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EMERGING MARKETS PANEL: COMPOUNDING AROUND THE WORLD

BRAZIL – UNITED ARAB EMIRATES - GERMANY

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Vanessa Pinheiro, BS Pharm, MSc, RPh – Noha Shalaby, BPharm – Franziska Scharpf, MPharm

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DISCLAIMER

DISCLAIMER: The information contained in this program, which may include treatment modalities,

diagnostic and therapeutic information, and instructions related to regulatory guidelines and current

standards of practice for pharmacy compounding, is FOR EDUCATIONAL PURPOSES ONLY and should not

be taken as a treatment regimen, product indication, suggested treatment modality, or suggested

standard of practice. NOTE TO MEDICAL OR ALLIED HEALTH PROFESSIONAL: Any treatments, therapies, or

standards of practice must be fully investigated and prescribed by a duly licensed medical practitioner in

accordance with accepted professional standards and compendia. Any regulatory or practice standard

must be fully investigated by a licensed pharmacist in accordance with accepted professional practice

standards and compendia.

VANESSA PINHEIRO, BS Pharm, MSc, RPh

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• Compounding pharmacist with over 19 years of experience

• Pharmacist consultant for MEDISCA Network’s TSS department

• Specialty training in non-sterile compounding, pharmaceutical technology, cosmetology, and veterinary compounding.

• Surveyor and Standard Committee member, Brazil’s National Association of Pharmaceutical Masters

• Received a Master’s degree in Science, University of São Paulo• Former Professor, College of Pharmacy at the University of Suprema

in Brazil.

NOHA SHALABY, BSPharm

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• Compounding pharmacist with over 7 years experience compounding in the Middle East Region.

• First licensed compounding pharmacist in the UAE.

• Certified in all compounding areas, including:• Aseptic compounding• Non-Sterile compounding• Hazardous drug compounding

FRANZISKA SCHARPF, MPharm

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• Compounding pharmacist with 13 years of experience

• Masters degree in Pharmacy from Kingston University in London

• Member of the Bavarian Chamber of Pharmacists

• Owner of the Apotheke Scharpf in Sonthofen Germany

• Provides compounding services in many niche areas, including:• Pain management• Hormone replacement therapy• Geriatric care• Pediatric care

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BRAZILCompounding Landscape

HISTORY

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Brazil is a vast country with a total surface area of 8.5 million Km2, covering 47% of South America. It is the fifth most populous country in the world, with a population estimated at more than 208 million in 2018. The country is divided into 5 regions encompassing 26 states, 1 Federal District (Brasília), and 5570 cities.

North – 3.2%

Northeast – 11.6%

South – 20.4%

Midwest - 8%

Southeast – 56.8%

COMPOUNDING HISTORY

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Since the mid-1980s, 3 factors have guided the growth of pharmaceutical compounding in Brazil:

• Lack of medication supply due to a new economic strategy (Cruzado economic plan).

• The growth of a health issue, the body cult, which created a demand for compounded preparations.

• An increase in the number of possibilities for compounding activities because more active ingredients were free from the patent obstacle.

COMPOUNDING HISTORY

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The amount of new compounding-only stores in Brazil has grown exponentially and continues to do so. This growth provides a new

professional perspective to those who graduate from pharmacy schools.

COMPOUNDING INDUSTRY – DATA SUMMARY

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There are 7,545

compounding

pharmacies in

Brazil.

An increase of 8.8% in

the number of

compounding

pharmacies from 2014

to April 2018.

5,995 are the

headquarters -

growth of 5.1% from

2014 to April 2018

1,550 are second

locations - growth

of 25.8% from

2014 to April 2018

67.7% of

companies

have up to 20

employees.

Panorama 2018 – Socioeconomic data from Brazilian Compounding Pharmacies - Anfarmag

COMPOUNDING INDUSTRY – DATA SUMMARY

13Panorama 2018 – Socioeconomic data from Brazilian Compounding Pharmacies - Anfarmag

Annual revenue of

$1.5 billion USD in

2017

The average age of

the compounding

pharmacies is 14

years and 7 months

An average of 7.2

employees per

compounding

pharmacy

53,986 jobs

and there was an

increase of 0.6%

from 2014 to 2017

WHO REGULATES COMPOUNDING IN BRAZIL?

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Health Department

ANVISA - National Health Surveillance Agency

2000: Approved the first Technical Regulation about the Good Compounding Practices

(RDC 33/2000)

WHO REGULATES COMPOUNDING IN BRAZIL?

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In 2007 – A new Technical Regulation about Good CompoundingPractices was approved by ANVISA (RDC 67/2007).\

The compounding pharmacies have been classified in 6 (six) groups of activities since then:

GROUP OF ACTIVITIES

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Groups Activity/Origin of compounded ingredients Regulations to meet

Group I Compounded preparations with ingredients/raw material, including those of vegetal origin.

Technical Regulation and Annex I

Group II Compounding of narrow therapeutic index substances Technical Regulation and Annex I and II

Group III Compounding of antibiotics, hormones, cytostatics, and controlled substances

Technical Regulation and Annex I and III

Group IV Sterile product compounding Technical Regulation and Annex I and IV

Group V Compounding of homeopathic substances Technical Regulation and Annex I (when applicable) and V

Group VI Unit dose forms repackaging and the repackage of unit dosages for health services (hospitals)

Technical Regulation and Annex I and IV (when applicable) and VI

ALLOWABLE COMPOUNDING

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In Brazil, compounding pharmacies are allowed to dispensecompounded medications that are commercially available, but everyformula should be dispensed according to a prescription.

Each prescription must contain at least:

• composition;

• dosage form;

• dosage frequency and the route of administration.

REQUIRED LAYOUT

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Dispensing Room

Equilíbrio Compounding Pharmacy – São Paulo

REQUIRED LAYOUT

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Compounding Room

Equilíbrio Compounding Pharmacy – São Paulo

REQUIRED LAYOUT

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Quality Control Lab

Equilíbrio Compounding Pharmacy – São Paulo

REGULATORY ISSUES

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Pharmacies should have dedicated compounding rooms with an anteroomto compound any of the three following therapeutic classes:

Hormones;

Antibiotics;

Cytostatics.

These compounding rooms should have negative pressure and must bedesigned to prevent the emission of particles to the lab or to theenvironment, for personnel and environmental protection, and to avoidcross contamination.

REGULATORY ISSUES

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Compounding Rooms

Equilíbrio Compounding Pharmacy – São Paulo

CONCLUDING REMARKS

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This was a brief presentation about compounding market in Brazil.

Each country’s regulatory agency imposes restrictions specific to that country, andunderstanding these obstacles are a universal problem that allows compoundingpharmacists to see they are not alone in their struggles.

As a Brazilian pharmacist, I can see the pride and commitment of compoundingpharmacists in Brazil in their efforts to enable recovery and ensure good health of theirpatients through the art of compounding.

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UNITED ARAB EMIRATESCompounding Landscape

THE STORY REVEALED

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1 2 3

THE BEGINNING

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THE CHALLENGES THE MILESTONES

ACHIEVED

2018 & BEYOND

THE BEGINNIG

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Responsibility

Value

Planning

THE CHALLENGES ALONG THE WAY

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HC

Authorities

Collaboration

Physicians

Acceptance

Patients’

Education

Qualified Personnel

THE MILESTONES ACHIEVED

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Achieving Good Compounding Practice

Expanded Physicians Base

Superior Counselling Programs

Pharmacy Profession Enhancement

2018 & BEYOND

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• BHRT

• Pain Management

• Vitamin Drips

Popular Niche Markets

• Topical & Transdermal

• Capsules

• IV Infusions

Main Dosage Forms

• Anti – Aging

• Aesthetics

• Pain ManagementCurrent Trends

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GERMANYCompounding Landscape

PHARMACY IN GERMANY

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• 20,023 community pharmacies (year 2016) provide medication to the population

• Freedom of establishment• Anywhere, anytime, complies with the law (e.g. operating rooms

min. 110m²)

• Owner/Operator of a pharmacy must always be a pharmacist

• No Pharmacy Chains

• Selling pharmaceuticals via mail order

• Prices for Prescription-only drugs are uniform nationwide• Fixed fee per package

PHARMACY HISTORY

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• Compounding History• Since 1240

• Friedrich II von Hohenstaufen split medicinal activity and pharmaceutical activity

• Pharmacopeia Germanica• Editio I, 1872 (Pharm. Germ. Edit. I = DAB1

COMPOUNDING TODAY

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7.4

2.6 2.4

1.1

0

1

2

3

4

5

6

7

8

2015

Formulations

Standard formulations Methadone preparations Cytostatic preparations Individually prepared parenteral solutionsin millions

COMPOUNDING TODAY

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136

8276

140

0

20

40

60

80

100

120

140

160

2016

Standard Formulations by Age Groups

Children (<15 years) Youth (15-19 years) Adults (20-64 years) Seniors (>65 years)

Number per 1000 SHI insured

COMPOUNDING REQUIREMENTS

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• Regulatory• Medicines Act

• Pharmacopoea & DAC/NRF• Pharmaceutical rules for manufacturing and inspection

• Pharmacies Rules and Regulations• Equipment • Quality assurance

• Raw materials & Primary Packaging

• Compounding (individual, bulk)

• Pricing

• Personal• Pharmacist• Pharmacy technician

EQUIPMENT

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• The Pharmacy has to be equipped to compound the following dosage forms:

• Solutions, Emulsions, Suspensions• Ointment, Cremes, Gele, Pastes• Capsules, Powders• Mixtures of Phytotherapeutics (e.g. Teas)• Suppositories, Ovules• Sterile products (except parenterals)• Water for injection• Equipment and Test-Kit for quality assurance of raw materials and compounded produtcs

QUALITY ASSURANCE

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Raw Materials

Supply Source

Entrance Test

Documentation

Storage

QUALITY ASSURANCE

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Formulations

Plausability

Manufacturing instructions

Manufacturing

BUD

Labeling

Inspection & release

COMPOUNDING MARKETS IN GERMANY

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• CFS 1200• Liquid incapsulation

• Quantos• Pure api

• Ursatec• Conservative free

• Fluidextrakte

• Spagyrik

• Homöopathic

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