NTA Level 5 • Semester 1 • PST05102

Strategies of Preventing Misuse of Controlled Substances

Law and Policies in Pharmacy Practice • Source Session/Topic 7

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Session 7: Strategies of Preventing Misuse of 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 the following terms used in preventing misuse of controlled substance.

Drugs,

Prevent,

Drug prevention,

Diversion and

Drug diversion.

Mention the aim of preventing misuse of controlled substances

Explain the common risk areas and methods of misuse or diversion of controlled substances.

Explain ways used to prevent misuse of controlled substances.

Explain the effective prevention principles of misuse of controlled substance.

Resources Needed:

Flip charts, marker pens, and masking tape

Black/white board and chalk/whiteboard markers

SESSION OVERVIEW

Step

Time

Activity/

Method

Content

5 minutes

Presentation

Introduction, Learning Tasks

10 minutes

Buzzing

Presentation

Definition of the Following terms

Drugs

Prevent

Drug prevention

Diversion and

Drug diversion

10 minutes

Presentation

Aim of Preventing Misuse of Controlled Substances

20 minutes

Buzzing

Presentation

The Common Risk Areas and Methods of Misuse or Diversion of Controlled Substances.

40 minutes

Presentation

Ways Used to Prevent Misuse of Controlled Substances.

30 minutes

Presentation

The Effective Prevention Principles of misuse of controlled substance.

5 minutes

Presentation

Key Points

5 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 Terms Used in this Session (10 minutes)

Activity: Buzzing (5 minutes)

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

What do the following terms mean?

Drug

Drug prevention

Drug diversion

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

A drug is defined as a substance that changes the body in some ways. This includes controlled drugs, over-the-counter and prescribed medication, volatile substances, alcohol and tobacco.

By definition, to “prevent” something means to stop something from happening. “Drug prevention” traditionally has referred to a range of activities, from regulation to education, with the aim of controlling the supply of drugs and reducing of the demand for them.

Diversion The term includes any unaccountable loss, theft, and use for unintended purposes, or tampering of a drug.

For purposes of this session, drug diversion is a medical and legal concept involving the transfer of any legally prescribed drug from the individual for whom it was prescribed to another person for any illicit use, including any deviation that removes a prescription drug from its intended path from the manufacturer to the intended patient.

STEP 3: Aim of Preventing Misuse of Controlled Substances (10 minutes)

The aim of preventing misuse of controlled substances are;

To prevent misuse of initial use of controlled substances,

To delay ill-use beginning of use of controlled substances,

To providing wider support and reducing the repertoire of risk and problematic behaviours of misuse of controlled substance.

To promote cessation of misuse controlled substances and

To reduce harms resulting from misuse of controlled substances.

STEP 4: The Common Risk areas and Methods of Misuse or Diversion of Controlled Substances. (20 minutes)

Activity: Buzzing (5 minutes)

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

Which are the common risk areas of misuse or diversion of 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

Examples of common risk points and methods of misuse or diversion of Controlled Substances are divided in five ways shown below;

Procurement.

Purchase order and packing slip removed from records,

Unauthorized individual orders for Controlled Substances on stolen Drug, Enforcement Administration Form 222 and

Product container is compromised.

Preparation and Dispensing.

Controlled Substances are replaced by product of similar appearance when pre-packaging,

Removing volume from pre-mixed infusion,

Multi-dose vial overfill diverted and

Prepared syringe contents are replaced with saline solution.

Prescribing.

Prescription pads are diverted and forged to obtain Controlled Substances,

Prescriber self-prescribes Controlled Substances,

Verbal orders for Controlled Substances created but not verified by prescriber and

Written prescriptions altered by patients.

Administration.

Controlled Substances are withdrawn from an Automated Distribution Device (ADD) on discharged or transferred patient,

Medication documented as given, but not administered to patient,

Waste is not adequately witnessed and subsequently diverted and

Substitute drug is removed and administered while Controlled Substances is diverted.

Waste and Removal.

Controlled Substances waste is removed from unsecure waste container,

Controlled Substances waste in syringe is replaced with saline and

Expired Controlled Substances are diverted from holding area.

STEP 5: Explanations of Ways Used to Prevent Misuse of Controlled Substances in Pharmacy. (40 minutes)

We can prevent misuse of controlled substance in our pharmacy by controlling the following;

Procurement Controls

All controlled substance are procured from the pharmacy. If other departments or individuals are authorized to procure controlled substance, there are checks and balances established to ensure the same policies and procedures are consistently followed throughout the organization.

The number of people authorized to order controlled substance is limited to individuals authorized and defined by policy.

Electronic controlled substance ordering system (CSOS) is used and controlled substance ordering system (CSOS) order files are backed up to an organization based system to ensure that archived files are readily retrievable by designated personnel.

Separation of duties exists between the ordering and receipt of controlled substance.

Two authorized individuals count and sign (two signatures) for controlled substance upon receipt (packing slip) and confirm that what is received matches what was ordered and invoiced (purchase order and invoice).

A pharmacist reconciles controlled substance received against what is indicated on the delivery ticket or invoice and documents receipt as required; the documents will be signed or initialled. Controlled substance purchase invoices are compared to controlled substance orders and receipt into the pharmacy’s perpetual inventory. Since the invoice–receipt pair may both be removed with controlled substance diversion, invoices also are reconciled to statements or wholesale purchase history reports to detect missing invoices. Staff should be cross-trained and rotated through functions related to procurement and pre-packaging.

If the personnel who provides the second count at check-in is not a pharmacy employee (e.g., at a small organization where only one pharmacy employee is available), the designated personnel receive appropriate training.

Controlled substance inventory levels are routinely reviewed, and orders are based on usage to minimize excess stock.

There are processes to track and reconcile controlled substance products when preparation is outsourced to a third-party vendor.

There are procedures for inter organization transfer and transport of controlled substance, including distribution from or to a central distribution hub within an organization.

There are procedures for transfer of controlled substance between pharmacies.

The organization establishes a policy that discrepancies in the procurement process will be documented and brought to the attention of the director of pharmacy or designated pharmacy manager.

Preparation and Dispensing Controls

A perpetual inventory is maintained and a blind count process is used when adding or removing controlled substance from a pharmacy inventory location.

Access to controlled substance inventory is limited, with controls to identify who accessed the inventory, when the inventory was accessed, and what changes were made to the inventory.

Effective access controls are in place to ensure the integrity of the inventory and provide for accurate, timely surveillance.

To minimize opportunities for controlled substance diversion during repackaging, controlled substance are purchased and dispensed in unit dose packaging whenever possible. There are diversion controls in place when controlled substances are repackaged by pharmacy personnel, including separation of duties.

Automated dispensing device technology is utilized in patient care areas for the distribution and accountability of controlled substance.

In patient care areas, automated dispensing device managed controlled substance counts are verified by a blind count each time a controlled substance drawer/pocket/cabinet is accessed (unless unit-of-use dispensing technology is employed).

In patient care areas, controlled substance managed through automated dispensing devices are manually inventoried by two authorized personnel if a blind count has not been performed within one week.

In patient care areas, controlled substance not managed through automated dispensing devices are manually inventoried by two authorized personnel every shift.

Controlled substances managed through automated dispensing devices are stored in a location with single pocket or unit of use access when possible.

Barcode-scanning is utilized when replenishing automated dispensing devices.

When dispensing, removal from the pharmacy inventory is matched to the refill transaction on the patient care unit to validate that controlled substance reach their destination.

Controlled substances returned from nursing units to the return bin of the automated dispensing device or to the pharmacy are matched to the controlled substance received by the pharmacy and documented in the perpetual inventory or a return to active inventory transaction on the automated dispensing device.

Returns from the patient care and procedural areas (e.g., emptying a return bin) have an auditable verification of return. Returns are inspected for integrity

Prescribing and Administration controls.

A valid order from an authorized prescriber exists for all controlled substance administered, and the number of controlled substance allowed via automated dispensing device override status is minimized.

There is a process to identify and verify authorized prescribers within either an electronic or manual ordering system. There is also a process to identify and verify authorized prescribers and prescriptions written by medical residents or other providers who are authorized to prescribe controlled substance under the organization’s Drug Enforcement Administration registration (e.g., use of a suffix).

Pharmacists clarify any orders for which prescriber identity is uncertain or other factors create doubt about the legitimacy of the prescription or order.

Oral orders for controlled substance entered into the medical record are reviewed for appropriateness and accuracy by the ordering prescriber before cosigning orders.

Prescriptions or orders for controlled substance are re-evaluated regularly (e.g., through use of automatic stop reminders, by discontinuing and reordering controlled substance per organizational policy when patients transfer to a different level of care). Medical staff, in coordination and consultation with the pharmacy department, develops and implements an automatic stop-order system for controlled substance when there is not a specific time or number of doses prescribed.

Organization policy prohibits authorized prescribers prescribing for themselves or an immediate family member.

The organization assesses lock-out times for automated dispensing devices and duration for temporary access, including appropriate number and units of automated dispensing devices for which each personnel is granted access.

Controlled substances are retrieved from inventory as close to the time of administration as possible. Controlled substance retrieved for a patient is the package size equivalent to, or closest available to, the dose to be administered.

When being administered to a patient, Controlled substance infusions are secured in locked infusion pumps.

All CS drawn up into syringes, if not immediately administered, are labelled per organizational policy, and the initials of the HCW who drew up the drug are written on the label. Syringes are kept under the direct control of the person preparing the syringes until administration to the patient, and the initials on prepared syringes are verified immediately before administration to ensure that the syringe has not been switched. Generally, only single doses are drawn up into a syringe. When sequential doses are required from a single syringe, there is a method to track the dose ordered versus the dose administered.

In areas in which Controlled substance are not managed through automated dispensing devices, Controlled substance administration records (CSARs) are accurate and include the following information:

Date and time administered

Medication name

Medication strength

Dosage form

Dose administered

Signature of the personnel who administered the

Dose

Amount wasted (if applicable), with co-signature

Proof of count verification per shift

Signature of personnel who transferred the balance

Forward when transcribing to another Controlled substance administration records.

Returns, Waste, and Disposal controls.

Controlled substance are stocked in as ready-to-use form as possible (e.g., avoiding the use of multidose vials) and in the lowest commercially available units frequently prescribed to patients. Inventory is routinely evaluated for opportunities to reduce the need to waste.

Procedures require that Controlled substance be wasted immediately or as close to the time of administration as possible; there is an established timeframe allowed per policy.

The wasting of all Controlled substance requires an independent witness and documentation, except in situations in which waste is being returned to the pharmacy for assay and wasting.

An individual witnessing Controlled substance wasting verifies that the volume and amount being wasted match the documentation and physically watches the medication being wasted per policy for safe disposal and in a manner that the Controlled substance is not retrievable.

There is a procedure for wasting fentanyl transdermal patches according to Food and Drug Administration or state-specific guidelines in a manner that renders the fentanyl irretrievable or otherwise deactivated before disposal

Pharmaceutical waste containers render Controlled substance unrecoverable, irretrievable, and unusable. Containers and their keys are secured, and a process for waste removal and disposal that ensures that chain of custody controls are maintained is implemented

Potentially reusable products issued from automated dispensing devices are returned to a secure return bin Returns, Waste, and Disposal

Procedures require that Controlled substance be wasted immediately or as close to the time of administration as possible; there is an established timeframe allowed per policy.

The wasting of all controlled substance requires an independent witness and documentation, except in situations in which waste is being returned to the pharmacy for assay and wasting.

Potentially reusable products issued from automated dispensing devices are returned to a secure return bin or pocket and not to the original automated dispensing device pocket, and these returns are witnessed and have an auditable verification of return. Returns are inspected for integrity.

Empty controlled substance containers are discarded in limited-access waste containers that render the waste irretrievable and waste procedures comply with organizational procedures for waste management.

Expired or otherwise unusable controlled substance are clearly identified as such and stored in a location separate from other medications. They are properly accounted for with a perpetual inventory list that is regularly verified, as is other controlled substance inventory within the pharmacy, and the inventory is monitored until return via reverse distributor or destruction and disposal in accordance with legal requirements. The frequency of returns and destruction ensures that inventory is not allowed to accumulate, but returns and destruction are done at least quarterly.

Documentation provided by the reverse distributor is verified and corresponds with the pharmacy perpetual inventory record of expired and unusable controlled substance before the drugs leave the pharmacy.

Drug Enforcement Administration registrant or his or her designee assists with all phases of transfer of controlled substance to a reverse distributor or hazardous waste disposal company.

Items returned via reverse distribution are reconciled with the reverse distribution log of controlled substance.

If the inventory quantities are double-counted separately by the reverse distributor, these recorded quantities should be reviewed and reconciled with the pharmacy inventory list before the medications leave the pharmacy.

Special Considerations for Retail Settings in controls misuse of controlled substances.

There are physical access controls, such as secured storage cabinets only accessible by badge or biometric access, to limit and track access by personnel.

The organization has security measures in place (e.g. cameras) to monitor theft and provide an avenue for discrepancies to be resolved in a timely manner.

The organization has systems in place for documentation and monitoring of controlled substances inventory adjustments made by pharmacy employees, controlled substances prescriptions cancelled and returned to stock, and controlled substances prescriptions left at will call past 10 days from processing.

The pharmacy’s point-of-sale system is interfaced with prescription management software and has developed reports to identify discrepancies.

The pharmacy has developed a report or auditing process to compare controlled substances purchases with utilization to identify discrepancies and trends.

The pharmacy has a system for accepting hard-copy controlled substances prescriptions that provides documentation of employee chain of custody and files controlled substances prescriptions sequentially.

The pharmacy has a system in place to audit documentation of employee chain of custody.

The pharmacy maintains a perpetual inventory of Schedule II controlled substances that is maintained and audited at least monthly.

STEP 6: Effective Prevention Principles of Misuse of Controlled Substances. (30 minutes)

Below is a list of principles based on society that should be used to guide effective prevention of misuse controlled substance effort, but this is not necessarily an exhaustive list some research and evidence continue to highlight these as important elements of effective prevention for misuse substance effort.

The principles are;

Prevention initiatives should be comprehensive, employing multiple approaches in multiple settings.

In multiple approaches programs that use knowledge, affective (e.g. self-esteem) and skills elements have been shown to be more effective than knowledge or awareness only.

In multiple settings there is some evidence to support the idea that combined parent, peer and school interventions support successful positive outcomes. So, for example, if young people are the target audience then programs should seek to address peer influence, school, family and community issues.

Programs, therefore, should be well planned and aware of;

The target population (who the program is aimed at, ensuring it meets local need);

The setting (where it is going to take place);

The approach (what is going to be done and how) and

How it is going to be evaluated.

Prevention initiatives should be active and skills based.

Active learning approaches have been found to be more beneficial than passive learning.

Examples of specific skills include improved communication, assertiveness skills, and skills for resisting peer pressure.

Prevention initiatives should be of sufficient quantity and quality.

The greater the needs of the participants, the greater the intensity of the prevention misuse of controlled substance initiative. The effects of interventions tend to gradually decay over time; therefore, effective interventions could include a follow-up or booster session(s) to sustain the impact.

Prevention initiatives should be theory driven.

Prevention initiatives should take into account what has been proven to work. There are many programs and/or approaches that have been shown to make a difference and these should influence your work.

There is no point in doing something “for the sake of it”, nor is there any point in “reinventing the wheel”. However, when using interventions that have been evaluated elsewhere, any social or cultural differences should be taken into account.

Prevention initiatives should encourage the development of positive relationships.

Where children and young people are enabled to develop strong positive relationships especially with peers, parents, teachers and/or significant adults, this is associated with positive outcomes.

Prevention initiatives should encourage people to look at both the long and short- term consequences associated with misuse of controlled drug/substance.

Focusing on the longer-term negative effects of substance use only may not impact on younger users. Many people, especially young people, are influenced more by the “here and now”, rather than by long-term consequences. A positive attitude toward use has consistently been shown to be a risk factor for problematic alcohol and drug use.

Prevention initiatives should consider the value of normative education.

Correction of misconceptions about the perceived high prevalence, availability and acceptability of drug use can be beneficial. This is especially true if the young person’s key friends are not active drug users.

If young people believe that the majority of their peer age group is doing something, they will be more likely to copy that behaviour. Surveys show that drug use, more so than alcohol use, remains relatively low among young people in Northern Ireland, and this should be reinforced in prevention settings.

Prevention initiatives should avoid poorly constructed and delivered “one-off talks” or group information sessions.

More intensive programs have been shown to be more effective, although the fact that there are many sessions alone does not guarantee effectiveness. Ultimately, it may be better to have one hour of good evidence-based material and delivery rather than several mediocre sessions involving poor material.

STEP 6: Key Points (5 minutes)

The aim of preventing misuse of controlled substances

Common risk areas and methods of misuse or diversion of controlled substances.

Ways used to prevent misuse of controlled substances.

Effective prevention principles of misuse controlled substance.

STEP 7: Evaluation (5 minutes)

Which ways are used to prevent misuse of controlled substances in pharmacy?

How can we prevent misuse of 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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