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Group # 1: Diagnosis Requirement on Prescription
Name: Atla Adera, Shawna Austin, Jessica Fiedelak, Reina Nakasone, My Phan, Inna Vasilyev, Jenny Wong
1. Describe the problem
According to the study To Err Is Human: Building a Safer Health System cited in the Institute of
Medicine report, 44,000 to 98,000 Americans die annually due to medication errors. In addition, medication
errors also ranks number 8 in the leading causes of death in the United States and estimated costs range
from $17 to $29 billion as a result of medication errors.1
Based on the Institute for Safe Medication Practices (ISMP), one of the common things leading to
medication errors is communication failure.1 This includes bad handwriting, misinterpretation of the
prescription, drugs with similar names and multiple uses, and the use of abbreviations. Having the indication
on the prescription would greatly reduce the number of medication errors due to problems discussed above.
This is even more important when considering the perspectives from both patients and pharmacists.
For instance, when the prescription is brought to the community pharmacies, pharmacists don't normally
have the patient's diagnosis, or indication, for the prescription. This type of information is very crucial to
make judgments of whether the drug is appropriate for the treatment. Prescriptions are required to have
certain information such as strength, dose, quantity, etc, but often do not have the indication.2 This creates
a problem when strength and dosage are appropriate only for certain conditions. The role of the pharmacist
is the last line of communication to make sure the patient receives the right treatment. By not having the
diagnosis information, even a small difference in dosage and strength can cause serious harm to the patient.
It is true that pharmacist can call the prescriber to get the information they need before filling a prescription
but this takes time and will thus cost money.
From the patient's perspective, some patients may not like having the diagnosis on the prescription
because they feel it would violate their privacy. However, since a pharmacist is part of the healthcare team
there is no violation of privacy in having the pharmacy employees see the diagnosis, and in fact many
patients may come to realize the large role a pharmacist plays in their safety and health.
2. Delineate the boundaries of the problem
There has been no requirement of having diagnosis on a prescription since before pharmacy became
a profession. When the profession began pharmacists were only responsible for counting pills and minor
compounding activities. Since the pharmacy became a profession pharmacists have become much more
knowledgeable about many facets of healthcare. This leads to greater safety for their patients.
Currently, we have WAC 246-871-050 to control the minimum requirement of information on the
prescription2. It does not currently require diagnosis to be a part of the prescription, although diagnosis
adds to the pharmacist’s knowledge, and thus the safety of the patient.
Not having diagnosis on the prescription can be the source of medication errors and can cause delays
in the time it takes to fill a prescription as well as add challenges to the counseling a pharmacist provides.
For instance, knowing the diagnosis for the patient allows the pharmacy to process insurance, like DSHS,
without waiting to ask the patient or their doctor. Often a patient will not know their diagnosis, and actually
getting in touch with the doctor can take up a lot of time for both the pharmacy and prescriber personnel.
Knowing the diagnosis allows the pharmacist to double check if the patient is receiving the right medication,
strength, and dosing schedule for the patient and diagnosis.
This is a national problem, but Washington has never shied away from being the first to increase the
happiness and safety of their patients, even if it means changing the way things have stood for many years.
The nation is eager to find solution to medical errors, including those that occur in the dispensing process.
Washington is innovative enough to take this step forward towards preventing medication errors, which have
been largely ignored until recently, but have been a safety hazard to patients since people began practicing
medicine.
3. Develop a fact base
It is hard to disagree that medication errors are a major problem. According to the report of the
Jackson M, Reines W. A Systematic Approach to Preventing Medication Errors. Available from
http://www.uspharmacist.com/index.asp?page=ce2790/default.htm.
2
Drug Distribution and Control, Washington Administrative Code (WAC) 246-871-050. Pharmacy Lawbook
2003. Washington State Department of Health, Board of Pharmacy (p. 170).
1
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Institute of Medicine, To Err Is Human: Building A Safer Health System, released in November 1999, more
people die from medical errors than from motor vehicle accidents, breast cancer, or AIDS. The US
healthcare spends $ 37.6 billion annually on costs associated with medical errors with medication errors
contributing $ 2 billion.1
The American Hospital Association identifies having incomplete patient information as one of the
causes for medication error.3 Not knowing the diagnosis for a particular prescription or previous diagnoses
of conditions a patient may still be experiencing falls under incomplete patient information. By having more
complete information, such as diagnosis, pharmacists can prevent many of the 7000 deaths
that occur annually in the United States due to drug errors.4
4. Describe your goals and objectives for resolving the problem and how you might measure change.
Being part of the health care team, pharmacists have strived in many ways to deliver the safest and
fastest pharmaceutical care to their patients. We believe requiring diagnosis on the prescription would
provide safer and faster care by meeting a few goals.
These goals include reducing medication related errors and making patient counseling more effective. The
objectives would include less medication errors being reported to
the Board of Pharmacy and other institutions of health, and a higher medication compliance being reported.
There are already many reports being done constantly on medication errors and their cost, both in
money and in quality of life, by many different organizations and institutions. Improvements in these scores
after diagnosis becomes a requirement of a prescription could show that this requirement is increasing
medication safety. Many pharmacies keep track of the average number of prescriptions they fill daily, which
when divided by the hours spent working on these gives an average amount of time spent per prescription.
If the diagnosis requirement is saving time then the pharmacy should be able to process more prescriptions
per day, and thus spend less time on each prescription. Studies could also be done on patient compliance,
which is a favorite topic of several University of Washington School of Pharmacy professors.
5. Identify the Policy Envelope
There are many variables at work in medication dispensing errors. These variables may include
staffing, lack of information, poor or incorrect information, and how busy the pharmacy filling the
prescription is. Although requiring diagnosis will not help staffing it will provide important information to the
pharmacist, who will then not have to call the prescriber or prescriber’s staff, from whom they could receive
poor or incorrect information. This requirement helps busy pharmacies by cutting down the time it takes to
fill a prescription, which allows for more time to be spent on very important things like safety checks or
patient counseling.
Many pharmacies will like the idea of cutting the time it takes to fill a prescription because in the long
run it can lead to a greater cash flow. Cutting back medication errors will decrease the cost of medication
errors to pharmacies, hospitals, and other healthcare institutions. Prescribers will have to take the extra few
seconds to add the diagnosis to a prescription, but this saves them the time of getting a telephone call or fax
later of which much more time must be spent to locate the patient’s file and retrieve the necessary
information. The other major interest in this requirement will come from companies that are currently
manufacturing and testing prescriber order entry systems, as well as businesses that have already
implemented prescriber order entry systems. It’s true that this would add another required field, but many
already include an optional field where the indication can be entered. These manufacturers would be
interested in finding whether or not diagnosis will be required as quickly as possible, due to the way that
pharmacies are moving away from paper prescriptions and more toward computerized prescriptions.
6. What are the potential costs and benefits to resolving the problem?
Despite our best intentions, economy is always a factor when deciding whether a new procedure or policy
should be implemented. There are some costs associated with requiring a medication’s indication to be
placed on all prescriptions. One, there is the cost associated with creating a new standardized prescription
form that would include a space to write the indication. While forms without such a prompt could be used,
this would likely increase the rate of prescribers forgetting to include the indication and would result in a
Medical Errors: The Scope of the Problem. Fact sheet, Publication No. AHRQ 00-P037. Agency for
Healthcare Research and Quality, Rockville, MD. http://www.ahrq.gov/qual/errback.htm
4
Nordenberg, T. Make No Mistake: Medical Errors Can Be Deadly Serious. Available from
http://www.fda.gov/fdac/features/2000/500_err.html.
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phone call. The cost associated with revising paper prescriptions, however, could be circumvented if this
information was standardized for online electronic prescriptions. If this proposal was included at the onset of
developing the software and technology no additional cost should be added. Other minor costs include
adjusting pharmacy software to include a field for entering the indication or code, but this is likely minor. The
benefits are decreased pharmacist’s time spent on the phone calling prescribers to clarify prescriptions. In a
study by Ingrim et. al.,5 it was estimated that a pharmacist spent between ten to eleven minutes per
telephone call to verify or get information that was missing from a prescription. This could result in many lost
salary hours per day that a pharmacist could be spending in providing more direct patient care. Finally, the
most important benefit is the possible reduction of medication errors. This could save money in not having to
re-process erroneously filled prescriptions, not to mention possible healthcare costs associated with treating
a patient following an adverse event (doctor visit, medication to correct symptoms from adverse event, etc.).
Pharm 543 Law & Ethics: Problem Definition.
Group : 2 Time frame that a prescription for Schedule II drugs is valid
Group Members: Aimee Breitfelder, Candace Kim, Christopher McCowan, Uzoma Okeke, Diana Regina,
Christopher Schaffner, Naomi Sweeney, Lincoln Wright.
Drugs in Schedule II of the Controlled Substance Act1 such as morphine, methadone, oxycodone, and
amphetamine are those substances that have some approved medical use. However, they have a high
potential for abuse with severe ability to cause psychological or physical dependence. 6,2 Many of these drugs
are prescribed for the treatment of severe pain. Therefore, it is expected that it should be filled in a timely
manner for immediate treatment.
The current problem with the law, regarding Schedule II (CII) prescriptions, is that the written
prescription is valid for one year from the date it is written. Since CIII and CIV prescriptions are only valid for
six months after the date that they are written, it is logical that CII prescriptions should have an even
shorter time frame during which they may be filled. This discrepancy in the law increases the likelihood that
CII medications will not be used by the patient in the manner they were originally intended. For example, a
patient may see his or her physician because of severe pain and may receive a prescription for a CII narcotic.
This patient may choose not to fill the prescription because the pain is markedly improved in a few short
hours. However, a few months later a new injury may arise that produces severe pain. Instead of seeing his
or her physician and possibly having a serious problem correctly diagnosed, the patient chooses to fill the old
CII prescription. Although the patient will receive relief from the pain, the medication may be covering up a
more serious condition. Conversely, a patient who chose not to fill the 7prescription may later fill it for use by
someone else. A second problem with the current law is that it allows individuals who obtain CII medications,
for the purpose of unlawful distribution, a greater time frame in which they may have a prescription filled.
As the current law stands, the pharmacist may be placed in a potentially difficult situation when
deciding if they should fill a CII prescription that has been written some time ago. By shortening the duration
that the prescription is valid, the pharmacist will have clear guidelines as to whether he or she should accept
the prescription.
So where did this discrepancy in the law come from? Before Title 21 C.F.R section 1300 was written
there were no restrictions on how long a CII was valid. If a CII prescription was a month or more old or if no
date was written on the prescription a pharmacist was required to call the physician to verify that the
prescription should still be dispensed.8 The reasoning behind this was to discourage the filling of a
prescription that had been unused and was now being filled for someone else in pain. 3 When Title 21 was
written the issue of expiration of CII drugs was overlooked. Other controlled medications such as CIII or
CIV's were given a six month expiration according to 1306.22 of the title. This left the problem of
determining the valid filling time of a CII to the individual boards of pharmacy. In Washington state the
expiration of CII's is currently based on WAC 246-869-100(2) (d). It states that no prescription is valid after
Ingrim NB, Hokanson JA, Guernsey BG, Doutre WH, Blair Cw Jr., Verrett TJ. Physician noncompliance
with prescription-writing requirements. Am J Hosp Pharm. 1983 Mar;40(3):414-7.
6
Washington State Legislature, “Uniformed Controlled Substances Act”
http://www.leg.wa.gov/RCW/index.cfm?fuseaction=section&section=69.50.206
2
Washington State Legislature, “Uniformed Controlled Substances Act”
http://www.leg.wa.gov/RCW/index.cfm?fuseaction=section&section=69.50.205
8
A phone interview with Jack an RPh at Union Center Pharmacy, Seattle, WA 12 Oct 2004.
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a year from the date it was written. This leaves CII prescriptions with an expiration of one year, six months
longer than CIII's and C IV’s, which are supposed to be less addicting than the CII's. Therefore, due to the
hazards that the current law poses, we suggest a change.
Many states have taken the initiative to remedy this ongoing problem by implementing fill time
requirements that go above and beyond that of our state of Washington. Schedule II drugs have some of the
strictest time limits for filling in states such as Texas, Delaware, Illinois, and Vermont. These states have
implemented laws that state schedule II controlled drugs shall not be filled more than seven days after
issuance of the prescription. Vermont is the exception to this, having a stricter time limit of five days. Other
states, such as West Virginia, California, and Louisiana, have time requirements ranging from one month to
six months.9
The goal in limiting Schedule II filling time is to provide a consistent system for pharmacists to
implement when patients delay in presenting a CII prescription. By limiting the time that the prescription is
valid, pharmacists will no longer be required to assess and determine the existence of a patient’s medical
condition and potentially be liable for dispensing a drug that is no longer necessary. Furthermore, the
proposed modification would prevent inter-pharmacy variability, when one pharmacy accepts the prescription
and another does not. This will prove to be more consistent and less confusion will occur. Accordingly, this
change in the law may lead to a decrease in patients addicted to these drugs. It may also lead to a decrease
in reported adverse events related to filling CII prescriptions that do not coincide with the prescribed
indication.
However, the impact of the proposed change extends beyond the pharmacist as both the primary
care provider and the patient would potentially be affected. The possibility of detrimental effects for the
primary care provider and the patient would most likely be an issue for patients taking maintenance
medications, including patients taking CII drugs for an indication other than pain, such as Ritalin for ADD.
The physician may be affected as it could result in an increased number of patient visits if they require
additional prescriptions. The patient may be affected when they are refused a prescription that they feel they
have the right to fill. However, the proposed modification to the law would be for the purpose of reducing
abuse potential rather than causing unnecessary burden. Therefore, ways to overcome that burden, such as
allowing post dated prescriptions to be written for maintenance medications, would be needed to offset the
potential barrier.
Although, there are issues relating to the proposed change that could be objected by some, such as
the potential barrier to medications for patients on maintenance medications, there are innumerable benefits
to resolving the problem. Above and beyond the decreased inadvertent abuse potential of CII’s by patients
filling a CII prescription later or patients distributing CII's to friends and family, there are also benefits by
decreasing the risk of illegal diversion of narcotics if unfilled CII prescriptions fall into the wrong hands.
Therefore, the proposed changes to the filling of CII drugs is a logical choice that will provide long term
benefits to pharmacists, the rest of the health care team, and the patient.
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Pharm 543 Problem Definition Assignment
Group 3, Introduction of CPR Certification for Pharmacy Licensure in Washington State
Group Members: Kellie Dillin, Anna Knopp, Elena Meeker, Jamie Mensik, Lindsey O’Malley, Jason Orthel,
Kevin McDermott
1. Describe the problem
Pharmacists are vital members of the healthcare team.
As the most easily accessible healthcare
professional, pharmacists come in contact with a wide variety of individuals, who seek or require
healthcare services. As a result of their thorough education, pharmacists function as safeguards for their
patients, ensuring that people under their care are not exposed to harmful medications, inappropriate
doses, or dangerous interactions. More than ever, a growing number of community members are coming
to pharmacists with questions regarding health screenings, lifestyle issues, and counseling.
Against this background, one key aspect of education and training appears to be lacking for many of
the pharmacists licensed in Washington State. Cardiopulmonary resuscitation (CPR) is a simple act, used by
those who claim to be healthcare providers, to help maintain the life of an individual, as expected by
members of the community if the need were to arise. Given that pharmacists are such important members
of the healthcare field, who come in contact with a vast number of patients, and the fact that Washington is
such a progressive state, it is now time to ask why current CPR is not required of pharmacists licensed in
9
The National Association of Boards of Pharmacy. www.nabplaw.net.
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Washington.
Pharmacists are highly educated healthcare professionals that must always be recognized as
knowledgeable, trustworthy caregivers who are focused on protecting and prolonging patient lives. It is time
to address and remedy the above-mentioned gap in training, which in turn, places their patients at risk. As
healthcare providers, all pharmacists have the duty, and should have the ability, to know and administer
CPR. There is no valid reason for pharmacists to be exempt from this issue of care. Washington State
should require current CPR certification for all able-bodied licensed pharmacists, regardless of practice
setting.
2. Delineate the boundaries of the problem
Since pharmacists have never been required to stay certified in cardiopulmonary resuscitation (CPR)
as a condition for license issuance and renewal in the State of Washington, there have always been
pharmacies without a staff member certified to respond in case of an acute cardiac or respiratory emergency.
This problem is present across the rest of the United States. Successful change is most likely to be fostered
at the state level. In the State of Washington, we are known for enacting new standards to improve our
profession’s ability to serve the public. By requiring current CPR certification as a condition of license
issuance and renewal in the State of Washington, we have the potential to foster a model for improved
patient care across the country.
3. Develop a fact base
In the United States, over 680 people are victims of sudden cardiac death each day. 10 However, if
patients receive early CPR and defibrillation within 3-5 minutes of cardiac arrest, followed by early advanced
care, their chances of survival can increase by over 50%. Indeed, cardiopulmonary resuscitation (CPR) is
internationally recognized as a valuable life-saving tool. The International Liason Committee on Resuscitation
(ILCOR), a group composed of seven resuscitation associations, including the American Heart Association,
performed a review of several international studies in 2001. This review indicated that cardiac arrest victims
who receive bystander CPR are about 2.5 times more likely to survive than those who do not.11 The most
recent studies support this evidence as well. The third phase of large Canadian trial published in the New
England Journal of Medicine this summer found that cardiac arrest victims were 3.7 times more likely to
leave the hospital alive if they received bystander CPR. As a result, this study concluded that public health
officials should dedicate increased resources to CPR training and promotion.12 Unfortunately, most cardiac
arrest victims do not receive bystander CPR, and statistics have shown that, even when it is given, the
quality of CPR is far from ideal.2
Pharmacists, as widely accessible healthcare professionals, are in a prime position to help meet the
urgent need for increased bystander CPR. While CPR certification may be required of many hospital
pharmacists by their employers, no regulations exist to regulate the certification of community pharmacists.
It is this latter group that is of particular importance, as community pharmacists serve patients outside
medical centers and thus would be ideally suited to perform CPR until the arrival of the emergency medical
team. We propose that all pharmacists, with a few notable exceptions, be required to obtain and maintain
current CPR certification as part of their continuing education requirements.13
10
Cardiopulmonary Resuscitation (CPR) Statistics. [Internet] Dallas (TX): American Heart Association;
c2004 [cited 2004 11 Oct]. Available at: http://216.185.112.5/presenter.jhtml?identifier=4483
Chamberlain DA, Hazinski MF; European Resuscitation Council; American Heart Association; Heart and
Stroke Foundation of Canada; Resuscitation Council of Southern Africa; Australia and New Zealand
Resuscitation Council; Consejo Latino-Americano de Resusucitación. Education in Resuscitation: An
ILCOR Symposium: Utstein Abbey: Stavanger, Norway: June 22–24, 2001.Circulation 2003;108:25752594.
12
Stiell IG, Wells GA, Field B, Spaite DW, Nesbitt LP, De Maio VJ, Nichol G, Cousineau D, Blackburn J,
Munkley D, Luinstra-Toohey L, Campeau T, Dagnone E, Lyver M; Ontario Prehospital Advanced Life
Support Study Group. Advanced cardiac life support in out-of-hospital cardiac arrest. N Engl J Med
2004;351:647-56.
11
13
Administrative procedures and requirements for credentialed health care providers; Washington
Administrative Code, Chapter 246-12 (2003). (Washington State Legislature, http://www.leg.wa.gov)
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4. Describe your goals and objectives for resolving the problem and how you might measure the change.
The current situation regarding cardiopulmonary resuscitation (CPR) and pharmacists is that only
some pharmacists are CPR certified. Furthermore, most pharmacists that are CPR certified are satisfying the
requirements for the immunization certification available in this state. As a group promoting pharmacists as
health care professionals, our goal is to require that all pharmacists are certified in CPR and maintain this
certification annually as part of continuing education. One of the main benefits of this project will be that
citizen access to CPR will be increased. Many high risk patients visit community pharmacies on a regular
basis and will be in a safer environment with CPR certified pharmacists. Although we will not be gathering
statistics to measure the outcome of our project, we are certain that our project is in the best interest of our
patients and will help further our profession.
5. Identify the policy envelope
The problem of allowing Pharmacists to practice without CPR training is difficult to measure.
However, the benefits of requiring such training could potentially be realized in one incident. Pharmacists
provide pharmaceutical care to a variety of patients each day, including populations susceptible to cardiac
accidents. Clearly, these patients stand to benefit from any expertise the Pharmacist is able to provide.
While some may express concern regarding the liability issues of performing CPR, the Pharmacy
Profession also stands to gain by providing yet another community service. In addition, we propose that CPR
training should be counted toward CE (continuing education) credits, providing a more tangible benefit.
The institution of mandatory CPR training for Pharmacists is not a radical policy proposal. RCW
18.64.005 empowers the Board of Pharmacy to determine requirements for licensure in the state of
Washington and similar CE requirements already exist.14 For example, seven hours of AIDS education must
be completed prior to licensure.15 The board also mandates the completion of 15 CE hours per year in order
to maintain licensure.16 Including a CPR requirement among these regulations would benefit both patients
and the profession.
6. What are the potential costs and benefits to resolving the problem?
An important part of policy analysis is determining the cost to benefit ratio. Many organizations will
not implement a new program unless it will benefit financially from the endeavor. The policy requiring
continued CPR certification for pharmacists has a potential to impact various diverse pharmacy settings
including hospital, clinic, independent, and chain stores. The administrative goals of these organizations are
different, which may impact their acceptance of this plan. It is therefore important to make the certification
program financially sound, even beneficial, to get unanimous support for our policy.
The policy we propose will not be a financial burden to any of the above stated corporations because
many CPR certification classes are available at no cost to participants. The training is essentially free. The
policy has a potential to be economically beneficial because we propose to make it count for continued
education (CE) credits, which are required for all pharmacists. If the pharmacist can fulfill the CPR
requirement and get 2 CE credits for free, then we believe the corporations will be advocates for our plan.
Pharmacy 543 Assignment #2
Group #4 Recommendation for Minimum Patient Counseling Guidelines
Melissa Buss, Tracy Chen, Rhea Coquia, Stephanie Kormeier, Ken Lau, Chris Stevens-Brodl, Shannon Wittke,
Judd Wright
1) Describe the Problem
Pharmacists have a professional obligation to ensure that patients leave the pharmacy understanding
how to correctly use their medications. Washington law requires pharmacists to counsel patients for each
prescription, but the extent of the counseling is not clearly defined. Many pharmacists do not give thorough
directions to patients or persuade them to comply with the prescribed therapy. Patients who use their
medications incorrectly may not achieve therapeutic results and may even harm themselves. Washington law
should define a set of minimum counseling guidelines for the pharmacists to use. Better counseling laws
would reduce prescription non-adherence, ultimately reducing costs to the health care system and improving
the health of patients.
2) Delineate the Boundaries of the Problem
The Washington State Board of Pharmacy has required pharmacists to provide patient counseling on all
new prescriptions and as needed on refill prescriptions for approximately 29 years. 1 In 2000 the law was
14
15
16
RCW 18.64.005. Pharmacy Law Book, 2003. Washington State Department of Health, pg. 2.
WAC 246.863.120. Pharmacy Law Book, 2003. Washington State Department of Health, pg. 152.
WAC 246.861.090. Pharmacy Law Book, 2003. Washington State Department of Health, pg. 147.
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amended from providing oral explanation on the directions for use and additional information, to direct
patient counseling to promote safe and effective administration of the medication. In 2001, it was amended
again to clarify that the pharmacist is responsible for providing sufficient patient counseling to promote
proper medication administration to facilitate an appropriate therapeutic outcome, but not to determine the
optimal therapeutic outcome for any patient.2
However, without a set of minimal standard for patient counseling to assure that the right patients are
receiving the right medications and given sufficient information to properly administer the medications, not
only is patient safety at great risk, treatment adherence can also be compromised if pharmacists only read
the directions from the label without actively interacting with patients. The potential for medication errors is
on the rise due the number of drugs that both look and sound alike. Costs associated with medication
adverse events can be greatly reduced if patients are counseled correctly when they pick up their
prescription medication.
3) Develop a Fact Base
The following is a list of the kind of evidence we need for our argument to be persuasive, and some ideas
about where to find it:
Evidence
Resource
Number of prescriptions dispensed in
WA BOP, IOM, CDC?
state/year
Number of non-Medicaid prescriptions
Medicaid, IOM
dispensed in state/year
Number of adverse drug events/year
IOM
occurring in outpatient setting
Cost of above adverse events, in lives and
Literature
economically
Rate of adherence or nonadherence to
Literature
prescribed drug regimens
Cost of nonadherence: hospital admissions for Literature
uncontrolled chronic disease, work days lost,
extended or additional tx, lawsuits
Martha Dye-Whelan (lawsuits?)
Public opinion of benefit of pharmacist
PubMed, published studies
counseling
Anticipated cost of implementing standards
Published reports on costs of OBRA ’90 to
pharmacies
Patient counseling laws in other states
NABP
4) Describe Your Goals and Objectives for Resolving the Problem, and How You Might Measure Change
The objective of this legislation is to reduce medication errors by pharmacists and technicians. Our goal
would be to reduce the current number reported to the Board of Pharmacy by 20 % in two years. The
measurement would be a count of reports of a specified type (e.g. medication errors where the patient
actually took/was administered an incorrect drug/dose/strength).
The goal of this project is to compose a set of minimum counseling guidelines to be followed by
pharmacists. These guidelines will apply to patients who are receiving new and refilled prescription. By
following these guidelines, pharmacies will automatically provide high quality patient care and increase the
therapeutic efficacy of the medication. It is our hope that through these guidelines, there will be an increase
in the respect community pharmacists receive from the public; thus increasing the number of citizens
seeking consultations with their pharmacist regarding over-the-counter products as well as prescription
items. In order to assess the effectiveness of these guidelines, pharmacies will be required to include self
stamped surveys in patients’ prescription bags. This survey will include questionnaires regarding the service
(counseling) they received in the pharmacy as well as the effect of that service to their recovery. The
pharmacy will also be subject to random inspections by a member of the board of pharmacy or its
representative. This inspection maybe conducted as much as once a month or as little as once a year.
5) Identify the Policy Envelope
Expanding counseling services to patients relies upon the need for adequate staffing in the pharmacy so
that work can continue while the pharmacist is busy interacting with his/her patients. If implemented, we
would expect to see pharmacists spending an increasing portion of their day involved in direct patient
contact. In an era where patient privacy is of paramount concern, the establishment of separate patient
counseling rooms or counters would reflect an increased focus on the exchange of medical information
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between patients and their pharmacist. We might also expect to see an increased willingness on the part of
insurance companies to compensate pharmacists for expanded counseling services that may be required for
some patients under certain situations.
The most important stakeholders in this issue are, of course, the patients themselves. While many
patients still refuse the offer to be counseled on their medications by a pharmacist, and are within their
rights to do so, many others wish to take a more active role in their health care and rely upon pharmacists
for important drug information that their primary care provider may not know or may not have the time to
explain.
Pharmacists obviously have a stake in this issue as well. Depending upon the volume of workload, many
pharmacists are under considerable time constraints and may not believe they have enough time to counsel
patients in more detail. But there is reason to suspect that certain segments of the profession are ready and
willing to take on the task. Research suggests that among pharmacists, those who have recently graduated
from pharmacy school are already more likely to convey to their patients adequate information about a drug,
its intended use, side effects, and precautions than any other subgroup within the profession.
Insurance companies can also be expected to be impacted by expanded regulations regarding
counseling. The trend is toward greater demand for reimbursement to pharmacists for the time spent
counseling; if the law is changed to require more extensive counseling services, we can expect greater
pressure on insurance companies to compensate pharmacists for the additional work that may be required.
6) What are the Potential Costs and Benefits to Resolving the Problem
Costs:
Decreased availability to fill prescriptions due to counseling requirements leads to demand for more
pharmacists and/or technicians. In the short term this may result in more medication errors. Mandating
counseling from what is currently in the realm of professional judgment to a legal minimum may ultimately
lower society's respect for the judgment of those professionals.
Benefits:
Counseling creates an additional check which should lead to correct medication usage and can potentially
decrease costs related to adverse events (because there are fewer adverse events when meds are used
correctly). Requirement "forces" companies to make more labor available to fulfill counseling duties, possibly
shifting pharmacist duties from counting and bottling to Drug Utilization Reviews and counseling.
1. WSR 00-16-108. Proposed Rules. Department of Health.
WSR 01-04-055. Permanent Rules. Department of Health.
Pharm 543 Laws & Ethics: Problem Definition
Group Number 5 – Intern Preceptor Relations
Group Members: Katharine Monaco, Katy Lashua, Meghin Gjerswold, Sovanny That, Christopher Stephens,
Alen Chen, Jaqueline Dierck.
1. Describe the problem
Interns and preceptors do not spend enough one-on-one time together in training. This is based on personal
experiences of several interns.
2. Delineate the boundaries of the problem
The problem has existed for as long as there have been interns. It is linked to preceptor time limitations and
work load. It is also linked to preceptors not knowing what their responsibilities to interns are. This problem
is ubiquitous.
3. Develop a fact base
We hope to contact the Board of Pharmacy regarding complaints filed against preceptors by their respective
interns as well as complaints filed against interns as a result of improper training. Interviews of interns and
preceptors about how the training process is going can also be provided as evidence.
4. Describe your goals and objectives for resolving the problem, and how you
might measure change.
·
To establish a specific minimum time requirement for preceptors to spend with their interns on a
monthly basis – documentation from both parties required.
·
Increase the requirements for preceptor licensing.
·
Change the evaluation forms so interns and preceptors can rate or grade their experiences with one
another.
Change can be measured by evaluating the number of complaints filed with the board of pharmacy.
5. Identify the policy envelope
Variables: Staffing, medication errors, competency of interns
Stakeholders: All involved – interns, preceptors, pharmacy staff, patients
PHARM 543: Rescheduling Pseudoephdrine to Schedule V
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Group 6
Members: Nick Dire, , Tasha Wong, Thoa Vo, Melanie Petilla, Jason Boyd, Huong Nguyen, Joyce Wang
1. According to the National Drug Intelligence Center (NDIC), a subgroup of the DEA, methamphetamine
poses the largest drug threat to Washington due to its wide availability and low cost. It is the drug most
associated with violent crimes in Washington and its abuse rate has been declared “high” by 45 out of 53
state and local law enforcement agencies included in the 2002 NDIC National Drug Threat Survey. Since
1998, the state’s methamphetamine production, which highly relies on attaining over-the-counter ephedrine
or pseudoephedrine products such as Sudafed, has increased three fold ranking us third only to California
and Missouri.
As pharmacists and healthcare providers, we believe we have the ability to help fight Washington’s
increasing methamphetamine problem by regulating the distribution of Sudafed and other pseudoephedrine
over-the-counter products. Though we support the proper use of the medication, we propose classifying
Sudafed as a schedule V drug in order to provide more stringent standards for increased regulation.
2. Methamphetamine is a derivative of amphetamine. Amphetamine can be traced back to 1887,
where it was first synthesized in Germany. However, it had no medical purpose until the late 1920’s when
tests were done to determine its potential uses.
Amphetamine’s first use was an inhaler to treat congestion in the 1930’s. In 1937, it was also
available by prescription in a tablet form and marketed as Benzedrine. However, it was abused and used by
non-asthmatics that were looking to get a new “high”. It was also converted into tablet form by prescription
only in 1937.
In 1919, the Japanese discovered how easy methamphetamine, a more potent derivative, was to
make. In addition, due to its high water solubility they used to inject its contents into the body. In the U.S.,
they produce it under the name Desoxyn.
It became more widely used during World War II. It became popular due to the fact that it was easily
accessible in tablet form and keep the men going during the ordeal.
In the 1950’s, dextroamphetamine (Dexedrine) and methamphetamine (Methedrine) were
synthesized legally. They were also very readily accessible to the public. Thus along with the increase in use
came the increase of abuse. They became the “cure all” for treating everything from weight to depression.
However, there was a dramatic shift in the 1960s once it could be injected. In order to combat this
increase the 1970 Controlled Substances Act was passed which restricted the legal production of
methamphetamine used for injection classifying it as a Schedule II drug, meaning that it has a high potential
for abuse.
In the U.S., methamphetamine has been called the “Crack of the 90’s” since there has been an
increase of its distribution and abuse in the past few years. This is indicated by investigations, seizures,
price, purity, and abuse data. President Bill Clinton took action against its distribution when he signed the
Methamphetamine Control Act of 1996. Here the law states that the chemicals used in production of
methamphetamine are regulated. It also increased the consequences of producing or distributing it.
In July of 2000, the Methamphetamine Anti-Proliferation Act was passed which reinforces sentencing
and gives training to Federal as well as State law enforcement dealing with methamphetamine investigations
involving clandestine methamphetamine laboratory. In addition, continues to aid substance abuse prevention
efforts and increase controls on distribution of the product.
Methamphetamine is addictive and can be synthesized easily using products that are readily
accessible all across the U.S. In 1997 the National Household Survey on Drug Abuse (NHSDA) estimated that
there were about 5.3 million Americans that have tried it at one point in time.
http://www.stopmethaddiction.com/history-of-meth.htm#Top%20of%20page
3. Methamphetamine labs are a problem in the state of Washington. There are already laws in place in the
revised code of Washington to protect against the sale of pseudoephedrine, because of its use in the
manufacturing of methamphetamine: Finding -- 2004 c 52: "The legislature finds that quantities of
ephedrine, pseudoephedrine, and phenylpropanolamine continue to be sold at the wholesale and retail levels
far in excess of legitimate consumer needs. The excess quantities being sold are most likely used in the
criminal manufacture of methamphetamine. It is therefore necessary for the legislature to further regulate
the sales of these drugs, including sales from out-of-state sources, in order to reduce the threat that
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methamphetamine presents to the people of the state." [2004 c 52 § 1.]
http://www.leg.wa.gov/RCW/index.cfm?section=18.64.044&fuseaction=section
According to the National Drug intelligence Center in Feb 2003 edition of Washington Drug
Intelligence Center, Methamphetamine production in the state of Washington is a very large problem. In
2002 the state is ranked 3rd after California and Missouri in number of Methamphetamine labs that were
discovered and dissolved.
Since this law has been enacted in the state of Oklahoma, statistics are being collected and reported.
The Oklahoma state board of pharmacy has numbers that show a decrease in the number of
methamphetamine labs in the state after the law went into effect. According to the Kansas City Star the
number of meth labs has decreased by 124 and saved tax-payers almost $500,000 in clean-up costs since
enacting the law in April of 2004 (6 months ago). Because of the new law, there have been increases in the
sales of pseudoephedrine in neighboring states. Mark Woodward, spokesman for the Oklahoma Bureau of
Narcotic and Dangerous Drugs Control is quoted in the article as saying, “It emphasizes the importance for
surrounding states to also pass this law. If we can get some of these other states on board, that's going to
really, really help."
http://www.mapinc.org/drugnews/v04/n1001/a04.html?397
Sales from convenience stores is a problem and our law would stop sales from convenience stores.
Pierce County identified a major bust of a convenience store by the DEA resulting in the seizure of almost
400,000 tablets of pseudoephedrine. (Alcohol and drug abuse institute at the UW)
http://depts.washington.edu/adai/pubs/arb/arb04_04.pdf
Methamphetamine is a dangerous drug and represents a major challenge to agencies with police
powers. 90.9% of State and local law enforcement agencies in the Pacific region of the United States ranked
methamphetamine as their greatest drug threat. Law enforcement agencies also said that cocaine and
methamphetamine were the largest contributors to violent crimes.(National Drug intelligence Center).
http://www.usdoj.gov/ndic/pubs8/8731/meth.htm
4. Our concern is that methamphetamine use is on the rise in Washington because
users can easily access products containing pseudoephedrine, the main ingredient
in meth. Therefore, by making pseudoephedrine into a schedule V drug, we hope to
decrease pseudoephedrine sales by wholesalers by 10%, by retailers by 20%, and
by out-of-state sources by 10% in the next year. By reducing the sales of
pseudoephedrine, we hope to reduce the number of meth labs in Washington by 10%
in a period of 1 year.
5. Pseudoephedrine is one of the precursor drugs used to make methamphetamine. In 2001, at the request
of the governor, the Legislature passed a low restricting the sale pseudoephedrine products. (RCW
69.43.110) There are still some unprofessional conducts which violated the law by selling more than the
allowable amount of pseudoephedrine products. The variables which can be measured regarding the
problems are the illegal manufacturing and abuse of methamphetamine in Washington State, the lacking of
controlled pseudoephedrine transactions by the pharmacists because pseudoephedrine products are OTC
products, lacking of strong enforcement of selling pseudoephedrine products.
6. There are potential costs and benefits when classifying pseudoephedrine as a schedule five drug. For
example, retail stores can better regulate the amount of pseudoephedrine sales in the store by keeping it
behind the counter, requiring photo ID, and maintaining proper documentation on the sales of the drugs.
This reduces the amount of loss that could occur due to the potential of embezzlement by those seeking the
drug for illegal uses. With decrease loss, retail stores will not have to raise the price on these drugs to
accommodate for the loss, which will be beneficial to the consumers. Moving pseudoephedrine to a schedule
five status can also significantly decrease the number of methamphetamine labs in the community.
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Methamphetamine use has been linked to a higher crime rate and increase in environmental dumping. The
result of making pseudoephedrine and pseudoephedrine containing products less accessible for the drug
seekers is a safer and cleaner community. A benefit for pharmacists is that they can provide counseling of
the drugs and address any concerns with the patient on their medications.
7
Pharm 543 Group 7
Problem Definition for Verbal Communication Law Revision
Kristen SooHoo, Christy Weiland, Jennifer Fidler, Virginia Krause, Trang Le, Anh Nguyen, Vinh Phan
1.
21 CFR 1306.03 b states that “A prescription issued by an individual practitioner may be
communicated to a pharmacist by an employee or agent of the individual practitioner.” In current medical
practice, a practitioner’s agent is often a receptionist or medical assistant who has very sparse drug
knowledge, if any. When an agent with little or no drug knowledge calls in a prescription to a pharmacy,
there is a potential that the agent will misread, misunderstand, or miscommunicate the practitioner’s
prescription to the pharmacist. This poses a threat to patient safety by increasing the potential for a
medication error to occur.
Furthermore, when a practitioner’s agent calls in a prescription to a pharmacist, sometimes the agent
does not know the drug strength, dose, or directions. When the pharmacist asks the agent to clarify one of
the above details, the agent, not having drug knowledge or the ability to use professional judgment in this
instance, must either put the pharmacist on hold to check with the practitioner or call the pharmacist back.
This wastes the agent’s, practitioners, and pharmacist’s time and resources. By legally limiting pharmacists
to only accept prescriptions over the telephone from practitioners or registered nurses, the number of
potential medication errors and wasted time and resources can be significantly reduced.
2.
Prescription errors are a chronic problem for all healthcare providers across the nation.
Prescription errors have been steadily increasing over the past several years. 17 There are as many as 7,000
deaths annually in the United States from incorrect prescriptions, according to Carmen Catizone of the
National Association of Boards of Pharmacy. He told The Washington Post that as many as 5 percent of the 3
billion prescriptions filled each year are incorrect. With the number of prescriptions expected to climb to 4
billion by 2004 and the number of pharmacists steadily decreasing, there are bound to be "problems down
the road," Catizone said.18 While the number of pharmacists is decreasing there is an increase in new drugs,
the number of prescriptions, patient awareness, access to healthcare and improved technology. These
factors all contribute to an increased risk for prescription errors. That is why it is imperative that we
implement a law that will limit the agents that can call in a prescription to practitioners and registered
nurses.
3.
Miscommunication between the doctor’s office and the pharmacy can result in errors in dispensing. A
study by University of Manchester, UK has shown that 24% of errors were a result of misreading the
prescription19. We can minimize these errors by improving communication through limiting which type of
healthcare employee can call in a new prescription to the pharmacy.
In another case study by Dr. David Bates of Brigham and Women’s Hospital in
Boston, MA, we can see that there is equal frustration by physicians over medication errors.20 Since we
believe this group of providers will be our most difficult audience to convince, we intend to show that they
will appreciate this change as much as pharmacists. Dr. Bates explains the phases of outpatient “medication
process” include “prescribing, transcribing, dispensing, administering and monitoring.” The proposed
addition to our current law will affect the transcribing stage of the process. In this case, an error was made
when a medical assistant called in a new prescription which was taken by a pharmacy technician. Neither
www.health-minder.com/HealthMinderNews/Dec2002/page2.html. Accessed 10-9-04
http://www.consumeraffairs.com/news/pharmacy_errors.html. Accessed 10-9-04
19
Ashcroft DM, Quinlan P, Blenkinsopp A. Prospective study of the incidence, nature and causes of
dispensing errors in community pharmacies. Pharmacoepidemiol Drug Saf. 2004 Sep 6
17
18
20
Bates MD, A 40 year old woman notices a medication error
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person had received adequate training to carry out this responsibility. In Washington, it is illegal for a
technician to receive new prescriptions; however, with the numbers of medication errors that are occurring,
it is important to refine the prescription translation/writing process in whatever ways we can.
Currently, the US federal law allows physicians to delegate this task to any of their employees. 21 We
will investigate how other regions have dealt with this issue. For example, in British Columbia, the law states
that pharmacies can only take prescriptions directly from the practitioner or their voice recording. 22 In
developing evidence to convince the Washington Board of Pharmacy that we need to restrict verbal order
authority, we will find further studies from PubMed and Medline. We will also consult with pharmacists in
local pharmacies to understand how they feel about this proposed policy.
4.
There are three main goals we hope to accomplish by implementing this law. The first goal is to
reduce medication errors that occur from phoned in prescriptions from an employee that lacks education or
experience with drug names, prescription directions, interactions, etc. The second goal is to create a more
direct relationship between the patient, physician and pharmacist. This increase in communication will allow
for improved patient care, where we are all working together to enhance the patient’s quality of life. Finally,
we hope that this law will save time and money for the pharmacist and the patient.
If appropriate personnel communicate the medication order, there will be less chance of
miscommunication and medication errors. The pharmacist can also spend their time on other important
issues. The frequency of medication errors requires another checkpoint step. If the pharmacy is the only
place for checkpoints, we have a step involved in obtaining a new prescription that has no check on it. In
order to improve patient safety, educated medical professionals, including anyone with prescribing authority
and their nurses, should be calling in new prescriptions.
After implementing this law, we could measure the number of medication errors that occur from
phoned in prescriptions and either compare it to the number of errors prior to the law, or compare it to the
number of errors in other states that do not have this regulation.
5.
There are several measurable variables regarding the current regulation of a prescription being
translated to a pharmacist by an agent of the individual practitioner such as medication errors, lost time and
money. This problem could be measured by the amount of medication errors pharmacists receive due to
incorrect information like drug name, dosing, directions, or any other information significant to the patient
from a non-trained employee of the prescriber. Other measurable variables are the time and financial loss
experienced by the pharmacy and prescriber when prescription information is verbally transferred and the
pharmacist needs clarification or has additional inquiries. This requires the agent to talk to the doctor, clarify
the information, and relay it back to the pharmacist. Not only does this process take time, but it also costs
the pharmacy to have their pharmacists, who get paid hourly, spending their time on prescription clarification
instead of more productive matters. If a doctor or nurse calls in the prescription to begin with, he or she
should be able to answer many of the questions the pharmacist may have regarding the prescription or the
patient.
The most important person who should have an interest in the risk of medication errors is the
patient, because he/she is the one who could potentially have an adverse event due to an error in
prescription translation. However, the average patient is not aware of the possible errors, so I think the most
vocal stakeholders will be the prescribers’ offices. This change in policy would force the offices to change the
duties of their staff. This would increase the amount of work for the nurses and prescribers and decrease the
amount of work for the others in the office. Since nurses’ and prescribers’ time is worth more financially, in
regards to business, it will also result in an increase cost for the office. Other stakeholders in this policy
include the pharmacist and pharmacy interns. Requiring prescriptions to be phoned in by only prescribers or
registered nurses will allow pharmacists to feel more confident that information is being verbally transferred
correctly.
6.
Resolving this problem would possibly require increased staff for the prescribers. The major cost of
resolving this problem is a higher wage that is expected for a more educated individual. However, there are
21
22
Persons entitled to issue prescriptions. 21CFR1306.03. Revised April, 1, 1998.
British Columbia Legislation By Laws. Law 5: Community Pharmacy 38.2.4
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great benefits to this more stringent requirement. Resolving this problem will reduce the inefficient use of
time for order clarification among nurses, doctors, pharmacists, and other staff involved throughout the
process, which in turn reduces the cost in staffing. Furthermore, there will be a decrease in healthcare costs
from the resulting reduction of medication errors.
8
Group 8: Clearing Confusion: Identifying PAs Authorized to Prescribe Schedule II Medications.
Rick Bockovich, Julie Duong, Sunshine Gascon, Yvonne Hewett, Esther Labib-Kiyarash, Leonie Neville, Allison
Pham, Janna Tseng
1.
Describe the problem:
Under current Washington state law WAC 246-918-035, licensed certified physician assistants (PA-Cs) may
prescribe controlled substances, including Schedule II drugs. Those persons licensed before July 1, 1999 and
persons possessing an interim PA permit may or may not have prescriptive authority in this state.
Although a credential search database is available through the Washington State Department of Health web
site, all providers are listed as "physician assistant" only. No distinction is made between providers who may
legally prescribe Schedule II medications and those who may not. This information is available directly from
the Medical Quality Assurance Commission on weekdays only.
This poses a problem for pharmacists because we are legally liable to dispense only those prescriptions which
come from legitimate sources. Pharmacists need access to accurate provider information, including
prescriptive authority, through an expanded search engine or web site. By ascertaining the validity of
Schedule II prescriptions from physician assistants, pharmacists can protect themselves and potentially, their
patients.
2.
Delineate the boundaries of the problem:
There is no existing system for pharmacies to determine the prescriptive authority and scope of practice of
Physician Assistants.
3.
Develop the fact base:
In order to estimate the scope of the problem we will assemble anecdotal evidence based on group member
experience. In addition articles from journals such as Health Service Research 2003 edition will be used in
an attempt to quantify the number of Pas practicing in Washington State and the quantity and level of care
being provided.
An unpublished and unfinished study prepared by the Board of Medicine in Virginia and presented to the Joint
Commission on the Health Care will be used to illustrate that this problem is not limited to Washington State.
4.
Describe goals and objectives for resolving the problem and how to measure change:
Our goal is to establish a database or resource for pharmacies, that will be available at any hour, that will
clearly state the prescriptive authority and scope of practice for all PAs practicing within Washington State.
Change can be measured by increased productivity and a reduction in the number of prescriptions that fail to
be processed due to uncertainties concerning prescriptive authority.
5.
Identify the policy envelope:
The biggest variable that can be measured regarding this problem is time. Pharmacists lose valuable time
trying to find out if a PA is authorized to prescribe schedule II medications. This takes away from time that
should be spend performing important tasks such as drug utilization reviews and patient counseling. Just as
pharmacists lose valuable time, so do patients. Patients want their prescriptions filled in a timely manner.
They already don’t understand the time necessary to accurately fill a prescription. In addition, pharmacists
spend too much of that time on issues such as insurance.
It makes sense to establish a list or website that is accessible to pharmacies containing information on PA’s
so that precious time isn’t wasted on this task too. Another variable that can be measured is money. How
much money is spent on the resources needed to find out whether a PA is authorized to prescribe a CII or
not? Examples of resources used are labor, computers, internet, and phone line. Lost customer base is also a
variable that can be measured. Sick customers are not the most patient of customers. An extra five minutes
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might be the difference between them staying loyal to the pharmacy or choosing to go elsewhere. The final
variable that can be measured is licensure. A pharmacist is putting his license on the line when he fills an
unauthorized CII prescription.
As evident from the variables discussed above, the stakeholders involved are the pharmacists, the
pharmacies where they work, and the customers who get their prescriptions filled there.
6.
Costs & Benefits related to solving the problem:
Instalation or creation of an online database will require time and resources. It will require computers to
host the site (which already exist within the DOH), people to put up the information and update it (which
also already exist within the DOH), and people to maintain the infrastructure upon which the site is based
(again, already in the DOH).
9
Establishment of an open database which clearly states the prescriptive authority and scope of practice for all
PAs that practice within Washington State will enable pharmacists to fill and process prescriptions in a more
timely manner.
Pharm 543: Problem Definition
Group 9: Revision of Schedule II Prescription Expiration Date
Group Members: Brionne Alvord, Carson Huntoon, Nicole Miller, Dora Banjanin, Cori Nelson, Angie Lambert,
Abdi Tache
1. Describe the Problem
Currently, due to an oversight in Washington State law, PracAct RCW 69.50.308, Schedule II prescription
drugs have an expiration date of 12 months from the date written. This law has no mention of Schedule II
drugs, which are more addictive and have a greater abuse potential, then the Schedule III and IV drugs. On
the other hand, both Schedule III and IV prescription drugs have a six month expiration date. Our goal is to
have stricter regulation of the Schedule II drugs, by adopting a prescription expiration date that is seven
days from the date written. This change would make Schedule II prescribing laws more consistent with the
prescribing laws of the other scheduled drugs and that of other states. States such as California, Texas and
Illinois23, have implemented the seven day prescription expiration date and have been successful in reducing
the number of problems associated with the abuse and misuse of Schedule II prescriptions.
A Drug Enforcement Agency Testimony on December 11, 2001, before the House Committee on
Appropriation, suggests a correlation between drug abuse potential and a state's ability to monitor
prescribing24. The states mentioned above, have a lower number of OxyContin® prescriptions written; a
Schedule II drug, which has the highest abuse potential and tends to be the abused drug of choice. It is
believed that the low number of OxyContin® prescriptions written, is due to the stringent prescription
monitoring programs, along with the short validity of the prescription of the Schedule II drugs.
As pharmacists, our chief values are to be more consistent with the Controlled Substance Act and to be
confluent with the states that have already adopted similar regulations. In addition, changing the validity
length of prescriptions, would automatically establish stricter guidelines for monitoring the use of Schedule II
drugs. The RCW’s omission of the reasonable expiration date for the Schedule II drugs increases the medical
community’s liability, and decreases patient safety. Changing this issue would also affect drug abusers,
because “drug-seeking behavior” would be easier to identify and help can be administered promptly.
In our proposal, Stimulant Schedule II drugs used for treatment of Attention Deficit Hyperactive Disorder
and Attention Deficit Disorder would be exempt from the “seven day expiration date”. These prescriptions
would have a six month expiration date. This exemption is necessary for the convenience of the patients on
these chronic medications, but provides for physician monitoring, and making the Schedule II law consistent
with current Schedule III and IV laws.
2. Delineate the Boundaries of the Problem
TX PracAct Sec. 481.074., CA PracAct 11166, IL PracAct 570/312
Hutchinson, Asa. DEA Congressional Testimony--Drug Enforcement Administration Before the House
Committee on Appropriations. [Internet]. Alexandria [VA]. December 11, 2001. [cited 2004 Oct 8].
Available from: http://www.usdoj.gov/dea/pubs/cngrtest/ct121101.html
23
24
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The United States Controlled Substances Act does not delineate any time limit on filling Schedule II
drugs, it only states that they must not be refilled. The Washington Controlled Substances Act took on
almost the same wording as the federal, resulting in an omission of a time limit. As a result, this federal
“oversight” has become a statewide problem. Other states have adopted their own laws about time limits of
filling Schedule II drugs, from 5 days to 6 months. There is wide variability of Schedule II fill limits.
Washington has yet to make any changes to the federal law of a one year limit. Washington’s current law
regarding expiration of Schedule II drug prescriptions promotes problems such as ailments being treated
inappropriately and incorrectly due to late fills. It increases the chances of drugs being used for different
indications other than intended. It may also aid in drug hoarding and abuse. There have been lawsuits
about schedule drugs being filled late and drug abuse. This is bringing attention and urgency to this issue,
as it is a “glitch” that needs to be fixed as soon as possible.
3. Develop a Fact Base
1. What are some other states doing in regards to Schedule II expiration?
West Virgina-WV BReg §15-2-7
a. Prescriptions. “A prescription for a Schedule II controlled substance is valid for ninety (90)
days from the date issued. A pharmacist may fill the prescription after ninety (90) days if the
prescriber confirms to the pharmacist that he or she still wants the prescription filled and the
pharmacist documents upon the prescription that the confirmation was obtained.”
Texas-TX PracAct Sec. 481.074
d. “…a person may not fill a prescription for a controlled substance listed in Schedule II after
the end of the seventh day after the date on which the prescription is issued.”
Delaware-DE BReg 4
h. Expiration of Prescriptions. “Prescriptions for controlled substances in Schedules II and III
will become void unless dispensed within seven (7) days of the original date of the
prescription or if the original prescriber authorizes the prescription past the seven (7) day
period.”
Louisiana-LA BReg 2525
B. “A prescription for a controlled dangerous substance listed in Schedule II, III, IV, V shall
expire six months after the date written.”
Vermont-VT BReg 3.700
“No prescription for a schedule II controlled drug shall be filled more than five days after
issuance of the prescription.”
Virginia-VA BReg 18 VAC 110-20-290
A. “A prescription for a Schedule II drug shall be dispensed in good faith but in no case shall
it be dispensed more than six months after the date on which the prescription was issued.”
2. What are the Schedule II abuses and prevalence seen nationally and locally?
A.
The Drug Enforcement Agency (DEA) intends to monitor the prescribing practices of Schedule
II medications to look for illicit drug abuse. At the same time, it does not presume to know
when a patient in pain is in need of Schedule II narcotics and leaves this up to the good
judgment of the medical professional. This is an interesting article in it demonstrates the
DEA’s desire to work with states and regulatory agencies to protect patients with chronic pain
and to identify problematic patterns of drug use. 25
B.
An article addresses the problematic use of oxycodone in recent years and how the use of
polypharmacy26 contributing to deaths from addiction. This article also emphasizes that the
largest impact from the abuse of oxycontin is on legitimate patients with chronic malignant
pain, who are unable to rely on effective treatment regimens due to “opiophobia”. 27
Woodward, Terrance. Prepared Witness Testimony—The Committee on Energy and Commerce
[Internet]. Washington D.C. [District of Columbia]. 2001 Aug 28 [cited 2004 Oct 7]. 3 pages. Available
from: http//energycommerce.house.gov/107/hearings/0828200Hearings363/Woodworth596.htm.
26
This article defines polypharmacy as multiple drug use.
27
Robert, Teri. OxyContin: The Saga Continues! [Internet]. [cited 2004 Oct 5]. Available from:
http://headaches.about.com/cs/druginfo/a/oxy_saga_p.htm.
25
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C.
The 2002 National Survey on Drug Use and Health (NSDUH) reported illicit drug use at 19.5
million for Americans ages 12 and older.28 While marijuana remains the drug of choice for
abusers, national trends statistically confirm an increased use of psychotherapeutics,
particularly within the class of narcotic analgesics. In 2002 NSDUH determined that 70% of
illicit drug users who did not use marijuana chose psychotherapeutics, and within that class,
71% used pain relievers.29
The significant abuse of narcotics and opiates has specifically permeated Washington.
Narcotic/analgesic combinations outnumbered incidence of heroin abuse in Seattle in 2001.30
According to the National Institute on Drug Abuse, Seattle ranked the highest of the national
big cities that year in its increase of narcotic analgesic and opiate use, a rate of 123
percent.31 The potency of these drugs is also evident in the number of deaths in King County
relative to the total drug-induced deaths from the years 1999 to 2001. The Drug Abuse
Warning Network of the Department of Human and Health Services reported 21 deaths in
King County in 1999 from narcotic analgesics as the single drug involved in death; this
number dramatically increased to 53 and 57 in 2000 and 2001, respectively, with methadone
and oxycodone used most frequently.32 In 2001 narcotic analgesics alone accounted for 39%
of the total drug-induced deaths in King County.33 These prescription-only drugs when
abused are fatal.
Rising illicit use of Schedule II drugs is leading to unintentional deaths. The Department of
Human and Health Services further notes in the 2001 Mortality Data that 74% of the druginduced deaths were accidental and unexpected.34 The extent of this expanding abuse
unfortunately reaches beyond current illicit drug users. The National Survey on Drug Use and
Health approximated 4.7 percent (11 million) of Americans 12 and over within 2002 drove at
least once under the influence of an illegal drug; an astonishing 18% of 21 year olds reported
having driven under the influence that year.35 The effects of substance abuse are no longer
confined to individuals as an increasing number willingly interact with society while
intoxicated with harmful agents that seriously alter physical and mental function.
The trends are pushing toward substantially increased abuse of Schedule II narcotic
analgesics and opiates. Realizing the potency of these drugs and their potential harm and
fatality for both illicit drug users and those within their association in society, Schedule II
drugs must require at least the same restrictions as the less frequently abused and less
harmful and far reaching Schedule III to V medications.
D. It is also of note that court cases have been filed suing manufacturers of Schedule II’s (most
notably Purdue, manufacturer of OxyContin®) for damages due to addiction to opiates. See
4 below.
3. What are current guidelines for prescribing schedule II medications for control of pain?
A.
The National Guideline Clearinghouse has used Washington States Labor and Industry Board
U.S. Department of Health and Human Services—Substance Abuse and Mental Health Services
Administration. Section 2. Illicit Drug Use. Results from the 2002 National Survey on Drug Use and
Health: National Findings.
29
SAMHSA. Results from the 2002 National Survey on Drug Use and Health
30
National Institutes of Health. Epidemiologic Trends in Drug Abuse Advance Report, December 2002.
National Institute on Drug Abuse.
31
NIH. Trends in Drug Abuse Advance Report, December 2002.
32
U.S. Department of Health and Human Services—Substance Abuse and Mental Health Services
Administration. Mortality Data from the Drug Abuse Warning Network, 2001. www.samhsa.gov
33
SAMHSA. Drug Abuse Warning Network, 2001.
34
SAMHSA. Drug Abuse Warning Network, 2001.
35
SAMHSA. Results from the 2002 National Survey on Drug Use and Health
28
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guidelines to set a standard of practice in the prescribing an dispensing of controlled
substance for the relief of chronic non-malignant pain. The guidelines specifically outline a
method of documentation and evaluating information to provide the best therapy possible to
prevent pain, but to avoid an addiction. Included are: “a finite treatment plan that does not
exceed six weeks, description of reported pain relief from each medication, justification of the
continued use of each controlled substances, and documentation of attempts at weaning,” to
name a few. It also states that in cases of acute traumatic pain that “schedule II drugs
should be prescribed for no longer than 2 weeks.”36
B.
The World Health Organization has guidelines on the prescribing for chronic non-malignant
pain. This emphasizes the precautious necessary properly treat pain by avoiding undertreatment yet preventing addiction.37
C.
Purdue Pharma along with the Federal Food and Drug Administration (FDA) has revised the
product information insert to include a black boxed warning as to the high abuse potential of
OxyContin®. They have also clarified the indications for use to emphasize the inappropriate
use of this in patients with acute pain not requiring continual pain relief.38
4. What issues have been raised in the process of judicial review?
A.
Katherine A. Hoover, appellant, v. The Agency For Health Case Administration, etc., Appelle.
This case illustrates the difficulty doctors’ face when prescribing controlled substances to
patients with chronic pain. Hoover, a doctor licensed to practice in the state of Florida, had
her license suspended by the Department of Business and Professional Regulation for excess
dispensing of Schedule II narcotics. Hoover appealed the board’s decision which was
reversed in the Third District Court of Appeals, because the agency did not establish the
necessary burden of proof to revoke her license.39
B.
Foister, et al., v. Purdue Pharma, L.P., et al. Several patients in state of Kentucky are
accusing Purdue of not providing the information necessary to advise of their product
OxyContin®’s abuse potential. All plaintiffs are admitted to an opiate addiction and “drug
seeking” behavior prior to taking OxyContin®. Purdue was awarded the favor of the court for
being unable to establish the oxycodone containing drug to be the source of these
addictions.40
C.
Dee v. Wal-Mart Stores, Inc. This case highlights the importance of patients filling
prescriptions for indicated uses. Nicole Dee was prescribed Duragesic® 50 mcg patches for a
Caesarian delivery, which she did not fill. However, 4 months later she had the prescription
filled at a Wal-Mart Pharmacy for pain induced by a fractured ankle. The pharmacist did not
question the time elapsed from the date the prescription was written; the patient used the
prescription that night and died from hypoventilation. The Court of Appeals found the
Guidelines for outpatient prescription of controlled substances, schedules II-IV, for workers on time-loss
[Internet]. Washington State Department of Labor and Industries - State/Local Government Agency
[U.S.]. 1992 (revised 1999 Jun; republished 2002 Aug) [cited 2004 Oct 8]. 8 pages. NGC:003225.
Available from: http://www.guideline.gov/.
37
Achieving balance in national opioids control policy—Guidelines for assessment [Internet]. World Health
Organization. 2004 Jul 28 [cited 2004 Oct 9]. 2 pages. Available from:
http://www.who.int/medicines/library/qsm.
38
Dear Doctor Letter [Internet]. Food and Drug Administration-[US]. 2001 Jul 18 [cited 2004 Oct 5].
Available from: http://www.fda.gov/medwatch/safety/2001/oxycontin.htm.
39
Hoover v. The Agency for Health Care Administration. 1996 Fla. Accessed:
http://www.law.uh.edu/healthlaw/law/StateMaterials/Floridacases/Hoover.htm. [2004 Oct 9].
40
Foister, et al., v. Purdue Pharma, L.P., et al. 2003 Dec 30 KY. Accessed via Lexis-Nexis at
http://web.lexis-nexis.com/ [cited 2004 Oct 7].
36
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pharmacist guilty of negligence due to not addressing the patient’s lack of education for
opiate medications.41
D.
McCauley v. Purdue Pharma, L.P. This is another case of opioid dependent patients seeking
restitution from Purdue from the use of OxyContin®. The most interesting thing in this case
was the experts stating that “patients who used opioid analgesics for pain relief as prescribed
developed addiction only if they had a prior history of substance abuse.” The case was
granted in favor of Pharma for reasons sited above in B.42
5. Why are schedule II stimulants used to treat ADHD and ADD exempt from 7 day expiration, but will have
a limit of six months placed upon it?
(Working on this topic- patient/parent issues)
4. Describe your goals and objectives for resolving the problem and how you might measure change
Our goal is to reduce the expiration date on Schedule II prescriptions. By changing the law we hope to
minimize substance abuse, reduce adverse drug interactions and limit controlled substance diversion. Our
objective is to change the expiration date on Schedule II prescriptions from one year to seven days. We can
measure change by observing if the expiration date on Schedule II prescriptions decreases and by how much
it decreases.
5. Identify the policy envelope:
10
Variables that can be measured regarding this problem include the number of adverse drug reactions due
to late CII prescription fills. Another variable that can be monitored is the time between the date of when a
prescription was written and the date when it was filled. The most important variable is simply the
expiration date for Schedule II prescriptions.
There are several stakeholders in this problem. Patients are at risk because of the current situation.
Patients may not realize the danger of filling a CII prescription for an unintended use. Parents would be
interested if their children are on CII medications. More specifically, if the child was on a medication for
ADHD parents may be concerned about increased visits to the doctor’s office. Doctors are also interested in
this situation. They should be concerned about their patients filling CII prescriptions for non-diagnosed
reasons. Doctors would also be interested since limiting the length of a CII prescription may require more
office visits and more prescription writing. The community in general should be concerned since drug abuse
can result in billions of dollars spent on crime prevention, treatment programs and other healthcare costs.
The DEA would also have an interest in this situation since they monitor prescribing and dispensing of
controlled substances.
Pharm 543: Problem Definition
Group 10: Alternative & Complimentary Medicines Curriculum Change
Group Members: Stephanie Decker, Shea Beal, Jennifer Glasco, Misty Kelley, Kristi Metz, Brian Myers, Joey
Niedner
Describe the problem
Our project will focus on the addition of alternative and complimentary medicines as required
curriculum at the University of Washington School of Pharmacy and recommended by the accrediting
organization that proposes curricular suggestions. We will define alternative and complimentary medicines as
any folk medicine, herbals, botanicals, dietary supplements, minerals, vitamins, and plant remedies.
Alternative and complimentary medicines (defined from now on as “supplements”) have created
several concerns regarding patient safety. Depending on the supplement, harmful interactions with drugs,
diseases, and foods can result if a patient is not careful or does not understand that such an adverse event is
possible. To make matters worse, generally pharmacists do not possess adequate knowledge of these
supplements and may not be able to recognize a possible adverse event or make recommendations.
Dee v. Wal-Mart Stores, Inc. 2004 June 30. Accessed via Lexis-Nexis at http://web.lexis-nexis.com/
[cited 2004 Oct 7].
42
McCauley v. PurduePharma, L.P. 2004 August 18. Accessed via Lexis-Nexis at http://web.lexisnexis.com/ [cited 2004 Oct 7].
41
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The bottom line is that these supplements are out there and are being used by a large number of
people, most of which are seniors, which is the portion of the population that consumes the majority of
prescription and OTC drugs. Both health care professionals and patients are uneducated regarding the safety
and use of supplements.
Delineate the boundaries of the problem
Supplement use has been around for as long as drugs have, however, with the trend towards self
treating becoming more popular, they will have a more pronounced impact on the safety of patients who do
not consult a healthcare professional when mixing supplements with drugs. The pharmacist is the most
available healthcare professional, yet many lack the knowledge to properly counsel and recommend
supplements with regard to existing drug therapy. A class at the UW has been offered regarding this subject;
however it is only two credits and is not required.
This project is linked to a larger, nationally felt, problem. Supplement use, marketing, and industry is
poorly regulated and not well understood. Pharmacists are not learning about these issues in school and
aren’t required to take any continued education courses pertaining to supplements either. Ill prepared
pharmacists, unregulated advertising, increased availability, and the tendency for patients to self treat all
contribute to this problem.
Develop a fact base
The Handbook of Nonprescription Drugs contains information regarding the regulation of
supplements by the FDA. It covers the DSHEA act of 1994 and the relative frequency of use in various
populations, which indicate in increased market for supplements that will only grow. Also, information from
Dr. Elmer’s Alternative Medicines course will be used to establish our fact base.
Describe your goals and objectives for resolving the problem, and how you might measure change
Our goal is to have Pharmacist’s graduate from their schools with a solid foundation in the knowledge
of supplements so that they can properly advise patients in their use. We will measure change on whether or
not the Accreditation Council for Pharmacy Education (ACPE) recommends a general knowledge of
supplements as required curriculum.
Identify the policy envelope
Some variables regarding this issue pertain to providing proper instruction in alternative medicine
information. There may not be an ample supply of instructors qualified to teach in this area due to the fact
that it has never been a required area of study in pharmacy schools. The people and organizations that will
be interested are the students and faculty of the University of Washington School of Pharmacy and the
students and faculty of all pharmacy schools around the country.
What are potential costs and benefits to resolving the problem
Potential costs involving this scenario may involve hiring new faculty qualified to teach material
pertaining to supplements. This in turn could change tuition. However, a review of curriculum at the
University of Washington School of Pharmacy is on the horizon and it may be possible to change the current
Alternative Medicines class from non required elective to a required elective, such as PHARM 412 (OTC
drugs). Change the curriculum via this format may only change cost slightly if at all. However, this does not
answer the cost for other universities around the country.
The benefits from this change in curriculum will increase the safety of supplement use if a pharmacist
is consulted. Ideally, reduced drug, disease, and food interactions will be reduced, which will result in
increased patient health.
11
Pharm 543 MTMS
Group 11
Margaret Sopalski, Lisa Choe, George Gunther, Michelle Mai, Kathleen Amazona, Yen Duong, Jeong Park
1. Describe the problem
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Over the past 20 years, there has been a shift in the philosophy of pharmacy
practice from clinical to that of pharmaceutical care. This progression in our profession expounds the idea
that we are trained professionals in the specialty of drug information and therapy, and therefore we should
play an active and positive role in our patients’ lives where drug management and therapy are concerned.
Along with the progression of our profession is the concept of being able to bill for pharmacy services
other than dispensing. These other services include performing a comprehensive review of a patient’s
medication and management of that medication; creating a program with the patient that will assist in the
patient’s compliance with a medication regiment. The basis for billing is that patients would be able to
receive these services if insurance would assist in payment, as well as compensating pharmacists for their
time taken away from dispensing.
The problem that exists in the MTMS portion of the Medicaid bill is that it states “any health care
professional” as being able to bill for MTMS services. As students, we fill that pharmacists are the members
of the healthcare team that are best suited for providing MTMS services because of our extensive education
in drug pharmacology, drug therapeutics, and drug information. We do not deny that there maybe some
specialists, such as a certified diabetes educator, that may have more knowledge than a regular ARNP for
example, and therefore we feel that the language should be changed to state “a pharmacist or certified
specialist in the area of disease or drug”.
2. Delineate the boundaries of the problem
The problem has existed ever since the doctor of pharmacy program was implemented, which gave
pharmacists more training in various pharmacy services. There are no historical antecedents, yet the issue
arose six months ago when the CFR was put up for open comment. Now that pharmacists have more
extensive training prior to licensure, they must choose between providing pharmacy services for free, but of
benefit to the patient, or dispensing a prescription, which brings in most of the retail revenue and profit. As
profit keeps an enterprise afloat, many pharmacists have chosen not to provide pharmacy services to the full
extent of their capabilities.
3. Develop a fact base
The issue of allowing pharmacists to bill for medication therapy and management services has been
around for years. Pharmacists may be able to finally have the opportunity to bill for such services through
the ongoing Medicare part D addendum. Having the chance to be recognized as the provider of choice with
regards to patients’ medication therapy and management is an area worth pursuing.
Aside from dispensing medications, pharmacists are now proving their capabilities through their personal
interactions with patients. These interactions can include such pharmacy services as dyslipidemia
management, and diabetes, osteoporosis and blood pressure screenings. These current services provided by
pharmacists are one of the many examples where pharmacists are vital in improving patient health outcomes
and quality of life in patients. One of Project ImPACT’s (Improve Compliance and Persistence with Therapy)
endeavors focused on hyperlipidemia management and demonstrated the usefulness and influence
pharmacists had in improving cholesterol levels in patients.43 In addition, another Project ImPACT success,
on osteoporosis screening, showed the accuracy and effectiveness of pharmacists to screen for patients at
high risk for osteoporosis.44 As pharmacists we have access to drug information, and are proficient in the
training and education required of drug therapy management. There fore we are able to provide optimal
care for patients in monitoring and managing disease states and chronic conditions.
4. Describe your goals and objectives for resolving the problem and how you might measure change.
The goal is to let pharmacists be recognized as primary providers of medication therapy
management. Pharmacists are the health care professional with specialized academic and professional
training focused exclusively on pharmaco-therapeutics and medication therapy management. Pharmacists
who work in a collaborative relationship with physicians, nurses, and other practitioners can enhance
appropriate use of medications, patients’ compliance, and reduce potential adverse events and overall
Blumi BM, McKenney JM, Cziraky MJ. Pharmaceutical service and care results in Project ImPACT:
Hyperlipidemia. J Am Pharm Assoc 2000;40:157-65.
44
Goode JK, Swiger K, Blumi BM. Regional osteoporosis screening, referral, and monitoring program in
community pharmacies: Findings from Project ImPACT: Osteoporosis. J Am Pharm Assoc 2004
Mar/Apr;44(2):152-60.
43
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healthcare cost.
Objectives: To provide a foundation for billing of pharmacy services. To increase the number of
pharmacists practicing MTMS. To improve patient health outcomes.
5. Identify the policy envelope
Many medication therapy management services such as diabetes education require extensive
education, training, experiences, and specific protocol. If other healthcare providers such as nurses were
allowed to bill for MTMS, then the quality of MTMS would be more difficult to control and measure. The
standards of pharmacy services would not only be established by pharmacists, but also by other healthcare
providers. The differences in standards may jeopardize the high quality that patients need in pharmacy
services.
In order to justify the billing of high quality, pharmacy services, such services should be provided by
pharmacists only. If the services were provided under other healthcare providers’ standards, then the billing
of those services should be processed under their own billing code, and not be billed as MTMS.
6. Potential costs and benefits:
Cost- Potential to increase tension between pharmacist and other health care providers if MTMS is inclusive
only for pharmacists.
Cost: The increased volume of pharmacy services may reduce the volume of prescription filling.
Cost: Disenfranchising our partners on the health care team so that pharmacists are not able to lobby for
progressive change in legislation on scope of practice.
Benefit- Pharmacists will be recognized for the services being provided and will be a more reliable resource
for other health care providers.
Benefit: Pharmacies have access to a variety of products, providing patients more choices and providing
supplies more efficiently compared to other healthcare providers.
Benefit: Allowing only pharmacists to bill for MTMS might increase the need for the physicians and
pharmacists to work collaboratively, creating more collaborative work agreements (CWA) and thus benefiting
both professions.
Benefit: Patients will be able to schedule appointments with pharmacists more quickly than physicians.
Benefit: Pharmacists can take a more proactive role in initiating, modifying or changing a patients drug
therapy (with physician approval) increasing patients’ health outcomes.
Benefits: By providing MTMS, pharmacists can prove their capabilities not only to the patients to but to other
health care providers as well, and improve relations between the health care team.
12
Pharm 543 - Group 12
Title: Clarification of the role of the pharmacist in the offering of patient counseling
Members: Ping Zeng, Hoa Tran, Nadia Ordonez, Phong Tran, Richard Dyke, Angelique Williams,
Cathy Taketa
1.
Describe the problem
In the Washington State Pharmacy Lawbook 2003, WAC 246-869-220, it is unclear that the pharmacist is the
only individual in the pharmacy that can make the patient-counseling offer. The law does not address the
role of technicians and assistants in offering the provision of patient counseling by a pharmacist. From a
pharmacist’s perspective, uncertainty regarding legal obligations and restrictions for themselves and the staff
that they supervise is unacceptable in light of the fact that personal licensure is at stake. The need for
clarification arises from the disparity between the law, as enforced by the Washington State Board of
Pharmacy (i.e. the Board), and the actual practice of pharmacy. In addition, it is also unclear whether the
offer of counseling on refill prescriptions must also be made by a pharmacist.
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2.
Delineate the boundaries of the problem
It is believes that this uncertainty has existed since WAC 246-869-220 became effective on September 30,
1991. While this problem might appear to be primarily a community pharmacy issue, it also has implications
for outpatient hospital pharmacies.
3.
Develop a fact base
Two types of evidence will be necessary to persuade others of the existence and severity of this problem.
First, demonstration that pharmacists in Washington State are unsure concerning their legal requirement to
make the offer of counsel to patients on all prescriptions. This evidence can be gathered either directly
through interviews with pharmacists or indirectly through observation of pharmacy practice in both the
community and outpatient hospital pharmacy. Second, public records concerning disciplinary action taken
against pharmacists in Washington State for failure to dispense in a manner consistent with the Board’s
interpretation of the Law.
4.
Describe your goals and objectives for resolving the problem, and how you might measure change.
The goal of this project is to eliminate any uncertainty concerning a pharmacist’s legal obligations concerning
the dispensing of prescriptions. Subsequently, this should reduce the number of licenses that are suspended
in the state for “failure to dispense.”
5.
Identify the policy envelope
The variables that can be measured concerning the problem include staffing (i.e. are technicians making the
offer of counseling as a time saving measure at pharmacies that are understaffed)
6.
What are the potential costs and benefits to resolving the problem?
The potential costs of resolving this problem include education or reeducation of pharmacists regarding the
law as it applies to the dispensing of prescriptions. This information could be communicated through a
newsletter or mass mailing or possibly as part of a required continuing education course. The primary
benefit of resolving this problem is the reduction in the number of pharmacists who lose their license for
failure to properly dispense a prescription. This would also serve to preserve access to pharmaceutical care
services by maintaining the number of practicing pharmacists.