PL&E - Regulation and Classification of Medicines

Question 1

What are the three classes of medicinal products for humans under the Human Medicines Regulations 2012?

Answer 1

• General Sales List (GSL)
• Pharmacy Only Medicines (P)
• Prescription Only Medicine (POM)

Question 2

Describe General Sales list?

Answer 2

• Available as self-selection
• Pharmacist is not required for the sale or supply

Question 3

Describe Pharmacy Only Medicines (P)

Answer 3

• Can only be sold from a registered pharmacy
• Pharmacist or person actin under the supervision of a pharmacist must be present
• Over the counter

Question 4

Describe Prescription Only Medicine (POM)

Answer 4

• Requires a prescription written by an appropriate practitioner
• Requires supervision for safe use
• Responsible pharmacist must be present

Question 5

What are benefits of increasing availability to medicines OTC?

Answer 5

• Quick relief of disorder
• Individual self-care/ autonomy
• Rapid/convenient access

Question 6

What are the barriers of increasing availability to medicines OTC?

Answer 6

• Side effect profile
• Possibility of misdiagnosis and delay of treatment
• Potential for harm from incorrect use

Question 7

What are the signs of possible misuse of drugs?

Answer 7

• Lack of symptoms
• Rehearsed answers
• Impatient or aggressive
• Opportunistic
• Specific products; wanting certain that contain only pseudoephedrine or ephedrine
• Paraphernalia; purchase items which can be used to manufacture methylamphetamine e.g. lithium batteries
• Requests large quantities
• Makes frequent requests

Question 8

What is the max supply for pseudoephedrine and ephedrine?

Answer 8

720 mg of pseudoephedrine
OR 180 mg of ephedrine

Question 9

What are the three methods of emergency contraception?

Answer 9

• Oral levonorgestrel; max effect if taken within first 12 hours after UPSI
• Oral ulipristal acetate; effectiveness can be reduces if patient takes progesterone
• Copper IUD; most effective and can be left in situ for up to 10 years