PolyGuard Tech:Knowledge - MSD Sheets -Extract Test Report - University

PolyGuard

CONTROLLED DRUG DESTRUCTION KITS

PRODUCT DESCRIPTION

The denaturing of controlled drugs could be classified as 'waste processing' and , as such, may require a waste processing license. However, the Environment Agency and the Home Office have agreed that the denaturing of medicines as required under the Misuse of Drugs Regulations will not be subject to this requirement.

When denaturing Controlled Drugs the commercially available the Controlled Drug destruction Kit should be used. Under no circumstance should any process which includes grinding, dissolving in soapy water or bleach or mixing with cat litter (or similar) be used.

The PolyGuard Controlled Drug Destruction kit not only denatures but actually destroys the controlled drugs compared to other similar products that only denature the drugs, giving greater security and confidence. The PolyGuard system is unique to all other Controlled Drug Destruction kits.

HOW IT WORKS

The PolyGuard system employs an active agent to break the chemical bonds of the drugs and after 48 hours the drug will no longer be active. The PolyGuard system also contains Activated Carbon which when the active parts of the drug are broken down these chemicals are soaked into the Activated Carbon which locks them away.

Once the water has been added the PolyGuard powder starts to work, the contents will then turn to a semi-solid gel within 30 seconds. After the kit has been jellified the active agent starts to dissolve the drugs eg tablets, and break down the active constituents within the drugs. As this is taking place these actives are soaked into the Activated Carbon rendering the drugs within the kit not only denatured but destroyed, and irretrievable.

The kit should then be incinerated as is normal practice.

The PolyGuard system is PATENTED and is totally NEW and UNIQUE.

APPLICATION

Controlled drugs should be removed from their blister packs where necessary, there is no need to crush tablets. Tablets and any liquids should be emptied into the PolyGuard Controlled Drug Destruction kit, and water added as indicated. The contents should then be shaken until fully mixed which takes less than 30 seconds. After approximately 48 hours the contents of the kit is broken down and the controlled drugs are not only denatured but are also destroyed.

The whole kit should subsequently be disposed of in the relevant waste bin for incineration.

FEATURES AND BENEFITS

 

  • Quick denaturing process which saves time, less than 30 seconds
  • Actually DESTROYS the drugs and not only denatures
  • No need for crushing of tablets
  • Patented technology
  • Wide neck jars for easy filling
  • Screw threaded leak resistant lid
  • Different kit sizes for all needs
  • Label with printed instructions
  • Easy to use

PACKAGING/SIZES

100ml – 5cm diameter, 6.5cm high 250ml – 7cm diameter, 8cm high 500ml – 11cm diameter, 8cm high 1000ml – 10.5cm diameter, 12cm high 2000ml – 10.5cm diameter, 21cm high

 

Other sizes are available upon request.

TESTING RESULTS

Controlled Drug Destruction Kits 100% of Morphine that had been destroyed or rendered irretrievable after 48 hours, independently tested by the University of Hertfordshire,

Full report on request..

Extracts below from the University report

EXECUTIVE SUMMARY

Recent publications and discussion in the professional literature have highlighted that many currently available controlled drug destruction/ denaturing kits do not actually chemically denature the drug and that many pharmacists were unaware of this fact. If the drug is still in its active form this leaves the drugs open to potential abuse if the chain of custody is not maintained from the Pharmacy to the incinerator. If addicts are able to remove the used destruction kits at any point in this chain they will have access to a cocktail of controlled drugs in a convenient easy to use semi-solid dosage form.

The aim of this study was to determine if a new kit developed by Yorkshire Hygiene Solutions actually chemical destroys the drug within it. For this purpose one example controlled drug, morphine, was used as a test item.

In order to meet these aims, morphine was chosen as a representative test drug and a HPLC method used for analysis.

Two version of the PolyGuard kit were tested and the ability of these kits to degrade morphine was determined. A known quantity of morphine was added to the kits and the drug content assayed immediately and the assay repeated after 48 hours to determine the extent of drug destruction.

When the full kit containing the SAP as is the case with the commercially available kit 98.45% of the morphine was degraded within 48h. When the kit with the SAP removed (supplied by the manufacture to aid the testing) was used 99.09% of the morphine was degraded within 48h.

1         INTRODUCTION

There are a number of commercially available controlled drug denaturing/ destruction kits available on the market. These kits are supposed to destroy the controlled drugs so that they can be safely disposed of, however a recent publication (Traynor 2014) and discussion in the professional literature have shown that in many cases the drug remains intact and chemically unchanged after 72 hours in these kits. This has led to much discussion amongst Pharmacists, with many confessing to be unaware that these kits were not designed to chemically denature the drugs within them. The danger of this is that current UK guidelines require CD destruction kits to be securely stored for only 48 hours, after which they can be disposed of as pharmaceutical waste. If the drug is still in its active form this leaves the drugs open to potential abuse if the chain of custody is not maintained from the Pharmacy to the incinerator. If addicts are able to remove the used destruction kits at any point in this chain they will have access to a cocktail of controlled drugs in a convenient easy to use semi-solid dosage form. Anyone determined to get controlled drugs could simply swallow the gel from the kits, or in search of quicker drug absorption, rub the gel into any mucosal membrane including the lining of the buccal, nasal or rectal cavities. Following recent publicity of this data a number of countries around the world are known to be considering adoption of similar regulations to those currently in place in the UK.

2         AIMS

The aim of this study was to determine if a new kit developed by Yorkshire Hygiene Solutions (PolyGuard)actually chemical destroys the drug within it. For this purpose one example controlled drug, morphine, was used as a test item.

 

 

 

MATERIAL SAFETY DATA SHEET

PolyGuard - Controlled Drug Destruction Kit Powder


 

 

 

Page 1

Version : 3

 

Revision date: 06/02/2018

 

 

1. IDENTIFICATION OF THE SUBSTANCE/PREPARATION AND OF THE COMPANY/UNDERTAKING

 

Product Name:             PolyGuard – Controlled Drug Destruction Kit Powder Type of product:         

Mixture

 

Recommended use:    CD Absorbent Powder is used in the denaturing of controlled drugs

 

 

Manufacturer details:              Yorkshire Hygiene Solutions Ltd

Unit 8 Omega Business Village Northallerton Business Park, Northallerton, North Yorkshire DL6 2NL United Kingdom

Phone:                                        +44 (0) 1609 760285

E-Mail:                                         [email protected]

Website:

Emergency contact details: New Cross Hospital, Avonley Road, London SE14 5ER.

+44 (0)171 635 9191

2. HAZARDS IDENTIFICATION

 

2.1. Classification of the substance or mixtures

Not Classified

2.2    Label elements

Hazard pictogram                    None

Signal Word                              None

Hazard statements                   None Precautionary statements None Additional elements                 None

2.3    Other Hazards

The product swells in water. The product when wet renders surfaces extremely Slippery

PBT and vPvB assessment:

Does not fill the criteria according to Annex XIII of REACH

3. COMPOSITION / INFORMATION ON INGREDIENTS

 

3.1. Substances

Not applicable, this product is not a substance

3.2 Mixtures

Hazardous components – Contains no reportable hazardous substance.

 

4. FIRST AID MEASURES

 

4.1 – Description of first aid measures

Inhalation:                      Move to fresh air. No hazards which require special first aid measures

Skin contact:                 Wash off with soap and water. Get medical attention if irritation develops and persists

Eye contact:                  Rinse immediately with plenty of water, also under eye lids, for at least 15 minutes. In case of persistent eye irritation, consult a physician

Ingestion:                       Rinse mouth with water. Do NOT induce vomiting. Get medical attention

4.2.    Most important symptoms and effects, both acute and delayed

None

4.3.    Indication of any immediate medical attention and special treatment needed

None

Other information – product swells in water

 

5. FIRE FIGHTING MEASURES

 

5.1 Extinguishing media: Unsuitable extinguishing media None

5.2.Special Hazards arising from the substance mixture

Hazardous decomposition products: Thermal decomposition may produce nitrogen oxides, carbon oxides. Hydrogen cyanide maybe produced in the event of combustion in an oxygen deficient atmosphere

5.3 Advise for fire-fighters

Protective measures – in the event of fire, wear self-contained breathing apparatus

 

6. ACCIDENTAL RELEASE MEASURES

 

6.1    Personal precautions, protective equipment and emergency procedures Product swells in water. The product when wet renders surfaces extremely slippery Protective equipment – Wear adequate personal protective equipment (see section 8 exposure controls/personal protection)

Emergency precautions – keep people away from spills

6.2    Environmental precautions

As with all chemical products, do not flush into surface water

6.3    Methods and material for containment and cleaning up

Spills – DO NOT flush with water. Clean up promptly by sweeping up or vaccum.

Keep in suitable closed containers for disposal. After cleaning flush away traces with water

6.4    References to other sections

Section 7 : Handling and storage: Section 8: Exposure controls/personal protection : Section 9 Physical and chemical properties: Section 13 Disposal considerations.

 

7. HANDLING AND STORAGE

 

7.1    – Precautions for safe handling

No special precautions required

7.2    – Conditions for safe storage

Keep in a dry place. Keep container closed when not in use. Incompatible with strong acids and oxidising agents

 

8. EXPOSURE CONTROL/PERSONAL PROTECTION

 

8.1    - Control parameters

National occupational exposure limits

None

Derived No and minimum effect levels

None Known

Predicted no-effect concentrations

None Known

8.2    Exposure controls:

Use local exhaust if dusting occurs. Natural ventilation is adequate in absence of dust

 

Eye/face protection – Safety glasses with side shields

Skin Protection – work clothes protecting arms, legs and body

Hand Protection – PVC or other plastic material gloves

Respiratory protection – No personal respiratory equipment normally required. Dust masks recommended where working powder concentration is higher then 10mg/m3 Additional advise – handle in accordance with good industrial hygiene and safety Practises

Environmental exposure controls – Do not allow uncontrolled discharge of product into the environment. Do not flush into surface water

 

9. PHYSICAL AND CHEMICAL PROPERTIES

 

Appearance:                                       Granular solid. white

Odour:                                                  None

PH                                                         5-8 @5g/l

Melting point/freezing point           >150C Relative density                                 0.6-0.9

Vapour pressure:                              Not available

Solubility:                                            Insoluble in water

Partition coefficient                          -2 Auto ignition temperature                         >150C

 

10. STABILITY AND REACTIVITY

 

10.1    – Reactivity – Not known

10.2    – Chemcial stability – Stable under normal conditions

10.3    – Possibility or hazardous reactions – Oxidising may cause exothermic reactions

10.4    – Conditions to avoid – None Known

 

10.5    – Incompatible materials – Incompatible with strong acids and oxidising agents

10.6    – Hazardous decomposition products – Thermal decomposition may produce: nitrogen oxides, carbon oxides, Hydrogen cyanide.

 

11. TOXICOLOGICAL INFORMATION/ FIRST AID PROCEDURE

 

11.1 – Toxicological effects

Acute oral toxicity – LD50/oral/rat>5000 mg/kg

Acute dermal toxicity – LD50/dermal/rat >5000 mg/kg

Acute inhalation toxicity – The product is not expected to be toxic by inhalation

Skin irritation – Not irritating

Serious eye damage/irritation – Not irritating Respiratory skin sensitisation – Not irritating Mutagenicity – Not mutagenic Carcinogenicity – Not Carcinogenic

 

12. ECOLOGICAL INFORMATION

 

12.1    –Toxicity

Acute toxicity to fish – LC50/Danio rerio96 hours >100mg/l (OECD203)

Acute toxicity to invertebrates – EC50/Daphina magna/48 hours >100mg/l (OECD 202) Acute toxicity to algea – IC50/Scenndesmus subspucatus/72 hours >100mg/l (OECD 201)

 

12.2    – Persistence and degradability Degradation – Not readily biodegradable Hydrolysis – Does not hydrolyse Photolysis – No date available

 

13.             DISPOSAL CONSIDERATIONS

 

13.1 Waste treatment methods

Dispose of in accordance with local and national regulations. Can be landfilled or Incinerated, when in compliance with local regulations.

Contaminated packaging can be disposed of in accordance with local regulations Can be landfilled or incinerated, when in compliance with local regulations.

 

14. TRANSPORT INFORMATION

 

Land transport (ADR/RID) – Not classified Sea transport (IMDG) – Not classified

Air Transport (IATA) – Not classified

 

15.             REGULATORY INFORMATION

 

15.1    – Safety, health and environmental regulations/legislation specific for the substance or mixture

All components of this product have been registered or pre-registered with the European chemicals agency or are exempt from registration

15.2    – Chemical safety assessment

A chemical safety assessment for this product has been carried out by the person responsible for producing this safety data sheet. All relevant information used to conduct this assessment are included in this safety data sheet as well any resulting risk reduction measures

16.             OTHER INFORMATION

 

This MSDS sheet as prepared in accordance with the following Regulation (EU) No. 2015/830

Regulation (EU) No. 1271/2008 Regulation (EU) No. 1907/2006

All information contained in this Material Safety Data Sheet and the health, safety and environmental information are considered to be accurate to the best of our knowledge as of the issue date specified above. However, no warranty or representation, expressed or

implied, is made as to the accuracy or completeness of the data and information contained in this data sheet.

Health and safety precautions and environmental advice noted in this data sheet may not be accurate for all individuals and/or situations. It is the user’s obligation to evaluate and use this product safely and to comply with all applicable laws and regulations.

This information given is based on our knowledge of the product at the time of publication. The attention of the user is drawn to the possible risks incurred by using the product for any other purpose other than that for which it was intended. END OF MSDS.

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

% Morphine that can be detected after 48 hours

 

 

DenKit (Denwood)

100

110.95±10.82

Controlled Drug Destruction Kit (Safer Options)

100

107.41±6.72

Controlled Drug Destruction Kit (PHS)

100

96.56±6.61

PolyGuard Controlled Drug Destruction Kit (YHS LTD)

100

1.55±0.44

 

 

Reference

M J Traynor 2014 – Investigation into the functionality of controlled drug denaturing / destruction kits

 

 

EXECUTIVE SUMMARY

 

Recent publications and discussion in the professional literature have highlighted that many currently available controlled drug destruction/ denaturing kits do not actually chemically denature the drug and that many pharmacists were unaware of this fact. If the drug is still in its active form this leaves the drugs open to potential abuse if the chain of custody is not maintained from the Pharmacy to the incinerator. If addicts are able to remove the used destruction kits at any point in this chain they will have access to a cocktail of controlled drugs in a convenient easy to use semi-solid dosage form. The aim of this study was to determine if a new kit developed by Yorkshire Hygiene Solutions actually chemical destroys the drug within it. For this purpose one example controlled drug, morphine, was used as a test item.

 

In order to meet these aims, morphine was chosen as a representative test drug and a HPLC method used for analysis. A known quantity of morphine was added to the kit and the drug content assayed immediately and the assay repeated after 48 hours to determine the extent of drug destruction. When the full kit was tested 98.45% ±0.44 of the morphine was degraded within 48h.

 

 

 

Reference

M J Traynor 2014 – Project Report – Testing of controlled drug destruction kits

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

% Morphine that can be detected after 48 hours

 

 

DenKit (Denwood)

100

110.95±10.82

Controlled Drug Destruction Kit (Safer Options)

100

107.41±6.72

Controlled Drug Destruction Kit (PHS)

100

96.56±6.61

PolyGuard Controlled Drug Destruction Kit (YHS LTD)

100

1.55±0.44

 

 

Reference

M J Traynor 2014 – Investigation into the functionality of controlled drug denaturing / destruction kits

 

 

EXECUTIVE SUMMARY

 

Recent publications and discussion in the professional literature have highlighted that many currently available controlled drug destruction/ denaturing kits do not actually chemically denature the drug and that many pharmacists were unaware of this fact. If the drug is still in its active form this leaves the drugs open to potential abuse if the chain of custody is not maintained from the Pharmacy to the incinerator. If addicts are able to remove the used destruction kits at any point in this chain they will have access to a cocktail of controlled drugs in a convenient easy to use semi-solid dosage form. The aim of this study was to determine if a new kit developed by Yorkshire Hygiene Solutions actually chemical destroys the drug within it. For this purpose one example controlled drug, morphine, was used as a test item.

 

In order to meet these aims, morphine was chosen as a representative test drug and a HPLC method used for analysis. A known quantity of morphine was added to the kit and the drug content assayed immediately and the assay repeated after 48 hours to determine the extent of drug destruction. When the full kit was tested 98.45% ±0.44 of the morphine was degraded within 48h.

 

 

 

Reference

M J Traynor 2014 – Project Report – Testing of controlled drug destruction