Utrecht University MSc-student Aradhana Kohli starts this month at GIMS for her MSc-theses. In preparation for her research project she made a summary of the two BSc-theses which where conducted in 2015 year at GIMS.
Summary BSc-theses 2016
Based on this research there are large differences found in regulations and legislation, prescription and delivery, availability and access to medicines among the countries studied. Factors such as education, war, government, culture and religion and economic state of a country have a significant impact on both regulating and monitoring these rules. The level of passive awareness among the healthcare specialists was high for nearly all the studied critical dynamics for all the countries. However the level of active awareness (in a way that one sees, or participates actively in, progress) was low in especially low and middle income countries.
This study didn’t provide hard outcomes, but can certainly provide a basis for a follow-up study in the field of global medication safety. Especially firstly in the analysis of the obstructions for increasing the active awareness of healthcare professionals.
Medicines are by their nature always ‘poisons’ as they can influence (drastically) the fysiology of an organism.
So let’s turn around the general idea that medicines can have negative side effects and correct it into;
only by carefull prescription and use the patient can benefit from the positive side effects of potential ‘poisons’.
That’s why at GIMS we use this back side on our business cards.
In the ever intensifying discussions about the cost of new, and very expensive (oncology) drugs, a widely heared argument from industry is that they are ‘obliged’ to their shareholders to perform financially this well. Otherwise they would not be able to attract investors and therefor their output of innovative medicines will be endangered.
An interesting development is that there is building up more pressure from big investors, like pension funds and ‘society sensitive’ banks, to also consider the effects on society as a whole of the strict financial focus Big Pharma feels it has to oblige to.
Can activistic share holders alter the direction of the developments?
Then they might also take in consideration that ‘inviting’ or pushing , Big Pharma to take active co-responsibilty for the Medication Safety related issues is a desirable societal goal aswell. GIMS can help!
From the PGEU website:
‘Community pharmacists have been working in the development of processes and tools to ensure Patient Safety in community pharmacies, but it is important that both community pharmacists and health policy makers realise the synergies that can arise from integrating those processes in the Patient Safety path.
Moreover, community pharmacy practice is becoming patient centred and process oriented. Dispensing the appropriate medicine and providing the relevant information and care, to the right person, at the right time is central in the community pharmacist’s daily practice. All pharmacists’ daily activities are one way or another linked to Patient Safety. That is why it is not possible to identify single initiatives towards ensuring Patient Safety in community pharmacies without contextualizing them in the community pharmacy setting, the distribution chain and the continuum of care.
However, medication safety is certainly an area where pharmacists’ expertise are of vital importance.’
MSH (Managements Sciences for Health) published it’s MDS-3 , 2014, (Managing Access to Medicines and Health Technologies) in which clear statements are made about medication safety risks which are likely to exist in low- and middle income countries.
From summary chapter 35:
‘Poor product quality, adverse drug reactions and medication errors greatly influence health care systems by negatively affecting patient care and increasing costs. Most of the statistics documenting the issues and highlightening the importance of pharmacovigilance come from developed countries, therefor low- and middle income countries likely have greater problems because of the poorer state of their health system infrastructure, the unreliable supply and quality of medicines, the lack of adequately trained essential health care staff, and their limited access to communication and information technology.’
In co-production with Dr. Jennifer Sellin (Lecturer Dept. of International & European Law Faculty of Law, Maastricht University), an article is in preparation.
In this upcoming article a logical link will be made between the human right to Health, and therefor an access to medicines and hence ALSO to be able to use the medicines safely.
Big Pharma is an industry famous for ongoing excellent financial results and thereby loved by investors and analysts.
The Dutch business paper ‘Financiële Dagblad’ produced an article, by Thieu Vaessen on 8 February, which made quite clear how good the industry is doing:
Big Pharma: operational profit margin: 29,4%
Average on 300 international firms: operational profit margin 11,8%
GIMS wants to state: we all find it very logical that car manufacturers have invested for decennia heavely in the (direct) safety of their products, isn’t it then equilly logical if Big Pharma does the same for the (indirect) safety of their products??
Money can’t be the problem.
In cooperation with a pharmacy student from Utrecht University, Ms Aradhana Kohli, as part of her MSc-thesis, the following will be addressed in a more abstract way:
1) Create a blueprint for a (international applicable) screening and rating model of all structures, processes, actors, factors and the corresponding critical dynamics (Attitude, Knowledge, Tools) between them, concerning Medication Safety in a country.
2) Use the designed screening and rating model on the Dutch situation and evaluate the screening model.
3) Use the results from the Dutch screening for advice on the desired follow up in The Netherlands.
The research project starts in April 2016 and will take six months.
When it comes down to getting a better insight in all the actors and factors within a nation, having an influence on the theme of Medication Safety for an individual patient/consumer, a picture is helpfull.
GIMS created this one:
Alfa actors: health care practioners (doctors, pharmacists, nurses) and retail.
Beta actors: professional organisations of HCP’s, national health care institues (like NICE for the UK), health care software providers, pharmaceutical retail formulas, pharmaceutical wholesale, pharmacovigilance organisations.
Gamma actors: national medicines regulatory bodies, national inspectorate, ministeries of health, academia, patient & consumer organisations, pharmaceutical industry, insurance bodies and/or companies, international bodies like WHO, EMA, EFPIA, PGEU, Cochrane.
Delta factors: national medicines and healthcare legislation, culture, religion, economics, politics, stability and prosperity of a society.
On the 7th of January GIMS was happy to perform a presentation in the section ‘Work in Progress’ at the WHO Winter Meeting of the WHO Collaborating Centre for Pharmaceutical Policy and Regulation in Utrecht, The Netherlands.
Interest from the audience was generated and new contacts were made.