International Journal of Clinical Trials
Solanki ND et al. Int J Clin Trials. 2015 Feb;2(1):14-19
http://www.ijclinicaltrials.com pISSN 2349-3240 | eISSN 2349-3259
DOI: 10.5455/2349-3259.ijct20150203
Research Article
Prescription audit in outpatient department of multispecialty hospital in
western India: an observational study
Nilay D. Solanki*, Chaital Shah
Department of Pharmacology, Ramanbhai Patel College of Pharmacy, CHARUSAT, Changa, Gujarat, India
Received: 20 August 2014, Revised: 17 December 2014
Accepted: 25 December 2014
*Correspondence:
Mr. Nilay Solanki,
E-mail: [email protected]
Copyright: © the author(s), publisher and licensee Medip Academy. This is an open-access article distributed under
the terms of the Creative Commons Attribution Non-Commercial License, which permits unrestricted non-commercial
use, distribution, and reproduction in any medium, provided the original work is properly cited.
ABSTRACT
Background: Studying the prescribing audit is that part of the medical audit which seeks to monitor, evaluate and if
necessary, suggest modifications in the prescribing practices of medical practitioners. Our objective was to study the
Prescription Audit in Out Patient Department of in Multispecialty Hospital in western India.
Methods: An Observational study was carried out during the period of 2012-2013. Total 150 prescriptions of Out-
patient department were collected, scrutinized and statistically analyzed with Reporting procedures to pharmacy and
quality department. We have also considered Statistical Process control (SPC) to provide the guidance on how the
process may be improved by reducing variation & to assess the performance of a process.
Results: Total 150 patients were evaluated for Prescription Audit, out of which 60% were Male & 40% were Female
cases. In the same mainly 13 parameter were assessed according to the checklist provided by the Hospital with total
1950 (150*13) counts; from this 1126 Counts were under compliance, 74 Counts were non-compliance & 750 Counts
were not applicable. 50 cases were analyzed for 3 months, showed better compliance rate of prescription audit
parameters in February 2013 compared to December 2012, while non-compliance rate in prescription audit was
reduced as time progresses.
Conclusions: A definite role of clinical pharmacist, in the process control by utilizing SPC during prescription audit.
The members of the hospital and Quality committee need to focus on findings of it, which help them during
accreditation by regulatory authority.
Keywords: Prescription audit, Clinical pharmacist, SPC, Hospital quality committee
INTRODUCTION accepted standards.2 Studying the prescribing audit is that
part of the audit which seeks to monitor, evaluate and if
Measuring the flow of prescriptions from physicians to necessary, suggest modifications in the prescribing
pharmacist to patients, Prescription Audit offers the most practices of medical practitioners.3
comprehensive overview of performance, detailing
parameter as per the check list of prescription audit. The The main tool used to direct administration of medicines
quality of life can be improved by enhancing the in a hospital setting is the Prescription and
standards of the medical treatment at all levels of the Administration Record. There are many variations in use,
health care delivery system. A medical audit oversees the but most contain the following sections: Basic patient
observance of these standards.1 An ‘audit’ is defined as information identifies the prescription with the correct
‘the review and the evaluation of the health care patient. Often ‘filled in’ using a sticky addressograph
procedures and documentation for the purpose of label, which introduces the real possibility of serious
comparing the quality of care which is provided, with the error. Previous adverse reactions/allergies for
International Journal of Clinical Trials | January-March 2015 | Vol 2 | Issue 1 Page 14
Solanki ND et al. Int J Clin Trials. 2015 Feb;2(1):14-19
communicating important patient safety information the overall documentation procedure in hospital which
based on a careful drug history or the medical record. helps to find out the reason for incomplete prescription
Other medicines charts Notes any other hospital files of admitted patients and quality level of
prescription documents that contain current prescriptions documentation of Out Patient as well as in patient
being received by the patient (e.g. Anticoagulants, departments were improved.
insulin, oxygen).
Main aim of the study was to observe different types of
A fundamental principle of rational prescribing, Prescription Audit parameters & evaluate the compliance
deserving of consideration prior to writing any & non-compliance data of audit according to the checklist
prescription, is that, on the balance of probability, the as per National Accreditations Board of Hospitals Health
patient has a significantly greater chance of deriving (NABH).
benefit from the prescribed medication than being
harmed. This judgment depends on knowledge of four METHODS
important areas: The clinical and medication history,
including previous adverse reactions; The clinical Study setting
diagnosis; Relevant patient and clinical factors that might
influence drug action, e.g. age, pregnancy, renal and The study was carried out at Out-patient Department of
hepatic impairment; and Familiarity with the medicine to Sterling multispecialty Hospital during the period of
be prescribed. Uncertainty in any of these areas is likely December 2012 to February 2013. An Observational
to increase the chances of adverse outcomes. study in which patients receiving medication during
treatment were included and studied.
Good clinicians have always organized some kind of
systematic review of their daily work, recording and Inclusion Criteria:
assessing the accuracy, of their diagnosis and the
outcome of their treatment. We have learnt to call this Prescription sheets of Patients who attained the Out-
activity as audit. It will be not appropriate to define patient Department. Male & female patients were
medical audit without discussing the concept on which its included in the Study
definition is based. However, for simple understanding of
the issue medical audit is defined as the evaluation of the Exclusion Criteria:
quality of the medical care through the analysis of the
medical records in the retrospect.4,5 Patients who refused to take medication.
Potential benefits of prescription audit6: Patients who were not willing to participate in
the study.
1. Identify and promote good practice
Source of data
2. Improve professional practice and quality standards
From the Out-patient department the prescription file
3. Supports learning and development of staff and Data collection, Data scrutiny and statistical analysis,
organizations Reporting procedures- report to the pharmacy and quality
department. No patient interaction was considered, the
4. Identify and eliminate poor or deficient practice only patients file was referred after taking prior
permission from hospital authority.
5. Identify and eliminate waste
Statistical Analysis
6. Promote working with multidisciplinary teams
Statistical Process Control (SPC) method was useful for
7. Allocate resources (financial, human) to provide better evaluation of Medical Audit. In the SPC analysis, if the
patient care lower control limit has a negative value, they are posted
as equal to zero. If some points lie above the Upper
8. Develop opportunities to present findings with relevant Control Limit, it implies that the process is producing
faculty and facilitate shared learning. poorer quality result & must be remedied. If the points lie
below the Lower Control Limit the implication is that the
Prescription Audit Checklist are considered as following process is producing better quality of results & action
points: Patient Information, Sig or directions, Quantity should be taken to see that what has caused this
dispensed, Refills and date prescribed, Prescriber improvement & whether it can be incorporated
signature, prescribers degree, brand vs. generic drugs. 7 permanently in the process.
Role of clinical pharmacist and Pharmacologist in SPC has four main applications, which are as below.8
prescription audit can provide valuable information about
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Solanki ND et al. Int J Clin Trials. 2015 Feb;2(1):14-19
1. To achieve process stability RESULTS
2. To provide the guidance on how the process may be There are total 13 parameters was accessed for the
improved by reducing variation prescription Audit. From the table we can predict that in
total 150 sample case of prescription audit, only 3 % (74
3. To assess the performance of a process count) cases had the non –compliance, 58% (1126 count)
cases have the set process & 38 % (750 count) cases
4. To provide information to assist management decision. these parameter have not applicable.
Table 2: Compliance & non- compliance data during
the prescription audit.
Parameters of Prescription Yes No NA
Audit
Dose of Drug 144 6 0
Dosage of Drug 144 6 0
Route of Drug 144 6 0
Frequency 139 11 0
Date 133 17 0
Legible 144 6 0
Know Allergy Documented 0 0 150
Uniform Location of Treatment 143 7 0
Order
Non Standard Abbreviation 0 0 150
Used
Presence of Therapeutic 0 0 150
Figure 1: Data collection method for prescription Duplication, if any
audit. Drug Interaction if Any 0 0 150
Table 1: Prescription audit checklist. Food Drug Interaction if any 0 0 150
Signature of Doctor 135 15 0
Prescription audit checklist
Prescription Audit Total Counts 1126 74 750
Audit Parameters Yes/ No/NA % of Total Counts 58 3 38
Name of patient
Age The demographic reports of our study showed age-wise
OPD number distribution (Tables 3), 4.1% of patients were found
Dose of drug below 20 years of age, 16.2% of patients were found
Dosage of drug between 21 to 40 years of age group, 43.2% of patients
Route of drug were found between 41 to 60 years of age group, and
Frequency / Time of 36.5 % of patients were found above 61 years of age
administration group.
Date
Legible Table 3: Age – wise distribution of prescription audit.
Known allergy
documented No of patients < 20 20-40 40-60 > 60
years year year year
Uniform location of
treatment order 150 (Total number 11 42 52 45
of patients)
Non-standard abbreviation
used 68 ( Patients with 3 12 32 27
Non-compliance)
Presence of therapeutic
duplication, If Any % of total Non- 4.1 16.2 43.2 36.5
compliance
Drug interaction, If Any
Food drug interaction, If
Any During the study of 150 cases there are mainly 13
Signature of Doctor parameters were checked according to the checklist
Yes=compliance; No=non-compliance; NA=not applicable
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Solanki ND et al. Int J Clin Trials. 2015 Feb;2(1):14-19
provided by the Hospital. So there were total 1950
Counts (150x13). SPC Study of Prescription Audit
Parameter for December 2012
Out of 1950 Counts, 1126 Counts were compliance, 74
Counts were non-compliance & 750 Counts were not NO MEAN UCL LCL
applicable.
Month-wise compliance & non- 8.0
compliance analysis 6.0
5.0
4.0 4
600 506 3.0
500 2.0
347 350 1.0
Counts
400 0 0 0 0 0
270 277
300 YES
200 126 NO
100 33 23 18
NA
0
Dec/12 Jan/13 Feb/13
Month
Prescription Audit Parameter
Figure 2: Month wise compliance and non-compliance
of prescription audit. Figure 3: SPC study of prescription audit parameter
for December 2012.
Figure 2 showed that during the Month wise study of the
50 (650 counts) cases for the 3 months, in the December
2012 there were 270 Counts of Compliance & 33 Counts SPC Study of Prescription Audit
of Noncompliance, in the month of January 2013 there Parameter for January 2013
were 350 Counts of Compliance & 23 Counts of Non-
NO MEAN UCL LCL
compliance & in the Month of the February 2013 506
Counts of compliance & 18 Counts of Non-compliance.
7.0
In SPC analysis conducted for the Prescription Audit for
the OPD Ward, the mean (Total no of defects in during 5.0
audit / Total no of Parameter) is 2.5385, UCL (Mean + 4.0
3xSqr of Mean) is 7.3183 & LCL (Mean - 3xSqr of
Mean) is -2.2413, so that only date has 8 counts during 2.0 2
1.0 1.0 1.0
the study (Figure 3) which was above the UCL of 7.3183. 0 0 0 0 0
Again the SPC study conducted in the month of January
2013 showed mean range 1.7692, UCL was 5.7595 &
LCL was -2.2211, so that only date has 7 counts during
the study which is above the UCL of 5.7595 (Figure 4).
In last month SPC analysis the mean was found 1.3846,
UCL was 4.9146 & LCL was -2.1454, so that only date Prescription Audit Parameter
has 4 counts during the study which was under the UCL
of 4.9146.
Figure 4: SPC study of prescription audit parameter
for January 2013.
In all instances from the month of December 2012 to
February 2013 error had to be solved at the first &
specialized training of the staff was necessary to reduce
the same.
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Solanki ND et al. Int J Clin Trials. 2015 Feb;2(1):14-19
comparison of quality of prescribing in different clinical
SPC Study of Prescription Audit settings.17 Medication error can also be linked to
Parameter for February 2013 prescription audit evaluation system. Root causes
analysis of this system can be considered as integral part
NO MEAN UCL LCL or tool of Prescription audit.18
CONCLUSION
4.0
Month wise study showed that numbers of the non-
3.0 compliance in prescription audit was reduced from 33 (in
the month of December 2012) to 18 (in the month of
2.0 2.0 2.0 2.0 2 February 2013). This is mainly due to the hospital
management has implemented the suggestion provide by
1.0 clinical Pharmacist (project trainee) to improve their
processes by mean of SPC analysis.
0 0 0 0 0
The management of the hospital or Quality committee
had focused on results of this prescription audit. In nut
shell we can conclude that the process set by the NABH
is the robust one and involvement of Clinical Pharmacist
& Pharmacologist for in the Prescription audit process is
possible which helps the Hospital management during
accreditation.
Prescription Audit Parameter ACKNOWLEDGEMENTS
Figure 5: SPC study of prescription audit parameter The authors are thankful to the Principal of Ramanbhai
for February 2013. Patel college of Pharmacy for providing constant
encouragement and support during the study and to the
DISCUSSION staff members of sterling hospital at Baroda for helping
us throughout the study period.
The result suggested that methodology selected for data
collection was appropriate supported by literature.9 In Funding: The study was funded by Ramanbhai Patel
healthcare implementation of guidelines has generally College of Pharmacy, CHARUSAT, Changa
been reported as fragmented and inconsistent 10 and still Conflict of interest: None declared
remains a significant challenge for various healthcare Ethical approval: The study protocol was approved in
organizations.11-13 Various factors including the lack of Human Research Ethics Committee
training of the care providers in quality management14,
lack of awareness of the details of the guidelines, and the REFERENCES
lack of acceptance of the given recommendations by
1. Curtis P. Medical audit in general practice. J R Coll
those involved in the process of care. The initial problems
Gen Pract. 1974;24(146):607-11.
of learning to use statistical techniques at the work place
2. Patterson HR. The problems of audit and research. J
may also be an obstacle, although experience tells us that
R Coll Gen Pract. 1986;36(286):196.
this may not be such a daunting task.15 By mean of
3. Srishyla M, Mahesh K, Nagarani M, Mary C,
Statistical Process Control is a decision making tool
Andrade C,Venkataraman B. Prescription audit in
which allows you to see when a process is working
an Indian hospital setting using the DDD (Defined
correctly and when it is not. Variation is present in any
Daily Dose) concept. Indian Journal of
process, deciding when the variation is natural and when
Pharmacology. 1994;26(1):23-8.
it needs correction is the key to quality control.15 As per
4. Joshi SK.Quality Control Study. In: Joshi SK,
our study compliance rate of prescription audit
Quality Management in Hospitals.2nd. Jaypee
parameters was 58 %, which has to be improved by use
Brothers;2008:50-7.
of SPC analytical tool, while non-compliance rate low
5. Sharma R,Mehta M. The text book of NABH
which was appreciable. In our study Month wise of the
Guideline. 3rd 2008:100-125.
compliance of prescription audit rate was improved as
6. Hepler CD,Strand LM. Opportunities and
time progresses, while non-compliance rate was reduced
responsibilities in pharmaceutical care. Am J Hosp
due to use of SPC, adapted for the data collection of
Pharm. 1990;47(3):533-43.
prescription audit by practice. Another reliable tool can
7. Jyoti N,Kaur S. To analyze the Impact of Serial
be used as prescription quality Index for measuring and
Prescription Audits with Active Feedback on
or auditing quality of prescribing in the different diseases
conditions and can be useful for assessment and
International Journal of Clinical Trials | January-March 2015 | Vol 2 | Issue 1 Page 18
Solanki ND et al. Int J Clin Trials. 2015 Feb;2(1):14-19
Quality of Prescription Behaviour. J Clin Diagn 15. Available.
Res. 2013;7(4):680-3. http://smallb.in/sites/default/files/Guide%20to%20S
8. Benneyan JC. Using statistical process control tatistical%20Process%20Control%20Techniques.pd
(SPC) to measure and improve health care quality. f. Accessed 5th December 2013.
Conference Proceedings Institute of industrial 16. Available.
Engineers; 1996. http://www.imshealth.com/deployedfiles/ims/Global
9. Ploeg J, Davies B, Edwards N, Gifford W, Miller /Content/Insights/IMS%20Institute%20for%20Healt
PE. Factors influencing best-practice guideline hcare%20Informatics/Responsible%20Use%20of%
implementation: lessons learned from 20Medicines/IHII_Advancing_Responsible_Use_of
administrators, nursing staff, and project leaders. _Meds_Report.pdf. Accessed 5th December 2013.
Worldviews Evid Based Nurs. 2007;4(4):210-9. 17. Suthar JV,Patel VJ. Prescribing quality in patients
10. Clark M. Barriers to the implementation of clinical with chronic diseases at primary and secondary
guidelines. J Tissue Viability. 2003;13(2):62-4, 6, 8 health care facilities using prescription quality index
passim. tool. Int J Basic Clin Pharmacol. 2014;3(3):553-9.
11. Burnier M. Blood pressure control and the 18. Solanki ND,Shah C. Root cause analysis of
implementation of guidelines in clinical practice: medication errors at a multi-specialty hospital in
can we fill the gap? J Hypertens. 2002;20(7):1251- Western India. Int J Basic Clin Pharmacol.
3. 2013;2(6):819-23.
12. Solberg LI. Guideline implementation: why don't
we do it? Am Fam Physician. 2002;65(2):176, 81-2.
13. Ross TK. A statistical process control case study. DOI: 10.5455/2349-3259. ijct20150203
Qual Manag Health Care. 2006;15(4):221-36. Cite this article as: Solanki ND, Shah C. Prescription
14. VanderVeen LM. Statistical process control: a audit in outpatient department of multispecialty hospital
practical application for hospitals. J Healthc Qual. in western India: an observational study. Int J Clin
1992;14(2):20-5, 8-9. Trials 2015;2:14-9.
International Journal of Clinical Trials | January-March 2015 | Vol 2 | Issue 1 Page 19
