Medicinal Cannabis Security Challenges - PharmOut · Medicinal Cannabis Security Challenges. Zohar...

Medicinal Cannabis Security Challenges

Zohar Dromi

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• Cannabis remains the dominant illicit drug in Australia

• widespread domestic cultivation

• The number of national cannabis arrests increased from 75,105 in 2014–15 to

a record 79,643 in 2015–16

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Cannabis - arrests

• Alcohol and cannabis are the most common substances detainees self-

reported using in the 48 hours prior to detention.

• Seventy five percent of multiple drug users tested positive to both cannabis

and methamphetamine.

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They’re young, careless and armed

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Expanding the supply

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Australian code of good wholesaling practice for medicines in schedules 2, 3, 4

& 8:

• Section 9 Security arrangements and procedures- other than for CD and GHIV

• Section 10 Additional measures for management of controlled drugs (cd) and

other goods with high illicit value (GHIV)

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Regulation

• A security risk assessment

• Wholesalers should review the Security Risk Management Plan, at least

annually.

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Section 9 Requirements

• Suitable surveillance and detection systems should be installed.

• Connected to a control room.

• Access to storage facilities and other security-sensitive areas should be

limited to those personnel who are required to have it.

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Section 9 Requirements

• A senior manager should be appointed to have overall responsibility for the

security

• Standard operating procedures for security, handling methods and reporting

of theft or misuse of medicines should be developed and enforced

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Section 9 Requirements

• The services of a consultant who has registration or licensing in security in at

least one State/Territory and appropriate industry knowledge should be

engaged to assist in the preparation of the Security Risk Management Plan in

compliance with AS/NZS ISO 31000:2009, and review of the plan when the

plan is updated to reflect operational changes that result in a significant

increase in risk.

National Coordinating Committee on Therapeutic Goods Effective date 1 April 2011.

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Section 10 Requirements

“This guideline is designed to allow flexibility on the part of a licence applicant,

focusing on the outcomes to be achieved rather than dictating specific

measures that need to be implemented.”

ODC, October 2016

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Flexibility

•Deter – discourage from attempting to breach security measures.

•Delay – making the breach of security measures more difficult or slower.

•Deny – access control.•Detect – Audits.•Defend – actions taken to respond to a security breach

• Serves as a managerial tool.

• Guideline for the investment of resources.

• Flag gaps in operations and planning.

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Risk assessment

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Understanding Risk Management

Eliminate

Reduce

Manage/ Respond

The wider the coverage – the greater the chance you will identify most of your

weakness.

The cycle of risk

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Shield Risk Assessment TemplateTHREAT/RISK LIKELIHOOD VULNERABILITY

/ SEVERITYRISK

LEVELForceful entry to the site through Main Reception Areas.

4 5 HIGH

Undercover/Discreet entry to the site through main reception areas.

5 5 HIGH

Unauthorized access to restricted products by an employee.

2 4 MED

Unauthorized access to restricted products by an external employee person (visitor/subcontractor)

3 5 HIGH

Forceful entry through building service door, windows and vehicle gates During Operating Hours.

3 4 MED

Forceful entry through building service door, windows and vehicle gates After Operating Hours.

4 5 HIGH

Breaking and entering on site through the facility roof.

2 4 MED

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The Threat

Minor offences • Theft • Drugs• Bullying • Sexual abuse • Vandalism

Major offences

• Cold /hot weapon • Short/long range • Hostage situation

Unsafe Environment

The Basics of Security

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Procedures

Staff Capabilities - HR

Infrastructure

Infrastructure

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Infrastructure

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Infrastructure

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• Mandatory requirement: The licence holder must maintain an intruder

resistant cannabis site

• A room containing cannabis should not share a wall with the exterior of the

building unless that exterior wall has additional controls.

Security of Medicinal Cannabis, ODC

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Risk assessment

Open Plantation Farming ?

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Equipment - How To Maximize Value

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+ +

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• Staff Awareness

• Revision Protocols (Procedures & Audits)

• Personnel – dedicated staff

• Infrastructure

• Technology

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Procedures

• Set expectations, but keep it simple

• Creating unity in work (flexibility needed).

• Consistent level of operations.

• Security plan - break the routine.

• Emergency plan - when pressure strikes.

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Procedures and Structure

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Staff CapabilitiesIs my security staff effective?

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Effective Security – Operational Testing

• The Goal : Establish a Centralized Security mechanism.

• The focus of a Comprehensive Master Plan is to

enhance the security of assets that include people,

information, property and facilities against security

threats

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Security Master Plan (SMP)

PreventionAwareness

Deterrent

Response Recovery

Security is an Ongoing Challenge

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Employees arrivingDetected

EventIntegrated Security

Vehicle Of InterestAlert

Person Of InterestAlert

Graffiti / Fence BreachedAccess

Authentication

• Identify and map the risks • Find the most cost effective solutions• Set procedures• Document the plan • Choose personal • Allocate responsibilities • Train the staff

• Test the plan and make changes

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How To Design A Defensive Operational Plan?

• Buildings and grounds are well maintained.

• Employees feel safe reporting crime, security and safety problems.

• Problems are addressed quickly and appropriately.

• Access is controlled and visitors are monitored.

• All areas are safe by design or by staff Supervision.

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A Secure Site

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Cyber Security – Who’s Responsibility?

CommunicationsSecurity

Physical Infrastructure

Radio/PhoneSecurity

Computer Security

Document Security

Staff Reliability INFORMATION

SECURITY

• Packaging

• Formatting

• Compounding

• Certificates

• Access to manufacturing processes /

Recipes

• Access to QC results

• Access to clients’ information

• Access to suppliers’ information

• Schedule of products

receipt/despatch

• Access to security control systems

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Possible risks associated with information assets, would be falsification or access to:

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Any Questions?