Compounding Pharmacy

Code:

MI075177

Acronym:

FARMAG

Keywords
Classification	Keyword
OFICIAL	Technological Sciences

Instance: 2019/2020 - 2S

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	20	Official Curriculum	4	-	3	52	81

Teaching language

Portuguese

Objectives

To provide students with a thorough knowledge on the technical, scientific and regulatory aspects related to Compounding, in order to provide them the necessary professional skills on compounding and dispensing compounded medicines in community pharmacy and hospital pharmacy.

Learning outcomes and competences

Learning outcomes: 

In the end, the student should:

1) master the technical, scientific and regulatory aspects inherent to compounded medicines;

2) to properly compound sterile and nonsterile compounded medicines, in their different dosage forms, adopting in every situation the appropriate technical procedures to ensure obtaining medicines with quality, safety and efficacy, in compliance with the applicable regulatory requirements;

3) to properly dispense compounded medicines, taking into account the nature of the products and the pathophysiological profile of the patients.

Skills:

In the end, the student should have developed professional skills on Compounding, namely on the preparation and dispensing compounded medicines in community pharmacy and hospital pharmacy.

Working method

Presencial

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

The syllabus of the Curricular Unit was designed on the assumption that students have knowledge on Anatomy, Histology, Physiology, Biochemistry, Pharmaceutical Chemistry, 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 and the United Sates Pharmacopoeia. 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 / Study Visits: 2 x 50 minutes / week.

In addition to the established schedules for classes, the 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	50,00
Trabalho de campo	50,00
Total:	100,00

Amount of time allocated to each course unit

designation	Time (hours)
Estudo autónomo	40,00
Frequência das aulas	45,00
Trabalho de campo	15,00
Total:	100,00

Eligibility for exams

The attendance to the theoretical and practical / laboratory classes is a prerequisite for obtaining frequency and, therefore, for the admission of the students to the final exam of the Unit.

According to the FFUP Assessment Standards, the student fulfills the attendance requirements if the number of absences to theoretical and practical classes not exceed 25% of scheduled classes.

Calculation formula of final grade

COMPONENTS OF THE EVALUATION:

- DISTRIBUTED COMPONENT (0-20) – valued on the basis of the works presented by students along the term (50%);

- FINAL EXAM (0-20) – written exam that focuses on all matters actually taught in lectures and practical classes along the term (50%).

 

FINAL SCORE CALCULATION (0-20):

Final Exam score x 0.5 + Distributed Component score x 0.5

 

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

Students with a score less than 9.5 are considered failed.

Special assessment (TE, DA, ...)

In accordance to the FFUP Assessment Standards and the applicable legislation.

Classification improvement

In accordance to the FFUP Assessment Standards.

Observations

Given the scientific and also professional character intended for this Curricular Unit, 1/3 of the classes are held at the Pharmacy of the Hospital de São João, aiming to promote the contact of students with the professional reality and allow the realization of practical work in real conditions, namely compounding cytotoxic substances, eye drops, intravitreal injectables, parenteral nutrition, pediatric medicines, etc.