Education and Practice

Patient Safety Organizations – 2017 Update

John M. Kessler

Community pharmacy is doing much better in its patient safety efforts these days as evidenced by the new deployment of patient safety evaluation systems in large numbers of pharmacies. Since 2008, more than 8,000 community pharmacies have voluntarily implemented systems to identify risks, report errors and near-misses, learn from these events and implement corrective actions to reduce the burden of harm1. In addition, these pharmacies are sharing their event data within Patient Safety Organizations (PSOs) to help one another learn. This sharing has not always been the case. Community pharmacy does not have a long history of systematically learning from mistakes nor effectively identifying and reducing risks. This contrast begs the question: why have so many community pharmacies improved their safety efforts? The pivotal Institute of Medicine report in 20002 identified that errors and adverse events were largely unreported due to a national culture of fear, blame, and litigation. The IOM report concluded that errors and harm will repeat unless they are reported, investigated, analyzed, shared with others, and acted upon. A major recommendation was that: Congress should

pass legislation to extend peer review protections to data related to patient safety and quality improvement that are collected and analyzed by health care organizations for internal use or shared with others solely for purposes of improving safety and qual-

ity. This recommendation set the stage for the federal Patient Safety and Quality Improvement Act (the “Act”) of 2005 and the formation of Patient Safety Organizations (PSOs), whose role is to provide a confidential and protected framework for reporting, analyzing, and sharing reports of errors, adverse events, close-calls, unsafe conditions, root cause analyses, and other quality improvement-related information. Detailed information about PSOs can be found here: https://www.pso.ahrq.gov/ For the first time ever, pharmacies that are not part of hospital systems or other peer review programs can now benefit from statutory protections, but only if they voluntarily joined a PSO. As of March 29, 2017 there are 86 PSOs in existence (https:// www.pso.ahrq.gov/listed/). Eight PSOs self-identify pharmacy as a specialty, and three list retail pharmacy as the type of facility served. Table 1 lists the PSOs located in North Carolina; two serve the Carolinas HealthCare System, and one serves primarily hospitals and related facilities. Table 2 shows those PSOs that specifically list retail pharmacy as the type of facility served. Pharmacies can join one or more PSOs regardless of where the PSO is located.

Table 1. PSOs Located in North Carolina*

Carolinas HealthCare System Patient Safety Organization Carolinas Rehabilitation -

Patient Safety Organization NC Quality Center PSO (NC Hospital Association)

Table 2. PSOs Listing Retail Pharmacy as the Type of Facility Served*

Alliance for Patient Medication Safety (serves all states) The PSO Advisory, LLC (serves all states) The Patient Safety Research Foundation, Inc. (serves Walgreens Pharmacy)

*For up-to-date contact information to all PSOs see: https:// www.pso.ahrq.gov/listed. Tables 1 and 2 are based on voluntarily reported profiles from each PSO.

What is the PSO mission?

PSO mission statements vary, yet they share two common themes – 1) to achieve the highest levels of quality and safety, and 2) to protect patient safety work product from discovery.

What are the quality and safety benefits of joining a PSO?

In addition to providing safety training, education, consultations, and toolkits, PSOs work with their members to develop robust safety structures and processes – in brief, a patient safety evaluation system. PSOs help their members identify and recognize the hidden-risks in their workflow. As one example, design flaws in the pharmacy workflow (both clinical judgment and technical dispensing activities) can lead employees to take short-cuts or create work-arounds that can allow a dangerous prescription to reach the patient. These behaviors can readily become “normalized” practice, desensitizing employees from the risks and off-setting the protections of normal safety checks. In brief, safe practices drift into unsafe habits, and situational awareness declines. From a clinical perspective, these practices include failing to manage allergy information, drug interaction alerts, high-dose alerts, and effective communication with their patients. PSOs also aggregate and analyze data from their members, increasing the odds of detecting trends not readily visible in individual pharmacies. Pharmacies identify and report qualityrelated events to the PSO; all with the goal of identifying risks in the system to develop new learnings. Pharmacies can also benefit when they engage their PSO to conduct “deep dives” into their data for comparative analyses. Collected and reported quality and patient safety data are shielded by federal confidentiality and privilege protections. This means that when you adhere to the Patient Safety Rules, you cannot be forced to disclose information identified as Patient Safety Work Product (PSWP) in criminal, civil, administrative, or disciplinary proceedings. PWSP includes event reports, Root Cause/Systems Analyses, minutes of quality and safety meetings, analytical/trend reports, communications to/from the PSO, and related information listed in the Act. Your PSO will assist you in designing your Patient Safety Evaluation System (PSES) to maximize these protections. Your PSES is your “protected workspace” and is the system of procedures and policies for collecting, managing, and analyzing information for reporting to a PSO.

What are the responsibilities of pharmacies that join a PSO?

To maximize the legal protections afforded by the Act, pharmacies must enter into a contractual agreement to join a PSO, develop and maintain a PSES, conduct all quality and safety activities within the PSES, maintain PSWP as confidential and protect PSWP from disclosure outside the PSES. PSOs, with their members, must conduct the patient safety activities listed in Table 3. 1. Efforts to improve patient safety and the quality of health care delivery 2. The collection and analysis of patient safety work product (PSWP) 3. The development and dissemination of information regarding patient safety, such as recommendations, protocols, or information regarding best practices 4. The utilization of PSWP for the purposes of encouraging a culture of safety as well as providing feedback and assistance to effectively minimize patient risk 5. The maintenance of procedures to preserve confidentiality with respect to PSWP 6. The provision of appropriate security measures with respect to PSWP 7. The utilization of qualified staff 8. Activities related to the operation of a patient safety evaluation system and to the provision of feedback to participants in a patient safety evaluation system

Have PSOs been effective in accomplishing their mission?

Quality and safety mission

PSOs have increased the adoption of best practices related to reporting, analyzing and acting upon quality-related events. They routinely publish recommendations to improve the workflow and safety culture.

They provide expertise, education, and tools to facilitate the conduct of thorough and credible root cause/system analyses. As one example, the Alliance for Patient Medication Safety, a community pharmacy PSO, has assisted several thousands of community pharmacies implement a continuous quality improvement program with standardized reporting software and analytical tools for use within a PSES. Its program includes educational and consultative services designed to strengthen the pharmacy’s response to all types of quality-related events, while also teaching how to prevent future events from causing harm.

Legal protection mission

PSOs have been successful in preventing release of confidential and protected information when courts, regulatory agencies, and others have requested disclosure of the PSWP. In one of the earliest legal challenges to the protection and privileges of the Act, Walgreens Pharmacy successfully argued in a 2010 trial court case that its quality-related event reports were PSWP and not subject to legal discovery. Furthermore, the 2010 court decision was unanimously upheld by an appeals court review in Illinois in 2012. Most importantly, however, these protections can be realized only when the pharmacy adheres to the nuanced and increasingly complex interpretations of the Patient Safety Rule. Your PSO helps assure you are compliant. The Alliance for Quality Improvement and Patient Safety (AQIPS) supports its member PSOs with legal counsel and education. AQIPS also tracks key court cases. Of local interest in North Carolina, a settlement agreement was reached and the complaint was dismissed without the facility having to disclose PSWP. AQIPS served as an expert witness on whether the PSES was designed properly and how the PSWP was created.

Is my pharmacy required to join a PSO?

There is no legal requirement to join a PSO. It’s a voluntary decision; however, your pharmacy must be a contractual member of a PSO and comply with the Patient Safety Rule to enjoy the legal protections and derive the clinical benefits. Chief Clinical Officer

SecondStory Health, LLC jkessler@secondstoryhealth. com

Disclosures: Dr. Kessler is a collaborator with various PSO’s and AQIPS. He is the medication safety expert for the Alliance for Patient Medication Safety.

Should my pharmacy join a PSO?

It’s a difficult decision to “go it alone” in patient safety and quality assurance. As noted in this brief review, PSOs can provide federal legal protections, but only to their members. PSOs also directly connect busy pharmacies to safety expertise and resources that might otherwise be less readily available.

1. Personal communication, Tara Modisett, Executive Director for the Alliance for Patient Medication Safety PSO, April 26, 2017. 2. To Err Is Human: Building a Safer Health System. Linda T. Kohn, Janet M. Corrigan, and Molla S. Donaldson, Editors; Committee on Quality of Health Care in America, Institute of Medicine. 2001 https://www.nap.edu/search/?ter m=to+err+is+human&x=0&y=0

John M. Kessler, B.S. Pharm., PharmD

BPS CONTACT Ernest Wright ewright@aphanet.org 202-429-7510

www.bpsweb.org

Board of Pharmacy Specialties Announces New Specialties in Cardiology and Infectious Diseases

Washington, D.C. – The Board of Pharmacy Specialties (BPS) is pleased to announce the approval of two new specialties; cardiology pharmacy and infectious diseases pharmacy. This announcement follows the final review of the petitions for each new specialty that took place during the BPS Board meeting held on February 8, 2017. Harold Godwin, the 2017 Chairman of the BPS Board of Directors and Professor Emeritus at the University of Kansas School of Pharmacy provided the following comments: “The Board of Pharmacy Specialties is very pleased to formally acknowledge two new pharmacy specialties. The recognition of these specialties further illustrates our growth as a clinical profession and our ever increasing responsibilities in providing patient care. I want to also acknowledge the collaborative efforts of the four national pharmacy associations that developed these petitions. That type of collaboration is critical to the continued success of the pharmacy profession.”

Cardiology Pharmacy

Cardiology pharmacy becomes the tenth BPS specialty. The petition was submitted jointly by the American College of Clinical Pharmacy, American Pharmacists Association and the American Society of Health-System Pharmacists. The petitioning organizations have defined Cardiology Pharmacy practice as follows: Cardiology Pharmacy practice specializes in the delivery of direct patient care services by pharmacists as members of interprofessional healthcare teams, working to ensure the safe and effective use of medications in patients with cardiovascular disease. These specialists focus on disease prevention and treatment, including evidence-based medication use and related care that improve both short- and longterm outcomes for patients. Cardiology specialists practice across the spectrum of care, including ambulatory, acute and intensive care. Pharmacists in this practice review, analyze and monitor multifaceted clinical information to make reasoned decisions for patients with multiple comorbidities and highly complex mediation regimens.

Infectious Diseases Pharmacy

Infectious diseases pharmacy becomes the eleventh BPS specialty. The petition was submitted jointly by the American College of Clinical Pharmacy, American Pharmacists Association, American Society of Health-System Pharmacists and the Society of Infectious Diseases Pharmacists. The petitioning organizations have defined Infectious Diseases Pharmacy practice as follows: Infectious Diseases Pharmacy practice specializes in the use of microbiology and pharmacology to develop, implement, and monitor drug regimens that incorporate the pharmacodynamics and pharmacokinetics of antimicrobials to optimize therapy for patients. The practice requires pharmacists to use clinical and evidence-driven knowledge to develop appropriate antimicrobial therapies to more rapidly resolve infections while decreasing adverse events, complications and resistance. The practice includes direct patient care provided through interprofessional health care teams, collaborative leadership of antimicrobial stewardship programs, education of health care providers, preventive services including immunizations, and advocacy for appropriate antimicrobial utilization. Specialty pharmacy practice in infectious diseases uniquely improves public health by optimizing antimicrobial potential in individual patients and narrowing the resistance trends that occur in society by preventing progression of antimicrobial resistance and infectious diseases.

Next Steps

The next steps in the specialty certification process are outlined below: •BPS will issue a call during the first week of March 2017 for nominations to serve on the Cardiology and Infectious Diseases Pharmacy Specialty Councils. The closing date for nominations will be May 1, 2017. • BPS will appoint nine members to each Council by June 2, 2017. •The Councils will convene, on dates to be determined, in July 2017. •Examination item writing for the new specialties will begin during the third quarter of 2017 with a goal of offering the first examination in September 2018.

Added Qualifications Program

The BPS Board will re-evaluate the current Added Qualifications program. However, the Board anticipates that the Added Qualifications program for Cardiology and Infectious Diseases will end as of December 31, 2017 based upon the plan to offer the first examinations in those specialties in 2018. Individuals currently holding Added Qualifications can keep those credentials until they expire but will not be able to renew them. The National Commission for Certifying Agencies (NCCA) standards prohibit BPS from conferring Board Certification to those who hold Added Qualifications in either Cardiology or Infectious Diseases without passing the respective certification examination. William Ellis, BPS Executive Director added, “The growth of BPS and the addition of new specialties reflects the growth and maturation of the pharmacy profession. BPS is committed to being responsive and flexible in evaluating possible specialties that will improve patient care through recognition and promotion of specialized training, knowledge, and skills in pharmacy through the specialty board certification of pharmacists.” Eleven specialties are currently recognized by BPS including: (1) Nuclear Pharmacy, since 1978; (2) Nutrition Support Pharmacy, since 1988; (3) Pharmacotherapy, since 1988; (4) Psychiatric Pharmacy, since 1992; (5) Oncology Pharmacy, since 1996; (6) Ambulatory Care Pharmacy, since 2009; (7) Critical Care Pharmacy, since 2013; (8) Pediatric Pharmacy, since 2013; (9) Geriatric Pharmacy in 2017 (through CCGP); (10) Cardiology Pharmacy in 2017; and (11) Infectious Diseases Pharmacy in 2017. BPS certification exams are administered at over 500 locations worldwide, the Spring testing window application deadline is March 6, 2017 and the Fall 2017 registration will be open from May 8, 2017 until August 1, 2017. Candidates can register by going to the BPS website at www.bpsweb.org.

About the Board of Pharmacy Specialties

The Board of Pharmacy Specialties (BPS) was established in 1976 as an autonomous division of the American Pharmacists Association (APhA). The mission of the Board of Pharmacy Specialties is to improve patient care and increase awareness of the need for BPS Board Certified Pharmacists as integral members of multidisciplinary healthcare teams through recognition and promotion of specialized training, knowledge, and skills in pharmacy and specialty board certification and recertification of pharmacists throughout the world. Board Certification through BPS has become recognized as the gold standard for determining which pharmacists are qualified to contribute at advanced practice levels as a result of the rigorous standards mandated by BPS board certification and recertification. Today over 30,000 pharmacists worldwide hold BPS certification.