Implanon®

► As you display slide #41:

§ Tell participants that you are now going to review the process of preparing for and inserting the implant.

§ Reinforce the point that the Implanon® training and hands-on practice they will receive shortly should be considered as a supplement to review of the Prescribing Instructions. It IS NOT a substitute or alternative to careful examination and study of the Prescribing Instructions.

Display slide #42 and emphasize that:

§ The information on the slide is the same as that contained in the Prescribing Instructions.

§ As just mentioned, participants should carefully review the prescribing instructions before inserting Implanon® for the first time.

§ Insertion is accomplished using the pre-loaded, disposable applicator. The use of the applicator is substantially different from the use of a classical syringe.

§ The insertion procedure is opposite of giving an injection; in that when inserting Implanon®, the obturator portion of the applicator must remain fixed while the cannula (needle) is retracted from the arm.

Make sure participants understand that during a normal injection the plunger is pushed and the body of the syringe remains fixed – during an Implanon® insertion, the obturator remains fixed and the needle is retracted. (NOTE: This may be a difficult concept for some participants to grasp – be sure to reinforce this concept at every opportunity during the training session.)

Remind participants that the positioning of the patient is important for proper insertion. The patient should lie on her back with her non-dominant arm turned out and bent at the elbow. Emphasize that participants should refer to the illustration in the Prescribing Information if they are unsure about the positioning of the patient. The positioning will also be discussed later on in this program.

Make sure participants understand that the patient should not be in a sitting position because of the danger of a fall or injury she should become faint or light-headed during the procedure.

► As you display slide #43, strongly emphasize the importance of proper placement and location of Implanon®.

Point out that the labeling emphasizes superficial placement: “Implanon® should be inserted subdermally, i.e., just under the skin (subcutaneously).”

Strongly emphasize the labeling information stating that “When Implanon® is inserted too deeply (intramuscular or in the fascia) this may cause neural or vascular damage. Too deep insertions have been associated with paresthesia (due to neural damage) and migration of the implant (due to intramuscular or fascial insertion), and, in rare cases with intravascular insertion. Moreover, when the implant is inserted too deeply, it may not be palpable and the localization and/or removal can be difficult later on.”

Stress and emphasize the importance of marking the skin and cleaning the site with a disinfectant.

Remind participants that it is important to apply anesthetic not only at the insertion site, but all along the insertion canal because:

§ The insertion needle may cause discomfort to the patient.

§ Making an opening along the entire insertion canal with the anesthetic needle and then injecting some liquid will make the insertion of the Implanon® needle easier because the anesthetic fluid has created a path for it to follow.

Emphasize the need to keep the needle sterile after removing it from the blister package and remind participants that, if the needle becomes contaminated, they should use a new package with a new sterile applicator for the insertion process.

► Slide #44 contains an animation to illustrate the location where the implant will sit within the patient’s arm.

Introduce the animation to the participants, then click on the box labeled Anatomy to display the actual animation.

► Source animation: Anatomy_v3.avi

► Slide #45 reinforces the importance of inserting Implanon® superficially.

Make sure participants understand that inserting the implant too deeply could result in damage to the brachial artery, the median nerve, the basilic vein or the medial cutaneous nerve, either at insertion or removal at a later stage.

► You may also wish to make participants aware that if the implant is inserted too deeply, the health care provider may not be able to palpate it and removal may be complicated. Palpation immediately after insertion is essential to confirm that the Implanon® implant has been properly inserted and will effectively inhibit ovulation.

Display slide #46 and review each of the steps of the process of removing the disposable applicator and verifying the presence of the implant in preparation for insertion.

Remind participants that they should refer to the labeling and Prescribing Information before inserting Implanon® for the first time.

► As you discuss this slide:

§ Emphasize the importance of checking for the presence of the white colored implant.

§ Demonstrate the process of tapping the needle shield to bring the implant into the needle tip.

§ Strongly emphasize the importance of keeping the applicator in an upright position (needle pointed upward) to prevent the implant from dropping out.

► As you display slide #47, keep in mind that the most important point conveyed on the slide is the fact that the needle tip should be slightly angled (~20º) as the skin is punctured.

Strongly emphasize that the importance of proper needle angle and stress that:

§ An angle that is too steep may result in an insertion that is too deep.

§ An angle that is too shallow will make it more difficult to puncture the skin.

► Slide #48 continues presentation of the steps in the insertion process. As you display the slide, emphasize the process of lowering the applicator to the horizontal position and lifting the skin with the tip of the needle.

Demonstrate the process of lowering the applicator to the proper horizontal position and lifting the skin.

Explain and demonstrate the process of inserting the needle to its full length while keeping the skin lifted and the applicator parallel to the skin.

Strongly emphasize that when the implant is placed too deeply, paresthesia and migration of the implant may occur. Moreover, removal can be difficult later on.

As you review the steps of the procedure, EMPHASIZE that you need to lift the skin after insertion of the needle in order to keep the insertion superficial.

Display slide #49 and continue discussing the steps of the insertion process.

Discuss and demonstrate the location of the obturator seal and the process of breaking the seal.

Discuss and demonstrate the process of holding the applicator with one hand and turning the obturator 90º using the free hand. Make sure participants have a clear understanding of the direction in which the obturator should be turned; e.g., toward the patient.

Respond to and clarify any questions participants may have about the direction the obturator should be turned, what is considered a 90º turn, etc.

Display slide #50 and continue discussing and demonstrating the steps of the insertion process by illustrating the process of fixing the obturator parallel to the patient’s arm with one hand and retracting the canula out of the arm using the other hand.

► As you discuss the process of holding the obturator and retracting the canula, be sure to share any personal experiences you have had with the insertion process, as well as any tips you may have for completing the canula retraction process correctly.

Emphasize that once the needle has been fully inserted, the Implanon® obturator itself should not move relative to the arm. Once the needle has been fully inserted, the obturator should remain in a stationery and fixed position as the canula is retracted.

Display slide #51 which describes the process of verifying that the implant is no longer in the applicator.

Demonstrate and illustrate the process of:

§ Checking the needle for the absence of the implant.

§ Palpating the patient’s arm to verify the presence of the implant.

§ Having the patient palpate the arm to verify the presence of the implant.

Strongly reinforce the importance of immediately verifying the presence of the implant by palpation. Emphasize that the implant should be palpable by BOTH the patient and the health care provider. If it is not palpable, the health care provider should complete further investigation immediately; preferably through ultrasound or other localization techniques which will be discussed in a moment.

Remind participants that a patient who cannot confirm the presence of Implanon® through palpation should be counseled to utilize backup contraceptive protection until the presence of Implanon® is confirmed.

Review each of the post insertion steps as described on slide #52.

Tell participants to refer to the Prescribing Information if they have any questions about counseling the patient regarding follow-up care.

► You may wish to remind participants to counsel patients to leave the pressure bandage in place for the recommended 24-hour period as its primary purpose is to minimize bruising at the insertion site.

Emphasize the importance of completing the User Card. Discuss its role as a reference during removal. Direct health care providers to emphasize that patients should keep the User Card in a safe place and bring it with them when they have Implanon® removed.

Display slide #53 and allow approximately 4-6 minutes to receive and respond to questions participants may have about the subject of the insertion procedure.

Be careful to manage and monitor the total time of the presentation. If your presentation is running long, you may wish to abbreviate this Q & A session and respond to individual participant questions during the Insertion Practice segment.

Display slide #54 and click the photo to display the insertion animation.

► After the animation sequence has been displayed, solicit and respond to any participants questions regarding the insertion process. As you recap the animation, be sure to highlight and emphasize:

§ The proper initial angle of the needle.

§ The process of lowering the applicator while lifting the skin so the applicator is parallel with the patient’s arm.

§ The process of holding (fixing) the obturator with one hand as you retract the canula out of the arm using the other hand.

► Source animation: c2_s1.mpg

► Slide #55 contains a full-motion video of the entire preparation, insertion and post-insertion procedure.

Use the video to review and summarize the entire insertion procedure prior to allowing participants to practice. To display the video, double-click the black box on the slide. Remind participants to observe the video closely as they are going to practice the procedure in just a few minutes.

Note: There is no voiceover or narration during the video, so you may wish to point out key aspects of the process to participants as it displays.

► Source: InsertionLive_320-240.wmv

Introduce slide #56 by strongly reemphasizing the importance of validating the presence of the Implanon® implant through palpation immediately after insertion.

Tell participants that if the implant cannot be palpated, they should assume it is not there and advise the patient to utilize alternative contraception methods until the presence of the implant is confirmed through imaging techniques such as ultrasound.

Make a transition to the discussion of improper techniques by telling participants that you are now going to present some animations that illustrate incorrect insertion techniques.

► Slide #57 contains an animation of the consequences of not lifting the skin during the insertion procedure.

Tell participants what to watch for during the animation, then double-click the photo to play the animation.

Note: There is no voiceover or narration during the animation, so you may wish to point out key aspects of the animation to participants as it displays.

Point out that failure to lift the skin during the insertion will result in an Implanon® implant that is inserted in the fat. While an Implanon® implant inserted into the fat layer will still be effective, it may be impalpable and make validation of proper insertion difficult.

► Source: demo3D-3_320-240_revised.wmv

► Slide #58 discusses an incorrect insertion and contains an animation illustrating the consequences of pushing on the obturator (as though one were giving an injection).

Tell participants what to watch for during the animation, then double-click the photo to play the animation.

Note: There is no voiceover or narration during the animation, so you may wish to point out key aspects of the animation to participants as it displays.

Point out that pushing on the obturator (rather than withdrawing it) may result in an insertion that is too deep or insertion of an implant that cannot be located by palpation.

► Source: demo3D-2_320-240_revised.wmv

► Slide #59 contains an animation of the consequences of an incorrect angle of insertion.

Tell participants what to watch for during the animation, then double-click the photo to play the animation.

Note: There is no voiceover or narration during the animation, so you may wish to point out key aspects of the animation to participants as it displays.

Show participants how inserting at an incorrect angle can lead to insertion into the muscle or fascia.

► Even though the implant is still considered effective if inserted into the muscle or fascia, the following problems could occur (among others):

§ Implant is not palpable and confirmation of presence must be obtained via visualizing techniques such as ultrasound.

§ Migration may occur

§ Removal may be complicated due to difficulty locating the implant or due to damage to surrounding structures.

Replay the animation a second time, if necessary, to call attention to any details that may be helpful to participants’ overall learning.

► Source: demo3D-4_320-240_revised.wmv

Insertion Procedure Practice—This segment of the workshop should take approximately 15–20 minutes and utilizes slides 61–63.

Make sure you have reviewed the practice session guidelines contained in this Leader Guide and know what participant techniques to evaluate before leading this segment of the workshop.

Instruction for Implementation of the Practice Session

Make a first insertion demonstration yourself for the whole group.

Distribute the dummy arms and applicators to participants. (You will be assisted by the Medical Representative present).

Tell participants you are going to walk through the first insertion practice together, as a group.

Using slides 61 – 63, walk through each step of the procedure and have participants mirror the steps as you discuss them.

NOTE: Each segment of the procedure is illustrated by a separate animation sequence. These animations DO NOT include voiceover narration so you can provide the commentary and highlight specific areas as you choose during the animation.

► After everyone has completed the first procedure as a group, allow participants to progress at their own pace. Monitor and supervise as necessary. If you are working with a co-facilitator, you may wish to divide participants into groups to maximize your ability to give everyone individual attention.

Make sure every participant completes at least 3 practice insertions. You should view and evaluate at least 1of the 3 insertions, but it is not necessary to view all of them.

Display slide #61 and tell participants the group is now going to practice the first part of the procedure.

Describe the steps involved in positioning the applicator.

► After describing this portion of the process, demonstrate it for the group using a dummy arm. When you are finished, ask the group to mirror the steps you just demonstrated.

Display slide #62 and describe the process of lifting the skin.

Describe the steps involved in positioning the applicator.

Demonstrate this portion of the process using a dummy arm.

► When you are finished, ask the group to mirror the steps you just demonstrated.

Observe each participant as they imitate your actions during this part of the process.

Display slide #63 and describe the process fixing the obturator with one hand and retracting the canula with the other hand.

Demonstrate the process for the group using a dummy arm, then ask the group to mirror the steps you just demonstrated.

Demonstrate the process of verifying implant insertion by checking the needle for the absence of the implant after insertion. Make sure all participants complete this step of the process after every practice insertion.

► After everyone has completed the process as a group, direct participants to complete at least 2-3 additional insertions at their own pace. Circulate among the participants so that you have an opportunity to observe, evaluate and individually critique every participant as they complete one procedure.

Display slide #64 and use it to introduce and position the localization discussion.

NOTE: This segment focuses on localizing the Implanon® implant after insertion and again prior to removal. This discussion should take 7–12 minutes.

SEGMENT OVERVIEW

Make sure that the following points are discussed at the appropriate times during your discussion of the importance of localization and the localization process:

§ Localization is an essential component of the insertion and removal process. The Implanon® implant should always be localized (either by palpation or other techniques) immediately after insertion and immediately prior to removal.

§ The Implanon® implant is non-radioopaque and will not be visible with an X-ray or CT imaging method.

Display slide #65 and position the information regarding the importance of localizing the Implanon® implant.

Emphasize that there are 2 points in time where the health care provider should localize the Implanon® implant by palpation or by other means:

§ Immediately after insertion

§ Prior to removal

Make the point that the first localization effort should always be by palpation and that additional localization efforts must be made ONLY IF the Implanon® implant cannot be located by palpation.

Remind participants that if, at any time, they are unsure about whether the implant is present (since it cannot be confirmed by palpation) and that the patient must always be counseled to use condoms or alternative contraception until the presence of the implant can be confirmed.

Display slide #66 and tell participants that it focuses on localization before removal.

Be sure to emphasize to participants that exploratory surgery is strictly discouraged.

Emphasize to participants that health care providers who cannot locate the implant by palpation, or feel they may not have enough experience to confidently remove a deep or difficult to locate implant, shouldn’t try to do so.

Tell participants to contact their Schering-Plough representative in such situations. Every local Schering-Plough office will be able to supply a list of qualified health care providers who have experience in removing implants that are difficult to localize.

► Slide #67 discusses the imaging techniques that are appropriate for use in localizing the Implanon® implant.

► As you discuss the slide, make the following key points:

§ The least invasive way of finding an implant is ultrasound. Ultrasound is preferred since it is usually the most accurate as well as it gives a 3-dimensional picture.

§ When attempting to localize an implant, participants should try ultrasound first.

§ An MRI may also be used to confirm the presence of the implant. Following verification of the presence of the implant, removal can be performed under live ultrasound guidance.

► You may wish to tell participants that incidents in which the implant moves or migrates are very rare and if there is movement, it is usually only a centimeter or less and in the same plane.

► Difficulty localizing an implant is more commonly caused by deep insertion or insertion at a location other than that recommended in the Prescribing Information.

► An ENG assay is a blood test that is done to identify the presence of an implant by confirming the presence of the hormone it releases. The number of laboratories that perform this test are limited, so it can only be done in the Netherlands. Health care providers considering completion of an ENG assay should contact their local Schering-Plough representative for more information.

► Additionally, due to cross-reactivity, the test cannot be done if the patient is using any other type of hormones. If the patient is using an alternative hormone contraceptive, the assay cannot be completed.

Display slide #68 as you discuss the use of ultrasound as a localization method.

Make the following points:

§ Proper equipment is required to utilize this technique.

§ When using ultrasound, you don’t actually see the implant on the image. As will be illustrated by the examples in subsequent slides, you are actually looking for a sharp acoustic shadow.


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