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Key Medicine Knowledge > Non-Clinical Stuff > Flashcards

Non-Clinical Stuff Flashcards

1
Q

What act regulates Controlled Drugs (CDs) in the UK?

A

The Misuse of Drugs Act 1971 and the Misuse of Drugs Regulations 2001.

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2
Q

What are Schedule 1 drugs, and can they be prescribed?

A

Schedule 1 drugs, such as LSD and ecstasy, have no therapeutic use and can only be used for research with a Home Office license.

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3
Q

What are examples of Schedule 2 drugs?

A

Examples include morphine, diamorphine, and methadone.

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4
Q

Where must Schedule 2 drugs be stored in a pharmacy?

A

In a locked, secure Controlled Drug cupboard.

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5
Q

Do Schedule 2 drugs need to be recorded in a CD register?

A

Yes, all transactions involving Schedule 2 drugs must be recorded in a Controlled Drug register.

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6
Q

Do Schedule 3 drugs require a CD register?

A

No, Schedule 3 drugs do not require recording in a CD register.

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7
Q

Give examples of Schedule 3 drugs.

A

Examples include buprenorphine, tramadol, and gabapentin.

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8
Q

Are Schedule 3 drugs required to be stored in a CD cupboard?

A

Some Schedule 3 drugs, like buprenorphine, require secure storage, while others, like phenobarbital, do not.

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9
Q

Which schedule 3 drugs are not required to have safe custody

A

Phenobarbital (used for epilepsy)
Gabapentin
Pregabalin
Midazolam
Tramadol

These drugs can be stored alongside regular medicines in the dispensary and do not require the same stringent security measures as other CDs in Schedule 3, such as buprenorphine and temazepam, which must be kept in a CD cupboard.

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10
Q

What is the validity period of a prescription for Schedule 2, 3, and 4 Controlled Drugs?

A

The prescription is valid for 28 days from the date of signing.

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11
Q

What special requirements must be included on a Controlled Drug prescription?

A

The dose, form, strength, and total quantity must be stated in both words and figures.

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12
Q

Can Controlled Drugs be prescribed on repeat prescriptions?

A

Schedule 2 and 3 drugs cannot be prescribed on repeat prescriptions.

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13
Q

What records must be kept in the CD register for Schedule 2 drugs?

A

Date, patient or supplier details, quantity received or supplied, and remaining stock balance must be recorded.

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14
Q

How long must the CD register be kept after the last entry?

A

The CD register must be kept for 2 years after the last entry.

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15
Q

What is required for the destruction of expired Schedule 2 Controlled Drugs?

A

Destruction must be witnessed by an authorized person, and the event recorded in the CD register.

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16
Q

Can Schedule 2 and 3 drugs be supplied via emergency supply?

A

No, except for phenobarbital for epilepsy.

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17
Q

What is the maximum supply of Controlled Drugs recommended on a prescription?

A

No more than 30 days’ supply is recommended for Schedule 2, 3, and 4 drugs.

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18
Q

Do Schedule 4 drugs require special storage or CD register records?

A

No, Schedule 4 drugs do not require special storage or CD register records.

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19
Q

Can patients return Controlled Drugs to a pharmacy, and what is required for destruction?

A

Yes, patients can return CDs. No witness is required for patient-returned CDs, but one is required for the destruction of expired stock.

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20
Q

What is the punishment for failing to comply with Controlled Drug regulations?

A

Non-compliance can lead to fines, legal action, and loss of a pharmacist’s registration with the GPhC.

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21
Q

Are pharmacists required to report any suspected loss or misuse of Controlled Drugs?

A

Yes, any suspected misuse or loss must be reported to the CD Accountable Officer or the police.

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22
Q

What information is required on a private prescription for Schedule 2 and 3 Controlled Drugs?

A

It must be written on an FP10PCD form and submitted to the NHSBSA.

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23
Q

Can patients drive while taking Controlled Drugs like opioids?

A

Patients should be advised not to drive if they feel drowsy or impaired, as drug-driving laws apply.

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24
Q

What should be done if there’s a discrepancy between the CD register and actual stock?

A

Any discrepancies must be investigated and reported to the CD Accountable Officer.

25
Q

For how long must records of private Controlled Drug prescriptions be kept?

A

They must be retained for 2 years.

26
Q

What drugs fall under Schedule 5, and do they require a CD register?

A

Low-strength codeine and dihydrocodeine preparations. No CD register is required for Schedule 5 drugs.

27
Q

Can Schedule 5 Controlled Drugs be sold over the counter (OTC)?

A

Yes, certain low-dose Schedule 5 drugs like codeine and dihydrocodeine can be sold as Pharmacy (P) medicines.

28
Q

How should mistakes in the CD register be corrected?

A

Mistakes should be corrected by crossing out the error with a single line, and the correct information should be entered alongside with a clear annotation of the error.

29
Q

How often should stock checks of Controlled Drugs be carried out?

A

Stock checks should be done regularly (best practice is at least once a week) to ensure accurate record-keeping and stock balance.

30
Q

Who can authorize the destruction of expired Schedule 2 Controlled Drugs?

A

An authorized person, such as a CD Accountable Officer
or an inspector, must witness the destruction of expired stock.

31
Q

What should be done if a Controlled Drug prescription does not meet all legal requirements?

A

The prescription is invalid and should not be dispensed. The prescriber must be contacted to rectify any missing or incorrect details.

32
Q

How long is the prescription validity for Schedule 5 drugs?

A

Schedule 5 drug prescriptions are valid for 6 months, similar to regular prescription-only medicines (POMs).

33
Q

What is the maximum supply of Schedule 2, 3, and 4 drugs that should ideally be prescribed?

A

The recommended maximum supply is 30 days to minimize the risk of misuse.

34
Q

Are Schedule 4 Part 1 (benzodiazepines) drugs subject to prescription writing requirements like Schedule 2 and 3 drugs?

A

No, but the prescription is only valid for 28 days, and they are not subject to strict wording requirements.

35
Q

What is required for the safe storage of Controlled Drugs in community pharmacies?

A

Controlled Drugs (Schedules 2 and some Schedule 3) must be stored in a locked CD cupboard that complies with the Misuse of Drugs (Safe Custody) Regulations 1973.

36
Q

What records must be kept when dispensing Controlled Drugs from a private prescription?

A

A record must be made in the private prescription register for Schedule 2 and 3 drugs, and the prescription must be retained for 2 years.

37
Q

Can a Controlled Drug prescription be post-dated for future use?

A

Yes, a CD prescription can be post-dated, but it will only be valid 28 days from the stated date on the prescription.

38
Q

What documentation must be submitted to the NHS Business Services Authority (NHSBSA) for Controlled Drugs on private prescriptions?

A

All private prescriptions for Schedule 2 and 3 Controlled Drugs must be submitted on FP10PCD forms at the end of each month.

39
Q

What factors determine whether a drug is classified under Schedule 2 or Schedule 3?

A

The classification depends on the drug’s potential for misuse, the need for medical use, and its safety profile.

40
Q

What are instalment prescriptions used for?

A

Instalment prescriptions are used for dispensing Controlled Drugs in smaller, regular doses to manage long-term treatment, usually for opioid dependence.

41
Q

For which Controlled Drugs are instalment prescriptions commonly issued?

A

Instalment prescriptions are commonly issued for methadone and buprenorphine (e.g., Subutex) for opioid substitution therapy.

42
Q

What schedules of Controlled Drugs can be prescribed using an instalment prescription?

A

Instalment prescriptions can be used for Schedule 2 and Schedule 3 drugs, such as methadone and buprenorphine.

43
Q

What key phrase must be included on an instalment prescription?

A

The phrase “Instalments of [drug name] may be supplied at intervals stated” must be included.

44
Q

What additional details must be provided on an instalment prescription?

A

The prescription must specify:

The amount of drug to be dispensed per instalment.
The interval between instalments (e.g., daily, weekly).

45
Q

What happens if the patient misses an instalment dose?

A

If the patient misses more than three consecutive days, the remaining instalments should not be supplied, and the prescriber must be contacted for further instructions.

46
Q

Can a pharmacist dispense an instalment early if the patient requests it?

A

No, instalments cannot be dispensed early, as the prescription must be strictly followed according to the specified intervals.

47
Q

How long is an instalment prescription valid?

A

An instalment prescription is valid for 28 days from the date it is signed or the start date indicated on the prescription.

48
Q

Can an instalment prescription be split across multiple pharmacies?

A

No, instalments must all be dispensed from the same pharmacy to ensure continuity of care and compliance with the prescription.

49
Q

Can a prescriber authorize instalments to be provided if the pharmacy is closed on a specific day?

A

Yes, the prescriber can include instructions to dispense double doses in advance when the pharmacy will be closed (e.g., Sundays or public holidays).

50
Q

Can a Controlled Drug instalment prescription be post-dated?

A

Yes

51
Q

What is medicines reconciliation?

A

the process of creating an accurate list
of a patient’s current medication and comparing this to those in the patient’s medication record
with the goal of providing the patient with the correct medication

52
Q

What is a cohort study?

A

a study where a group of people are identified and followed over a period of time to see how their
exposures affect their outcomes. This type of study is normally used to look at the effect of suspected risk
factors that can’t be controlled experimentally – for example, the effect of smoking on lung cancer

53
Q

What is a randomised control trial?

A

a study where people are randomly allocated to receive (or not receive) a particular intervention

54
Q

What is a cross sectional study?

A

an epidemiological study that describes characteristics of a population

55
Q

How should vinca alkaloid drugs be delivered?

A

IntraVENOUS only.

Inadvertent intrathecal use can cause severe neurotoxicity, which is usually fatal

56
Q

What is The key legislation in the Data Protection Act 2018 and the General Data Protection Regulation (GDPR).

A

Understand Data: Identify and protect personal and health data.
Obtain Consent: Get explicit patient consent and record it.
Legitimate Use: Use data only for healthcare purposes.
Minimize Collection: Collect only necessary data.
Ensure Accuracy: Keep data up-to-date and correct errors.
Secure Data: Use encryption, passwords, and secure storage.
Respect Rights: Fulfill patient rights (access, correct, erase, etc.).
Have a Policy: Implement a GDPR-compliant data protection policy.
Appoint a DPO: Assign a Data Protection Officer if needed.
Train Staff: Educate staff on GDPR principles.
Report Breaches: Notify ICO within 72 hours of any breach.
Conduct DPIAs: Assess privacy risks for new technologies/processes.

57
Q

Do you need ethical approval in an audit?

A

You do not need ethics approval to conduct a clinical audit.

58
Q
A

Key Medicine Knowledge (40 decks)

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