E-DRUG: Berlin Declaration and Algerian pharmacovigilance
----------------------------------------------------------
This an abstract in English of the article published in the French
bulletin BIPmat volume 7, N°2, 2005 *.
1. Presentation of Berlin Declaration on Pharmacovigilance
The I.S.D.B Workshop describes the obstacles that hinder the good
functioning of pharmacovigilance in an international context, and
proposes some solutions in order to improve it (ISDB Workshop 31
October/1 November 2003) in part, and the author of the present
article try to implement the recommendations in his own country in
other part. This is a summary of Berlin Declaration:
The Pharmacovigilance obstacles:
- The competitive context: some medicines are launched on an
international scale by aggressive commercial practices, and so are the
'me too', which consequently increases the undesirable effects that had
not been detected during clinical trials, and often incites the
physician and the patient to forsake the old medicines, that are more
sure and less expensive (essential medicines).
- Non representativeness as a whole population: The patients on which
had been done the clinical trials before the medicine
commercialization are far from being representative of the population
taken as a whole (lacks of data about pregnancy, breast feeding, old
patients), whereas, once commercialized, the medicine is prescribed to
a larger and less selective population.
- Overestimated efficacy: The medicine advertisements as well as the
clinical trials overestimate the medicine efficacy and minimize the
risks, the data related to risks are generally underestimated.
- Absence of declarations: Besides the fact that the undesirable
effects declarations are not encouraged, the pharmaceutical industries
show almost any interest to make declarations to the public
pharmacovigilance, because it may hinder the promotion of their
medicines, and decrease the turnover. In the same way, the
representatives of the industry sometimes hesitate to transmit the
undesirable effects, because that could be detrimental to the firm
they work for, as well as for their wages that are fixed according to
the turnover they achieve by a medical visit. The patients who can
declare their own observations, especially in the case of chronic
and/or ambulatory treatments, are not associated to the undesirable
effects declaration system.
- Confidentiality of data: The undesirable effects data are not easily
accessible to the professionals of health as well as to the patients.
- Counterfeited and contaminated medicines: penetrates the market more
and more and cause a big number of undesirable effects and
inefficiency.
- Pre-eminence of the lucrative goal to the detriment of the public
health: Some illnesses and indications are created by the
pharmaceutical industry for commercial aims. Besides, Medicines
Agencies depend on more and more royalties paid by pharmaceutical
firms to register and to merchandise their medicines, these royalties
allow the agencies to be fewer tributaries of the public funds and the
tutelage of the ministry of health. That may considerably reduce the
experts objectivity.
- The pharmacovigilance budget: this one is not well identified in
the total budget of the Medicine Agency.
- Hospital fails: The autonomy of the patients under an ambulatory
treatment in replacement of the hospitable treatment (by anticancer
medicines, by heparin..), often causes an under declaration of
undesirable effects. In addition to the non-existence among the
professionals of health of an official responsible in
pharmacovigilance, consequently the secondary effects are often
neglected.
- Antagonistic functions: When the medicine agency assures two
functions as antagonistic as the concession of the marketing
authorization and the medicine withdrawal decision, it certainly fails
to its duties, because it can not decide of an immediate withdrawal of
a medicine after having given the commercializing agreement, that not
only reduces its credibility concerning the evaluation of the
medicinal security, but also causes conflicts with the manufacturer.
However, the multifunctional character of the Agency (medicinal
product control, medical devices, dietetics, blood labile components,
organs and tissues, cosmetics, inspection, pharmacovigilance and
medical devices survey establishments, etc.), the huge of these
responsibilities generates many uncontrolled conflicts of interests.
- Absence of post-commercialization studies: Is a big prejudice to the
medicine security, and an obstacle to the pharmacovigilance.
- Lack of training in Pharmacovigilance: Physicians notify only 3% to
5% of the undesirable effects they meet, this is due: to the lack of
training in pharmacovigilance, the bad monitoring of the patients,
doubts on causal agents, the lack of time, and they consider that the
notifications are not useful, they ignore the procedure or lack of
remuneration for their declarations or lack of time specified to
investigations, sometimes because of a non availability of the reports
formularies. Pharmacists are not trained to detect the pharmaceutical
signals especially in hospitals (i.e, how to detect which department
or physicians use medicines with elevated risks, either new or with
underestimated safety). Midwives are not associated to the undesirable
effects compilation as well as nurses who can play the role of
sentries and alert physicians in undesirable effect cases.
To improve the system of Pharmacovigilance:
The structures of pharmacovigilance must:
- benefit from a financial autonomy, a moral authority, and an
independence toward the agencies that deliver the marketing
authorization.
- encourage the undesirable effect declarations among practitioners
and patients.
- promote a register of the clinical trials to facilitate the
information compilation, and make them at the professionals of health
disposal.
- form the professionals of health to pharmacovigilance, and inform
patients on undesirable effects.
- institute transparency rules in the Good Practice of
Pharmacovigilance.
- create an international collaboration for a better undesirable
effect surveillance.
- make the actualized reports relative to pharmacovigilance at the
public disposal on a simple request. The clause of confidentiality
doesn't have any sense as it mainly aims at protecting the public
health.
- train in pharmacovigilance: medical students (to assess the
benefit-risk ratio and to avoid prescription mistakes), pharmacy
students (to analyze the prescription, to inform patients on
undesirable effects, how to recognize them, at to whom to address, and
how to create a good physician-pharmacist partnership before the
patient take his medicines), also train trainees midwives as well as
nurses.
- encourage the undesirable effects notification by all medical and
paramedical professionals by using declaration formularies available
on the Web. Pharmacists can report the adverse reactions due to a
self-medication or a polypharmacy consumption, and thus participate to
the adverse drug monitoring by analysing the prescribed medicines
before they are delivered and administered (to prevent risks of
mistakes before administration), they must also declare the
undesirable effects that occur after the medicine intake.
2. The Algerian pharmacovigilance and the Declaration of Berlin
Description of the Algerian context: The unfavourable context to
Pharmacovigilance exists in Europe as well as in Algeria, but some
important variants have to be pointed out. In Algeria, it is the
importers of medicines and medical devices which are the intermediates
between the pharmaceutical industry and the drugs market who
complicate the situation, for them the interest at stake is the fund
of a commercial transaction that they hope the most profitable.
Indeed, Algeria had decided since 1973 for a medicine purchase system
based on national needs identified by a group of experts by the
creation, by decree, of the ''Commission Nationale de Nomenclature''
(CNN) in 1980. The CNN played the role of an authorizing commission
delivering the marketing authorization until its fall into abeyance
after 1997. On the other hand, the CNN didn't really participate in
the setting up of a national medicines policy but only
commercialization. The abeyance of the CNN after 1997 provoked a
deregulation of the commercialization authorization. In parallel
direction, the Algerian legislator created, in 1998, the centre
national de pharmacovigilance et de matériovigilance (CNPM) to hoist
Algeria to the rank of the countries which had developed a protective
medicinal system by the surveillance of medicines and medical devices
put on his national market.
The CNPM, a public establishment endowed with a financial autonomy,
and independent from the registration authority, is quite adequate
with the Declaration of Berlin, long before the proclamation of this
one. The CNPM works in the international recommendations and with the
necessary transparency, as its deliberations are transmitted to the
health professionals by a bulletin, and communicated to the health
administration and the pharmaceutical industry. The works of its
commissions take place with no complaisance and with the insurance of
the non-existence of conflict of interest among its experts. In
Algeria, we separated between the commercialization authorization
(drug registration system) which is granted by the CNN, which has
three committees within which there is a pharmacovigilance one,
independant from the CNPM, this later undertakes specifically the
supervision during the post-marketing phase to detect any new or under
assessed undesirable effect at the time of the registration phase by
CNN.
The obstacles to the pharmacovigilance in Algeria :
Algeria which doesn't produce its medicines and import the big
majority of its medicinal consumption cannot be considered as those
nations where the medicine is an income source and a financial factor
of the national development. Regarding the difficulties met by the
CNPM, it is necessary to talk about some tentative for its
marginalization in taking decisions about its missions and its
competences (i.e, a delay of execution of withdrawals by
administrative authority). Besides, any of its demands formulated to
its tutelage, concerning its infrastructure development received
unfavourable response, in addition of the slowness to operate vital
nominations for the future of the institution.
Propositions to improve pharmacovigilance in Algeria
- The CNPM must attend to the independence of its decisions to prevent
the under assessed undesirable effects at the post marketing phase of
medicines assessment. Besides, the CNN as a national authority that
undertakes the evaluation and the registration of medicines at pre
marketing phase, CNN must be reactivated to avoid the drifts that not
only have some consequences on the population's health, but also on
the medicine repayment budget allocated by the social
security.
- The World Health Organization recommended in its last bulletin to
organize independent centres of Pharmacovigilance in every country to
assure the medicines safety. The current regulation system in Algeria,
return for some adjustments in its working, is even operational to
protect patients and population in general.
- Algeria that buys from abroad the 4/5 of its medicines need must not
increase the registration and the commercialization of me too that
causes sanitary security problems and increase the costs of
hospitalizations due to undesirable effects, in many cases without any
new benefit.
- Our country should focus on the evaluation cost-effectiveness and
benefits-risks ratios before the commercialization of medicines
through the reinforcement of the
CNN.
- to improve the adverse drug monitoring and the reporting
system during the period of post marketing by sustained work of the
CNPM, in order to avoid some health over costs due to
hospitalizations, and to prevent invalidities and deaths by
undesirable effects.
- to promote the rational use of medicines and struggle against the
therapeutic resources wasting; this activity is quite original in
pharmacovigilance (particularly in developing countries).
* Further informations :
HELALI Abdelkader, Professor and Director
Editor of BIPmat
Centre National de Pharmacovigilance et de Matériovigilance
B.P 247
Bab El Oued
16009. Algiers (Algeria)
"CNPM CNPM" <pharmacomateriovigilancedz@hotmail.com>