national - goi...training for trainers program being conducted at nib, noida 201416 107 faculty...

Chapter 8

Training

NATIONALDRUG SURVEY

Ministry of Health & Family Welfare | National Drug Survey 2014-16102

Training

Ministry of Health & Family Welfare | National Drug Survey 2014-16 103

National Institute of Biologicals

It is widely experienced that best of ambitious projects can go wrong if people are not trained adequately as the success or failure of project would depend

upon their efficiency and delivery. Therefore, training of stakeholders associated with Drugs Survey i.e. Central and State Drugs Inspectors, representatives of Civil Society /Pharmacy Council of India was always considered crucial to the successful completion of the task.

TRAINING CONCEPT

The stakeholders for the Survey were Drugs Inspectors who were the Sample Drawing Officers (SDOs) and representatives of Civil Society /Pharmacy Council of India who accompanied the SDOs to ensure that the SOPs were complied with during the Drug sampling process so as to make the study credible. A meeting with Drug Regulators for States and UTs was held at CDSCO Headquarter, New Delhi for feedback on Survey methodology. This was followed by another feedback meeting on methodology held at Chennai with Trainers from southern States of India. Thereafter, a pilot study was conducted in NCR to study the feasibility and validity of the proposed methodology and AKS Software. Inputs from these events were very useful in improvising the methodology and Training Module.

TRAINING OBJECTIVES

The objectives for the Committee on training were:

l Frame learning objectives for training (Exhibit 8.1)

l Prepare training module for training of stakeholders

l Impart Training to the stakeholders

TRAINING PURPOSE

Primary purpose of the training was to make stakeholders fully conversant with the steps to be taken for locating the Source, sample collection, packaging and dispatch as per the guidance document. In addition, secondary and equally important purpose was to make stakeholders ensure 100% compliance to

TRAINING


Training

SOPs for locating the Source, sample collection, packaging, dispatch and acknowledgement.

Exhibit 8.1Learning Objectives of Training

1. Understand goal of training

2. Understand roles and responsibilities of

stakeholders

7. Internalize skills as per SOP through

training video

6. Understand application of AKS software for uploading sampling data

5. Understand process for

sampling, packaging documentation and

dispatch

4. Understand randomized steps for Retail Outlets,

molecules and collection process

3. Develop behavioural skills and process for facilitation to ensure success of the Survey

KEY ASSUMPTIONS IN TRAINING

Prior to finalisation of training module, few key assumptions were made and the training was planned accordingly. First assumption was that trainers were trained centrally who in turn cascaded training in different CDSCO zones. Secondly, the teams of stakeholders were trained jointly. Third assumption was to ensure that training made all stakeholders understand and respect each other’s role and work as a team. Stakeholders were familiarized with



Drug sampling information form, other formats and AKS software. In addition to formats and AKS software, stakeholders were trained on processes for information collection, archival and dissemination at the stages of sample collection, packaging and transportation including acknowledgement. To make stakeholders comprehend the processes, learning objectives were framed and a specially developed animated video was made available to trainers when they imparted training.

ROLES AND RESPONSIBILITIES OF STATE DRUG CONTROL DEPARTMENTS

State Drug Controllers were the Nodal Coordinating Officers who were to ensure efficient and smooth conduct of the study in following manner:

l Ensure Drugs Inspectors were available for one day training program at respective training locations

l Provide details of the names of the Drugs Inspectors along with email ID and Mobile no. and districts where they were to be deployed on the specified days

l Ensure that the sample collection schedule was drawn and complied with

l Ensure availability of trained Drugs Inspectors and representatives of Civil Society /Pharmacy Council of India for the sampling as per schedule

l Issue and retrieve numbered seal for each Drugs Inspector to be used while packing of collected samples

l Monitor and facilitate the activity of the Drug sampling in coordination with Program Management Team at NIB

ROLES AND RESPONSIBILITIES OF REPRESENTATIVES OF CIVIL SOCIETY /PHARMACY COUNCIL OF INDIA

Primarily, representatives of Civil Society /Pharmacy Council of India observed the effort and brought credibility to the sample collection process. They were to play supportive role during this study as follows [also see exhibit 4.2 in Chapter 4]:

l Make themselves available and promptly participate with Drugs Inspectors for sample collection at designated place and time

l Observe and thereby ensure that samples are collected as per Survey protocol


Training

l Observe and thereby ensure that collected samples were properly sealed and signed prior to dispatch to NIB

l Ensure that all relevant documents are completed on site and countersign the same along with Drugs Inspectors

l Ensure that all information is kept confidential and sign a confidentiality and conflict of interest undertaking

l Not to speak to any media person regarding the Survey till final report is in public domain

l Ensure all activities are done as per agreed timelines

CASCADE METHODOLOGY

At least 56 trainers (28 teams) were involved for the training cascade. These trainers included 28 Drug Control Officials and equal number of representatives of Civil Society/ Pharmacy Council of India. Each team consisted of 01 Drug control official and 01 representatives of Civil Society /Pharmacy Council of India. All trainers underwent “Training for Trainers” program in two batches at NIB, Noida (Exhibit 8.2). The trainers were provided computers with AKS software and wifi access at NIB. Assessment for robustness and debugging of processes was linked to this training. These trained trainers then imparted training to stakeholders.

Exhibit 8.2

Training for trainers program being conducted at NIB, Noida



Faculty members explaining training purpose and survey methodology

Trainers during mock sampling from dummy pharmacies set up at NIB


Training

For the purpose of next stage of training, Drugs Inspectors as Sample Drawing Officers and equal number of representatives of Civil Society /Pharmacy Council of India were identified. List of items including infrastructure requirements at all training locations was provided to the Nodal Coordinating Officers for their respective States. Access to AKS Software for sampling and data entry formed part of training process. For this purpose, every training location was provided with adequate computers. To further standardise the training process all trainers were provided with Frequently Asked Questions (FAQs) and Glossary of terms.

TRAINING SUPPORT

Considering the magnitude of the training program, it was presumed that much facilitation will be required for the smooth conduct of the sessions at the Pan-India level. Therefore, Program Management Team consisting of Director, NIB and Drugs Survey - Core Expert Committee Members coordinated with Nodal Coordinating Officers. Core Expert Committee Members were deployed at different States to facilitate the training process.

TRAINING ROLLOUT

The training was planned in different zones of CDSCO. As number of stakeholders available from each State would vary, the zonal availability was designed to make it comparable in numbers. Zone wise training centers were identified and nodal officers were assigned to each center. By and large entire training process was conducted simultaneously at about 28 locations and completed in 2 - 4 working days (exhibit 8.3, 8.4, 8.5).



Exhibit 8.3Highlights from the training of trainees program


Training

Exhibit 8.4Pan India Training Locations



Exhibit 8.5Zone Wise Training Centers

SOUTH ZONE

NORTH ZONE

NOIDA, LUCKNOW,

(Delhi, Uttarakhand, Uttar Pradesh)

JAMMUSRINAGAR

(Jammu & Kashmir)

CHANDIGARH(Haryana, Punjab, Himachal Pradesh,

Chandigarh)

JAIPUR(Rajasthan)

THIRUVANANTAPURAMKOCHI

(Kerala, Lakshadweep)

CHENNAIMADURAI

PUDDUCHERRY(Tamil Nadu, Andaman

& Nicobar island, Puducherry)

HYDERABAD-2(Telangana, Andhra

Pradesh)

BENGALURUHUBLI

(Karnataka)


Training

Exhibit 8.5 Contd.Zone Wise Training Centers

EAST ZONE

PATNARANCHI

BHUBANESWAR(Bihar, Jharkhand,

Odisha)

KOLKATA(West Bengal, Sikkim)

AIZWAL(Tripura, Mizoram,

Nagaland, Manipur)

GUWAHATI(Arunachal Pradesh, Assam, Meghalaya)

MUMBAINAGPUR

AURANGABADBAMBOLIM

(Maharashtra, Goa)

WEST ZONE

AHMEDABAD(Gujarat, Daman &

Diu)

RAIPUR(Chhattisgarh)

BHOPAL(Madhya Pradesh)



OUTCOME

The structured video based training for Drugs Inspectors, representatives of Civil Society /Pharmacy Council of India facilitated the process of sampling, documentation, packaging and dispatch by better understanding and easy recall of step wise processes. Understanding of the behavioural aspects also raised self esteem and pride of stakeholders in being involved in this project of national importance. As a result of this preparedness, they could anticipate resistance and resolve issues in the field by seeking cooperation of the pharmacy owners, Govt. distributors and port officials. Additionally, the representatives of Civil Society realised the professional role of Drugs Inspectors in the field which resulted in a greater respect for the Drug regulators. The representatives of Pharmacy Council of India acquired understanding of the adverse impact of Spurious and NSQ Drugs on public health and developed skills in methodology of estimating the extent of this problem. All in all, trained stakeholders became major contributors in achieving overarching goal of the Drugs survey and became a national talent pool of skilled manpower.


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