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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
HOUSEKEEPING
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Download the Slides Questions No photography, audio, or video
recordings
Cell Phones
https://education.lp3network.com/WCC2018
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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
THANK YOU FOR LISTENING
QUESTIONS?
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