Журнал "Ремедиум " за 2008 год
Remedium digest #7 ( July)
Remedium digest #7 ( July)
Main topic of Remedium in July is reformation of pharmaceutical and medical education. The authors of the article are very famous and authoritative people - Mikhail Paltsev, president of I.M. Sechenovs’ Medical Academy, Head of Board of Medical and Pharmaceutical University Association, Professor, Member of Russian Academy of Sciences, Russian Academy of Medical Sciences and Ivan Krasnyuk I.M. Sechenovs’ Medical Academy pharmaceutical faculty dean. The article deals with problems of development and reformation of medical and pharmaceutical higher and post graduate education.
Higher medical education is rather popular so for last several years the amount of pharmaceutical faculties in Russia doubled.
Universities faced a very difficult mission to change all education processes according to new market needs. Which are
- Increasing amount of drugs
- Drugstore displacement to consulting work
- More availability of innovative and complicated drugs
Medical education should be reformed according to common strategy of education reform but it is needed to safe academic autonomy to develop continual system of professional and post graduate education and to strengthen material and technical (including clinical) bases of medical universities.
Main changes in Russian pharmaceutical education
The article “Quality of drugs advertising – methods of assessment” in column “Requirements and consumption” deals with practical application of methods of drugs advertising assessment. The author of the article, professor of Kursk State Medical University, Natalia Dremova made estimation of OTC drugs advertising according to 2 characteristics – design and informative depth.
Design determines advertising effectiveness as one of the way of sales promotion and maximization of sales volume, second characteristic – informative depth is a guarantee of consumer authoritative informing about advertised drugs features. List of criteria (for example: reference to the case of recovery, fullness of informative and advertising blocks and manufacturers details, presence of product picture e t.c.) for advertising quality assessment was formed according to these two ways.
Each criteria was assigned particular amount of points from 1 to 3 where 3 balls means that criteria perfectly fits to quality of advertising enforcements, 2 balls means that criteria has slight modifications from applicable requirements and 1 ball means that criteria is out of keeping with applicable requirements.
Nevertheless, the author notes that despite such detailed analysis the assessment of printed advertising characteristics is rather subjective that’s why after that consumer survey was made.
On the other hand characteristics of informative depth and perceptual efficiency must be estimated by real experts that’s why the list of criteria could be different according to the aims of survey.
Final estimation of advertising booklet, by subjective characteristics and data got from consumer survey, will be determined as average ball over all examined respondents. Competence of each specialist should be considered while analysis of all assessments. The final estimation of analyzed booklet will be determined as “ weighted average” estimation with a glance to competence.
Booklets of 46 products was taken to the survey: 10 local manufacturers and 35 international manufacturers and 1 booklet of Russian-French joint venture.
As a result no booklet got maximum amount of balls (99), average assessment of booklets was about 60-80 balls, so it means that manufacturers tries to make booklets which will comply with market requirements.
Here are some results of the analysis.
· The trade name of the product was repeated from 2 to 7 times
· Almost all booklets have a picture of the product but do not have any information about storage conditions
· Advertising message contains motives of health, confidence, energy and activity and mostly addressed to wide circle of consumers without any segmentation
· In third part of booklets necessity of reading using direction was mentioned as safety measures and only 10 booklets from 100 contain information about contra indications
Analysis of booklet regularity shows that all of them fits Russia law.
· In 30% of booklets approvals/ presumptions of consumer illnesses are greeted
· Only in 75% of booklets consumer won’t have an impression that advertised drug must be taken by healthy person
· In 60% of booklets make an impression that doctors advice is not needed
So the biggest part of manufacturers whose drugs was taken for the survey pay great attention for promotion of their products and consider their duty to inform consumers and to help them to make right and informed choice of drugs.
OTC drugs advertising culture is in the beginning of formation. Due to methods of assessment of drugs advertising quality can assist to organize this work on another more high level and will be useful for doctors, pharmacists and consumers.
World wide experience of pharmacist engaging into the process of gathering information about drugs side effects is described in article “Pharmacist assistance in pharmacovigilance system and in drugs safety monitoring” published in column “Management in healthcare sector”
In USA pharmacists are main link in system of collection information about drugs side effects. 40% of messages in Netherlands and 20% in Great Britain are made by pharmacists so the role of pharmacists in pharmacovigilance systems of these countries is rather big. At the same time in Finland, Sweden, Denmark, Island and Estonia pharmacists are not involved in national pharmacovigilance systems. Not long ago (since January, 1, 2005) Norwegian pharmacists were invited to collect information on a voluntary basis.
According to WHO survey in 1999 pharmacists in Indonesia, Vietnam, Oman, Czech Republic, Rumania and Slovakia are not allowed to collect information about drugs side effects. Main argument against it is that pharmacists of those countries doesn’t have sufficient clinical background. At the same time knowledge and background of doctors about drugs can be challenged because of little attention paid to these subjects in education programs of Medical Universities. That’s why today it is very important for pharmacovigilance to provide cooperation of pharmacists and doctors in which they can add each other, that will allow them to share their experience and knowledge of rational and safety use of drugs.
In Russia was included into WHO International drugs monitoring program. Russian Federal Centre of Drugs Safety Monitoring was invited for active collaboration and was provided with International WHO database of drugs side effects. All these facts allow to create system of drugs safety monitoring corresponded with international rules and as a result to solve a problem of safety of registered drugs more successfully.
In column “Industry” you can read an article prepared by Remedium observer Svetlana Romanova “Steps for success: dynamics of manufacturers ratings 2007”. The analysis of ratings’ dynamics was made according to the data of state statistical reporting and volume and dynamics of drugs production indexes.
The most successful 2007 was for “Pharmstandart-Leksredstva”, except QII it was on the 1 place in ranking and at year end was also on the first place (Table1). Share of drugs manufacturing by industrial groups increased from 35,49% in QI to 42,36% in QIII and ate year end 2007 was 40, 73. ( Table 2, 3) Pharmstandart showed steady growth of drugs manufacturing share from 8,55% in QI to 13,2 in QIII and its’ average index is 11,8%.
In comparison with previous year share of industrial groups increased only 0, 04 points. Analysis showed that all industrial groups increased ( the most sufficient Pharmstandart – 4,13 points) except Microgen.
Dynamics of Top 10 of manufacturers by indexes of output you can see below (Table 3) В 2007
Column «CIS Pharm markets» in July deals with Kazakhstan. Besides description of main tendencies of market development of this country you’ll find interview with very famous in Kazakhstan pharmacist, the author of more than 80 original researches, professor Galina Pavelkovskaya. Mrs. Pavelkovskaya expressed her opinion on Kazakhstan’s pharmaceutical sector development and suggests ways of solving main problems of the sector.
She suppose that it’s impossible to talk about changes in pharmaceutical sector and its’ development without help from the government. International companies activity in Kazakhstan demonstrates that local manufacturers forced to work in very rough competitive frames. Government must control all pharmaceutical sector and in case it is needed must stay main decision maker and financial leverage.
In order to increase competitive capabilities of local manufacturers government should give them strong support like preferences and privileges. Also it is needed to improve professional education quality, to enlarge the list of pharmaceutical occupations, to reduce the terms for drug registration and especially for re-registration, to facilitate charge and the procedure all kind of expertise, to lessen all administrative barriers for import/export of raw and supporting materials and goods. Local manufacturers should develop their own primary and supporting materials production.