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

– “ 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.

“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 form

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 done by competent authorities

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