PROTOCOL FOR PROJECT

ANTICOAGULANT MANAGEMENT STEWARDSHIP PROGRAMME

Abin.C, Anusree.S, Anupama.R, Ajmal.K.K, Anas.M
5th year Pharm.D, Department of Pharmacy Practice, Al Shifa College of Pharmacy
Research Guide: Prof. (Dr) T.N.K Suriyaprakash
Introduction:
VTE composing PE and DVT is a common clinical problem and is associated with substantial
morbidity and mortality with most hospitalized patients having at least 1 risk for VTE and this risk
persists for several weeks after discharge. According to Epidemiologic International Day for the
Evaluation of Patients at Risk for Venous Thromboembolism in the Acute Hospital Care Setting
(ENDORSE) studies, 40% at risk patients do not receive adequate prophylaxis. Evidence-based
guidelines from the American College of Chest Physicians (ACCP), National Institute for Health and
Clinical Excellence (NICE) categorize VTE risk and recommend prophylaxis regimens according to
type of operation and known patient risk factors. Only 59% of patients admitted to surgical wards and
considered at-risk for VTE received adequate thromboprophylaxis. Surgery patients seems to be at
higher risk for VTE when compared to medical patients
VTE is no longer a rarity in India with the proportion of patients considered at risk for VTE (53.6%)
was similar to that of the global patients at risk for VTE (51.8%) according to ENDORSE, Indian
subset data. Although the incidence of DVT in India is comparable to that in the Western countries,
the awareness level of VTE is particularly low among Indians. The global ENDORSE data showed
that 50.2 per cent at-risk patients received ACCP-recommended prophylaxis, while in India, very low
proportion of at-risk patients (17.4%) received ACCP-recommended prophylaxis. This confirms the
need for increasing awareness about VTE risk, optimum risk assessment, and improved
implementation of appropriate thromboprophylaxis in at-risk hospitalized patients. This will help in
successful management of VTE and prevent the morbidity and mortality due to VTE.
Although Anticoagulation Management stewardship programme by pharmacists have been conducted
in Western countries, the focus has mainly been on the Cardiology department and there has been a
lack of studies on the effectiveness of pharmacist interventions in the Orthopedic surgery department
where the VTE risk is highest. AHRQ calls thromboprophylaxis against VTE as No.1 patient safety
practice and the clinical pharmacist interventions can help in improving the adherence of therapy to
the cutting-edge guidelines and improving patient safety thus leading to the overall economic benefits
for patients on a long-term basis.

AIM:
i.

Audit of the current practices of assessment of VTE risk and prophylaxis in orthopedic

ii.
iii.

surgery department of a tertiary care hospital and adherence to guidelines.

Providing feedback on deviation from standard guidelines to the Orthopedic Surgeon.
To prepare a protocol under the guidance of Orthopedic Surgeon for the effective risk
assessment of VTE and bleeding as well as the therapeutic choice to be followed on the

iv.

basis of risk of VTE.

Re-audit the practices in the department to estimate the adherence to guidelines after
pharmacist intervention.

INCLUSION CRITERIA:

Orthopedic surgical Inpatients

Age>18 years
Underwent surgical procedure which required general or regional anaesthesia.

EXCLUSION CRITERIA:

Pregnant Patients
Age <18 years
Admitted solely for the treatment of VTE
Patients in whom the key data is not available (type of surgery)
Admitted for diagnostic testing
Patients taking voluntary discharge prior to the procedure

METHODOLOGY:
The study will be conducted in the in-patients of Orthopedic surgery department of the institution. The
patients will be selected on the basis of the inclusion and exclusion criteria as stated above and the
study will be performed in 3 phases.
Phase 1 (Pre-intervention/Audit period): Duration of this phase will be 1-2 months and NICE audit
form will be the tool used to evaluate the current practices. Caprini score will be used to evaluate the
number of patients who are on the risk of VTE during this phase and classify the patients into very
low, low, moderate or high risk group. The recommendations of Antithrombotic therapy and
prevention of thrombosis, 9th edition ACCP guideline and American Association of Orthopedic
Surgeons guideline for VTE prophylaxis will be used as standards to evaluate the recommended VTE
prophylaxis for each risk group. The bleeding risk of the patients will also be accounted.

Phase 2 (Intervention Period): The deviation from the standards will be recorded and a feedback on
the initial audit will be submitted to the general surgeon under whose authority this project will be
performed. Under the guidance of the Orthopedic surgeon, protocol will be formulated on the basis of
ACCP and AAOS recommendations (taking into consideration the local resources and guidelines
available for the implementation) for the screening and stratification of patients admitted to the
department as well as for the VTE prophylactic measures to be done in the post-operative period.
Phase 3 (Post-intervention/Re-audit period): The initial audit will be re-performed for a period of 5
to 6 months to assess the adherence to the guidelines after the pharmacist intervention to assess the
impact of the feedback and protocol preparation. Appropriate use of statistical methods will be used to
furnish the results as to evaluate the significance of the implementations on the practices of the
orthopedic surgery department.

Resources to be used:

i.
ii.
iii.
iv.

Caprini Risk Assessment Model

AAOS VTE Prophylaxis Guidelines
ACCP guidelines for VTE prophylaxis is Orthopedic Surgery Patients
NHS audit form

SIGNIFICANCE OF THE STUDY:

In USA over 1 year, a 300-bed hospital that lacks a systematic approach to VTE prevention can expect
roughly 150 cases of hospital-acquired VTE. Approximately 50 to 75 of those cases will be
potentially preventable because of missed opportunities to provide appropriate prophylaxis.
Approximately five of those patients will die from potentially preventable PE. There will also be
heavy economic impact on the patients thus affecting their overall quality of life. Coming to the
Indian scenario, the risk ratio is higher owing to inferior VTE prophylactic practices compared to US.
ASHP recommends the surveillance of VTE prophylaxis in hospitals as part of clinical pharmacy
activities thus contributing the overall pharmaceutical care concept