Law Flashcards
Why should we regulate medicines?
- To ensure public safety
- No medicine is 100% safe
- Regulation allows control of
- Availability
- Access
- Information
- Quality
What is a medicine?
Law L7, pg 15
Meaning of ‘therapeutic purpose’
a) Preventing, diagnosing, monitoring, alleviating, treating, curing, or compensating for, a disease, ailment, defect, or injury; or
b) influencing, inhibiting, or modifying a physiological process; or
c) testing the susceptibility of persons to a disease or ailment; or
d) influencing, controlling, or preventing conception; or
e) testing for pregnancy; or
f) investigating, replacing, or modifying parts of the human anatomy
Four levels of classification
- Prescription Only Medicine
- restricted Medicine (aka Pharmacist only)
- Pharmacy-only medicine
- All other medicines are deemed to be general sale
- Medicines Act s.3(3)
- Controlled drugs
Controlled Drugs
- Risk of harm to individuals or society
- Class A eg. heroin
- Class B eg. morphine
- Class C eg codeine
- Class A & Class B CD prescriptions must be written on a H572 form - a triplicate prescription form
Prescription only medicine
- Prescription medicine means a medicine that is declared by regulations or by a notice given under section 106 to be one that, except as may be permitted by regulations, may be —
a) Sold by retail only under a prescription given by an authorised prescriber, veterinarian, or delegated prescriber; and
b) supplied in circumstances corresponding to retail sale only –
(i) under a prescription given by an authorised prescriber, veterinarian, or delegated prescriber; or
(ii) in accordance with a standing order; and
c) administered only in accordance with –
(i) a prescription given by an authorised prescriber, veterinarian, or delegated prescriber; or
(ii) a standing order
Prescription only medicine
Medicines Act s.18 Sale of medicines by retail
- Except as provided in sections 25, 27, and 30 to 33, or as may be permitted by regulations made under this Act, no person shall, in the course of any business carried on by that person, sell by retail, or supply in circumstances corresponding to retail sale, or distribute by way of gift or loan or sample or in any other way
(a) Any prescription medicine unless
(i) The medicine is sold, supplied, or distributed by a pharmacist in a pharmacy or hospital; or
(ii) the medicine is supplied in accordance with a standing order by a person who is authorised to supply and administer any specified class or description of prescription medicine under that standing order; or
(2) No person may sell by retail any prescription medicine otherwise than under a prescription given by an authorised prescriber, a veterinarian, or a delegated prescriber
(2A) No person may supply, in circumstances corresponding to retail sale, any prescription medicine otherwise than –
(a) Under a prescription given by an authorised prescriber, a veterinarian, or a delegated prescriber; or
(b) in accordance with a standing order
Prescription only medicine
SUMMARY
- Can only be sold with a prescription (unless Medicines Regulations allow otherwise)
- Prescription must be written by an authorise prescriber
- Sold, supplied, distributed by a pharmacist in a pharmacy or hospital (unless exceptions apply)
Examples:
- Amoxicillin - antibiotic;
- tramadol - pain relief;
- Insulin - diabetes
Non-prescription medicines
- Also known as “over the counter” or OTC medicines
- Includes: restricted, pharmacy-only & general sale medicines
Restricted medicine/ Pharmacist only
Medicines Act s.3 Meaning of medicine, new medicine, prescription medicine, and restricted medicine
Restricted medicine means a medicine that is declared by regulations made under this Act or by a notice given under section 106 to be on that, except as may be permitted by the regulations, may be –
(a) Sold by retail only by a pharmacist in a pharmacy or hospital; or
(b) Supplied in circumstances corresponding to retail sale only –
i) By a pharmacist in a pharmacy or hospital; or
ii) in accordance with a standing order
Restricted Medicine / Pharmacist only
- Medicines Act s.18 Sale of medicines by retail
- Except as provided in sections 25, 27, and 30 to 33, or as may be permitted by regulations made under this Act, no person shall, in the course of any business carried on by that person, sell by retail, or supply in circumstances corresponding to retail sale, or distribute by way of gift or loan or sample or in any other way
(b) any restricted medicine unless the medicine is sold, supplied, or distributed by a pharmacist in a pharmacy or hospital;
Medicines regulations R.54A Sale of Medicines Registers
- A record of the sale of restricted medicines must be kept
Medicines Act s.42B Security of pharmacies
- Prescription & restricted medicines must be stored in a way that prevents public gaining ready access to them
Restricted Medicine / Pharmacist only
- Can be sold without a prescription
- Can only be sold by a pharmacist in a pharmacy or hospital
- Record of sale must be kept
- Must be stored out of reach of public
Examples:
- Chloramphenicol eye preparations; nystatin drops for oral thrush;
- zolmitriptan nasal spray for migraine
General sale medicine
- No definition in the law
- Can be sold by anyone, from any store
Examples
- Antacids - Gaviscon, Mylanta; paracetamol tablets in small pack sizes; acyclovir cream to treat cold sores
Prescription except when
- Some medicines appear to be restricted medicines, but are legally classified as “prescription when…?
- Influenza vaccine:
- Prescription EXCEPT when administered to a person 13 years of age or over by a registered pharmacist who has successfully completed a vaccinator training course approved by the ministry of health and who is complying with the immunisation standards of the Ministry of Health
- As it is not a restricted medicine, it does not have to be sold at a pharmacy. Pharmacists will travel to workplaces to administer the influenza vaccine to people at their workplace, instead of requiring them to visit the pharmacy
Multiple classifications
- Many medicines will have multiple classifications
- Smaller sizes may be general sale, larger sizes pharmacy-only
- Low strengths may be restricted medicines, higher strengths prescription medicines
- Different formulations may be different classifications - tablets vs liquids vs injectables
- Different indications may be different classifications
Who decides on classification?
- Medicines classification Committee makes recommendation to the Minister of Health (MA s.9)
- Meets twice a year
- two from each of: NZ Medical Association; Pharmaceutical Society NZ; Ministry of Health
Medicines which may be available without a prescription shall be able to either
a) Show substantial safety in use in the prevention or management of the condition or symptom under consideration
b) Be for conditions or symptoms that can be diagnosed and managed by a pharmacist
c) Be easily self-diagnosed and self-managed by a patient
What criteria do the Medicines Classification Committee (MCC) consider?
- Patient access
- Accuracy
- Efficacy
- Precedent
- Therapeutic index
- Toxicity
- Abuse potential
- Inappropriate use
- Precautions
- Communal harm and/or benefit
Where do we find the classification?
- Legislation (but not always up-to-date) - medicines Regulations Schedule 1
- Medsafe website
- NZF formulary entry
Examples
L7, pg 35, 36 & 37
- Amoxicillin
- Omeprazole
- Ioratadine
Cartwright inquiry
L11, pg 6, 7 & 8
Code of Health & Disability Services Consumers’ Rights
- Came into effect on 1 July 1996
- Only Code of Rights of its kind in the world
- It is delegated legislation and has full legal effect
- States that consumers have rights and providers have duties
How does the code of health & disability services consumers’ rights apply to you?
- Provider is defined as ‘health care provider or disability services provider’
- ‘health care provider’ definition is very broad. Includes:
- Any health practitioner
- A person who is receiving training or gaining experience under the supervision of a health practitioner
- Consumer is defined as ‘a health consumer or disability services consumer; and for the purposes of rights 5,6,7(1), 7(7) to 7(10), and 10, includes a person entitled to give consent on behalf of that consumer
Clause 1
A provider must take action to
a) Inform consumers of their rights and
b) Enable consumers to exercise their rights
Rights 1-3
- “attitudinal umbrella” under which all services must be delivered
What that might look like in a pharmacy
- L11, pg 14
RIGHT 1 Right to be treated with respect
1) Every consumer has the right to be treated with respect
2) Every consumer has the right to have his or her privacy respected
3) Every consumer has the right to be provided with services that take into account the needs, values and beliefs of different cultural, religious, social, and ethnic groups, including the needs, values, and beliefs of Maori
RIGHT 2 Right to freedom from discrimination, Coercion, Harassment, and Exploitation
- Every consumer has the right to be free from discrimination, coercion, harassment, and sexual, financial or other exploitation
RIGHT 3 Right to Dignity and independence
- Every consumer has the right to have services provided in a manner that respects the dignity and independence of the individual
RIGHT 4 - Standard of care
- Right to services of an appropriate standard
- What might that look like in pharmacy
- L11, pg16
1) Every consumer has the right to have services provided with reasonable care and skill
2) Every consumer has the right to have services provided that comply with legal, professional, ethical, and other relevant standards
3) Every consumer has the right to have services provided in a manner consistent with his or her needs
4) Every consumer has the right to have services provided in a manner that minimises the potential harm to, and optimises the quality of life of, that consumer
5) Every consumer has the right to co-operation among providers to ensure quality and continuity of services
RIGHT 5 Right to effective communication
1) Every consumer has the right to effective communication in a form, language, and manner that enables the consumer to understand the information provided. Where necessary and reasonably practicable, this includes the right to a competent interpreter
2) Every consumer has the right to an environment that enables both consumer and provider to communicate openly, honestly, and effectively
Right 6 Right to be fully informed
- What might that look like in pharmacy?
- L11, pg 19
1) Every consumer has the right to the information that a reasonable consumer, in that consumer’s circumstances, would expect to receive, including
a) An explanation of his or her condition; and
b) An explanation of the options available, including an assessment of the expected risks, side effects, benefits, and costs of each option; and
c) Advice of the estimated time within which the services will be provided; and
d) notification of any proposed participation in teaching or research, including whether the research requires and has received ethical approval; and
e) Any other information required by legal, professional, ethical, and other relevant standards; and
f) The results of tests; and
g) The results of procedures
2) Before making a choice or giving consent, every consumer has the right to the information that a reasonable consumer, in that consumer’s circumstances, needs to make an informed choice or give informed consent
3) Every consumer has the right to honest and accurate answers relating to services, including questions about
a) The identity and qualifications of the provider; and
b) The recommendation of the provider; and
c) How to obtain an opinion from another provider; and
d) The results of research
4) Every consumer has the right to receive, on request, a written summary of information provided
Right 7 Right to make an informed choice and give informed consent
- What might that look like in pharmacy
- L11, pg 22
L11, pg 20 & 21
RIGHT 8 Right to support
- Every consumer has the right to have one or more support persons of his or her choice present, except where safety may be compromised or another consumer’s rights may be unreasonably infringed
- The patient might want to have someone come into the consultation room with them
Right 9 Rights in respect of teaching or research
- The rights in this code extend to those occasions when a consumer is participating in, or it is proposed that a consumer participate in, teaching or research
- On placement the preceptor will ask if the student can observe while they administer a vaccine
Right 10 Rights to Complain
1) Every consumer has the right to complain about a provider in any form appropriate to the consumer
2) Every consumer may make a complaint to -
a) The individual or individuals who provided the services complained of; and
b) Any person authorised to receive complaints about that provider; and
c) Any other appropriate person, including-
i. An independent advocate provided under the Health and Disability Commissioner Act 1994; and
ii. The Health and Disability Commissioner
3) Every provider must facilitate the fair, simple, speedy, and efficient resolution of complaints
4) Every provider must inform a consumer about progress on the consumer’s complaint at intervals of not more than 1 month
5) Every provider must comply with all the other relevant rights in this Code when dealing with complaints
Health infprmation
- Important to the individual
- Expect it to be considered as confidential
- Want it to be considered sensitive
- Has ongoing use
Health Information Privacy code 1994
- Applies to everyone working in the health sector who handles health information
- HIPC substitutes information privacy principles in the Privacy Act 1993 - therefore HIPC used by health professionals
- Applies to health information relating to identifiable individuals
- Wherever possible people should know what is happening to their information and should retain a measure of autonomy in that process
Health information Privacy Code 1994
- Collecting information
- Rules 1-4
- Storing information
- Rules 5 & 9
- Using information
- Rules 6-8
- Disclosing information
- Rules 10-11
Health Information Privacy Code 1994
1) Only collect health information if you really need it
2) Get it from the person concerned
3) Tell them what you’re going to do with it
4) be considerate when you’re getting it
5) take care of the information once you’ve got it
6) People can see their health information if they want to
7) they can correct it if its wrong
8) Make sure health information is accurate before you use it
9) Get rid of it when you’re done with it
10) Only use it for the purpose you got it for
11) Only disclose it if you have a good reason
12) be careful with unique identifiers
Collecting information
Rule 1 - Purpose of collection of health information
- Only collect information you need
- Openness at time of collection
Collecting information
Rule 2 - Source of Health Information
- Collect from the individual concerned
- Except where
- Individual or representative authorises someone else
- Compliance compromises individuals interest
- Not reasonably practicable
- Should identify source of information
- Should confirm accuracy of information at later date with individual
Collecting Information
Rule 3 - Collection of information from individual
- Patient should be aware:
- Information is being collected
- Why the information is being collected
- Who is going to see the information
- What happens if the information is not given
- Rights to access information & correct it
Collecting information
Rule 4: manner of collection
- health information must not be collected by unlawful, unfair, or unreasonably intrusive means
Storing information
Rule 5 - Storage & Security of Health Information
- Information must be protected against:
- Loss
- Access, use, modification, or disclosure without appropriate authority
- Other misuse
- When sharing information - do so in a way to prevent unauthorised disclosure
- When disposing of information - preserve privacy
Storing Information
Rule 9 - Retention of Health Information
- Do not keep health information for longer that it is required
- Health (Retention of health information) Regulations 1996 -> 10 years
Using information
- Rule 6 - Access to personal health information
- Individuals have a right to access their health information
- Access may not be refused on the grounds that the health professional ‘owns’ the records
- Parents & guardians do not have automatic right to their children’s health information
Using information
- Rule 7 - Correction of Health Information
- Individual has a right to request correction of information
- Or that a statement of correction sought be attached to file
- And inform other relevant people of the correction
Using Information
- Rule 8 - Accuracy etc of health Information to be checked before use
- Must ensure that information is up to date, complete, relevant, & not misleading
Disclosing information
- Rule 10 - Limits on use of health information
- How you can use information within an agency
- Only for the purpose it was collected
- Or for a directly related purpose
Disclosing Information
- Rule 11 - Limits on disclosure of health information
- Who else you can tell (outside agency) about patient
- Does not oblige an agency to disclose information - allows disclose
Disclosing Information
- Health Act 1956
- s.22F Communication of information for diagnostic and other purposes
- Allows information to be shared amongst health professionals about an individual
- Aim to promote sharing of information to assist ongoing treatment
- Must be known providers to that individual. Does not require individuals consent
- Allows information to be shared amongst health professionals about an individual
Rule 12 - Unique identifiers
- Does not include individuals name
- In Healthcare system - NHI
- National Health Index
- Restricts how these can be assigned & how they can be used
- To prevent health information being linked with other personal information without consent/knowledge
- NHI is specific to health sector
