Compounding Pharmacy

Code:

MI075177

Acronym:

FARMAG

Keywords
Classification	Keyword
OFICIAL	Technological Sciences

Instance: 2016/2017 - 1S

Active?	Yes
Responsible unit:	Pharmaceutical Technology Laboratory
Course/CS Responsible:	MSc in Pharmaceutical Sciences

Cycles of Study/Courses

Acronym	No. of Students	Study Plan	Curricular Years	Credits UCN	Credits ECTS	Contact hours	Total Time
MICF	18	Official Curriculum	5	-	4	52	108

Teaching language

Portuguese

Objectives

Provide students with a thorough knowledge on the technical, scientific and regulatory aspects related to Compounded Medicines, in order to give them the necessary skills to perform well in professional preparation and dispensing of these medicines in community pharmacy and hospital pharmacy, including the adoption, in each concrete situation, of the appropriate technical procedures, to ensure the preparation of medicines with quality, safety and efficacy and in compliance with the regulatory requirements.

Learning outcomes and competences

Learning outcomes:
At the end of this course, students should master the technical, scientific and regulatory aspects related do Compounded Medicines.

Skills:
Appropriate skills to perform well in the different professional fields of this matter, namely in the formulation, preparation, quality control, storage, preservation and dispensing of compounded medicines, taking in every situation appropriate technical procedures to ensure obtaining medicines with quality, safety and efficacy and in compliance with the regulatory requirements.

 

Working method

Presencial

Pre-requirements (prior knowledge) and co-requirements (common knowledge)

The program of this subject has been organized under the assumption that students have knowledge of Anatomy, Histology, Physiology, Biochemistry, Microbiology, Pharmacology, Immunology, Pharmaceutical Technology, Biopharmacy and Pharmacokinetics, Pathophysiology and Pharmacotherapy.

Program

1)
Definitions and concepts in Pharmaceutical Compounding.
Current importance of compounded medicines in therapy. Reasons for preparing medicines on small scale at the community and hospital pharmacies.
Preparation of compounded medicines: part of the pharmaceutical practice. Roles and responsibilities of pharmacists.
Individualizing therapy: personalization of medicines composition and dosage form according to the pathophysiological profile of patients. Emerging areas for compounded medicines. Impact of Pharmacogenomics and Personalized Medicine.
Medical areas in which compounded medicines are more frequent.
Pharmaceutical Compounding and Pharmaceutical Care. Clinical Compounding: clinical dispensing compounded medications. Pharmacotherapeutic follow-up of patients.

2)
Bibliographic sources supporting the preparation and quality control of compounded medicines. Galenic formularies and their importance. The Portuguese Galenic Formularium (FGP) and the United Sates Pharmacopoeia (USP Pharmacists' Pharmacopeia). Monographs of compounded medicines, standards, recommendations, information.

3)
Compounding non-sterile and sterile medicines. Calculations. Pharmaceutical aspects related to small scale preparation of the different dosage forms.
Compounding cytotoxic medicines.
Compounding total and partial parenteral nutrition.
Pharmaceutical incompatibilities. Stability and beyond-use dates of compounded medicines.
Quality of raw materials, packaging materials and finished products.
Quality assurance. Quality manual. Standard operating procedures.
Packaging and labeling of compounded medicines.
Study of concrete formulas of compounded medications and discuss of related pharmacotherapeutic and pharmaceutical aspects.
Splitting and repackaging of industrialized medicines.

4)
Regulatory issues related to compounded medicines.
Practical aspects of the legislation applicable to compounded medicines: scope, Officinal Preparations (“Preparados Oficiais”) and Magistral Formulas (“Fórmulas Magistrais”), responsibilities of physicians and pharmacists, raw materials authorized, use of industrialized medicines, advance preparation of compounded medicines, hiring by hospitals to prepare compounded medications, supply of raw materials.
Good Compounding Practices in Community and Hospital Pharmacies: definitions and concepts, standards relating to personnel, facilities and equipment, documentation, raw materials, packaging materials, compounding, quality control, labeling.
Calculating the price of compounded medicines.
General system of State reimbursement of the price of compounded medicines.
Elimination of outdated raw materials.

 

Mandatory literature

Barbosa Carlos Maurício; Estudo comparativo de formulários galénicos. ISBN: 972-98579-3-8
Barbosa, C.M. (Coord.); Formulário Galénico Português, CETMED - ANF, 2001
Barbosa, C.M. (Coord.); Formulário Galénico Português, CETMED - ANF, 2005
Allen Loyd V.; The^art, science, and technology of pharmaceutical compounding
US Pharmacopeial Convention USP; USP Pharmacists' Pharmacopeia 2008-2009, USP UNITED STATES PHARMACOPEIAL CONV.
IJPC; International Journal of Pharmaceutical Compouding
Pinto, Susana; Desenvolvimento Galénico de um Veículo para a Preparação de Suspensões de Benzoato de Metronidazol, Faculdade de Farmácia da Univ. Porto, 2006
DR; Legislação aplicável
Soares, MA (Coord.); Medicamentos Não Prescritos - Aconselhamento Farmacêutico, Farm. Portuguesa, 2002 (Barbosa, C.M. "Aspectos Farmacêuticos da Terapêutica Dermatológica", Chap. 34)
Vários; Artigos científicos de carácter especializado (entregues pelo docente)

Complementary Bibliography

Trissel, L.A. ; Trissel’s Stability of Compounded Formulations, 5th Edition, American Pharmacists Association, 2012. ISBN: 9781582121673
Nahata, M.C.; and Pai, V.B.; Pediatric Drug Formulations, 6th Ed., Harvey Whitney Books, 2011. ISBN: 978-0-929375-32-8

Teaching methods and learning activities

Theoretical classes: 2 x 50 minutes / week.
Practical/Laboratory classes: 2 hours / week.
In addition to the established schedules for classes, professor is available to meet students at any time previously agreed.

keywords

Health sciences > Pharmacological sciences
Health sciences > Pharmacological sciences > Pharmacy
Technological sciences > Technology > Pharmaceutical technology
Technological sciences

Evaluation Type

Distributed evaluation with final exam

Assessment Components

designation	Weight (%)
Exame	70,00
Trabalho de campo	30,00
Total:	100,00

Amount of time allocated to each course unit

designation	Time (hours)
Estudo autónomo	45,00
Frequência das aulas	45,00
Trabalho de campo	10,00
Total:	100,00

Eligibility for exams

The attendance to the theoretical and practical/laboratory classes is a prerequisite for obtaining frequency.

Calculation formula of final grade

EVALUATION COMPONENTS:
- DISTRIBUTED COMPONENT is valued on the basis of works presented by students along the term, reaching a maximum score of 6 (0-6).
- FINAL EXAMINATION consists on a written exam that focuses on all matters actually taught in lectures and practical / laboratory classes along the term, reaching a maximum score of 14 (0-14).

FINAL SCORE (0-20)
Final score is calculated by the following way:
Final examination score (0-14) + Distributed Component score (0-6)

Students with a final score equal to or higher than 9.5 are considered approved.
Students with a final score lower than 9.5 are considered failed.

ORAL EXAMINATION:
Students who have obtained final score equal to or higher than 9.5 may voluntarily apply for an oral examination in order to improve their score on the subject.
Students should deliver the application in SGAE 48 hours after publication of the ratings.
Oral examination covers all materials actually taught in lectures and practical / laboratory classes along the term.
When an oral examination occurs, the final score is only dependent on the performance of the students on this examination.