PL&E 2 - regulation and classification of medicines

what are the 3 classes of medicinal products for humans under the Human Medicines Regulations 2012?

general sales list (GSL), pharmacy only (P), prescription only (POM)

describe what GSL medicines are

available as ‘self'-selection’ from:

• registered pharmacies - only when a ‘responsible pharmacist’ is in place

• other retail outlets that can be ‘closed to exclude the public/be locked’ such as supermarkets - pharmacist not required for sale or supply

describe what P medicines are

can only be sold from a registered pharmacy premises by a pharmacist or person acting under the supervision of a pharmacist

must not be accessible to public by self-selection

specific regulations related to certain products within this category

what does the term ‘over the counter’ medicines include?

GSL and P

describe what POM medicines are

generally subject to the restriction of requiring a prescription written by an appropriate practitioner

require a legal prescription for a medicine for a specific person and purpose

require supervision for safe use - include medicines that are prone to misuse/new product/parenteral use

who can write a prescription for a POM medicine?

doctors, dentists, pharmacists, IP nurses, dieticians etc

can medicines be classified under more than one class?

yes - depending on formulation, strength, quantity, indication or licensing

give some benefits of moving medicines up classification (eg, from P to GSL)

quick relief of disorder, individual self-care/autonomy, rapid/convenient access for patients

give some risks of moving medicines up classifications (eg, from P to GSL)

side effect profile, possibility of misdiagnosis, potential for harm from incorrect use

what is the potential for misuse with pseudoephedrine?

in illicit production of methylamphetamine (crystal meth) - a Class A Controlled Drug

what is the max. supply of pseudo/ephedrine?

a product or combination of products that contain more than 720mg of pseudoephedrine OR 180mg of ephedrine at once, without a prescription

how should pseudoephedrine and ephedrine be sold?

can sell either one or the other - not both at once (without a prescription)

sale should be made by the pharmacist or by pharmacy staff who have been trained and are competent to deal with any issues, and know when it is necessary to refer to the pharmacist

what are some red flags when selling medicines with the potential for misuse?

rehearsed/scripted answers, targeting newly qualified/younger pharmacists, asking for specific brands that do not combine drug with other chemicals, making frequent visits, wishes to purchase item which can be used to make illegal drug (eg, for cystal meth - lithium batteries)

what is pseudoephedrine?

widely used decongestant P medicine

where can suspicions of drug misuse be reported to?

local GPhC inspector, local controlled drugs liaison police officer or accountable officer

what are codeine and dihydrocodeine?

solid dose OTC, short term treatment of acute, moderate pain that is not relieved by paracetamol, ibuprofen or aspirin alone

what pack size classifies codeine as a POM?

more than 32 tablets

what must the PIL for codeine/dihydrocodeine state?

indication and that it can cause addiction or headache if used for more than 3 days

information about the warning signs of addiction

what legal classification are paracetamol and aspirin?

have MAs as POM, P and GSL medicines depending on pack size and formulation

what are the legal sales restrictions on paracetamol and aspirin?

not more than 100 non-effervescent tablets or capsules can be sold to a person at one time (as more potential for use in suicide)

no legal limits on OTC effervescent formulations - use professional judgement to decide appropriate quantity to supply

when in doubt if formulation is effervescent or not, should be sold and restricted as non-e

what are the 3 forms of oral emergency contraception in the UK?

1. copper intrauterine device (Cu-IUD) - not supplied in a pharmacy

2. oral ulipristal acetate

3. oral levonorgestrel

describe ulipristal acetate - emergency contraception

30mg tablet

licensed for emergency contraception within 120 hours (5 days) of unprotected sexual intercourse or failure of contraceptive method

describe oral levonorgestrel - emergency contraception

1500 microgram tablet

licensed for women aged 16 or over for emergency contraception within 72 hours as P medicine

can still supply if under 16 if on prescription as is now POM medicine not P

what must you be aware of when supplying emergency contraception?

patients should be assessed to ensure that they are competent (eg, free from signs of abuse), they intend to use the medicine appropriately and it is clinically appropriate (ie no contraindications)

how should you treat cases of children under age 13 requesting emergency contraception?

seriously, with presumption that it should be reported to social services (unless there are exceptional circumstances backed by documented reasons for not sharing information

what is the Fraser criteria?

that you can provide contraception or sexual health advice to a child or young person under 16 as long as, in England and Wales, certain criteria are met

list the Fraser criteria

• they have sufficient maturity and intelligence to understand the nature and implications of the proposed treatment

• they cannot be persuaded to tell their parents or allow the practitioner to help them

• they are very likely to begin or continue having sexual intercourse with or without contraceptive treatment

• their physical and mental health is likely to suffer unless they receive the advice or treatment

• the advice or treatment is in their best interest

what can you do if you don’t feel confident supplying emergency contraception?

refer patient to a different provider rather than make a sale

other providers include family planning clinics, general practice clinics etc