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Retail medicine supply (to patients)

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Some terms

• POM = prescription-only• NP = “OTC” • Wrong term! American and European meanings:

– Europe: NP medicines– USA: anything sold in the pharmacy without

prescription

• Is there a counter? Also „under the counter”?

• GSL = General Sales List: NP that can be sold not only in pharmacies (if such exists)

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The first issue: PHARMACIESand other places for retail

medicine supply

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In your opinion: how old are the „pharmacies”?

i.e. establishments where drugs are compounded/sold

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„Medicines” were already compounded also in the

Prehistoric Age

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Pharmacies - traditions

Pharmacy in ancient China

Pharmacy in ancient Egypt

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Pharmacies – traditions 2

Pharmacy in ancient Babylon

ancient Arabic pharmacy

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Pharmacy traditions 3

Pharmacy in ancient Greece

Galen

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Pharmacy traditions 4

Avicenna

(ibn Sina?)

Persian? Middle East Asian?

Pharmacy in a medieval European Monastry

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Pharmacy traditions 4

Pharmacy in the 18th Century USA

Late 19th Century

pharmacy laboratory

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Contemporary pharmacies

Drugs to patients

• Retail drug sales– Community pharmacies– Some specialised/ordinary shops

• Hospital pharmacy

• By medical doctors (is at called also „pharmacy”?)

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Retail drug selling - various models

„Ethical model”• Pharmacy is mostly a health-care

institution, different from „shops”• Mostly medicines sold• Pharmacists run the pharmacy, mostly

they are the owners• Profession overcomes profit-orientation

(no „owner-investors” who take away the profit)

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Retail drug selling - various models

„Business-oriented model”

• (or liberal model): pharmacy is one of the specialised shops (drug-store)

• Any product sold that makes profit cosmetics, some food, but also cakes and whisky in the USA…

• some „OTCs” sold also outside pharmacies

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„OTC” retail selling - various models

From

• “any drug is pharmacy only”

through

• GSL (shops, fuel stations, department stores)

to

• distant/Internet sellings

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Drugs sold not only in Drugs sold not only in pharmacies: GSLpharmacies: GSL

• In the recent Member States of the EU, it is possible, e.g. in

• B, DK, GE, GR, IR, NL, UK (phyto products: +AT, PO!), CZ, PL, SVN, SW…

• also in Hungary

• Norway…

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Self-service pharmacy for NP Self-service pharmacy for NP drugsdrugs

DK, FI, SW, UK (GR only a few products, NL under discussion)

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Internet-, TV-, distant sellingInternet-, TV-, distant selling

• DK, FI, GE, UK, NL, also in Hungary (from pharmacies only)

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Owner of pharmacy not only Owner of pharmacy not only pharmacistpharmacist

In these countries chain pharmacies also possible

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Magistral drug Magistral drug compounding in compounding in

pharmaciespharmacies

• Not available in many EU Member States

• The meaning of “pharmacy” (Canadian example)

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Other provisions, easy to misunderstand

Austria 7741 inhabitants/pharmacy• but 1086 community pharmacies plus

1009 „drug-seller physicians”!the Netherlandes 10.000 inhab./pharmacy• but 1600 community pharmacies plus

4190 “drugstores”, among them 430 „outlets” in common shops (also at groceries)

Russia – the translation of „pharmacist”

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Thus...

…when discussing retail pharmacy affairs, be careful to identify what “pharmacy” and “pharmacist” mean in the given country!

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What is a pharmacy? 1

What kind of goods sold?• Mostly drugs, no open shelves• Mostly drugs, also self-service from open

shelves (to pharmacist or to the cassier)• Boots in the UK (many cosmetics, also a

“pharmacy” inside• USA: every kinds of goods + open shelves +

window for prescriptions• Canada: department-store “pharmacy”

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What is a pharmacy? 2

Is a pharmacist needed in it?• even the owner must be• at least one pharmacist is available all time• pharmacist director, not all time• physician-handled pharmacy, too• pharmacy technician for OTCs• satellites, outlets at normal shops• OTCs at fuel stations, etc.

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What is a pharmacy?

Is there „magistral” drug production on the spot?

• yes, both acc. to physicians’ individual prescripitons and „official formulae” – individual prescriptions

• no, only ready drug products (manufactured in factories) sold

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The core of the issue

• Is the community pharmacy a health-care institution or a shop?

• ex factory price + margins - Governments want to decrease consumer prices by avoiding pharmacists’ services plus drug price competition among drug retailers

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Establishment of a new Establishment of a new pharmacypharmacy

• Private - State-owned?

• No limitation (competition driven) or even distribution (WHO! Remote areas, islands, per inhabitants, distance between)

• Magistral compounding? injection in post-Soviet pharmacies vs. factories, dialysis solutions

Magistral injections?

• As a rule, industrial level manufacture gives higher assurance

• In some post-Soviet countries: the pharmacies had better corcumstances!

• Otherwise, simple dosage-forms are compounded in pharmacies

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Story: preparation of solutions for dialysis

Preparation – mean survival time of dialysed patients

• In a Central Asian post-Soviet country (in 1995): in a bath-tube, with a paddle

• Hungary 20 years ago: in hospital pharmacies

• Hungary nowadays: dialysis centres (GMP-level manufacture)

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3 years

6-7 years

10+ years

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Authorisation of a new Authorisation of a new pharmacypharmacy

• Should it be authorised? (WHO requirement…)

• By whom?

• Any conditions (e.g. personnel requirements, facilities, equipment)?

Authorisation of a retail pharmacy

• No authorisation?

• Ministry of Health?

• Local Governments (municipality)?

• Other?

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Any limitation of new retail pharmacy establishment?

• Absolutely free (new pharmacy in the same building)?

• Area limitation? (e.g. one pharmacy per square kilometer, given number per village, etc.)

• Inhabitant limitation? (e.g. 5.000 inhabitants to each pharmacy)

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Premises-equipment requirements?

• None?

• Minimum area (square meters)?

• List of equipments (applicable when there is magistral compounding)

• If any, where and by whom is it specified? MoH Decree, oether?

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Inspection of pharmaciesInspection of pharmacies

• Is it available? By whom? Ministry, local health authority, consumer protection…

• Inspection of drugs sold outside the pharmacies?

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Pharmacies on dutyPharmacies on duty??(E.g. during night, on holidays)

• Regulated? By whom? Who (if any) appoints on-duty pharmacies and sets the time-frames for operation?

• Or regulated „by the business”?

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The second issue:The second issue:the PHARMACISTthe PHARMACIST

What is his/her role?What is his/her role?

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The evolving role of a pharmacist (WHO) 1

• Physician: prescribes medicines

• Nurse: administers medicines

• Pharmacist?

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The evolving role of a pharmacist (WHO) 2

The role of the Pharmacist?Expert of medicines!• how the medication should be used• interaction with other (e.g. OTC)

products• maximise benefits and minimise

Adverse Drug Reactions

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The evolving role of a pharmacist (WHO) 3

The role of the Pharmacist? cont’d

• How to use medicines in the most effective and appropriate manner

• NP e.g. pain relief – advising patients

• how to use an asthma inhaler

• how to store medicines at home

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The evolving role of a pharmacist (WHO) 4

The role of the Pharmacist? cont’d

• what foods to avoid during this medication

• what to do if a dose is missed• compounding, preparing, dispensing

medicines• Evolving role – roboting in

dispensing

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Information provided

• Is there any mandatory/advised information the pharmacist must/should provide when selling drugs?

• Two misconcepts: - „natural” = safe - „non-prescription” („OTC”) = no adverse

effect like other commodities

The evolving role of a pharmacist (WHO) 5

• Pharmaceutical care– Blood sugar measurement– Blood pressure measurement– Etc.

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Special issue: complementer/alterna-tive/tr

aditional medicine• Is it recognised?

• Traditional medicine pharmacies or mixed ones or only traditional healers?

• Homeopathic pharmacies?

Hospital pharmacies

Hospital

• What is hospital? Is there a legal definition?– any that has in-patient facilities?– minimum number of beds?– named wards (e.g. internal disease,

surgery…)

• Public, private, both?

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Different hospitals may exist…

Mayo Clinic in the USA

Hospital in Africa

Hospital in Bangladesh

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Physicians, treatments…Physicians, treatments…

acupuncture in Asia

Consulting and treatment in

Malaysia

Chief physician in former Soviet Central

Asia

Doctor in Europe

Hospital pharmacy

• Is there a definiton?– E.g. establishment to serve in-patients in

hospital wards

• Mandatory in every hospital?• If not, what is the requirement? (E.g. No of

beds, town/regional hospitals, etc.)• May existing hospital pharmacies serve

other hospitals?• Instead, community pharmacies serve

hospitals?

Establishment of a hospital pharmacy

• Is there an authorisation system, or it is the decision of the hospital administrator?

• If authorisation• by whom?• Are there criteria for the facilities and

personnel?• Is there any rule where could it be placed

within the hospital (e.g. not in the cellar)

Hospital pharmacy categories

Are there different categories? E.g.• only distributing registered medicines• also magistral preparations• also compounding sterile parenterals• Also mixed infusions (citostatic?)• unit dose distribution• clinical pharmacy• also working as a community pharmacy

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These are the issues you should identify first when

going home or target country and starting the

practice!

Exam topic!

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Retail drug supply

• The meaning of retail drug supply• Prescription and supply categories• Retail drug selling models• Pharmacy as health-care institution or a „shop”• Establishment of a new community pharmacy – possibilities• Magistral (in-pharmacy) compounding• Products a pharmacy may sell• Inspection of pharmacies• The roles of a pharmacist• (In all cases detail the situation in your country!)

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Hospital pharmacies

• Definition: hospital, hospital pharmacy

• Different organisation of drug supply of hospital patients

• Establishmentof a hospital pharmacy

• Possible categories of a hospital pharmacy