Sale and Supply 1

Question 1

Responsible pharmacist legislation

Answer 1

Health Act 2006- each registered pharmacy is to have a responsible pharmacist in charge of the business where this relates to sale or supply of medicines
Medicines Act 72A- RP must ensure the safe and effective running of the pharmacy business for sale and supply

Question 2

RP requirements

Answer 2

Must sign in and out to show when they have taken charge of the pharmacy
A notice must be displayed conspicuously, showing the pharmacists name, registration number and the declaration that they are the RP

Question 3

Absence of the RP

Answer 3

The RP may be absent for a maximum period of two hours during the business hours between midnight and midnight
If absent, the RP must remain contactable by staff and be able to return with reasonable promptness, or arrange for another pharmacist to be available

Question 4

Activities during absence of RP

Answer 4

Sale of GSL medication and the assembly process

Question 5

Activities if no RP has taken charge of a pharmacy

Answer 5

The local health board or primary care organisation must be informed as they have a contract to dispense NHS prescriptions
Failure to inform would be a breach of contract

Question 6

How do medicines reach the pharmacy?

Answer 6

The manufacturer is responsible for production of the medication
Wholesalers purchase products from manufacturers and act as suppliers to pharmacies
Pharmacies order medication from wholesalers based on the stock they sell over the counter and prescriptions they dispense to patients

Question 7

Problems with the supply chain

Answer 7

Today’s distribution network for medicinal products is increasingly complex and involves many players
As such it is becoming easier for falsified medicines to enter the supply chain
Falsified medicines are fake medicines that pass themselves off as real, authorised medicines

Question 8

Falsified medicines

Answer 8

May contain ingredients of low quality or in the wrong doses
May be deliberately and fraudulently mislabelled with respect to their identity or source
May have fake packaging, the wrong ingredients, or low levels of the active ingredients
Can be a health threat as they do not pass through the usual evaluation of quality, efficacy and safety

Question 9

Falsified vs counterfeit medicines

Answer 9

Falsified medicines are fake medicines that are designed to mimic real medicines
Counterfeit medicines are medicines that do not comply with intellectual-property rights or that infringe trademark law

Question 10

Vulnerabilities in the supply chain

Answer 10

False labelling of ingredients
Counterfeits sold to wholesalers
Adulterated raw materials
Adulteration by pharmacists
Toxic ingredients

Question 11

Illicit medicines examples

Answer 11

EU commission press release April 2006
Fakes of Rimonabant (Sanofi Aventis) for treatment of obesity and smoking cessation are being offered for sale on the internet, patients who buy unlicensed, counterfeit or illicit copies may be putting health at risk

Question 12

EU directive on falsified medicines for human use

Answer 12

In July 2011 the EU adopted a new directive on falsified medicines for human use
This directive aims to prevent falsified medicines from entering the legal supply chain and reaching patients
It introduced harmonised safety and strengthened control measures across Europe by applying new measures

Question 13

New safety measures- safety features of medicines

Answer 13

Two safety features to be placed on the packaging of most human medicines: a unique identifier (a 2-dimension barcode) and an anti-tampering device

Question 14

New safety measures- supply chain and good distribution practice

Answer 14

New responsibilities for wholesalers and a definition of brokering activities as well as new responsibilities for brokers
Revised GDP guidelines include specific provisions for brokering activities

Question 15

New safety measures- active substances and ingredients

Answer 15

From July 2013, all active substances manufactured outside the EU and imported into the EU have had to be accompanied by a written confirmation from the regulatory authority of the exporting country

Question 16

New safety measures- internet sales

Answer 16

The directive has introduced an obligatory logo that will appear on the websites of legally operating online pharmacies and approved retailers in the EU
The logo will allow patients and consumers to identify authorised online pharmacies and approved retailers providing authentic authorised medicines

Question 17

Other measures adopted by manufacturers

Answer 17

Dosage forms- with more complex shapes and more elaborate printing
Packs with expensive printed features- overt measures, holograms, covert measures, tags and biological markers
Radio frequency identification tags- programming devices that can track the product through the supply chain

Question 18

Classification of medicines

Answer 18

Three classes of medicinal products for humans under the Human Medicines Regulations 2012
Medicines should not be considered normal items of commerce
Final decision on sale or supply is one determined by the professional judgement of the pharmacist

Question 19

General Sales Medicines

Answer 19

Medicines that can be sold in any retail outlet that can close so as to exclude the public
Defined as a product that is not a POM or a P but is covered by an authorisation of which it is a term that the product is to be available on general sale; or
is covered by an EU marketing authorisation and is not classified as a POM and the licensing authority has determined should be available on general sale

Question 20

P-only medicines

Answer 20

A medicine that is licensed as a GSL but for which the manufacturer wishes to restrict sales or supplies through pharmacies only, e.g. 30-sachet packets of Fybogel
GSLs can only be sold once a pharmacist has assumed role of RP but the pharmacist may be physically absent for a period of time while remaining responsible

Question 21

P medicines

Answer 21

Any medicinal product which is not a POM or classified as a GSL
Can only be sold from a registered pharmacy premises by a pharmacist or a person acting under the supervision of a pharmacist

Question 22

Self selection of P meds by patients

Answer 22

The self selection of P medicines is prohibited

Question 23

GSL and P meds in hospital

Answer 23

All classes of meds except CDs are stored under the same conditions
Supply is also made in the same way as any other medicine

Question 24

Meds liable to misuse

Answer 24

Pharmacists are empowered to refuse to sell or supply any medicines if the sale or supply of the medicines is contrary to the pharmacist’s clinical judgement
This can include suspected misuse

Question 25

GSL meds liable to misuse

Answer 25

All products containing solvents or propellants e.g. glues, nail varnish remover, freeze/heat sprays
Chemicals e.g .ascorbic acid (vitamin C)
Stimulants e.g. caffeine
Laxatives

Question 26

P meds liable to misuse

Answer 26

Products containing opiates e.g. codeine in co-codamol, dihydrocodeine in paramol and morphine in kaolin and morphine
Sedating antihistamines
Laxatives
Sympathomimetics, particularly ephedrine and pseudoephedrine

Question 27

Pseudoephedrine and ephedrine

Answer 27

Widely used decongestant pharmacy medicines
There is potential for misuse in the illicit production of methylamphetamine (a class A controlled drug)
There are legal restrictions on the quantities that can be sold or supplied without prescription

Question 28

Pseudoephedrine and ephedrine restrictions

Answer 28

Unlawful to sell more then 720mg of pseudoephedrine or 180mg of ephedrine at any one time without a prescription
Unlawful to sell any pseudoephedrine product at the same time as an ephedrine product without a prescription
Sales or supplies should either be made by the pharmacist or by pharmacy staff who have been trained and are competent

Question 29

Signs of misuse

Answer 29

Nervous or guilty behaviour
Lack of symptoms
Rehearsed answers
Impatient or aggressive
Opportunistic
Specific products
Paraphernalia
Quantities
Frequency

Question 30

P meds requiring consultation

Answer 30

Must be satisfied that there is need for the medication
Counselling given on how to take it and any problems that should be expected or reported
Often need to ask personal questions- privacy is essential
E.g. Tamsulosin, EHC (levonelle), orlistat

Question 31

Pseudoephedrine and ephedrine restrictions

Answer 31

Unlawful to sell more then 720mg of pseudoephedrine or 180mg of ephedrine at any one time without a prescription
Unlawful to sell any pseudoephedrine product at the same time as an ephedrine product without a prescription
Sales or supplies should either be made by the pharmacist or by pharmacy staff who have been trained and are competent