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Drug Regulatory Affairs > Narcotic drugs > Flashcards

Narcotic drugs Flashcards

1
Q

what are the three main elements of international drug problem?

A

illiegal cultivation and production od drugs, traicking and smuggling of drugs
drug use, abuse and dependence

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2
Q

What are the united nations bodies?

A

United Nations Office on Drug and Crime (UNODC) with the commission on Narcotic Drugs( CND)
the international Narcotics Control Board (INCB)

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3
Q

what is the purpose of the chedules annexed list?

A

to control and limit the use of these drugs according to a classification of their therapeutic value, risk of abuse and health dangers
to minimize the diversion of precursor chemicals to illegal drug manufacturers

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4
Q

How are Narcotic drugs callsified?

A

the signle convention on Narcotic drugs of 1961

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5
Q

which other susbtances are being controlled by the UN system

A

the convention on Psychotrpic substances of 1971

the convention against llicit traffic in Narcotic Drugs and Psychotropic substances of 1988

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6
Q

what is the single convention limits exclusively to?

A

to medical and scientific purposes the production, manufacture, export, import, distribution of trade in, use of possession of drugs

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7
Q

what is the Yellow list?

A

List of Narcotic Drugs under international control), which classifies narcotic drugs in four schedules

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8
Q

What does Schedules 1 contain and examples?

A

Harmfulness: Substnaces with addictive properties, presenting a serious risk of abuse

Degree of control: Very strict, they are all subject to all measures of control application to drugs under this convention

examples: Cannabis and its derivatives, cocaine, heroin, morphine

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9
Q

What does Schedules 2 contain and examples?

A

Harmfulness: Substnaces normally used for medical purpose and given the lowest risk of abuse

Degree of control: less strict

examples: Codeine, propiram

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10
Q

What does Schedules 3 contain and examples?

A

Harmfulness: preparations of substances listed in Schedules II, as well as preparations of cocaine

Degree of control: Leninet: according to the WHO, theses preparations prsent no risk of abuse

examples: preparations of codeine, propiram

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11
Q

What does Schedules 4 contain and examples?

A

Harmfulness: the most dangerous substances, already listed in S1, which are particulary harmful and of extremely limited medial or therapeutic value

Degree of control: Very strict, leading to a complete an on the production, manufacture, export and import of, trade in, possession or use of any such drug expect for amounts which may be necessary for medica and scientific research

examples: Cannabis and cannabis resin heroin,

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12
Q

EMCDDA stands for?

A

European Monitoring Centre for Drugs and Drug Addiction

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13
Q

responsibility of the EMCDDA?

A

to provide:
1. factual overview of European drug problems
2. solid factual basis to support the drug debate
3. policymakers with the data for developing sound drug laws and policies
to help professionals and practitioners identofying best practices and new areas of research

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14
Q

the EU legislation is?

A

limied to Eu Regulation that define classes of precursors

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15
Q

what does the EU legislation doesn’t do?

A

it does not establish different classes of narcotic or psychotropic substances

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16
Q

on what does the EU commissio make a proposal for he control measures of a new psychoactive substances (NPS)

A

following early warning and risk assessment

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17
Q

what are new psychoactive substances (NPS)

A

these are drugs that are not controlled under the UN drug control convention but which may pose similar threats to health

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18
Q

examples of NPS

A

synthetic cannabionids
opiods
stimulants and hallucinogens

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19
Q

how is systhetci cannabionids monitored?

A

in Europe by the European Monitoring Centre for Drugs and Drug Addiction through the EU Early Warning System

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20
Q

what does the early warning system does?

A

allows EU to rapidly identify and react to public health threats cased by new substances (3-steps legal framework)

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21
Q

The EMCDDA is responsible for the first two steps which are?

A

operating an early warning system togetehr with europol and conduction risk assessments

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22
Q

what are the four statutory basis of the Narcotic drugs Act?

A
  1. The prescription of narcotic drugs by physicians, dentist and veterinarians (Nacrotic Drugs Prescription Ordinance)

the domestic trade in narcotics (ordinance on the domestic Trade in Narcotic Drugs

The foreign trade in narcotics (Ordinance concerning the foreign Trade in Narcotics)

the cost and fees chargeable for the various official acts performed by the BfArm for the purpose of monitoring he licit trade and traffic in narcoitcs

23
Q

what does the narctotoc drugs legislation includes?

A

precursor monitoring Act

24
Q

whats’s the aim of precursor monitoring Act ?

A

aims to prevent and prosecute absive diversion and use of so-called precusors for the purpose of liilcit manufacture of narcotics

25
Q

precursor monitoring Act is to ensure?

A

to ensure medically necessary supply of the population with narcotics

to preclude, the abuse of narcotic drugs and the development and maintenance of a narcotics addiction

26
Q

which substances are defined in the Narcotic drugs Act?

A

substances and preparations listed in Schedules I to III of the act

27
Q

on what is the inclusion of the substances based on?

A

scientifally justified, based on its mode of action, potential to used dependence, possibility of producing narcotics from it

28
Q

Defintions of the Narcotics Drugs according to the NDA?

A

Drug which have been listed exhaustively in the three schedues of the NDA, as well as preparations, molecular compounds, isomers, ester, ethers and salts of the listed susbtances as specified in the schedules of the NDA

29
Q

what deso exempt preparation means?

A

a preparation listed in Annexes I to III which is exempted in whole or in part , from the legislation govering narcotic drugs

30
Q

Schedules to the NDA (I)

A

includes “ non-marketable norcotics”. These are illicit narcotics without current evidence based medical benefit

31
Q

Schedules to the NDA (II)

A

includes “licit narcotic drugs, but not available as such on special prescription

32
Q

Schedules to the NDA (III)

A

marketable narcotic drugs available on special prescription, prescribed by physiciens, dental (opium, morphine)

33
Q

what are opoids?

A

inlcudes compounds extracted from the poppy seed as well as semisythetic and synthetic compounds with similar priperties

34
Q

Federal opium agency is respsonsible for?

A

Control of legal trade in narcotic drugs

35
Q

out of what does the narcotic prescription consists?

A

a triple set of dcouments
Part 1: for the pharym to keep (least sheet of the prescription
Part 2: is intened for the pharmacy for settlement–> first sheet of the prescription
Part 3: remains with the prescriver–>middle sheet of the prescription

36
Q

what is printed on the prescription?

A

an individual nine-digit prescription number

37
Q

what is the majo psychactive consituent in cannabis?

A

Delta-9tetrahydrocannabinol (THC)

38
Q

compounds which are structurally similar to THC are referred to as?

A

cannabionoids

39
Q

cannabis is?

A

a generic term used to denote the several psychoactive preparations of the plant cannabis sativa

40
Q

what is the regulatory framework at the international level?

A

the used of cannabis is limited to schientific and medical purpose

41
Q

what does the national agency do?

A

they have to report to the international Narcotics contril board (INCB) on

  1. quantities of cannabis that are used for medical purposes
  2. on the number of patients who are treated using cannabis-based medicines
42
Q

what is the ragulation on national level?

A

medical use of cannabis and other controlled drugs may invlove monitoring the behaviour of prescribers ans patients

43
Q

why should the behavious of the prescribers and patient be monitored?

A

to ensure that cannabis-based medcines are apropriately prescribed
that thay are not diverted to non-medical use or absuded by patients

44
Q

what is the responsibility of the authorities of cannabis at EU level?

A

ensures consistent regulation of pharmaceuticals across the EU

45
Q

MA of the cannabis is done through?

A

CP DP and MRP

46
Q

what is the responsibility of the authorities of cannabis at national level?

A

license use of a medicinal product based on European requirements for MA

47
Q

what was added to the Cannabis as medicine act in 2017?

A

they created a mcechnim for quality-controlled cannabis supply, including domestic production

48
Q

what are the points describe in the Cannabi as Medicine Act

A

Patients can get medical prescription for dried cannabis flowers and extracts of standarddiesed quality, if other treatment options are exhausted

prescription ofr any life-threatening illness, affect the patients quality of life permanenetly

49
Q

what is the maximum amount of cannabis per mouth

A

100 g per month of cannabis in the form of dried flowers

50
Q

why was cannabis agenecy was et up?

A

to establish domestic production and to enure that cannabis preparations supplied are of standardised quality

51
Q

can cannabis drug be prescribt withot a formal MA?

A

yes, primarily through compassionte or exceptional use programmes, where the prescription is done by a licensed medical practitioner an approval by pharmaceutical regulator for the patient

52
Q

are Cannabidiol considered as narcotic drug under the EU level?

A

no, they can be qualified as food, provided that the other conditions of the EU ffod saftey regulations are also met

53
Q

How are low THC products regulated ?

A

some countries state that a product cotaining less than 0.3 % or 0.2 % THC is not controoled uder drug laws

Drug Regulatory Affairs (15 decks)

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