throbber
Back to Basics
`
`This research-based protocol might change the way you give intramuscularinjections.
`
`By Suzanne C. Beyea, MS, PhD,
`
`AJN / January 1996 / Vol. 96, No. 1
`
`AstraZeneca Exhibit 2054 p. 1
`InnoPharma Licensing LLC v. AstraZeneca AB IPR2017-00900
`
` ind Leslie H. Nicoll, MS, MBA, PhD
`
`needle. (Inserting a needle through the rubbertopof a
`vial can dull the needle or removethe needle coating
`that helpsit glide through the skin.) If you’re using a
`prefilled unit-dose syringe, check that no medication
`has dripped ontothe needle.If it has, wipe the needle
`with a dry,sterile pad before the injection.
`
`Choosing the — size syringe
`
`Whatsize syringe should you use? Try to matchit as
`closely as possible to the volume you'll be injecting.
`Less than 0.5 mL requires a low-dosesyringe that
`most closely approximates the required dose. A fine-
`ly graduated syringe (a tuberculin syringe, for exam-
`ple) will help ensure that the correct dose is adminis-
`tered.
`Research on the maximum volumeto be drawn
`up for a single injection is still inconclusive. The best
`recommendation seems to be this: For a large muscle
`such as the gluteus medius, use no more than 4 mL
`for adults and 1 to 2 mLforchildren and persons
`with less developed muscles; for the deltoid, use no
`more than 0.5 to 1 mL. Of course, you’ll want to
`minimize discomfort andtissue damage by adminis-
`tering a large dose slowly.
`Needle gauge and length depend on the consisten-
`cy ofthe solution and howfar the needle mustbe in-
`jected to reach the muscle. For most solutions, a 21-
`or 23-gauge needle is small enough to minimizetis-
`sue injury and subcutaneous leakage, yet large
`enoughto allow easy passage. Needle length de-
`pendsontheinjection site. The ventrogluteal (VG)
`area has the most consistent depth of subcutaneous
`tissue; in adults, the adipose layer is always less than
`3.75 cm. Generally, use a 1.5-inch needle for adults
`and a 1-inch needle for children.Sites with less sub-
`cutaneousfat, such as the deltoid or vastuslateralis,
`may require a 1-inch needle.
`
`o you rememberthefirst time you gave a
`patient a “shot”? Were you nervous and
`hesitant? Administering medications by
`intramuscular (IM) injectionis often the
`first invasive skill that nursing students learn.
`What manyof us don’t recall, however, is that
`even this mostbasic skill has a solid research base.
`Researchers havestudied IM sites, syringes, needles,
`and medication volumes. They’vealso studied inter-
`ventions that can reduce pain and discomfort.
`We asked over 200 nurses if they were aware of
`this research base. Mostsaid they werenot. Frankly,
`neither were we. So wedecided to explore thelitera-
`ture, going back to the 1920s. We found over 90
`studies related to IM injections. Using this literature
`and research base, we developed the following pro-
`tocol for IM injections.
`
`Preparing the medication
`Preparing an IMinjection is as importantas adminis-
`tering it. Whenever possible,use a filter needle to
`draw up medication from an ampule orvial. Hold
`the container pointed down. Don’t use the last few
`drops in the container; some have been found to
`contain foreign substances, such as glass and rubber
`particles, that you mightdraw upinto thesyringe.
`To minimize pain caused by tracking a medication
`through subcutaneoustissue, changeto a dry,sterile
`needle before giving the injection.If you’re using a
`prefilled syringe to draw up medication from a vialor
`ampule,instill the complete dose (from both the pre-
`filled syringe and thevial or ampule) into anothersy-
`ringe. This ensures that you'll be using a sharp, clean
`
`
`
`RYUJIOTANI
`
`Suzanne C. Beyea is an associate professor at Saint Anselm
`College, Manchester, NH. Leslie H. Nicollis a research associ-
`ate at the Muskie Institute, University ofSouthern Maine,
`Portland.
`
`34
`
`

`

`Selecting the injection site
`We suggest the VG asthe primary site for anyone over seven
`monthsold. The underlying muscle is well developed, and the
`site is free of nerves and blood vessels. Research showsthat in-
`juries—includingfibrosis, nerve damage, abscess, tissue necro-
`sis, muscle contraction, gangrene, and pain—have beenasso-
`ciated with all the commonIM sites (dorsogluteal, deltoid, and
`vastus lateralis, for example) except the VGsite.
`There are, of course, contraindications for using the VG
`site: muscle contraction, damagein the area, and administra-
`tion of hepatitis-B vaccine. With adults, use the deltoid to ad-
`minister hepatitis-B vaccine; with infants under seven months,
`use the vastuslateralis.
`To identify the VGsite, position the palm of yourright
`handon the left greater trochanter so your index finger points
`toward the anterior superioriliac spine. (Use your left hand on
`the right greater trochanter.) Now spread your middle finger
`to form a V.Theinjectionsiteis in the middle of the V.
`
`Preparing the patient
`As with anyinjection site, carefully assess it by observation
`and palpation.If the site is indurated,inflamed, or damaged,
`choose anothersite. If all injection sites show evidence oftis-
`sue damage,consideran alternate route.
`If the VG site appears acceptable, position your patient so
`that the muscle atthesite relaxes by followingthese steps:
`-
`© For patients lying on their side, have them flex the knee,
`then pivot the leg forward from the hip approximately 20° so
`it can rest on the bed.
`* For patients in the supine position, have them flex the
`knee on the side where they’ll receive the injection (for exam-
`ple, the right knee for an injection on therightside}.
`¢ Forpatients in the prone position, have them “toe-in”to
`internally rotate the femur.
`Although it’s possible to access the VGsite while the patient
`is standing, this poses an obvioussafety risk for both the pa-
`tient and yourself.
`Prior to injection, cleanse a circular area, twoto three inches
`in diameter, with a 70% alcohol wipe. Wait at least 30 sec-
`ondsto let the alcoholdry so it won’t be introduced into sub-
`cutaneoustissue during the injection, which cancauseirrita-
`tion ofthetissue.
`
`How to administer the injection
`Donotuse an air bubble in the syringe. A holdover from the
`days of reusable syringes, this can affect the medication
`dosage by 5% to 100%. Modern disposable syringes are cali-
`brated to give the correct dose without an air bubble.
`Which injection technique should you use? Nursing text-
`books describe two methods: spreading the skin between your
`fingers, and pulling the skin down orto one side (the Z-track
`technique). Spreadingthe skin increases the risk of medication
`leaking into the needle track and the subcutaneoustissue. The
`Z-track technique virtually eliminates this risk; it also pro-
`duces fewer complications andless discomfort, makingit the
`technique of choice.
`When administering an IM injection,insert the needle quick-
`ly and smoothly, using a dartlike motion andsteady pressure,
`at a 90° angle to theiliac crest, in the middle of the V you
`
`AJN / January 1996 / Vol. 96, No. 1
`
`formed with your fingers. After insertion, aspirate for five to
`10 seconds. That may seem like a long time, but when the
`needle is in a small, low-flow bloodvessel, it takes a while for
`the blood to appear. If no blood appears, inject the medica-
`tion slowly—approximately 10 seconds per mL. This slow,
`steady rate promotes comfort and allowstimeforthetissues
`to expand and begin absorbingthe solution.
`After you’ve injected the solution, wait 10 seconds so that
`the medication can diffuse through the muscle. Then smooth-
`ly withdraw the needle at the same angle of insertion. Once
`the needleis out, use a dry, sterile sponge to apply gentle pres-
`sure at the site. Don’t massagethesite; this could cause tissue
`irritation.
`Encourage the patient to perform leg exercises, such asflex-
`ion and extension, to help the muscle absorb the medication.
`Inspect the injection site within two to four hours. When you
`administer the next injection, check the formersite for red-
`ness, swelling, pain, or other evidence oftissue damage. These
`findings are not normalor to be expected. They should be
`documented according to your agency’s policy and communi-
`cated in a timely mannerto the primary physician for further
`evaluation and treatment measures.
`
`More research is needed
`The research on IM injections isstill continuing. An important
`area for study is the volume that various musclescansafely
`and comfortably absorb. For example, researchers have
`found various absorption rates for different muscles, but no
`one has documented the rate of absorptionin the gluteal
`medius(target muscle of the VG site) or comparedit with oth-
`er muscles. More research also needs to be done on interven-
`tions for complications from IM injections. Although more
`than 200 adverse effects have been documented in thelitera-
`ture, no onehas explored theefficacy of various interventions
`in minimizing these complicationsafter they occur and in pro-
`moting healing.
`Nurses have always wanted to provide a level of care that
`ensures the fewest possible negative outcomes. Today, this
`means studying the research that hasa direct influence onclin-
`ical practice. Next time you give an IM injection, follow the
`protocoloutlined here. Your techniquewill be solidly ground-
`ed in research,
`
`SELECTED REFERENCES
`
`Beecroft, P. C., and Redick, S. A. Possible complications ofintramuscularinjections
`onthe pediatric unit. Pediatr.Nurs. 15(4):333-336, 376, July-Aug. 1989.
`Beyea, S. C., and Nicoll, L. H. Administration of medications via the intramuscular
`route: An integrative review oftheliterature and research-based protocolfor the
`procedure. Appl.Nurs.Res. 8(1):23-33, Feb. 1995.
`Cockshott, W.P., et al. Intramuscular orintralipomatousinjections? N.Engl.J.Med.
`307(6):356-358, Aug, 1982.
`Farley, H.F., et al. Will that im needle reach the muscle? Am].Nurs. 86(12):1327—
`1328, Dec. 1986.
`Keen, M. F. Comparisonofintramuscular injection techniquesto reducesite
`discomfort andlesions. Nurs.Res. 35(4):207-210, July-Aug. 1986.
`Keen, M.F. Get on the right track with Z-track injections. Nursing 20(8):59, Aug.
`1990.
`
`Newton, M.,et al. Reviewing the “big three”injection techniques. Nursing 72(2):
`34-41, Feb. 1992.
`Rettig, F. M., and Southby, J. R. Using different body positions to reduce discomfort
`from dorsoglutealinjection. Nurs.Res. 31(4):219-221, July—Aug. 1982.
`Zenk, K. E. Beware of overdose. Nursing 3:28-29, Mar. 1993.
`
`35
`
`AstraZeneca Exhibit 2054 p. 2
`
`

This document is available on Docket Alarm but you must sign up to view it.


Or .

Accessing this document will incur an additional charge of $.

After purchase, you can access this document again without charge.

Accept $ Charge
throbber

Still Working On It

This document is taking longer than usual to download. This can happen if we need to contact the court directly to obtain the document and their servers are running slowly.

Give it another minute or two to complete, and then try the refresh button.

throbber

A few More Minutes ... Still Working

It can take up to 5 minutes for us to download a document if the court servers are running slowly.

Thank you for your continued patience.

This document could not be displayed.

We could not find this document within its docket. Please go back to the docket page and check the link. If that does not work, go back to the docket and refresh it to pull the newest information.

Your account does not support viewing this document.

You need a Paid Account to view this document. Click here to change your account type.

Your account does not support viewing this document.

Set your membership status to view this document.

With a Docket Alarm membership, you'll get a whole lot more, including:

  • Up-to-date information for this case.
  • Email alerts whenever there is an update.
  • Full text search for other cases.
  • Get email alerts whenever a new case matches your search.

Become a Member

One Moment Please

The filing “” is large (MB) and is being downloaded.

Please refresh this page in a few minutes to see if the filing has been downloaded. The filing will also be emailed to you when the download completes.

Your document is on its way!

If you do not receive the document in five minutes, contact support at support@docketalarm.com.

Sealed Document

We are unable to display this document, it may be under a court ordered seal.

If you have proper credentials to access the file, you may proceed directly to the court's system using your government issued username and password.


Access Government Site

We are redirecting you
to a mobile optimized page.





Document Unreadable or Corrupt

Refresh this Document
Go to the Docket

We are unable to display this document.

Refresh this Document
Go to the Docket