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Flashcards in Sale and Supply 1 Deck (31):

Responsible pharmacist legislation

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


RP requirements

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


Absence of the RP

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


Activities during absence of RP

Sale of GSL medication and the assembly process


Activities if no RP has taken charge of a pharmacy

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


How do medicines reach the pharmacy?

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


Problems with the supply chain

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


Falsified medicines

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


Falsified vs counterfeit medicines

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


Vulnerabilities in the supply chain

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


Illicit medicines examples

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


EU directive on falsified medicines for human use

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


New safety measures- safety features of medicines

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


New safety measures- supply chain and good distribution practice

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


New safety measures- active substances and ingredients

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


New safety measures- internet sales

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


Other measures adopted by manufacturers

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


Classification of medicines

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


General Sales Medicines

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


P-only medicines

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


P medicines

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


Self selection of P meds by patients

The self selection of P medicines is prohibited


GSL and P meds in hospital

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


Meds liable to misuse

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


GSL meds liable to misuse

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


P meds liable to misuse

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


Pseudoephedrine and ephedrine

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


Pseudoephedrine and ephedrine restrictions

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


Signs of misuse

Nervous or guilty behaviour
Lack of symptoms
Rehearsed answers
Impatient or aggressive
Specific products


P meds requiring consultation

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


Pseudoephedrine and ephedrine restrictions

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