Law Flashcards
Why are medicines regulated?
to ensure:
1. quality (stability and purity)
2. safety
3. efficacy
minimise (avoidable) risks and optimise benefits
How are medicines regulated?
general description
through regulation activities:
1. premarket screening
2. labelling and promotional regulations
3. postmarket survelliance
List the classifications of medication & basic definition of each
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
List factors to consider when classifying
five factors
- unintended misuse
- consumer benefits / communal harm (risks : benefits ratio)
- potential worsened outcomes due to self-management
- overdose and abuse/misuse potential
- undesirable side effects
What is medsafe and its purpose?
[i] Medsafe is NZ’s medicines and medical devices regulation authority
[ii] Medsafe is responsible for administrating Medicines Act 1981 and Medicines Regulations Act
What does the Medicines Act define? Who can prescribe medicines?
Medicines Act 1981: part i
|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.
Purpose of regulation & state 10 patient rights
Code of Health and Disability Consumers’ Rights Regulation: part iiii
Promotes and protects rights of health consumers and disability services consumers.
- respect
- freedom from discrimination
- dignity and independence
- services of an appropriate standard
- effective communication
- be fully informed
- make an informed choice and give informed consent
- support
- teaching or research
- complain
Describe the 8 aspects convered in the MRA
Medicines Regulations Act 1984: part ii
- storage
- PLACE of storage, manufacture and sale
- prescribing medicines: can only prescribe within their scope of practice
- dispensing medicines
- compounding medicines
- packaging of medicines
- personnel: must stay clean.
- infected persons: people with a communicable disease cannot be associated with supplying + written notice.
List the 7 privacy principles of HIPC
Health Information Privacy Code: part iii
|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 **
When storing medicines, you must…
Medicines Regulations Act 1984: specific details
aspect 1: storage
- avoid contamination from odour, moisture, creatures and dust
- comply with storage requirements
- store medicines separate from food (in case of leakage)
- not expose to toxic substances (in case of contamination)
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
- light
- ventilation
- cleanliness
- properly constructed building
- sanitation, sinks, water, toilets must be provided & in good condition
- use of dwellinghouse for manufacturing or packing is prohibited
hint: how much medication is supplied
Quantity of supply
Medicines Regulations Act 1984: specific details
aspect 3: prescribing
- 6 months’ supply of oral contraceptive
- 3 months’ supply in any other case
hint: how long dispensing is viable for after printed date
Expiration
Medicines Regulations Act 1984: specific details
aspect 3: prescribing
|+| 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.
hint: details about the prescriber, patient & medicine
Prescription much contain…
Medicines Regulations Act 1984: specific details
aspect 3: prescribing
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
What are the two instances when medication can be supplied without a prescription?
Medicines Regulations Act 1984: specific details
aspect 3: prescribing
|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.
hint: five people
Who can dispense medicines?
Medicines Regulations Act 1984: specific details
aspect 4: dispensing
- pharmacists
- dispensary technicians
- pharmacy graduates
- pharmacy technicians
- students (under supervision)
hint: six requirements
What information does a label require?
Medicines Regulations Act 1984: specific details
aspect 4: dispensing
- 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
hint: five requirements
How must the label be formatted / look?
Medicines Regulations Act 1984: specific details
aspect 4: dispensing
- written in English
- legible
- appropriate colour
- proper positioning of label
- not obscured by other labels
What size should lettering be?
Medicines Regulations Act 1984: specific details
aspect 4: dispensing
no smaller than 1.5mm OR no smaller than 0.75mm if container is small.
hint: five people
Who can compound?
Medicines Regulations Act 1984: specific details
aspect 5: compounding
- pharmacist
- pharmacy graduate
- pharmacy technician
- students
- dispensary technicians (if they have done a pharmacy apprenticeship)
…can compound if under supervision of pharmacist
When can a pharmacist add a diluent to liquid medicine?
Medicines Regulations Act 1984: specific details
aspect 5: compounding
to adjust dose so it’s easier to measure if it will not affect medicine composition.
hiint: 6 requirements
What are the requirement of containers when packing medicine?
Medicines Regulations Act 1984: specific details
aspect 6: packaging
- 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.
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
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
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
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
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
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.
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
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)
