HCPC's May 1, 2000 Comments to FDA

Following is the text of a letter sent by the HCPC to the U.S. Food and Drug Administration in response to an FDA request for comments on the shortage of licensed pharmacists:

May 1, 2000

Vincent C. Rogers, D.D.S., M.P.H.
Associate Administrator
Bureau of Health Professions
Health Resources and Services Administration
Room 8C05, Parklawn Building
5600 Fishers Lane
Rockville, Maryland 20857

Dear Dr. Rogers:

On behalf of the Healthcare Compliance Packaging Council (HCPC), I thank you for this opportunity to submit comments regarding the study underway within the U.S. Department of Health and Human Services regarding AShortages of Licensed Pharmacists.@

By way of background, the HCPC is a not-for-profit trade association that was formed in 1990 to promote the many benefits of unit dose blister and strip packaging formats. HCPC members include manufacturers of pharmaceutical films, foils, and paperboard used in the manufacture of unit dose blister and strip packaging, as well as blister packaging machinery manufacturers, contract packaging firms, and others with an interest in pharmaceutical packaging issues and/or ways to improve compliance with pharmaceutical regimens. For further information on the HCPC, I invite you to visit our Web site at www.unitdose.org.

After reviewing the notice published by your office in the March 16, 2000 edition of the Federal Register, the HCPC offers the following comments regarding questions 8 & 9:

Question 8: Uses of automation or technology to assist pharmacists, such as the use of electronic transmission of prescriptions, methods of streamlining dispensing processes, and technologies that may be under development to improve efficiency of pharmacists in their duties (emphasis added).

As you know, the current paradigm for dispensing solid oral dosage pharmaceuticals pursuant to a doctor=s prescription in the United States typically requires that a pharmacist or pharmacy technician repackage the proper amount of drug product from a bulk container to an individual cap and vial closure. Known as Acount and pour, lick and stick,@ this is a labor intensive activity that C according to a recent study performed by the consulting firms of Arthur Andersen, LLP C takes up more than twenty percent of pharmacy personnel time, and distracts pharmacists from providing more important, professionally fulfilling activities.

According to the Arthur Andersen study, in fact, 68 percent of pharmacist time is spent on tedious administrative requirements. Broken down, the study found that 21.2 percent of pharmacy personnel time is spent A...retrieving drug from storage, counting pills, filling container, preparing/placing label, returning drug to storage, bagging prescription;@ while an additional 24.3 percent of pharmacy personnel time is spent A...entering patient/doctor/drug profile into computer system, complying with 3^rd party requirements, resolving conflicts with PBMs, correcting clinical conflicts.@ Lastly, according to the study, 16.3 percent of pharmacy personnel time is spent A...placing [the packaged prescription] into will call, retrieving drug from will call, delivering prescription to patient, counseling patient, cashiering (emphasis added).@

The HCPC believes that the amount of time required for pharmacists and pharmacy personnel to process and prepare orders is detrimental to patients, pharmacy personnel, and the entire healthcare system. In short, by perpetuating a system under which years of training in pharmacy sciences are wasted on unnecessary, tedious, and physically taxing Acount and pour, lick and stick@ chores, everyone suffers. Pharmacists and pharmacy personnel suffer from repetitive stress disorders, tedium, and Aburn out,@ while patients suffer from higher costs and reduced counseling opportunities. Indeed, as the Arthur Andersen study clearly shows, time available for pharmacy personnel to counsel patients is at a bare minimum, while the time required to process and prepare prescriptions is maximized. Moreover, as I will describe in greater detail, a 1994 study conducted by the Michigan State University School of Packaging, demonstrates that the costs of dispensing prescriptions under the current paradigm are much greater than they need be.

Throughout most of the rest of the world, in fact, solid oral dosage pharmaceuticals are dispensed in formats commonly referred to as Aoriginal packaging@ or AOP.@ These unit dose formats C which typically consist of plastic film that has been formed into separate cavities to house individual pills, tablets, or capsules, and is covered with an aluminum backing C are also commonly used in the United States for over-the-counter (OTC) medications, as well as some pharmaceutical products (most oral contraceptives, certain antibiotics, and physician samples).

The term AOP@ stems from the fact that these formats are prepared by the pharmaceutical manufacturer, and shipped to pharmacies Aprepackaged,@ with no need for pharmacy personnel to transfer pharmaceuticals from one container to another when preparing prescriptions. When OP formats are used for pharmaceutical distribution, in fact, there are one-third fewer steps required of pharmacy personnel to fill a prescription as noted in Table One below:

Based on available research, as well as experience in other countries, and simple common sense, the HCPC posits that greater use of OP formats for pharmaceutical distribution in the United States would: 1) reduce the amount of time needed to fill prescriptions; 2) reduce the number of repetitive motion injuries suffered by pharmacy personnel (especially those attributable to constant screwing/unscrewing of bottle caps); 3) free up pharmacy personnel to increase patient counseling; 4) potentially reduce the number of pharmacy personnel needed to fill prescriptions; and 5) reduce costs. As the Arthur Andersen study concluded:

This study categorized 89 detailed pharmacy activities, of which pharmacists are involved in approximately 63. We believe, from a practical standpoint, that pharmacists need only be involved in 12-15 key activities. This would free up approximately 60-70% of the pharmacist time to perform more value-added activities, such as disease management and other health related activities.

With regard to cost reduction, as previously noted, the MSU School of Packaging has estimated the combined costs (labor and materials) needed for pharmacy personnel to fill a 30-count prescription using a cap and vial closure is $2.76, versus $1.71 - $2.14 when a OP format is used (depending on the cost of materials used with the OP format). Multiplied by the weekly prescription volume of 1,546 C estimated by Arthur Andersen as an industry average C these savings amount to approximately $49,843 - $84,412 per pharmacy annually. Such savings could be used to increase pharmacy personnel salaries as an incentive to join the profession, or to continue working within the profession. Savings could also be used to hire additional pharmacy personnel and, thereby, reduce workloads and lengthen pharmacy service careers.

Question 9: The impact of Internet and mail order pharmacies on the demand for pharmacists.

The HCPC believes that the recent growth in Internet pharmacies will eventually spur greater use of unit dose formats. According to AInternet Pharmacy Practice,@ a paper prepared by Katherine K. Knapp, Ph.D. for AAPhA 2000 C the American Pharmaceutical Association Annual Meeting@ held March 10-14, 2000 in Washington, D.C., the number of retailers offering prescription drugs online has grown from less than 10 percent in 1997 to more than 60 percent in 1999.

Moreover, according to Dr. Knapp, the potential for Internet pharmacy sales growth (both direct to consumer and business to business) is enormous. She notes, for instance, that:

The number of Internet users in the United States [is] projected to increase from 63 million in 1998 to 177 million in 2003.

The number of Internet users worldwide [is] projected to increase from 142 million in 1998 to 502 million in 2003. 

In 1999, more than 50 percent of Internet users were adults, and slightly more than 10 percent of these users were seniors.

The average Internet user earns $58,000 per year, as compared with the average income of $37,000 per year.

Some large pharmacy chains offer prescription drugs at prices that are 10 - 30 percent lower than those in their own Abrick-and-mortar@ stores.

Combined with demographic data regarding the aging of the Ababy boomer@ generation in the United States, and the fact that people consume greater amounts of pharmaceutical drugs as they age, there is every indication that Internet pharmacies will play an ever increasing role in pharmaceutical distribution.

An interesting aspect of this is that C due to their ability to centralize processing facilities and the extra time available to fill prescriptions ordered online C Internet pharmacies have much greater capabilities to prepare orders in unit dose formats than do personnel working in Atraditional@ pharmacies. If pharmaceuticals are not available from manufactures in OP formats, in other words, Internet pharmacies are poised to repackage individual prescriptions into such formats if they see significant consumer demand, or if they are provided incentives to do so from third party payers such as governmental entities and insurance providers.

As competition grows amongst Internet pharmacies, in fact, the HCPC predicts that one or more of these entities will eventually offer a variety of packaging options as a means of differentiating themselves from their competitors. While the impact of this on the need for licensed pharmacists is presently unclear, it is likely that repackaging from bulk to unit dose formats by Internet pharmacies would most likely be performed either mechanically or by trained technicians rather than licensed pharmacists.

To the extent that Congress and the U.S. Department of Health and Human Services are concerned that a shortage of licensed pharmacists looms in the short or long-term future, the HCPC strongly recommends that steps be taken now to encourage greater use of unit dose blister and strip packaging. Not only do unit dose formats offer the benefit of reduced labor costs for pharmacy personnel as well the time needed to prepare prescriptions, they also: 1) decrease the incidence of medication errors; 2) offer increased child resistance; 3) increase shelf life for pharmaceuticals; and 4) provide tamper evidence.

With regard to reductions in medication errors, the HCPC notes that both the Institute of Medicine and the National Safety Partnership have endorsed use of unit dose formats as a means of reducing medication errors. According to the IoM, in fact, AIf medications are not packaged in single doses by the manufacturer, they should be prepared in unit doses by the central pharmacy. Unit dosing...reduces handling as well as the chance of calculation and mixing errors.@ Similarly, in a list of ACurrent Best Practices for Providing Organizations and Practitioners@ released by the National Patient Safety Partnership on May 12, 1999, the NPSP recommended that, AUse of unit dose drug distribution systems [be implemented as a Best Practice] for inpatient care; also use such systems for outpatient care, where appropriate.@ The U.S. Department of Veterans Affairs has also implemented unit dosing systems throughout many of its facilities as a means of reducing medication errors.

With regard to child resistance, the U.S. Food and Drug Administration has recognized the inherent child resistant capabilities of unit dose formats. In the preamble to FDA=s Final Rule regarding AIron-Containing Supplements and Drugs: Label Warning Statements and Unit-Dose Packaging Requirements,@ in fact, the Agency noted that:

...unit-dose packaging, even conventional unit-dose packaging, limits pediatric access to multiple dosage units of product. Moreover, the effectiveness of unit-dose packaging to limit pediatric access to product is not dependent on proper reclosure of the packaging. In contrast, the effectiveness of closure type packaging to limit pediatric access is dependent on proper reclosure of the container. If the closure is compromised (i.e., opened, improperly reclosed, or damaged), all of the contents of the package are readily available for ingestion. FDA=s concern is limiting the possibility that the product will be injurious to health. Unit-dose packaging, even conventional unit-dose packaging, will help to accomplish this end by limiting the amount of iron that a child can consume in a short period of time.

Unit dose formats are among the packaging options recognized as tamper evident by the U.S. Department of Health and Human Services, and they also increase shelf life by reducing exposure to atmospheric conditions such as humidity each time a bulk container is opened in a pharmacy to transfer solid oral dosage units to a cap and vial closure.

Despite all of these benefits, U.S. pharmaceutical manufacturers have been slow to adopt unit dose formats as original packaging. The HCPC believes that this is largely due to the difficulty involved in shifting any paradigm. Simply stated, change does not come easily.

For that reason, we believe that the U.S. government should craft as many incentives and encouragements as possible to promote greater use of unit dose formats as original packaging by pharmaceutical manufacturers. By doing so, pharmacists would: 1) have more time to counsel patients; 2) suffer fewer work-related injuries; 3) enjoy economic benefits; and 4) likely continue to be attracted to the pharmacy sciences industry. The general public would also benefit from safer, more reliable packaging, as well as the increased counseling that would be available to them when they fill their prescriptions.

The HCPC thanks you again for this opportunity to submit comments on this important issue. Please feel free to contact me should you have any questions, or need additional information.

Sincerely,

Peter G. Mayberry

Peter G. Mayberry
Executive Director

February 3, 2000 Letter to the Editor of the 
Wall Street Journal

Following is the text of a letter sent by the HCPC to the editor of the Wall Street Journal in response to an article that appeared in the February 3, 2000 edition: 

Michael Miller, Editor
Wall Street Journal, Marketplace
200 Liberty Street
New York, New York 10281

RE: "A DESIGN WITH TWISTS AND TURNS," WSJ FEBRUARY 3, 2000

Dear Mr. Miller:

On behalf of the Healthcare Compliance Packaging Council, I am writing in response to the article by Michael J. McCarthy that appeared in today's edition of the Wall Street Journal ("A Design With Twists and Turns"). While Mr. McCarthy did a good job of describing how difficult it can be for manufacturers of pharmaceutical caps to make their products simultaneously child resistant and senior friendly, the HCPC was disappointed that the article failed to mention successes achieved on this same front by manufacturers of pharmaceutical blister packs.

There are, in fact, several examples of "new school" blister packs designed to meet the seemingly paradoxical requirements of the U.S. Consumer Product Safety Commission that pharmaceutical packaging be both child resistant and senior friendly. One example is the Dosepak® from Westvaco which has achieved the highest possible level of safety in child resistant protocol testing, while also passing the senior friendly portion of the protocol. Another example is the Slidepack® developed by a major contract packaging firm in Philadelphia, Pennsylvania. I attended the "Washington industry conference" noted in Mr. McCarthy's article and -- despite the fact that I was wearing Vaseline-glazed goggles and heavy gloves -- was personally able to quickly remove six tablets from a Slidepack distributed by Mr. Bitner. Other examples of blister formats that have passed both the child resistant and senior friendly portions of the CPSC protocol, and are already on the market, include the Helidac® Therapy Kit (Prometheus Labs) and the PREVPAC® (TAP Pharmaceuticals).

When it comes to child resistance, blisters are superior to bottles. According to the U.S. Food and Drug Administration, this is true even for blisters that lack fortifications needed to pass the child resistant portion of the CPSC protocol. While some child resistant blisters can be difficult for older people to open, the HCPC believes that the Holy Grail of child resistant/senior friendly packaging will ultimately be found in the form of a unit dose blister pack instead of a cap-and-vial closure.

Sincerely,

Peter G. Mayberry

Peter G. Mayberry,
Executive Director

HCPC Statement Regarding February 2, 2000 Hearing on "Adverse Drug Events" held by Senate Committee on Health, Education, Welfare, and Pensions

Following is the text of an HCPC statement submitted to the Senate Health Committee on February 2, 2000:  

HEALTHCARE COMPLIANCE PACKAGING COUNCIL COMMENDS SENATE HEALTH COMMITTEE EFFORTS TO ADDRESS HOSPITAL MEDICATION ERRORS

Falls Church, Virginia, February 1, 2000 -- The Healthcare Compliance Packaging Council, a not-for-profit trade association established in 1990 to promote the many benefits of superior pharmaceutical packaging, today commended the Senate Committee on Health, Education, Labor, and Pensions for continuing its hearings on medical errors. "We are especially encouraged," noted Peter G. Mayberry, HCPC Executive Director, "by the agenda that the Senate Health Committee has selected for its February 1, 2000 hearing. 'Understanding adverse drug events' is a tremendously significant issue that deserves national attention." Considering that, on average, an estimated seven percent of all hospitalized patients -- some 2 million people -- experience an adverse drug event each year, the HCPC believes that inquiry by the Senate Health Committee is critical and timely. Moreover, in light of the fact that proven, cost-effective steps have already been identified to address the problem, the HCPC commends the Senate Health Committee for soliciting testimony from experts who are familiar with steps that could be taken today to reduce adverse drug event incidents by fifty percent or more. "One of these steps," Mr. Mayberry noted, "is the adoption of unit dose pharmaceutical packaging by drug manufacturers, hospitals, and other inpatient facilities throughout the country."

Most people are familiar with unit dose formats, or blister packs and strips, through over-the-counter medications and prescription birth control pills. With solid oral dosages such as pills or tablets, these formats separate each dosage unit in its own compartment or blister cavity. As Mr. Mayberry explained, "What many people may not know, is that unit dose formats can be combined with bar code technology such that no medication could be dispensed unless the doctor's prescription, the patient's medical chart, and the drug itself all match up correctly. These dispensing systems are already available, and are considered state-of-the-art when it comes to ensuring that the right drugs are given to the right patients at the right time."

"As far as we know," Mr. Mayberry continued, "every group that has examined the problem of in-patient adverse drug events has recommended the use of unit dose formats as a solution."

Institute of Medicine Recommends Unit Dose as the 
Rx for Hospital Medical Error Reduction 

In a report released by the prestigious Institute of Medicine on November 29, unit dose packaging is recommended to prevent medication errors that occur in hospital settings.  The report notes that hospital medication errors are responsible for up to 96,000 deaths every year (more than highway accidents, breast cancer and AIDS combined), and lays out a series of recommendations intended to reduce these tragic events by up to 50 percent.

Among the recommendations is the following (pages 166-167):

Implement Unit Dosing:  If medications are not packaged in single doses by the manufacturer, they should be prepared in unit doses by the central pharmacy.  Unit dosing -- the preparation of each dose of medication by the pharmacy -- reduces handling as well as the chance of calculation and mixing errors.  Unit dosing can reduce errors by eliminating the need for calculation, measurement, preparation, and handling on the nursing unit and by providing a fully labeled package that stays with the medication up to the point of use....As a cost cutting measure, unfortunately some hospitals have recently returned to bulk dosing, which means that an increase in dosing errors is bound to occur.