Environmental Impact of Medicines

Code:

MI155192

Acronym:

IAM

Keywords
Classification	Keyword
OFICIAL	Health Sciences

Instance: 2021/2022 - 1S

Active?	Yes
Responsible unit:	Toxicology 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	4	-	3	52	81

Teaching language

Portuguese

Objectives

The environmental impact of medicines represents a key area of pharmaceutical knowledge and practice, particularly in the following areas:

- In the preparation and evaluation of new market authorization dossiers.

- In the environmental impact of drugs and their metabolites as well as excipients and other pharmaceutical use products.

- In the collection and destruction of drugs out of use.

- In the treatment of wastewater contaminated pharmaceutical products.

The main objective of this curricular unit is to provide the students actual information from the theoretical, practical and regulatory point of view about the environmental impact of pharmaceutical drugs and other health sciences related products, as well as to develop processes to eliminate the inherent environmental risks.

Learning outcomes and competences

Students should be prepared to use the acquired knowledge in their practice as Pharmacists, Teachers and Researchers, particularly in the transmission of that knowledge to the community and to new professionals, in monitoring the separation and destruction of drugs and other health products, as well as the implementation of environmental impact assessments and/or interpretation of the respective results. In this last point, the acquired skills are of special relevance in evaluating reports of submission of marketing authorization of pharmaceutical products to national and international regulatory authorities.

Contribution of learning outcomes to the MICF objectives

Contribution to the Pharmaceutical Act:

b) Registration, manufacture and control of medicines for human and veterinary use and medical devices;
h) Information and consultation on medicines for human and veterinary use, medical devices, both on prescription and over-the-counter, for health professionals and patients, in order to promote their correct use;
i) Supervision, monitoring and control of the distribution, dispensing and use of human and veterinary medicines and medical devices
l) To perform, interpret and validate toxicological, hydrological and bromatological analyses;

 

Contribution to Table 2 of Directive 2005/36/EC

(c)    adequate knowledge of the metabolism and the effects of medicinal products and of the action of toxic substances, and of the use of medicinal products;

(d) adequate knowledge to evaluate scientific data concerning medicines in order to be able to supply appropriate information on the basis of this knowledge;

(e) adequate knowledge of the legal and other requirements associated with the pursuit of pharmacy.

 

Contribution to the skills defined in the document "FIP Global Competency Framework":

1.2 Health promotion  

1.2.2 Advise and provide services related to health promotion; disease prevention and control (e.g. vaccination); and healthy lifestyle 

1.2.3 Identify and support national and local health priorities and initiatives

 

1.3 Medicines information and advice  

1.3.1 Counsel the patient/population on the safe and rational use of medicines and devices (including the selection, use, contraindications, storage, and side effects of non-prescription and prescription medicines)

 

2.3 Dispensing

2.3.2 Accurately report defective or substandard medicines to the appropriate authorities 2.3.7 Label the medicines (with the required and appropriate information)

 

2.4 Medicines

2.4.1 Advise patients on proper storage conditions of the medicines and ensure that medicines are stored appropriately (e.g. humidity, temperature, expiry date, etc.)

3.6.5 Improve and manage the provision of pharmaceutical services .

Working method

Presencial

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

It is necessary to have chemical, pharmacological, biochemical, and microbiological knowledge acquired from the first to the fourth year of the course.

Program

Lectures

1. Definition of ecotoxicology and its applicability to pharmaceutical products.

2. Contamination and pollution.

3. Occurrence, fate and environmental impact of pharmaceutical products.
3.1. Environmental entrance paths for the different pharmaceutical products.
3.2 Environmental exposure to high quantities of pharmaceutical products.
3.3 Reasons for the environmental risk assessment of pharmaceutical products.
3.4 Factors to be taken into account in the environmental risk assessment.
3.5 Fate of pharmaceutical drugs in wastewater treatment plants (WWTP). 
3.6 Pharmaceutical residues in WWTP effluents.
3.7 Pharmaceutical residues in water and soil compartments. 3.8 Pharmaceutical compounds with predicted ecotoxicological effects.

4. Destruction of pharmaceutical products.
4.1 Landfills.
4.2 Encapsulation.
4.3 Inertization.
4.4 Vitrification.
4.5 Incineration.
4.6 Chemical and physical destruction.
7. Destruction of pharmaceutical drugs in WWTP.

5. EMEA guidelines for the environmental risk assessment of pharmaceutical drugs.

6. Hospital residues.


Practicals

1. Bezafibrate-induced peroxisome proliferation in mice liver.

2. Inhibition of synaptosomal sodium-potassium ATPase by aluminum.

3. Monitoring fresh water quality with Daphnia magna.

4. Cholinesterase inhibition by environmental pollutants

5. Use of Ames test to evaluate the mutagenicity of environmental samples.

Mandatory literature

Daughton Christian G. 340; Pharmaceuticals and personal care products in the environment. ISBN: 0-8412-3739-5
Kummerer Klaus ed.; Pharmaceuticals in the environment: sources, fate, effects and risks. ISBN: 3-540-41067-8

Teaching methods and learning activities

a) Presentation of the program in the first lecture. Lectures are ministered with help of visual support obtained from Powerpoint prepared data. Laboratory studies are meant to be a practical support for subjects learnt in lectures.

keywords

Natural sciences > Environmental science > Ecology > Ecotoxicology

Evaluation Type

Evaluation with final exam

Assessment Components

designation	Weight (%)
Exame	100,00
Total:	100,00

Amount of time allocated to each course unit

designation	Time (hours)
Estudo autónomo	29,00
Frequência das aulas	26,00
Trabalho laboratorial	26,00
Total:	81,00

Eligibility for exams

Student attendance to the laboratorial classes is mandatory. Those students whose attendance is lower than 3/4 of the classes effectively taught are considered as without attendance, as long as these classes represent more than 50% of the classes predicted. - Attendance to Theoretical classes is not compulsory.

Calculation formula of final grade

The final exam is quoted to 20 values. The theoric component corresponds to 14 values, and the laboratorial component to 6 values.

Examinations or Special Assignments

Not applicable

Internship work/project

Not applicable

Special assessment (TE, DA, ...)

As defined in the evaluation rules of the FFUP.

Classification improvement

• At the time of appeal, it is only possible to improve the classification of the theoretical component, requiring registration in academic services for this purpose.

Observations

Mobility Students

In addition to students who can quickly develop Portuguese comprehension skills (namely Spanish and Italian), Mobility Students with fluency in English are accepted. The UC is taught in Portuguese, however, the teachers provide bibliography and support in English. In addition, the Mobility Students assessment processes can be, if requested, in English.

Changes arising from the Covid-19 Contingency Plan

Scenario of limitation in the capacity of rooms and laboratories for face-to-face classes

• Changes to “Objectives”, “Learning Outcomes and Skills” and “program”:




• Without substantial changes




• Changes to “Teaching methods and learning activities”:




• Theoretical classes will be in person, up to the capacity limit of the classroom, with synchronous videoconference, at the established times and using platforms such as Colibri-Zoom and Panopto for students who do not have access to the classroom;


• The laboratory classes take place in the laboratories, respecting 50% of the usual capacity, with the division of the class in even and odd shifts (indexing the shift to even and odd weeks of the year: https://calendar.center/pt/semana-par- or-odd /).




• The explanation classes of laboratory work will be pre-recorded on video and made available (prior to the respective laboratory classes) to students.








• Changes in “Type of Assessment”, “Assessment Component”, “Occupation Component”; Frequency Obtaining ”; “Formula for calculating the final classification” and “Classification Improvement”:




• Without substantial changes, however, some evaluation processes may take place at a distance

Scenario of all classes taking place at a distance

• Changes to “Objectives”, “Learning Outcomes and Skills” and “program”:




• Without changes. However, the absence of the laboratory component partially compromises the described objective of developing methodological skills and the learning result associated with the interpretation of protocols and experimental data




• Changes to “Teaching methods and learning activities”:




• Theoretical classes will be taught in synchronous videoconference, at the established times and using platforms such as Colibri-Zoom and Panopto;


• Laboratory classes are taught in synchronous sessions in which laboratory protocols are presented and discussed, as well as the expected experimental results.


• Collaborative work in the area of ​​risk communication in toxicology will be scheduled throughout the semester in synchronous sessions




• Changes in “Type of Assessment”, “Assessment Component”, “Occupation Component”; Frequency Obtaining ”; “Formula for calculating the final classification” and “Classification Improvement”:




• Without substantial changes, however, some evaluation processes must take place at a distance