COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC:

Get the latest research information from NIH: Menu

The Direct Access Study: Access to Hormonal Birth Control Through Community Pharmacies

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00065871
Recruitment Status : Unknown
Verified November 2004 by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD).
Recruitment status was:  Active, not recruiting
First Posted : August 5, 2003
Last Update Posted : April 6, 2007
Information provided by:
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Brief Summary:
Hormonal birth control methods include birth control pills, patches, and vaginal rings; they are normally available only with a doctor's prescription. This study will evaluate a program designed to increase the availability of birth control by allowing pharmacists to give women hormonal birth control without a doctor's prescription. Under this program, pharmacists will evaluate women who want to use birth control according to specific guidelines created by doctors. If a woman meets the criteria in the guidelines, a pharmacist could then give her the appropriate form of hormonal birth control.

Condition or disease Intervention/treatment Phase
Contraception Behavioral: Contraceptive Screening by Pharmacist Behavioral: Contraceptive Prescribing by Pharmacist Not Applicable

Detailed Description:

The Institute of Medicine's Committee on Unintended Pregnancy urges increasing access to contraception through broadening the range of health professionals that provide birth control. Evidence-based family planning practice no longer requires a physical examination before prescribing hormonal contraceptives to women. Community pharmacists efficiently provide emergency contraceptive pills (ECP) and women report satisfaction with the direct access. These women, as well as many women purchasing less effective over-the-counter (OTC) contraceptive methods, could benefit from more pharmacist-dispensed birth control choices, such as hormonal methods. The Direct Access Study will assess the feasibility of pharmacists, under Collaborative Drug Therapy Agreements with independent prescribers, providing hormonal contraceptives in community pharmacies. Specifically, the study will evaluate the impact upon hormonal contraception initiation and continuation rates when women's care is managed by pharmacists.

Using Collaborative Drug Therapy Agreements jointly developed with licensed prescribers (physicians and nurse practitioners), pharmacists in four Fred Meyer pharmacies will identify women who are at risk of unintended pregnancy and will offer to evaluate them for their suitability to safely use oral contraceptives, contraceptive patches, or the contraceptive vaginal ring. Through self-administered medical and contraceptive history questionnaires, interested women will select the most suitable contraceptive methods. Pharmacists will then complete the screening process and prescribe hormonal contraceptives according to the protocol guidelines.

Pharmacists will encourage women to follow up with a primary care practitioner or family planning clinic for cervical exams and reproductive tract infection screening as indicated. Pharmacists will have authority to provide an initial 3-month prescription and an additional 9-month prescription if blood pressure is normal at a three-month revisit. Effectiveness of pharmacists' interventions will be measured by initiation and continuation of hormonal methods by women to whom pharmacists have offered them. Feasibility will be determined by measurement of both acceptability and sustainability. Acceptability will be measured by surveys of women, pharmacists, and prescribers. Sustainability will be measured by economic and work-flow outcomes for the pharmacies, including evidence that women, private third-party payers, and public payers are willing to pay for the services. If safety is documented after preliminary analysis, injectable contraceptive methods will be added to the study.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Enrollment : 250 participants
Allocation: Non-Randomized
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Improving Contraceptive Practice and Delivery Through Community Pharmacists: The Direct Access Study
Study Start Date : June 2003
Study Completion Date : February 2006

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Birth Control

Primary Outcome Measures :
  1. The number and characteristics of women who seek hormonal contraceptives from pharmacists as evidenced by study consent or enrollment.
  2. The number and characteristics of women not able to obtain hormonal contraceptives due to contraindications, costs, etc.
  3. The proportion and characteristics of those women who continue to use the initial method after 3, 6, and 12-months compared with national literature and with women who do not obtain the method by direct pharmacist access.
  4. Safety evaluation to include prescribing protocol adherence (no women with absolute contraindication given estrogen; blood pressure monitoring done prior to more than three cycles of estrogen methods; no woman given a hormonal method while pregnant.

Secondary Outcome Measures :
  1. The number and characteristics of women who choose hormonal contraceptives for the first time compared to national literature.
  2. The amount of time required for pharmacists to be trained and to conduct the defined interventions in the course of their ongoing pharmach practice.
  3. The number and characteristics of eligible Medicaid waiver applicants enrolled by pharmacists compared with state figures for other providers.
  4. The proportion of billed insurance claims that are paid.
  5. The number and types of referrals to clinicians made by pharmacists and the proportion of counseled clients who follow through on the referrals that were made.

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes

Inclusion Criteria

  • At risk for unintended pregnancy
  • Access to participating Fred Meyer Pharmacy
  • English-speaking
  • Health insurance or ability to pay for contraceptive care

Exclusion Criteria

  • Age less than 18 years
  • Age greater than 45 years
  • Unable to become pregnant
  • Not English speaking
  • Not planning to remain in area
  • Not planning to use the same pharmacy
  • Unable to pay for services

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00065871

Layout table for location information
United States, Washington
Fred Meyer Pharmacy
Kent, Washington, United States
Fred Meyer Pharmacy
Kirkland, Washington, United States
Fred Meyer Pharmacy
Puyallup-South Hill, Washington, United States
Fred Meyer Pharmacy
Seattle-Broadway, Washington, United States
Bartell Drugs, University Village
Seattle, Washington, United States
Sponsors and Collaborators
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Layout table for investigator information
Principal Investigator: Jacqueline Gardner, PhD University of Washington
Layout table for additonal information Identifier: NCT00065871    
Other Study ID Numbers: HD42427
First Posted: August 5, 2003    Key Record Dates
Last Update Posted: April 6, 2007
Last Verified: November 2004
Keywords provided by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD):
Pharmacist prescribers
Increased access
Hormonal contraception
Birth control pills
Birth control patch
Vaginal contraceptive ring
Additional relevant MeSH terms:
Layout table for MeSH terms
Contraceptive Agents
Reproductive Control Agents
Physiological Effects of Drugs