Transcript DMosoiu_reglamentatoin

Description of the current
system of drug control in
Romania
Prof. Daniela Mosoiu, MD, PhD
Hospice Casa Sperantei
Brasov, Romania
Background for new regulations
2001 the work on the new law begun with
international meeting
constant tehnichal support through PPSG
(Policy Pain Study Group)
Support from experts from Spain and France
through Twining Convention
New regulations
– Law No. 339 Nov 2005 regarding the legal
framework for narcotic and psychotropic
plants, substances
– Application norms: published in the
Official Monitor No. 18 on 11th Jan 2007
– The instructions No 103/1970 regarding
implementation of Law No.73/1969 were
nullified when the new regulations were
adopted
New dispositions
The control of the use and stocks of opiods
medication in the responsabiliy of the
Health Ministry instead of Police
The patients did not requiere anymore to be
individually authorised in order to receive
opioid treatment
The pharmacies did not required anymore
authorization for dispensing opioids
Challenges regarding prescription
National authorities – to maintain strict
control and evidence
Health professionals – less restrictions
regarding prescription, especially on
opioids
Patients – better access for adequate pain
treatment
Prescription of opioid medication
(Tabel II)
– Who can prescribe?
– What can be prescribed?
– Prescription validity
– Prescription form
– Who can deposit opioid medication?
– Patient holding opioid medication
Prescription of opioid medication
(Tabel II)
– Who can prescribe?
– All authorized physicians
– Art.32. – (1) Medical prescription for narcotic and psychotropic
substancies can be be done, for ambulatory treatment, by any licensed
physicians, with medical purpose, to any patient, regardless of his/her
illness, if the physician considers ithe necesary as medical treatement
(2) Responsibility for appreciation of eligibility of patints in need for
taking this kind of medication and the appropriate prescription, belongs totally to
the physician who prescribes.
Prescription of opioid medication
(Tabel II)
– What can be prescribed?
– Maximum 3 substances
pharmaceutical forms on one
prescription
Art.37. – (1) One prescription can include maximum 3 substacies, or
just one medicine with maximum 3 pharmaceutical formulas, and
only the quantity necessary for 30 days.
Prescription validity
– Art.36 – (3) Prescription for
medications containing substances
from Table II […] must be presented at
the pharmacy site in no more than 10
days from prescription, and the one
containing substances from Table III
[…] in no more than 30 days.
Prescription form
Prescription form
– “When is necessary, for the same patient, to
prescribe medications from different lists and/or
medication which contain substances which are
not controlled by these norms, the form for the
most rigorous controlled substance should be
used”
– “Physician can release a new prescription within 30
days, for the same patient, if there are changes in
the health status of the patient during the treatment
that require the change of dose or medication or
because of the exhaust of the prescribed dose.
– Prescription are fill-in integral and readable
– Any change, but not more than 2 changes, must be
confirmed with signature and stamp. Changes can
be made only if the prescription remains readable.
Prescription form
• “The prescription forms can be obtained from directions
[authorities] of county public health, respectively from
Direction [Authority] of Public Health from Bucharest.
• The evidence of physicians who are prescribing is kept by the
authorities which distribute the prescription forms
Prescription form
– Medical prescription for narcotics and
psychotropic drugs it is released in 4 copies, one
for the patient, one for pharmacy and, if the case,
one for House of Health Insurance; one copy
remains in the prescription form book of the
physician who prescribed.
– In the medication is charged, the copy for Health
Insurance House it is canceled and remains in the
prescription form book of the physician who
prescribed.
Prescription of opioids (Table II)
– Who can store opioid medication?
– Public and hospital pharmacies
– General practitioners offices
– Specialty offices (authorization art.
26)
Prescription of opioids (Table II)
– Who can posess opioid medication?
– The patient can have opioid medication
only if this was prescribed by a physician
– International travelers: “certificate for
being allowed to have narcotic and
psychotropic medication with
therapeutically purpose
Certificate for narcotics and psychotropics
for international travelers
• Physical persons from Romania who are under treatment
with medication from Table II and who want to travel
abroad, need to request from Public health Ministry a
certificate for having narcotic and psychotropic medication
with therapeutically purpose.
• The certificate is requested by the physician who is
prescribing or by the patient. There is request form with
medical prescription form as annex.
• The total quantity of the medication can be the necessary
one for entire travel but no longer than 30 days.
• For each drug a certificate is released, available for 30 days.
Prescription in inpatient units
– With their own pharmacy
– Without their own pharmacy
– Prescription with narcotics and psychotropics for
admitted patients it is available for 24 hours, in
– special cases for 72 hours
Emergency kits
• Can be held by human and veterinary medical offices, other
health human units, airplanes, ship and ambulances
• Can contain injection formulas of:
– Table II: Alfentanyle, Fentanyle, Hydromorphone, Morphinum, Remifentanyle,
Sufentanyle
– Table III: Clonazepam, Diazepam, Fenobarbital, Midazolam, Pentazocina
Prescriber physician rights
• Recognition of professional competence
• Audit from public health professionals
• Different regulations for licit and illicit use
Narcotics evidence (Table II)
– Evidence of narcotic substances and medication
from table II is done by daily recording and
centralization in a special evidence register.
– The special evidence register is signed by
responsible person, daily.
– Obligation of recording belongs to all physical
and juridical persons who are authorized to have
activities with plants, substances and medication
from table II
– Art. 57 – Evidence of medication from table III can
be done alongside with concoction that don’t
contain substances from this table, using any
informational support, as long as information is
permanently readable and available for audit
Protection of narcotics
– Art. 59 – Plants, substances and medications from
table II […] must be preserved in closets with key,
without inscription, only for this special use.
– The access to this closet belongs to responsible
person or his/her replacer
– Protection of the forms: Any abstraction, loss or
accidentally destruction is immediately
announced by the physician to the public health
authority which released the forms.
Conclusions
Law according to European
recommendations and scientific
knowledge regarding the correct pain
treatment
Adequately training and information has
allow transition from previous modality of
prescription to the newest one