer appropriate for administration. The beyond-use date differs from the expiration date, which is the shelf life of a commercially available product (generally prior to manipulation) as labeled on the product by the manufacturer. In addition to the physical and chemical stability, the sterility of the CSP is also a factor in determining the beyond-use date. Unless sterility testing

validates the sterility of a CSP, beyond-use dating of the CSP should not exceed the parameters as indicated in Table 1 on page 156. Controlled temperature storage areas must be monitored and logged daily to ensure the product quality.

Maintaining Product Quality and Control

The quality and integrity of the CSP must be maintained, even after it leaves the compounding facility. Therefore, proper packaging, handling, transport, and storage of CSPs are essential. For example, the use of a cooler or ice pack to maintain appropriate temperature may be necessary if the CSP needs to be shipped over a significant distance. Other considerations include administration, redispensed CSPs, education and training, packaging CSPs for transit, and storage of CSPs outside of the compounding facility.

Patient or Caregiver Training

Patients and/or caregivers must receive proper instruction of the storage, handling, and administration of CSPs. Training programs designed for patients and/or caregivers must meet a number of objectives that include hands-on demonstration and practice with actual items that will be used by the patient and/or caregiver.

Patient Monitoring and Adverse Event Reporting

Patients must be monitored throughout the duration of CSP therapy to ensure the continued appropriateness of therapy; they must be able to readily access personnel at the compounding facility if they have questions or concerns regarding the CSP therapy. In addition to having an effective mechanism in place to identify and report adverse events, the compounding facility should also employ a means to analyze adverse event reports in order to prevent future occurrences.

Quality Assurance Program

The compounding facility should have a formal quality assurance program that addresses how the facility will monitor, evaluate, correct, and improve all of the processes outlined in Chapter 797. The identification of objectives, measurable indicators, and other components of the quality assurance program should be re-evaluated on an annual basis.

Enforcement of USP Chapter 7972

USP Chapter 797 can be enforced by the state boards of pharmacy, particularly in states where the statutes or regulations reference USP standards. More importantly, USP Chapter 797 provides a basis for

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Those attending NABP’s Fall Educational Conference (FEC) November 11-14, 2004, at the Renaissance Vinoy Resort and Golf Club in St Petersburg, FL, will have the opportunity to hear some of the leading experts in the pharmacy profession during the Conference’s continuing education (CE) sessions. These sessions’ topics range from federal/state regulatory and legislative actions in 2004 to recent efforts to address the regulation of pharmacy compounding.

New SessionNABP is proud to offer

a new session entitled “Performing Internet Drug Buys” from 8 to 9:30 AM on Sunday, November 14. Given the recent challenges posed to regulators and enforcement authorities to protect the public from unsafe medications entering the United States drug supply via importation and diversionary means, some regulatory and law enforcement agencies have conducted various drug buys that validate concerns of purchasing medications from questionable online pharmacies. During this session, participants will have the opportunity to examine the ease with which pharmaceuticals can be purchased without a prescription, the lack of quality of medications received, and the difficulty of establishing the origin of the drugs purchased. The Iowa Board

of Pharmacy Examiners will present significant findings of its investigations concerning Internet pharmacies and will also explore how the investigations were conducted. By the conclusion of this session, participants will be able to identify key steps in conducting an Internet drug buy as part of their respective regulatory or enforcement agency’s investigatory responsibilities. (See page 171 for more information on this session.)

Friday, November 12The Conference’s first

session, “Federal/State Regulatory and Legislative Actions in 2004,” held from 8:15 to 9:45 AM, will feature Susan C. Winckler, RPh, Esq. Currently vice president for policy and communications and staff counsel for the American Pharmacists Association (APhA), Winckler is responsible for coordinating APhA’s legislative, regulatory, and private sector advocacy agenda and public relations programs. She also serves as a frequent spokesperson for APhA. Previous positions with APhA include group director of policy and advocacy, director of policy and legislation, director of practice affairs, and manager of special projects. Before joining APhA, Winckler directed the implementation of the Iowa Medicaid Drug Prior Authorization Program for the Unisys Company and worked for the Iowa Pharmacy

Association), and for a community pharmacy in Iowa. “The Changing Landscape of Importation: Patient Safety and Accessibility” from 10 AM to noon, will feature Gary R. Matzke, PharmD, FCP, FCCP, AACP/AAAS Health Policy Fellow, Health Team, Senator Judd Gregg, Senate Committee on Health, Education, Labor & Pensions.

Joining Dr Matzke will be Gary A. Schnabel, RPh, RN, member, NABP Executive Committee and executive director of the Oregon State Board of Pharmacy and Tom Engels, vice president of public affairs for the Pharmacy Society of Wisconsin.

Saturday, November 13NABP’s professional affairs

manager, Charisse Johnson, PharmD, MS, along with Leah Foster, vice president of BuzzeoPDMA, will speak at “The Inspection and Accreditation of Wholesale Distributors: Regulating with Limited Resources” session from 8:30 to 10 AM.

Prior to joining NABP in 2003, Dr Johnson practiced at Lawndale Christian Health Center in Chicago, IL, where she helped establish a multidisciplinary diabetes clinic and task group. She also served as a clinical staff pharmacist at Little Company of Mary Hospital in Evergreen Park, IL, where she was a member of the pain improvement team, served

as a preceptor for pharmacy students, and was involved in formal staff and patient education. Dr Johnson presently serves as the chair of University Relations for the Chicago Pharmacists Association. She also serves as director-at-large for the National Pharmaceutical Association.

Foster, vice president of BuzzeoPDMA, has an extensive background in auditing and sample programs within the pharmaceutical industry. She has more than 25 years of experience in the banking and pharmaceutical industries. In her current position, Foster assists pharmaceutical companies and distributors to determine their level of compliance with Food and Drug Administration (FDA) regulations. When she moved to the pharmaceutical industry in 1990, Foster was instrumental in working with the Regulatory Department and senior management to develop the company’s compliance program – this ranged from sample shipments through distribution, reconciliation, and reporting of loss and theft to FDA.

Speakers for “Recent Efforts to Address the Regulation of Pharmacy Compounding,” held from 8:30 to 10 AM, include Gayle Brazeau, PhD, Associate Dean for Academic Affairs, University of Buffalo, School of Pharmacy &

Fall Conference

Fall Conference Speakers Offer Experience, Expertise

(continued on page 171)

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Fall Conference

Thursday, November 112 - 6 PM

Registration/Information Desk Open

6 - 8 PM

Welcome ReceptionCo-hosted with ASPL(Buffet dinner will be served.)

Friday, November 127 AM - noonRegistration/Information Desk Open

7 - 8 AM

Continental Breakfast

8 - 8:15 AM

Welcome Remarks

8:15 - 9:45 AM

Federal/State Regulatory and Legislative Actions in 2004Co-hosted with ASPLProgram #205-999-04-006-L03(0.15 CEUs or 1.5 Contact Hours)Speaker: Susan C. Winckler, RPh, Esq, Vice President, Policy and Communications, and Staff Counsel, American Pharmacists Association

9:45 - 10 AM

REFRESHM EN T BRE AK

10 AM - noonThe Changing Landscape of Importation: Patient Safety and Accessibility

Program #205-000-04-007-L03(0.20 CEUs or 2.0 Contact Hours)Speakers: Gary R. Matzke, PharmD, FCP, FCCP, AACP/AAAS Health Policy Fellow, Health Team, Office of Senator Judd Gregg, Senate Commitee on Health, Education, Labor & Pensions

Gary A. Schnabel, RPh, RN, Member, NABP Executive Committee, and Executive Director, Oregon State Board of Pharmacy

Tom Engels, Vice President of Public Affairs, Pharmacy Society of Wisconsin

Sponsor: Pfizer US Pharmaceuticals

Noon - 1:15 PM

Luncheon Co-hosted with ASPL

Afternoon/Evening Free

Saturday, November 137:30 AM - noonRegistration/Information Desk Open

7:30 - 8:30 AM Continental Breakfast

8:30 - 10 AM The Inspection and Accreditation of Wholesale Distributors: Regulating with Limited Resources

Program #205-000-04-008-L03(0.15 CEUs or 1.5 Contact Hours)Speakers: Leah Foster, Vice President, BuzzeoPDMACharisse Johnson, PharmD, MS, Professional Affairs Manager, NABP

10 - 10:15 AM Refreshment Break

10:15 AM - 12:15 PM

Recent Efforts to Address the Regulation of Pharmacy Compounding

Program #205-000-04-009-L04(0.20 CEUs or 2.0 Contact Hours)Speakers: Gayle Brazeau, PhD, Associate Dean for Academic Affairs, University of Buffalo, School of Pharmacy and Pharmaceutical Sciences

Kevin E. Kinkade, RPh, Executive Director, Missouri Board of Pharmacy

Jerrod Roberts, RPh, Chairman, Standards Task Force, Pharmacy Compounding Accreditation Board

Afternoon/Evening Free

Sunday, November 147 - 10 AM Registration/Information Desk Open

7 - 8 AM

Continental Breakfast

8 - 9:30 AM Performing Internet Drug Buys

Program #205-000-04-010-L04(0.15 CEUs or 1.5 Contact Hours)Speaker: Lloyd K. Jessen, JD, RPh, Executive Director/Secretary, Iowa Board of Pharmacy Examiners

9:30 - 9:45 AM Refreshment Break

9:45 - 11:15 AM Medicare Prescription Drug, Improvement, and Modernization Act of 2003: New Opportunities in Medication Therapy Management and Electronic Prescribing

Program #205-000-04-011-L03(0.15 CEUs or 1.5 Contact Hours)Sponsor: Medco Health Solutions, IncSpeakers: Simon P. Cohn, MD, MPH, FACP, Chairman, National Committee on Vital and Health Statistics and National Director for Health Information Policy, Kaiser Permanente Medical Care Program

Craig A. Miner, RPh, JD, Division of Drug Plan Policy at the Centers for Medicare and Medicaid Services

11:15 - 11:30 AM Closing Remarks

Fall Educational Conference ProgramSpecial Sessions co-hosted with the American Society for Pharmacy Law (ASPL)

November 11-14, 2004 The Renaissance Vinoy Resort and Golf Club St Petersburg, FL

NABP and the NABP Foundation are approved by the Accreditation Council for Pharmacy Education (ACPE) as providers of continuing pharmaceutical education. ACPE Provider Number: 205. Participants may earn up to 10 hours of ACPE-approved continuing education credit from NABP. Participants in continuing pharmaceutical education programs will receive credit by completing a “Statement of Continuing Pharmaceutical Education Participation” and submitting it to the NABP office. A validated Statement will be sent as proof of participation within approximately six weeks. Full attendance and completion of a program evaluation form for each session are required to receive continuing pharmaceutical education credit and a Statement of Participation.

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Association News

Around the AssociationNABP Past President, John P. Plummer, Passes Away

Past President of NABP and former Member of the West Virginia Board of Pharmacy, John P. Plummer, passed away September 5, 2004. In lieu of flowers, the family has requested that donations be made to the St Charles Borromeo Catholic Church Parish School, 21505 Augusta Ave, Port Charlotte, FL 33952 or the Holy Rosary Catholic School, 2105 SW Green Oaks Blvd, Arlington, TX 76017.

NABP’s Johnson Honored with Young Pharmacist Award

Charisse Johnson, PharmD, MS, professional affairs manager at NABP, was awarded the Young Pharmacist Award at the 57th Annual Meeting of the National Pharmaceutical Association (NPhA), held in New Orleans, LA, July 23-27, 2004. The award recognizes eager and effective participation in the affairs of the NPhA and contributions to the profession of pharmacy.

(continued on page 164)

Compounding Pharmacy Accreditation Program Development Under Way

NABP is pleased to report that the development of the Pharmacy Compounding Accreditation Board’s (PCAB) voluntary compounding accreditation program is on schedule. PCAB anticipates having the program’s first accredited compounding pharmacy by early 2005. NABP, a member of PCAB’s Governing Board, is responsible for the development and ongoing activities including the accreditation program for compounding pharmacies.

NABP and PCAB’s Collaboration Efforts

The Standards for Pharmaceutical Compounding Accreditation, the foundation for the development of the voluntary pharmacy compounding accreditation program, were created by NABP in conjunction with the PCAB Standards Task Force Committee, and were approved by the Governing Board during its meeting on September 27, 2004. Now that the standards are approved by the eight organizations that comprise the PCAB

Governing Board, the application package and surveyor packages will be finalized, thus incorporating the final standards.

PCAB is also calling for surveyors to assist in the screening of candidates who wish to participate in the surveyor training program. As of press time, 32 individuals have expressed interest in serving as a surveyor. The surveyors’ duties will be similar to those of Verified Internet Pharmacy Practice Sites™ inspectors, in that they will ensure the pharmacies are adhering to PCAB’s standards. If you know of anyone who would be willing to become a volunteer surveyor and assist with the accreditation process, please contact NABP’s Customer Service Department at 847/698-6227 or via e-mail at custserv@nabp.net.

The PCAB Governing Board has also announced the hiring of Richard P. “Dick” Penna, former executive director of the

American Association of Colleges of Pharmacy, to assist in the administrative aspects of PCAB, including the recruitment and appointment of

an executive director.

“We are extremely excited to be involved with PCAB and are looking forward to the integration, development,

and implementation of PCAB,” stated NABP President Donna M. Horn.

Along with NABP, PCAB’s Governing Board consists of the American College of Apothecaries, the American Pharmacists Association, the International Academy of Compounding Pharmacists, the National Community Pharmacists Association, the National Council of State Pharmacy Association Executives, the National Home Infusion Association, and the United States Pharmacopeia.

Please refer to future issues of this Newsletter for further information on PCAB and its activities.

PCAB is . . . calling for surveyors to assist in the screening of candidates who wish to participate in the surveyor training program.

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Legal Briefs(continued from page 153)

the rangers. The court held that disclosure to law enforcement officials under these circumstances did amount to a waiver of the constitutionally protected privacy rights of the patient.

The appellate court granted the petition of the physician effectively

denying the ability of the Board to subpoena the patient records under these particular facts. Without just cause and a narrowly tailored subpoena, the court refused to allow the Board access to patient records.

This case presents interesting issues to regulatory boards relative to the authority to conduct investigations. Under the California standard and

based upon the statutory and constitutional privacy principles, the Board has a high standard to meet merely to investigate a complaint. This is true, in spite of the legal requirement for the Board and its investigators to maintain discovered matters in confidence until certain triggering events occur. On the other hand, privacy rights are recognized

Association News

Do you know a colleague or a board of pharmacy that exemplifies the mission of NABP? NABP is pleased to express its appreciation and recognize those individuals and boards. The Association is accepting nominations for NABP’s 2005-2006 Lester E. Hosto Distinguished Service Award (DSA), Lester E. Hosto Inspector DSA, and Fred T. Mahaffey Award to be presented at NABP’s 101st Annual Meeting, May 21-24, 2005, at the Sheraton New Orleans Hotel in New Orleans, LA.

Lester E. Hosto DSA/Inspector DSA

Named in memory of NABP’s 1990-1991 President Lester E. Hosto, the DSA is the highest honor bestowed by the Association. DSA nominees, through their actions, best exemplify the mission and objectives of NABP, regardless of their affiliation with the Association.

NABP Calls for 2005-2006 Awards NominationsFred T. Mahaffey Award

Named in honor of NABP’s executive director emeritus, the Fred T. Mahaffey Award recognizes a member board of pharmacy that has made substantial contributions to the profession of pharmacy during the past year. The nominated board’s efforts must have contributed to the protection of the public health and welfare through the enforcement of state and federal laws, regulations, and the advancement of NABP’s goals and objectives as specified in the Constitution and Bylaws.

Honorary PresidentNABP is also accepting

nominations for the 2005-2006 Honorary President who will be announced during the 101st Annual Meeting and recognized during the 102nd Annual Meeting in San Francisco, CA, May 6-9, 2006. NABP’s 2004-2005 Honorary

President William L. “Buck” Stevens, RPh, will be honored at NABP’s 101st Annual Meeting Awards Dinner.

Nominees for Honorary President must meet the following criteria:

� service on one or more of NABP’s committees or task forces;

� participation in district and Annual Meetings;

� exemplary services for, or on behalf of, the Association;

� strong commitment to NABP, the mission of the Association to protect the public health, and the profession of pharmacy; and

� affilation (either current or past) as a board member or as an administrative officer of an active or associate member board.

NABP President Donna M. Horn will present the Lester E. Hosto DSA/Inspector DSA and Fred T.

Mahaffey Awards during the 101st Annual Meeting Awards Dinner.

Nominations for these awards must be received at Association Headquarters no later than December 31, 2004. Letters of nomination, along with a brief biography or current resume or curriculum vitae of the nominee, must include an account explaining why the nominee should be considered for an award. The NABP Executive Committee will review the nominations and select the Honorary President and award recipients. Please submit your nomination to NABP Executive Director/Secretary Carmen A. Catizone at NABP Headquarters, 700 Busse Highway, Park Ridge, IL 60068. For more information, call 847/698-6227 or e-mail custserv@nabp.net.

providing individuals with a confidentiality protection. If a practitioner and patient both refuse to disclose, the board will need to uncover wrongdoing through additional means. Where do pharmacists and pharmacies within your jurisdictions fall regarding disclosure restrictions?

Bearman v Superior Court, 11 Cal. Rptr. 3d 644 (App. Ct. CA 2004)

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Around the Association

Boards Announce New Members, Reappointments Idaho

Michael D. Merrill, RPh, was reappointed as a member of the Idaho Board of Pharmacy by Governor Dirk Kempthorne. His term expires June 30, 2009.

MassachusettsMassachusetts Governor

Mitt Romney appointed the following Massachusetts Board of Registration in Pharmacy members:

Donald D. Accetta, MD, was assigned to the Board as a physician member on June 18, 2004. His term expires December 1, 2008.

Marilyn Barron was reappointed to the Board as a public member on July 20, 2004. Her term expires November 30, 2005.

Joel R. Berman, RPh, was named a member of the Board on June 16, 2004. His term expires November 29, 2007.

Steven Budish was designated as a public member of the Board on May 18, 2004. His term expires December 1, 2009.

George Cayer, RPh, was named a long-term care member of the Board on June 18, 2004. His term expires on December 1, 2008.

(continued from page 162)

Professional Affairs

FDA Continues to Warn Consumers About Counterfeit Drugs

On June 30, 2004, Food and Drug Administration alerted consumers of confi rmed reports of counterfeit Viagra® (sildenafi l citrate) that were dispensed from two pharmacies located in California. The counterfeit product closely resembles genuine Viagra tablets with respect to size, shape, color, and imprinting. However, the counterfeit drugs have subtle differences in tablet edging, fi lm coating, imprinting font, and packaging. At press time, FDA, along with Pfi zer, Inc, the legitimate manufacturer of Viagra, was analyzing the counterfeit products to determine their true composition and whether or not they posed any health risks; fortunately, no injuries had been reported. For more

information, including comparative photos between the counterfeit drug and genuine Viagra, refer to Pfi zer’s “Dear Pharmacist” letter posted on the company’s Web site at www.pfi zer.com/subsites/counterfeit_importation/mn_pharmacist_viagra.html. FDA’s press release may be accessed at www.fda.gov/bbs/topics/news/2004/NEW01083.html.

Exactly one month after the counterfeit Viagra product was discovered, FDA expressed concern regarding counterfeit versions of the prescription drugs Zocor® (simvastatin) and carisoprodol, which were imported from Mexico by United States citizens. Tests of these products revealed that the counterfeit Zocor, reportedly purchased at Mexican border town pharmacies and sold under the name Zocor 40/mg (lot

number K9784, expiration date November 2004, and lot number K9901, expiration date December 2006), did not contain any active ingredient. Likewise, the counterfeit carisoprodol 350/mg (lot number 68348A) test results indicated the products differed significantly in potency when compared to the authentic product. FDA has requested that anyone who may have purchased these products from Mexican pharmacies contact his or her physician and the local FDA field office. FDA continues to investigate this matter and is working with Mexican authorities to ensure that further sale and importation of these products are halted. For more information on counterfeit Zocor, visit www.fda.gov/bbs/topics/ANSWERS/2004/ANS01303.html.

(continued on page 168)

NABP is seeking volunteers to serve on its Advisory Committee on Examinations (ACE). ACE oversees the development and administration of all of the Association’s examination programs. The Committee also considers policy matters, develops long-range planning strategies, and recommends appropriate action to NABP’s Executive Committee.

Opportunity for Appointment to ACE

The Association is now accepting applications for two member appointments; the three-year terms begin June 1, 2005. Interested individuals should submit a written statement of interest and a current resume or curriculum vitae to NABP Executive Director/Secretary Carmen A. Catizone at NABP Headquarters no later than December 31, 2004.

ErrataIn the July 2004 NABP

Newsletter article entitled “NABP Performs Internet Drug Buy,” the dosage of the Xanax® NABP received in the drug buy was inconsistently written as both 0.25 mg and 1 mg.The correct dosage is 0.25 mg. The term “tablehem” was incorrectly used to reference the drug; the correct spelling is “tabletten.” NABP regrets the errors.

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Feature News

MTM Services(continued from page 158)

and program criteria during an MTM Services pharmacy stakeholder conference hosted by the American Pharmacists Association (APhA) on May 25, 2004, in Washington, DC. The goal of the conference was to come to a consensus and strengthen the pharmacy profession’s position on the

types of services recognized under MTM. In addition to NABP, the organizations that contributed to the development of this defi nition include the Academy of Managed Care Pharmacy, American Association of Colleges of Pharmacy, American College of Apothecaries, American College of Clinical Pharmacy, APhA,

American Society of Consultant Pharmacists, American Society of Health-System Pharmacists, National Association of Chain Drug Stores, National Community Pharmacists Association, and National Council of State Pharmacy Association Executives.

“The inclusion of MTM services in the Medicare Act is truly a revolutionary

and historic event for the practice of pharmacy,” says NABP President Donna M. Horn. “I am proud that NABP joined with the other pharmacy organizations in the coalition to create an outline of MTM services that will benefi t the health of patients and further establish pharmacists as key providers in the health care fi eld.”

Medication Therapy Management Services Definition and Program Criteria

A program that provides coverage for Medication Therapy Management services shall include:

a. Patient-specifi c and individualized services or sets of services provided directly by a pharmacist to the patient*. These services are distinct from formulary development and use, generalized patient education and information activities, and

other population-focused quality assurance measures for medication use.

b. Face-to-face interaction between the patient* and the pharmacist as the preferred method of delivery. When patient-specifi c barriers to face-to-face communication exist, patients shall have equal access to appropriate alternative delivery methods. Medication Therapy Management programs shall include structures supporting

the establishment and maintenance of the patient*-pharmacist relationship.

c. Opportunities for pharmacists and other qualifi ed health care providers to identify patients who should receive Medication Therapy Management Services.

d. Payment for Medication Therapy Management Services consistent with contemporary provider payment rates that are based on the time, clinical intensity,

and resources required to provide services (eg, Medicare Part A and/or Part B for CPT [Current Procedural Terminology] & RBRVS [Resource-Based Relative Value Scale]).1

e. Processes to improve continuity of care, outcomes, and outcome measures.*In some situations,

Medication Therapy Management Services may be provided to the caregiver or other persons involved in the care of the patient.

(continued from page 158)

1 Association policy does not allow NABP to take a position on payment issues.

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Association News

National Drug Advisory CoalitionChair ........................................................ Robert P. Giacalone

Ohio State Board of Pharmacy

Member ...................................................Joseph W. Cranston American Medical Association

Member ............................................................... Anita Ducca Healthcare Distribution Management Association

Member .................................................................... Jerry Hill Florida Department of Health

Member .........................................................Bruce Krichmar Pharmaceutical Distributors Association

Member ............................................................Scott Lassman Pharmaceutical Research and

Manufacturers of America

Member ........................................................Kevin Nicholson National Association of Chain Drug Stores

Member ........................................................... John P. Santell United States Pharmacopeia

Member ............................................. Douglass Scheckelhoff American Society of Health-System Pharmacists

Ex-Officio Member ......................................... Ilisa Bernstein Food and Drug Administration

Ex-Officio Member ......................................... John A. Fiacco Cardinal Health

Ex-Officio Member .........................................Lewis Kontnik Lew Kontnik Associates

Ex-Officio Member .............................................David Searle Pfizer, Inc

Government Affairs SubcommitteeMember ...................................................... Michael A. Moné

Versailles, KY

Member .................................................. Richard A. Palombo New Jersey Board of Pharmacy

Member ...................................................... Gary A. Schnabel Oregon State Board of Pharmacy

Ex-Officio Member ........................................... Ross Brickley American Society of Consultant Pharmacists

Ex-Officio Member ........................................ Julie D. Frazier Tennessee Board of Pharmacy

2004-2005 Committee and Task Force AppointmentsNABP President Donna M. Horn appointed the following individuals to serve as members of the Association’s 2004-

2005 committees and task forces. Every effort has been made to accommodate individual requests to serve on a committee or task force and to ensure uniform representation from all regional districts.

Task Force on Active/Associate MembershipChair .......................................................... Patricia F. Donato

New York Board of Pharmacy

Member .................................................... John R. Dorvee, Jr Vermont Board of Pharmacy

Member ............................................ William T. Douglass, Jr West Virginia Board of Pharmacy

Member ....................................................... Dennis M. Jones South Dakota State Board of Pharmacy

Member ..................................................... Kendall M. Lynch Tennessee Board of Pharmacy

Member ....................................................... Richard J. Oubre Louisiana Board of Pharmacy

Member ........................................................... Sara St Angelo Indiana Board of Pharmacy

Alternate ......................................................... Sheila Mitchell Tennessee Board of Pharmacy

Task Force to Develop Recommendations to Best Reduce Medication Errors in Community Pharmacy PracticeChair ...................................................................... Karen Ryle

Massachusetts Board of Registration in Pharmacy

Member ....................................................... Philip P. Burgess Illinois Department of Financial and Professional Regulation,

Division of Professional Regulation – State Board of Pharmacy

Member ...................................................... Susan DelMonico Rhode Island Board of Pharmacy

Member ...................................................Reginald B. Dilliard Tennessee Board of Pharmacy

Member ................................................................ David Fong California State Board of Pharmacy

Member .........................................................Linda K. McCoy Arizona State Board of Pharmacy

Member .................................................Edward G. McGinley New Jersey Board of Pharmacy

Alternate ........................................................Wayne A. Camp Louisiana Board of Pharmacy

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Association News

Alternate ..............................................................Bob ParradoFlorida Board of Pharmacy

Committee on Law Enforcement/LegislationChair ....................................................................Gay Dodson

Texas State Board of Pharmacy

Member ......................................... Anthony W. Alexander, JrNew Jersey Board of Pharmacy

Member ......................................................... Joshua M. BolinIndiana Board of Pharmacy

Member ...................................................George L. BowersoxNew Hampshire Board of Pharmacy

Member .................................................... Kathryn H. Craven Nevada State Board of Pharmacy

Member ................................................... Monica K. FranklinTennessee Board of Pharmacy

Member .........................................................Stephen R. Statz South Dakota State Board of Pharmacy

Alternate .......................................................... Diana L. Baker Utah Board of Pharmacy

Committee on Constitution and BylawsChair ................................................................... Jerry Moore

Alabama State Board of Pharmacy

Member ........................................................ C. Richard Allen Georgia State Board of Pharmacy

Member ............................................................Kevin Borcher Nebraska Board of Pharmacy

Member ......................................................... James T. DeVita Massachusetts Board of Registration in Pharmacy

Member ............................................................ Susan Ksiazek New York Board of Pharmacy

Alternate .........................................................Harold B. Sparr Massachusetts Board of Registration in Pharmacy

The City of New OrleansSite of NABP’s 101st

Annual MeetingMay 21-24, 2005,

Sheraton New Orleans Hotel, New Orleans, LA

Often called the “Crescent City” because it was established on a great bend of the Mississippi River, New Orleans was built on the high ground nearest to the mouth of the Mississippi, which

Photo source: www.concierge.com/photo

is 110 miles downstream. New Orleans’ elevations range from 12 ft above sea level to 6.5 ft below sea level. To protect the city from fl ooding, an inventive system of water pumps, drainage canals, and levels was built nearly a century ago.

(Source: Greater New Orleans Business Community, http://gatewayno.com/history/new orleans.html)

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Feature News

defi nes unit-of-use packaging as “any container closure system designed to hold a specifi c quantity of drug product for a specifi c use and dispensed to a patient without any modifi cation except for the addition of appropriate labeling.” Both proposals would involve some (particularly initial) costs to manufacturers, and the Task Force suggested that manufacturers and repackagers initially consider implementing unit-of-use packaging both for newly approved products and those most likely to be counterfeited.

The Task Force made a similar recommendation for tamper-evident packaging: “As with unit-of-use packaging, . . . FDA does not believe that tamper-evident packaging presents a high enough hurdle for counterfeiters to make it effective as a stand-alone anti-counterfeiting measure. . . . [The packaging] can be helpful, but only as one layer in a multi-layered anti-counterfeiting strategy.”

Authentication technologies for either pharmaceutical products (for example, chemical taggants) or labeling and packaging (such as inks or holograms) are seen as another currently available deterrent to counterfeiting. Because sophisticated and well-fi nanced counterfeiters

Counterfeit Medications(continued from page 151)

can overcome these obstacles, the Task Force recognized using “multiple, periodically changing, authentication measures on a product-specifi c basis” as an important element in an anti-counterfeiting strategy.

Other technologies available to help in the fi ght against counterfeiting include such options as “pattern-spotting” software. Like the credit card technology that points out unusual spending patterns in card usage, it can help pinpoint medication purchases that appear suspicious or unusual.

Drug PedigreesIn virtually every critique

of the drug distribution system, pedigree papers –records that would accompany every prescription medication at every step from manufacturer to dispenser and contain information on all transactions – are highlighted as an essential component of safeguarding the prescription drug supply. Congress originally mandated drug pedigrees in the Prescription Drug Marketing Act of 1987. Implementation, however, was postponed. The wholesale distributor industry has been concerned over the years about the logisti cs of incorporating pedigree paper requirements into its business models. In response to these concerns, the implementation of the mandate has been stayed and remains in force today. Although several critics of the pedigree mandate note that pedigree papers are themselves subject to forgery and other

fraud and are only as credible as the due diligence applied to double-checking them, a system void of any pedigree is not acceptable to NABP.

FDA, in its Task Force report, set the ambitious goal of industry-wide adoption of electronic track and trace technologies by 2007. If this date can be met, it will likely be in the form of radio frequency identifi cation (RFID) technology. RFID allows products to be traced from manufacturer to dispenser through unique computer chips assigned to products and placed on the corresponding pallets, cases, or packages. Quick industry-wide adoption of this technology is an aggressive target; as the Task Force noted, “Important unresolved issues include the need to develop standards and business rules for RFID, the need to address database management issues, and the need to determine the effect of RFID on product quality.”

Track and trace technologies are widely hailed as the most promising technique to thwart counterfeiters. “Use of mass serialization to uniquely identify all drug products intended for use in the United States is the single most powerful tool available to secure the US drug supply,” FDA’s Task Force stated. Because every step of a given medication’s passage through the supply chain would be documented and easily verifi able, counterfeited drugs would be

Around the Association(continued from page 164)

William A. Gouveia, RPh, MS, was also appointed as a member of the Board on June 18, 2004. His term expires December 1, 2009.

Sophia Pasedis, RPh, was selected as a member of the Board on June 16, 2004. Her term expires November 29, 2007.

MinnesotaGovernor Tim Pawlenty

designated Kay L. Dvorak, RPh, as a member of the Minnesota Board of Pharmacy on June 30, 2004. Her term expires January 30, 2008.

OhioOn June 25, 2004,

Kevin James Mitchell, RPh, was appointed as a member of the Ohio State Board of Pharmacy by Governor Bob Taft. His term expires June 30, 2008.

OklahomaGovernor Brad

Henry named John Douglas Lassiter, RPh, to the Oklahoma State Board of Pharmacy on July 1, 2004. His term expires June 30, 2009.

Idaho Board Names New Offi cers

Frank R. Casabonne, RPh, was elected chairman of the Idaho Board of Pharmacy. Dwayne E. Sheffl er, RPh, was elected vice chairman.

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Feature News

harder to slip, unnoticed, into the system.

Anti-counterfeiting consultants agreed on the importance of these technologies, with a caveat. “Although RFID offers enormous potential, anti-counterfeiting experts agree that even RFID technologies can be counterfeited.” Anti-counterfeiting advocates stress that RFID alone will not be the final solution – paying strong attention to business practices will also be essential.

Rules and RegulationsOne of the major elements

intrinsic to ensuring a safe medication distribution system lies in lawmakers’ and regulators’ ability to set and enforce standards for appropriate business practices. One element of standard setting and enforcement is penalties, which, at their current levels, are often seen as inadequate to sufficiently deter potential counterfeiters. Drug counterfeiting has become in many cases a fabulously lucrative endeavor. As the Florida grand jury pointed out, “The potential profits available to corrupt wholesalers rival those found [in] narcotics trafficking. . . . [T]he profits from the crime far outstrip the potential penalties.”

FDA’s Task Force report likewise concluded that “[c]urrent sentencing guidelines for counterfeit drug distribution are not commensurate with the public health threat posed

by this criminal activity.” The agency stated that it would “pursue its request that the United States Sentencing Commission consider amending the sentencing guidelines to increase substantially criminal penalties for manufacturing and distributing counterfeit drugs and to provide specifically for enhanced penalties based on the level of risk to the public health involved in the offense.” As of press time, the Commission was considering the matter.

There can be unscrupulous individuals at every step in the prescription drug supply chain who are responsible for the counterfeiting problem. However, most observers point to illegitimate wholesalers as the weakest link – the link where often lax rules and regulations combine with inadequate inspection resources to provide criminals with ample opportunities to ply their trade.

Virtually all stakeholders agree that more stringent requirements for wholesalers need to be created and enforced. Moreover, these requirements need to be consistent nationwide. Because counterfeiters not only act within but across (often many) state lines, only consistent rules will prevent counterfeiters and illegitimate wholesalers from moving from one state to another in search of looser licensing requirements and laxer enforcement.

To prevent counterfeiting by unscrupulous wholesale

distributors, some states have revised and enacted new laws for distributors. Nevada, for example, passed legislation in the late 1990s that established stronger registration requirements and limited the amount of product that could be traded from wholesaler to wholesaler. Since then, the number of wholesalers licensed in Nevada has decreased dramatically, though the number in neighboring states has climbed.

Florida has been at the forefront of recent legislative action, passing its 2003 “Prescription Drug Protection Act” that overhauled the state’s regulations for wholesalers. Among other provisions, the Act tightened registration requirements for wholesalers, increased fees, and strengthened enforcement provisions. Florida’s legislation has been highly regarded, and served as an important resource for NABP’s October 2003 Task Force on Counterfeit Drugs and Wholesale Distributors that resulted in NABP’s updated Model Rules for the Licensure of Wholesale Distributors (see “NABP, FDA Combine Efforts in Battle Against Counterfeit Drugs” in the April 2004 NABP Newsletter, and “Protecting the US Medication Distribution System” in the July 2004 Newsletter).

Other states have chosen to address one or another aspect of the issue, rather than mandate an immediate overhaul.

The Colorado Legislature, for example, recently passed a bill demanding increased record keeping requirements for wholesale distributors. The California Legislature, meanwhile, has been considering a bill that largely addresses the handling of dangerous drugs and devices. At press time, provisions of the bill included a requirement that electronic pedigrees accompany dangerous drugs in all steps from manufacturer to dispenser.

FDA, in its Task Force report, strongly endorsed the universal adoption of NABP’s revised Model Rules for the Licensure of Wholesaler Distributors. “Adoption of the [NABP] Model Rules by all States would have a significant impact on protecting the nation’s drug supply by ensuring that all persons and entities involved in wholesale distribution of drug products met stringent licensing criteria and maintained high ethical and business standards,” the Task Force concluded.

Counterfeiting drugs has become a sophisticated and well-financed criminal activity. No countermeasure by itself will successfully and permanently deter the criminals involved. However, if all stakeholders employ numerous strategies in a consistent manner on a nationwide and industry-wide basis, they can help ensure that the nation’s prescription drugs remain safe and effective.

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Feature News

defining products that are appropriately compounded or contaminated, adulterated, misbranded, or otherwise not compliant with acceptable standards.5 Some state boards of pharmacy have begun implementing USP Chapter 797 in current and revised regulations regarding compounding and sterile preparations. For example, as of January 1, 2004, the Kentucky Board of Pharmacy requires that all compounding personnel comply with USP Chapter 797 standards. Recognizing that it may take considerable time and resources for pharmacies to become compliant, the Board is working with compounding pharmacists to achieve an orderly transition to the new USP standards.6 The Indiana Board of Pharmacy appointed a rule subcommittee on the issue of sterile compounding and was targeted to release its revised rules for public comment in late 2004.7 Similarly, the South Carolina Board of Pharmacy appointed a Compounding Task Force that set forth new guidelines effective June 2005 for sterile compounding, resulting in new permit and inspection requirements for those pharmacies that perform

sterile compounding.8 Other state boards of pharmacy such as Montana, Ohio, Vermont, and Wyoming have expressed intent to address regulations in the near future regarding sterile compounding.

PCAB and Accreditation of Compounding Pharmacies

Established in April 2004, the Pharmacy Compounding Accreditation Board (PCAB), composed of leading phar-macy and regulatory organiza-tions includ-ing NABP, is currently creating an accreditation program for compounding pharma-cies that will enhance the quality of compounding practices and raise aware-ness of compounding. Initially, the PCAB accredi-tation program will target pharmacy sites engaged in compounding at a desig-nated level of complexity – specifically, community pharmacies that com-pound sterile products. The program is expected to accredit its first pharmacy compounding site by early 2005.

The Joint Commission on Accreditation of Healthcare Organizations (JCAHO) began to survey for compliance with USP Chapter 797 on July 1, 2004. Initially providing awareness and education to those entities not aware of the new USP Chapter, the organization will particularly focus on USP Chapter 797 standards that relate to current JCAHO standards.

Although many have voiced concerns about the difficulties in fully imple-menting the standards set by USP Chapter 797, state phar-macy boards along with pharmacy organiza-

tions, have recognized the importance of promoting regulations and standards that ultimately move toward the goal of im-proving patient safety. As regulations are updated to reflect the content of USP Chapter 797, boards must consider the time and effort needed for pharmacies to become compliant. At the same time, pharmacies should quickly evaluate and determine objectively via a formal plan how they intend to reach compliance.

References:1. Morbidity and Mortality

Weekly Report. Exophiala infection from contaminated injectable steroids prepared by compounding pharmacy– United States, July-November 2002. JAMA. 2003; 289:291-293.

2. Niedowski E, Bor J. State to probe Hopkins death: 2-year-old cancer patient died after receiving improper IV mixture. Baltimore Sun. December 20, 2003.

3. King LD. Considering compounding? America’s Pharmacist. September 2002: 17-20.

4. The United States Pharmacopeia, 27th rev, and the National Formulary 22nd ed. USP Test and Assays Chapter <797>. Pharmaceutical Compounding–Sterile Preparations. Rockville, MD: The United States Pharmacopeial Convention; 2004.

5. Thompson C. USP publishes enforceable chapter on sterile compounding. Am J Health-Syst Pharm. 2003; 60:1814-1817.

6. Kentucky Board of Pharmacy News. September 2004.

7. Indiana Board of Pharmacy News. May 2004.

8. South Carolina Board of Pharmacy News. May 2004.

USP 797(continued from page 159)

. . . [S]tate pharmacy boards along with pharmacy organizations, have recognized the importance of promoting regulations and standards that ultimately move toward the goal of improving patient safety.

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Association Highlights

Pharmaceutical Sciences. Dr Brazeau has held faculty appointments at the University of Houston and the University of Florida before joining the University of Buffalo. Her research interests focus on understanding the biochemical and toxicological intramuscular or systemic administrator. Dr Brazeau is currently the past-chair for the Council of Faculties for the American Association of Colleges of Pharmacy and is currently serving on the Association’s Board of Directors.

Joining Dr Brazeau is Kevin E. Kinkade, RPh, former NABP president. Kinkade, executive director of the Missouri Board of Pharmacy since 1984, assists in the development of policies for Board approval and ensures that all approved policies are carried out; advises and assists the Board

VAWD

wholesalers to become more familiar with VAWD. The pilot inspections are modeled after the on-site portion of the VAWD accreditation process; however, they do not confer nor do they indicate VAWD accreditation.

“NABP is excited to have BuzzeoPDMA as a partner in the VAWD program,” declares NABP President Donna M. Horn.

“BuzzeoPDMA is highly respected in the wholesale distribution industry. The inspection resources that BuzzeoPDMA offers, coupled with expertise and information from NABP’s wholesaler clearinghouse, are vital to assisting states in the licensure of wholesale distributors and determining the qualifications of VAWD applicants.”

BuzzeoPDMA was chosen to perform the inspections required for VAWD

accreditation because of the company’s knowledge encompassing physical and systems security integration, chemical and pharmaceutical manufacturing and distribution, wholesaling, pharmacy operations, and drug sample accountability and compliance. In addition, BuzzeoPDMA has professional relationships with the US Drug Enforcement Administration, FDA, and state agencies.

(continued from page 149)

Ronald W. Buzzeo, RPh, BuzzeoPDMA president and chief executive officer adds, “BuzzeoPDMA is excited about the opportunity to assist NABP in its efforts to maintain the integrity of the US drug distribution system by providing critical support for NABP’s VAWD program.”

For more information about BuzzeoPDMA, visit its Web site at www.buzzeopdma.com; to inquire about the VAWD program, contact NABP via e-mail at custserv@nabp.net.

(continued from page 160)

in developing regulations relating to the practice of pharmacy; and appears before the Administrative Hearing Commission or other court proceedings and, when required, provides testimony concerning disciplinary cases or the Board’s official position. Kinkade has received many honors and awards including the Missouri Society of Health System Pharmacists Thomas J. Garrison Achievement Award in 2002, the NABP Presidents’ Award in 1999, and the Missouri Society of Hospital Pharmacists Pharmacist of the Year in 1996.

Jerrod Roberts, RPh, chairman of the Standards Task Force, Pharmacy Compounding Accreditation Board (PCAB) also speaking during this session, is the owner and pharmacist-in-charge of North Pointe Pharmacy as well as owner of a consulting service for pharmacy practices specializing in compounding pharmaceuticals. An active

member of the pharmacy profession, Roberts has held many positions and/or assisted on various committees and boards.

Sunday, November 14The session“Performing

Internet Drug Buys,” held from 8 to 9:30 AM, features Lloyd K. Jessen, RPh, JD, as speaker.

Lloyd K. Jessen has been the executive director/secretary and drug control program administrator at the Iowa Board of Pharmacy Examiners since 1990. Prior to his current position, he served as the Board’s chief investigator from 1987 to 1990. Jessen has been the recipient of many honors and awards including the Recognition Award for Exceptional Performance from FDA in 1999 and the American Jurisprudence Award in 1982.

NABP’s concluding session, “Medicare Prescription Drug, Improvement, and Modernization Act of 2003: New Opportunities

in Medication Therapy Management and Electronic Prescribing,” which will be held from 9:45 to 11:15 AM, will feature Simon P. Cohn, MD, MPH, FACP, and Craig A. Minor, RPh, JD.

Dr Cohn serves as the chairman of the committee on standards and security for the National Committee on Vital and Health Statistics and is also the national director for health information policy at Kaiser Permanente Medical Care Program.

Minor is a part of the Division of Drug Plan Policy at the Centers for Medicare and Medicaid Services.

Attendees will obtain a wealth of information from these speakers at the Conference and, time permitting, will be able to ask questions at the end of each session.

For more information, please contact the NABP Meetings Desk at 847/698-6227 or e-mail custserv@nabp.net.

Speakers

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Association Highlights

october 2004

Reminder

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nabp newsletter

The winter administration of the

Foreign Pharmacy Graduate Equivalency

Examination™ will be held December 4,

2004, in Brooklyn, NY; Northlake, IL (Chicago);

and San Mateo, CA. Those accepted to sit for

the examination must register by October 25, 2004. Please visit www.

nabp.net for more information.

NABP held three of its annual Board Program Review and Training Sessions for staff of the state boards of pharmacy in August and September 2004. Pictured above from left to right are attendees of the August 27, 2004 session: Anita Selph, Arizona State Board of Pharmacy; Kelley Villeneuve, Louisiana Board of Pharmacy; Sally Green, North Carolina Board of Pharmacy; Catherine Brunick, Colorado State Board of Pharmacy, Carol Willess, Texas State Board of Pharmacy; and Mariah Krass, Delaware State Board of Pharmacy.