JP2002336331A - Injection administration scheduling method and recording medium for the same - Google Patents

Abstract

PROBLEM TO BE SOLVED: To completely use up injection in a cartridge by administration on a final day in the case of carrying out administration of the injection in a cartridge to a patient over a plurality of days according to a prescribed administration reference quantity (mg/kg/week). SOLUTION: This injection scheduling method has a step for inputting the weight of the patient, a step for inputting the cartridge capacity of the injection and a previously designated administration reference quantity, and a step for calculating and outputting a per diem administration quantity in which an administration quantity per day is nearly equal and the injection can be used up by administration on the final day.

Description

DETAILED DESCRIPTION OF THE INVENTION

[0001]

BACKGROUND OF THE INVENTION 1. Field of the Invention The present invention relates to an injection administration scheduling method and a recording medium therefor. Preparations, particularly injections, may be used to treat patient diseases. In this case, an injection is usually administered to a patient by a doctor, but for certain injections, the patient injects himself (self-injection).
One example of the injection is human growth hormone.

[0002] The above-mentioned self-injection is performed on a patient-initiated basis and without the supervision of a physician. Therefore, the injection must be self-injected while strictly complying with the predetermined administration reference amount. To this end, the physician schedules the injection and administers a cartridge and an injector containing the injection to the patient. The present invention describes an administration scheduling method for such an injection.

[0003]

2. Description of the Related Art As will be apparent from the following description, the present invention can be applied to any kind of injection, but the following description is made by taking the above-mentioned human growth hormone preparation (hGH) as an example. (A), (b), (c), (d), and (e) of FIG. 9 are diagrams schematically illustrating an example of an administration process of hGH.

In FIG. 1A, a cartridge 3 filled with an injection hGH is inserted into a holder 2 in FIG. In FIG. 2B, a press-fit attachment 4 is attached to one end of the holder 2. In FIG. 1C, the needle 5 is attached to the tip of the holder 2. In FIG. 4D, when a clickable knob provided at one end of the press-fitting attachment 4 is rotated one click at a time in the direction of the arrow shown in the drawing, a predetermined amount of injected hGH is press-fitted into the distal end side of the holder 2. .

When the tip of the press-fit attachment 4 is pressed, the needle 5 is pushed outward. Thus, the pen-type injector 1 is completed as shown in FIG. This is pressed against a predetermined part of the human body in the direction of the arrow to complete the injection. The amount of hGH injected by this injection can be adjusted by the patient himself / herself depending on how many clicks in FIG. 9D are performed. In this case, the amount of hGH required per week depends on the weight of the patient. Stipulated. For example, 0.175 mg / kg of the patient's body weight is administered daily in approximately equal amounts during the week. Therefore, a new cartridge 3 is added to the pen-type injector 1.
After the is inserted, until the hGH in the cartridge 3 is completely used, the injector 1 is used while changing only the needle 5 every day.

[0006]

As described above, when hGH is used as an injection, there is an administration reference amount designated in advance for the hGH. In the above example, 0.175 mg / kg body weight must be administered during one week, so the above reference dose is 0.175 mg / kg / week. Moreover, this amount must be kept almost even every day for any one week.

Assuming that the above conditions are the first condition,
Two second conditions must be satisfied. The second condition is that after starting injection of hGH using a new cartridge 3, when the last injection is performed on the last day, the hGH must be used up without leaving a drop in the cartridge 3. . If the second condition is not satisfied, it is necessary to start using the second cartridge 3 newly while leaving unused hGH in the first cartridge 3. This is extremely uneconomical, given that hGH is relatively expensive.

Therefore, generally, the hGH is first used up without remaining in the first cartridge 3, and the shortage of the specified amount of hGH on that day is supplemented with a new second cartridge 3. Is being done. Therefore, two injections are performed that day. However, in view of the fact that hGH is generally administered to infants in many infants, it is strongly desired to avoid such double injections as much as possible and to relieve infants of pain.

[0009] Under such circumstances, when instructing the patient on the dosing schedule of hGH, the physician must spend a considerable amount of time preparing the dosing schedule so as to avoid the above-mentioned double beating as much as possible. No. However, weighing the patient at the visit and formulating the dosing schedule, the fact that there are actually multiple cartridge volumes (eg 5 mg, 8 mg and 10 mg), and the minimum dose (one click indent) Considering that there are a plurality of types (eg, 0.05 mg, 0.2 mg, and 0.1 mg), etc., it is a great burden for doctors to create such an optimal administration schedule during busy medical hours. Problem.

Accordingly, the present invention has been made in view of the above problems,
It is an object of the present invention to provide a method for scheduling administration of an injection such as hGH, and a recording medium for the method, which enable a doctor to use a computer to create an optimal administration schedule according to the weight of each patient. It should be noted that the process of creating a dosing schedule, which has been performed manually by a physician by trial and error, is not simply replaced by computer processing. To put it the other way around, no operation method could be found that would allow the above-mentioned administration schedule creation process to be processed by a computer.

As a result of intensive studies, the present inventors have found that the above-mentioned calculation method which can be processed by a computer can be realized, and have completed the present invention.

[0012]

FIG. 1 is a diagram showing a schematic system configuration to which an administration scheduling method according to the present invention is applied. The treatment system 10 shown in FIG. 1 is mainly configured by a computer 13 held by a doctor 12.

First, a doctor 12 is provided with a recording medium 11 for storing a program created based on the present invention.
The doctor 12 reads the doctor 12 from the provided recording medium 11.
Is installed in the computer 13 owned by the computer. This is shown as "administration schedule creation software" 14 for the injection in the figure.

The doctor 12 activates the software 14 and first inputs various necessary data. The administration schedule creation software 14 runs the program based on the above input data and outputs a target administration schedule table. The output administration schedule table is provided to the patient 15 together with the pen-type injector 1 containing the cartridge 3 described above.

That is, the doctor 12 determines the weight of the patient, the cartridge capacity (for example, 5 mg, 8 mg, 10 mg, etc. described above),
By simply inputting required data such as the minimum dose (one click) from the keyboard of the computer 13, an administration schedule table that can completely use up one cartridge 3 provided to the patient 15 in a predetermined number of days is provided. It is created by the administration schedule creation software 14.

[0016]

FIG. 2 is a flow chart showing the basic steps of the method according to the invention. FIG. 3 is a modified flowchart of FIG. The flowchart of FIG. 2 includes the following steps. Step S11: Enter the weight of the patient.

Step S12: Input the cartridge volume of the injection provided exclusively for the patient and the administration reference amount specified in advance for the injection. Step S13:
Based on the above input information, the daily dose of the injection is approximately equal, and the daily dose that can use up the injection in the cartridge in the last day of administration is calculated and output.

In the above step, the injection is h
When it is GH or the like, generally, the body weight is expressed in kg, the cartridge capacity is expressed in mg, and the reference dose is expressed in mg / kg / we.
Often specified in units of ek. Step S1
Looking at 3, the same cartridge 3 is stored until the injection is used up, and the injection is administered using the above-described pen-type injector (1 in FIG. 9) capable of setting the minimum dose by a click operation. In this case, the above-mentioned daily dose can be displayed by clicking.

Examples of numerical values calculated based on the basic steps of the present invention described above will be shown. FIG. 4 shows a numerical example of a daily dose calculated based on the present invention (part 1),
FIG. 5 is the same figure (No. 2). The calculation conditions of the numerical examples shown in FIGS. 4 and 5 are as follows. The injection used was hGH.

The reference dose of hGH is 0.175 to
0.19 mg / kg / week, cartridge 3 used
Has a cartridge capacity of 10 mg. Further, one click of the cartridge 3 (see the arrow on the right side of FIG. 9D)
Is 0.1 mg. Under the above-described calculation conditions, on each of various body weights, on the first day of the administration of hGH,
FIG. 4 and FIG. 5 show the results of calculating the daily dose on day 3, day 3,... Based on the present invention.

In an actual calculation example, the weight is 15 kg, 16 kg,
Calculation results are obtained for each of 17 kg... 49 kg and 50 kg. For simplicity, FIGS. 4 and 5 show numerical examples of only five types of 15 kg, 22 kg, 33 kg, 44 kg, and 50 kg. . Weight 15kg
Specifically, the hGH daily dose (daily dose) is 0.175 mg / day.
0.3 mg (3 clicks) and 0.4 mg respectively on the first day, the second day ... the 26th day while keeping the kg / week
(4 clicks): 0.4 mg (4 clicks). The sum of these 26 days is equal to the cartridge capacity, ie, 1
0 mg, and the hGH in the cartridge 3 was completely used up by the administration on the 26th day of the last day.

Looking at the body weight of 33 kg, the daily dose of hGH is 0.175 mg / kg.
/ Day, 0.9 mg (9 clicks) and 0.8 mg (8
Click): 0.8 mg (8 clicks). The total of these 12 days is the above cartridge capacity, ie 10mg
And the hGH in the cartridge 3 is completely used up by the administration on the 12th day of the last day.

The above-mentioned administration schedule corresponding to the weight of each patient is output from the computer 13 to the doctor 12 as an administration schedule table shown in FIG.
2 provide to patient 15. In this case, in addition to the input steps of the first step S11 and the second step S12 in FIG. 2, a fourth step S14 in which the patient inputs an administration start date for starting administration of the injection hGH for the new cartridge 3 is performed. (FIG. 3).

Then, in a third step S13, a calendar displaying the daily dose amount for each day is generated. That is, the administration schedule table is provided to the patient in the form of a calendar. FIG. 6 is a diagram showing an administration schedule calendar provided to a patient by a doctor.

The example of the figure is a dosing schedule calendar provided when a pen-type injector 1 was provided together with three cartridges to a patient weighing 15 kg who came to the hospital on December 7, 2000. Numerical examples of the daily dose at this time are the same as the numerical examples shown in the first column (15 kg in weight) in FIGS. 4 and 5. Patients will self-inject hGH daily according to the numbers shown on this calendar.

As described above, when a plurality of new cartridges are provided to the patient, a calendar in which the daily dose is displayed for each of the second and subsequent cartridges is generated. Further, a marking for clearly identifying the daily display for the first cartridge and the daily display for each of the second and subsequent cartridges is made.

In the example of FIG. 6, the calendar for the marking is color-coded. The period indicated by B in FIG. 6 is blue, the period indicated by G is green, and the period indicated by Y is yellow. The first cartridge is used up in the blue B period, and the second and third cartridges are used up in the green G and yellow Y periods. FIG.
In the example, the patient needs to return to the hospital on February 23 and receive a new cartridge from the doctor. The doctor again measures the patient's weight on this day, creates a dosing schedule calendar corresponding to the patient's weight by the computer 13, and outputs it from the printer.

In the examples shown in FIGS. 4, 5 and 6, the administration of hGH is continued without resting all day, but the administration may need to be stopped periodically depending on the patient. In such a case, in addition to the administration start date in the fourth step S14 in FIG. 3, the number of rest days for hGH administration to be stopped is further input, and in the third step S13 in FIG. Then, a predetermined calculation is performed to calculate a daily dose. In addition, a calendar is generated that displays the daily dose and the days when the administration of hGH is suspended, on a daily basis. In this case, the daily display of the first cartridge, the daily display of each of the second and subsequent cartridges, and the daily display of the day when hGH administration is stopped can be clearly identified. Make the marking.
For example, on the suspension day, B, G, Y, etc. are not colored and are left colorless.

Returning now to FIG. 1, in the medical system 1 according to the present invention, on the right end of FIG. 5, days 26, 17, and 12 and on the right end of FIG. In addition, the patient of each weight can automatically inject a prescribed daily dose without leaving a drop of hGH in each cartridge and automatically use up the dosing schedule table (calendar in FIG. 6) to completely use up the hGH in the cartridge. Can be created by the doctor 12. For this purpose, the schedule creation software 14 in the computer 13 is provided from the recording medium 11.

Here, the recording medium 11 according to the present invention is a computer-readable recording medium storing a program for causing the computer 13 to execute a predetermined calculation procedure. More specifically, in the predetermined calculation procedure, at least the weight of the patient, the cartridge capacity of the hGH provided exclusively for the patient, and the administration reference amount specified in advance for the hGH are input to the computer 13. At the time (“data input” in FIG. 1), the daily dose of hGH is almost equal, and the daily dose that can use up the hGH in the cartridge in the last day is calculated. is there.

According to the implementation of the present invention, X _n (n = 1,
2 ...) is the daily dose on day n, a is the cartridge capacity, b and c are the lower and upper limits of the reference dose, respectively, and R is the number of days off the administration (if any). the above predetermined operation procedures, at least the following formula _{X 1 + X 2 + ... +} X n = a b ≦ X 1 + X 2 + X 3 + ... + X 7-R ≦ c b ≦ X 2 + X 3 + X 4 + ... + X 8 the _{-R ≦ c · · · · ·} b ≦ X n-1 + X n + X 1 + ... + X 5-R ≦ c b ≦ X n + X 1 + X 2 + ... + X 6-R ≦ c the number of days n satisfying simultaneously The procedure includes a procedure of determining the daily dose a / n obtained from the number n of days, and allocating the daily dose a / n so that the hGH in the cartridge is used up by administration on the last day. The above “increase / decrease by day” means that, for example, referring to the first column of FIG. 4, the daily dose is adjusted to 0.3 mg, 0.4 mg, 0.3 mg, and the like. I do.

The details of the above calculation procedure will be described below with reference to a flowchart. FIG. 7 is a flowchart (part 1) showing details of the calculation procedure based on the present invention, and FIG. 8 is a flowchart (part 2). [1] Conditions required for administration schedule for obtaining first, without considering the days to rest the administration, the dosage schedule of only day of administration X _1, X _2, ..., and X _n. However, the amount administered on the first day is X ₁ , and the amount administered on the second day is X
_2, the amount to be administered to day n and X _n, shall be used up completely single cartridge administration of n days. The number of days when one cartridge is actually used is the number obtained by adding the number of days of rest to n. In addition, the number of days during which dosing is stopped in one week is R
Days. From the given conditions, X _{1 to} X _n must satisfy the following conditions.

[0033]

(Equation 2)

Here, the capacity of one cartridge is a (m
g), the patient determines that the required hGH dose per week is b (mg / w
eek) or more and c (mg / week) or less (see S21 in FIG. 7). Equation (1) is obtained from the condition that one cartridge is completely used up in n days of administration. Also, if the R-day administration is absent during the week, the total weekly dose will be equal to the total amount on consecutive (7-R) days of this schedule. Therefore, from the condition that the total amount of consecutive (7-R) days must be equal to or more than b (mg / week) and equal to or less than c (mg / week) in any (7-R) days, the expression (2) N inequalities are obtained.

The minimum dose of the cartridge is d (m
Assuming g), each of X _{1 to} X _n must be a multiple of d. [2] Conditions to be satisfied by n In order to satisfy the conditions shown in [1], conditions that must be satisfied by n are obtained. First, when the respective sides of the n inequalities of the equation (2) are added, since X _{1 to} X _n appear (7−R) times on the middle side of the equation (2), nb <(7− R) (X ₁ + X ₂ +... + X _n ) <nc nb <(7−R) a <nc (3) Here, since a, b, c, and n> 0, this equation (3) becomes

[0036]

(Equation 3)

(S22). (N
The same condition is derived for the case of <7.) Further, since n represents the number of days of administration for using up one cartridge, it must be an integer. Therefore, n must be an integer satisfying equation (4). If there is no integer n that satisfies this condition, the average value of (7-R) a / c and (7-R) a / b is calculated to reduce the error, and the integer closest to that value (below the decimal point) The number (rounded to the first place) is set to n (S23). [3] Creation of administration schedule X _{1 to} X _n are obtained using n satisfying the formula (4).

First, assuming that a cartridge having a capacity of a (mg) is used evenly for n days, the daily dose is a / n
(Mg). However, X _{1 to} X _n must be a multiple of the minimum dose d (mg) of the cartridge. Therefore,

[0039]

(Equation 4)

If e is defined as in equation (5), the condition can be satisfied by setting the daily dose to e-click or e + 1-click and setting a schedule. In other words, the daily dose is e × d (mg), (e + 1)
× d (mg), and using for n days, the cartridge of capacity a (mg) can be completely used up by administration of n days.

Therefore, the day when ed (mg) is administered is defined as y
Assuming that the day when (e + 1) × d (mg) is administered is z day,

[0042]

(Equation 5)

Is obtained (S25). Here, if the capacity a of the cartridge is not a multiple of the minimum dose d of the cartridge, it is assumed that a is a multiple of d since there is no schedule that clearly satisfies the condition.
Therefore, y and z satisfying Expression (7) are integers. From the above results, administration of e × d (mg) was performed on day y, (e
It can be seen that if the administration of +1) × d (mg) is performed for z days, the cartridge having the capacity a (mg) can be completely used up by administration for n days.

In the following, actually, the administration of e × d (mg) is allocated to the y day, and the administration of (e + 1) × d (mg) is allocated to the z day to obtain the final dosage schedules X _{1 to} X _n . Procedure. Hereinafter, for the sake of explanation, the day on which e × d (mg) is administered is referred to as “A administration day”, and the day on which (e + 1) × d (mg) is administered is referred to as “B administration day”. First, a comparison is made between y and z to determine which of “A administration day” and “B administration day” is larger (S26).

When z is larger (when “B administration day” is larger), the dose (e + 1) × d of “B administration day” is
₀ , the dose _{ed of} the “A administration day” is v _1, and the interval n / y (the fractional part is rounded down) between the “A administration days” between the “B administration days” is “step” ( S27). When y is larger (“A administration day” is larger), “A
An interval n / z at which the “B administration day” is inserted between the “A administration days”, where v _{0 is} the dose ed of the “administration day” and v ₁ is the dose (e + 1) × d of the “B administration day”. (Truncation after the decimal point) is set as “step” (S28). Step S27
In steps S28 and S28, the smaller value of z and y is defined as q.

Next, the variables i and “count” (variable for counting the smaller administration days) are initialized to 0 (S29), and i is increased by 1 (S34).
The following procedure is repeated while i is less than n (loop from S30 to S35). i is the value in step S27 or S28
Is a multiple of “step” set in “
The dosage of the day if unt "is less than q is set to v _1,
“Count” is increased by 1 (S33). The dosage of the other day, and v ₀ (S32). With this process,
It is possible to insert the smaller dosing days at "step" day intervals between the larger dosing days.

X _{1 to} X _n obtained by the above procedure
Means that the administration day of e × d (mg) is y day, (e + 1) × d (m
The day of administration of g) is included on the z day. [4] Evaluation of Error In the above method, n for satisfying the necessary conditions of Expressions (1) and (2) was calculated, and a schedule for completely using the cartridge in these n days was obtained. However, Equations (1) and (2) are only necessary conditions for achieving the target conditions, and are not sufficient conditions. Therefore, the calculated schedule finally achieves the target conditions. Not happen. That is, when the total dose is calculated for all the consecutive seven days of the schedule calculated by the above method, the total dose may not be a value between the minimum and the maximum of the dose given in the condition. It is also conceivable that there is no integer n that satisfies Expression (4), that is, there is no schedule that satisfies the condition.

Therefore, in order to quantitatively evaluate the errors caused by these causes, the present system calculates the total dose for all consecutive seven days of the finally calculated schedule, and calculates the maximum value and the minimum value thereof. The maximum error for the value and dose was indicated. With this system, cartridge capacity 10 (mg), dosage 0.175-
0.19 (mg / kg / week), the minimum dose of the cartridge was 0.1 (mg), and the schedule was calculated for each 1 (kg) for patients weighing 15 to 45 (kg). .175 (mg).

This result has been evaluated by clinicians as being within a margin of error that can be adequately utilized in clinical practice.

[0050]

As described above, according to the present invention, by inputting necessary data into a computer, one cartridge can be completely replaced on the last day while maintaining the administration reference amount specific to each injection. A dosing schedule that can be used up is obtained. Therefore, it is possible to eliminate the "double injection" in which the shortage of the first cartridge is supplemented by the second cartridge.

[Brief description of the drawings]

FIG. 1 is a diagram showing a schematic system configuration to which an administration scheduling method according to the present invention is applied.

FIG. 2 is a flowchart showing the basic steps of the method according to the invention.

FIG. 3 is a modified flowchart of FIG. 2;

FIG. 4 is a diagram (part 1) showing a numerical example of a daily dose calculated based on the present invention.

FIG. 5 is a diagram illustrating a numerical example of a daily dose calculated based on the present invention (part 2).

FIG. 6 is a diagram showing an administration schedule calendar provided to a patient by a doctor.

FIG. 7 is a flowchart (part 1) showing details of a calculation procedure based on the present invention.

FIG. 8 is a flowchart (part 2) showing details of a calculation procedure based on the present invention.

FIG. 9 (a), (b), (c), (d) and (e)
FIG. 3 is a diagram schematically showing an example of an administration process of hGH.

[Explanation of symbols]

 DESCRIPTION OF SYMBOLS 1 ... Pen-type injector 2 ... Holder 3 ... Cartridge 4 ... Press-in attachment 5 ... Needle 10 ... Treatment system 11 ... Recording medium 13 ... Computer 14 ... Administration schedule creation software

────────────────────────────────────────────────── ───

[Procedure amendment]

[Submission date] September 3, 2001 (2001.9.3)

[Procedure amendment 1]

[Document name to be amended] Statement

[Correction target item name] 0028

[Correction method] Change

[Correction contents]

[0028] FIG. 4, in the example of FIGS. 5 and 6, but continues to administer also rest without hGH day and some patients also pause administered periodically. In such a case, in addition to the administration start date in the fourth step S14 in FIG.
Further enter the number of rest days to suspend the administration of GH,
In step S13, a predetermined calculation is performed in consideration of the number of rest days, and a daily dose is calculated. further,
A calendar displaying the daily dose and the day when the administration of hGH is stopped is displayed on a daily basis. In this case, a daily display of the first cartridge,
The daily display for each of the cartridges subsequent to the first one and the daily display for the day when the administration of hGH is suspended are marked so as to be clearly distinguishable. For example, on the suspension day, B, G, Y, etc. are not colored and are left colorless.

 ──────────────────────────────────────────────────続 き Continued on the front page (72) Inventor Yoshito Otake 3-10-17 Shoan, Suginami-ku, Tokyo F-term (reference) 4C341 LL30

Claims (9)

[Claims] 1. A first step of inputting a patient's weight, a second step of inputting a cartridge capacity of an injection provided exclusively for the patient and a pre-specified administration reference amount for the injection, Based on the input information, the daily dose of the injection is approximately equal, and the daily dose that can use up the injection in the cartridge in the last day of administration is calculated. And a third step of outputting. An injection administration scheduling method, comprising: 2. The method of claim 1, wherein the body weight is expressed in kg, the cartridge volume is expressed in mg, and the reference dose is defined in units of mg / kg / week. 3. The daily dose when the same cartridge is housed until the injection is used up and the injection is administered using a pen-type injector capable of setting a minimum dose by a click operation. The method according to claim 1, wherein the number of clicks is displayed. 4. In addition to the input steps of the first and second steps, the method further includes a fourth step of inputting an administration start date at which the patient starts administering the injection for a new cartridge. The method according to claim 1, wherein in the third step, a calendar displaying the daily dose is displayed on a daily basis. 5. In addition to the administration start date in the fourth step, the number of rest days during which the administration of the injection is suspended is further input, and in the third step, the calculation is performed in consideration of the number of rest days. The method according to claim 1, wherein the daily dose is calculated and a calendar displaying the daily dose and the days when the administration of the injection is stopped is displayed on a daily basis. 6. When a plurality of new cartridges are provided to the patient, a calendar that displays the daily dose for each of the second and subsequent cartridges is generated, and a daily calendar for the first cartridge is generated. Display and 2
5. The method according to claim 4, wherein the marking is performed so as to clearly identify the daily indication of each of the subsequent cartridges. 7. When a plurality of new cartridges are provided to the patient, a calendar displaying the daily dose for each of the second and subsequent cartridges is generated, and a daily display of the first cartridge is performed. 6. A marking for clearly identifying a daily display of each of the second and subsequent cartridges and a daily display of the day when the administration of the injection is stopped is performed. the method of. 8. When at least a patient's weight, a cartridge capacity of an injection provided exclusively for the patient, and a reference dose prescribed in advance for the injection are input to a computer, The dose of the injection is substantially equal, and
A computer-readable recording medium storing a program for causing the computer to execute a procedure for calculating a daily dose at which the injection in the cartridge can be used up in the last day of administration. 9. The method according to claim 1, wherein at least the following equations (1) and (2) are used. (Where X _n (n = 1, 2,...) Is the daily dose on the n-th day, a is the cartridge capacity, b and c are the lower and upper limits of the reference dose, respectively, and R is the number of days off from administration. ), And the number of days n that simultaneously satisfies
9. A procedure of allocating the injection in the cartridge to be used up in the last day of administration while increasing / decreasing the daily dose a / n obtained from the above on a daily basis.
A computer-readable recording medium according to claim 1.