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Retail medicine supply (to patients). 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 ” ?
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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)
The first issue: PHARMACIESand other places for retail medicine supply
In your opinion: how old are the „pharmacies”? i.e. establishments where drugs are compounded/sold
„Medicines” were already compounded also in the Prehistoric Age
Pharmacies - traditions Pharmacy in ancient Egypt Pharmacy in ancient China
Pharmacies – traditions 2 ancient Arabic pharmacy Pharmacy in ancient Babylon
Pharmacy traditions 3 Galen Pharmacy in ancient Greece
Pharmacy traditions 4 Pharmacy in a medieval European Monastry Avicenna (ibn Sina?) Persian? Middle East Asian?
Pharmacy traditions 4 Late 19th Century pharmacy laboratory Pharmacy in the 18th Century USA
Drugs to patients • Retail drug sales • Community pharmacies • Some specialised/ordinary shops • Hospital pharmacy • By medical doctors (is at called also „pharmacy”?)
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)
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
„OTC” retail selling - various models From • “any drug is pharmacy only” through • GSL (shops, fuel stations, department stores) to • distant/Internet sellings
Drugs sold not only in pharmacies: 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…
Self-service pharmacy for NP drugs DK, FI, SW, UK (GR only a few products, NL under discussion)
Internet-, TV-, distant selling • DK, FI, GE, UK, NL, also in Hungary (from pharmacies only)
Owner of pharmacy not only pharmacist In these countries chain pharmacies also possible
Magistral drug compounding in pharmacies • Not available in many EU Member States • The meaning of “pharmacy”(Canadian example)
Other provisions, easy to misunderstand Austria 7741 inhabitants/pharmacy • but 1086 community pharmacies plus 1009 „drug-seller physicians”! the Netherlandes 10.000inhab./pharmacy • but 1600 community pharmacies plus 4190 “drugstores”, among them 430 „outlets” in common shops (also at groceries) Russia – the translation of „pharmacist”
Thus... …when discussing retail pharmacy affairs, be careful to identify what “pharmacy” and “pharmacist” mean in the given country!
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”
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.
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
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
Establishment of a new pharmacy • 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
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) 3 years 6-7 years 10+ years
Authorisation of a new pharmacy • 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?
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)
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?
Inspection of pharmacies • Is it available? By whom? Ministry, local health authority, consumer protection… • Inspection of drugs sold outside the pharmacies?
Pharmacies 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”?
The evolving role of a pharmacist (WHO) 1 • Physician: prescribes medicines • Nurse: administers medicines • Pharmacist?
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
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
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
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.
Special issue: complementer/alterna-tive/traditional medicine • Is it recognised? • Traditional medicine pharmacies or mixed ones or only traditional healers? • Homeopathic 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?
Different hospitals may exist… Hospital in Africa Mayo Clinic in the USA Hospital in Bangladesh 46
Physicians, treatments… Doctor in Europe Consulting and treatment in Malaysia acupuncture in Asia Chief physician in former Soviet Central Asia 47
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