Requirements for Storing Controlled Substances

Session 6: Requirements for Storing Controlled Substances

Total Session Time: 120 minutes

Prerequisites

None

Learning Tasks

By the end of this session students are expected to be able to:

Define store for controlled substances

Mention an authorized personnel and responsibilities for storing controlled substances

List the storage requirements for controlled substance

Mention the equipment for storing controlled substances

List storage restriction for storing controlled substances

Resources Needed:

Flip charts, marker pens, and masking tape

Black/white board and chalk/whiteboard markers

SESSION OVERVIEW

Step

Time

Activity/

Method

Content

1

5 minutes

Presentation

Introduction, Learning Tasks

2

5 minutes

Presentation

Definition store for Controlled Substances

3

30 minutes

Presentation

An Authorized Personnel and Responsibilities for Storing Controlled Substances

4

30 minutes

Brainstorming

Presentation

The Storage Requirements and Equipments for Controlled Substance

5

30 minutes

Presentation Buzzing

Storage Restriction for Storing Controlled substances

6

10 minutes

Presentation

Key Points

7

10 minutes

Presentation

Evaluation

SESSION CONTENTS

STEP 1: Presentation of Session Title and Learning Tasks (5 minutes)

READ or ASK students to read the learning Tasks and clarify

ASK students if they have any questions before continuing.

STEP 2: Definition of Store for Controlled Substances (5 minutes)

A store is a room where medicines are kept under lock and key for the security and safety of controlled substance.

It is an area set aside into which all the items and materials required for production, sale/distribution are received, where they are housed for safekeeping, and from which they will be issued as required.

Also refers to a service department headed by a store-keeper who is responsible for a proper storage, protection and issuing of controlled substance.

Controlled substances must be stored securely. Controlled substances should be separated from other drugs or other hazardous chemicals. This practice will help to prevent loss by limiting access to only those who are assigned to work specifically with controlled substances. It is recommended that access be limited to a minimum number of approved personnel as possible. When in use, controlled substances should never be left unattended.

STEP 3: Authorized Personnel and Responsibilities for Storing Controlled Substances (30 minutes)

Authorized Personnel are individuals designated by the specific institution to access and work with controlled substances under a specific condition of Controlled Substance requirement.

The authorized personnel responsibilities are as follows;

Use controlled substance exclusively for the purpose stated in guidelines

Maintain a secure storage location for controlled substance at all the time.

Return controlled substance to the secure storage location when not in use.

Record dispensation of any controlled substance in the log sheet.

Do not share keys for room of controlled substance with non-authorized personnel.

Report controlled substance inventory discrepancies, suspected misuse, or theft to the responsible in charge immediately.

STEP 4: Storage Requirements and Equipments for Controlled Substances (30 minutes)

Activity: Brainstorming (5 minutes)

ASK students to brainstorm on the following question:

What requirements and equipments are needed for storing controlled substances?

ALLOW few students to respond

WRITE their responses on the flip chart/ board

CLARIFY and SUMMERIZE by using the content bellow

Storage and security of controlled substance require a coordinated approach that includes facility controls (e.g., camera surveillance), physical access controls (e.g., locks or biometric access technology), and frequent inventory checks and surveillance to allow discrepancies to be discovered in a timely manner.

Key elements of controlled substance storage and security include the following;

Controlled substance are stored in a locked and secured location (e.g. Automated dispensing devices, safe, locked cabinet/drawer) at all times unless in the direct physical control of an authorized individual. When implementing or assessing facility and physical access controls, the security and safety of controlled substance are taken into consideration.

Storing controlled substance in transportable lock boxes or “fanny packs” is avoided. If used, such lock boxes follow the same requirements for storage, security, and chain-of custody controls as other inventory. Transportable lock boxes are not considered secure and are stored in a locked area accessible only to authorized personnel when not in use or otherwise unattended.

There is a defined process to ensure that only authorized individuals have access to controlled substances. Access to controlled substances. Storage areas is minimized and limited to authorized personnel. There is a complete assessment of all personnel with access privileges to ensure that only those permitted to access have access (i.e., currently employed, temporary employees, or licensed independent practitioners with privileges), and removal of access privileges occurs immediately upon separation.

There are policies and procedures regarding controlled substances. Access, including restrictions through assignment, key controls, and the use of passwords. For automated dispensing devices, biometric identification with a user ID is preferred over passwords. Controlled substances cabinets and carts that are not automated dispensing devices are secured with an electronic lock that requires a user-specific biometric identification, code, or badge swipe. Access is recorded and retrievable for surveillance.

Where traditional key lock security and manual inventory systems are used, there is a procedure to track keys, secure keys after hours, replace lost keys, and change locks. Any personnel authorized to have access to or prescribe controlled substances will be able to provide appropriate photo identification upon request.

The physical plant should provide for monitoring of secure locations (e.g., video surveillance and recording), particularly in high-volume storage areas at risk for theft and diversion, such as the main pharmacy vault, inventory storage location, and packaging areas.

Camera surveillance should be considered

In locations where there is high risk for diversion,

In locations where electronic or biometric access is not available,

In remote locations, and

To assist with an active diversion investigation.

Automated dispensing device technology should be utilized in high-volume controlled substances. Areas, including the pharmacy, anesthesia and surgery locations, high-volume clinics, and outpatient procedure areas.

When delivering controlled substances to an automated dispensing device, restocking an automated dispensing device, or pulling returns from the return bin, there should be a witness or other verification process (as previously described in the Monitoring and Surveillance section).

Controls are in place to monitor pharmacy inventories for discrepancies. Within pharmacy areas with automated dispensing device vault management, controlled substances. Are manually inventoried by two rotating, licensed, or otherwise authorized pharmacy personnel (e.g., pharmacy technicians) monthly. For high-volume or high-risk areas, more frequent verification audits are considered to prevent or minimize inventory count discrepancies and minimize the time window for discovery of the discrepancy. At least one of those conducting the inventory is a licensed pharmacist. For pharmacies without automated dispensing device vault management, a physical inventory is conducted at least once per month but preferably weekly. The inventory count includes expired or otherwise unusable controlled substances awaiting disposal or transfer to a reverse distributor.

Controlled substances counts managed by automated dispensing devices or done manually are verified by a blind count each time a controlled substance drawer, pocket, cabinet, or refrigerator is accessed, except when unit-of-use dispensing technology is deployed.

Inventory verification is conducted for controlled substance managed by automated dispensing devices by two authorized HCWs if a blind count has not been performed within one week. Controlled substance not managed by automated dispensing devices is manually inventoried by two authorized HCWs at the beginning and end of every shift when the area is open for services. Patient-specific controlled substance infusions are contained in a secured lock box utilizing no-port tubing unless under constant surveillance. Keys and access to these controls are limited and tracked as with any keys and lock boxes.

Documents used to procure or prescribe controlled substance are secured and monitored with the same diligence as controlled substance to prevent theft or loss.

STEP 5: Restriction for Storing Controlled Substances (30 minutes)

Activity: Buzzing (5 minutes)

ASK students to pair up and buzz on the following question for 2 minutes

What are the restrictions for storing controlled substances?

ALLOW few pairs to respond and let other pairs to add on points not mentioned

WRITE their response on the flip chart/board

CLARIFY and SUMMARIZE by using the content below

Do not share controlled substance storage facilities.

Use controlled substance storage areas only for controlled substance inventory and their inventory log book(s).

Do not transfer controlled substance from its original container for storage purposes.

Do not store other chemicals or supplies in a controlled substance storage unit.

Do not store controlled substance in a corridor.

Plan to allow access to locked area in case of unannounced inspection/audit.

Keep storage key(s) in the physical custody of Authorized Personnel at all times.

You can make multiple key copies and assign them to them-listed Authorized Personnel.

Do not store keys in an unlocked drawer or hanging unlocked on the wall.

When Authorized Personnel leave their position in the lab:

Change combinations or retrieve the individual's keys.

Document Authorized Personnel security changes in the inventory log book.

STEP 6: Key Points (10 minutes)

A store is a room where medicines are kept under lock and key for the security and safety of controlled substance

Authorised personnel only should be allowed to handle controlled substances

Controlled substances must be kept safely

With engaged inter professional leadership and collaboration; organizations can foster a culture of organizational and individual awareness and accountability for controlled substance diversion prevention and response.

STEP 7: Evaluation (5 minutes)

What are the requirements for storing controlled substances?

What are the restrictions for storing controlled substances?

What are the responsibilities of authorised personnel in storing controlled substances?

References

MSH and WHO (2012). Managing Access to Medicines and Health Technology, (3rd Edition). Kumarian Press

MoHSW (2003). Tanzania, Food, Drugs and Cosmetics Act, Government Printers Dar es Salaam

MoHSW (2011). Pharmacy Act, Government Printers Dar es Salaam

United Republic of Tanzania (1971). the drugs and prevention of illicit traffic in drugs act, Government Printers Dar es Salaam

United Republic of Tanzania (2011). Public Procurement Act, Dar es Salaam

MoHSW (2003). The National Health Policy, Government Printers Dar es Salaam

MoHSW (1991). The National Drug Policy, Government Printers Dar es Salaam

United Republic of Tanzania (1993).Medical Stores Department Act, Government Printers Dar-es-salaam

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