Study-Unit Description

Study-Unit Description


CODE PHR3604

 
TITLE Product Safety, Pharmaceutical Law and Ethics

 
LEVEL 03 - Years 2, 3, 4 in Modular Undergraduate Course

 
ECTS CREDITS 8

 
DEPARTMENT Pharmacy

 
DESCRIPTION PRODUCT SAFETY:
- Product safety design and assessment
- Types and sources of toxic materials
- Toxicology testing
- Hazard and risk assessment
- Relationship between formulation and toxicity
- Dose-toxicity relationship
- Pre-clinical drug safety evaluation
- In vitro and in vivo techniques in drug safety assessment and clinical trials: monitoring, adjustment and summarization
- Post-marketing safety evaluation: monitoring, assessing and reporting adverse drug responses
- Qualification of impurities, degradants, residual solvents and leachables

PHARMACEUTICAL LAW:
- History and development of law: overview and objectives, current changes, role of law, sources of law
- Standards and the need for them: Policy, legislation and regulation
- Responsibility and liability
- Deregulation and self- regulation in industry
- The local and international scenario: overview and objectives, the Medicines Act and Health Care Professionals act, 1st and 2nd wave markets, the EU, harmonization
- Manufacture and placing a product on the market: Rational use of medicines, Good Manufacturing Practice (GMP), Good Distribution Practice (GDP), Pharmacovigilance and post- marketing surveillance

ETHICS:
- Ethics, morals and values
- The relationship between ethics and law
- Professionalism and professional judgement
- Assistance and support to the pharmacist, inter and intra professional relationships, observation of quality and legal standards, responsibility and accountability
- Confidentiality and patient-centred systems

Study-unit Aims:

This study aims to describe all required attributes for product safety and to highlight the need and importance for it. Ethical and legal considerations are introduced.

Learning Outcomes:

1. Knowledge & Understanding:

By the end of the study-unit the student will be able to:
- Understand the importance of product and procedure safety.
- Appreciate ethical issues.
- List laws governing the pharmaceutical industry.
- Describe pharmacovigilance procedures.

2. Skills:

By the end of the study-unit the student will be able to:
- Work safely and ethically in different pharmacy scenarios.
- Liaise with colleagues, pharmacists and other personnel.
- Take decision making processes that support professional, ethical and legal frameworks.

Main Text/s and any supplementary readings:

- Dale JR, Appelbe GE. Pharmacy law and ethics. London: Pharmaceutical Press; 1989.
- Dukes G. The law and ethics of the pharmaceutical industry. Amsterdam: Elsevier; 2006.
- The Malta Medicines Act, 2003.
- Moini J. Law and ethics for pharmacy technicians. New York: Delmar Cengage Learning; 2010.

 
RULES/CONDITIONS Before TAKING THIS UNIT YOU MUST TAKE PHR2602

 
ADDITIONAL NOTES Pre-Requisite Study-units: PHR1606, PHR1607, PHR2606, PHR2607

 
STUDY-UNIT TYPE Lecture

 
METHOD OF ASSESSMENT
Assessment Component/s Assessment Due Resit Availability Weighting
Online Examination (3 Hours) SEM2 Yes 100%

 
LECTURER/S Lilian M. Azzopardi
Doris Baldacchino
Dianne Butler
Sandra Mifsud Bonnici

 
The University makes every effort to ensure that the published Courses Plans, Programmes of Study and Study-Unit information are complete and up-to-date at the time of publication. The University reserves the right to make changes in case errors are detected after publication.
The availability of optional units may be subject to timetabling constraints.
Units not attracting a sufficient number of registrations may be withdrawn without notice.
It should be noted that all the information in the description above applies to study-units available during the academic year 2020/1. It may be subject to change in subsequent years.

https://www.um.edu.mt/course/studyunit