Medication Errors: How To Prevent Them and What Can Happen When They are Made

Medication Errors: How To Prevent Them and What Can Happen When They are Made Angelo J. Cifaldi, R.Ph., Esq. acifaldi@wilentz.com 732-855-6096 Satish V. Poondi, R.Ph., Esq. spoondi@wilentz.com 732-855-6154 Wilentz, Goldman, & Spitzer P.A. 90 Woodbridge Center Drive Woodbridge, NJ 07095 © Angelo Cifaldi, 2011

What is a Medication Error • "A medication error is any preventable eventthat may cause or lead toinappropriate 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." - National Coordinating Council for Medication Error Reporting and Prevention

ISMP’s “ten key elements” of the medication-use system • Patient information: Failure to obtain the patient’s pertinent demographic (age, weight) and clinical (allergies, lab results) information • Drug information: Failure to provide accurate and usable drug information • Communication of drug information: Miscommunication between MD, R.Ph. and RN • Drug labeling, packaging and nomenclature: Drug names that look-alike or sound-alike, as well as products that have confusing drug labeling and non-distinct drug packaging • Drug storage, stock, standardization, and distribution: Lack of Standard drug administration times, drug concentrations • Drug device acquisition, use and monitoring: Lack of safety assessment of drug delivery devices and/or a system of independent double-checks • Environmental factors: Environmental factors that often contribute to medications errors include poor lighting, noise, interruptions and a significant workload. • Staff competency and education: Staff education should focus on priority topics, such as: new medications being used in the hospital, high- alert medications, medication errors that have occurred both internally and externally, protocols, policies and procedures related to medication use. • Patient education: Patients must receive ongoing education • Quality processes and risk management: The way to prevent errors is to redesign the systems and processes that lead to errors rather than focus on correcting the individuals who make errors.

Creating a System to Prevent Medication Errors • New and Existing Board of Pharmacy regulations dealing with Medication Errors • Medication Errors probably cannot be eliminated 100%, but utilizing best practices can greatly reduce them.

Board of Pharmacy RegulationsAudit Trail Requirement • N.J.A.C. 13:39-7.6: Audit Trail • On or after April 5, 2011, a pharmacy shall maintain an audit trail that records and documents the unique and secure user identifier(s) of the • Pharmacist • Pharmacy Technician • Intern • Extern

Board of Pharmacy RegulationsAudit Trail Requirement • Audit trail applies to each step pf prescription handling • Intake • Processing • Fulfillment • Dispensing N.J.A.C. 13:39-4.19

Board of Pharmacy RegulationsAudit Trail Requirement • All Entries to the audit trail made by a pharmacy technician, intern, or extern shall be reviewed and approved by the pharmacist; • Audit trail documentation shall be generated at the time each function is performed • If more than one R.Ph. involved, the unique identifier of R.Ph. responsible for the accuracy and appropriateness of each function must be recorded

Board of Pharmacy RegulationsAudit Trail Requirement • Audit trail documentation must be maintained for at least a period of five years. • Computer systems that automatically generate the unique and secure user identifier without requiring an entry by the responsible party are prohibited • Appropriate documentation identifying the identifier must be maintained for at least five years after the last date of employment

Board of Pharmacy RegulationsPharmacy Technicians A pharmacy technician may: • Retrieve prescription files, patient files and profiles, and other pharmacy records • Enter data • Prepare labels • Count, weigh, measure, pour and compound prescription medications • Fill automated systems • Accept authorization for renewals and requests for refills • Provided that the prescription remains unchanged • The pharmacy technician or applicant shall identify him/herself as a pharmacy technician when accepting authorization from a physician or his/her agent N.J.A.C. 13:39-6.15

Board of Pharmacy RegulationsPharmacy Technicians A pharmacy technician may not: • Receive new verbal prescriptions • Interpret a prescription or medication order for therapeutic acceptability and appropriateness • Verify dosage and directions • Engage in prospective drug review • Provide patient counseling • Monitor prescription usage • Override computer alerts without first notifying pharmacist • Transfer prescriptions from one pharmacy to another pharmacy • Violate patient confidentiality

Board of Pharmacy RegulationsPharmacy Technicians Pharmacists shall not supervise more than 2 pharmacy technicians unless… • Written job descriptions, task protocols, and policies and procedures regarding technician duties to perform • Each pharmacy technician passes the National Pharmacy Technician Certification Examination (or a board approved certification program) AND fulfills the requirements to maintain this status • OR completes a program that includes a testing component that has been approved by the board

Board of Pharmacy RegulationsMaintaining Patient Profiles • Greater number of Board of Pharmacy inspections focusing on Patient Profiles • Recommend random self audits • Verify Information • Maintaining accurate and complete profiles helps reduce medication errors

Board of Pharmacy RegulationsMaintaining Patient Profiles • The following information shall be recorded in the profile system (N.J.A.C. 13:39-7.19): • Family name and first name; • Address and telephone number; • DOB; • Original or refill date the medication is dispensed; • Prescription number; • The practitioner’s name; • Name, Strength, and Quantity of the drug dispensed; • Pharmacist’s comments relevant to the patient’s drug therapy; and • Any allergies • If no allergies, then that must be documented

Board of Pharmacy RegulationsMaintaining Patient Profiles • “All prescription patients who patronize a pharmacy shall have a profile record . . . and the pharmacist shall inquire as to whether other prescription drugs are being concomitantly utilized in order to establish a current drug history for the patient.” Id.

New Prescription Labeling Requirement • P.L. 1977, c.240 (C.24:6E-9) • Effective January 29th, 2010 • If a nonbrand name drug product is dispensed, the pharmacist shall include on the label of such drug product dispensed pursuant to a prescription, the name of the brand name drug and the name of the generic drug. The information required pursuant to this section shall be in the following form, with the generic name and brand name inserted as appropriate, “- - - - - - - Generic for - - - - - - .” • Example: Simvastatin Generic for Zocor

Manner of Issuance of Prescriptions for Schedule II Substances • Traditional New Jersey Rule: Physician may prescribe a maximum of 30 days or 120 dosage units, whichever is less, unless an exception applies. • Multiple Prescriptions now allowed N.J.A.C. 8:65-7.5

Manner of Issuance of Prescriptions for Schedule II Substances • Physicians are permitted to issue multiple prescriptions authorizing a patient to receive a total of up to a 90-day supply of a Schedule II controlled dangerous substance provided: • Each separate prescription is issued for a legitimate medical purpose by the physician acting in the usual course of professional practice; • The physician provides written instructions on each prescription, other than the first prescription if it is to be filled immediately, indicating the earliest date on which a pharmacy may fill each prescription • The physician determines that providing the patient with multiple prescriptions in this manner does not create an undue risk of diversion or abuse; and • The physician complies with all other applicable State and Federal laws, rules and regulations.

Collaborative PracticeProposed Regulations • New rules authorizing pharmacists to engage in collaborative practice with licensed physicians have been proposed. • The proposed regulations are up for public comment • Collaborative practice will allow for greater inter-disciplinary communication

Preventing Medication Errors: Use of Best Practices • Importance of documenting actions including phone calls to M.D. • Inventory controls • Routine checks for expired medication • Purging the “Will Call Bin” • Educate employees • Not limited to those within the pharmacy department • Downstream activities (i.e. drivers) should be included • Written Policies and Procedures

Negligence One must look at the following questions: • Does defendant owe a duty to the plaintiff? • What standard of care applies? • Did the defendant breach the duty to conform to the standard of care required by law? • Was the defendant’s conduct a cause in fact of defendant’s harm?

Negligence • Was the defendant’s conduct the proximate cause of the plaintiff’s harm? • Did the plaintiff suffer actual damage compensable in negligence? • Was the plaintiff’s negligence a contributing factor?

Elements of a Negligence Case • Duty • Standard of Care • Breach • Cause in Fact • Proximate Cause • Damages • Vicarious Liability • Joint and Several Liability

Duty • The law normally imposes a duty to use due care on everyone. • It is generally accepted that a pharmacist owes a duty of care to a patient and their dependents. • This is based on the pharmacist-patient relationship.

Standard of Care • After finding a duty, one next must examine whether the defendant’s conduct created an unreasonable risk of harm to others. • In the pharmaceutical setting that question would be framed with regard to a pharmacist.

Standard of Care (Differs Depending on the Relationship) • Reasonable Person Standard • Professionals a) Basic Standard b) Expert Testimony c) Special Considerations

Standard of Care • Reasonable Person Standard • In a non-professional setting, the reasonable person standard is utilized in this analysis. • It asks how would a reasonable person have acted under similar circumstances.

Standard of Care • Professionals • The standard of care utilized in a professional setting is that which would be exhibited by a professional under similar circumstances. • It is important to note that this standard does not require at all times the professional to act correctly.

Standard of Care 2a) Basic Standard- Professional conduct is measured against the minimum common skill of members in good standing in the profession.

Standard of Care 2b) Expert Testimony - Is generally required in determining how a professional would have acted under similar circumstances. In pharmacy matters a pharmacist would give testimony.

Standard of Care 2c) Special Considerations i) Locality Rule-Professionals will be held to the standards of their locality. Thus, standards may differ in a large city and a small town. ii) Specialists-Held to the national standard. iii) Civil and Criminal Statutes-If there is a specific civil liability statute on point, the pharmacist is subject to that penalty. Usually only a criminal statute applies, and it is less clear.

Breach • In performing a negligence analysis, one must simply determine whether defendant in fact breached the applicable standard of care discussed above. • To make this determination, one need look at the facts and determine if a breach occurred.

Cause in Fact After the plaintiff has proven the above elements the next issue is whether defendant’s conduct was a cause in fact or factual cause of plaintiff’s harm.

Cause in Fact • “But For Test” • Substantial Factor Test • Action vs. Inaction • Summers vs. Tice

Cause in Fact • “But For Test”- The but for test requires the injured party prove that his injury would not have occurred “but for” the negligent actions of defendant.

Cause in Fact 2. Substantial Factor Test- • Can be more stringent than the “but for” test. • Defendant’s negligent conduct must have been a “substantial factor” in causing the plaintiff’s injury.

Cause in Fact • Action vs. Inaction- • Defendants can be held responsible for actions as well asinactions. • Action-Dispensing the wrong medication. • Inaction-Failure to warn of an adverse reaction.

Cause in Fact • Summers vs. Tice • Two hunters fired their shotguns in the plaintiff’s direction. • A shotgun pellet lodged in the plaintiff’s eye. • Since it was impossible for the plaintiff to prove who shot the gun that caused his injury the burden was placed on both defendants and both were held responsible.

Proximate Cause • If all the above elements are established, plaintiff must then demonstrate proximate cause. • This is sometimes referred to as legal cause.

Proximate Cause Definition: Proximate cause is concerned with policy considerations limiting the scope of liability. For example: is it to society’s benefit to hold the pharmacist liable for a certain type of conduct? Foreseeability: The proximate cause issue centers on whether the injury was reasonably foreseeable as resulting from the conduct in question. Palsgraph v. Long Island Railroad.

Damages • Mental Pain and Suffering • Physical Pain and Suffering • Medical Expenses • Lost Wages and Future Earnings (PA) • Child Care Costs • Loss of Consortium • Negligent Infliction of Emotional Distress • Punitive

Damages • Mental Pain and Suffering • Mental anguish from an injury. • Physical Pain and Suffering • Actual inflicted pain. • Medical Expenses • Only those expenses not paid by insurance • Lost Wages and Future Earnings • Plaintiff may be eligible for wage reimbursement for lost work days and disability.

Damages • Child Care Costs • Cost of raising a child or other relevant damages. • Loss of Consortium • Plaintiff may sue based on his or her loss of the right of his/her spouse to the company of, help of, affection of, and sexual relations with his or her mate.

Damages • Negligent Infliction of Emotional Distress • One has a legal duty to use reasonable care to avoid causing emotional distress to another individual. • An example is when a mother witnesses the injury of her child. • Punitive • A court can award damages in amounts that exceed the economic losses and general damages of an injured party. These are intended solely to punish the defendant because of reckless or malicious acts. -

Vicarious Liability (Respondent Superior) • An employer is liable for the negligence of his employees. • For example, the pharmacist could be liable for the negligence of a technician if he had a duty to check his work.

Joint and Several Liability Those who act together in committing a wrong, or whose acts if independent of each other, unite in causing a single injury. Thus, the defendants can be held fully or partially responsible for the entire injury.

Application negligence principles to pharmacy negligence case: Case #1 Riff vs. Morgan Pharmacy, William T. Stack, MD

Case: Riff vs. Morgan Pharmacy, William T. Stack, MD. Parties Involved • Plaintiff: Patricia Riff & Joseph Riff • Defendants: William T. Stack, MD Morgan Pharmacy

Case: Riff vs. Morgan Pharmacy, William T. Stack, MD. Facts • On January 24, 1979, Patricia Riff was complaining of a migraine headache where her family physician, William T. Stack prescribed her 12 Cafergot suppositories. • The instructions on the prescription were to insert one in the rectum “every four hours for headache”, with no refills.

Case: Riff vs. Morgan Pharmacy, William T. Stack, MD. Facts • The prescription was filled at Morgan Pharmacy where no additional instructions were given regarding the use and dangers of the drug. • On that evening, between Jan. 24th and the morning of Jan. 25th, Mrs. Riff inserted 3-4 suppositories before obtaining relief. • Mrs. Riff experienced a second migraine three months later. She then used the remaining suppositories from her first migraine attack until her supply ran out.

Case: Riff vs. Morgan Pharmacy, William T. Stack, MD. Facts • Mr. Riff requested a refill at Morgan Pharmacy which was given with the same instructions. As a result, Mrs. Riff used 15-17 suppositories by inserting one every 4 hours. • On August 27, Mrs. Riff experienced a third migraine headache. She discovered she only had one suppository left so her husband requested another refill at Morgan Pharmacy. Mrs. Riff used 5-6 suppositories. • Cafergot suppositories come in a box that contains instructions as to the maximum safe dosage. However, it is undisputed that the only instructions the pharmacist gave Mrs Riff was insert one Cafergot suppository every 4 hours for relief.

Medication Errors: How To Prevent Them and What Can Happen When They are Made