Public health authorities regulate in the public interest to protect health, ensure patient access to safe medicines, stimulate innovation and encourage a competitive market.1 Pharmaceutical regulation supports various components of a national pharmaceutical policy, including research and development (through regulation of clinical trials and provision of scientific advice), authorisation of medicinal products, regulation of the supply chain (manufacturers, wholesale dealers and pharmacies), pharmacovigilance and the rational use of medicinal products (through information about medicinal products and the use of medicines). The tangible public health outcomes of these processes are access, availability and affordability of medicinal products which are of good quality, and safe and efficacious when used rationally.peer-reviewe

Flores, Gavril

Vella Bonanno, Patricia

OAR@UM

Issue 18  Summer 2012 Journal of the Malta College of Pharmacy Practice          29Enhancing the choice and use of medicines: An overview of the Medicines Authority’s strategy to empower patients and consumers and support healthcare professionals 1 Operations and regulatory affairs manager Medicines Authority, Gzira Email: gavril.ﬂores@gov.mt2 CEO Medicines Authority, Gzira Email: patricia.vella@gov.mtKey wordsInformation on medicinal products, choice and use of medicinal products, patient empowermentThe preamble of Directive 2001/83/EC stipulates that prescribers and pharmacists must have access to neutral, objective sources of information about products available on the market.2 The Pharmaceutical Forum (2007) presents ten core quality principles on information to patients on diseases and treatment options.  These are objective and unbiased information, evidence-based, reliable, accessible, relevant and appropriate, patient oriented, up to date, understandable, transparent, and consistent with statutory information.3 Coulter and Ellins (2007) argue that a number of patient focused quality interventions can be taken to engage patients in their own or their family’s individual care, including improving health literacy, clinical decision-making, self-care and patient safety.4One of the objectives of the Medicines Authority is to provide objective and unbiased information on medicinal products. This is done in a number of ways including the evaluation of the labelling on medicinal products, approval of the information on the patient information leaﬂet (PIL) and of the Summary of Product Characteristics (SPC) and the publication of the list of authorised medicines and the approved PIL and SPC on its website.  The Authority set a communications strategy and activities were planned.  The ﬁrst priority was to make information about medicines accessible to healthcare professionals and to patients and consumers.  In 2010-2011 a speciﬁc national set of initiatives entitled ‘Know Your Medicines’ which were mainly targeted at patients and consumers were carried out. The initiatives were aimed at informing patients and consumers about medicines thus supporting and empowering them to participate in decisions for the choice of their medicines and to use their medicines rationally. The initiatives were based on a need analysis carried out between September 2010 and January 2011.An analysis of public knowledge and use of medicinesA needs analysis was carried out with the aim of identifying the public’s knowledge about medicines, awareness on the medicines lifecycle, trust in medicines and awareness on choice and use of medicines. Two hundred telephone interviews were conducted over a period of ﬁve months, between September 2010 and January 2011.  A stratiﬁed sample of ﬁve hundred people was used based on gender, age and locality. Therefore the response rate was of 40%. The interviews were conducted 1Gavril Flores BA, CYM, MA2Patricia Vella Bonanno BPharm(Hons), MSc, PhDPublic health authorities regulate in the public interest to protect health, ensure patient access to safe medicines, stimulate innovation and encourage a competitive market.1  Pharmaceutical regulation supports various components of a national pharmaceutical policy, including research and development (through regulation of clinical trials and provision of scientiﬁc advice), authorisation of medicinal products, regulation of the supply chain (manufacturers, wholesale dealers and pharmacies), pharmacovigilance and  the rational use of medicinal products (through information about medicinal products and the use of medicines). The tangible public health outcomes of these processes are access, availability and affordability of medicinal products which are of good quality, and safe and efﬁcacious when used rationally.Educational aimss  4O FAMILIARISE WITH THE -EDICINES !UTHORITY STRATEGY TO EMPOWER PATIENTSs  4O PRESENT THE RESULTS OF THE -ALTESE PUBLICS KNOWLEDGE ON THE USE OF medicinesIssue 18  Summer 201230          Journal of the Malta College of Pharmacy Practicebetween 08.00am and 08.00pm to ensure that working participants are also reached.  The research showed that 66% of participants seek advice or information before taking non-prescription medicine for the ﬁrst time while 12% never seek advice or information. 91% of participants mostly trust the doctor as a source of information on medicines, whilst 5% mostly trust the pharmacist. A total of 58% of participants claim to seek information on non-prescription medicines from doctors, 29% from pharmacists and 6% from the internet.   Almost half of participants responded that they always read the package leaﬂet before taking a non-prescription medicine for the ﬁrst time, 14% frequently read the package leaﬂet, 22% read it sometimes and 14% never read the package leaﬂet mainly because the information is provided by the doctor or pharmacist.  Over 85% of participants do not know the difference between innovator and generic medicines.  71% of those who use the internet graded it as a ‘very good’ or ‘good’ source of information on medicines.  41% of respondents who use the internet said that the information which they get from the internet affects which treatment/medicine they buy. A small percentage (3%) of respondents said that they bought medicine over the internet, claiming wider selection, convenience and price as the main reasons for doing this, while 8% of respondents said that they are not concerned about the authenticity or safety of medicines available for sale on the internet.  With regards to storage of medicines, 75% of participants declared that they store medicines in humid places such as kitchens and bathrooms.Activities carried out as part of the communications strategy The results of the study were assessed to ensure that the information provided and the initiatives undertaken are in line with the needs of the general population. A National Initiative entitled ‘Know Your Medicines’ was launched in January 2011 to support healthcare professionals, patients and consumers on the choice and use of medicines. The initiatives included:1. The development of the Malta Medicines List (www.maltamedicineslist.com) as a source of information on all authorised medicines.  The list includes advance searching and ﬁltering functionalities and links to Summary of Product Characteristics and Package Leaﬂets.2. A speciﬁc webpage with targeted information for patients and consumers (www.knowyourmedicines.com).  Both websites will be integrated in a new website on medicines with enhanced features.3. Active participation in traditional media through articles, interviews and programs and the use of social online (e.g. Facebook) to reach different age groups.4. Two widely distributed information leaﬂets in Maltese and English languages. One of the leaﬂets has a question and answer format in line with the gaps identiﬁed through the needs analysis and another leaﬂet presented information on innovator and generic medicines and a section on falsiﬁed medicines. 5. Development of a Know Your Medicines Helpline.6. SMS and e-mail notiﬁcations for information related to safety and quality of medicines.7. Delivery of continuous professional development sessions for pharmacists organised by the Malta College of Pharmacy Practice and participation in sessions for pharmacists organised by the Malta Chamber of Pharmacists.8. Collaboration with other regulators and the Consumers Affairs Council to organise information sessions speciﬁcally targeted to consumers.9. Information meetings about legislation in collaboration with the Malta EU Action Steering Committee.10. Papers for local and international journals, including an article on the ﬁrst Seven Years of EU Pharmaceutical Legislation in Malta on the WHO Drug Information Journal.5Way forwardThe Medicines Authority will continue with the implementation of its communications strategy and the next step is the provision of targeted information based on the needs of speciﬁc stakeholders (healthcare professionals, patients and consumers and industry). A new website incorporating advanced features and with information targeted for different stakeholder groups will be launched in the following months. Moreover the initiatives taken to date will be evaluated. The Medicines Authority is grateful to all health care professionals and associations for their collaboration, particularly in reviewing and distributing the information material.  Feedback and recommendations for further development and for future communication and information initiatives is welcome. References1  European Commission. 2006. Better Regulation – Simpliﬁcation Explained. Luxembourg: Ofﬁce for Ofﬁcial Publications of the European Communities.   Available at: http://ec.europa.eu/governance/better_regulation/documents/brochure/br_brochure_en.pdf. Accessed 4th May  20122  Directive 2001/83/EC on the community code relating to medicinal products for human use as Amended by Directive 2004/27EC of the European Parliament and the Council of Europe, 31st March 2004.  Ofﬁcial Journal (L136) 30th April 2004.  3  Pharmaceutical Forum. 2007. Methodology for use of the Core quality principles of information to patients. Available at: http://ec.europa.eu/enterprise/sectors/healthcare/ﬁles/docs/itp_methodo_en.pdf. Accessed 4th May  2012.4  Pharmaceutical Forum. 2007. Methodology for use of the Core quality principles of information to patients. Available at: http://ec.europa.eu/enterprise/sectors/healthcare/ﬁles/docs/itp_methodo_en.pdf. Accessed 4th May  2012.5  Vella Bonanno, P. & Flores, G. (2011) Seven Years of EU Pharmaceutical Regulation in Malta. WHO Drug Information. Vol. 25, No. 4. Geneva.Key pointss  4HE -EDICINES !UTHORITY HAS A PUBLIC HEALTH REMIT TO PROVIDE OBJECTIVE AND UNBIASED information on medicinal products.s  ! TOTAL OF  OF PARTICIPANTS OF A STUDY CONDUCTED BY THE -EDICINES !UTHORITY SEEK advice or information before taking non-prescription medicine for the ﬁrst time while 12% never seek advice or information. Over 85% of participants do not know the difference between innovator and generic medicines.  Most participants use the internet as a source of information on medicines and 3% of respondents said that they bought medicine over the internet, claiming wider selection, convenience and price as the main reasons for doing this.  s  4HE -EDICINES !UTHORITY LAUNCHED THE @+NOW 9OUR -EDICINES )NITIATIVES TO EMPOWER patients and consumers and support healthcare professionals in the choice and use of medicines. 

Enhancing the choice and use of medicines : an overview of the Medicines Authority’s strategy to empower patients and consumers and support healthcare professionals

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Enhancing the choice and use of medicines : an overview of the Medicines Authority’s strategy to empower patients and consumers and support healthcare professionals

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