Overview of regulatory Framework

Question 1

Benzodiazepines

Answer 1

Psychoactive drugs
• Used for anxiety, insomnia, panic attacks
• Enhance the effect of neurotransmitter GABA
thus promoting calm

Question 2

medicinal plants

Answer 2

Valeriana officinalis
Piper methysticum
Cannabis sativa

Question 3

Valeriana officinalis

Answer 3

Roots are usually mainly used
• valerenic acid, sesquiterpenes and valepotriates
• Use for insomnia, nervous tension due to anxiety
• counter indications such as headache, dizziness,
mechanism of action similar to benzodiazepines;
however, instead of binding to the gamma subunit
like a benzodiazepine, it appears to bind to the beta subunit on the GABA-A receptor instead.

Question 4

Piper methysticum

Answer 4

• Kava kava
• natives prepared a mixture of the
plant's extract with water or coconut
milk (PIPER, 1998)
• lactones, kavalactones or
kavapirones
• enhanced ligand binding to gammaaminobutyric acid A (GABAA)
receptors

Question 5

Cannabis sativa

Answer 5

• Easily recognisable plant
• Was used initially as antimalarial and
anti rheumatic drug, aphrodisiac,
narcotic, treatment of both nausea
and headaches
• Cannabinoids
• The most psychoactive cannabinoid
in cannabis is Δ9-
tetrahydrocannabinol (THC)

Question 6

The world of Synthetic Cannabinoids
and Designer Drugs
• Designer Drugs
(analogs)
• Circumvent the
legislation by

Answer 6

twisting the tail on

the molecule

Question 7

Three legislations

Answer 7

Medicines Act
• Medicines Regulations
• Misuse of Drugs Act And Regulations

Question 8

The Medicines

Act 1981…

Answer 8

regulates medicines,
related products and
medical devices in New
Zealand. The Act ensures
that the medicines and products used
in New Zealand are safe and effective.

Question 9

Medicines Act sets out:

Answer 9

requirements for the approval, classification, manufacture, sale,
distribution, advertising, prescribing and dispensing of medicines
• licensing requirements for the medicines distribution chain, including
wholesalers and pharmacies
• requirements for the approval of related products
• post-market controls on medicines and medical devices

Question 10

What is a Medicine ?

Answer 10

• Any substance that is manufactured,
imported, sold or supplied wholly or principally
for administering to human beings for a
therapeutic purpose

Question 11

Therapeutic Purpose means

Answer 11

• treating or preventing disease
• A named substance may or may not be a
medicine

Question 12

“Herbal remedy” means

Answer 12

a medicine (not being or
containing a prescription medicine, or a restricted
medicine, or a pharmacy-only medicine) consisting of –
(a) Any substance produced by subjecting a plant to
drying, crushing or any other similar process; or
(b) A mixture comprising two or more such substances
only; or
(c) A mixture comprising one or more such substances
with water or ethyl alcohol or any inert substance

Question 13

What is a Controlled Drug ?

Answer 13

• A controlled drug means any substance
specified or described in the schedules of the
Misuse of Drugs Act
• A named substance is a controlled drug
whatever its purpose

Question 14

Schedules in the Medicines Legislation

Answer 14

• General Sales
• Pharmacy Only Pharmacist Only
• Prescription

Question 15

Medicines Act
and Medicines Regulations
Ensuring the……??
of medicines

Answer 15

• Safety
• Quality
• Efficacy

Question 16

Misuse of Drugs Act And Regulations

Ensuring there is:

Answer 16

• Penalty
• Control
• Security
• Recording
• Storage
• Gatekeeping

Question 17

MEDSAFE
Mission
•

Answer 17

• Medicines and Medical Devices Safety Authority

To enhance the Health of New Zealanders by
regulating Medicines and Medical Devices to maximise
safety and benefit

Question 18

MEDSAFE
Before Distribution:?
Acceptable Standards of:
•

Answer 18

• Evaluation

Safety
• Quality
• Efficacy
• Approval of Products

Question 19

After Distribution

Answer 19

• Compliance
• Surveillance
• Personnel
• Premises
• Practices
• Monitoring of the chain of distribution

Question 20

Opioids

Answer 20

• Substances that act on opioid receptors

* are primarily used for pain relief, including anesthesia

Question 21

Opioids 2TEMGESIC examples

Answer 21

Morphine -class B
Heroin- class A

Question 22

Morphine

Answer 22

cause sleep
• The primary source of morphine is
isolation from poppy straw of the opium
poppy.
It acts on the Central Nervous System
(CNS) to decrease the feeling of pain

Question 23

Heroin

Answer 23

Opioid firstly synthesized mainly to
substitute morphine
acts on Brain and Nervous System

Question 24

CLASS A

Answer 24

Heroin
Cocaine
Mescaline

Question 25

Class B (3 parts)

Answer 25

Morphine
Opium
Amphetamines

Question 26

Class C (3 parts)

Answer 26

Benzodiazepines
Codeine
Buprenorphne