Evaluation of treatment with Oseltamivir during the 2009 H1N1 (swine flu) pandemic: the problem of incomplete clinical information.
Abstract: During the H1N1 (swine flu) pandemic of 2009, the World Health Organization (WHO) confirmed more than 14,000 deaths globally; this included a death toll of 147 in Iran. In order to evaluate (a) the appropriateness of the Oseltamivir dose through calculation of a patient's creatinine clearance (CrCl) and (b) the quality of data in the medical charts, we conducted a retrospective study at the Shariati Hospital in Tehran. All admissions to the hospital between the dates 1 October 2009 and 31 January 2010 were evaluated, amounting to a total of 51 patients' charts, including 8 outpatient charts. Of these 51 charts, 26 (51%) contained all the information necessary to evaluate the CrCl. However, there was at least one piece of information missing (e.g. the patient's weight; serum creatinine) from each of the remaining 25 charts (49% of the sample), which made it impossible for us to evaluate the dose. These results demonstrate how crucially important it is to ensure that all the necessary patient information is correctly registered at the time of admission in order to minimise medication errors.

Keywords (MeSH): Drug Utilization Evaluation; Oseltamivir; Medical Records: Evaluation; Iran.

Supplementary keywords: Health Information Management; Swine-Origin Influenza; H1N1 Virus.
Article Type: Report
Subject: Oseltamivir phosphate (Usage)
Oseltamivir phosphate (Health aspects)
Public health (Research)
Swine influenza (Casualties)
Swine influenza (Drug therapy)
Authors: Hanafi, Somayeh
Hayatshahi, Alireza
Torkamandi, Hassan
Javadi, Mohammad Reza
Pub Date: 02/01/2012
Publication: Name: Health Information Management Journal Publisher: Health Information Management Association of Australia Ltd. Audience: Academic Format: Magazine/Journal Subject: Health Copyright: COPYRIGHT 2012 Health Information Management Association of Australia Ltd. ISSN: 1833-3583
Issue: Date: Feb, 2012 Source Volume: 41 Source Issue: 1
Topic: Event Code: 310 Science & research
Product: Product Code: 8000120 Public Health Care; 9005200 Health Programs-Total Govt; 9105200 Health Programs NAICS Code: 62 Health Care and Social Assistance; 923 Administration of Human Resource Programs; 92312 Administration of Public Health Programs
Geographic: Geographic Scope: Iran Geographic Code: 7IRAN Iran
Accession Number: 286971367
Full Text: Introduction

In 2009, the new strain of H1N1 influenza virus caused a global outbreak that was referred to as the swine flu pandemic. The outbreak began in Mexico and spread to the United States, South American countries, Europe, Asian countries and the Middle East, including Iran. The World Health Organization (WHO) confirmed 14,286 deaths worldwide, including 1,450 deaths in the Middle East (UpToDate 2009; WHO 2010). In Iran, the confirmed number of swine flu cases was reported as 3,672, with a death toll of 147.

H1N1 influenza causes mild symptoms in the majority of patients but in some cases, such as patients with asthma, diabetes and obesity, symptoms can be severe and many of these patients may need hospitalisation. Mild symptoms include fever, sore throat, cough, headache, muscle and joint pains, while in severe cases patients may experience more severe respiratory involvement and higher risk of secondary bacterial pulmonary infections. As with seasonal flu, this flu pandemic typically occurred via person-to-person transmission through respiratory droplets (CDC 2009)

Oseltamivir is a viral neuraminidase inhibitor and the recommended dose for an adult patient is 75 mg in capsule or liquid form taken once daily for 10 days for prophylaxis, staring within 48 hours of exposure. The treatment dose would be 75 mg in capsule or liquid form, taken twice daily for five days, with the first dose to be taken within 48 hours of the initiation of symptoms. However, it is recommended that the dose be adjusted for patients with renal insufficiency with a creatinine clearance (CrCl) of 10-30 ml/min. In this population, the prophylactic dose would be 75 mg every other day or 35 mg daily, and the treatment dose would be 75 mg daily (APhA 2009; CDC 2009).

According to the American Center of Disease Control (CDC) guidelines, Oseltamivir was considered as one of the pharmacotherapy options to be used in both prophylaxis and treatment of swine flu (H1N1) cases. In severely ill and obese patients, some experts recommended doubling the dose (e.g. 150 mg twice daily as treatment in patients with normal renal function and 150 mg daily in patients with renal impairment). For patients with CrCl less than 10 ml/min with no dialysis, Oseltamivir is not recommended (APhA 2009).

Considering the above guidelines, it is necessary to have access to patients' weight and renal function in order to prescribe appropriate prophylactic or treatment doses of Oseltamivir, either for outpatient or inpatient cases.

Based on an urgent evaluation conducted by the CDC and New York City Department of Health in May 2009, obesity (Body Mass Index [BMI] above 30 kg/m2) was considered as a risk factor for more severe H1N1 flu symptoms among admitted patients. In that evaluation, 92% of patients admitted to New York City medical centres were obese and obesity could be an independent risk factor for their disease severity. During the study, four patients died, three of whom were obese. CDC necessitated recording a patient's weight at the time of admission in order to evaluate the correlation between obesity and the incidence or severity of the symptoms (Glare 2007).

Information in standard patient charts includes demographics (i.e. gender, age, height, weight and race), allergy history, patient's medical history, medications (doses and schedules), social history, family history and contact information. The Medication Administration Record (MAR) is another important section of medical charts in hospitals and care centres where nurses register the ordered medications, route of administration, dose, schedule and each time a drug is given to a patient (exact time and date). With appropriate use of the MAR system, many of the medication duplications, unwanted deletions and other errors could be resolved. Bates, Leape and Cullen (1998) and Benjamin (2003) compared the computerised MAR system with traditional paper-based methods of recording patient information such as medical history, demographics and allergy profile. It was found that utilisation of new technology to keep and process patient's medical records reduced medication-related errors from 84% to 55% (Bates, Leape & Cullen 1998; Benjamin 2003).

In the current study, we evaluated patients' charts and records for both inpatient admissions and outpatient visits to assess the appropriateness of H1N1 flu treatment or prophylaxis by Oseltamivir at the Shariati Hospital, one of the teaching hospitals affiliated with Tehran University of Medical Sciences (TUMS) in Tehran, Iran. In this hospital, medical records are written on paper and kept in folders, with new information added to each section chronologically as the patient experiences new medical issues. While collecting our data for this study, we noticed missing information in patients' charts on such a large scale that we decided to study the issue of missing data in addition to undertaking an evaluation of the Oseltamivir dose. Other studies have also drawn attention to inappropriate data recording in patients' charts (Arroliga & Pien 2003; Glare 2007). Thus, the aims of this study were twofold: (i) to evaluate the appropriateness of H1N1 flu treatment; and (ii) to evaluate the quality of the data in the medical charts.

Method

Study design

We conducted a retrospective study through medical chart review at the Shariati Hospital, one of the TUMS major teaching and research centres in Tehran. Medical charts with the admission dates from the beginning of October 2009 to the end of January 2010 inclusive were included in the review because the majority of our swine flu suspected cases were admitted during this period.

Sample

Charts were reviewed for a total of 51 patients including 8 outpatients and 43 inpatients. The mean age of the sample was 45.8 years and included 27 males and 24 females (52.9%, 47.1%). Among these patients, 26 (51.0%) were admitted to the pulmonary ward due to more severe symptoms, 16 patients (31.4%) were treated in other units since they were admitted there originally and 8 outpatients (15.7%) started treatment at the emergency room (ER) and were sent home with the medication supply. The criteria for either prophylaxis or treatment were instructed through the hospital's infection control committee which was accordant with the CDC 2009 guidelines (CDC 2009), and the decision regarding who received treatment or prophylaxis was based on the Polymerase Chain Reaction (PCR) results, symptoms and patient history.

Materials

In order to collect the information, the Shariati Hospital Pharmaceutical Care Department team designed a questionnaire, which included a patient's demographic information (weight, height, age, and gender), hospital and contact information, laboratory data (serum creatinine, blood urea nitrogen, PCR results for the H1N1 virus), clinical symptoms, medication dose, frequency, duration and administration records. The questionnaire was validated by clinical pharmacists in the Shariati Hospital Pharmaceutical Care Department. Reliability was established with internal consistency of a > .7. A hospital pharmacist was assigned to gather data by reviewing patients' charts and filling in the questionnaires accordingly. Where body weight was missing from the record, if a telephone number was available, a call was made to collect body weight information from the patient, to evaluate the Oseltamivir dosage given (in the absence of body weight) at the time of treatment.

Data analysis

Descriptive analyses were undertaken with SPSS software version 17, and results are reported as percentages.

Results

For the 51 patients whose medical charts were reviewed in this study, the PCR test was negative in 49 cases (96.1%) versus 2 positive cases (3.9%). Oseltamivir was used as a treatment in 50 cases (98.0%) and prophylaxis in 1 case (2.0%). The majority of patients were treated based on their major symptoms at the time of admission and these are listed in Table 1.

[FIGURE 1 OMITTED]

In the data review, we found that some patient demographic details, laboratory results and even contact information were missing. Figure 1 shows the distribution of patients with missing weight or laboratory (CrCl) information.

Figure 2 shows the accessibility of patient by phone contact in order to obtain his or her weight if it was missed in the medical chart. All patients who had weight, age and serum creatinine information in their charts at the time of treatment (26 patients, 51%) had appropriate Oseltamivir dosing based on their renal functions. Of all the patients, 27.5% did not have serum creatinine and weight recorded in their medical charts; 21.5% did not have serum creatinine or weight recorded in their medical charts. So we were unable to calculate their renal function and the appropriateness of the Oseltamivir dosing.

We also did not find an appropriate medication administration record in over 70% of our cases.

Discussion

The first objective of our study was to evaluate if patients received appropriate Oseltamivir dosing based on their renal function. All patients who had weight, age and serum creatinine information in their charts had appropriate Oseltamivir dosing based on their renal functions.

Another important aim of our study was to determine whether all necessary information regarding weight, age and serum CrCl was available in patients' medical charts. Among 51 evaluated charts, 26 (51%) had all necessary information to evaluate the Cr cl. All other charts (49%) had at least one missing piece of information (patient's weight, serum creatinine) which prohibited the assessment of the appropriateness of their medication dose. Some of the patient demographic, laboratory and even contact information was missing from the medical charts.

As previously mentioned, recording the patients' weight in their charts is crucially important when drug dosing is based on the patient's weight and renal function. Vancomycin and Aminoglycosides are other examples, in both cases to avoid bacterial resistance on the one hand, and renal and ototoxicity on the other, where the antibiotic dose should be adjusted based on patient's weight and renal function (Rybak, Lomaestro & Rotschafer 2009; Rybak 2006).

In two separate studies by Spicer, Gibson and Bloe (Scotland) and Fahimi, Baniasadi and Behzadnia (Iran), both conducted in teaching hospitals, the teams evaluated the appropriateness of Enoxaparin utilisation and dosing, using patient's weight and renal function. In the Spicer, Gibson and Bloe study, patients' weight information was missing for 22% of patients on Enoxaparin, while the dose is supposed to be weight based. Among cases with patient's weight, physicians (84%) and then nurses (51%) estimated patient's weight instead of using scales (Fahimi, Baniasadi and Behzadnia 2008; Spicer, Gibson & Bloe 2009).

As with Oseltamivir, Enoxaparin, Vancomycin and many other medications, recording correct patient's weight is vital since the dose is weight based or must be adjusted per renal function calculation which also requires patient weight (Macie, Forbes & Foster 2004).

Many hospitalised patients with trauma, gastrointestinal surgeries and cancers may suffer from malnutrition and need either parenteral or enteral nutrition. In both treatments, knowing patient's weight and allergy information is extremely important for caloric, protein and fluid calculations and also prevention of possible hypersensitivity reactions to any of the treatment items (Himler, Rangiah & Bajorek 2007; Ziegler 2009).

Patient contact information, including telephone number, email address and mailing address, is an important factor for both inpatient wards and outpatient clinics because this information is essential for contacting the patient regarding his or her diagnosis, treatment plans and also in cases such as medication recalls so the medical team can access patients while maintaining their privacy (Weisdorf, Lysne & Wind 1987).

In our study, only 39% of patients had their weight recorded in their medical charts, and for 27.5%, serum creatinine was not recorded. This made it almost impossible to calculate their renal function and thus the appropriateness of their Oseltamivir dosing. Furthermore, we did not find an appropriate medication administration record for more than 70% of our cases.

Relevance of this research for health information management

There are departments of patients' medical records in academic medical centres worldwide. Even small hospitals keep medical information and have appropriate backup systems that enable them to retrieve information when needed. The custodians of patients' records are primarily concerned with accurate, timely and complete patient information, in whatever record format their institution employs, and ensuring that records are available when required for patient care. Good quality information ensures the best care for the patient and minimises harm, both to the patient and to the institution through medicolegal repercussions. This work is relevant to health information management because it highlights the risks to both patients and institutions when essential information is missing, and may encourage Health Information Managers to promote more comprehensive note-taking and data entry during the admission process, as well as during ongoing patient care. Authorities such as ministries of health can promote the keeping of good medical records by designing appropriate forms and ensuring that hospital personnel who access these forms are appropriately trained in their use. This would facilitate medical professionals' access to accurate patient data when necessary for clinical services, clinical trials and even following up medical complaints.

Conclusion

These results and those from previous studies highlight the need for an appropriate training system for physicians, pharmacists and nurses in medical information recording, in both paper-based and computerised systems, to reduce medical errors. Before advancing to computerised medical information systems and electronic medical charts, we recommend an urgent and appropriate chart revision course, including the 'front page', which contains patients' demographic information, allergy profile, and their contact details. We also recommend the utilisation of MAR to keep track of pharmacotherapy and the medication administration profiles from the time of patients' admission through to their discharge.

References

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Arroliga, M. and Pien, L. (2003). Penicillin allergy: consider trying penicillin again. Cleveland Clinic Journal of Medicine 70(4): 313-4, 317-18, 320-21.

Bates, D., Leape, L. and Cullen, D. (1998). Effects of computerized physician order entry and a team intervention on prevention of serious medication errors. Journal of the American Medical Association 280: 1311-16.

Benjamin, D. (2003). Reducing medication errors and increasing patient safety: case studies in clinical pharmacology. Journal of Clinical Pharmacology 43: 768-83.

CDC (2009). Interim guidance for infection control for care of patients with confirmed or suspected novel influenza A (H1N1) virus infection in a healthcare setting. Atlanta, GA, US Department of Health and Human Services, CDC. Available at: health.state. tn.us/.../TDH%20Infection%20Control%20Guidelines.pdf (accessed15 July 2010).

Fahimi, F., Baniasadi, S. and Behzadnia, N. (2008). Enoxaparin utilization evaluation: an observational prospective study in medical patients. Iranian Journal of Pharmaceutical Research 7(1): 77-82.

Glare, J. (2007). Enoxaparin in NSTE ACS-Incorrect doses lead to worse outcomes. Archives of Internal Medicine 167: 1539-44.

Himler, S., Rangiah, C. and Bajorek, B. (2007). Failure to weigh patients in hospital: a medical safety risk. Internal Medicine Journal 37: 647-50.

Macie, C., Forbes, L. and Foster, G. (2004). Dosing practices and risk factors for bleeding in patients receiving enoxaparin for the treatment of an acute coronary syndrome. Chest 125: 1616-21.

Rybak, M. (2006). The pharmacokinetics and pharmacodynamics of vancomycin. Clinical Infectious Diseases 42 (suppl-1): S35-S39. Available at: http://cid.oxfordjournals.org/content/42/ Supplement_1/S35.full

Rybak, M., Lomaestro, B. and Rotschafer, J. (2009). Therapeutic monitoring of vancomycin in adult patients: a consensus review of the American Society of Health System Pharmacists and Infectious Diseases Society of America. Available at: www.ajhp. org/content/66/1/82.full.pdf+html

Spicer, K., Gibson, P and Bloe, C. (2009). Weight assessment in cardiac patients: implications for prescription of low molecular weight heparin, enoxaparin. Postgraduate Medical Journal 85: 124-27.

CDC (2009). Update: novel influenza A (H1N1) virus infection Mexico, March-May, 2009. Atlanta, GA, US Department of Health and Human Services, CDC. Available at: http://www.ncbi.nlm.nih. gov/pubmed/19498336 (accessed 5 June 2010).

Weisdorf, S., Lysne, J. and Wind, D. (1987). Positive effect of prophylactic total parenteral nutrition on long term outcomes of bone marrow transplantation. Transplantation 43: 833-38.

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Somayeh Hanafi PharmD

Tehran University of Medical Sciences

Pharmaceutical Care Department

Dr. Shariati Hospital

Jalal-e-Al-e Ahmad, Tehran

IRAN

Tel: +98 2184 902 363

email: somayeh_hanafi@yahoo.com

Alireza Hayatshahi PharmD, BCPS

Tehran University of Medical Sciences

Pharmaceutical Care Department

Dr. Shariati Hospital

Jalal-e-Al-e Ahmad, Tehran

IRAN

Tel: +982184902364 (Work)

email: ahayatshahi@yahoo.com

Hassan Torkamandi PharmD

Tehran University of Medical Sciences

Pharmaceutical Care Department

Dr. Shariati Hospital

Jalal-e-Al-e Ahmad, Tehran

IRAN

Tel: +98 2184902364 (Work)

email: htorkamandi@yahoo.com

Corresponding author

Mohammad Reza Javadi PharmD, BCPS

Tehran University of Medical Sciences

Pharmaceutical Care Department

Dr. Shariati Hospital

Jalal-e-Al-e Ahmad, Tehran

IRAN

Tel: +982184902364 (Work)

email: mrjavadi@sina.tums.ac.ir
Table 1: Clinical symptoms and chief conditions of
patients at the time of admission

SYMPTOMS       N       %

Fever         42    (82.4%)
Cough         41    (80.4%)
Myalgia       28    (54.9%)
Dyspnea       27    (52.9%)
Chills        15    (35.3%)
Sore throat   13    (25.5%)
Headache      12    (23.5%)
Vomiting       9    (17.6%)
Diarrhea       8    (15.7%)
Chest pain     8    (15.7%)
Weakness       8    (15.7%)
Coryza         7     13.7%)
Pneumonia      5     (9.8%)
Confusion      5     (9.8%)
Dizziness      4     (7.8%)
Arthralgia     2     (3.9%)
Tachypnea      1     (2.0%)

Figure 2: Patients' contact accessibility for the
purposes of gathering information about their weight

Weight in the chart      39%

Weight through phone
contact                  24%

No weight, no contact
information              37%

Note: Table made from pie chart.
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