Home Print this page Email this page Small font size Default font size Increase font size
Users Online: 359
Home About us Editorial board Search Ahead of print Current issue Archives Submit article Instructions Contacts Login 


 
 Table of Contents  
BRIEF COMMUNICATION
Year : 2016  |  Volume : 5  |  Issue : 3  |  Page : 212-214

Ganciclovir use evaluation in kidney transplantation departments


1 Isfahan Pharmacy Students' Research Center, Isfahan University of Medical Sciences, Isfahan, Iran
2 Isfahan Kidney Diseases Research Center, Isfahan University of Medical Sciences, Isfahan, Iran
3 Isfahan Kidney Diseases Research Center; Department of Clinical Pharmacy and Pharmacy Practice, Isfahan University of Medical Sciences, Isfahan, Iran

Date of Web Publication7-Jul-2016

Correspondence Address:
Shirinsadat Badri
Isfahan Kidney Diseases Research Center; Department of Clinical Pharmacy and Pharmacy Practice, Isfahan University of Medical Sciences, Isfahan
Iran
Login to access the Email id

Source of Support: None, Conflict of Interest: None


DOI: 10.4103/2279-042X.185742

Rights and Permissions
  Abstract 

Objective: In this study, we evaluated certain aspects of the usage and administration of one lifesaving, high-cost medication, i.e., Ganciclovir for the prevention and treatment of cytomegalovirus (CMV) infection in transplant patients.
Methods: This study was performed from 2013 to 2015 by conducting a medication use evaluation (MUE) program in the kidney transplantation departments of two tertiary care hospitals in Isfahan, Iran. The MUE criteria for the drug were developed by applying drug information references. In every category of data, the number (percent) of cases, in which drug therapy was in accordance with the predetermined criteria, was calculated.
Findings: During the study period, 67 cases were observed. The only documented drug interaction was the minor interaction of Ganciclovir with mycophenolate mofetil in 77% of the patients. In all patients, intravenous (IV) infusion was the route of administration, mainly in the peripheral veins. Four patients showed adverse drug reaction, which leads to Ganciclovir discontinuation. Ganciclovir was administered despite contraindication in 34.3% of the patients.
Conclusion: In this study, we faced a relatively unacceptable situation, in which Ganciclovir is handled somehow inappropriately. It seems necessary to develop an updated local guideline to approximate the administering pattern of such costly medications to standard protocols.

Keywords: Cytomegalovirus; Ganciclovir; kidney transplantation; medication use evaluation


How to cite this article:
Mozaffar M, Shahidi S, Badri S. Ganciclovir use evaluation in kidney transplantation departments. J Res Pharm Pract 2016;5:212-4

How to cite this URL:
Mozaffar M, Shahidi S, Badri S. Ganciclovir use evaluation in kidney transplantation departments. J Res Pharm Pract [serial online] 2016 [cited 2019 Nov 18];5:212-4. Available from: http://www.jrpp.net/text.asp?2016/5/3/212/185742


  Introduction Top


Medication use evaluation (MUE) is a continuous and structural analysis of drugs usage, which is routinely authorized and managed by an interdisciplinary team. [1] This process involves a comprehensive review of practitioner prescribing, pharmacist dispensing, nurse administering, and patient use of medication. [2] By comparing the actual status of drug use to predetermined standards, MUE can detect inappropriate or unnecessary drug therapy. MUE findings may help health-care systems to improve prescribing patterns and optimize the use of scarce resources. [3],[4] Pharmacists as an integral participant of MUE programs can improve the quality of patients care by preventing unnecessary or inappropriate medication usage and adverse drug reactions. [5],[6],[7]

MUE programs should be planned to include the drugs considered to be problematic if not used correctly or the drugs prescribed to be used for specified diseases or special populations. Organ transplant recipients receive immunosuppressive regimens which put them at an increased risk for opportunistic infections such as cytomegalovirus (CMV). Ganciclovir is the medication mostly used to prevent or treat CMV infection in this patient population. [8],[9] No comprehensive study has yet been done to assess the usage pattern of this antiviral drug in the hospital wards. We designed this study as a MUE program to address certain aspects of Ganciclovir use, namely, adverse reactions, contraindications, drug interactions, and its administration by nurses.


  Methods Top


This study was designed as a prospective cohort from 2013 to 2015 to characterize the usage pattern of Ganciclovir in concordance with the predefined assessment criteria by conducting a MUE program in the kidney transplantation departments of two tertiary care university-affiliated hospitals in Isfahan, Iran. Assessment criteria were developed to evaluate the appropriateness of Ganciclovir use by applying the Ganciclovir package insert and Lexicomp® drug information handbook. A pharmacist performed data collection in the wards by reviewing patients' medical documents and charts and laboratory findings, as well as observing the nurses' performance regarding drug storage, handling, and preparation for administration.

The collected data were categorized and analyzed using Statistical Package for Social Sciences software, version 20.0, for Windows (SPSS, Chicago, IL, USA). In every category of data, the number (percent) of cases, in which drug therapy was in accordance with the predetermined criteria, was calculated.


  Results Top


During the study period, 67 cases were observed. The only documented drug interaction was the minor interaction of Ganciclovir with mycophenolate mofetil in 77% of the patients, which is not a clinically important interaction.

In Ganciclovir handling, nurses did not observe the precautions regarding hazardous agents [10] (wearing gloves, glasses, mouth mask, and using laminar air flow hood).

According to Ganciclovir package insert, [11] after dissolving the dry substance, the solution can be stored at room temperature and can be used within 12 h; while the diluted infusion solution should be kept in refrigerator and should be used within 24 h. However, in these wards, after Ganciclovir powder reconstitution, the solution was stored in refrigerator for at least 24 h and further dilution with normal saline or dextrose water took place before administration. During a short time of study period (from June 2013 to October 2013) because of drug resources' shortage in the country and also considering the cost, nurses had to store reconstituted vials for 72 h; however, thereafter, owing to relatively better situation regarding drug supply, the storage time was reduced to 24 h.

In all patients, IV infusion was the route of administration; however in three cases, Ganciclovir was infused within <1 h. As recommended in drug information references, [12] Ganciclovir should be infused only into the central veins with good blood flow, but our nurses' choice was mainly the peripheral veins. In most cases, the set of infusion was flushed with normal saline before drug administration, but in some cases, the set of infusion was flushed only if the patient needs to receive another parenteral drug, using this set. While it is emphasized that Ganciclovir should be administered postdialysis, this rule was not followed in one case.

From 67 patients, four patients showed adverse drug reaction (two cases of neutropenia and two cases of thrombocytopenia), which leads to Ganciclovir discontinuation. Ganciclovir was administered despite contraindication (hemoglobin <8 g/dL) in 34.3% of the patients.


  Discussion Top


MUE studies can recognize inappropriate and/or unnecessary high-cost drug therapies by comparing the actual status of medication use with predetermined standards or guidelines. When problems are identified, interventions are designed and implemented to improve drug use, which mainly include conducting educational programs, provision of drug information, making change in hospital policies and procedures, or changes in the drug formulary. [13],[14]

Establishing the MUE process in hospitals is the key way to promote effectiveness and safety of drug therapy, while optimal medication therapy can lead to improved patient outcomes and minimized overall costs. [14]

This study is the first MUE on Ganciclovir in kidney-transplanted patients. The purpose was to study the pattern of utilization in our hospitals for this high-cost medication. Ganciclovir is used in the transplantation centers of Iran since many years ago; however, by conducting this study, we faced a relatively unacceptable situation, in which the medication is handled somehow inappropriately by nursing staff. It seems necessary to develop and implement an updated local guideline to approximate the administering pattern of such important and highly used medications to standard protocols. Additional opportunities to improve the medication use may exist through health-care staff education. Pharmacists can ease this process by addressing areas which need improvement through conducting and re-evaluating the MUE processes. [15]


  Authors Contribution Top


Maryam Mozaffar (the pharmacist) contributed in data collection. Shahrzad Shahidi and Shirinsadat Badri developed the idea of research and designed the study. All authors contributed in data analysis and manuscript preparation.

Financial support and sponsorship

This research was done as a Pharm.D thesis projected with the financial support of the vice-chancellery for Research and Technology of the Isfahan University of Medical Sciences, Isfahan, Iran.

Conflicts of interest

There are no conflicts of interest.

 
  References Top

1.
Phillips MS, Gayman JE, Todd MW. ASHP guidelines on medication-use evaluation. American Society of Health-system Pharmacists. Am J Health Syst Pharm 1996;53:1953-5.  Back to cited text no. 1
    
2.
SHPA Committee of Specialty Practice in Drug Use Evaluation. SHPA standards of practice for drug usage evaluation in Australian hospitals. J Pharm Pract Res 2004;34:220-3.  Back to cited text no. 2
    
3.
le Grand A, Hogerzeil HV, Haaijer-Ruskamp FM. Intervention research in rational use of drugs: A review. Health Policy Plan 1999;14:89-102.  Back to cited text no. 3
    
4.
Holloway K, Green T. Tools to investigate the use of medicines. In: Drug and therapeutics committees: A practical guide. France: World Health Organization (WHO); 2003. p. 71-94. Available from: http://www.apps.who.int/medicinedocs/pdf/s4882e/s4882e.pdf. [Last accessed on 2015 Dec 30].  Back to cited text no. 4
    
5.
SHPA Committee of Specialty Practice in Clinical Pharmacy. SHPA standards of practice for clinical pharmacy. J Pharm Pract Res 2011;41:144-5.  Back to cited text no. 5
    
6.
Dahdal WY. Inter-professional education and collaborative practice: National competencies of two nations. ACCP Int Clin Pharm 2011;1:1-2.  Back to cited text no. 6
    
7.
American Society of Hospital Pharmacists. ASHP guidelines: Minimum standard for pharmacies in hospitals. Am J Health Syst Pharm 2013;70:1619-30.  Back to cited text no. 7
    
8.
Kotton CN. CMV: Prevention, diagnosis and therapy. Am J Transplant 2013;13 Suppl 3:24-40.  Back to cited text no. 8
    
9.
McDevitt LM. Etiology and impact of cytomegalovirus disease on solid organ transplant recipients. Am J Health Syst Pharm 2006;63 19 Suppl 5:S3-9.  Back to cited text no. 9
    
10.
National Institute for Occupational Safety and Health (NIOSH). NIOSH List of Antineoplastic and Other Hazardous Drugs in Healthcare Settings; 2014. Available from: http://www.cdc.gov/niosh/docs/2014-150/pdfs/2014-150.pdf. [Last accessed on 2015 Dec 30].  Back to cited text no. 10
    
11.
Hoffmann F. Ganciclovir Package Insert. Nutley, NJ: Roche Laboratories Inc.; August 2008.  Back to cited text no. 11
    
12.
Ganciclovir (systemic): Drug information. In: UpToDate. Waltham, MA . http://www.uptodate.com/contents/ganciclovir-systemic-drug-information. [Last accessed on 2015 Dec 30].  Back to cited text no. 12
    
13.
Moore T, Bykov A, Savelli T, Zagorski A. Guidelines for implementing drug utilization review programs in hospitals. Available from: http://www.apps.who.int/medicinedocs/documents/s22114en/s22114en.pdf. [Last accessed on 2015 Dec 30].  Back to cited text no. 13
    
14.
Drug utilization review: Mechanisms to improve its effectiveness and broaden its scope. The U.S. pharmacopeia drug utilization review advisory panel. J Am Pharm Assoc (Wash) 2000;40:538-45.  Back to cited text no. 14
    
15.
Schrand LM, Behmer-Miller KA, Ross MB, Mutnick AH. Medication use evaluation: A work in progress. Pharm Pract Manag Q 2000;20:1-15.  Back to cited text no. 15
    




 

Top
 
 
  Search
 
Similar in PUBMED
   Search Pubmed for
   Search in Google Scholar for
 Related articles
Access Statistics
Email Alert *
Add to My List *
* Registration required (free)

 
  In this article
Abstract
Introduction
Methods
Results
Discussion
Authors Contribution
References

 Article Access Statistics
    Viewed1520    
    Printed18    
    Emailed0    
    PDF Downloaded158    
    Comments [Add]    

Recommend this journal