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ORTHO-EVRA TRANSDERMAL SYSTEM (The Patch)

VIEWS: 29 PAGES: 13

									                 ORTHO EVRA TRANSDERMAL SYSTEM (The Patch)


I. INTRODUCTION
   Ortho Evra is a combination transdermal contraceptive patch containing 6.0 mg
   norelgestromin (NGMN) and 0.75mg of ethinyl estradiol (EE). The patch has a
   contact surface area of 20cm2. It releases 150 micrograms of norelgestromin and
   20 micrograms of ethinyl estradiol into the bloodstream per 24 hours. In 2008 the
   manufacturer changed the package insert to address the slight increase in the risk of
   adverse events including venous thromboembolism.

    Ortho Evra is a thin, matrix-type patch consisting of three layers:
     The backing layer (polyethylene/polyester) protects the contents from the
       environment.
     The middle layer contains the hormones. Inactive components of this layer
       include: polyisobutylene/polybutene adhesive, crospovidone, non-woven
       polyester fabric and lauryl lactate.
     The release liner protects the adhesive layer during storage and is removed just
       prior to application. It is made of polyethylene terephthalate (PET) film with a
       polydimethylsiloxane coating on the side in contact with the middle adhesive
       layer.

     Following application of the Ortho Evra, the hormones reach reference levels within
     48 hours. The patch can maintain serum concentrations in the target range through
     9 full days. Hormone absorption was also tested under various environmental
     conditions such as a health club (sauna, whirlpool, treadmill) and in a cold water
     bath. The hormone concentrations in the bloodstream remained within the reference
     range.

II. CLIENT SELECTION
     Indications - Ortho Evra may be provided when contraindications do not exist.
       o For contraception

      Contraindications (WHO 3--Use of method not usually recommended unless
       other more appropriate methods are not available or acceptable, WHO 4--
       Method NOT to be used)
       o History of or current deep vein thromobosis (DVT)/pulmonary embolism (PE)
          (WHO 4)
       o History of cerebrovascular accident (stroke) (WHO 4)
       o Known thrombogenic mutations (e.g. Factor V Leiden, Prothrombin mutation,
          Lupus Anticoagulant, Protein C, Protein S and Antithrombin deficiencies)
          (WHO 4)
       o History of or current ischemic heart disease (WHO 4)
       o Multiple cardiovascular risk factors
                 Age > 35 years old and any tobacco use (WHO 3,4)
                 Diabetes mellitus with nephropathy, retinopathy, neuropathy, other
                    vascular disease or diabetes of >20 years duration (WHO 3,4)


Revised 1/2010                              1
                           Uncontrolled chronic hypertension, or controlled hypertension and
                            tobacco use (WHO 4)
          o      Active liver disease (viral hepatitis and cirrhosis) (WHO 4)
          o      Liver tumor (adenoma or malignant) (WHO 4)
          o      Breast cancer (current or past) (WHO 4)
          o      Prolonged immobilization due to recent/anticipated surgery or illness (WHO 4)
          o      Valvular heart disease with complications (pulmonary hypertension, history of
                 sub-acute bacterial endocarditis, risk of atrial fibrillation) (WHO 4)
          o      Migraine with aura
          o      Known or suspected pregnancy (WHO 4)
          o      Gallbladder disease (currently symptomatic) (WHO 3)
          o      Cholestastic jaundice with pregnancy (PI)
          o      Jaundice with prior hormonal use (WHO 3)
          o      Undiagnosed vaginal bleeding (PI)
          o      Cancer of the endometrium or other known or suspected estrogen -
                 dependent neoplasia (PI)
          o      Systemic Lupus Erythematous – With positive (or unknown) antiphospholipid
                 antibodies (WHO 4)
          o      Severe hypertension
                          (systolic ≥160 or diastolic ≥ 100) (WHO 4);
                          (systolic >140-159 or diastolic of 90-99 (WHO3)
          o      Hypersensitivity to any component of this product


In 2005, the package labeling for Ortho Evra was changed to include recent findings
that 60% more estrogen is absorbed from the patch than from some low dose pills and
the ring. Increased levels of estrogen may raise the risk of side effects, including VTE.
There are conflicting findings regarding increased risk of DVT. Two recent studies (one
comparing the patch to a pill with levonorgestrel and the other to a pill with
norgestimate) found a two-fold increased risk of blood clots among women using the
patch, although in absolute numbers, the risk remains very low. Even a two-fold
increase risk is dwarfed by the risk of VTE associated with pregnancy. A third study,
recently updated with an additional 17 months of data, found no increase in risk for DVT
in patch users compared to a norgestimate-containing pill. Clients need to be aware of
this issue since there have been law suits related to it.
The FDA considers Ortho Evra safe and effective when it is used according to the
labeling. (Sources: FDA, Ortho, January 18,2008)




Revised 1/2010                                   2
III. MANAGEMENT OF WOMEN WITH SPECIAL CONDITIONS REQUIRING
     FURTHER EVALUATION
      Decisions regarding individualized management, follow-up intervals, the need for
       additional testing or referral must be made based on protocols approved by the
       Medical Director. In addition, there should be consultation with the Medical
       Director if needed. A Request for Hormonal Contraceptives by Women with Risk
       Factors Consent Form must be signed and this must be documented in the
       medical record for any of the following medical conditions:

         Adverse Cardiovascular Risk Profile (WHO 3,4)
          o Tobacco use
          o Reported hyperlipidemia
                   CHO>240mg/dl, LDL>160 mg/dl, HDL<40 mg/dl, triglycerides 200-
                      499 mg/dl. (There is no mandatory cholesterol/lipid screening
                      requirements in Title X).
          o Diabetes
          o Chronic hypertension (> 140 systolic or > 90 diastolic)
          o Family history of premature coronary heart disease (CHD) in male first
            degree relative <55 years of age
          o Family history of premature coronary heart disease (CHD) in female first
            degree relative <65 years of age.

         Diabetes Mellitus (WHO 2, 3)
             o Ortho Evra use in women with diabetes must be individualized. As risk
                factors increase in number or severity, the less appropriate it is to
                prescribe Ortho Evra.
                     If the client is prehypertensive or hypertensive, it is mandatory to
                       consult the woman’s health care provider.

         High Blood Pressure (WHO 3)
          o If hypertension is controlled with diet or medication, the complete
             cardiovascular risk profile must be considered.
              Close follow-up is necessary to determine whether blood pressure
                elevation results from Ortho Evra use. If so, Ortho Evra should be
                discontinued or a different method used (as described in the blood
                pressure flow chart – see appendix A).
              Ortho Evra may induce hypertension in a very small percentage of
                previously normotensive women. If an Ortho Evra user is found to have a
                blood pressure of 140 systolic or above or 90 diastolic or above, the rise
                should be interpreted as being due to the Ortho Evra. Ortho Evra must be
                discontinued if such rise persists.

         Migraine without aura >35 years old (WHO 3,4)




Revised 1/2010                                 3
         Post-partum
          o Breastfeeding up to 6 weeks (WHO 4)
          o Breastfeeding 6 weeks to 6 months (WHO 3)
          o Non-breastfeeding < 3 weeks (WHO 3), < 4 weeks (PI)

         Medication Issues with Ortho Evra
          o Certain drugs may interact with Ortho Evra and may decrease the
            effectiveness in preventing pregnancy.

                 Drugs known to increase liver enzyme metabolism/decrease
                                contraceptive effectiveness
Anti Epilepsy Drugs (AEDs) - may also be used to treat certain psychiatric illnesses,
headaches, chronic pain and other conditions (WHO 3)
Carbamazepine (Tegretol) Oxcarbazepine (Trileptal) Phenobarbital, Phenytoin (Dilantin),
Primidone (Mysoline), Topirimate (Topamax)- mild

Anti-HIVs (HAARTS)- See management section below. (WHO 2)
Antiretroviral – Ritonavir-boosted protease inhibitors (WHO 3)
Note - Data is limited and rapidly changing. For up-to-date information check:
http://hivinsite.ucsf.edu

Anti-Mycobacterials (Drugs used to treat tuberculosis) (WHO 3)
Rifampin, Rifampicin, Rifamate

Other
         Natural medications may decrease efficacy (St. John’s Wort) (PI)
         Antifungals – Griseofulvin (PI)

         Management
          o HAARTs - HIV positive women who choose to use hormonal contraception
            should be encouraged to use condoms with each act of intercourse. Choice
            of hormonal contraceptive should be based on the woman’s HAART regimen
            and in consultation with provider delivering HIV care.

          o Anti-Epileptic Drugs (AEDS) and others listed above - Use of back-up barrier
            methods and the benefits and risks of using DMPA, IUD, or sterilization as
            alternatives should be discussed with women who need a high degree of
            protection.

          o There is no pharmacologic evidence that the acute or chronic use of systemic
            antibiotics (ie tetracycline, ampicillin) decreased the efficacy of Ortho Evra in
            women who use it correctly. The Ortho Evra package insert states that
            possibly certain antibiotics may decrease the effectiveness of use. Clients
            should be advised of this when deciding whether or not to use a back-up
            method of contraception.

         OrthoEvra may be less effective if client weighs 198# or more

Revised 1/2010                                  4
IV. MEDICAL SCREENING AND EVALUATION
     Comprehensive medical data base (history, physical examination and laboratory
      testing) should be completed prior to provision of Ortho Evra.

         Delayed Exam: Physical exam and related preventative services should not be
          deferred beyond 3 months after the initial visit and may not be deferred beyond 6
          months (unless there is a compelling reason for extending the deferral in the
          clinician’s judgment). Pelvic exams are not required on 13-18 y/o unless
          indicated. The reason for the deferral must be documented in the client’s medical
          record. A complete history and BP is required in the medical record.

         Written results of the physical exam done elsewhere within the last 12 months is
          acceptable. MDCH pap smear protocol guidelines must be followed for pap
          smear screening. Clients transferring from another provider must have a blood
          pressure measurement prior to providing Ortho Evra. A breast exam for women
          over 20 years of age must be offered if a hormonal method is prescribed.

V. CLIENT INFORMATION/INFORMED CONSENT
    Must Include:
      o Information/counseling regarding all contraceptive options available
      o Information (written or verbal) specific to Ortho Evra including effectiveness,
        benefits, risks, use, danger signs, potential side effects, complications and
        discontinuing issues, as documented in the FDA-approved Product Package
        Insert (PPI)
      o Information regarding sexually transmitted infections (STIs, including HIV
        infections) and counseling that Ortho Evra provides no protection against
        STI/HIV.
      o Client Information/Consent Form (Method Specific Consent)
      o A Request for Hormonal Contraceptives by Women with Special
        Conditions/Risk Factors (such as tobacco use, reported hyperlipidemia,
        diabetes, chronic hypertension, or multiple cardiovascular risk factors, as
        indicated.

         The Client Must be Given:
          o Written and verbal instruction on method use (package insert may be used)
          o A copy of the FDA approved product package insert (PPI). The importance of
             reading the FDA pamphlet must be encouraged.
          o A copy of the Method Specific Consent Form, if the client requests.
          o Emergency 24 hour telephone number and location where emergency
             services can be obtained
          o Clinic access information

VI. PRESCRIBING ORTHO EVRA
    Up to 14 cycles of Ortho Evra may be prescribed for initial and annual clients.
    Quick Start: Use is an off-label practice supported by clinical research and
      endorsed by the WHO.
      o Quick Start (same day start method) can be initiated if it is reasonably certain
         client is not pregnant and the client is not in need of emergency
         contraception. Instruct the client to apply the first patch on the day of the

Revised 1/2010                                5
                 clinic visit and use a backup method (condoms, etc.) for 7 days. If there is
                 concern about undetectable early pregnancy, the client should return for a
                 repeat pregnancy test 2 weeks. If the repeat pregnancy test is negative and
                 the client has no signs of pregnancy (i.e. nausea, breast tenderness),
                 continue the method.

         Timing of initiation: The table below should be followed when initiating Ortho
          Evra. Alternative timings must be individualized to ensure contraceptive
          protection.

         Current Method                      Apply Patch                                    Back Up

 No effective contraception           Anytime in cycle if it is certain client is   If more than 5 days since
                                      not pregnant                                  menstrual bleeding
                                           If possibility of pregnancy is          started, back-up for 7
                                              suspected, a highly sensitive         days
                                              urine test must be completed.
                                              If pregnancy test is negative,
                                              initiate patch and advise client
                                              to repeat urine test in 2 weeks


 COCs or NuvaRing®                    Anytime within 5 days of the last COC         None
                                      tablet.
                                      Within 24 hours of ring removal               None

 Progestin-only pills                 Any day of the month. There should be         None
                                      no skipped days between last pill and
                                      first day of Ortho Evra® use

 IMPLANON                             On same day implant is removed                Back up method for
                                                                                    7days

 DMPA                                 On day when next injection is due             None

 Paragard® or Mirena® in place        On same day IUD is removed                    Back up method for 7
                                                                                    days
 Post surgical abortion
                                      Within 5 days of completed procedure          None

 Post medical abortion                OK to initiate prior to ultrasound
                                      confirmation of termination of
                                      pregnancy

                                      Day of Misoprostol up to 7 days after         None
                                      Mifepristone

                                      Beyond 7 days after Mifepristone if
                                                                                    Back up method for 7
                                      intercourse not already resumed
                                                                                    days




Revised 1/2010                                       6
       Guidelines for Management of Deviations from the Recommended Regimen
        If the patch becomes loose or has fallen off:
          o For less than 1 day (24 hours) - advise the client to reapply the patch or to apply new
              patch immediately. No back up contraception is needed. The patch change day
              stays the same.

            o    For more than 1 day or if the client is unsure how long the patch has been loose or off
                 - advise the client that she may become pregnant. She should start a new 4 week
                 cycle immediately by putting on a new patch. This becomes day 1 of the new cycle
                 and is the new patch change day. The client must be advised to use back up
                 contraception for the first week of this new cycle.

                    The client should be advised not to attempt to re-apply a patch that is no longer
                     sticky, if it has become stuck to itself or another surface, if it has other material
                     stuck to it, or if it has previously become loose or fallen off. Advise the client
                     never to use tape or wraps to keep the patch in place. If the patch cannot be
                     reapplied, a new patch should be applied immediately.

           If the client has forgotten to change her patch:
            o At the start of any patch cycle (week one/day 1) - the client must be advised that she
                 could become pregnant. She should be advised to use back up contraception for one
                 week. She can apply the first patch of her new cycle as soon as she remembers.
                 This will give her a new day 1 and a new patch change day.
            o In the middle of a patch cycle (week 2 or 3):

            o    If the client has forgotten to change her patch for 1 or 2 days, she can apply a new
                 patch as soon as she remembers. She should be advised to apply her next patch on
                 her normal patch change day. No back up contraception is needed.

            o    If the client has forgotten to change her patch for more than 2 days, she should be
                 advised that she could become pregnant. She should start a new 4 week cycle as
                 soon as she remembers by putting on a new patch. She will have a new day 1 and a
                 new patch change day. She should be advised to use back up contraception for the
                 first week of her new cycle.

            o    At the end of a patch change cycle (week 4) - if the client has forgotten to remove her
                 patch, she can take it off as soon as she remembers. She should be advised to start
                 her next cycle on her normal patch change day. No back up contraception is
                 needed.

            o    At the start of the next patch cycle (week one/day1) - If the client forgets to apply her
                 patch, she should be advised that she could become pregnant. She should apply the
                 first patch of the new cycle as soon as she remembers. She will have a new day 1
                 and a new patch change day. She should be advised to use back up contraception
                 for the first week of her new cycle.

           If a client has adhered to the prescribed regimen and misses 2 consecutive periods,
            pregnancy should be ruled out.
           Ortho Evra must be discontinued if pregnancy is confirmed during use.




Revised 1/2010                                          7
VII. MANAGEMENT OF SIDE EFFECTS AND COMPLICATIONS
     Warning Signs of ACHES – May or may not be related to Ortho Evra use and
       further clinical evaluation is necessary to determine continuation.
       o A - Abdominal pain
       o C - Chest pain
       o H - Headaches
       o E - Eye Problems
       o S - Severe Leg Pain
     Vaginal Bleeding - Irregular menstrual patterns (spotting to menstrual flow) are
       common in the first 2-3 cycles of use, if these patterns continue past the first
       three cycles or if heavy bleeding continues, the client needs to be assessed.
       o Irregular bleeding - After determining consistent usage; no underlying
           pathology; R/O pregnancy; and if not at risk of STIs; reassure client. Use of a
           3 day course of NSAIDS may help.
       o Amenorrhea - R/O pregnancy
     Other side effects such as skin irritation, nausea, vomiting, breast tenderness,
       and headache should be further assessed.


VIII. FOLLOW-UP
       Ortho Evra users must be advised to return to the clinic:
        o If a significant hormonal related problem is suspected
        o If at increased risk for complications resulting from OrthoEvra use
        o If pre-hypertensive (systolic BP is 120-139 or diastolic BP is 80-89 on 2
          consecutive visits) client may continue Ortho Evra but should be counseled
          regarding lifestyle modifications. Referral to Primary Care Provider is also
          recommended.
        o At each Ortho Evra related medical visit, the client should be queried about
          changes in personal history, headaches, blurred or double vision, pain or
          swelling in arms or legs, chest pain or shortness of breath, abdominal pain,
          jaundice or severe depression.

     IX. DOCUMENTATION
          Order must be written in medical record initially, annually and upon method
           change.
          All Ortho Evra (patches) distributed must be documented in the medical
           record and/or computer system.
          All education/counseling sessions must be documented.




References:
World Health Organization (WHO). Medical Eligibility Criteria for Contraceptive Use. Third Edition, 2004
Manufacturers FDA approved Product Package Insert (PPI)




Revised 1/2010                                      8
                   Algorithm For The Management Of Clients Using CHC
                           Who Develop High Blood Pressure




          Reference: National Heart, Lung, and Blood Institute. Reference card from the seventh report of
          the joint national committee on prevention, detection, evaluation, and treatment of high blood
          pressure (JNC 7). May, 2003, Publication No. 03-5231.
          http://www.nhlbi.nih.gov/guidelines/hypertension/phycard.pdf Retrieved: February 2006

                                                                                          Appendix A


Revised 1/2010                                       9
          Client Information/Consent Form for Ortho Evra (The Patch)

Before you start using Ortho Evra, be sure you understand both the benefits and the
possible problems of using Ortho Evra (The Patch). This information sheet lists the
danger signs you should watch for. If you have any questions we will be happy to
discuss them with you.

You will get written information on the use, effectiveness, and medically recognized
benefits and risks of the available birth control methods and devices. You will get FDA
approved information provided by the manufacturer. You should read the information
and ask questions about anything you do not understand.

Ortho Evra works in the same way that birth control pills work, most of the benefits, risks
and side effects are considered to be the same for both methods but we know less
about its effects than we know about the effects of the Pill. Research studies with Ortho
Evra users are continuing.

Ortho Evra contains two hormones that are similar to hormones produced by a woman’s
body. They primarily work to prevent pregnancy by keeping eggs from being released
by the ovaries. You should not use the Patch if you have reason to believe that you
might be pregnant. In early studies of this new contraceptive, the pregnancy rate of
users was less than 1 per 100 women. Evra prevents pregnancy if you remember to
apply a patch once a week for three out of four weeks.

Benefits from using Ortho Evra include:
 predictable, regular menstrual cycles
 decreased menstrual cramps and blood loss
 less iron deficiency anemia
 less acne
 some protection from non-cancerous breast tumors and ovarian cysts
 some protection from ovarian and uterine lining cancer
 decreased risk of infections of the pelvis(PID)
 fewer ectopic pregnancies

There may be less protection from pregnancy when Evra is used with certain drugs,
especially those used to control seizures. You should talk to your clinician about what
to do if you take any other medicine with the Patch. If you see a healthcare provider for
any reason, you should tell them that you are using the Patch.

Patch users have a slightly greater chance than non-users of developing certain serious
problems that may become fatal in rare cases, including:
 blood clots in the legs that can travel to the lungs
 heart attack
 stroke
 liver tumors

You should not use the Patch if you have had, now have, or develop in the future:
 blood clots in the veins or arteries
 serious liver disease
 a heart attack or stroke
 cancer of the breast, or uterus
 headaches with numbness or weakness in the arms or legs
 headaches with vision problems or feeling as if the room is spinning
 migraine headaches and you are 35 years of age or older

Revised 1/2010                              10
    multiple cardiovascular risk factors (tobacco use, diabetes, high blood pressure, high
     cholesterol)
    valvular heart disease with complications
    known clotting conditions
    gallbladder disease (currently symptomatic)
    undiagnosed vaginal bleeding
    jaundice with prior hormonal contraceptive use or with pregnancy
    prolonged immobilization due to recent/anticipated surgery or illness
    known or suspected pregnancy
    allergy to any component of the patch
    systemic lupus

Minor reactions to Evra may include:
 nausea, vomiting
 weight gain or loss
 breast tenderness
 spotting between periods
 skin irritation at the patch site

You should watch for the following danger signs and to report any to a clinician
immediately:
 sharp or crushing chest pain or coughing blood
 shortness of breath
 unusual swelling or pain in the legs or arms
 sudden severe headaches
 changes in the frequency, severity, or associated symptoms of your headache
 eye problems such as loss of vision
 severe pain in the stomach or abdomen
 yellowing of the skin or eyes
 severe depression
 new lump in your breast
 unusually heavy bleeding from the vagina
 no period after having a period every month

Using the Patch does not protect against sexually transmitted infections and a serious
infection could cause sterility. If you or your partner has other sexual partners, you
should use latex condoms to prevent infections, even though you are using the Patch.

The Patch may be less effective for women weighing more than 198 pounds (90kg).




Revised 1/2010                               11
  I have read the above and understand the Client Information/Consent Form. I hereby
  request that a person authorized by _______________________________________
  (agency name) examine and treat me and that the Ortho Evra ® be provided to me.
  I have been given the package insert and have been advised to read the entire
  insert. I have had the opportunity to ask any questions.



  Signature of Client                                       Date:


  Signature of Witness                                      Date:

  Copy of consent given to client                       Declined




Revised 1/2010                           12
                     REQUEST FOR HORMONAL CONTRACEPTIVES
                 BY WOMEN WITH SPECIAL CONDITIONS/RISK FACTORS




Name of Client: ______________________________________

Before you give your consent, be sure you understand the information we have given
you. If you have any questions as you read, we will be happy to discuss them with you.
You can change your mind at any time about using this method. Remember that your
consent is entirely voluntary. You may ask for a copy of this form.

There are special risk factors that increase the chance of developing a serious problem
while using Combined Hormonal Contraceptives (CHC). The more risk factors you
have the greater your risk. The following risk factors have been identified:

_______Tobacco use
_______ Reported Hyperlipidemia
_______ Diabetes
_______ Chronic Hypertension
_______ Familial premature coronary heart disease
        Other


I have been counseled, have read the fact sheet and above statement, and I clearly
understand the risk factors. After thorough discussion with the clinician regarding my
risk factors we have agreed that combined hormonal contraceptives will be prescribed
for me.


Signature of Client              Date    Signature of Witness             Date




Revised 1/2010                             13

								
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