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Flashcards in Sale and Supply 1 Deck (31)
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1
Q

Responsible pharmacist legislation

A

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

2
Q

RP requirements

A

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

3
Q

Absence of the RP

A

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

4
Q

Activities during absence of RP

A

Sale of GSL medication and the assembly process

5
Q

Activities if no RP has taken charge of a pharmacy

A

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

6
Q

How do medicines reach the pharmacy?

A

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

7
Q

Problems with the supply chain

A

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

8
Q

Falsified medicines

A

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

9
Q

Falsified vs counterfeit medicines

A

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

10
Q

Vulnerabilities in the supply chain

A
False labelling of ingredients
Counterfeits sold to wholesalers
Adulterated raw materials
Adulteration by pharmacists
Toxic ingredients
11
Q

Illicit medicines examples

A

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

12
Q

EU directive on falsified medicines for human use

A

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

13
Q

New safety measures- safety features of medicines

A

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

14
Q

New safety measures- supply chain and good distribution practice

A

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

15
Q

New safety measures- active substances and ingredients

A

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

16
Q

New safety measures- internet sales

A

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

17
Q

Other measures adopted by manufacturers

A

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

18
Q

Classification of medicines

A

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

19
Q

General Sales Medicines

A

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

20
Q

P-only medicines

A

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

21
Q

P medicines

A

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

22
Q

Self selection of P meds by patients

A

The self selection of P medicines is prohibited

23
Q

GSL and P meds in hospital

A

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

24
Q

Meds liable to misuse

A

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

25
Q

GSL meds liable to misuse

A

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

26
Q

P meds liable to misuse

A

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

27
Q

Pseudoephedrine and ephedrine

A
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
28
Q

Pseudoephedrine and ephedrine restrictions

A

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

29
Q

Signs of misuse

A
Nervous or guilty behaviour
Lack of symptoms
Rehearsed answers
Impatient or aggressive
Opportunistic
Specific products
Paraphernalia
Quantities
Frequency
30
Q

P meds requiring consultation

A

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

31
Q

Pseudoephedrine and ephedrine restrictions

A

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