MARYLAND BOARD OF PHARMACY
MEDICATION ERROR TASK FORCE REPORT
Stanton G. Ades, Board President
W. Irving Lottier, Jr., Board Secretary
Melvin N. Rubin, Board Treasurer*+
John H. Balch* Wayne A. Dyke
Jeanne Gilligan Furman*± Ramona McCarthy Hawkins*+
Barbara Faltz Jackson* + Rev. William E. Johnson+
Raymond Love, PharmD. ** Laura Schneider
Donald Yee*±
*Pharmacy Practice Committee Members
**Pharmacy Practice Committee Chair
+Participated in the Medication Error Task Force
±Medication Error Task Force Co-Chairpersons
LaVerne G. Naesea, Executive Director
Paul Ballard, Board Counsel
Michelle Andoll, Compliance Officer
James D. Slade, Legislative and Regulations Officer
Deitra Gale, Compliance Specialist
Bruce M. Gordon, PharmD., Facilitator
Gail Bormel Alan Friedman Milt Nichols
Angela Bryant Nathan Gruz Bert Nicholas
Diane Cousins Yelee Kim GG Patel
David Chen Andy Klinger Steven Samson
Thomas Cheun Mark Levi Howard Schiff
Fred Choi Robert Mcauley Lisa Souder
Elizabeth Cowley Judy McMeekin Peter Tam
Jennifer Devine Laurie Mohler Nancy
Tzeng
Lisa Eicher Dr. Samir Neimat Angelo Voxakis
Robert Feroli Barbara Newman Winston Wong
Gary Flax Lieser Mayo-Michelson
PARTICIPANT
BACKGROUNDS
State Regulatory Hospital
Federal Regulatory Consumer
Home Infusion Community Pharmacy-Chain
Community Pharmacy- Independent Pharmaceutical Manufacturer
Health Insurance Industry State Professional Organizations
National Professional Organization Student
University
INTRODUCTION
It is the Maryland Board of Pharmacy’s mission to protect the public health, safety and welfare. In an effort to reduce medication errors to the benefit of the public health and in response to growing public awareness and professional concern about the serious problem of errors in the medication delivery system, the Board of Pharmacy (the Board) formed a Medication Error Task Force in November 1999.[1] Oversight of the Task Force was assigned to the Board’s Pharmacy Practice Committee. The Medication Error Task Force was charged with recommending strategies the Board could utilize to guide practitioners and pharmacy permit holders[2] in redesigning medication systems to reduce the incidence and severity of medication errors in Maryland. The Medication Error Task Force utilized two approaches to meet its charge:
(1) Developing and recommending options for the Board to use in addressing medication errors; and
(2) Assisting the Board in developing strategies to implement the options that the Board selects to address.
MEMBERSHIP
AND ORGANIZATION
In order to address the medication error issue in pharmacy practice globally, the Board’s Pharmacy Practice Committee solicited input from a broad base of groups and stakeholders in the pharmacy community. Bruce M. Gordon, Pharm.D., a health care industry consultant who is experienced in medication error prevention, volunteered to act as a facilitator for the Medication Error Task Force. Chain community, independent community, hospital, home infusion, managed care, and long-term care pharmacies were represented on the Task Force. Representatives from the health insurance industry, the Food and Drug Administration and the United States Pharmacopoeia (USP) also participated in the Task Force.
Recognizing the fact that the issue of medication errors in pharmacy practice is impacted by other health care disciplines, the Maryland Hospital Association, the Board of Nursing and the Board of Physician Quality Assurance were invited to participate on the Task Force. These organizations were kept abreast of the Task Force’s activities. On occasion, representatives from the Board of Nursing and the Board of Physician Quality Assurance attended Medication Error Task Force meetings.
The Task Force meetings were open to the public and anyone in attendance was allowed to participate in the proceedings. The Task Force met monthly from November 1999 to February 2001 and again from May 2001 to July 2001. A sub-group of the Medication Error Task Force worked on drafting regulations for the Task Force’s endorsement and the Board’s consideration from February 2001 to May 2001.
METHODS
The first step to fulfilling the Task Force’s charge was educating members on the issues affecting medical errors. This included presentations by the group facilitator on how a medication error may be defined, common factors that contribute to errors and an overview of the current literature and trends on medical error prevention. The educational process also included a survey asking how other state boards of pharmacy are addressing medication errors, a review of existing reporting systems and an overview of state and federal legislative initiatives related to medical errors.
Using this newly acquired education and drawing from their collective experiences, the Task Force worked to identify a range of appropriate strategies. After considering factors such as potential level of impact of particular strategies on the reduction of medication errors, and the ability to measure that impact, potential strategies were developed and recommended to the Board for implementation. Based on the accepted strategies, the Task Force constructed for the Board’s consideration, regulations necessary to implement the recommended strategies.
While the Medication Error Task Force has disbanded, its participants continue to assist the Board in carrying out the recommended strategies as needed. It is anticipated that the Task Force will reconvene in the future to assess the impact of the Board’s initiatives on medication error prevention and make further suggestions as needed.
MEDICATION ERROR TASK FORCE
RECOMMENATIONS AND IMPLEMENTATION
In broad terms, the Medication Error
Task Force recommendations fell into three categories, and are as follows:
1. Educational
initiatives for consumers and pharmacy practitioners,
2.
System-oriented
action in response to errors reported to the Board,[3]
and
3.
Requirements
for mandatory pharmacy quality assurance programs
designed
to address medication errors.
With the exception of the requirements
for mandatory quality assurance programs, the Board has made significant
progress in the implementation of the Task Force recommendations. As discussed later in this report, however,
legislation will be required to enable the development of meaningful quality
assurance and error reporting programs in certain settings.
Educational
Initiatives for Consumers and Practitioners
The
first recommendation made by the Medication Error Task Force reflects
recognition of the need for broad-based medication and human error education
for both consumers and health care providers.
This recommendation is in line with the concerns discussed by a focus
group at the 12th Annual Conference of the National Academy of State
Health Policy that involved representatives from 20 different states.[4] Education must take place before changes may
be anticipated in pharmacy practice.
The Task Force recommended, and the Board agreed, that the Board should
develop and distribute relevant educational materials for both consumers and
members of the pharmacy community. This
is one area where Task Force members will likely continue to work with the
Board to help identify and select timely information that should be
disseminated.
·
Practitioner Education
The Task Force determined that a systems-approach[5] to reducing medication errors is an effective way of reducing errors. To that end, and after much heated discussion, the Task Force adopted the National Coordinating Council for Medication Error Reporting and Prevention’s (NCCMERP) definition of medication error that identifies all points within the health care delivery system where an error may occur. The NCCMERP definition is as follows:
A medication error is any preventable event that may cause or lead to inappropriate medication use or patient harm while the medication is in the control of the health care professional, patient, or consumer. Such events may be related to professional practice, health care products, procedures, and systems, including prescribing; order communication; product labeling, packaging, and nomenclature; compounding; dispensing; distribution; administration; education; monitoring; and use.[6]
The Medication Error Task Force’s own struggle to come to a consensus on how to define a medication error and what practitioners can do to prevent errors demonstrated the need for practitioner training in this area.
Practitioners must understand that in order to reduce errors, whether the error effects the patient or not, the entire medical and medication delivery system must be examined. Practitioners must also understand their proper role in error prevention. An error that reaches a patient is not generally the result of one factor in the system, but is the result of multiple breakdowns within the medication system. In addition it is important that the public understand these concepts as well.
Practitioners must be able to identify the process failures, investigate the error, assess their practice settings to identify probable causes for an error or potential error, and respond appropriately. Through the promulgation of regulations, pharmacy permit holders will be required to ensure their pharmacy employees receive annual training in medication error prevention.
The Board’s newsletter and website will be used to raise practitioner awareness of the types of medication errors reported in pharmacy literature, their potential causes and preventative measures that may be adapted to a particular setting. The Board will also make available information on specific training and educational opportunities on medication errors for practitioners. This information may include resources on how to conduct a root-cause analysis[7] of an error or how to establish a quality assurance program. The Board is also promulgating regulations relating to practitioner education.
·
Patient Education
Patients and their caregivers play a vital role in the delivery of health care. The patient or caregiver is often the last step in the health care delivery system and often the last opportunity to detect or prevent a medication error before harm can occur. Patients who are knowledgeable about their medication, know what questions to ask a health care practitioner and know how to detect a potential medication error.
The Public Relations Committee of the Board is developing two brochures aimed at informing consumers. One will educate and inform consumers of their role in medication safety and error prevention. The second brochure will outline the Board’s complaint process and provide instructions on how to file a complaint if the consumer wishes to report an incident to the Board.
The educational materials for consumers will explain:
1. The patient’s role in medication error prevention,
2. Steps that may be taken to prevent errors, and
3. What a patient can do if an error is suspected.
The brochures will be posted on the Board’s website and distributed at health related consumer events attended by Board staff, Board members, and other pharmacy organizations. The brochures may also be made available to pharmacy permit holders to distribute to their patients. The first brochures are anticipated to be published shortly. Publication and development of additional educational materials for the consumer will be ongoing. The Board is presently promulgating regulations that will require pharmacy permit holders to provide patients or their caregivers with certain information concerning their role in the medication delivery system.
System-Oriented
Action in Response to Error Reported to the Board
Through the
Complaint Process
It is the conclusion of the Medication Error Task Force, and the Board agreed, that medication errors are often the result of a system failure rather than an individual’s incompetence.
Traditional efforts at error reduction have focused on individual practitioners, using training, exhortation, rules and disciplinary action to improve performance. Human factors specialists and error experts reject this approach because it is more effective to change the system as a whole than to target individuals for improvement (Mornay, in Human Error in Medicine, 1994). Since most of what people do is governed by the system, the causes of error belong to failures in the system and often lie outside the direct control of the individual work force. Therefore, the way to prevent errors is to redesign the systems and processes that lead to errors rather than focus efforts on correcting the individuals who make errors. Effective strategies for reducing errors include making it impossible or difficult for staff to make an error and promoting the detection and correction of errors before they reach a patient and cause harm.[8]
USP states in its “General Principles for Patient Safety Reporting Systems” memorandum that “[t]here should be a nonpunitive culture for reporting healthcare errors that focuses on preventing and correcting system failures and not on individual or organization culpability.”[9] Such a culture of non-punitive reporting will foster practitioner ‘buy-in’ and open and complete reporting.
Because the Task Force determined that system failures are often the cause of errors, the committee recommended a system-oriented approach to addressing errors. The Board adopted and has implemented this approach as an initial approach. If, however, an individual’s incompetence or knowledge deficit is identified as the likely cause of the error, the Board may pursue remediation, re-education or restrict a license, which may include suspension or revocation. The Board will continue to address complaints involving system-related medication errors in a system-oriented manner.
When a medication error is reported to the Board by way of a complaint, the pharmacist(s) involved and the pharmacy permit holder are both asked to provide a response. When the analysis of the incident indicates that a system problem contributed to the error, a plan of corrective action is developed. To assist the pharmacy permit holder and licensee in this task, the Board’s Disciplinary Oversight Committee has implemented, and will continue to expand upon, an informal meeting process involving practitioners and permit holders. The process is designed to analyze the contribution of system weaknesses in the commission of errors and develop an action-plan for system changes that will minimize the possibility of a similar error occurring again. One benefit of this process is that the Board and the practitioner work together to identify the problem and possible solutions. The focus is placed on the system’s failure rather than an individual’s failure. In this manner, the process becomes collaborative and the practitioner and pharmacy permit holder are more receptive to working with the Board to achieve the common goal of improved patient safety.
The end product of this process may be an informal, non-public letter of agreement between the Board and the licensee and/or permit holder. Violation of the agreement may lead to formal disciplinary action by the Board and the issuance of public sanctions. However, if the Board finds the event sufficiently serious, formal charges may result. This process has been in place for approximately 6 months, and to date there has been no report of recurrence of a particular error by a consumer or stakeholder.
Requirements
for Mandatory Pharmacy Quality Assurance Programs
Designed to
Address Medication Errors
· Patient Safety Requires
Action-Oriented Quality Assurance Programs that include Adverse Medical Events.
Most adverse events are a result of system failures, not the failure of any specific practitioner. In order to reduce the frequency and severity of adverse events, systems within health care entities must be reviewed. This is called the “systems-review approach” to error reduction. Disciplining a health care professional after an event will not prevent the error from occurring again, if the system within the entity is flawed.
Although many entities have quality assurance programs, action-oriented quality assurance programs are necessary to reduce adverse events, as opposed to programs that merely collect information and react to events that have already occurred. Reporting medication errors without proper system-review will not reduce medication errors.
· Sufficient Legal Protection Must be
Provided to Health Care Practitioners Who Report
USP states that “[c]onfidentiality protections for patients, healthcare professionals, and healthcare organizations are essential to the ability of any reporting system to learn about errors and effect their reduction.”[10]
Congress has attempted to address medical or medication errors and
confidentiality or evidentiary privilege, with little progress. USP presented at the February 2001 Task
Force meeting, the status of H.R. 3672, S. 2738, S. 2743, S 2378, S. 2038. There has been no formal activity on these
bills since June 2000.[11]
If practitioners are required to report to an entity that is not a recognized medical review committee (sometimes called a peer review committee),[12] or is not otherwise presently provided protection from discoverability in some other manner, laws would have to be enacted to protect the information from discovery in a lawsuit. See Appendix B for present statute. Additionally, if practitioners are required to report errors internally[13], again some may be exposed to civil liability. Potentially, 88% of the pharmacies in Maryland are not afforded this protection from discoverability.[14]
With respect to discoverability, the applicable Circuit Court rule states that “…[i]t is not ground for objection…that the information will be inadmissible at trial if the information sought appears reasonably calculated to lead to the discovery of admissible evidence.”[15] Therefore the net of what may be discovered in a civil proceeding is very wide. Evidence that may be discovered may then be admissible in the proceeding depending on the particular circumstances of a case.[16]
Non-institutional pharmacies do not have committees that would meet the definition of a medical review committee and are not provided protection from discoverability. If a non-institutional pharmacy is required to have a highly detailed internal error reporting system in an effort to reduce medication errors, presently, that information would be discoverable in a civil proceeding against that pharmacy and its agents, and depending on the circumstances of the case, admissible as evidence in a trial.
Other states have, or are addressing, the discoverability issue. California is one
example of a state that has addressed the issue in its medication error statute. Effective January 1, 2002, pharmacies in California will be required to maintain quality assurance programs aimed at reducing medication errors.[17] California implemented the statute in order to effectuate regulations. The California statute reads as follows.
4125. (a) Every pharmacy shall establish a quality assurance
program that shall, at a minimum, document medication errorsattributable, in whole or in part, to the pharmacy or its personnel.The purpose of the quality assurance program shall be to assesserrors that occur in the pharmacy in dispensing or furnishingprescription medications so that the pharmacy may take appropriateaction to prevent a recurrence. (b) Records generated for and maintained as a component of apharmacy's ongoing quality assurance program shall be considered peerreview documents and not subject to discovery in any arbitration,civil, or other proceeding, except as provided hereafter. Thatprivilege shall not prevent review of a pharmacy's quality assuranceprogram and records maintained as part of that system by the board asnecessary to protect the public health and safety or if fraud isalleged by a government agency with jurisdiction over the pharmacy.Nothing in this section shall be construed to prohibit a patient fromaccessing his or her own prescription records. Nothing in thissection shall affect the discoverability of any records not solelygenerated for and maintained as a component of a pharmacy's ongoingquality assurance program. (c) This section shall become operative on January 1, 2002.[18] The quality assurance program is a program that is established and maintained within the specific entity, and not by a regulatory or other governmental agency.[19] The California Board has the authority to review the quality assurance records if “necessary to protect the public health and safety or if fraud is alleged by a government agency with jurisdiction over the pharmacy.”[20] In the proposed California regulations, the pharmacy must maintain the quality assurance review records for one year.[21] California’s approach is consistent with the Medication Error Task Force’s findings. California requires an on-going quality assurance program within a pharmacy, without requiring mandatory external reporting. The statute allows the California Board of Pharmacy to review the quality assurance records to protect the public health. This is an important point because without this authority the Board would not be able to ensure that a proper quality assurance program was being operated by a pharmacy. The California statute only protects records generated and maintained as a part of the on-going quality assurance program, and does not protect all records. This too is important because not all pharmacy records should be protected. If an injury is caused by a medication error the patient should be able to obtain her prescription records and use those records in a lawsuit. California’s law makes this clear when it states that “[n]othing in this section shall be construed to prohibit a patient from accessing his or her own prescription records.”[22]
Texas takes a similar approach to the quality assurance programs.[23] It does not require external reporting. Texas also makes the records generated pursuant to a quality assurance program non-discoverable.[24] Many other states are addressing the issue of medication and medical errors as well, including Florida, Massachusetts, Minnesota and New York.
If protection is provided for records that are maintained pursuant to a quality assurance program, the protection should be extended so that if a quality assurance program shares its records with another quality assurance program for the purpose of reducing errors, the protection from discoverability is not lost. The I.O.M. report recommended the following.
Congress should pass legislation to extend peer review protection to data related to patient safety and quality improvement that are collected and analyzed by healthcare organizations for internal use or shared with others solely for the purpose of improving safety and quality.[25]
USP agrees with this position.
Reporting systems should facilitate the sharing of patient safety information among healthcare organizations and foster confidential collaboration with other healthcare reporting systems.[26]
Protection of quality assurance information that is shared with other entities for the purpose of reducing errors is important, whether in federal or state law. Texas attempts to address this issue in several provisions.
(c) Except as otherwise provided by this section, all proceedings and records of a pharmacy peer review committee are confidential, and all communications made to a pharmacy peer review committee are privileged.
…
(f) Unless disclosure is required or authorized by law, records or determinations of or communications to a pharmacy peer review committee are not subject to subpoena or discovery and are not admissible as evidence in any civil judicial or administrative proceeding without waiver of confidentiality executed in writing by the committee….[27]
It is important to provide protection from certain discoverability for quality assurance records so that pharmacies may document and review, in detail, system flaws in an attempt to reduce medication and other errors. This protection must be provided by the legislature. Without these protections from discoverability, but with the need to address medication errors, the Board is promulgating limited regulations to address this issue.
· Mandatory Reporting Does Not
Reduce Adverse Events
Mandatory reporting programs for adverse events presently exist with consistently low reporting numbers. The Joint Commission on Accreditation of Healthcare Organizations (JCAHO) has operated a Sentinel Event Program since 1995. If a healthcare organization is accredited by the JCAHO it is “encouraged” to self-report sentinel events to JCAHO.[28] Health care organizations view this reporting as mandatory because heavy sanctions can be levied if proper procedures are not followed, including sanctions of up to $3,500 a day for “for cause” surveys, and loss of accreditation.[29] As of August 30, 2001, JCAHO has reviewed 1,398 sentinel event reports through their national reporting program.[30] This is in sharp contrast to the 98,000 estimated fatalities reported by certain studies, as reported in the I.O.M. report, To Err is Human.[31]
Requiring that health care professionals report themselves to their own licensing Board will be ineffective. It is analogous to a driver reporting to the police that he has been speeding, so that the police may give the driver a speeding ticket or revoke the driver’s license. Licensees will not report speeding, or adverse medical events. The events will not be reported to the licensing Board, and most probably, will not be reported to the health care entity’s quality assurance program. If the events are essentially “swept under the rug” the systems-review approach will be ineffective, and the system will not be improved, to the benefit of the patient.
The Task Force does not oppose mandatory reporting but it feels that due to under-reporting, it does not provide an adequate amount of useful information. The Task Force would not recommend mandatory reporting because it believes that it will quell error reporting. If mandatory reporting is required, it must be coupled with protection from discoverability and a non-punitive approach to addressing the reported errors. Additionally, if mandatory external reporting is required, the cost of implementing and operating a program must be considered, and structures must be established to collect, analyze and disseminate information in a timely manner.
Open and complete error reporting by those directly involved in the event and review of adverse events by those directly in charge of the particular health care delivery system will cause system improvement to occur. Because systems vary among institutions and pharmacies, reporting to a committee within a health care entity or particular pharmacy is most appropriate because each can modify its particular system to reduce medication errors. This type of reporting is called “internal reporting.” It is of tantamount importance that health care practitioners ‘buy-in’ to the reporting process and its ultimate goal, otherwise open reporting will not occur. Incentives to report must be established to create ‘buy-in’. Incentives can include the lure of creating a safer environment for patients and staff. Showing that the information is used to improve the system can foster practitioner ‘buy-in’. Protection from discoverability will encourage practitioner buy-in as well.
Therefore the Medication Error Task Force recommended to the Board that a non-punitive, voluntary, internal reporting approach should be used when addressing medication errors. This does not mean that the Board will take a hands-off approach. Weighing what information the Board may be privy to in order to protect the public health with the need to foster open reporting is a difficult issue. The Board must monitor programs and provide guidance where appropriate. The Board believes it has addressed these issues appropriately in the limited regulations it is presently promulgating based on the Task Force’s recommendations.
Present
Status of Proposed Regulations
The
Medication Error Task Force recommended that the Board implement regulations
relating to medication errors with the understanding that a systems-approach to
addressing medication errors must be the basis of any regulation. The Medication Error Task Force, along with
the Pharmacy Practice Committee of the Board, drafted proposed regulations
entitled “Patient Safety Improvement.”
The regulations, which have been approved by the Board for publication
and are in the process of promulgation, include:
¾A documented quality assurance program that includes a process
to identify, investigate and promote the prevention of medication
errors, and