INSTRUCTIONS

Please read the below case study and answer the questions that follow with detailed specifics to support your answers. Please upload your Word document to your instructor for grading.

A Visit to Her Regular Primary Care Clinic

Zoya worked at the same factory for 5 years. On a Monday morning in the middle of a cold winter she returned home after a night shift by 8 a.m., feeling ill. When asked by John, her partner, what was wrong, she explained that she had a sore ear and would be making an appointment with the doctor. John had been in a relationship with Zoya for many years. Zoya's right ear had been bothering her for about 3 days. As she seemed fine and was not in any great pain, John went to work.

Zoya booked an appointment with a local primary care clinic, the Get Well Clinic. This clinic was not her first choice. Her preferred family general practitioner (GP) worked at another clinic 2 km away. She had rung them first that morning, but after detailing the nature of her problem she was told that they had no appointments available for the next 3 days.

The Get Well Clinic was a very busy, fully accredited clinic with many doctors. Zoya had frequently visited this clinic for the last 10 years, usually when her family GP had no available appointments. At Get Well it was common for the doctors to see certain patients regularly as well as patients who might attend the clinic to see any doctor available on the day.

On that day Zoya saw Dr. Stanley, a very experienced 70-year-old physician. He was a registered GP who had worked in the medical profession for almost 50 years and had practiced as an associate at Get Well for the last few years. He usually worked around 20 hours per week, mostly on weekdays, but also sometimes assisted the clinic on weekends. He was highly esteemed by his patients and colleagues.

The Consultation

Dr. Stanley saw Zoya shortly after 11:00 a.m. During the consultation Zoya complained of a severe earache that was affecting the entire right side of her face.2 She said that the pain had been bothering her for 3 days. Ear pain is a common reason for primary care consultations and is the 20th most frequent complaint cited by patients. GPs typically see 14 patients with ear pain in every 1000 consultations (Britt et al., 2010). Zoya also told Dr. Stanley that she was a smoker.

Dr. Stanley took her history and examined both of Zoya's ears with an otoscope.3 He noticed that the outer ear canal was very inflamed on the right side. The middle ear appeared normal, and he made the diagnosis of otitis externa, an inflammation of the outer ear and ear canal. He did not detect any abnormalities when he performed a routine examination of Zoya's abdomen, throat, heart, and lungs with her lying on the examination table. Dr. Stanley's usual practice was to treat otitis externa with topical antibiotic ointments or alternatively with oral medication. Given the severity of Zoya's ear infection, he decided to prescribe the oral antibiotic cefaclor (Ceclor).4

Dr. Stanley's usual practice was to check a patient's records for details of any recorded allergies and ask the patient three questions:

1. Are you taking any medications?
2. Are you allergic to anything?
3. And, are you allergic to any medications?

If the patient answered "yes" to any of these questions, he would ask further questions to ascertain what medications the patient was allergic to. Dr. Stanley could not recall more details of his assessment and could not recall his conversation with Zoya in relation to allergies. He later gave evidence that it was not his usual practice to review a patient's previous notes in detail prior to a consultation.

Writing the Prescription

The Get Well Clinic used an electronic system to maintain medical records. The entire medical record was maintained electronically; there were no paper records at this clinic. At the time of Zoya's consultation, the vast majority of GPs (77%) were prescribing electronically, and 54% maintained electronic medical records (i.e., paperless systems offered by commercial clinical software packages that enable practitioners to enter progress notes, write prescriptions, and order laboratory tests, as well as other tasks) (Britt et al., 2010). Most software packages also provide degrees of clinical decision support, such as access to clinical evidence and tools to check for drug allergies as well as drug-drug and drug-disease interactions. The prescriptions were created electronically, and printed copies were given to the patient.

Dr. Stanley was never proficient with the desktop computer in his consultation room. When he started working at the clinic he was given some basic training on the use of electronic medical records. He was aware about the procedure for entering the details of a consultation (clinical progress notes). He knew that the electronic medical record allowed him to go back and review the details of previous consultations and that it contained details of medications prescribed to the patient and any allergies that had been reported. His usual practice when seeing a patient was to first obtain a history from the patient as to the presenting complaint, conduct an examination, and then provide or recommend necessary treatment. When the patient left the room, he would make a note of the consultation before the next patient came in. It was not his practice to enter notes on the computer while the patient was in the room.

He gave Zoya a handwritten prescription for Ceclor, (a brand name for cefaclor), at a dose of 375 mg to be taken twice per day for 5 days. He also provided her with a medical work certificate for 1 day off work. The consultation lasted about 10 minutes. After Zoya left the room, he immediately made his consultation note on the computer at 11:17 a.m. He failed to notice the allergy information on the screen when entering his clinical progress notes into the electronic record. Contrary to his normal practice, he did not review his notes to look for a reference to drug allergies.

The Fatal Dose

Zoya took the prescription to a local pharmacist to have the medication dispensed. It appears that the medication was dispensed without question. She then returned home and took the first prescribed dose. Shortly after midday John returned home to find Zoya unconscious, lying sideways across the bottom of the bed on her side, with her legs over the edge of the bed, and looking red with a number of welts on her body. Her face was swollen and she was not breathing. He shouted her name, but she did not respond and her lips were blue. When he could not rouse her, he called the emergency services at 12:18 p.m. His call was dispatched to the ambulance service, and they talked him through the process of resuscitation (CPR). He had no formal training in CPR.

An ambulance arrived at 12:26 p.m., and the paramedics noted that Zoya was in full cardiac arrest. She had no pulse and was not breathing. The paramedics commenced CPR and continued to work at the scene for almost an hour. Adrenaline and atropine were administered, and she was intubated and transferred to a hospital. A box of medication labeled cefaclor was found by the paramedics on the lounge room table with one tablet missing from the blister pack.

Zoya arrived at the local hospital at 1:29 p.m. and was admitted to the intensive care unit (ICU) in critical condition and requiring ongoing life support. Over the next 2 days her condition deteriorated, with a loss of spontaneous respiration and the onset of hypotension and hypothermia. On Wednesday at 9:59 a.m. a perfusion scan was conducted that showed Zoya's cerebral perfusion was absent, which indicated that she had no blood perfusing her brain. At 10:58 a.m. the doctors stated that she satisfied the criteria for brain death. She was extubated, all medications were stopped, and she was pronounced dead at 1:07 p.m.

Below diagram depicts a summary of events that occurred (i.e. Zoya's story).

The Aftermath

Zoya had suffered an immediate anaphylactic5 reaction most likely mediated by IgE6. Allergic reactions are characterized by the development of systemic hemodynamic collapse within 1-2 hours of medication administration (Antibiotic Expert Group, 2010). Anaphylaxis to cephalosporin antibiotics is rare (estimated at 0.0001-0.1%), but it can be fatal (Kelkar & Li, 2001). In Australia, there are approximately 15 anaphylaxis-related deaths each year (6.4 deaths per 10 million population) (Liew et al., 2009). Of the 112 anaphylaxis-related deaths between 1997 and 2005, 57% were linked to medications. Most deaths have occurred in adults older than 55 years of age. Cefaclor is a moderate-spectrum cephalosporin antibiotic and is generally not recommended for the treatment of otitis externa by the Australian guidelines for general practice (Antibiotic Expert Group, 2010). Moreover, cefaclor is contraindicated in patients with a prior allergic reaction to a cephalosporin or a history of severe or immediate (IgE-mediated) allergic reaction to penicillins or carbapenems (including urticaria, anaphylaxis, or interstitial nephritis, DRESS syndrome, or Stevens-Johnson syndrome) (Rossi, 2011). The Australian guidelines state that a cephalosporin, a carbapenem, or penicillin should not be given if there is a clear or vague history of an immediate (IgE-mediated) reaction to penicillin (Antibiotic Expert Group, 2010; Rossi, 2011). It is not known if Dr. Stanley had access to or considered any clinical guidelines during the time he examined the patient.

Dr. Stanley later became aware that Zoya had allergies to Ibilex (cephalexin), Ilosone (erythromycin), and sulfa-based drugs, and this sensitivity was noted in Zoya's medical record. He had failed to observe the entry in her electronic record that indicated her allergies. He could not recall an alert on the screen in relation to patient allergies. Rather, he recalled that it was necessary to scroll back to the top of the record to check for this information. He was later advised that information relating to allergies appears on the screen at the top of every patient record. He knew that cefaclor was similar to cephalexin in that it belonged to the same group of antibiotics called cephalosporins and that patients who were allergic to cephalosporins can suffer a variety of reactions. He said later that had he known that Zoya had an allergy to cephalexin he would not have prescribed cefaclor.

Dr. Stanley had no previous performance issues with his practice. Six days after Zoya's death he resigned from the Get Well Clinic, never resumed medical practice, and let his medical registration lapse. He accepted that the information about allergies would likely have been on the screen at the time he typed the note of his consultation with Zoya. As a consequence of Zoya's death he became depressed and suffered considerably. He demonstrated considerable guilt, shame, and self-reproach about the effect and outcomes of his treatment of Zoya.

Conclusion

The tragic outcome was over in 2 days. A simple antibiotic allergy was not identified during a routine consultation for a commonly treated condition. A prescribing error occurred and propagated through the system. It was not detected when writing the prescription due to the use of a hybrid medical record system whereby the prescription was written on paper and the progress notes were entered electronically after the patient had left the room. The error was also not detected when the medication was dispensed by the pharmacy, and the patient died from anaphylaxis after taking one tablet.

Questions

1. Human factors research has taught about the need for system redundancies. Where was the redundancy in the system? Identify redundant processes or components in the system that can detect and mitigate the effects of prescribing errors.
2. Compare and contrast the advantages and disadvantages of health systems with high levels of continuity of care. Using this lens, what part do you think continuity of care played in this case?
3. What actions can be taken by the organizations, professional bodies, and individuals to prevent such incidents in future?Discuss specifically actions that could have been taken bytwoof the following:
4. Zoya
5. Zoya's family
6. The Get Well Clinic
7. The family GP
8. The pharmacy
9. The local hospital
10. Examine how allergies are recorded and evaluate the display of allergy information in prescribing and dispensing software. Discuss the role of software standards.
11. What role did health literacy limitations potentially play in this case?
12. What is the role of patients or consumers and their caregivers in health care? Will they be expected to play a different role and take more responsibility for their health care, especially with the advent of personal health records that all citizens can access and maintain electronically?
13. How might personal or shared electronic health records help in preventing adverse events?