I have been a part of the APhA House of Delegates (HOD) since I was a resident in Illinois and currently serve for the State of Alaska. It is an honor and pleasure to play an important role in the policy-making process, to be on the ground floor of changes in our profession, and to help guide the direction of the Association. Several policy items were adopted by the HOD during the 2012 APhA Annual Meeting & Exposition and are reviewed here.
Drug supply shortages have a critical impact on pharmacy practice every day, in every pharmacy practice setting. The HOD developed policy addressing drug shortages to ensure that the supply chain allows much needed medications to be delivered to patients. APhA “supports the immediate reporting by manufacturers to the U.S. Food and Drug Administration (FDA) of disruptions that may impact the market supply,” “supports revising current laws and regulations that restrict the FDA's ability to provide timely communication to pharmacists,” “and encourages the FDA, the Drug Enforcement Administration (DEA), and other stakeholders to collaborate in order to minimize barriers … that contribute to or exacerbate drug shortages.” The adopted policy also states, “APhA encourages pharmacists and other health care providers to assist in maintaining continuity of care during drug shortage situations.” Managing drug shortages leads to frustrations of all health care providers, potential medication errors, higher cost of therapy, and/or potential delay of therapy.1–3
This policy will assist with awareness of the seriousness of issues and assist in working toward developing processes to “maintaining continuity of care during drug shortage.”
Contemporary pharmacy practice
The Joint Commission of Pharmacy Practitioners 2015 Vision for Pharmacy Practice is, “Pharmacists will be the health care professional responsible for providing patient care that ensures optimal medication therapy outcomes.” At the American Medical Association (AMA) HOD in 2010, pharmacy scope of practice was discussed and two resolutions were passed. Ten organizations of pharmacy developed a response to AMA. The collaborating organizations stated they “strongly urge the AMA to correct the identified areas noted in the AMA Scope of Practice Data Series: Pharmacists Document,” and AMA developed resolution in response: “directs the organization to develop model state legislation to address the expansion of pharmacist scope of practice that is found to be inappropriate or constitutes the practice of medicine.”4
The APhA2012 HOD responded with the following wording:
- APhA asserts that pharmacists should have the authority and support to practice to the full extent of their education, training, and experience in delivering patient care in all practice settings and activities.
- APhA supports continuing efforts that lead to the establishment of a consistent and accurate perception by the public, lawmakers, regulators, and other health care professionals of the role and contemporary practice of pharmacists.
- APhA supports continued collaboration with stakeholders to facilitate adoption of standardized practice acts, appropriate related laws, and regulations that reflect contemporary pharmacy practice.
- APhA supports the establishment of multistate pharmacist licensure agreements to address the evolving needs of the pharmacy profession and pharmacist-provided patient care.
- APhA urges the development of consensus documents, in collaboration with medical associations and other stakeholders, that recognize and support pharmacists' roles in patient care as health care providers.
- APhA urges universal recognition of pharmacists as health care providers and compensation based on the level of patient care provided using standardized and future health care payment models.
Controlled substances regulation and patient care
The Controlled Substances Act has been in place since 1970.5
Many changes in health care practice and technology have influenced the distribution of controlled substances. Abuse of controlled substances has reached new heights in the United States. Unfortunately, unintentional overdoses are seen in emergency departments on a daily basis. DEA has added new laws to help address some of these issues, but this may influence access to the needs of legitimate patients to controlled substances. The HOD adopted policy to address this timely issue:
- APhA encourages the Drug Enforcement Administration (DEA) and other regulatory agencies to recognize pharmacists as partners that are committed to ensuring that patients in legitimate need of controlled substances are able to receive the medications.
- APhA supports efforts to modernize and harmonize state and federal controlled substance laws.
- APhA urges DEA and other regulatory agencies to balance patient care and regulatory issues when developing, interpreting, and enforcing laws and regulations.
- APhA encourages DEA and other regulatory agencies to recognize the changes occurring in health care delivery and to establish a transparent and inclusive process for the timely updating of laws and regulations.
- APhA encourages the U.S. Department of Justice to collaborate with professional organizations to identify and reduce (a) the burdens on health care providers, (b) the cost of health care delivery, and (c) the barriers to patient care in the establishment and enforcement of controlled substance laws.
ASHP Expert Panel on Drug Product Shortages. ASHP guidelines on managing drug product shortages in hospitals and health systems. Am J Health Syst Pharm. 2009;66:1399–406.[CrossRef]
Dragic J. Analysis of drug shortages in a hospital pharmacy. Eur J Hosp Pharm. 2012;19:130–1.
Institute for Safe Medication Practices. ISMP survey on drug shortages. ISMP Medication Safety Alert! 2010;15(15):4.
Controlled Substances Act, Pub. L. 91-51, 84 Stat. 1236, enacted October 27, 1970, codified at 21 U.S.C Title 21, Chapter 13 § 801.
The APhA HOD always allows for a dynamic exchange of ideas, vision, and action. The policy brought before the house was particularly important based on ever-increasing concerns regarding patient safety and the medication supply. During the previous few years, pharmacists (and patients) have been challenged by disruption of the drug supply, counterfeiting of products, and increasingly difficult management of controlled substances. The policies approved at the 2012 HOD squarely place many of these issues in the realm of applied scientific research in both the clinical and basic sciences. The science to alleviate many of these issues is available; therefore, it will truly be a matter of translating the science into practical use and general acceptance by the community, from production to distribution.
Approved policies included improved systems management, enhanced notification and tracking strategies of drug product (from manufacturer to the ultimate dispensing of the medication to the patient), and rational management of controlled substances, all of which have considerable impact in the pharmaceutical scientific community.
Increased research into the integration of epidemiology with pharmaceutical manufacturing will justify the production of medically necessary pharmaceutical products in a timely and appropriate manner. Predictions for matching supply and demand can be streamlined, including rational production of sufficient product within predicted safety margins. Contingency plans will need further development to minimize the impact on the individual patient in the event of supply disruption. Again, studies justifying these approaches are imperative to shift many manufacturing strategies from market driven to patient centered. Potential over- and underproduction of drug product will be minimized, which will certainly have a direct economic effect in an era in which health care costs are skyrocketing.
Improved patient safety will be linked to evolving technologies in which product tracking and resistance to tampering are constantly monitored. These must eventually include scanning technologies and rapid communication of disruption, tampering, counterfeiting or diversion of supplies. The interface of emerging technologies and scientific knowledge with regulatory bodies will require recruitment of scientists who can readily negotiate this rapidly expanding environment.
For example, developments in microencryption, holographic imaging, and DNA tracking can potentially identify all counterfeit product, resulting in almost error-free tracking of individual products. These developments alone will stem the flow of the currently unidentifiable counterfeit product into the market.
In addition, the HOD policy encourages unit-of-use packaging as an industry standard. This has been clearly demonstrated to improve patient safety and outcomes. Further evidence-based studies are needed to support the economic advantage of this approach in light of reduced harm to patients and thereby reduction in health care costs.
Appropriate access to controlled substances
Considerable challenges continue to surround patient access to appropriate controlled substances. APhA encourages the centrality of the pharmacist in maintaining the integrity and therapeutic outcomes for the necessary use of controlled substances. As found with the other issues concerning diversion and counterfeiting, the use of advanced tracking technology along with effective communication will reduce the burden of managing controlled substances by clinicians and patients. In addition, systems management, harmonization of state and federal laws regulation, collaborative efforts by professional organizations, and enhanced regulation will improve these efforts.
The ultimate goal of these APhA2012 HOD policies is improved patient safety and therapeutic outcomes while maintaining an economically viable system. Although not an easily attainable goal, the current trends and findings in science will provide the foundation for implementation and leadership for an improved health care system.
Student pharmacists from around the country engaged in lively discussion regarding issues facing our profession during the APhA–ASP HOD at APhA2012, resulting in the adoption of five resolutions.
As the medication expert, pharmacists are poised to advance antimicrobial stewardship strategies and supplemental components in the hospital and health system setting. Antimicrobial stewardship programs, especially those including pharmacists in a leadership role, have been shown to greatly improve clinical outcomes without adding to the cost of care and, in some cases, have been shown to reduce costs. Without oversight of prescribing practices, the misuse of antimicrobials will continue to add to the growing problem of drug resistance and negatively impact clinical outcomes. Pharmacists and student pharmacists have the opportunity to have a positive effect on clinical outcomes by implementing the strategies from antimicrobial stewardship practices in a manner that is feasible at their institution or practice setting.
Resolution 2012.1 was adopted as follows:
- APhA–ASP encourages hospitals, community pharmacies, and other health systems to implement and continually optimize antimicrobial stewardship programs according to current guidelines.
- APhA–ASP encourages pharmacists and student pharmacists to take an active role in the implementation and continuation of antimicrobial stewardship practices, including, but not limited to, prospective audits, formulary restrictions, dose optimization, and education to minimize drug-resistant organisms and improve clinical outcomes.
Schools and colleges of pharmacy and pharmacist demand
According to the American Association of College of Pharmacy's 2010–11 Profile of Pharmacy Students, 11,487 student pharmacists graduated from a pharmacy degree program in 2010. This is a 36.8% increase compared with the 7,260 student pharmacists who graduated in 2000. The Department of Health & Human Services has stated that the supply of pharmacists is growing at a faster rate than was previously projected. Because such uncertainty exists in the marketplace, we believe that current and future schools and colleges of pharmacy must take pharmacy manpower demand data into consideration when expanding, in order to ensure responsible growth in relation to demand for our services. By conducting projected demand studies before expansion or creation, schools and colleges of pharmacy can gain a better understanding of their long-term success potential.
Resolution 2012.2 was adopted as follows:
APhA–ASP strongly encourages that all current and future schools and colleges of pharmacy considering the creation, expansion, or reduction of PharmD programs evaluate the projected demand for pharmacists nationally, and in their local, state, and regional area prior to taking such actions.
Medication disposal and drug take-back programs
The National Survey on Drug Use and Health reported that in 2009, more than 70% of people who abused prescription pain relievers for nonmedical purposes were receiving these medications from their friends and family, although only 17% of the medications were prescribed for them. Student pharmacists encourage regulations allowing pharmacies to serve as take-back locations for all medications, including controlled substances. Such measures can reduce the environmental impact of unused or expired medication and decrease the possibility of these medications being misused or abused. In assisting with this public health issue, financial and legal liability to pharmaceutical stakeholders should be minimized to increase participation in this program.
Resolution 2012.3 was adopted as follows:
- APhA–ASP encourages the profession of pharmacy, federal and state regulatory agencies, law enforcement, waste management authorities, and other appropriate entities to develop and implement standardized guidelines for the proper disposal of unused or expired medications that help prevent drug abuse and reduce harm to the environment.
- APhA–ASP supports state and federal regulations that allow pharmacies to take back unused or expired medications, including controlled substances, through a process that minimizes diversion, liability, and financial burden to all stakeholders.
- APhA–ASP encourages pharmacists and student pharmacists to serve as a source of information for the public on the proper disposal of unused or expired medications.
Pharmacy benefits manager practices
While student pharmacists agree that some pharmacy benefits managers (PBMs) do a good job adhering to fair business practices, we believe that unregulated auditing practices compromise patient care and make it harder for pharmacies to conduct business with PBMs. In response to the auditing issue, the Pharmacy Competition and Consumer Choice Act of 2011 is currently in committee in both the House of Representatives and Senate. The bill calls for prohibiting penalization of pharmacies for trivial errors and attempts to keep focus on actual pursuit of fraud. In addition to a standardized audit process, PBMs must notify patients in advance of coverage changes. Student pharmacists feel strongly that communications regarding the notifications should be standardized, comprehensive, and easy to understand for all patient populations.
Resolution 2012.4 was adopted as follows:
- APhA–ASP supports regulation of PBM and insurance company audit practices and encourages the implementation of a national standardized audit procedure to include, but not be limited to, audit timeframes, a written appeals process, documentation requirements, and adherence to fair business practices.
- APhA–ASP encourages all PBMs and insurance companies to notify patients prior to any changes or modifications in their plan that may include, but not be limited to, reaching their coverage gap, formulary adjustments, prior authorizations, and tier changes. The notification should be in a manner that is standardized, comprehensive, and easy to understand for all patient populations.
In 2010, 178 drug shortages were reported to FDA, and this number rose to around 300 in 2011. Currently, FDA is working to help prevent and decrease the impact of drug shortages, but they do not have the regulatory power to require reporting of drug shortages. FDA encourages manufacturers to voluntarily report drug shortages and manufacturing problems so they can assist with these issues and prevent shortages. As student pharmacists, we have witnessed the impact of drug shortages in the places we work and have seen how they can affect patients. Encouraging continued cooperation and timely communication between FDA and other stakeholders is important to anticipating and resolving drug shortages.
Resolution 2012.5 was adopted as follows:
APhA–ASP encourages transparency, cooperation, and timely communication between pharmacists, health care providers, FDA, manufacturers, distributors, and other stakeholders in the drug supply chain to anticipate and resolve drug shortages in order to reduce their impact on patient care.
The passion displayed by delegates was impressive and aided in making the APhA–ASP HOD sessions a great success. As 33,000 student pharmacists strong, we look forward to having a direct impact on our profession today and working throughout the next year to take action on these items. APhA2013 should be even more exciting and meaningful, and we look forward to seeing you in Los Angeles.
The Association Report column in JAPhA reports on activities of APhA's three academies and topics of interest to members of those groups.
The APhA Academy of Pharmacy Practice and Management (APhA–APPM) is dedicated to assisting members in enhancing the profession of pharmacy, improving medication use, and advancing patient care. Through the six APhA–APPM sections (Administrative Practice, Community and Ambulatory Practice, Clinical/Pharmacotherapeutic Practice, Hospital and Institutional Practice, Nuclear Pharmacy Practice, and Specialized Pharmacy Practice), Academy members practice in every pharmacy setting.
The mission of the APhA Academy of Pharmaceutical Research and Science (APhA–APRS) is to stimulate the discovery, dissemination, and application of research to improve patient health. Academy members are a source of authoritative information on key scientific issues and work to advance the pharmaceutical sciences and improve the quality of pharmacy practice. Through the three APhA–APRS sections (Clinical Sciences, Basic Pharmaceutical Sciences, and Economic, Social, and Administrative Sciences), the Academy provides a mechanism for experts in all areas of the pharmaceutical sciences to influence APhA's policymaking process.
The mission of the APhA Academy of Student Pharmacists (APhA–ASP) is to be the collective voice of student pharmacists, to provide opportunities for professional growth, and to envision and actively promote the future of pharmacy. Since 1969, APhA–ASP and its predecessor organizations have played a key role in helping students navigate pharmacy school, explore careers in pharmacy, and connect with others in the profession.
The Association Report column is written by Academy and section officers and coordinated by JAPhA
Contributing Editor Joe Sheffer of the APhA staff. Suggestions for future content may be sent to firstname.lastname@example.org