Pharmacy Controlled Drugs Regulations

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Questions and Answers

What is required for the destruction of out-of-date Schedule 2 controlled drugs?

It should not be segregated from other CDs.

It must be documented in a separate logbook.

It must be witnessed by an authorized person. (correct)

It must be witnessed by the Accountable Officer.

How long must records of returned Schedule 2 controlled drugs be kept?

3 years

1 year

7 years (correct)

5 years

Why is it necessary for a pharmacist to witness the destruction of CDs returned by patients?

To ensure proper handling and accountability. (correct)

To complete additional paperwork.

To fulfill legal requirements.

To comply with government regulations.

Who is NOT eligible to act as an authorized person for the destruction of Schedule 2 CDs?

The Accountable Officer Signup and view all the answers

What must pharmacies do with out-of-date CDs that require safe custody before destruction?

Keep them segregated from other CDs. Signup and view all the answers

What information is NOT typically required when recording the destruction of CDs returned by a patient?

Patient's medical history Signup and view all the answers

Which schedule of controlled drugs does NOT have a legal requirement for the presence of an authorized person during destruction?

Schedule 3 Signup and view all the answers

What is the purpose of denaturing controlled drugs before disposal?

To prevent misuse and protect the environment. Signup and view all the answers

Which of the following is a good practice when destroying Schedule 2 controlled drugs returned by patients?

Maintaining a record separate from the CD register. Signup and view all the answers

What is the preferred method for disposing of controlled drugs (CDs) in Schedule 2, 3, and 4?

Using CD denaturing kits Signup and view all the answers

What should be done with solid dose formulations before placing them in the CD denaturing kit?

Grind or crush them Signup and view all the answers

When using a CD denaturing kit, what is crucial to remember about adding liquids?

Do not exceed the fill line when adding liquid Signup and view all the answers

What is the recommended action if a denaturing kit is not available for solid controlled drugs?

Crush them and mix with warm soapy water Signup and view all the answers

What appropriate safety measures must be taken when denaturing controlled drugs?

Wearing PPE and ensuring a well-ventilated area Signup and view all the answers

After denaturing, where can the contents of the denaturing kit be disposed of?

In the general pharmaceutical waste bin Signup and view all the answers

How can liquids be safely disposed of when using a CD denaturing kit?

Pouring into the kit and mixing thoroughly Signup and view all the answers

What is a recommended substance for making controlled drug powder unrecoverable when no denaturing kit is available?

Cat litter Signup and view all the answers

What is the first step in disposing of an empty bottle that contained a controlled drug (CD)?

Rinse the bottle and pour rinsings into the CD denaturing kit Signup and view all the answers

What should be done with ampoules containing liquid controlled drugs before disposal?

The ampoule should be opened, contents emptied into a CD denaturing kit, and then disposed of in a sharps bin Signup and view all the answers

How should Fentanyl or Buprenorphine patches be disposed of?

Fold them over on themselves sticky side inwards before placing into the CD denaturing kit Signup and view all the answers

What is the recommended method for disposing of aerosol formulations of controlled drugs?

Expel them into water to prevent drug droplets from entering the air Signup and view all the answers

What should be done with ampoules containing a powder form of controlled drugs?

Add water to dissolve the powder and pour the mixture into the CD denaturing kit Signup and view all the answers

Study Notes

Collecting Controlled Drugs (CDs) on Behalf of a Purchaser

A letter of authority from the purchaser is required for someone to collect CDs on their behalf.
The letter should be signed and dated by the purchaser and include details of the messenger.
The pharmacy must be reasonably satisfied that the letter is genuine and must retain it for two years.

Destruction of CDs

Pharmacies are required to denature CDs prior to disposal.
Denaturing renders the drug irretrievable without specialized equipment.
Denaturing is essential to prevent misuse, protect the environment, and ensure safe transportation.
An exemption, known as the ‘T28 exemption’, allows pharmacies in England and Wales to denature CDs without a licence.

Destruction of Out-of-Date CD Stock

Out-of-date CD stock must be segregated from other CDs.
The destruction of schedule 2 stock must be witnessed by an "authorized person".
An Accountable Officer cannot be an "authorized person".
The authorized person will record the destroyed quantities in the CD register.
For schedule 3 CDs, it is good practice to have another staff member, preferably a registered healthcare professional, witness the denaturing process.

Destruction of CDs Returned by Patients

Returned CDs should be destroyed promptly and not allowed to accumulate.
Returned CDs should be segregated, stored securely, and marked for destruction.
Schedule 2 CDs returned by patients should not be recorded in the CD register.
It is good practice to maintain a separate record of returned schedule 2 CDs for seven years.
It is good practice to have another staff member witness the destruction.

Records for Returned CDs

The following information should be recorded for returned CDs:
- Date received
- Received by, with name and signature
- Patient's name and address, if known
- Name of CD
- Form and strength of CD
- Quantity of CD
- Role of person returning the CD, if known
- Date destroyed
- By pharmacist, with name and signature
- Witnessed by, with name and signature
Ideally, the first eight columns should be completed upon receipt of the CD and the last three columns completed when the CD is destroyed.

Denaturing Methods for CDs

Denaturing kits are recommended by the Home Office for denaturing controlled drugs.
CDs should be denatured before disposal, especially those in schedules 2, 3, and 4, part I.
Denaturing methods vary depending on the formulation, and specific instructions are provided in the Medicines and Healthcare products Regulatory Agency (MHRA) guidelines.
Ampoules containing liquid should be emptied into the denaturing kit.
Solid dosage forms should be crushed or ground before being added to the denaturing kit to prevent retrieval.
Fentanyl and buprenorphine patches should be folded sticky side inwards and placed in the denaturing kit.
Aerosol formulations should be expelled into water to prevent drug droplets entering the air.
After denaturing, the kit and its contents should be disposed of in the general pharmaceutical waste bin for incineration.

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Description

This quiz covers essential regulations related to the collection and destruction of controlled drugs (CDs) in pharmacies. It highlights the requirements for authorization letters, proper disposal methods, and safety protocols to prevent misuse. Test your knowledge on the T28 exemption and the proper destruction procedures for out-of-date CD stock.