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National Health (Residential Medication Chart) Determination 2012

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National Health (Residential Medication Chart) Determination 20121
National Health Act 1953
I, Felicity McNeill, First Assistant Secretary, Pharmaceutical Benefits Division of the Department of Health and Ageing, make the following determination under subsection 93A (2) of the National Health Act 1953.
Dated 9 July 2012
 
Felicity McNeill
Delegate for the Minister for Health
Contents
Part 1                          Preliminary
                    1.01      Name of determination                                                                        3
                    1.02      Commencement                                                                                  3
                    1.03      Definitions                                                                                          3
                    1.04      Purpose                                                                                             4
                    1.05      Application                                                                                         4
                    1.06      Applicable pharmaceutical benefits                                                      4
Part 2                          Conditions
                    2.01      General                                                                                              6
                    2.02      Conditions—standard fields                                                                6
                    2.03      Standard fields information—residential care service patients               6
                    2.04      Standard fields information—residential care services                          7
                    2.05      Standard field information—expiry date                                               7
                    2.06      Standard fields information—privacy notice                                         7
                    2.07      Standard fields information—medical practitioners                               7
                    2.08      Standard fields information—regularly administered pharmaceutical benefits 8
                    2.09      Standard fields information—insulin                                                     9
                    2.10      Standard fields information—PRN (as required) pharmaceutical benefits 10
                    2.11      Standard fields information : pharmaceutical benefits—short‑term medicines            10
                    2.12      Standard fields information—variable dose pharmaceutical benefits    11
                    2.13      Conditions—characteristics of certain standard fields                         12
                    2.14      Conditions—completing certain standard fields before supply of pharmaceutical benefit       12
 
 
Part 1                 Preliminary
  
1.01        Name of determination
                This determination is the National Health (Residential Medication Chart) Determination 2012.
1.02        Commencement
                This determination commences on 10 July 2012.
1.03        Definitions
                In this determination:
Act means the National Health Act 1953.
applicable pharmaceutical benefit—see section 1.06.
authority prescription has the meaning given by the Regulations.
Chief Executive Medicare has the meaning given by the Act.
CTG is an acronym of Closing the Gap.
current Poisons Standard has the meaning given by subsection 52A (1) of the Therapeutic Goods Act 1989.
healthcare identifier has the meaning given by the Healthcare Identifiers Act 2010.
PBS prescriber number means a PBS prescriber number issued by the Chief Executive Medicare.
Regulations means the National Health (Pharmaceutical Benefits) Regulations 1960.
residential care has the meaning given by section 41–3 of the Aged Care Act 1997.
residential care service has the meaning given by Schedule 1 to the Aged Care Act 1997.
residential medication chart has the meaning given by the Regulations.
Streamlined Authority Code has the meaning given by the National Health (Listing of Pharmaceutical Benefits) Instrument 2010.
Note   For the definitions of the following terms, see Part VII of the Act:
·      approved medical practitioner
·      approved pharmacist
·      pharmaceutical benefit.
1.04        Purpose
                This determination sets out:
                (a)    the pharmaceutical benefits that may be supplied to a patient receiving residential care in a residential care service, using a copy of a residential medication chart for the patient; and
               (b)    the conditions under which an approved medical practitioner or an approved pharmacist may supply the pharmaceutical benefits, using a copy of a residential medication chart, to a residential care service.
1.05        Application
                This determination applies to a supply of a pharmaceutical benefit or class of pharmaceutical benefits mentioned in section 1.06 if the supply is made:
                (a)    using a copy of a residential medication chart; and
               (b)    to a residential care service by an approved medical practitioner or an approved pharmacist; and
                (c)    for a patient receiving residential care in a residential care service.
Note   Paragraphs 93A (2) (a) and (b) of the Act mention ‘prescribed institutions’. Paragraph (b) of the definition of prescribed institution in subsection 93A (1) of the Act refers to a residential care service within the meaning of the Aged Care Act 1997. Also see the note to subsection 93A (2) of the Act.
1.06        Applicable pharmaceutical benefits
         (1)   For paragraph 93A (2) (a) of the Act, the applicable pharmaceutical benefits are those that are generally available for supply under Part VII of the Act.
         (2)   However, the applicable pharmaceutical benefits do not include a pharmaceutical benefit or class of pharmaceutical benefits:
                (a)    that is mentioned in Schedule 8 to the current Poisons Standard; or
               (b)    that is available for supply only under a special arrangement made by the Minister in accordance with section 100 of the Act; or
                (c)    that is available for supply only under a special arrangement made by the Minister in accordance with section 100 of the Act, in circumstances determined by the Minister under paragraph 85 (8) (b) of the Act; or
               (d)    that a medical practitioner prescribes, using an authority prescription, for a patient receiving residential care in a residential care service.
         (3)   Paragraph (2) (d) does not apply to a pharmaceutical benefit or class of pharmaceutical benefits if a situation exists in which the pharmaceutical benefit or class of pharmaceutical benefits:
                (a)    has no authority requirements; or
               (b)    has authority requirements that include a Streamlined Authority Code.
Note 1   The Poisons Standard 2012 is available on the internet at www.comlaw.gov.au.
Note 2   Paragraphs 93A (2) (a) and (b) of the Act mention ‘prescribed institutions’. Paragraph (b) of the definition of prescribed institution is in subsection 93A (1) of the Act and refers to a residential care service within the meaning of the Aged Care Act 1997. Also see the note to subsection 93A (2) of the Act.
Part 2                 Conditions
  
2.01        General
                This Part:
                (a)    is made for paragraph 93A (2) (b) of the Act; and
               (b)    sets out the conditions under which pharmaceutical benefits may be supplied to a residential care service.
Note 1   Section 1.05 sets out when this determination applies to a supply of pharmaceutical benefits.
Note 2   Paragraphs 93A (2) (a) and (b) of the Act mention ‘prescribed institutions’. Paragraph (b) of the definition of prescribed institution in subsection 93A (1) of the Act refers to a residential care service within the meaning of the Aged Care Act 1997. Also see the note to subsection 93A (2) of the Act.
2.02        Conditions—standard fields
         (1)   The standard fields on a residential medication chart must include the standard fields mentioned in:
                (a)    sections 2.03 to 2.08; and
               (b)    for an applicable pharmaceutical benefit to which section 2.09 applies—section 2.09; and
                (c)    for an applicable pharmaceutical benefit to which section 2.10 applies—section 2.10; and
               (d)    for an applicable pharmaceutical benefit to which section 2.11 applies—section 2.11; and
                (e)    for an applicable pharmaceutical benefit to which section 2.12 applies—section 2.12.
         (2)   Also, the standard fields on a residential medication chart must have the characteristics mentioned in:
                (a)    if the standard field is of a kind mentioned in subparagraphs 2.03 (a) (i) to (v) or paragraphs 2.03 (b) and (c)—subsection 2.13 (1); and
               (b)    if the standard field is of a kind mentioned in section 2.05—subsection 2.13 (2); and
                (c)    if the standard field is for insulin—subsections 2.13 (3) and (4); and
               (d)    if the standard field is for an applicable pharmaceutical benefit that is required to be administered in variable doses—subsection 2.13 (5).
2.03        Standard fields information—residential care service patients
                The standard fields for a patient who is receiving residential care in a residential care service must include a standard field for:
                (a)    the patient’s:
                          (i)    full name; and
                         (ii)    preferred name (if any); and
                        (iii)    date of birth; and
                        (iv)    Unit Record Number (URN) or Medical Record Number (MRN), expressed as ‘URN/MRN’; and
                         (v)    healthcare identifier; and
                        (vi)    Medicare number; and
               (b)    the patient’s allergies, including:
                          (i)    the drug or other substance that causes the allergic reaction; and
                         (ii)    the date, type and description of each allergic reaction; and
                (c)    the patient’s adverse drug reactions, including:
                          (i)    the drug or other substance that causes the adverse drug reaction; and
                         (ii)    the date, type and description of each adverse drug reaction; and
               (d)    any number specified on a card, issued by the Commonwealth, as an entitlement number (however described) for the patient.
2.04        Standard fields information—residential care services
                The standard fields for a residential care service must include a standard field for the residential care service’s:
                (a)    business name; and
               (b)    business address; and
                (c)    Residential Aged Care Service ID.
Note   To identify a Residential Aged Care Service ID, you may choose to use the search feature available on the website for the Aged Care Standards and Accreditation Agency www.accreditation.org.au. Type in the name of the residential care service and click on the button to start the search—a report on the residential care service (if available), including its Residential Aged Care Service ID, will appear.
2.05        Standard fields information—expiry date
                The standard fields for the period of validity of the residential medication chart must include a standard field for the expiry date of the residential medication chart.
2.06        Standard fields information—privacy notice
                The standard fields for a privacy notice must include:
                (a)    privacy information of the kind included on a prescription; and
               (b)    a reference to the Privacy Act 1988.
2.07        Standard fields information—medical practitioners
                The standard fields for a medical practitioner must include a standard field for the medical practitioner’s:
                (a)    full name; and
               (b)    address; and
                (c)    PBS prescriber number; and
               (d)    signature:
                          (i)    on the cover page of the residential medication chart for a patient; and
                         (ii)    for each pharmaceutical benefit that the medical practitioner prescribes for the patient using the residential medication chart.
Note   Paragraph (a) of the definition of PBS prescriber in Part VII of the Act includes a medical practitioner.
2.08        Standard fields information—regularly administered pharmaceutical benefits
         (1)   The standard fields for a regularly administered applicable pharmaceutical benefit must include a standard field for:
                (a)    particulars sufficient to identify the applicable pharmaceutical benefit, including the name and strength, expressed as ‘medicine’; and
               (b)    the applicable pharmaceutical benefit’s:
                          (i)    date of prescribing; and
                         (ii)    dose; and
                        (iii)    frequency of administration; and
                        (iv)    the route of administration; and
                (c)    the day, month and year of the date (the start date) to start administering the pharmaceutical benefit; and
               (d)    the day, month and year of the date (the stop date) to stop administering the pharmaceutical benefit; and
                (e)    a check box next to the word ‘Ongoing’; and
                (f)    a check box next to the words ‘Brand substitution not permitted’; and
               (g)    a check box next to the expression ‘CTG’; and
               (h)    the expression ‘PBS/RPBS’; and
                (i)    the words ‘Streamlined Authority Code’ and (immediately next to those words) 4 empty boxes, with each box being large enough for a single digit number to be clearly written in the box; and
                (j)    a box next to the heading, enclosing the name of each calendar month; and
                          (i)    next to a box enclosing the word ‘Date’—a numbered box for each day of each month, laid out on the page horizontally and numbered consecutively, beginning with ‘1’ and ending with ‘31’; and
                         (ii)    under the box enclosing the word ‘Date’—a column of several boxes, laid out on the page vertically, with:
                                   (A)     the first box enclosing the word ‘Times’; and
                                   (B)     each other box being empty and large enough for the time when the applicable pharmaceutical benefit is administered to be clearly written in the box; and
                        (iii)    next to the column of empty boxes mentioned in sub‑subparagraph (ii) (B)—several rows of boxes, laid out on the page horizontally, with each box being large enough for the initials of the person who administered the pharmaceutical benefit to be clearly written in the box.
         (2)   For paragraph (1) (j) (iii), there must be enough rows and enough boxes in the rows to allow the administration of the pharmaceutical benefit to be recorded for each day of the 4 month period of validity of the residential medication chart.
Note 1   See section 2.05 for the requirements for the standard field for the expiry date of a residential medication chart.
Note 2   For a provision that may affect whether the special patient contribution mentioned in subsection 85B (4) of the Act is payable by the Commonwealth if the Streamlined Authority Code is not written in the related section of the chart, see subsection 85B (5) of the Act.
2.09        Standard fields information—insulin
         (1)   The standard fields for an applicable pharmaceutical benefit that is insulin must include standard fields for:
                (a)    the information mentioned in subsection 2.08 (1), other than subparagraphs 2.08 (1) (j) (ii) and (iii); and
               (b)    a row of boxes, laid out on the page horizontally, with:
                          (i)    the first box enclosing the word ‘Time’; and
                         (ii)    each other box being empty and large enough for the time at which the patient’s blood glucose level is monitored to be clearly written in the box; and
                (c)    immediately under the row of boxes mentioned in paragraph (b)—a row of boxes, laid out on the page horizontally, with:
                          (i)    the first box enclosing the acronym ‘BGL’; and
                         (ii)    each other box being empty and large enough for patient’s blood glucose level to be clearly written in the box; and
               (d)    immediately under the row of boxes mentioned in paragraph (c)—a row of boxes, laid out on the page horizontally, with:
                          (i)    the first box enclosing the words ‘Time’; and
                         (ii)    each other box being empty and large enough for the time at which the pharmaceutical benefit is administered to be clearly written in the box; and
                (e)    immediately under the row of boxes mentioned in paragraph (d)—a row of boxes, laid out on the page horizontally, with:
                          (i)    the first box enclosing the words ‘Dose’; and
                         (ii)    each other box enclosing the abbreviation ‘u’ and being large enough for the dose to be clearly written in the box; and
                (f)    immediately under the row of boxes mentioned in paragraph (e)—a row of boxes, laid out on the page horizontally, with:
                          (i)    the first box enclosing the word ‘Initial’; and
                         (ii)    each other box being empty and large enough for the initials of the person who administers the pharmaceutical benefit to be clearly written in the box.
         (2)   For paragraph (1) (b) to (f), there must be enough rows and enough boxes in the rows to allow the administration of the pharmaceutical benefit to be recorded for each day of the 4 month period of validity of the residential medication chart.
Note   See section 2.05 for the requirements for the standard field for the expiry date of a residential medication chart.
2.10        Standard fields information—PRN (as required) pharmaceutical benefits
                The standard fields for an applicable pharmaceutical benefit that is required to be administered PRN (as required) must include standard fields for:
                (a)    the information mentioned in paragraphs 2.08 (1) (a) to (i); and
               (b)    the word ‘Indication’; and
                (c)    the expression ‘Max dose/24hr’; and
               (d)    a column of 4 boxes, laid out on the page vertically, with:
                          (i)    the first box enclosing the word ‘Date’; and
                         (ii)    the second box enclosing the word ‘Time’; and
                        (iii)    the third box enclosing the word ‘Dose’; and
                        (iv)    the fourth box enclosing the word ‘Initial’; and
                (e)    4 rows of empty boxes next to the column of 4 boxes mentioned in paragraph (d):
                          (i)    laid out on the page horizontally; and
                         (ii)    with each box in each row being large enough for the information mentioned in subparagraph (d) (i), (ii), (iii) or (iv) to be clearly written in the box.
2.11        Standard fields information—pharmaceutical benefits: short‑term medicines
                The standard fields for an applicable pharmaceutical benefit that is a short‑term medicine must include standard fields for:
                (a)    the information mentioned in paragraphs 2.08 (1) (a) to (i); and
               (b)    a column of 4 boxes, laid out on the page vertically, with:
                          (i)    the first box enclosing the word ‘Date’; and
                         (ii)    the second box enclosing the word ‘Time’; and
                        (iii)    the third box enclosing the word ‘Dose’; and
                        (iv)    the fourth box enclosing the word ‘Initial’; and
                (c)    4 rows of empty boxes next to the column of 4 boxes mentioned in paragraph (b):
                          (i)    laid out on the page horizontally; and
                         (ii)    with each box in each row being large enough for the information mentioned in subparagraph (b) (i), (ii), (iii) or (iv) to be clearly written in the box.
2.12        Standard fields information—variable dose pharmaceutical benefits
         (1)   The standard fields for an applicable pharmaceutical benefit that can be administered in variable doses must include standard fields for:
                (a)    the information mentioned in subsection 2.08 (1), other than subparagraphs 2.08 (1) (j) (ii) and (iii); and
               (b)    a row of boxes, laid out on the page horizontally, with:
                          (i)    the first box enclosing the words ‘Pathology result’; and
                         (ii)    each other box being empty and large enough for the pathology result to be clearly written in the box; and
                (c)    immediately under the row of boxes mentioned in paragraph (b)—a row of boxes, laid out on the page horizontally, with:
                          (i)    the first box enclosing the words ‘Dose prescribed’; and
                         (ii)    each other box enclosing the abbreviation ‘mg’ and being large enough for the dose prescribed to be clearly written in the box; and
               (d)    a row of boxes, laid out on the page horizontally, with:
                          (i)    the first box enclosing the words ‘Dose given’; and
                         (ii)    each other box enclosing the abbreviation ‘mg’ and being large enough for the dose given to be clearly written in the box; and
                (e)    a row of boxes, laid out horizontally, with:
                          (i)    the first box enclosing the words ‘Nurse initials’; and
                         (ii)    each other box being empty and large enough for the initials to be clearly written in the box; and
                (f)    a row of boxes, laid out horizontally, with:
                          (i)    the first box enclosing the word ‘Time’; and
                         (ii)    each other box being empty and large enough for the time at which the pharmaceutical benefit is administered to be clearly written in the box.
         (2)   For paragraph (1) (b) to (f), there must be enough rows and enough boxes in the rows to allow the administration of the pharmaceutical benefit to be recorded for each day of the 4 month period of validity of the residential medication chart.
Note   See section 2.05 for the requirements for the standard field for the expiry date of a residential medication chart.
2.13        Conditions—characteristics of certain standard fields
         (1)   The standard fields mentioned in the following provisions must be easily readable and clearly visible to a person looking at any page of the residential medication chart:
                (a)    subparagraphs 2.03 (a) (i) to (v);
               (b)    paragraphs 2.03 (b) and (c).
         (2)   The standard field for the expiry date mentioned in section 2.05 must be on the front page of the residential medication chart.
         (3)   The standard fields for a pharmaceutical benefit that is insulin must be in a part of the residential medication chart that relates only to insulin.
         (4)   The standard field for the patient’s blood glucose level must be next to the place in the residential medication chart where the date and time of administering the next dose of insulin after measuring the patient’s blood glucose level is to be recorded.
         (5)   The standard fields for a pharmaceutical benefit that is required to be administered in variable doses must be in a part of the residential medication chart that relates only to that pharmaceutical benefit.
2.14        Conditions—completing certain standard fields before supply of pharmaceutical benefit
                An approved medical practitioner, or an approved pharmacist, must not supply an applicable pharmaceutical benefit unless:
                (a)    an individual has completed the following standard fields:
                          (i)    the patient’s full name, mentioned in subparagraph 2.03 (a) (i);
                         (ii)    the Residential Aged Care Service ID of the residential care service in which the patient resides, mentioned in paragraph 2.04 (c).
                        (iii)    the medical practitioner’s full name, mentioned in paragraph 2.07 (a);
                        (iv)    the medical practitioner’s address, mentioned in paragraph 2.07 (b);
                         (v)    the medical practitioner’s PBS prescriber number, mentioned in paragraph 2.07 (c); and
               (b)    a medical practitioner has completed the following standard fields in the way described (if any) for the standard field:
                          (i)    the particulars sufficient to identify the applicable pharmaceutical benefit, expressed as ‘medicine’ and mentioned in paragraph 2.08 (1) (a);
                         (ii)    the date of prescribing the applicable pharmaceutical benefit, mentioned in subparagraph 2.08 (1) (b) (i);
                        (iii)    the dose of the applicable pharmaceutical benefit, mentioned in subparagraph 2.08 (1) (b) (ii);
                        (iv)    if applicable—the start date, mentioned in paragraph 2.08 (1) (c); and
                         (v)    if applicable—the stop date, mentioned in paragraph 2.08 (1) (d); and
                        (vi)    the frequency of administration of the applicable pharmaceutical benefit, mentioned in subparagraph 2.08 (1) (b) (iii);
                       (vii)    the route of administration of the applicable pharmaceutical benefit, mentioned in subparagraph 2.08 (1) (b) (iv);
                      (viii)    if applicable—the check box located immediately next to the word ‘Ongoing, mentioned in paragraph 2.08 (1) (e);
                        (ix)    if applicable—the check box immediately next to the words ‘Brand substitution not permitted’, mentioned in paragraph 2.08 (1) (f);
                         (x)    if applicable—the check box immediately next to the expression ‘CTG’, mentioned in paragraph 2.08 (1) (g); and
                        (xi)    if applicable—the standard field for the Streamlined Authority Code, mentioned in paragraph 2.08 (1) (i);
                       (xii)    the medical practitioner’s signature:
                                   (A)     on the cover page of the residential medication chart for a patient, mentioned in subparagraph 2.07 (d) (i); and
                                   (B)     for each pharmaceutical benefit that the medical practitioner prescribes for the patient using the residential medication chart, mentioned in subparagraph 2.07 (d) (ii).
Note 1   Paragraph (a) of the definition of PBS prescriber in Part VII of the Act includes a medical practitioner.
Note 2   See paragraph (b) of the definition of completed item in a residential medication chart in the Regulations for a requirement related to including the letters ‘PBS’.
Note
1.       All legislative instruments and compilations are registered on the Federal Register of Legislative Instruments kept under the Legislative Instruments Act 2003. See www.comlaw.gov.au.