A Prescription for Negligence Martin R. Dix, JD

A Prescription for Negligence Martin R. Dix, JD Akerman LLP

Disclosures Martin R. Dix declare(s) no conflicts of interest, real or apparent, and no financial interests in any company, product, or service mentioned in this program, including grants, employment, gifts, stock holdings, and honoraria. The American College of Apothecaries, Inc. is accredited by the Accreditation Council for Pharmacy Education as a provider of continuing pharmacy education.

Learning Objectives At the conclusion of this program, the participating pharmacist or technician will be able to: Describe relationships between medical malpractice cases and continuous quality improvement and peer review processes. Identify areas of malpractice risk for pharmacies and pharmacists. List common procedures related to malpractice cases. Explain the relationship of pharmacist disciplinary action to a malpractice case.

Dispensing Errors 1,2,3 In 2011, community pharmacies dispensed almost 4 billion prescriptions Pharmacists have direct responsibility for accurately dispensing prescription orders - dispensing errors are a critical concern for the practice of pharmacy Published studies regarding medication errors in community pharmacies are limited: overall dispensing error rates range from 0.26% to 24% 0.1% to 4% of prescriptions dispensed had the potential to contain clinically significant errors that could cause patient harm or discomfort Using a conservative estimate of a 1% overall dispensing error rate, this would translate to over 40 million dispensing errors in the US each year

Known Factors that May Cause or Contribute to Medication Errors Unavailable drug information Miscommunication of drug orders Handwriting Confusion between drugs with similar names Misuse of zeroes and decimal points Confusion of metric and other dosing units Inappropriate abbreviations Lack of appropriate labeling Dose miscalculations Knowledge Deficiencies Environmental factors such as lighting, heat, noise Interruptions Complex or poorly designed technology Poor procedures or techniques Job stress General failure to act in accordance with education and training Incorrect diagnosis Patient misuse of medication due to lack of patient information or education

Other Common Causes of Pharmacy Malpractice in a Retail Pharmacy Pharmacy technician fills bottle with the wrong drug and pharmacist fails to correct the error Pharmacy technician fills bottle with the wrong dosage and pharmacist fails to correct the error Pharmacy technician types instructions wrong and pharmacist fails to correct the error Pharmacy technician types wrong drug or wrong dose into the patient profile and pharmacist fails to correct the error Cashier places wrong prescription in patient s bag

Continuous Quality Improvement (CQI) Peer Review Process for review of pharmacy Quality Related Events A planned process, to record, measure, assess and improve the quality of patient care 18 states require CQI and another 4 recommend it Usually involves of the processes involved in why the QRE occurred

Quality Related Events Quality-Related Event means the inappropriate dispensing or administration of a prescribed medication including: A variation from the prescriber s prescription order, including, but not limited to: Incorrect drug; strength or dosage form Incorrect patient; or Inadequate or incorrect packaging, labeling, or directions. Failure to identify and manage: Over-utilization or under-utilization Therapeutic duplication Drug-disease contraindications Drug-drug interactions Incorrect drug dosage or duration of drug treatment Drug-allergy interactions Clinical abuse/misuse

CQI and Peer Review Most states protect peer review organizations documents Protected documents include incident and risk management reports, interviews, summaries, etc. Actual prescriptions and prescription records are not protected Florida protects peer review and CQI reports, FL Constitution allows discovery of certain documents Florida allows inspectors to see summaries

Potential Legal Consequences Associated with Prescription Medication Errors Civil Malpractice/professional negligence action where injured patient sues the pharmacy/pharmacist for harm caused by a medication error. If successful, the patient will receive a monetary award. Administrative Action taken by the state board of pharmacy against professional license. Discipline could result in public reprimand, monetary fine, and/or license probation, suspension, or revocation. Criminal Involves criminal charges, such as manslaughter or reckless homicide, against the pharmacist as a result of a medication error that caused patient death. If convicted, penalties could involve probation or jail sentence.

Pharmacist Malpractice and Discipline (Administrative Action) 4 Pharmacists can be disciplined for malpractice Example: Florida disciplines pharmacists for : (g) Using in the compounding of a prescription, or furnishing upon prescription, an ingredient or article different in any manner from the ingredient or article prescribed.

Pharmacist Malpractice and Discipline (Administrative Action) Committing an error or omission during the performance of a specific function of prescription drug processing, which includes: Receiving, interpreting, or clarifying a prescription Entering prescription data into the pharmacy s record Verifying or validating a prescription Performing pharmaceutical calculations Performing prospective drug review as defined by the board

Pharmacist Malpractice and Discipline (Administrative Action) Obtaining refill and substitution authorizations Interpreting or acting on clinical data Performing therapeutic interventions Providing drug information concerning a patient s prescription Providing patient counseling

Pharmacist Malpractice and Discipline (Administrative Action) 5 Pennsylvania Pharmacy Act Section 5. Refusal to Grant, Revocation and Suspension. (a) The board shall have the power to refuse, revoke or suspend the license of any pharmacist upon proof satisfactory to it that the pharmacist: (12) Is guilty of incompetence, gross negligence or other malpractice, or the departure from, or failure to conform to, the standards of acceptable and prevailing pharmacy practice, in which case actual injury need not be established.

Pharmacy Discipline Process is state specific Usually starts with a complaint Then an investigation by state investigators Some states have a probable cause process If no probable cause the case is dismissed If probable cause there is a complaint Usually offered a settlement agreement

Pharmacy Discipline Settlement Agreements Vs. Hearings Settlement Agreements Respondent admits that the allegations, if proven, would constitute violations of the Pharmacy Practice Act. Hearings Result in a Final Order Respondent has violated Section 465.016, Florida Statutes.

Pharmacy Discipline Board of Pharmacy Response: Punishment Ranges from admonishment, to fines, to specific conditions (i.e., remediation or programs), to suspension for set time, to revocation Protect the public and encourage compliance Education Help prevent future errors Protect the public

Traditional Causes of Action Negligence Per Se Negligence Civil Liability Act or omission by pharmacy provider in which care provided deviated from acceptable standards of practice and caused injury to the patient Non-intentional, but it happened! Pretty cut and dry; we have a duty; causation is usually at question!!!

Civil Liability 4 elements of professional negligence Plaintiff must prove ALL 1. Duty owed 2. Breach of duty 3. Causation 4. Damages

Civil Liability (Cont.) Typically a dispute between 2 citizens/legal entities involving $$$$$$$ Criminal and/or administrative action could also come from same dispute Injured party = Plaintiff (P or ) Person accused of causing injury = Defendant (D or )

Negligence Per Se Negligence Per Se involves a violation of a statute or regulation especially designed to protect the public safety Recovery may be had for Negligence Per Se when: The harm resulting from the violation is the type that the statute is designed to prevent, The plaintiff is a member of the class of persons sought to be protected by the statute, and The violation is the proximate cause of the plaintiff's injury

Reasons for using Negligence Per Se Plaintiff does not have to prove negligence - just prove violation of the law It makes the Defendant look worse

Negligence Per Se Estate of Johnson vs. Badger Acq. 6 Case against nursing home pharmacy (Omnicare) for: Failing to appropriately monitor the dispensing of medication Failing to appropriately monitor the proximity in which the same medication was dispensed Failing to adequately monitor patient s medication administration Failing to appropriately monitor and address adverse effects and drug interactions of medications Failing to conduct a thorough and adequate monthly drug regimen review

Johnson v. Badger Acquisition Failing to adequately and timely account, and reconcile, the controlled drugs to have been utilized Failing to appropriately monitor and address the undermedication/overmedication Failing to adequately assess that the dosage of the medication administered was inappropriate Failing to timely report irregularities in medication reviews to appropriate personnel Failing to adequately develop the appropriate policies and procedures relating to pharmacy services within the facility Failing to provide adequate in-service education and training to nursing home and pharmacy personnel Failing to properly hire, retain, train, and supervise a licensed consultant pharmacist to ensure that the residents received appropriate pharmacy services

Court held: Johnson V. Badger Acq. Omnicare had no legal duty to the patient Omnicare s role with nursing home was administrative and ministerial; Omnicare was responsible for recordkeeping and procedures Pharmacist has 4 duties: 1) He will compound the drug prescribed 2) He has used due and proper care in filling the prescriptions 3) The proper methods were used in the compounding process 4) The drug has not been infected with some adulterating foreign substance

Civil Liability Professional Negligence / Malpractice Element 1: Duty of Care A pharmacist must use the degree of care that a reasonable and prudent pharmacist would use under similar circumstances A pharmacist is bound simply to exercise the skill generally possessed by well-educated pharmacists who are considered competent in the profession of pharmacy We have a duty to foreseeable people Human or honest error is no defense for a pharmacist

Civil Liability Element 2: Breach of Duty Generally, when a pharmacist fills a prescription in a manner other than the way it was ordered he or she has breached a duty of care owed to the patient To breach a duty, there must be a standard of professional practice that exists and that the professional did not adhere to the standard Expert witnesses can help prove if there was or was not a standard of care to be followed (in instances other than misfills) Can breach a duty by omitting or failing to do something

Element 3: Causation Civil Liability Even if a pharmacist owes a duty of care and that duty is breached, the law still requires that the pharmacist s conduct CAUSED the alleged damages 2 Step Process P must show D s conduct was a substantial factor in the actual harm that occurred Actual cause usually proven by expert witness P must prove proximate causation to D Each link of chain must be foreseeable to the D ( but for test)

Civil Liability Element 4: Damages P must show Damages There is no recovery for negligence (or malpractice) if no harm was done If a mistake is detected and rectified before any physical harm can occur, there will probably be no compensable damages Compensable damages can be actual or punitive

Civil Liability From past judicial opinions, the most common type of prescription medication error leading to pharmacist liability for malpractice is the straightforward misfilling of a prescription with a drug other than what the prescriber intended. Previous legal cases have clearly established that pharmacists have a legal duty to their patients to accurately fill prescriptions Therefore, if there is a dispensing error and the patient, or plaintiff, bringing the lawsuit proves that the error caused harm, the patient or plaintiff will likely be successful in the malpractice action

Civil Liability Numerous state courts have addressed cases considering whether pharmacists can be civilly liable for allegations of intellectual errors Although some state courts have declined to allow civil liability, others have held that pharmacists can be liable for such errors Duty to Warn theory - patients injured by prescription drugs claim that the pharmacist had a duty to warn about the potential adverse effects and other dangers associated with prescription drugs

Civil Liability Expanded Responsibilities Pharmacists must still process orders accurately but also monitor and affect drug therapy outcomes OBRA 90 (failure to counsel or failure to monitor or identify; including potential problems such as addiction, excessive refills, side effects, therapeutic duplication, drug-disease contraindications, allergies Duty to Warn cases (many fall under topics just mentioned under OBRA 90 examples) Pharmaceutical Care (patient centered care) Model Medication therapy management/drug therapy management Further expansions? PMP (prescription drug monitoring) Cases Dispensing of CS (controlled substances) Compounding

Civil Liability Failure to Warn Claims The General Rule: No generalized duty to warn of adverse effects Learned Intermediary Doctrine Exceptions to the Rule: Obvious inadequacy on the face of the prescription Special knowledge of the pharmacist Voluntary undertaking Public expectations Limits on Expansion of the General Rule

Learned Intermediary Doctrine A majority of the states apply the learned intermediary doctrine to relieve pharmacists of liability That between the doctor and the pharmacist, the doctor is in the best position to warn the customer of a given medication's generalized risks. Viewed more pragmatically, the doctrine prevents pharmacists from constantly second-guessing a prescribing doctor's judgment simply in order to avoid his or her own liability to the customer Ignores patient counseling requirements

Klasch v. Walgreen (NV) 7 Duty to Warn Patient with sulfa drug allergy was warned about using these drugs by both the doctor and pharmacist. Patient used them anyway, had a severe allergic reaction went into a coma and died Both sides sought summary judgment Walgreen defended on Learned Intermediary Doctrine. [W]e hold that a narrow duty to warn exists where, as in the instant case, a pharmacy has patient-specific information about drug allergies, and knows that the drug being prescribed is contraindicated for the individual patient. In such instances, a pharmacy has a duty to warn either the prescribing physician or the patient of the potential danger.

Kowalski v. Rose Drugs (AR) 8 Learned Intermediary Doctrine Patient was taking: a mix of medications including: long and short acting opiates, benzodiazepines, muscle relaxers, and antidepressants. Then, Rose Drugs dispensed: a mix of medications including: long and short acting opiates, benzodiazepines, muscle relaxers, and antidepressants. Patient mixed with alcohol and died. Prescriptions written by Dr. Mann were filled at Rose Drugs.

Kowalski v. Rose Drugs (AR) Learned Intermediary Doctrine Court found: Controlled substances act does not create a duty to warn OBRA 90 imposes responsibilities on pharmacist, but does not create a duty to warn or a private cause of action against pharmacists Arkansas pharmacy laws and regulations do not create a duty to warn

Kowalski v. Rose Drugs (AR) Learned Intermediary Doctrine Maj. Opinion: ( Leaned Intermediary Doctrine): the patient must look to the physician, for it is only the physician who can relate the propensities of the drug to the physical idiosyncracies of the patient. It is the physician who is in the best position to decide when to use and how and when to inform his patient regarding risks and benefits pertaining to drug therapy: 2 Judge Dissent: The majority opinion fails to recognize that, far from being a robot, the pharmacist is a critical link in the prescription chain who owes a duty of due care to customers. Exception to Learned Intermediary Doctrine where drugs are contraindicated

BUSTETTER V. ARMOR COR. HEALTH SERV., INC. 9 Patient (prisoner) sues doctor, nurse, jail, and pharmacy for dispensing rosiglitazone (for Type II diabetes) when all involved allegedly knew he had Type I No duty to warn unless there is something wrong on the face of the prescription Case reviews Florida cases: McCleod - No duty to warn- duty to take proper care in dispensing prescription(1965) Pysz - No duty to warn of dangers of Quaaludes (1982)

BUSTETTER V. ARMOR Court concluded: Facts of this case more like Badger Acquisition and Estate of Sharpe (both C. PH s at nursing homes)-pharmacist never saw patient- not like Dee, Thobani and Arrington No duty to warn of a drug s ineffectiveness No duty to second guess the prescription if not obviously flawed or does not impose a risk of death

Duty to Not Dispense? After warning, Is there a duty to not dispense when drug is contraindicated? Can a pharmacist refuse to dispense when he or she does not know diagnosis? What happens if you refuse to dispense and person is injured?

Is the Learned Intermediary Doctrine Eroding? OBRA 90 and state patient counseling requirements Pharmacists hold themselves out as the drug experts More drugs More pharmacies and pharmacists More injuries

Civil Cases May start with either a claim or file a Complaint in court If a complaint, the pharmacist and pharmacy have to be served Once served, you have a set time to find a lawyer and Answer (usually 20 days) Discovery - Interrogatories Depositions Expert Witnesses Subpoenas and Request for Documents (HIPAA)

Civil Cases Motions Motion for Summary Judgment No facts in dispute and on any reading of the facts there is or there is not liability

Civil Cases Possible Scenarios: Dismissal Settlement Mediation Jury trial

Civil Cases Defenses to Negligence Contributory Negligence Comparative Negligence Failure to mitigate Assumption of the Risk Statute of Limitations

QUESTIONS?

References 1. The Use of Medicines in the United States: Review of 2011. Report by the IMS Institute for Healthcare Informatics. Available at: http://www.imshealth.com/ims/global/content/insights/ims%20institute%20for%20healt hcare%20informatics/ihii_medicines_in_u.s_report_2011.pdf 2. Flynn EA, Barker KN, Carnahan BJ. National observational study of prescription dispensing accuracy and safety in 50 pharmacies. J Am Pharm Assoc. 2003;43:191-200. 3. Kuiper SA, McCreadie SR, et al. Medication error in inpatient pharmacy operations and technologies for improvement. Am J Health-System Pharm. 2007;64(9):955-959. 4. Section 465.016, Florida Statutes. 5. Pennsylvania Pharmacy Act, Section 5. 6. Estate of Johnson v. Badger Acquisition, 983 So. 2d 1175 (Fla. 2d DCA 2008) 7. Klasch v. Walgreen Co., 264 P.3d 1155-2011. 8. Kowalski v Rose Drugs 2011 Ark. 44, 378 S.W.3d 109 (AR S. Ct. 2011). 9. Bustetter v. Armor Cor. Health Serv., Inc. Case No. 8:12-cv-1236-T-24 TGW (M.D. FL 2013)

Need More Information? Martin R. Dix, JD Akerman LLP 106 E. College Ave., Suite 1200 Tallahassee, FL 32301 (850) 224-9634 martin.dix@akerman.com