Week 13 / P medicines Flashcards

(48 cards)

1
Q

Q: Is there a definitive list of Pharmacy (P) medicines in the UK?

A

A: No, there is no definitive list of Pharmacy medicines.

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2
Q

Q: How can you identify if a medicine is a Pharmacy (P) medicine?

A

A: By checking the medicine’s marketing authorisation, packaging, or trusted references like the BNF.

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2
Q

Q: How are Pharmacy (P) medicines classified?

A

A: They are medicines that are not POM or GSL, or are classified as P in their marketing authorisation.

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3
Q

Q: What is the legal classification of medicines made in a pharmacy for retail sale under licensing exemptions?

A

A: They are classified as Pharmacy (P) medicines.

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4
Q

Q: Why should you avoid calling P medicines “Pharmacy only medicines”?

A

A: Because some products labelled “Pharmacy only” are actually GSL by legal classification, restricted by the manufacturer—not the law.

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5
Q

Q: What medicines are included under Schedule 15?

A

A: Aspirin, ibuprofen, and paracetamol.

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6
Q

Q: What is the legal classification of paracetamol 500mg tablets (non-soluble) in a pack of 16?

A

A: GSL (General Sale List).

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7
Q

Q: What is the legal classification of paracetamol 500mg tablets (non-soluble) in a pack of 32?

A

A: P (Pharmacy medicine).

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8
Q

Q: What is the maximum legal quantity of paracetamol 500mg tablets that can be sold over the counter?

A

A: 100 tablets (quantities over 100 are classified as POM).

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9
Q

Q: How many 32-tablet packs of paracetamol 500mg can be sold in one transaction to the same purchaser in a pharmacy?

A

A: Maximum of 3 packs (96 tablets) — selling 4 packs (128 tablets) would exceed the legal OTC limit.

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10
Q

Q: Are there legal maximum pack size restrictions for soluble paracetamol 500mg?

A

A: No legal maximum — use professional discretion.

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11
Q

Q: Do the same Schedule 15 rules apply to aspirin 300mg tablets (non-soluble)?

A

A: Yes, the same classification and sale limits apply.

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12
Q

Flashcard 1
Q: What can cause a POM to be classified as a P (Pharmacy) medicine?

Flashcard 2
Q: Give an example of a POM that is classified as a P medicine due to its small pack size.

Flashcard 3
Q: How can the indication affect the classification of a POM?

Flashcard 4
Q: Which controlled drugs can be exempt from POM status at low strengths?

Flashcard 5
Q: What is an example of a POM that can be sold as P, POM, or GSL based on the form and pack size?

A

1A: When the medicine is sold in small pack sizes, low strengths, for certain indications, or in certain forms.

2A: Hydrocortisone 1% cream, 15g — classified as P.

3A: Some POMs are classified as P medicines for specific indications, such as Naproxen 250mg for primary dysmenorrhea in women aged 15–50 years.

4A: Codeine, dihydrocodeine, and morphine are exempt from POM status when below a specified strength.

5A: Diclofenac — POM for systemic use, but for external topical use (e.g., creams, gels), it can be POM, P, or GSL depending on pack size.

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13
Q

Q: What are the requirements for the retail sale of Pharmacy (P) medicines?

A

A: The sale of P medicines can only occur if:

The premises is a registered pharmacy.

The seller is a pharmacist or is acting under the supervision of a pharmacist.

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14
Q

Q: Are there any exceptions to the retail sale requirements for Pharmacy (P) medicines?

A

A: Yes, in the event or anticipation of a pandemic disease, the sale of P medicines may be allowed under a protocol approved by a Government Minister.

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15
Q

Q: What standards must be followed when selling Pharmacy (P) medicines?

A

A: Sales must comply with GPhC Standards for Pharmacy Professionals and any related guidance on pharmacy staff and premises.

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16
Q

Q: Who can sell P medicines?

A

A: P medicines can only be sold by a pharmacist or a staff member acting under the supervision of a pharmacist.

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17
Q

Q: What is the legal definition of supervision for the sale of P medicines?

A

A: The pharmacist must:

Be aware of the sale.

Be in a position to intervene where necessary.

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18
Q

Q: Can a pharmacist supervise the sale of P medicines if they are not present in the pharmacy?

A

A: No, the pharmacist must be present in the pharmacy premises and able to supervise the sale. The sale cannot be supervised if the pharmacist is absent, even for a short time.

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19
Q

Q: Will the definition of supervision for the sale of P medicines change in the future?

A

A: Yes, changes to the definition of supervision may be made in the future, and these will be included in Level 4 lectures.

20
Q

Q: What is the focus of the RPS guidance on safe and effective use of medicines?

A

A: The guidance focuses on:

Maximising safety, effectiveness, and adherence.

Providing expertise and advice to support safe use of medicines.

Referring patients to pharmacists or other healthcare professionals when necessary.

Ensuring pharmacy medicines are not accessible for self-selection.

20
Q

Q: What is the role of pharmacy staff in patient experience and patient-centred care according to the RPS guidance?

A

A: Pharmacy staff should:

Support patient decision-making.

Treat patients with dignity and respect.

Respect privacy and confidentiality.

Actively seek the views of patients and carers in service delivery.

Provide clear, understandable information to help patients make informed choices.

21
Q

Q: What does the RPS guidance say about workforce development in pharmacies?

A

A: The guidance emphasizes:

Ensuring the pharmacy team has the right skills, capability, and capacity.

Providing induction and ongoing development for all pharmacy team members.

Planning and resourcing the workforce to support service quality, safety, and productivity.

22
Q

Q: What should pharmacists be cautious about when selling medicines with restricted pack sizes? [3]

A

A: Pharmacists need to:

Be aware of legal restrictions on pack sizes (e.g., GSL or P in small packs but POM in larger packs).

Consider the possibility of abuse, misuse, or inappropriate self-medication if large quantities are requested.

Offer smaller quantities or refuse the sale with explanation and appropriate signposting.

23
Q: What is the primary concern when selling any medicine according to the RPS guidance?
A: The welfare and safety of the patient must always be the prime concern when selling any medicine.
24
Q: What does the law say about the location of Pharmacy (P) medicines in the pharmacy?
A: The law does not specify where P medicines should be located, but it is considered good practice to avoid placing them on self-selection shelves.
25
Q: Why should P medicines traditionally be stored behind the pharmacy counter?
A: Storing P medicines behind the pharmacy counter: Reminds staff of the legal classification. Helps prevent unauthorized sales, especially when the pharmacist is not available to supervise the sale.
26
Q: What is one alternative way to display P medicines in the pharmacy?
A: One alternative is to place empty boxes of P medicines on self-selection shelves so patients can read the information before deciding to purchase, with the actual product exchanged at the pharmacy counter after suitability checks.
27
Q: How can P medicines be safely displayed to prevent unauthorized access?
A: P medicines can be placed in front of the medicine counter but behind lockable glass or plastic doors so patients can see the packaging but cannot access the medicines without assistance.
28
Q: What should pharmacy staff do when a customer requests a P medicine?
A: Pharmacy staff should ask appropriate questions to ensure the medicine is suitable for the patient, especially if the request is based on advertising or someone else recommending the product.
29
Q: Why are Ephedrine and Pseudoephedrine classified as P medicines?
A: They are classified as P medicines because they are used as decongestants but have the potential for misuse, particularly in the illegal production of crystal meth.
30
Q: What is the legal maximum quantity of Pseudoephedrine that can be sold in one transaction?
A: The legal maximum quantity of Pseudoephedrine that can be sold in one transaction is 720mg.
31
Q: What is the legal maximum quantity of Ephedrine that can be sold in one transaction?
A: The legal maximum quantity of Ephedrine that can be sold in one transaction is 180mg.
32
Q: Is it lawful to sell Pseudoephedrine and Ephedrine products at the same time?
A: No, it is unlawful to sell a Pseudoephedrine-containing product at the same time as an Ephedrine-containing product.
33
Q: Who should supervise the sale of Ephedrine or Pseudoephedrine products?
A: The sale should be made by a pharmacist or a trained member of staff acting under the supervision of a pharmacist.
34
Q: What should be done if there are grounds for misuse of Ephedrine or Pseudoephedrine?
A: Even if the request is lawful, it should be refused if there are grounds for misuse. Any suspicions of misuse should be reported to the local GPhC inspector, local CD police officer, or local CD accountable officer.
35
Q: What restrictions apply to Codeine and Dihydrocodeine as P medicines?
A: Codeine and Dihydrocodeine are used as analgesics for short-term treatment of acute moderate pain. They have a maximum pack size of 32 dose units and must include warnings about addiction and overuse.
36
Q: What warning must appear on the Codeine or Dihydrocodeine packaging?
A: The warning "Can cause addiction. For three days use only" must appear on the pack, along with information about the warning signs of addiction and the risk of overuse headache.
37
Q: What is the RPS recommendation for the sale of Codeine or Dihydrocodeine?
A: The RPS recommends that only one pack of Codeine or Dihydrocodeine be sold per transaction.
38
Q: Why has the safety of stimulant laxatives been under review by the MHRA?
A: The MHRA reviewed the safety of stimulant laxatives due to issues of misuse and abuse.
39
Q: Which stimulant laxatives are available OTC in the UK?
A: OTC stimulant laxatives include senna/sennosides, bisacodyl, and sodium picosulfate. Codanthramer and codanthrusate are stimulant laxatives but are classified as POM products.
40
Q: What did the MHRA announce in August 2020 regarding stimulant laxatives?
A: In August 2020, the MHRA announced changes to the regulation of OTC stimulant laxatives, including pack size restrictions, revised recommended ages for use, and new safety warnings.
40
Q: What pack size is allowed for GSL stimulant laxatives?
A: GSL stimulant laxatives are limited to a pack size of two short treatment courses (up to 20 standard-strength tablets, 10 maximum-strength tablets, or 100ml solution/syrup).
40
Q: What is the legal status of larger packs of stimulant laxatives?
A: Larger packs (up to 100 tablets) are classified as P medicines.
41
Q: What is the age restriction for GSL stimulant laxatives?
A: GSL stimulant laxatives are licensed for use in patients aged 18 years or older.
42
Q: What are the age requirements for children using stimulant laxatives?
A: Children under 12 years: Stimulant laxatives should not be used without advice from a prescriber. Children aged 12 to 17 years: Stimulant laxatives can only be supplied under the supervision of a pharmacist (P medicines).
43
Q: What warnings are now included on stimulant laxative packaging?
A: New warnings include: Overuse can be harmful due to fluid and electrolyte disturbances and potential disruption of intestinal function. These products do not aid weight loss.
44
Q: How is overuse of stimulant laxatives described in patient information leaflets?
A: The leaflets now warn that overuse of stimulant laxatives can be harmful and may lead to fluid and electrolyte disturbances and disrupt intestinal function.