APhA Academy of Student Pharmacists – House of Delegates
Report of the 2015 APhA-ASP Resolutions Committee
P R O P O S E D R E S O L U T I O N S A N D B A C K G R O U N D S T A T E M E N T S
2015.1 – Medication Synchronization
1.
APhA-ASP supports stakeholders’ implementation of medication synchronization as a standard of practice.
2.
APhA-ASP supports state and federal legislation encouraging third-party payers to cover the alignment of refills without the patient incurring additional out of pocket expenses.
3.
APhA-ASP encourages pharmacists and student pharmacists to provide education to all health care providers regarding medication synchronization.
4.
APhA-ASP encourages pharmacists and student pharmacists to promote patient awareness of the benefits and accessibility of medication synchronization programs.
5.
APhA-ASP encourages all schools and colleges of pharmacy to incorporate medication synchronization education in the curriculum.
Background Statement:
Medication synchronization, or “med sync,” is a service in which the pharmacy coordinates a prescription refill schedule to allow for the patient or caregiver to pick up all of his or her medications on a single, convenient day each month. Prior to enrolling a patient in a medication synchronization program, the pharmacist reviews the patient’s medications with the patient or caregiver, evaluates any medication compliance issues, and enrolls the patient in the program. Following the review, the pharmacy consolidates all of the patient’s medications to allow for a routinely scheduled pick-up.
Throughout the program, pharmacists are encouraged to evaluate patient medication use and medication adherence issues.
Synchronization would occur by performing prorated “short fills” or “long fills” depending on refill timing and cost to the patient.
1 In most cases, patients are given the choice to opt into medication synchronization programs. The process allows the pharmacy to identify changes in therapy and facilitate any care coordination in advance to dispensing the medications. Medication synchronization promotes the collaboration between the patient and pharmacist to align refills and improve medication adherence.
Overall, due to a range of factors influencing patient medication adherence, about 20%-50% of patients are non-adherent to medical therapy with people suffering from chronic conditions only taking half of their prescribed medicine.
2 According to the results of a study published in the Journal of the American
Pharmacists Association, adherence rates of patients participating in a medication synchronization program have 3.4 to 6.1 times higher adherence rates when compared to the adherence rates of a control group not participating in a medication synchronization program.
3 The non-adherence rate decreases further for chronic medications at a 1-year mark.
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The estimated annual cost burden of medication non-adherence in the United States is estimated to be greater than $289 billion.
3 Thus, the benefits of the implementation of medication synchronization programs would improve medication adherence, reduce the cost burden of medication non-adherence, promote the benefits regular medication reviews, and reduce inefficiencies and time wasted in the pharmacy. As of 2013, more than 20,000 community pharmacies implemented synchronization programs. As the implementation of these programs expands to become a standard of practice, education of pharmacists, student pharmacists, patients, and other stakeholders will be critical to maximize the benefits and accessibility of these programs.
On January 1, 2014, Medicare Part-D approved prorated fills for the purpose of medication synchronization programs, covering Medicare Part D eligible medications except oral antibiotics.
4
Currently, not all third party payers prorate refill supplies to synchronize medications, forcing patients to incur additional expenses in order to align their refills. Federal and state legislation should be pursued to prevent out-of-pocket expenses greater than a copayment or coinsurance. This measure would increase both patient medication adherence and pharmacists’ ability to provide quality patient care services.
References:
1.
Align My Refills. American Pharmacists Association Foundation. Accessed at: alignmyrefills.com. January 9,
2015.
2.
Medication Adherence – Improving Health Outcomes. American College of Preventative Medicine. 2011.
Access at: http://c.ymcdn.com/sites/www.acpm.org/resource/resmgr/timetoolsfiles/adherenceclinicalreference.pdf. January 10, 2015.
3.
Adherence and persistence associated with an appointment-based medication synchronization program.
American Pharmacists Association. J Am Pharm Assoc. 2013;53:576-583
4.
Med Sync catching on across nation. American Pharmacists Association. 2015. Accessed at: http://www.pharmacist.com/med-sync-catching-across-nation. January 9, 2015.
2015.2 – Labeling and Measurement of Oral Liquid Medications
1.
APhA-ASP supports mandatory inclusion of a precision measuring device, such as an oral syringe, with all prescription and non-prescription oral liquid medications.
2.
APhA-ASP encourages student pharmacists and pharmacists to educate patients and caregivers on accurate oral liquid medication administration.
3.
APhA-ASP supports the use of milliliters (versus teaspoons and tablespoons) as the standard unit of measure on all oral liquid medications.
Background Statement:
Between 2002 and 2012, 81.9% of medication errors involving children six and younger were attributed to liquid medications. The second and third most common causes of these medication errors were incorrect dose and confused unit of measure, respectively.
1 Sobhani et al. compared the use of dosing cups and syringes to measure a dose of an over the counter (OTC) product. The investigators concluded that no participants measured an excessive dose while using the syringe. Alternatively, 85.4% of participants using a dosing cup measured an excessive dose.
2
In response to the alarming findings of the two referenced studies and that of similar studies noting a lack of education and understanding pertaining to medication errors and dosing, the Centers for Disease
Control (CDC) launched the PROTECT initiative to address the alarming increase in emergency room
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visits due to OTC and prescription medication overdoses in children. The initiative focused on promoting safe medication packing with clearer dosing measures and labeling to ensure ease of administration by caregivers and increased education for parents and caregivers about proper use and administration of
OTC medications.
3
APhA-ASP affirms that student pharmacists, pharmacists, drug manufacturers, and other stakeholders have a crucial role in ensuring patient safety. The National Council for Prescription Drug Programs’ white paper describes the measures relating to the standardization of dosing designations by which these parties can play that role. The document addresses the necessary standardization of oral liquid medication container labels and the dosing devices commonly used with OTC liquid medications. The recommendations include packaging a precision measuring device with OTC oral liquid medications. The recommendations also include the adoption of milliliters as the standard unit of measure for such products.
4
A syringe is more precise as a measuring device than a dosing cup. The reliable precision of the dosing syringe will minimize dosing errors and, therefore, should be dispensed with any oral liquid medication and packaged with any OTC oral liquid product.
Additionally, the standardization of all units of measure to milliliters will decrease dosing and measurement confusion. Teaspoons and tablespoons are very unreliable. Teaspoons have been shown to range anywhere from 2.5 to 7.8 milliliters. Furthermore, production inconsistencies are common in measurement devices intended for cooking.
5
Patient education has also been shown to significantly improve dosing accuracy in liquid oral medications. McMahon et al. found that 83% of patients that used a dosing syringe without a demonstration could dose a medication accurately, while 100% of participants who received a demonstration dosed the medication accurately.
Yin et al. demonstrated that advanced counseling techniques with the provision of a precision measuring device is shown to be more effective (47.8% measured an accurate dose) than those who received neither (20.9% measured an accurate dose).
6 The provision of a precision measuring device and patient education and the standardization of units are synergistic in combination and beneficial to patient safety and quality of care.
References:
1.
Smith, MD, et al. Out-of-Hospital Medication Errors Among Young Children in the United States, 2002-2012.
PEDIATRICS. 2014; 134,5:867-876.
2.
Sobhani, P, et al. Accuracy of Oral Liquid Measuring Devices: Comparison of Dosing Cup and Oral Dosing
Syringe. The Annals of Pharmacotherapy. 2008;42:46-52
3.
The PROTECT Initiative: Advancing Children’s Medication Safety. Centers for Disease Control. Accessed at: http://www.cdc.gov/medicationsafety/protect/protect_initiative.html. January 9, 2015.
4.
NCPDP Recommends Standardized Metric Measurements of Oral Liquid Medication Labels. National Council for Prescription Drug Programs. Accessed at: https://www.nabp.net/news/ncpdp-recommends-standardizedmetric-measurements-on-oral-liquid-medication-labels. January 9, 2015.
5.
Yaffe, SJ, et al. Inaccuracies in Administrating Liquid Medication. Journal of the American Academy of
Pediatrics. 1975;56:327
6.
Yin, SH, et al. Liquid Medication Dosing Errors in Children: Role of Provider Counseling Strategies. Academic
Pediatrics. 2014;14,3:262-270
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2015.3 – Point of Care Testing
1.
APhA-ASP supports state and federal legislation that allows pharmacists and student pharmacists to provide point of care tests and related clinical services—under appropriate protocol and in collaboration with other members of the health care team—to increase patient access to care and screen or monitor for indications requiring care follow-up, referral, or therapy adjustment. Point of care testing and related clinical services such as subsequent referral, counseling and/or other interventions may include, but not be limited to, HIV, influenza, streptococcal and tuberculosis screenings.
2.
APhA-ASP supports the incorporation of point of care testing education and training throughout the pharmacy curriculum to train student pharmacists on appropriate administration of tests and management of results, including but not limited to, relevant counseling, documentation, reporting, and follow-up.
3.
APhA-ASP encourages the development of continuing education and training programs to enhance existing practitioner understanding and utilization of point of care testing.
4.
APhA-ASP encourages all stakeholders, including but not limited to, employers, patients, pharmacists, community pharmacies, health-systems, and third party payers to develop a compensation model recognizing the value and cost of pharmacist–provided point of care testing and the provision of related clinical services that is both financially viable and in the best interest of patients.
5.
APhA-ASP encourages all public health stakeholders and agencies to promote patient awareness of pharmacist–provided point of care testing and related clinical services for the purpose of improving community surveillance of disease prevalence.
Background Statement:
Point of Care (POC) tests are designed to be used at or near the site where the patient is located, do not require permanent dedicated space, and are performed outside the physical facilities of a clinical laboratory.
1 POC testing includes, but is not limited to, the Clinical Laboratory Improvement
Amendments (CLIA) waived laboratory services for HIV, influenza, respiratory syncytial virus, and group
A streptococcal pharyngitis. As the profession moves toward providing more quality patient care services, as members of the health care team, POC testing will have a role in expanding patient access to care, increasing community surveillance of infectious diseases, and continuing the expansion of pharmacy services.
2
Pharmacies in the United States receive an estimated 13 billion visits annually allowing pharmacists unsurpassed access to patients and placing them in an optimal position to link patients to care.
3
According to the Centers for Disease Control and Prevention (CDC) estimates, approximately 7 million people have undiagnosed diabetes, 240,000 people have undiagnosed HIV, and 800,000 people have undiagnosed Hepatitis C.
4 All of these diseases are detectable through POC testing and early detection of such disease states is imperative as treatment may become more complicated the longer they go undetected. Pharmacist administered POC testing can reach a larger number of people leading to rapid identification and quick intervention.
Federal law does not prohibit pharmacists or student pharmacists from performing POC testing; however, the provision of such services is currently limited due to variability and ambiguity in state
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legislation and regulation. As of 2012, 44 states had a collaborative drug therapy management (CDTM) provision within their state pharmacy practice act or similar regulations or statutes. In those states with a CDTM provision, only 19 have explicit regulations or statutes allowing pharmacists to conduct POC testing. Twelve states prohibited pharmacists from conducting POC testing. Additionally, out of 64,000 community pharmacies, only 8,856 (14%) are providing testing services using a CLIA waiver.
2
As pharmacists’ care shifts toward primary and preventive care, POC testing will become a standard practice in pharmacies. Despite this trend, the education and training programs required in order to ensure pharmacists and student pharmacists provide appropriate administration, follow-up, and or counseling in conjunction with POC testing is not expanding.
2 The Accreditation Council for Pharmacy
Education (ACPE) set forth guidelines, effective as of 2011, listing POC testing as an element which pharmacy practitioners should be knowledgeable and competent in before receiving their degree.
2 In
2012, the National Association of Chain Drug Stores (NACDS)-ACPE task force included “collect, interpret, and make recommendations based on the results” with regards to POC testing as practice competencies for entry-level practitioners.
2
For some of the diseases in question, like influenza, the timeliness of identifying the condition and placing the patient on an antiviral medication is important. The University of Nebraska Medical Center and Ferris State University have developed an ACPE-approved professional development certification program. The program trains pharmacists in physical assessment skills, the proper use of POC testing, how to incorporate the activity into clinical practice, and practice management related to the financial viability of the service.
2,3 The certification program has been endorsed by both the Society of Infectious
Diseases Pharmacists and NACDS.
2 These efforts demonstrate the increasing demand for the provision of POC testing by student pharmacists and pharmacists in the pharmacy setting.
References:
1.
Point of care testing. College of American Pathologists. Accessed at: http://www.cap.org/apps//cap.portal?_nfpb=true&cntvwrPtlt_actionOverride=%2Fportlets%2FcontentViewer
%2Fshow&_windowLabel=cntvwrPtlt&cntvwrPtlt%7BactionForm.contentReference%7D=policies%2Fpolicy_ap pII.html&_state=maximized&_pageLabel=cntvwr. January 9, 2015.
2.
Gubbins, PO, et al. Point-of-care testing for infectious diseases: Opportunities, barriers, and considerations in community pharmacy. Journal of the American Pharmacists Association. 2014;54(2):163-171.
3.
Burley, E, et al. Opportunities for pharmacists to improve access to primary care through use of CLIA-waved tests. Michigan Pharmacists Association. 2014;52(2):8-11
4.
Olsen, K, et al. Use of rapid diagnostic tests and point-of-care diagnostics by pharmacists. Nebraska
Pharmacists Association. Accessed at: http://www.npharm.org/Files/Newsandevents/AnnualConvention
/2014Handouts/CPESession03.pdf. January 9, 2015.
2015.4 - Increased Access to Opioid Reversal Agents
1.
APhA-ASP supports state and federal legislation to increase access to opioid reversal agents.
2.
APhA-ASP encourages pharmacists and student pharmacists to provide public education about opioid reversal agents, including proper administration in situations of opioid-related drug overdose.
Background Statement:
Over the past 30 years, fatal drug overdose has increased over six-fold, largely due to prescription opioid overdose-related deaths.
1 According to the Centers for Disease Control and Prevention (CDC), 46 people
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die each day from an overdose of prescription opioid painkillers in the United States. In 2012, health care providers wrote over 250 million prescriptions for opioid painkillers.
2
Opioid reversal agents are one of the best treatment options for patients who are experiencing an opioid overdose. Naloxone, an opioid receptor antagonist, is the most commonly used opioid reversal agent for treating opioid-related drug overdose. The effects of naloxone last for 30 to 120 minutes depending on the route of administration and can be administered repeatedly as needed without harm.
3
The primary effects of this medication are to reverse respiratory failure resulting from an opioid overdose and cause symptoms of withdrawal in an opioid-dependent patient. It has no pharmacological effect if the patient has not taken opioids, has no potential for abuse, and an overdose is highly unlikely.
4
While opioid overdoses can occur when the patient is with friends or family, most state practice laws discourage or disallow the prescription of drugs to a person other than the intended recipient (thirdparty prescription) or to a person who the physician has not examined (prescription via standing order).
5
Patients who are experiencing an opioid overdose cannot self-administer naloxone. The current regulatory state makes some health care providers uncomfortable prescribing naloxone due to legality and liability issues. If an opioid-related overdose were to occur, a third-party would have to “diagnose and treat” the overdose. Both New York and New Mexico have legislation granting health care professionals protection from civil and criminal liability resultant of naloxone prescription programs.
6
Beyond the position of the prescriber, many witnesses of overdose are reluctant to administer naloxone due to fear of prosecution for possession and administration of a prescription drug.
7
In April 2014, the Food and Drug Administration (FDA) approved Evzio, a naloxone take-home handheld auto-injector that talks the user through correct administration of naloxone, and is specifically indicated for the emergency treatment of a known or suspected opioid overdose. A study published in the Annals
of Internal Medicine found that for every 164 naloxone kits that are distributed, one patient’s life could be saved.
8
Community-based naloxone take-home programs, such as Project Lazarus, have been proven to decrease opioid-related drug overdose deaths. In 2007, Project Lazarus was established in Wilkes
County, NC; an area with the third highest rate of drug overdose in the country. This initiative promoted the collaboration of physicians, pharmacists, law enforcement, and community leaders to manage the rising rates of drug overdose in the community. Project Lazarus funded a program to advocate for the use of naloxone antidote kits. As a result, the program achieved rapid success reducing overdose death rates in Wilkes County by 69% between 2009 and 2011. Additionally, substance-abuse related emergency room admissions were decreased by 15.3% from 2008 to 2010.
9, 10
As of 2014, 26 jurisdictions in the United States have increased access to naloxone through the implementation of either prescription by standing order or third-party prescriptions. Additionally, 10 jurisdictions passed naloxone access laws during 2014, making a total of 28 jurisdictions that have implemented law changes related around naloxone and opioid-related drug overdose.
11
The most significant issue confronting the use of opioid reversal agents today is the lack of access. The most commonly addressed methods to increase patient access to naloxone include third-party prescribing, prescription standing orders, pharmacist prescribing, community-based take-home programs, and/or reclassification to OTC status. While each method has its advantages and
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disadvantages, any method of increased access would be beneficial. Methods of increasing access to opioid reversal agents should be within the state’s scope of practice.
State and federal legislation to increase access to these agents by not only health care providers, but to the public would effectively prevent deaths by opioid-related overdose. In addition to increasing access, the public and those to whom increased access is granted must be educated on signs and symptoms of opioid-related drug overdose and the proper and safe administration techniques.
References:
1.
Legal Interventions to Reduce Overdose Mortality. Network for Public Health Law. Accessed at: https://www.networkforphl.org/_asset/qz5pvn/network-naloxone-10-4.pdf. January 9, 2015.
2.
Opioid Painkiller Prescribing. The Centers for Disease Control Vital Signs. Accessed at: http://www.cdc.gov/vitalsigns/opioid-prescribing. January 9, 2015.
3.
Naloxone. Lexicomp Online, Hudson, Ohio. Lexi-Comp, Inc.; January 9, 2015.
4.
Expanding Access to Naloxone: Reducing Fatal Overdose, Saving Lives. Drug Policy Alliance. Accessed at: http://www.drugpolicy.org/docUploads/OverdoseReportMarch2009.pdf. January 9, 2015
5.
Naloxone Overdose Prevention Laws. Network for Public Health Law. Accessed at: http://lawatlas.org/query?dataset=laws-regulating-administration-of-naloxone#.U-Iv9ONdVg0. January 9,
2015.
6.
Beletsky, L. et al. Physicians’ Knowledge of and Willingness to Prescribe Naloxone to Reverse Accidental Opiate
Overdose. Journal of Urban Health: Bulletin to the New York Academy of Medicine. 2006;84(1):126-136
7.
Community Based Programs
8.
What is Naloxone? Drug Policy Alliance. Accessed at: http://www.drugpolicy.org/resource/what-naloxone.
January 9, 2015
9.
About Project Lazarus. Project Lazarus. Accessed at: http://projectlazarus.org/about-project-lazarus.
September 30, 2014.
10.
Project Lazarus. Community Care of North Carolina website. Accessed at: https://www.communitycarenc.org/population-management/chronic-pain-project/. September 30, 2014.
11.
Davis C. Naloxone Overdose Prevention Laws Map. Law Atlas. Accessed at: http://lawatlas.org/query?dataset=laws-regulating-administration-of-naloxone#.VD6FIvldWSo. October 15,
2014.
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