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PPP Test Revision > Law > Flashcards

Law Flashcards

1
Q

Why are medicines regulated?

A

to ensure:
1. quality (stability and purity)
2. safety
3. efficacy

minimise (avoidable) risks and optimise benefits

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2
Q

How are medicines regulated?

general description

A

through regulation activities:
1. premarket screening
2. labelling and promotional regulations
3. postmarket survelliance

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3
Q

List the classifications of medication & basic definition of each

A

Classification according to active ingredient:
1. Prescription Medicine: sold only under a prescription by authorised prescriber
2. Restricted Medicine: sold by retail by a pharmacist in pharmacy or hospital
3. Pharmacy Only Medicine: sold by retail in pharmacy or hospital
4. General Sale Medicine: not listed in classification schedules + can be sold by any outlet

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4
Q

List factors to consider when classifying

five factors

A
  • unintended misuse
  • consumer benefits / communal harm (risks : benefits ratio)
  • potential worsened outcomes due to self-management
  • overdose and abuse/misuse potential
  • undesirable side effects
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5
Q

What is medsafe and its purpose?

A

[i] Medsafe is NZ’s medicines and medical devices regulation authority
[ii] Medsafe is responsible for administrating Medicines Act 1981 and Medicines Regulations Act

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6
Q

What does the Medicines Act define? Who can prescribe medicines?

Medicines Act 1981: part i

A

|i| defines medicines
* a substance manufactured, imported, sold, or supplied to humans… “for therapeutic purposes” to “achieve pharmacological, immunological, or metabolic action”
* a medicine is also the “therapeutically active ingredient” used to make a substance.

|ii| defines dispending
* packaging, labelling, recording, and delivery of medicines + preparation of medicines for sale

|iii| authorised prescriber [nurse practitioner, optometrist, practitioner (dentist or medical practitioner), registered midwife, designated prescriber (other class of health professionals who can prescribe any specified prescription; ex. designated pharmacist prescribers)], delegated prescriber [health practitioner to whom a delegated prescribing order has been issued] or veterinarian

Therapeutic purpose meaning = preventing, diagnosing, monitoring, alleviating, treating, curing, or compensating for, a disease, ailment, defect, or injury; influencing, controlling, or preventing conception.

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7
Q

Purpose of regulation & state 10 patient rights

Code of Health and Disability Consumers’ Rights Regulation: part iiii

A

Promotes and protects rights of health consumers and disability services consumers.

  1. respect
  2. freedom from discrimination
  3. dignity and independence
  4. services of an appropriate standard
  5. effective communication
  6. be fully informed
  7. make an informed choice and give informed consent
  8. support
  9. teaching or research
  10. complain
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8
Q

Describe the 8 aspects convered in the MRA

Medicines Regulations Act 1984: part ii

A
  1. storage
  2. PLACE of storage, manufacture and sale
  3. prescribing medicines: can only prescribe within their scope of practice
  4. dispensing medicines
  5. compounding medicines
  6. packaging of medicines
  7. personnel: must stay clean.
  8. infected persons: people with a communicable disease cannot be associated with supplying + written notice.
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9
Q

List the 7 privacy principles of HIPC

Health Information Privacy Code: part iii

A

|1| collection of personal information
|2| storage and security of personal information
|3| requests for access to and correction of personal information
|4| accuracy of personal information
|5| retention of personal information
|6| use and disclosure of personal information
|7| using **unique identifiers **

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10
Q

When storing medicines, you must…

Medicines Regulations Act 1984: specific details

aspect 1: storage

A
  1. avoid contamination from odour, moisture, creatures and dust
  2. comply with storage requirements
  3. store medicines separate from food (in case of leakage)
  4. not expose to toxic substances (in case of contamination)
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11
Q

hint: must be well-maintained

6 requirements for place of sale, manufacture and storage

Medicines Regulations Act 1984: specific details

aspect 2: place of storage

A
  1. light
  2. ventilation
  3. cleanliness
  4. properly constructed building
  5. sanitation, sinks, water, toilets must be provided & in good condition
  6. use of dwellinghouse for manufacturing or packing is prohibited
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12
Q

hint: how much medication is supplied

Quantity of supply

Medicines Regulations Act 1984: specific details

aspect 3: prescribing

A
  • 6 months’ supply of oral contraceptive
  • 3 months’ supply in any other case
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13
Q

hint: how long dispensing is viable for after printed date

Expiration

Medicines Regulations Act 1984: specific details

aspect 3: prescribing

A

|+| oral contraceptive should not be dispensed after 9 months have elapsed from printed date
|+| every other medication should not be dispensed after 6 months have elapsed from printed date.

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14
Q

hint: details about the prescriber, patient & medicine

Prescription much contain…

Medicines Regulations Act 1984: specific details

aspect 3: prescribing

A

i. prescriber: signature, full name, full work address, and telephone number
ii. patient: surname, given name, home address, and date of birth (if child is under 13 years of age)
iii. medicine details: name; strength; total amount dispensed; total period of supply; and dose and frequency of dose OR application method and frequency

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15
Q

What are the two instances when medication can be supplied without a prescription?

Medicines Regulations Act 1984: specific details

aspect 3: prescribing

A

|1| an authorised prescriber can communicate orally to a pharmacist that they know personally a prescription for a prescription medicine that’s** required urgently**. A written prescription must be provided within 7 days. Medicine can only be dispensed ONCE without prescription.

|2| person who has been supplied medication before via prescription can be given emergency supply (72 hours) by pharmacist.

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16
Q

hint: five people

Who can dispense medicines?

Medicines Regulations Act 1984: specific details

aspect 4: dispensing

A
  1. pharmacists
  2. dispensary technicians
  3. pharmacy graduates
  4. pharmacy technicians
  5. students (under supervision)
17
Q

hint: six requirements

What information does a label require?

Medicines Regulations Act 1984: specific details

aspect 4: dispensing

A
  • medicine name
  • patient name
  • name and address of seller
  • if internal: dose and frequency OR if external: directions of use and frequency + “for external use only”
  • unique identifying code
  • dispensing date
18
Q

hint: five requirements

How must the label be formatted / look?

Medicines Regulations Act 1984: specific details

aspect 4: dispensing

A
  • written in English
  • legible
  • appropriate colour
  • proper positioning of label
  • not obscured by other labels
19
Q

What size should lettering be?

Medicines Regulations Act 1984: specific details

aspect 4: dispensing

A

no smaller than 1.5mm OR no smaller than 0.75mm if container is small.

20
Q

hint: five people

Who can compound?

Medicines Regulations Act 1984: specific details

aspect 5: compounding

A
  1. pharmacist
  2. pharmacy graduate
  3. pharmacy technician
  4. students
  5. dispensary technicians (if they have done a pharmacy apprenticeship)
    …can compound if under supervision of pharmacist
21
Q

When can a pharmacist add a diluent to liquid medicine?

Medicines Regulations Act 1984: specific details

aspect 5: compounding

A

to adjust dose so it’s easier to measure if it will not affect medicine composition.

22
Q

hiint: 6 requirements

What are the requirement of containers when packing medicine?

Medicines Regulations Act 1984: specific details

aspect 6: packaging

A
  • container must be easy to clean
  • must not use a container that has been previously used by a product that could contaminate medicine.
  • container must not be made of paper; can be made of cardboard
  • impermeable to moisture
  • container will not adversely react with contents
  • do not use container associated with food or drink.
23
Q

hint: six aspects

What does right 4 ensure patients’ have the right to? What are the aspects of this?

Code of Health and Disability Consumers’ Rights Regulation: specific

A

services of an appropriate standard
* with care and skill.
* comply with legal, professional, ethical, and other relevant standards.
* in a manner consistent with his or her needs.
* in a manner that minimises the potential harm + optimises the quality of life of consumer.
* co-operation among providers to ensure quality and continuity of services

24
Q

hint: two aspects

What does right 5 ensure patients’ have the right to? What are the aspects of this?

Code of Health and Disability Consumers’ Rights Regulation: specific

A

effective communication
* right to effective communication given in a form, manner and language that consumer can understand + interpreter if needed
* right to environment that enables open, honest and effective communication

25
Q

hint: 3 aspects

What does right 6 ensure patients’ have the right to? What are the aspects of this?

Code of Health and Disability Consumers’ Rights Regulation: specific

A

be fully informed
* right to information about condition: options available; expected risks, side effects, benefits, and costs of each option; when services will be provided; notification of any proposed participation in teaching or research; the results of tests and procedures
* right to the information that a reasonable consumer needs to make an informed choice or give informed consent.
* right to honest and accurate answers to questions relating to services, including— qualifications of provider; recommendation of the provider; how to obtain an opinion from another provider; the results of research; and right to receive a written summary of information provided.

26
Q

hint: six aspects

What does right 7 ensure patients’ have the right to? What are the aspects of this?

Code of Health and Disability Consumers’ Rights Regulation: specific

A

make an informed choice and give informed consent
* consent is freely given
* respects consumers’ autonomy
* shared decision-making process
* service may only be provided after informed consent given
* consumer must be presumed competent
* if consumer has diminished competence, right to make informed choices retained to extent (depending on competence level)

PPP Test Revision (20 decks)

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