Lecture 15: Legal Aspects Of Prescribing

Question 0

What are some cases which do not require a container type that can be readily and effectively resealed?

Answer 0

The contain bears a label with directions stating that the whole of the container must be used immediately on opening
And
The quantity and nature of the contents make it unlikely that less than the whole quantity will be used on more than one occasion

Question 1

What are the regulations on containers and packages of medicines?

Answer 1

Medicines cannot be packed, stored, sold, supplied or transported unless they are in a container which is
Impervious to the medicine
Can be effectively resealed after any portion of contents has been used
Is of the prescribed character or type
Is labelled in the prescribed manner
If the container is to be packaged, the package is required to be of prescribed character or type and labelled in a prescribed manner.

Question 2

What is the regulation of medicines and food and drink bottles?

Answer 2

Medicines, related products or cosmetics cannot be temporarily or permanently kept in a bottle, jar, tin plate, containr, culinary utensil or any other container type which has a brand, mark, statement or picture that indicates the presence of any food, drink or condiment

Or a distinctive container type which indicates food drink or condiment commonly or is currently being sold

Question 3

What is the regulation on safety containers?

Answer 3

Tablets, or other single item in solid form intending for oral consumptions, or comprising of medicine belonging to a class to which the regulation applies to cannot be sold unless the item is enclosed in a safety container.

Question 4

What are some exceptions to medicines being sold in a safety container?

Answer 4

An authorised prescriber directs either on the prescription or otherwise that

The medicine is not to be sold enclosed in a safety container or
That he or she does not wish the name of the medicine to appear on the label or

Where a pharmacist of the opinion that because of age or infirmity of a patient, a medicine used by that patient should not be enclosed in a safety container,

If the medicine is a capsile, pill, powder or other solid dosage form, prepared on a pharmacy with reference to the particular needs of a patient

Question 5

What kinds of medications does the safety container regulation apply to?

Answer 5

Aspirin and its salts
Medicines containing aspirin and its salts
Iron, in medicines for human containing more than 24mg of elemental iron per dose
Paracetemol and medicines containing paracetemol.

Question 6

What classes of medicines does the safety containers regulation applies to?

Answer 6

Barbituates- phenothiazine and its derivatives and salts (except dimethothiazine, methadilazine, promethazine and trimeprazine and their salts and molecular compounds: tricyclic, tetracyclic and analogous antidepressants.

Question 7

What is an authorised prescriber?

Answer 7

Practictioner, registered midwife or designated prescriber

Question 8

What is a designated prescriber?

Answer 8

This is a person other than a practitioner or registered midwife who belongs to a class of registered health professionals authorised by regulations made under this Act to prescribe any specified class or description of prescription medicines however the prescription must satisfy requirements specified in or imposed under those regulations

The designated practitioner must also satisfy any applicable requirement relating to competency, qualifications or training specified in or imposed under regulations made under this act

Question 9

Who are examples of designated practitioners?

Answer 9

Pharmacists, optometrists, nurse practitioners, diabetic nurse

Question 10

What kind of container must dispened medicines be in (if they are usually sold in a safety container?)

Answer 10

They should be dispensed in a safety container too

Question 11

What is a pharmacy graduate?

Answer 11

A person, who is not a pharmacist, but has 1 or more of the qualifications prescribed by the pharmacy council for registration as a pharmacist

Is actively taking steps towards registration as a pharmacist

Question 12

What is a pharmacy student?

Answer 12

Person who is undertaking but has not yet completed the course and examinations leading to a qualification of a kind prescribed by the pharmacy council

Question 13

What is a pharmacy technician?

Answer 13

Any person who has a national certificate in pharmacy (technician)

Question 14

What is a pharmacy technician student?

Answer 14

A person who is undertaking but has not yet completed training and examinations leading to a national certificate in pharmacy (technician)

Question 15

What is a registered midwife?

Answer 15

A health practitioner who is or deemed to be registered with the midwifery council established by section 114(3) of the health practitioners competence assurance act 2003 as a practitioner of the profession of midwifery

Question 16

What is a dentist?

Answer 16

Health practitioner who is deemed to be, registered with the dental council of NZ established by the health practitioners competence assurance act 2003 as a practitioner of the profession of dentistry

Question 17

What is a medical practitioner?

Answer 17

A health practitioner who is or is deemed to be registered with the medical council of NZ continued by the health practitioners competence assurance act 2003 as a practitioner of the profession of medicine.

Question 18

What is the regulation on prescribing medicines?

Answer 18

The medicine must be prescribed

For the treatment of a patient under the authorised prescriber’s care and within in accordance with all conditions stared in rhe authorised prescribers scope of practice.

Question 19

When can a designated prescriber prescribe medicines?

Answer 19

When the prescription medicine is a class or description that the designated prescriber is authorised to prescribe (by regulations made under the act)

The requirements specified in or imposed under those regulations are satisfied

Question 20

What is the regulation on period of supply of medicines?

Answer 20

There is a limit on the period of supply of prescription medicines.

An authorised prescriber may not on any occasion prescribe for any patint a quantity of prescription medicine that exceeds
6 months supply for OCs
3 months supply for any other case

Question 21

What is the regulation on sale of medicines by retail?

Answer 21

We cannot sell any prescription medicine other than what is prescribed by a practioner, registered midwife, veterinarian or designated prescriber

Question 22

What is the regulation on patient details?

Answer 22

Patient details must include
patient surname,
each given name
Address for person whose use the prescription is given

In the case of a child under 13 years, the date of birth of the child.

Question 23

What is the regulation on the requirements of prescribe details?

Answer 23

The prescriber details must be legibly and indelibly printed,
Signed personally by the prescriber with his usual signature
Dated
Set out the following info in relation to the prescriber:
Prescribers full name, full street address of prescribers place of work, postal address of prescriber and telephone number

Question 24

What kind of medicine details must be on the prescription as designated by regulation?

Answer 24

Name of medicine,
Strength, if appropriate
The total amount of medicine that may be sold or dispensed, or total period of time supply

If medicine is to be administered by injection or insertion into any cavity of the body or by swallowing, indicate the dose and frequency of administration

If medication is for application externally, indicate method and frequency of use

Question 25

What do the regulations say on verbal prescriptions?

Answer 25

These are for emergency cases only.
When medicine is urgently required
Must be prescribed by an authorised prescriber or veterinary surgeon

Must be communicated orally to the pharmacist whom he or she is known personally. Either speaking in person or on the phone.

However within 7 days a written prescription is required for confirmation of the oral communication

Question 26

What are examples of medicines, or medical devices which do not have a frequency of dose?

Answer 26

Warfarin and condoms

Question 27

What is the regulation on the expiry of prescriptions?

Answer 27

Prescription for a medicine other than an OC should not be dispensed on any occasion after 6 months have elapsed from the date on which the prescription was printed

For OC it is 9 months

Question 28

What is required on a medicines label as designated by regulation?

Answer 28

Name or description of nature of content
Name of patient
Name and address of seller
For medicines of internal use, the dose and frequency
Fr medicines of external use, a statement of directions of use and frequency and either “caution: not to be taken” or “ for external use only”

Unique identifying number or code for the prescription or record of supply

Date on which the medicine is packed, sold or supplied

Question 29

What are the regulations on generic substitutions?

Answer 29

Pharmacist can only supply an alternative brand of medicine if

Authorised prescriber or vet has NOT marked “no brand substitution permitted” on prescription or words with similar meaning

Substituted brand contains same active ingredient/(s) and no other active ingredients

Substituted brand is in the same dose form and strength

There is no clinical reason why the substituted brand should not be supplied

Pharmacist records brand substitution on the prescription

Pharmacist signs and dates prescription

Pharmacist informs patient of brand substitution

Question 30

What is an example of a medicine which does not permit brand substitution?

Answer 30

Warfarin brands are not determined to be bioequivalent.

Narrow therapeutic index so ADR risk

Question 31

What is the regulation on emergency supply of medicines?

When can a pharmacist provide an emergency supply of medicines?

Answer 31

Someone who has perviously been supplied with medicine on the prescription of an authorised prescriber for a particular condition and is sold or dispensed

By a pharmacist who is satisfied that person requires emergency supply of medicine for that condition (e,g, 3 day supply)

And in an amount not exceeding reasonable quantity for the person for a period of 3 days,
Or a minimum pack of a special container which would be impractical to dispense a smaller amount

Question 32

What are regulations on pharmacy records?

Answer 32

Every person who dispenses or supplies any prescription medicine or restricted medicine pursuant to a prescription shall not later than the ordinary business day after the medicine was dispensed or supplied, record the procedure in a prescriptions register or other form.

The record should have
Date of each transaction
Name of patient or owner of animal
Name of medicine supplied
Quantity of medicine supplied
Name of prescriber
In the case of prescription medicine, a unique identifiable code

Question 33

What is the regulation on dispensing medicines?

Answer 33

With some exceptions, (subclause 2)
No one other than an authorised prescriber, vet, pharmacist, pharmacy graduate, pharmacy technician, student or dispensary technician can dispense a prescription medicine

Dispensary technicians, pharmacy graduates, pharmacy technicians and students can only dispense under the direct personal supervision of a registered pharmacist