Medication Errors How To Prevent Them and What

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 o "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. " - National Coordinating Council for Medication Error Reporting and Prevention

ISMP’s “ten key elements” of the medication-use system o o o o o 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 nondistinct 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 o o New and Existing Board of Pharmacy regulations dealing with Medication Errors probably cannot be eliminated 100%, but utilizing best practices can greatly reduce them.

Board of Pharmacy Regulations Audit Trail Requirement o N. J. A. C. 13: 39 -7. 6: Audit Trail n 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 n n Pharmacist Pharmacy Technician Intern Extern

Board of Pharmacy Regulations Audit Trail Requirement o Audit trail applies to each step pf prescription handling n n Intake Processing Fulfillment Dispensing N. J. A. C. 13: 39 -4. 19

Board of Pharmacy Regulations Audit Trail Requirement q q q 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 Regulations Audit Trail Requirement q q q 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 Regulations Pharmacy Technicians A pharmacy technician may: n n n 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 o o N. J. A. C. 13: 39 -6. 15 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

Board of Pharmacy Regulations Pharmacy Technicians A pharmacy technician may not: n n n n n 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 Regulations Pharmacy Technicians Pharmacists shall not supervise more than 2 pharmacy technicians unless… o o 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 n OR completes a program that includes a testing component that has been approved by the board

Board of Pharmacy Regulations Maintaining Patient Profiles o o 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 Regulations Maintaining Patient Profiles o The following information shall be recorded in the profile system (N. J. A. C. 13: 39 -7. 19): n Family name and first name; n Address and telephone number; n DOB; n Original or refill date the medication is dispensed; n Prescription number; n The practitioner’s name; n Name, Strength, and Quantity of the drug dispensed; n Pharmacist’s comments relevant to the patient’s drug therapy; and n Any allergies o If no allergies, then that must be documented

Board of Pharmacy Regulations Maintaining 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. o

New Prescription Labeling Requirement o P. L. 1977, c. 240 (C. 24: 6 E-9) o Effective January 29 th, 2010 o o 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 o o 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 o 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: n n 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 Practice Proposed Regulations o o o 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 o o Importance of documenting actions including phone calls to M. D. Inventory controls n n o Educate employees n n o Routine checks for expired medication Purging the “Will Call Bin” 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: o o 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 o o o 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 A. B. C. D. E. F. G. H. Duty Standard of Care Breach Cause in Fact Proximate Cause Damages Vicarious Liability Joint and Several Liability

Duty o o o 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 pharmacistpatient relationship.

Standard of Care o o 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) 1. 2. Reasonable Person Standard Professionals a) Basic Standard b) Expert Testimony c) Special Considerations

Standard of Care 1. Reasonable Person Standard n n 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 2. Professionals n n 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 2 a) Basic Standard. Professional conduct is measured against the minimum common skill of members in good standing in the profession.

Standard of Care 2 b) 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 2 c) 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 o o 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 1. 2. 3. 4. “But For Test” Substantial Factor Test Action vs. Inaction Summers vs. Tice

Cause in Fact 1. “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 Testn n 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 3) Action vs. Inactionn n n Defendants can be held responsible for actions as well as inactions. Action-Dispensing the wrong medication. Inaction-Failure to warn of an adverse reaction.

Cause in Fact 4) Summers vs. Tice n n n 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 o o 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 1. 2. 3. 4. 5. 6. 7. 8. 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 1. n Mental anguish from an injury. Physical Pain and Suffering 2. n Actual inflicted pain. Medical Expenses 3. n Only those expenses not paid by insurance Lost Wages and Future Earnings 4. n Plaintiff may be eligible for wage reimbursement for lost work days and disability.

Damages 5. Child Care Costs n 6. Cost of raising a child or other relevant damages. Loss of Consortium n 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 7. 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. n n Punitive 8. 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. n -

Vicarious Liability (Respondent Superior) n n 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 o o Plaintiff: Patricia Riff & Joseph Riff Defendants: William T. Stack, MD Morgan Pharmacy

Case: Riff vs. Morgan Pharmacy, William T. Stack, MD. Facts o o 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 o o o 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. 24 th and the morning of Jan. 25 th, 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 o o o 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.

Case: Riff vs. Morgan Pharmacy, William T. Stack, MD. Facts o o On August 31, Mrs. Riff began experiencing discomfort in her right foot. She went to the hospital where they performed two angiograms to rule out the possibility of a blood clot. It was determined that there was no blood clot and that the toxic effects of an overdose of Cafergot was the cause. As a result, Mrs. Riff suffered permanent damage from diminished blood circulation and nerve damage to her foot.

Case: Riff vs. Morgan Pharmacy, William T. Stack, MD. Court Ruling (Trial Court - Jury) o Found both defendants liable for the damages caused by Cafergot suppositories. n n Dr. Stack was found negligent for not informing Mrs. Riff of the maximum dosage Morgan Pharmacy was found negligent for a breach of duty on the basis that the pharmacist should have either warned the patient of a maximum dose (since no dose was given) or informed the physician of the inadequacy of the directions on the prescription.

Case: Riff vs. Morgan Pharmacy, William T. Stack, MD. Court Ruling (Appellate Court – As to Pharmacy only) o Morgan Pharmacy’s argument on appeal: n o The function and duty of the pharmacy was only to supply the medication and not to warn. Also, the pharmacies conduct was not a substantial factor that caused the harm to Mrs. Riff Appellate Court Ruling n The argument by Morgan Pharmacy is incorrect and illustrated the disregard for the professional duty owed to the plaintiffs. Sufficient credible evidence was established to show that Morgan Pharmacy breached its duty by failing to warn the patient or notify the physician of the inadequacies of the prescription.

Case: Riff vs. Morgan Pharmacy, William T. Stack, MD. Judgement o o “The appellant would seem to argue that a pharmacy is no more than a warehouse for drugs and that a pharmacist has no more responsibility than a shipping clerk who must dutifully and unquestioningly obey the written orders of omniscient physicians. Such is not the case. ” “The practice of pharmacology is a regulated profession. Pharmacists are required to hold a degree in pharmacology from a school accredited by the American Council of Pharmaceutical Education, to complete an internship, and to pass a comprehensive examination administered by the State Board of Pharmacy…the State Board of Pharmacy is empowered and invested with the duty to regulate the practice of pharmacy. ”

Case: Riff vs. Morgan Pharmacy, William T. Stack, MD. o o “In determining the degree of skill required of a physician or other professional medical personnel, the law does not demand extraordinary skill, but, rather, that degree which ordinarily characterizes the profession. ” “A pharmacist is a professional. In the performance of his professional duties he will be held to a standard of care, skill, intelligence which ordinarily characterizes the profession. ”

Case: Riff vs. Morgan Pharmacy, William T. Stack, MD. o “In the instant case the pharmacy had a legal duty to exercise due care and diligence in the performance of its professional duties. Sufficient credible evidence was presented to establish that Morgan Pharmacy breached that duty by failing to warn the patient or notify the prescribing physician of the obvious inadequacies appearing on the face of the prescription which created a substantial risk of serious harm to the plaintiff. But for this negligence the error would have been corrected and the injuries would not have occurred. Causation was established. ”

Application negligence principles to pharmacy negligence case: Case# 2 Powers vs. Thobani, et al.

Case: Powers vs. Thobani, et al. Parties Involved o o Plaintiff: Robert Powers representing the Estate of late wife, Gail Powers Defendants: Shirin H. Thobani, M. D. , Your Druggist, Inc. , and B. A. L. Pharmacy, Inc. , D/B/A The Medicine Shoppe

Powers vs. Thobani, et al. Facts o o The late Mrs. Powers had been receiving approximately six months of treatment for neck and back pain. Mr. Powers claims that Dr. Thobani prescribed and the defendant pharmacies repeatedly filled, without caution, prescriptions for Oxy. Contin, Percocet, Soma, Xanax, and diazepam repeatedly over six months, in excessive amounts, and often within days of filling previous such prescriptions in the same pharmacy.

Powers vs. Thobani, et al. Facts o o o Filling continued in this manner until Mrs. Powers collapsed in her home and died the next day at the hospital without ever regaining consciousness. Autopsy revealed the cause of death was a “combined drug overdose” with all drugs stated prescribed by Thobani and filled by Your Druggist and The Medicine Shoppe. Mr. Powers’ attorney accused the pharmacies of negligence for failing to warn Mrs. Powers, her doctor, or her husband that the amount and combinations of her medications had the potential to be dangerous.

Powers vs. Thobani, et al. Court Ruling (Trial Court) o o Trial court in Florida dismissed the lawsuit pointing out that in Florida “there was no duty to warn by a pharmacist as a matter of law based upon the facts alleged in the case. ” The dismissal was based upon similar rulings in two cases filed in the Florida Court of appeals as well a Supreme Court precedent.

Powers vs. Thobani, et al. Court Ruling (Court of Appeals) o o Mr. Powers argued that the distinct facts in this case were too narrow in scope to compare with the other rulings and the primary issue in this case was whether pharmacists “owed a duty to provide for the health, safety, and welfare of their customers who had their prescriptions filled there commensurate with the prevailing standard of care. ” The case was appealed to the Fourth District Court of Appeals whom disagreed with the trial court and ruled that the “facts, as alleged and if proven at trial, could give rise to a breach of a pharmacist’s duty to his or her patients under the law” and quashed the dismissal and sent the case back to trial.

Powers vs. Thobani, et al. o o The case was then appealed to the Florida Supreme Court (not common procedure as the case had not proceeded to trial on merit). The Supreme Court agreed to review based on perception there was a conflict of opinion amongst lower courts in pharmacist failure to warn cases.

Powers vs. Thobani, et al. Judgment o “We hold that the trial court erred in dismissing the negligence claims against the pharmacies on a motion to dismiss. While we cannot say whether Power’s claims will necessarily survive a summary judgment motion or prevail at trial, we are unwilling to hold that under no set of alleged or discoverable facts could Powers sustain negligence claims against the pharmacies’ motions to dismiss under Florida law. ”

Powers vs. Thobani, et al. Judgment o o o Court ruled it was not dealing with a case of negligence but rather whether a cause of action for negligence may arise if a pharmacist does not use due proper care in filling a prescription. Florida appellate courts have recently begun to affirm negligence actions against pharmacists. The Court acknowledged contradictions in prior cases regarding duty to warn.

Powers vs. Thobani, et al. Judgment o “I can see no rational basis for distinguishing between a pharmacy's liability for filling a prescription incorrectly which causes serious injury or death and a pharmacy’s liability for filling a combination of prescriptions which the pharmacy knows or should know that because of the adverse interactions of the prescriptions there is a substantial likelihood that they will cause serious injury or death. ”

Powers vs. Thobani, et al. Judgment (continued) o “In the first instance, the pharmacy is negligent in compounding a prescription and in the second instance the pharmacy is negligent in filling a combination of prescriptions, which when taken together will have the same result as compounding the prescription improperly, or at a minimum is negligent in failing to warn its customer of adverse results of taking the prescriptions in combination with each other. In each instance the pharmacy fails to exercise reasonable care. ”

Application of principles of negligence to a pharmacy negligence case: Case# 3 Frye vs. Medicare-Glaser Corporation et al.

Frye vs. Medicare-Glaser Co. et al. Parties Involved o o Plaintiff: Corina Frye representing the Estate of Stephen Frye, Deceased Defendants: Medicare-Glaser Corporation, Dr. John Barrow, M. D. , Evelyn Nightengale, RPh.

Frye vs. Medicare-Glaser Co. et al. Facts o o o On August 28, 1986, Plaintiff’s decedent, Stephen Frye, had arthroscopic knee surgery performed by Dr. Barrow, who prescribed the drug Fiorinal post-surgery. The prescription was filled later that afternoon by Ms. Nightengale and she labeled the container using the label generated by the computer system of Medicare. Glaser Co. There was no explicit instruction on the prescription by Dr. Barrow to include a caution against alcohol while taking the medication.

Frye vs. Medicare-Glaser Co. et al. Facts o o In addition to the primary label, the program printed three additional auxiliary labels warnings: “May cause DROWSINESS”, “Caution: Federal Law prohibits transfer of this drug to persons other than the patient to whom it was prescribed”, and a label stating “something to the effect that alcohol may intensify the effect of this drug”. Ms. Nightengale applied the first two labels but left out the alcohol warning because she believed people might be offended to think the she believed they drank.

Frye vs. Medicare-Glaser Co. et al. Facts o o o On September 3, 1986, Stephen Frye was found dead in his trailer, and his date of death was estimated to be the evening of September 1. Plaintiff claimed that Stephen Frye died as a result of consuming Fiorinal and alcohol. Plaintiff filed a two count complaint against Dr. John Barrow, M. D. for medical malpractice, claiming Dr. Barrow failed to warn Stephen Frye of the dangerous effects of taking alcohol and Fiorinal. Count II was filed against Medicare-Glaser Co. and Evelyn Nightengale for “negligent undertaking”, claiming defendant undertook a duty to warn and failed to do so, causing the death of Stephen Frye.

Frye vs. Medicare-Glaser Co. et al. Court Ruling (Trial Court) o Trial court in Illinois granted a summary judgment motion in favor of the defendants, as they believed the complaint filed failed to show a cause of action. Court Ruling (Court of Appeals) o Trial courts decision was reversed and remanded as the court stated the defendants had no initial duty to warn but assumed a duty to warn by placing a warning on the drug. Thus, the defendants, were liable for providing a complete warning of the dangers of the drug combination, which they failed to provide in a negligent course of action.

Frye vs. Medicare-Glaser Co. et al. Judgment o o The appellate court ruling was reversed by the Illinois Supreme Court and the trial courts award of summary judgment was reinstated. Thus, the pharmacy was dismissed. “First, if we were to hold that by choosing to place the “drowsy eye” label on the Frye’s contained defendants were assuming duty to warn Frye of all of Fiorinal’s side effects, we believe that pharmacists would refrain from placing any warning labels on containers. Thus, consumers would be deprived of any warnings which might be beneficial. ”

Frye vs. Medicare-Glaser Co. et al. Judgment o o “Moreover, requiring Nightengale to warn Frye of all potential side effects of Fiorinal because she chose to warn him of the drug’s propensity to cause drowsiness would be difficult from a practical standpoint. ” In essence, the Supreme Court isolated the warnings Nightengale gave and indicated these were proper, thus, the pharmacist was not negligent since what he warned on was proper.

Case #4: Dooley vs. Everett Parties Involved o Plaintiff: Randy Dooley, Brenda Dooley on behalf of Brandon Dooley o Defendants: Leon E. Everett, MD Revco Discount Drug Center Revco D. S.

Dooley vs. Everett Facts o o Dr Leon Everett, a family physician, began treating Brandon Dooley (minor plaintiff) when he was three years old. In June of 1985, he was hospitalized for pneumonia and given Theophylline. In January of 1986, Dr. Everett diagnosed Brandon with asthma and again prescribed Theophylline is a prescription medication for asthma that has a recommended therapeutic range of 10 -20 micrograms per milliliter. Serum levels less than then 10 have no therapeutic value while those greater than 20 have potential toxicity. Revco filled the Theophylline various times between 9/14/1987 -12/17/1987. Dr. Everett had also increased the dose form 150 mg twice a day to 200 mg three times a day.

Dooley vs. Everett Facts o o o On 12/17/1987, Dr Everett prescribed Erythromycin 400 mg four times a day for 10 days concomitantly with the Theophylline 200 mg three times a day for Brandon. On 12/23/1987, Brandon suffered cerebral seizures as the result of toxic levels of Theophylline in his blood. At the time of the prescription, the package insert for Erythromycin stated that patients receiving Theophylline and Erythromycin together may be at risk for elevated Theophylline levels and toxicity, and that the dose of Theophylline may be needed to be reduced.

Dooley vs. Everett Facts o o o At the time Revco filled the prescription, they did not alert the plaintiff about the potential interaction nor did they contact Dr. Everett was familiar with potential side effects resulting from the toxic serum levels of Theophylline in the blood. He knew these included nausea, vomiting, and seizures. The pharmacist on duty at the time Brandon’s prescription was delivered did not know that Erythromycin could interact with Theophylline, and that this combination posed a risk of serious injury to Brandon.

Dooley vs. Everett Ruling o o The trial court held there was no duty to detect the interaction and thus, granted defendants’ Revco Discount Drug Centers, Inc. and Revco D. S. , Inc. ’s motion for summary judgment and dismissed plaintiffs’ complaint. The issue on appeal was whether the facts in the record there is a genuine issue of material fact regarding whether a pharmacist has a duty to warn a customer and/or the customer’s physician of the potential interaction between two different prescription drugs written by the same physician on two different days and which are filled as written by the same pharmacist on different days.

Dooley vs. Everett Ruling o o “The question is whether the scope of the duty owed by the pharmacist to the customer includes a duty to warn. The fact that the pharmacy owes it customer a duty in dispensing prescription drugs is without question. Revco simply argues that the duty to warn of potential drug interactions is not a part of its duty. The plaintiffs have introduced expert proof against this assertion. Therefore, whether the duty to warn of potential drug interactions is included within the pharmacist’s duty to his customer is a disputed issue of fact preventing the granting of summary judgment. ” “We therefore reverse the judgment of the trial court and remand for a trial on the merits. ”

Case #5: Huggins vs. Longs Drug Stores California, INC. Parties Involved o Plaintiff: Barbie Huggins o Defendants: Longs Drug Stores

Huggins vs. Longs Drug Stores California, INC. Facts o o Barbie and Robert Huggins are the parents of a child, Kodee, who received an overdose of an antibiotic (Ceclor) at two months of age due to the pharmacy’s negligence in providing instructions for dosage. Kodee’s pediatrician prescribed Ceclor for an ear infection on 10/09/1989. His mother first gave the drug between 7 and 8 p. m that evening and repeated the dose the next morning. When she returned from work around 4 p. m. , Kodee was “out of it” and thought it was due to medication. Kodee was unresponsive and appeared to be in a very deep sleep.

Huggins vs. Longs Drug Stores California, INC. Facts o o Thereafter, on October 10, Barbie received a call from her mother who told her that Kodee had received an overdose. She instructed Barbie not to give the baby any more medicine. Barbie than called her husband, Robert, letting him know of the mistake and than took Kodee to the pediatrician. The parents sued defendant pharmacy for damages for negligent infliction of emotional distress. In the complaint, the parents alleged that the pharmacy owed them a duty due to their relationship with the pharmacy. The parent’s also alleged that they resided with the child, obtained medical treatment, and cared for him.

Huggins vs. Longs Drug Stores California, INC. Facts o o o At her deposition, Barbie answered affirmatively when asked if her emotional distress started after her own mother had called her and advised her that there had been an overdose. However, in opposition to the motion, she submitted a declaration dated February 21, 1991, in which she stated that she observed her child’s lethargy prior to knowing its cause, and she suspected that the medication caused it. His lethargy worried her but “not a lot. ” Robert’s declaration showed that his distress occurred after he learned that his son was receiving an overdose of Ceclor. As to administration of the drug, Barbie stated she personally gave the drug October 9 and 10 but she was not sure who gave it on the morning of the 10 th. She said the pharmacist’s mistake caused her to make her own son ill which shocked and grieved her. She still worries about future effects of the over dose.

Huggins vs. Longs Drug Stores California, INC. Facts o o Although Robert saw his wife administer the drug in a dose of two and one- half teaspoons, he could not say if he gave the drug to Kodee himself; he did not recall ever doing so. Ron Spolar, a pharmacist, stated at deposition that the dosage should have been half a teaspoon or two and one- half cc’s rather than the two and one- half teaspoons on the prescription label. He stated that a pharmacist always has the duty to verify the quantity of a drug in filling a prescription.

Huggins vs. Longs Drug Stores California, INC. Ruling o o o In this matter, the court reversed the summary judgment and indicated their was a question of fact. The court believed the law could support a breach of the duty to the caregiver (mother) to her child whom she dispensed medication too. The court in suggesting a duty indicated the relationship of parties must not be overlooked. The question should be was there a special relationship between the pharmacist who labels a prescription for administration to an infant and the caregivers who purchase the prescription and rely on its directions? The court also believed that to sustain the negligent infliction of emotional distress claim, the plaintiff must show they are the parents or close relatives since these people will suffer a greater degree of distress. Extending the duty to non-related people would extend liability too far in the chain. Also, the court ruled that there must be a contemporous observation of the injury. One cannot only see the result of the injury.