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An overview of Albanian Pharmacovigilance system and its harmonization with the European pharmacovigilance legislation

Citation: Hoxha M , Zappacosta B and Franco M - An overview of Albanian Pharmacovigilance system and its harmonization with the European pharmacovigilance legislation - Biomedicine & Prevention issues (2024) - vol. 1 - (249) - DOI:10.19252/0000000F9

Malvina Hoxha,¹ Bruno Zappacosta,² Massimo Franco³
¹ Department of Chemical-Toxicological and Pharmacological Evaluation of Drugs, Faculty of Pharmacy, Catholic University Our Lady of Good Counsel, Rruga Dritan Hoxha, Tirana, Albania
² Department of Biomedical Sciences, Faculty of Medicine, Catholic University Our Lady of Good Counsel, Tirana, Albania
³ Department of Pharmacy - Pharmaceutical Sciences, Faculty of Pharmacy, University of Bari Aldo Moro, Bari, Italy

Introduction

World Health Organization (WHO) has defined adverse drug reactions (ADRs) as “A response which is noxious and unintended, and which occurs at doses normally used in humans for the prophylaxis, diagnosis, or therapy of disease, or for the modification of physiological function”.¹

Reporting the real-time health concerns by filling the adverse drug reactions reporting form does not only help in detecting ADRs, but also in reducing the real time health problems related to therapy, such as disruptions of the therapy, reduction of costs, and can help in reducing morbidity. However, there are many challenges in monitoring ADRs.

The aim of the pharmacovigilance (PV) system is to increase the safety of medicines, and to improve the public health. In Albania the pharmacovigilance office is established at the Albanian National Agency of Drug Control and Medical Devices (AKBPM). Only in the recent years the pharmacovigilance sector has undergone some changes. The aim of this paper is to assess the current Albanian legislative framework on pharmacovigilance, defining its problems, and future challenges, which can contribute in harmonizing it with the European pharmacovigilance legislation.

Methodology

The current Albanian Pharmaceutical legislation on pharmacovigilance was compared to the Directive 2012/26/EU of the European Parliament and of the Council amending the Directive 2001/83/EC in regard to pharmacovigilance,² and to the Regulation EU No 520/2012 of 19 June 2012 on the performance of pharmacovigilance activities.³ In addition, a literature search was conducted in Pubmed and Scopus databases using as keywords “Adverse drug reactions” and “Albania” for all studies carried out in Albania reporting the adverse drug reactions among health professionals and patients. Only few studies were found, and all of them reported the limited knowledge and reporting of ADRs among health professionals and patients.^4,5,6 The official website of the AKPBM was also searched for potential data on either reported ADRs in the country in the last years, or confirmed ADRs. No data were found in regard. Only the ADR reporting form for both patients and health care professionals were found in the AKBPM official website.

Pharmacovigilance legal framework

In Albania the pharmaceutical legislation 105/2014 ʺFor Мedicinal Products and Pharmaceutical Service", chapter XI, article 57 defines the Pharmacovigilance sector in Albania.⁷ The only changes made to law no. 105/2014, occurred on December 2022. The article 57 point 1, states that the pharmacovigilance sector, a structure of the Albanian National Agency of Drug Control and Medical Devices, operates on the basis of a regulation of the system of pharmacovigilance in the Republic of Albania and is responsible for gathering information on the occurrence of drug risks to patients, or to public health. This information, in particular, refers to adverse effects in human beings, as a result of the use of drugs in accordance with the indications described in the marketing authorization or not, as well as a result of inappropriate exposure to medicines. Adverse effects are reported via the Adverse Effect Reporting Forms for Patients and Health Professionals".

In addition, the recent changes made to the law, established for the first time in Albania (December 2022) the time limits of reporting ADRs.⁸ Specifically, it was reported that: “Unexpected adverse effects must be reported within 24 hours from day zero, serious ADRs within 15 days from day zero, and adverse effects within 90 days from day zero”. The person qualified for pharmacovigilance must be a resident of the Republic of Albania, must have completed the studies in the field of medicine, pharmacy, or dentistry, and be specialized or have completed certified training for pharmacovigilance. It is responsible for the establishment and maintenance of the pharmacovigilance system.

Adverse event reporting system in Albania

Healthcare professionals (pharmacist, doctors, dentists, nurses, physiotherapist, clinicians), and patients can report the suspected ADRs to AKBPM by sending the information (ADRs reporting form) electronically, or handle it physically to AKBPM. Patient reports are a valuable resource in exploring the information in signal detection. Fig. 1 shows the ADR reporting form for patients, and Fig. 2 shows the ADR reporting form for healthcare professionals.

Figure 1. ADR reporting form for patients. (*) Obbligatory fields

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Figure 2. ADR Reporting form for Healthcare Professionals. (We have evidenced in red all the part that differ from the ADRs patients reporting form) (*) Obbligatory fields

full size image

Current issues and future challenges

Albania is an associate member of WHO-Uppsala Monitoring Centre since 2011, and as a full member since 2020.⁹

Despite the recent legislative changes on pharmacovigilance, there are still many aspects on the pharmacovigilance system to be changed, and harmonized with the EU Pharmacovigilance Legislation starting from the ADR reporting form, for both patients and health care professionals.

Many details are still missing in the ADR reporting form of patients, and health care professionals, such as data on the respective trimester of pregnancy (1^st, 2^nd, 3d trimester), date of last menstruation of the patient. Information whether the suspected drug was taken in the past, and if it has caused the same reaction, should also be reported. Data on whether the adverse effect is a result of the incorrect use of drug (dose error, or wrong route of administration, or drug overuse) should be reported. Information whether other drugs were used to treat the reported adverse effect should also be included.

In case the ADR reporting form is not completed by the patient, but from other persons, such as parents, data on the reporter should be added (given name, family name, address, signature). In case the suspected drug is prescribed by a doctor, information on the doctor (given name, family name, telephone, email, address) should also be added in ADR patient reporting form. Patients should also be asked if the doctor was informed on the suspected ADR, and the situation should be further assessed if the patients allow the pharmacovigilance experts to get in touch with their physicians.

In the ADR reporting form of the health care professionals in the patient’s detail section, the patient ethnic origin should also be included. It should also be indicated whether the adverse reaction derive as a result of interaction, abuse, professional exposure, overdose, misuse, therapeutic error. The concomitant use of other products, such as, food supplements is also a very important information that is missing. Patient’s diagnosis should also be included. The section reporting the “givem name and family name of the health professional” reporting the suspected ADR should be obligatory, other than optional.

The lack of a specific section in the AKBPM website to publish periodically all the confirmed ADRs, and to be reviewed by patients is also another issue of the Albanian pharmacovigilance system.

Conclusion

General public and health professionals in Albania are not aware on the way to report ADRs, and the importance of the real time report of ADRs for the public health. Few studies carried out in Albania assessing the ADR signalling among health professionals, or patients confirmed the lack of knowledge in regard.^4,5,6 Although activities are carried out by the AKBPM in different scientific events to inform health professionals on the pharmacovigilance system, specifically on ADRs, still more effort should be done. In Albania citizens should be massively informed through media, social media, and not only through scientific events on the importance and procedures of reporting the ADRs in real time manner.

However, creating a pharmacovigilance network, with pharmacovigilance representatives from each city in Albania will help in monitoring and collecting in time manner the suspected ADR reports.

In conclusion, ADRs of medical devices, phytotherapeutics, cosmetics, etc. should also be reported. Specific questionnaires should be developed in regard, and general public should be informed (patients and health care professionals) through public media on the way of reporting ADRs even though they may not be serious, or frequent.

In addition, it is important to inform both patients, and health care professionals either on the lack of legal implications for the reporters, or on the privacy of patients’ identity. Views and opinions expressed are however those of the authors only and do not necessarily reflect those of the European Union. Neither the European Union nor the granting authority can be held responsible for them.

Abbreviations

ADR: Adverse drug reaction

EU: European Union

WHO: World Health Organization

PV: Pharmacovigilance

AKBPM: National Agency of Drug Control and Medical Devices

Declarations section

Ethics approval and consent to participate

Not applicable

Consent for publication

Not applicable

Availability of data and material

Not applicable

Competing interests

The authors have no conflict of interest to declare

Authors' contributions

M.H. prepared the manuscript, M.F. and B.Z. revised the manuscript.

Acknowledgements

The authors would like to thank the Erasmus+ Programme of the EU for funding the Jean Monnet Module Project entitled “Harmonization of the Albanian Pharmaceutical Legislation with the European Pharmaceutical Directive”-PHARM-EU.

References

World Health Organization. International Drug Monitoring: The Role of National Centres. Geneva: World Health Organization; 1972. (Technical Report Series No. 498). [Google Scholar]
Directive 2012/26/EU. https://eur-lex.europa.eu/legal content/EN/TXT/?uri=celex%3A32012L0026
Regulation EU No 520/2012. https://eur-lex.europa.eu/eli/reg_impl/2012/520/oj
Shkreli R, Dhamo K, Haloçi E, Tabaku A. Knowledge, Attitude and Practice towards Pharmacovigilance and Reporting of Adverse Drug Reactions among Health Care Professionals in Albania: A Cross-Sectional Study. Pak J Pharm Sci. 2023 May;36(3):713-721. PMID: 37580918.
Hoxha M, Spahiu E, Spahiu M, Zappacosta B. Reporting of Adverse Drug Reactions by Dentists and Dental Patients in Albania. International Dental Journal. doi: 10.1016/j.identj.2023.08.005.
Mehmeti I, Nelaj E, Simaku A, Tomini E, Bino S. Knowledge, Practice and Approaches of Health Professionals to Adverse Events Following Immunization and Their Reporting in Albania. Heliyon. 2017; Volume 3, Issue 6 , e00331
Ministria e Shendetesise. https://shendetesia.gov.al/wp-content/uploads/2019/02/LIGJ-Nr.105-2014-PER-BARNAT-DHE-SHERBIMIN-FARMACEUTIK.pdf
Parlament. http://www.parlament.al:5000/Files/202212141125442686Kalendari%20i%20punimeve%20%2022%20n%C3%ABntor-%2023%20dhjetor%202022.pdf
Uppsala Monitoring Centre. https://uppsalareports.org/articles/who-programme-member-update-march-2021/