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The Benefits of Vaginal Drug Administration—Communicating Effectively With Patients

  • Authors: Brad Davidson, PhD; Felicia Hance Stewart, MD; Susan Kellogg-Spadt, CRNP, PhD; Anita L. Nelson, MD
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Target Audience and Goal Statement

This FBHC monograph is designed for obstetrician/gynecologists and nurse practitioners who care for reproductive-age women needing contraception.

The overall goal of this monograph is to educate clinicians about how to broach possibly taboo subjects such as sex, the vagina, and vaginal administration of medication with patients.

Needs Assessment

Through needs assessment surveys, literature searches, advisory board suggestions, and previous meeting evaluations and market research, the FBHC has determined a need to address clinician-patient interactions about sex, the vagina, and vaginal drug administration.

Upon completion of this activity, participants will be able to:

  1. Describe how women view and care for their vaginas and their level of comfort when talking about sex and vaginal issues with their clinician
  2. Summarize optimal communication techniques about sex, the vagina, and vaginally administered medications for patients
  3. Integrate information about vaginal anatomy and physiology into discussions with patients to enhance their understanding of vaginal administration of medications
  4. Consider how language choices can impact use of vaginally administered medications by patients
  5. Realize how sex-positive messages about contraception can be of interest and value to patients


Author(s)

  • Brad Davidson, PhD

    Brad Davidson, PhD Account Director for MBS/Vox CommonHealth Company Wayne, New Jersey

    Disclosures

    Disclosure: Sources of Funding for Research: Amgen Inc, AstraZeneca Pharmaceuticals LP, Aventis Pharmaceuticals, Berlex Laboratories, Boehringer Ingelheim Pharmaceuticals, Inc, Bristol-Myers Squibb Company, GlaxoSmithKline, Novartis Pharmaceuticals Corp, Organon Inc, Ortho-McNeil Pharmaceutical, Inc, Ortho Dermatological, Pfizer Inc, Sanofi-Synthelabo Inc

  • Felicia Hance Stewart, MD

    Adjunct Professor of Obstetrics and Gynecology and Co-Director of the Center for Reproductive Health Research & Policy at the University of California, San Francisco.

    Disclosures

    Disclosure: Sources of Funding for Research: Berlex Laboratories, Organon Inc, Ortho-McNeil Pharmaceutical, Inc; Consultant: Barr Laboratories, Inc, Berlex Laboratories, Merck & Co, Inc, Pfizer Inc, Roche Pharmaceuticals

  • Anita L Nelson, MD

    Professor, Department of Obstetrics and Gynecology David Geffen School of Medicine at UCLA Medical Director,Women's Health Care Programs Harbor-UCLA Medical Center Torrance, California

    Disclosures

    Disclosure: Sources of Funding for Research: Berlex Laboratories, National Institutes of Health/National Institute of Child Health and Human Development, Organon Inc, Ortho-McNeil Pharmaceutical, Inc, Pfizer Inc; Speakers' Bureau: 3M Pharmaceuticals, Barr Laboratories, Inc, Berlex Laboratories, Columbia Laboratories, Inc, Eli Lilly and Co, Organon Inc, Ortho-McNeil Pharmaceutical, Inc, Pfizer Inc; Consultant: Barr Laboratories, Inc, Berlex

  • Susan Kellogg-Spadt, CRNP

    Director of Sexual Medicine, The Pelvic & Sexual Health Institute in Philadelphia, Pennsylvania; Assistant Professor of Obstetrics and Gynecology at Robert Wood Johnson Medical School; The University of Medicine and Dentistry of New Jersey; Adjunct Faculty Member of the University of Pennsylvania Graduate School of Nursing and The Planned Parenthood Federation Nurse Practitioner Program.

    Disclosures

    Disclosure: Sources of Funding for Research: 3M Pharmaceuticals, GlaxoSmithKline, QualiLife, Pharmaceuticals, Pfizer Inc, Ther-Rx Corporation, Wyeth Pharmaceuticals; Consultant: Organon Inc, Pfizer Inc


Accreditation Statements

    For Nurses

  • Approved by the Continuing Education Approval Program of the National Association of Nurse Practitioners in Women's Health.

    The Continuing Education Committee of the National Association of Nurse Practitioners in Women's Health (NPWH) has approved this activity for 1.2 contact hours. CE Approval # 05-20

    Contact This Provider

For questions regarding the content of this activity, contact the accredited provider for this CME/CE activity noted above. For technical assistance, contact [email protected]


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CE

The Benefits of Vaginal Drug Administration—Communicating Effectively With Patients: The Vagina: New Options for the Administration of Medications

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The Vagina: New Options for the Administration of Medications , Presented by Anita L. Nelson, MD

The Vagina: New Options for the Administration of Medications

The vagina has a rich system of defenses and dynamic microbiology, as well as a rich vascular plexus that makes it ideal for absorbing drugs, according to moderator Dr. Anita L. Nelson, who presented a brief overview of the anatomy, histology, and immunology of the vagina. According to Dr. Nelson, the classic teaching has been that the opening and lower one third of the vagina are narrow and open into a larger space after passing through the urogenital and pelvic diaphragms, which act like sphincters. Although this understanding has been updated by findings from magnetic resonance imaging studies performed by Dr. Kurt Barnhart and colleagues at the University of Pennsylvania Medical Center, Philadelphia, Pennsylvania, both anatomical explanations and clinical experience explain why the vagina can securely retain drug delivery systems. The lower portion of the vagina has a peripheral nerve supply that is sensitive to pain, while the upper vaginal nerves are supplied by the autonomic nervous system, making it possible for a device to be inserted into the upper vagina and not be felt (Figure 1).

  • The vaginal rugae increase the surface area of the vagina, helping to retain a medication that is placed in the vagina and enhancing drug absorption (Figure 2). The rugae also permit the vagina to expand to accommodate intercourse and allow placement of a speculum, diaphragm, or vaginal ring without trauma.

  • Vaginal nerves.

    Figure 1:

    Vaginal nerves.

    (Enlarge Slide)
  • The vaginal histology is defined by a stratified squamous epithelium; the upper vagina is a mucous membrane that is highly vascular and contains elastic fibers, as well as dense connective tissue and muscle (Figure 3). Arteries and veins form a plexus around the vagina, and venous drainage of the vagina does not immediately pass through the liver (Figure 4). These features make the vagina effective in the uptake of many drugs and stable for long-term, continuous drug delivery systems such as a vaginal ring.

  • Vaginal rugae.

    Figure 2:

    Vaginal rugae.

    (Enlarge Slide)
  • The vaginal defense system is analogous to those in the gastrointestinal (GI) and respiratory tracts. Langerhans cells (specialized macrophages) scavenge for bacterial antigens on the vaginal surface and then "present" those antigens to the T and B cells, which results in cell-mediated immunity and in the secretion of vagina-specific antibodies. In addition, continuous epithelial sloughing creates a physical barrier to bacterial invasion.

    Lactobacilli are the most prominent microbes in a healthy vagina. These organisms maintain the low pH of the vagina and attach with specific pili to the vaginal epithelium to block adhesion of competing pathogens. These and other microbes produce lactic acid to maintain the acidic pH of the vagina. They compete with other microbes for nutrients and generate antimicrobial bacteriocides, including hydrogen peroxides.

    According to Dr. Nelson, the attributes of the vagina can be used to introduce a woman to the concept of vaginal drug administration. "Typically, most women think of the vagina as an unhealthy environment, because they associate it with unpleasant vaginal discharge, infection, or aroma," she said. "We can use the protective properties of the vagina, such as the presence of lactobacilli, as a way of creating a positive image of the vagina in our patient's mind, emphasizing how it is protected on an ongoing basis by a robust defense system and hormonal influences. We can also educate the patient about how a method of birth control such as the vaginal contraceptive ring might be of benefit, for example, in terms of enhancing vaginal lubrication."

    She noted that 1 trial showed that the contraceptive ring does not cause vaginal infections, does not affect vaginal pH or adversely change microflora content, and does not damage the vagina or cervix.[1] In addition, this trial suggested that there may actually be a vaginal benefit associated with use of the ring, because it confers an intact, thick epithelial layer, a low pH that optimizes conditions for lactobacilli to resist potential pathogens, and a minimal inflammatory response.[1]

  • Arteries and veins of the vagina.

    Figure 4:

    Arteries and veins of the vagina.

    (Enlarge Slide)

History of Vaginal Drug Administration

  • Vaginal drug administration has a long history dating back to the Middle Ages, reported Dr. Nelson. This route of administration has long been employed for postmenopausal delivery of hormones, and vaginal administration of recreational drugs such as cocaine has been reported in the medical literature. "Clinicians are already using drugs routinely in the vagina; we use bromocriptine vaginally in the treatment of hyperprolactinoma in women who suffer from nausea and vomiting with oral administration. In many cases, vaginal administration has proven to be superior to oral administration," she said. Of note, a recent study of vaginal delivery of misoprostol compared with oral administration for the induction of labor showed the vaginal route to be superior, while another study demonstrated that vaginally administered indomethacin was more effective than oral indomethacin for halting preterm labor.[2,3]

  •  

Advantages of Vaginal Hormonal Administration

  • The vaginal contraceptive ring confers steady serum hormone levels (Figure 5) and produces lower serum concentrations compared with oral or transdermal delivery (ethinyl estradiol, 15 µg/d) (Table 1). It also avoids hepatic first-pass metabolism, as well as GI interference with absorption. Finally, Dr. Nelson noted that there is no need for daily administration and the ring is a discreet method, which appeals to many women.

  •  
  •  
  • Area Under the Curve (AUC) Comparisons (Days 0-28)

    Table 1:

    Area Under the Curve (AUC) Comparisons (Days 0-28)

    (Enlarge Slide)
  •  
  • Pharmacokinetic comparison of serum hormone levels with pill, patch and vaginal ring .

    Figure 5:

    Pharmacokinetic comparison of serum hormone levels with pill, patch and vaginal ring .

    (Enlarge Slide)

Introducing the Vaginal Route to Reproductive-Age Women

  • Dr. Nelson suggested that the vaginal contraceptive ring is a "breakthrough product for reproductive-age women. It is a way of introducing them to the concept of vaginal administration for systemic drugs." In addition to contraceptive hormones, menopausal hormones can be administered through the vagina. In the future, vaginal administration of glyminox gel for contraception and prevention of sexually transmitted infections (STIs), terbutaline gel for dysmenorrhea and endometriosis, cecropin-containing gel for the prevention of STIs, a lidocaine-releasing intravaginal ring for cervical anesthesia, an oxybutynin ring for overactive bladder, tenofovir gel and other microbicides for the prevention of vaginal HIV transmission, and an antibody III-174 vaginal implant for the prevention and treatment of herpes simplex virus-2 infection may be routine.[4]

    "I believe we need to start talking about vaginal drug administration at a younger age, so that at any time in her life, a woman will feel comfortable considering different drug delivery systems," she said. "We want women to recognize that the vagina is a very natural place to deliver medication. Vaginal administration often minimizes side effects associated with oral or transdermal routes. And finally, vaginal administration is very easy to use and is very discreet." Using the vagina as a route for contraception instead of just for the treatment of vaginal infections or vaginal dryness conveys to the woman that her vagina is an integral part of her body and an important, healthy part of being a woman.

  •  

References

  1. Archer DF, Raine T, Darney P, Alexander NJ. An open-label comparative study to evaluate the vagina and cervix of NuvaRing users. Fertil Steril. 2002;78(suppl 1):S25. Abstract.
  2. Zieman M, Fong SK, Benowitz NL, et al. Absorption kinetics of misoprostol with oral or vaginal administration. Obstet Gynecol. 1997;90:88-92.
  3. Abramov Y, Nadjari M, Weinstein D, et al. Indomethacin for preterm labor: a randomized comparison of vaginal and rectal-oral routes. Obstet Gynecol. 2000;95:482-486.
  4. Alexander NJ, Baker E, Kaptein M, et al. Why consider vaginal drug administration? Fertil Steril. In press.