july newsletter mr - nabp · 2016-07-07 · july 2004 99 consulting or visiting with a physician....

newsletterNational Association of Boards of Pharmacy®

aid to governmentthe profession

the public1904 to 2004

In This Issue. . . .Legal Briefs:

July 2004 / Volume 33 Number 6

Feature News: Protecting the US Medication Distribution System

Feature News: After Ephedra, More Dietary Supplements Still Contain Dangerous Ingredients

Association News: NABP’s Spunt Recognized in FASHP Practitioner Recognition Program

(continued on page 98)

100 102 104 112(continued on page 115)

NABP Performs Internet Drug BuyIn December 2003

and January 2004, NABP purchased drugs from several suspicious Internet pharmacy sites to demonstrate the ease with which pharmaceuticals can be purchased without a prescription. Drugs purchased and received ranged from a testosterone injection to an acne treatment that, in the United States, requires proof of a negative pregnancy test before the drug can be prescribed and dispensed to females. Often the origin of the drugs was unknown, a fact that adds to potentially dangerous situations that patients may encounter by taking drugs without the

supervision of a physician and a valid prescription.

Disturbingly, none of the drugs NABP received

appeared to be shipped from the country in which the pharmacy Web site was registered. After receiving the drugs, NABP sent the items to the United States Pharmacopeia (USP) for identification testing.

NABP ordered eight different drugs from five Web sites and received drugs from four of the

sites. All of these drugs were labeled in a foreign language. Drugs received include “Valium® 10 Roche, Tabletten Wirkstoff: Diazepam” (10 mg, #90 tablets); “Alprazolam Normon 1 mg Comprimidos EFG” (#30); “Codeisan” (30 mg, #40 tablets); “Roaccutane® isotretinoin 10 mg”

(#30 capsules); and “Testabol Depot® Testosterone Cypionate 10 ml For Intramuscular Injection” (4 x 10 ml vials, 200 mg/ml). NABP purchased several more drugs that were not sent to USP for testing:

Triple Play: It Must be Baseball Season

Drugs NABP purchased from suspicious sites ranged from properly packaged boxes to poorly sealed envelopes with plain international postage stamps covering the address side.

This Month on www.nabp.net: NABP/NAPRA Reissue Communiqué Addressing Importation under “Special Items.”

NABP 100th Annual Meeting Resolutions under “Special Items.”

NABP 2004 Officer Reports under “Special Items.”

NABP 2003-2004 Committee and Task Force Reports under “Special Items.”

NABP 100th Annual Meeting News Releases under “Headlines.”

Your state board of pharmacy’s current newsletter is now available under “State Newsletters.”

Upcoming MeetingsSunday-Tuesday, August 1-3, 2004 NABP/AACP District III Meeting Beau Rivage Resort and Casino Biloxi, MS

Thursday-Saturday, August 12-14, 2004 NABP/AACP District V Meeting Hilton Garden Inn Johnston, IA

Friday, August 27, 2004, Monday, August 30, 2004; Friday, September 10, 2004 Board Program Review and Training NABP Headquarters Park Ridge, IL

Thursday-Saturday, September 23-25, 2004 NABP/AACP District VI Meeting San Luis Resort Galveston, TX

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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

[email protected] 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

Association News

Xanax® 0.25 mg #30 Tabletten and Depronal (dextropropoxyfeen HCl) 150 mg #30 capsules.

Drugs Obtained With Ease

The astounding ease with which NABP was able to purchase prescription drugs via the Internet is what most concerns the Association. None of the sites required submission of a prescription; two sites did not request any medical information and, instead, merely required NABP to waive liability. Two sites asked for a very limited amount of medical information. To one of these sites, NABP provided the height and weight of a small dog and the Association was shocked to receive a shipment of Valium based on that information. The same online pharmacy sent daily refill reminders via e-mail, beginning two days after NABP received a shipment of 30 tablets of 0.25 mg Xanax.

One Internet pharmacy required that patients fill out a lengthy questionnaire, which NABP completed. The Web site requested an examination, but because the site did not explain

the type or extent of examination, whether a physician would perform it, among other things, NABP did not complete the order process. Despite cancelling NABP’s order and failing to render any services, the Web site never refunded the $400 for the carisoprodol, Didrex, and Vicodin ES® it charged to NABP.

Further proving that many online pharmacy sites do not verify legitimate doctor-patient relationships, the site offering Roaccutane shipped the drug without proof of pregnancy testing or other evidence to determine if the therapy was appropriate or solid evidence that the purchaser was male, as is required by Food and Drug Administration (FDA) and legitimate medical practice. Both male and female patients who take isotretinoin must be enrolled in manufacturer-

sponsored or FDA-approved monitoring programs. In fact, the pharmacy site shipped Roaccutane in contravention to its own policy, which clearly stated that the site would no longer ship Roaccutane to the US.

An excellent demonstration of the difficulty if not impossibility in ascertaining the origin of the drugs that were shipped was the testoterone injection NABP purchased. The drug was shipped from a pharmacy site that is registered in Slovenia, but the pharmacy site claims the drug manufacturer is based in Thailand. The Association’s research revealed that the drug may have originated in Greece because of the Greek postage. Furthermore, the credit card payment was processed by a payment site registered in Quebec, Canada. NABP also discovered that the drug supplier’s Web site was registered in the Republic of Seychelles, a country off the eastern coast of Africa.

Suspicious Internet sites appear to be marketing their drugs to consumers who wish to purchase prescription medications without the “hassle” of

Internet Drug Buy(continued from page 97)

An easily-obtained 30-day supply of Xanax 0.25 mg tablets, is shown above.

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consulting or visiting with a physician. This is exemplified by the cost of the Xanax that NABP ordered and received. NABP was charged $126 for a 30-day supply of 0.25 mg tablets; an average retail price for a 30-day supply of Xanax at US pharmacies is approximately $30.

USP’s Test ResultsDr Ron Manning, vice

president for Standards and Operations at USP, summarized the organization’s results, noting that four out of the five drugs NABP submitted for testing contained the correct and appropriate amount of the active ingredient.

“It is important to note that what we tested was a limited sample,” he noted. “According to these results, one in five patients could receive drugs that are not full strength. However, to have confidence in what the marketplace of drugs from Internet pharmacies looks like, one would have to perform a larger study over a longer period of time.”

The testosterone cypionate order contained four separate vials, two of which failed USP’s specification for potency because they contained only half the dosage indicated on the packaging. USP

Association News

also performed a visual inspection of the viscosity of each vial’s contents and found that a significant viscosity difference was found for two of the vials received. Potentially, variances in the viscosity of the testerone could alter its bioavailability, ultimately adversly affecting the intended therapeutic effect.

It is important to note that USP performed limited testing; several other tests that could uncover potential dangers to patient health were not performed, including tests for contaminants resulting from preparation or poor packaging. Manning explained that USP does not typically perform

this identification testing and that USP’s analysis was not meant to be comprehensive.

NABP’s Internet drug buy demonstrates the many possible dangers patients may encounter when ordering from suspicious Internet pharmacy sites. Many legitimate Internet pharmacies are doing business safely and ethically on the World Wide Web, but there appear to be even more suspicious pharmacies preying on patients who are unaware of the dangers of drugs that are quick and easy to obtain.

Patients can protect themselves from suspicious Internet pharmacies by purchasing drugs from Verified Internet Pharmacy Practice Sites™ (VIPPS®)-accredited pharmacies. By checking the list of VIPPS pharmacies on NABP’s Web site, www.nabp.net/vipps/consumer/listall.asp, patients can choose from a variety of Internet pharmacies that have proven safe practices. Patients can also learn the characteristics of suspicious pharmacy sites by visiting FDA’s Web site at www.fda.gov/oc/buyonline/default.htm, as well as NABP’s VIPPS FAQ Web page, www.nabp.net/vipps/consumer/faq.asp.

The site offering isotretinoin shipped the drug without proof of pregnancy testing or other evidence to ensure that the therapy was appropriate.

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Legal Briefs

Triple Play: It Must be Baseball SeasonBy Dale J. Atkinson

A particular chain drug store has several stores within North Carolina. Three pharmacists at three different stores within the chain make dispensing errors that are brought to the attention of the North Carolina Board of Pharmacy. At one store, the pharmacist was tendered a script for Cortisporin® Ophthalmic Suspension and erroneously dispensed Neo/Polymyxin Ear Solution. The pharmacist on duty that day worked from 9 AM to 9 PM and filled 288 prescriptions. He had been licensed for 25 to 30 years without being

Medication errors obviously are of utmost concern not only to patients,

prescribers, pharmacists, and pharmacies, but they also impact regulatory boards and the way such boards enforce applicable practice acts. Boards of pharmacy enforce the practice acts and other applicable legislation through, in part, the disciplinary process. Employers and other private sector mechanisms may also be implemented in an effort to reduce or eliminate errors in the health care community. While worthy of recognition, these private sector remedies may be influenced by financial factors and other issues outside of the realm of the public protection mission observed by regulatory boards. Boards of pharmacy are in a position to address medication errors through the disciplinary process and are encouraged to enforce this mandate. Consider the following.

the subject of a complaint or disciplinary action. The pharmacy permit holder was sanctioned by the Board in the following manner:

1. A reprimand of the pharmacy;

2. A requirement that the pharmacy “shall not allow pharmacists to dispense prescription drugs at such a rate per hour or per day as to pose a danger to the public health or safety”; and

3. That the pharmacy shall submit a written statement to the Board signed by current

pharmacists that they have read and understand the patient counseling rule.At a second facility, a

pharmacist was tendered a script for methotrexate 2.5 mg and erroneously dispensed amitriptyline 25 mg. On the day that script was filled, the pharmacist worked a 12-hour shift with one other pharmacist and they filled 328 scripts collectively. A few weeks earlier, the same pharmacist erroneously dispensed 48 units of prednisone 5 mg and 48 units of prednisone 10 mg in a 10-mg box on a prescription for prednisone 5 mg. The pharmacist worked a 12-hour solo shift and filled 347 scripts on that date. This particular pharmacist had been licensed for 10 to 15 years with no prior complaints or disciplinary actions. The pharmacy permit holder was sanctioned by the Board in the following manner:

1. That the pharmacy be cautioned regarding its failure to comply with the Board’s patient counseling rule; and

2. That the pharmacy permit be suspended for one day, such order stayed for a period of three years on the condition that:

3. The pharmacy shall not allow pharmacists to dispense prescription drugs at such a rate per hour or per day as to pose a danger to the public

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Legal Briefs

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

health or safety;4. The pharmacy shall

submit to the Board . . . a written statement signed by current pharmacists [that they have read and understand the] patient counseling rule . . . ;

5. The pharmacy shall comply with the laws governing the practice of pharmacy; and

6. The pharmacy shall comply with the regulations of the Board.At a third facility, the

pharmacist was tendered a script for penicillin VK 250 mg and erroneously dispensed albuterol sulfate 2 mg. On that day, the pharmacist was on duty from 8 AM to 3 PM and dispensed 215 prescriptions. The pharmacy received a reprimand for this error.

On March 19, 2001, the Board entered final orders on the three cases referenced above. The parent pharmacy filed an appeal to the North Carolina Superior Court, which consolidated the matters and ruled in favor of the Board and affirmed the sanctions entered against the pharmacy permits. The pharmacy appealed to the appellate court.

Noting recent revisions to the Administrative Procedures Act of North Carolina, the appellate court first addressed the standard of review and held that the lower court used the proper standard in finding in favor

of the Board. Next, the appellate court addressed the assignments of error argued by the pharmacy.

The pharmacy argued that the Board exceeded its authority by attempting to reprimand, discipline, regulate, and limit the operations of three pharmacies of the chain. In rejecting this argument, the court recognized that the Board is empowered to discipline a facility permit for the unlawful acts of its employees (citing Sunscript Pharmacy Corporation v North Carolina Board of Pharmacy, previously written about in the NABP Newsletter; “Pharmacist [MIS] Fills Script; Pharmacy Pays,” January 2002). The court cited the applicable statutes, one of which provides for the grounds for disciplining a facility permit for the same conduct as constituting grounds for disciplining a pharmacist licensee.

Next, the pharmacy argued that the Board unlawfully used in its adjudications a policy that the pharmacy is presumptively liable for the acts of its pharmacists and other employees. The court quickly dismissed this argument, stating that such an assignment of error is without merit. Based upon the Sunscript case, the court held that the Board need not employ such a presumption when the judicial decisions already find that a permit

holder may be liable for the actions of its pharmacists/employees.

Finally, the pharmacy argued that its due process and notice rights under the constitutions had been violated in that the Board improperly used a “150 rule” whereby when a pharmacist fills more than 150 scripts in a day and a mistake is made, it is presumed that the pharmacy should be sanctioned. In rejecting this argument, the court again cited the Sunscript case and emphasized that the pharmacy can be held responsible for the acts of its employees. Indeed, the court stated that the Board need not adopt such a “150 rule” in order to hold the pharmacy responsible. It noted that the Board orders did not cite a “150 rule” and did not make any findings concerning the number of scripts filled each day the errors occurred. The findings of dispensing errors were sufficient to warrant the conclusions of liability.

Boards of pharmacy should aggressively address workload issues that lead to errors in dispensing medications. Pharmacy permit holders and pharmacists should be held accountable for dispensing errors to more effectively protect the public through regulatory activities.

CVS Pharmacy v North Carolina Board of Pharmacy, 591 S.E. 2d 567 (App. Ct. NC 2004)

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Feature News

The investigative series and reports from Food and Drug Administration (FDA) do note that the counterfeit drug occurences are well organized and more sophisticated than previous incidences. Experts involved in the detection and prevention of the introduction of counterfeit drugs into the US medication distribution system caution that the present licensure systems and safeguards must be improved and enhanced to effectively combat this alarming trend. Criminal activity by professional diverters and counterfeiters sometimes occurs through the exploitation of loopholes and the fact that state and federal agencies often lack appropriate resources to stifle such activity. Additionally, the emergence of the Internet exposes American patients to an international drug supply

Protecting the US Medication Distribution System

In October 2003, The Washington Post began publishing a series of articles

that brought to light some disturbing and surprising news about the medication distribution system in the United States. This five-part series addressed the results of a year-long investigation conducted by The Post, which revealed that, despite a recent increase in the incidences of counterfeit drugs, the US medication distribution system was safe.

that is often tainted with drugs that are unfit and unsafe for use.

The World Health Organization (WHO) was one of the first entities to collect international data on drug counterfeiting. From the data WHO has collected, 78% of counterfeit drugs originate from developing countries, and 22% from industrialized countries. In countries like Argentina, Colombia, and Mexico, up to 40% of the total drug supply may consist of counterfeit drugs. FDA contends that counterfeit drugs are not as prevalent in the US because of strict federal and state oversight and precautions taken by pharmaceutical manufacturers, wholesale distributors, pharmacies, and pharmacists to protect the integrity of the medication distribution system. In fact, recent incidents of counterfeit products such as Neupogen®, Serostim®, and Ortho Evra®

have demonstrated the effective cooperation of both state and federal agencies, like the Florida Department of Health and FDA, and the pharmaceutical industry.

FDA Counterfeit Drug Task Force Examines Frailties of US Medication Distribution System

In an interim report released in October 2003, FDA’s Counterfeit Drug Task Force figuratively depicted various medication distribution models (refer to Figure I, next page). In Model 1, the most secure system, the pharmaceutical manufacturer distributes medications directly to the retailer, which often is a pharmacy, hospital, or other institution. Model 2 introduces a wholesale distributor and repackager into the system, which are often intermediaries between the pharmaceutical manufacturer and the retailer. In fact, three primary wholesale distributors distribute 90% of the prescription medication in the US. For the most part, primary wholesalers purchase medications from the pharmaceutical manufacturers and then distribute them to a retailer or secondary wholesaler.

Model 3 introduces a secondary wholesale

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Feature News

distributor. Secondary wholesale distributors may purchase medications from pharmaceutical manufacturers or other wholesale distributors and then sell them to retailers or other wholesale distributors (primary or secondary). Legitimate transactions between wholesale distributors may be beneficial to consumers for a number of reasons. Wholesale distributors may be able to take advantage of price discounts that are created when a pharmaceutical manufacturer or another wholesaler has a temporary

overstock of medication; wholesale distributors may help to quickly resolve an increased demand experienced by a retailer for a particular medication; and smaller wholesale distributors may be able to serve rural communities whose needs may not be directly met by larger wholesalers.

Model 3 represents the most vulnerable system; counterfeit and diverted drugs may be introduced into the medication distribution system through wholesale distributors or repackagers who purchase medications illegally from retailers or

foreign markets. Criminal activity can also occur amongst retailers who may attempt to illegally divert products by selling medication samples directly to patients. Also, as Model 3 illustrates, multiple transactions may occur between wholesale distributors before ultimately reaching the patient, which may increase the risk of introducing a counterfeit or diverted product. This risk further increases if the transactions are not properly authenticated or if there is inadequate due diligence among wholesale distributors.

1. FDA’s Counterfeit Drug Task Force Interim Report. Rockville, MD: US Department of Health and Human Services, 2003; www.fda.gov/oc/initiatives/counterfeit/report/interim_report.html.

Figure IFDA’s Counterfeit Drug Task Force Interim Report, October 2003 1

(The dotted lines indicate potentially illegal medication sales)

Drug Distribution Models

1. Manufacturer Retailer

Repackager

2. Manufacturer Wholesaler Retailer

Repackager

3. Manufacturer Wholesaler Wholesaler Retailer

Other Source of Drugs (eg, institutional pharmacies, closed door pharmacies, foreign markets)


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Feature News

Dietary supplements are readily available at many corner pharmacies or grocery stores, which makes them easily obtainable for consumers who believe that if they purchase an “all natural” dietary supplement for preventative and therapeutic purposes, there are no hazards involved in consuming the product. This is false – dietary supplements, like any supplement, when taken in excess or in conjunction with prescription medications, may cause serious adverse events that may be fatal.

Some examples of problems associated with the use of supplements include:

l aristolochia acid – an herb linked to kidney failure and cancer;

l yohimbe – a sexual stimulant linked to heart and respiratory problems; and

l bitter orange – an herb whose ingredients have effects similar to those of ephedra.

After Ephedra, More Dietary Supplements Still Contain Dangerous Ingredients

Even though this year has seen the ban of the popular weight loss

dietary supplement ephedra, many health groups believe that their work is still not done – that the ephedra ban was just the stepping stone to the ban of many more dietary supplements that contain dangerous ingredients.

Other common dietary supplements which contain ingredients which have been deemed dangerous include Ginkgo biloba, St John’s Wort, Ginseng, and Kava Kava.

Dietary Supplement Definition

The Dietary Supplement Health and Education Act of 1994 (DSHEA) defines a “dietary supplement” using several criteria:

l a product (other than tobacco) that is intended to supplement the diet that bears or contains one or more of the following ingredients: a vitamin, a mineral, an herb or other botanical, an amino acid, a dietary substance for use by man to supplement the diet by increasing the total daily intake, or a concentrate, metabolite, constituent, extract, or combinations of these ingredients;

l is intended for ingestion in pill, capsule, tablet, or liquid form;

l is not represented for use as a conventional food or as the sole item of a meal or a diet;

l is labeled as a “dietary supplement”; and

l includes products such as an approved new drug, certified antibiotic, or licensed biologic that was marketed as a dietary supplement or food before approval, certification, or license (unless the secretary of [the United States Department of] Health and Human Services [HHS] waives this provision).

Dietary Supplement Safety Precautions

A February 9, 2004 editorial in American Medical News (www.amednews.com), the American Medical Association’s online newspaper for physicians, stated, “The Food and Drug Administration’s [FDA] ban of dietary supplements containing ephedra is a big consumer protection victory. But the American public deserves much more.”

The amednews.com column goes on to mention that dozens of ephedra-containing products have been taken off the market after more than 18,000 people reported negative reactions, the most serious being stroke, heart attack, and even death.

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Feature News

Even though adverse reactions to dietary supplements, usually herbal products, have been reported, it is difficult to remove these products from store shelves due to the DSHEA. According to the DSHEA, dietary ingredients used in supplements are not subject to vigorous premarket safety evaluations required for new food ingredients and new uses of old food ingredients. Instead, supplement manufacturers are required to demonstrate that their product(s) are safe and that any representations or claims made about them are substantiated by adequate evidence to show that they are not false or misleading. To remove a certain dietary supplement from the market, DSHEA requires that FDA prove products pose significant risk to the public health and are, therefore unsafe. Also, FDA must rely on voluntary adverse event reports from manufacturers because FDA cannot force the supplement manufacturers to report adverse events. According to the American Medical News article, “. . . [V]oluntary reporting captures only 1% of adverse events.”

Many popular products, even when used following recommended dosing, may cause side effects. Ginko biloba, which is promoted to increase memory and blood flow to the brain,

can cause spontaneous bleeding and should not be taken with drugs such as aspirin, Coumadin®, Ticlid®, Plavix®, or Persantine® due to an increased risk of bleeding. Another example is St John’s Wort, a widely-used herb promoted as a natural antidepressant. Side effects of St John’s Wort include gastrointestinal disturbances, allergic reactions, fatigue, dizziness, confusion, and dry mouth; it should not be taken with prescription antidepressants because, in addition to increased side effects, the herbal product may alter the therapeutic effect of the prescription antidepressant.

Side effects are also common among vitamin and mineral supplements. Niacin, when taken in doses over the recommended daily allowance (RDA), can cause side effects such as gastrointestinal distress, mild to severe liver damage, myopathy, and maculopathy of the eyes. Side effects associated with the consumption of Vitamin A at more than the RDA of 25,000 international units consist of severe liver injury, including cirrhosis; bone and cartilage pathologies; and elevated intracranial pressure.

An April 12, 2004 Consumer Reports article entitled “Dangerous Supplements: Still at Large” references individuals who

have experienced significant adverse effects including kidney failure. The article noted that Beverly Hames and Donna Andrade-Wheaton both sought safe and natural treatments from acupuncturists who prescribed Chinese herbal medicine. In Hames’ case, she was prescribed several Chinese herbal products, five of which were later found to contain aristolochic acid. Four years later, in 1996, she had to undergo a kidney transplant due to kidney failure from the aristolochic acid. Donna Andrade-Wheaton also sought help from an acupuncturist and was prescribed half a dozen Chinese supplements to treat health conditions including endometriosis. At least one of these supplements contained aristolochia acid – after FDA released a nationwide aristolochia safety warning in 2001. In 2002, Andrade-Wheaton also underwent a kidney transplant, most likely due to the aristolochia acid.

A Stricter DSHEAThe warnings about

dietary supplements are out there, but they are not as predominant as those for prescription medications. What can be done to make dietary supplements safer and avoid dangerous side effects?

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Feature News

Dietary Supplements

The year 2003 saw the introduction of two US Senate bills to protect consumers from the adverse reactions of dietary supplements and force manufacturers to ensure the safety of their products before consumers buy them, instead of waiting until an adverse reaction occurs. Both bills have yet to be passed.

In March 2003, Senate Bill 722, the “Dietary Supplement Safety Act of 2003,” was introduced. The bill amends the

Senate Bill 1538, which was introduced in the Senate on July 31, 2003, states, “[the] DSHEA Full Implementation and Enforcement Act of 2003 . . . ensure[s] that the goals of the [DSHEA] are met by authorizing appropriations to fully enforce and implement such Act and the amendments made by such Act, and for other purposes.”

As previously stated, Congress has not passed either bill, so FDA will continue to warn the public about the dangers of dietary supplements through news releases, FDA’s Web site (www.fda.gov), and via other media.

federal Food, Drug, and Cosmetic Act to require that manufacturers of dietary supplements submit to FDA reports on adverse experiences with dietary supplements. The bill also calls for manufacturers to submit an annual report that discloses all adverse dietary supplement experiences. Postmarket surveillance may also be required for dietary supplements if the secretary of HHS determines that there is a reasonable possibility that a use or expected use of the dietary supplement by a great number of consumers may result in serious adverse experiences.

NABP on Dietary Supplements

NABP recognizes that many Americans are seeking to improve their health by taking dietary supplements in addition to prescription medicines. This shift has significantly impacted the practice of pharmacy by expanding the wealth of knowledge that a competent entry-level pharmacist must possess. Consequently, the revised North American Pharmacist Licensure Examination™ blueprint includes a competency statement specifically addressing the documented uses, adverse effects, and toxicities of dietary supplements.

Established in February 1993, NABP’s NABPLAW® Online is a specialized database that contains pharmacy statutes and regulations from all 50 state boards of pharmacy as well as the Guam and Puerto Rico boards of pharmacy. The database serves as a reference tool for anyone researching the current individual state pharmacy laws.

Searching NABPLAWNABPLAW is a well-

organized, easily searchable database. Searches of the laws and regulations of one, several, or all 50 states

NABP’s NABPLAW a Powerful Reference Tool for Manyand two territories can be achieved using keywords and phrases, which appear highlighted in the search results. Depending upon how detailed the user’s search is, there are three types of searches available:

l General Search – search by a word or a phrase;

l Expert Search – search a particular state or subset of a state’s statutes or regulations; and

l Advanced Search – allows for more searching options, including searches for exact phrases or synonyms.

After searches are completed, the results appear on the screen as a list of “hits.” These hits are then displayed within the document, table of contents, or both. NABPLAW allows users to “tag” and download relevant statutory and regulatory text. When an item is tagged the user can refer to the item at a later time without losing it. For those interested in trying out NABPLAW firsthand, a free demonstration is available on NABP’s home page at www.nabp.net.

Who Subscribes to NABPLAW?

Anyone who needs to stay informed about current pharmacy regulations will find the database useful. Listed below are the percentages of those parties subscribing to NABPLAW, as of press time.

l 51% – Pharmaceutical companies

l 20% – State boards of pharmacy

l 9% – Law firmsl 7% – Chain drug

companiesl 6% – Professional

associationsl 5% – Universities and

colleges

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Feature News

Distribution System

FDA’s Counterfeit Drug Task Force identified other potential weaknesses that may increase the susceptibility of the medication distribution system. Drug pedigrees, which record the transactions of a product throughout the medication distribution system, when incomplete, may make it more difficult to determine if the product is authentic.

Imported medications have posed another significant risk of introducing counterfeit and diverted drugs. Although the Prescription Drug Marketing Act of 1987 prohibited US-manufactured drugs destined for foreign markets to be reimported back into the US for sale, some consumers and even state and local governments have insisted on purchasing medications from foreign sources through online pharmacies and other means. This type of activity bypasses the federal and state regulatory framework designed to protect American consumers by ensuring the quality and safety of the product. Consequently, American consumers have sometimes been the victims of counterfeit, misbranded, adulterated, or substandard drugs.

The infrequent use of tamper-evident packaging was also cited as a vulnerability exploited

to introduce counterfeit or diverted products. Tamper-evident packaging prevents the original packaging from being used to “pass off” counterfeit and diverted product as authentic. Criminals have collected medication containers and other packaging from the trash facilities of pharmacies and other institutions and subsequently used the genuine packaging to parcel fake and diverted product.

Strengthening the US Medication Distribution System

On February 20, 2004, NABP released the updated Model Rules for the Licensure of Wholesale Distributors. The updated Model Rules, part of the Model State Pharmacy Act and Model Rules of the National Association of Boards of Pharmacy, were provided to protect the public from the deleterious effects of counterfeit drugs by assisting the state boards of pharmacy in maintaining the integrity of the US medication distribution system through the regulation of wholesale distributors. The updated Model Rules are the result of a concerted effort between NABP and other representatives from pharmacy, government, and the wholesale distributor industry to protect the public from the ill effects of counterfeit drugs and devices.

In addition to stricter licensing requirements such as criminal background checks and due diligence procedures prior to wholesale distribution transactions, the Model Rules mandate specific pedigree requirements for products that are particularly prone to adulteration, counterfeiting, or diversion. These products, as defined in the updated Model Rules, are designated as the National Specified List of Susceptible Products. In an attempt to reduce redundancy and confusion as states update and adopt regulation, it is highly recommended that states adopt the National Specified List of Susceptible Products that will be developed in conjunction with FDA, NABP, and other invited industry stakeholders. By mid-2004, NABP will appoint a standing committee, the National Drug Advisory Coalition. The National Drug Advisory Coalition will be primarily responsible for revising the National Specified List of Susceptible Products on no less than an annual basis. The National Drug Advisory Coalition will also be initially charged with drafting criteria that detail standards and guidance for the revision process.

Pharmacists’ Role in Deterring Counterfeit and Diverted Drugs

Many of the national pharmacy organizations have developed fact sheets or strategies to help pharmacists

ensure the integrity of medications. The fact sheets provide information on counterfeit drugs that may be useful regardless of practice type or setting. Common within the various sources of information is the need to encourage the education of pharmacy staff and other health care professionals on how to spot and report a suspicious product; advising that pharmacies eliminate the use of wholesale distributors that are not in good standing with the state board of pharmacy or other licensing agency; and urging the pharmacy to re-evaluate security measures to minimize the risk of diversion or entry of counterfeit products.

Lastly, pharmacists must also educate consumers on the problem of counterfeit and diverted drugs. Pharmacists should also encourage consumers to purchase their medications from credible sources. If consumers purchase medications from online pharmacies, pharmacists should encourage the use of Verified Internet Pharmacy Practice Sites™ (VIPPS®)- certified pharmacies, pharmacies recognized by NABP as appropriately licensed and prepared to practice pharmacy via the Internet in accordance with the criteria of the VIPPS program, which include an on-site inspection of the pharmacies’ facilities and a review of their policies and procedures.

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Feature News

Public hearings for the United States Department of Health and Human Services (HHS) Task Force on Drug Importation closed on June 1, 2004, and the Task Force is currently reviewing all testimony and comments to complete its study on importation by December 2004. The Task Force is charged with exploring whether or not processes for drug importation that assure patient safety can be established. In addition, it will determine the potential impact of drug importation on the health of American patients, medical costs, and the development of new medicines. The complete report will offer recommendations to HHS Secretary Tommy G. Thompson on how best to address the key questions posed by Congress as part of the Medicare Prescription Drug Improvement and Modernization Act of 2003.

Five listening sessions for various stakeholders were held in March and April and a public hearing was held on April 14, 2004. The listening sessions offered forums for groups who would be affected by drug importation:l March 19 – consumer

groupsl April 2 – health care

purchasersl April 28 – professional

health care providersl May 6 – industry

representatives

HHS Task Force Studies Illegal Drug Importationl May 14 – international

stakeholdersAccording to HHS,

the Task Force gathered information during these sessions regarding the following issues related to drug importation:

l Identify the limitations, including limitations in resources and in current legal authorities, that may inhibit the [HHS] secretary’s ability to certify the safety of imported drugs.

l Assess the pharmaceutical distribution chain and the need for, and feasibility of, modifications in order to assure the safety of imported products.

l Analyze whether or not anti-counterfeiting technologies could improve the safety of products in the domestic market as well as those products that may be imported.

l Estimate the costs borne by entities within the distribution chain to utilize such anti-counterfeiting technologies.

l Assess the scope, volume, and safety of unapproved drugs including controlled substances entering the US via mail shipment.

l Determine the extent to which foreign health agencies are willing and able to ensure the safety

of drugs being exported from their countries to the US.

l Assess the potential short- and long-term impacts on drug prices and prices for consumers associated with importing drugs from Canada and other countries.

l Assess the impact on drug research and development, and the associated impact on consumers and patients, if importation were permitted.

l Estimate agency resources including additional field personnel needed to adequately inspect the current amount of pharmaceuticals entering the country.

l Identify the liability protections, if any, that should be in place if importation is permitted for entities within the pharmaceutical distribution chain.

l Identify ways in which importation could violate US and international intellectual property rights and describe the additional legal protections and agency resources that would be needed to protect those rights.

NABP Participates in May 14 Stakeholder Meeting

During the Stakeholder Meeting on May 14, 2004,

NABP Executive Director/Secretary Carmen A. Catizone presented NABP’s stance on importation, as approved by the Association membership at NABP’s 100th Annual Meeting and Centennial Celebration. He explained that NABP’s member boards of pharmacy passed a resolution resolving that NABP will continue to oppose illegal importation of medications and express to Food and Drug Administration (FDA) the concerns of member states and strongly urge FDA or the appropriate legal authority to pursue actions against state and local governments for endorsing, promoting, or engaging in the illegal importation of medication.

“NABP has learned that medications shipped from locations purported to be in Canada have originated in Slovenia, Pakistan, and Vietnam,” Catizone told the Task Force. “Each progression to extend the distribution source to unknown borders further away from the FDA drug approval process and the state regulation of pharmacy practice makes the situation more dangerous. The extension of importation to countries lacking effective drug approval processes, regulatory systems, or practice standards furthers the erosion and destruction


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State boards of pharmacy – join the four boards that have already taken advantage of the signifi cant cost savings and convenience of NABP’s Web-only state newsletter program. The online newsletter, which is identical in format to the printed newsletter, saves a board printing and mailing costs totaling more than $7,000 in some states.

Like the printed state newsletter, boards can determine the frequency in which newsletters are posted online. While most boards select quarterly newsletters, some chose to run anywhere from one to three times a year.

HHS Task Force

Association News

of the entire regulatory system for the practice of pharmacy.”

He noted that NABP recognizes patients’ concerns about the affordability of medications, and cautioned that a solution resolving the confl ict of cost versus

safety must be developed to “address the needs of US patients and prevent irreparable damage to, if not the elimination of, the regulatory systems in the US.”

Catizone told the Task Force NABP believes that if importation is legalized NABP is prepared to discuss with regulatory agencies

and affected stakeholders the framework necessary to regulate the inter-border practice of pharmacy in the dispensing of medications to patients in the US and Canada. He explained that such a framework would provide protections similar to those experienced by US patients receiving drugs from out-of-state sources and would

focus on identifying and monitoring the source of medications.

Detailed information concerning the Task Force on Drug Importation including participating organizations and session transcripts can be found on the HHS Web site at www.hhs.gov/importtaskforce.

$ave a Bundle with NABP’s Web-only State Newsletter Program

For more information on the Web-only state newsletter program please contact the NABP editorial manager at 847/698-6227 or e-mail [email protected].

The Web-only state newsletter option, which saves boards up to 92% versus the printed version, includes:

Assistance from NABP’s editorial staff

Typesetting and layout

Production supervision

Web hosting

$580

State Newsletter Program Options

$7,559

Average Amountper Year in Dollars(dependent on number of printed copies)

Printed 4 issues

Web Only 4 issues


$8,000

7,000

6,000

5,000

4,000

3,000

2,000

1,000

(5,000 per issue)

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Patient Safety Corner

Introducing ‘Patient Safety Corner’NABP is pleased to

introduce the new “Patient Safety Corner” column that will appear in upcoming issues of the NABP Newsletter. The purpose of this column is to provide the boards of pharmacy with relevant information regarding the different elements of patient safety. The addition of the “Patient Safety Corner” is an example of NABP’s

commitment to keeping the boards of pharmacy connected by providing background information and regular updates on the patient safety programs undertaken by NABP on behalf of its member boards.

In September 2003, the Executive Committee identified the need for NABP to recognize patient safety as a priority for the

Association. NABP created a Patient Safety Center, the purpose of which is to support projects that will have a direct impact on patient safety and ultimately to decrease medication errors. Electronic prescribing and the inclusion of indications on prescriptions are two initiatives that have been identified as patient safety action items by the Executive Committee.

The following chart highlights the initiatives organizations are advancing in regard to electronic prescribing and their missions.

Suggestions on topics for future patient safety articles are welcome. Contact NABP’s Communications Department at 847/698-6227 or via e-mail at [email protected].

Organization Stakeholders Mission/Goal/Project

SOS Rx Coalitionl Run by the National Consumers

League

l Coalition comprised of more than 60 organizations

l Consumersl Accrediting bodiesl Patient safety organizationsl Physiciansl Pharmacistsl Caregiversl Employer groupsl Governmentl Pharmacy groups: NABP, American Association

of Colleges of Pharmacy; Academy of Managed Care Pharmacy; American Pharmacists Association; American Society of Consultant Pharmacists; American Society of Health-System Pharmacists®, Institute for Safe Medication Practices; National Association of Chain Drug Stores, Inc; Rite Aid; Walgreens

l A national coalition formed to promote the safe use of medications.

l Coalition’s work is two-tiered, aiming to produce both:1. Behavior changes in consumers

through education efforts

2. Institutional changes within the health care system through advocacy.

l Area of interest for NABP – Health care system advocacy accelerating the adoption of e-prescribing by establishing guiding principles and a standard for e-prescribing. An ideal e-prescribing model will be developed and promoted to health care professionals. A public education campaign will educate consumers about e-prescribing.l Funded by grant from Express

Scripts


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eHealth Initiative l Accrediting groups and quality improvement organizations

l Electronic transaction service companies and group purchasing organizations

l Employers and purchasersl Health systems, hospitals, and other

health care organizationsl Laboratories and ancillary servicesl Medical device manufacturersl Payers and other risk-bearing

institutionsl Pharmaceutical manufacturersl Practicing clinicians and physician

groupsl Public health organizationsl Research and academic institutionsl Standards organizations

l The mission of the eHealth Initiative is to drive improvement in the quality, safety, and efficiency of health care through information and information technology

l Strategic prioritiesl Increase awareness of the role

of information and information technology in driving greater quality safety, and efficiency within health care;

l Lay the foundation for an “interconnected, electronic health information infrastructure” by promoting the use of standards, connectivity, and private and secure methods of data interchange

l Build the case for public and private sector incentives to improve health and health care through the use of information and information technology

l Accelerating the adoption of computerized prescribing in the ambulatory environment (attended conference)l Goal: To rapidly expand the

adoption of computerized prescribing; in particular, to stimulate the adoption of computerized prescribing by physicians and other practitioners. Healthcare Collaboration Network (HCN): A National Demonstration Project Consortium of public and private sector organizations participating in the HCN. This is a national demonstration project that will show how electronic communications using common standards can help patients receive necessary and timely medical treatment; and also guard against medical errors, incorrect prescriptions, and adverse drug events.


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Around the Association

Association News

For the eighth year, NABP will offer its program review and training sessions for board of pharmacy staff. Training days are Friday, August 27, 2004; Monday, August 30, 2004; and Friday, September 10, 2004; all of the sessions will be held at NABP’s Headquarters in Park Ridge, IL.

At press time, 15 boards registered to participate in one of the three interactive training sessions. Attendees will review NABP’s Electronic Licensure Transfer Program® (ELTP®) North American Pharmacist Licensure Examination™ (NAPLEX®), Multistate Pharmacy Jurisprudence Examination® (MPJE®), and the Foreign Pharmacy Graduate Examination Committee™ certification program as well as the

Annual Program Review, Training Sessions for Board Staff Scheduled for Late Summer

Verified Internet Pharmacy Practice Sites™ (VIPPS®) accreditation program and Disciplinary Clearinghouse. Board staff will also learn about more recent programs such as the Pre-NAPLEX™, the Pre-FPGEE™, and the Pharmacist Self-Assessment Mechanism™, a component of NABP’s Continuing Professional Development program. Board staff will receive training on the use of Lotus Notes® for licensure verification, the Healthcare Integrity and Protection Data Bank/Disciplinary Clearinghouse reporting; MPJE and NAPLEX score replication and views; and state and pharmacy school roster reports and retrieval procedures.

NABP’s Department managers and Information Technology and Services

Department staff will provide the training and answer specific questions.

“We are pleased to offer these annual training sessions to board staff because it gives them an opportunity to receive one-on-one training from NABP staff and to exchange ideas with other board staff,” says NABP President Donna M. Horn.

The training sessions have expanded since 1996 when they only covered the Association’s ELTP program; now the review curriculum includes information about a wide range of NABP programs and services.

Questions about the training sessions or registration should be directed to the Customer Service Department by calling 847/698-6227 or e-mailing [email protected].


NABP’s Spunt Recognized in FASHP Practitioner Recognition ProgramAvery L. Spunt, MEd, RPh, FASHP, was named a fellow of the American Society of Health-System

Pharmacists® (ASHP) through the organization’s Fellows of ASHP Practitioner Recognition Program. This program recognizes excellence in pharmacy practice and promotes public awareness of pharmacists who have distinguished themselves in practice. The criteria for ASHP’s Practitioner Program is the following:

l Practiced in a concentrated area of pharmacy for at least 10 years;

l Demonstrated sustained practice excellence;

l Contributed to the total body of knowledge in pharmacy practice;

Attendees of the Importation Enforcement Workshop and Task Force gathered in Arlington, VA, on June 22, 2004, to discuss importation enforcement guidelines and strategies. Standing (from left to right) is Howard C. Anderson, Jr, former Executive Committee member and present executive director of the North Dakota State Board of Pharmacy; Richard A. Palombo, Executive Committee member and member of the New Jersey Board of Pharmacy; Patricia Good, chief, Liaison and Policy Section, Office of Diversion Control, Drug Enforcement Administration; Robert Joseph “Bob” Dufour, member of the Arkansas State Board of Pharmacy; Donna S. Wall, NABP chairperson and member of the Indiana Board of Pharmacy; William T. Winsley, executive director of the Ohio State Board of Pharmacy; Bill Veniot, New Brunswick Pharmaceutical Society registrar; and Donald H. Williams, former executive director of the Washington State Board of Pharmacy.

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NABPLAW

l 2% – Research groups, insurance companies

NABP encourages more state boards of pharmacy to take advantage of this research tool. NABPLAW can be utilized by boards as a means to research other states’ pharmacy regulations.

In addition to the state boards of pharmacy, many other organizations benefit from NABPLAW including:

l Schools/Colleges of pharmacy – exposure to the laws and regulations are essential to the

education of all pharmacy students.

l Health care marketing Research Companies – before research is launched, knowledge of current legal restrictions and guidelines can prevent costly false starts and misdirected effort.

l Internet pharmacy practice sites – it is essential to know the variations in laws and regulations from state to state in order to effectively, legally, and safely practice pharmacy via the Internet.

To subscribe to NABPLAW, download a

Publications Order Form from NABP’s Web site. The form can be found by clicking on “Who We Are” and “Publications;” the link to the form is located near the bottom of the page.

The yearly cost to subscribe to NABPLAW varies:

l Single site – $995l Multi-site (two to

five users) – $2,000l Multi-site (six to 10

users) – $3,000l Multi-site (11-15

users) – $4,000l Unl imited

cor por ate – $5 ,000l One-month

subscr ip t ion – $195

l Six-month subscr ip t ion – $695

l Sta te boards of phar macy – $295

For those state boards that already subscribe to NABPLAW, NABP reminds them to keep NABP informed about their states’ changing laws and regulations so the database can be updated.

NABPLAW payment options include check, money order, or credit card (MasterCard® or Visa®).

For more information about NABPLAW, please contact NABP’s Customer Service Department at 847/698-6227 or [email protected].


RAND Corporation l Major clients and sponsorsl Colleges and universitiesl Commerce and Industryl Governmentl Nationall State l Locall Internationall Foundationsl Professional organizationsl International organizations

l RAND Corporation is a nonprofit research organization providing objective analysis and effective solutions that address the challenges facing the public and private sectors around the world

l RAND Health, a unit of RAND Corporation, is the nation’s largest private health care research organization

l E-prescription developing standards for electronic prescribing systems – Pfizer sponsored study (results pending)

l Information technology to eEnhance patient health care – A study to determine how much patient care could improve and how much money could be saved if health care professionals around the United States increase their use of information technology (results pending)

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Around the Association

l Demonstrated ongoing commitment to educating practitioners; and

l Worked to support the profession (eg, through active membership and participation in ASHP).

Spunt received this honor during ASHP’s annual meeting on June 22, 2004, in Las Vegas, NV.

Washington Board Names Deputy Director

Lisa Salmi was named deputy director of the Washington State Board of Pharmacy.

Delaware Board Elects New Member

Angelo Chiari, RPh, was named a member of the Delaware State Board of Pharmacy on March 23, 2004. His term expires July 1, 2006.

Wyoming Board MovesThe Wyoming State

Board of Pharmacy recently moved. The Board’s new address is 632 S David St, Casper, WY 82601. The Board’s new e-mail address is [email protected].

(continued from page 112)NABP is pleased to

offer board delegates the opportunity to apply for the Association’s Annual Meeting Travel Grant for the 101st Annual Meeting, May 21-24, 2005, at the Sheraton New Orleans Hotel in New Orleans, LA.

The program will reimburse the board of pharmacy’s official delegate up to $750 in travel expenses including transportation, hotel accommodations, and meals. Boards of pharmacy that are not reimbursed for travel expenses by the state are eligible to receive a travel grant.

Apply Today for NABP’s Annual Meeting Travel Grant

Interested boards must have their offi cial delegate complete an application, which can be obtained by e-mailing the NABP Customer Service Department at [email protected] or downloading the application online at www.nabp.net. Applicants must submit documentation that their state will not provide reimbursement for Annual Meeting attendance. This documentation can be in the form of a per diem or travel policy, or a letter stating that the state will not reimburse the board of pharmacy for expenses incurred by attending NABP’s Annual Meeting. Grant monies

cannot be applied to Annual Meeting registration fees. All applications and supporting documents must be received at NABP Headquarters no later than December 31, 2004. Applicants will begin receiving notifi cation in February 2005 stating whether or not they have qualifi ed for a grant.

For more information, contact the Customer Service Department at 847/698-6227. Materials should be sent to the NABP Foundation, Attn: Annual Meeting Travel Grant Program, 700 Busse Hwy, Park Ridge, IL 60068.

Association News

Executive Committee Treasurer, Members Attend New Board Member Orientation

Pictured with Lawrence H. Mokhiber (left), NABP’s new treasurer, are NABP’s new Executive Committee Members Richard A. Palombo (center) and Charles Curtis Barr (right), during the New Board Member Orientation at NABP’s Headquarters in Park Ridge, IL, on June 18, 2004.

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Do you have an interesting idea for an article that relates to the boards of pharmacy and the practice of pharmacy? Send an

What Would You Like to Read About in the Next NABP Newsletter?

e-mail to the attention of the editorial manager at [email protected], and inform the Communications Department of your idea for an article. Or do you want

Association News

Thursday-Saturday, October 14-16, 2004 NABP/AACP District I Meeting Fairmont Algonquin Hotel St Andrews, New Brunswick, Canada

Thursday-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 District VIII Meeting 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/ASPL Fall Educational Conference Renaissance Vinoy Resort and Golf Club St Petersburg, FL

Saturday-Tuesday May 21-24, 2005 NABP’s 101st Annual Meeting Sheraton New Orleans New Orleans, LA

Upcoming Meetings

to know about a timely issue that is affecting the pharmacy world? E-mail us and mention what topic you would like further discussed or broadened.

mailto:[email protected]

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july 2004

National Association of Boards of Pharmacy

700 Busse Highway

Park Ridge, Illinois 60068

nabp newsletter

Association Highlights

ReminderIn order to keep the

information contained in NABPLAW® Online

current, please submit any new or amended pharmacy

laws and/or regulations as they are available to NABP’s Customer

Service Department at [email protected].

july newsletter mr - nabp · 2016-07-07 · july 2004 99 consulting or visiting with a physician....

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