After November 7, Patient Brochure and Physician Labeling Will be Required for all Types ofIntrauterine DevicesSource: Family Planning Perspectives, Vol. 9, No. 5 (Sep. - Oct., 1977), pp. 229-230Published by: Guttmacher InstituteStable URL: http://www.jstor.org/stable/2134435 .

Accessed: 14/06/2014 09:24

Your use of the JSTOR archive indicates your acceptance of the Terms & Conditions of Use, available at .http://www.jstor.org/page/info/about/policies/terms.jsp

.JSTOR is a not-for-profit service that helps scholars, researchers, and students discover, use, and build upon a wide range ofcontent in a trusted digital archive. We use information technology and tools to increase productivity and facilitate new formsof scholarship. For more information about JSTOR, please contact support@jstor.org.

.

Guttmacher Institute is collaborating with JSTOR to digitize, preserve and extend access to Family PlanningPerspectives.

http://www.jstor.org

This content downloaded from 188.72.126.181 on Sat, 14 Jun 2014 09:24:02 AMAll use subject to JSTOR Terms and Conditions

After November 7, Patient Brochure and Physician Labeling Will Be Required for Al Types of Intrauterine Devices After November 7, 1977, every woman who contemplates using an IUD will be given a brochure, written in lay lan- guage, that contains "all the information necessary for [her] to make an intelligent decision regarding IUD use and con- tinuation."' The brochure is to be pro- vided by the manufacturer of each IUD. The final wording of the pamphlet-first proposed by the Food and Drug Ad- ministration (FDA) in 1975-was pub- lished in the May 10, 1977, Federal Reg- ister. Although the FDA has, since 1970, required that information (in the form of a brief package insert) about the use of oral contraceptives and the possible health risks involved be given to women who take the pill, there has been no such information routinely available to wom- en electing to use the IUD.

The new regulations similarly estab- lish uniform physician labeling for the IUD, also to be required after November 7. Until then, only devices containing a drug (such as the Progestasert) or active metal (such as the Copper 7 and the Cop- per T) will have been required to carry labeling for the prescribing physician.

Patient Brochure

The patient brochure contains informa- tion that may affect a woman's decision to use the IUD, as well as data pertaining to its continued use. So that decisions to use or not to use IUDs will be based on full and complete information, the man- ufacturer must provide statistics on ex- pulsion, medical removal and use-effec- tiveness rates obtained during the clini- cal trials of the particular device. * Preinsertion information. The patient is advised that before the device is in- serted she should consider carefully-on the basis of the brochure and discussion with her doctor-whether the IUD or some other method of contraception is most suitable for her.

The brochure advises women to in- form their doctors if they have ever had, or suspect that they have had, any of a list of conditions which make the IUD unsuitable for them. Some conditions are listed because they may contribute to side effects related to insertion (fainting attacks), affect retention of the device (abnormalities of the uterus), or be ag- gravated by the presence of an IUD (anemia, heavy menstrual flow or severe

cramps, pelvic, vaginal or uterine infec- tion, or venereal disease). Also noted are suspected or possible pregnancy (which might end in a septic spontaneous abor- tion), suspicious or abnormal Pap smear, and heart murmurs and heart disease (since women with these conditions are more likely to develop bacterial heart in- fections). Women are warned about al- lergy to copper and Wilson's disease (a skin condition believed to result from abnormal copper metabolism), because these may contraindicate the use of cop- per-bearing devices. Women are also warned about reported adverse reactions ranging from such minor side effects as backache, intermenstrual spotting, faint- ing at the time of insertion, and pain and cramps, to more serious complications such as blood poisoning, bowel obstruc- tion, abdominal adhesions, ectopic preg- nancy and septic spontaneous abortion. The brochure does not indicate the fre- quency of these events. Women are also warned about possible expulsion or frag- mentation of the device and perforation of the uterus. * Postinsertion information. Full in- structions about how to check for the continued presence of the IUD are giv- en, along with the recommendation that if expulsion or displacement is suspect- ed, another form of contraception should be used until the woman can see her doc- tor. The device should be checked by a physician within three months of inser- tion, and at least once a year thereafter, the brochure advises. The woman is told to find out from her doctor if and when her particular type of IUD has to be re- placed.

The woman is instructed to call her doctor if she experiences severe or pro- longed bleeding, pelvic pain or cramps, exposure to venereal disease or disap- pearance of the IUD's tail. In addition, she is warned not to undergo medical diathermy treatments of the abdomen or lower back if she is wearing a metal IUD, since the IUD may heat up and damage surrounding tissue.

A special section is included on the hazards of pregnancy that may occur with an IUD in place. The woman is advised that the IUD should be removed if possible. If the device cannot be re- moved, the advisability of pregnancy termination should be discussed with her doctor.

Physician Labeling

The physician labeling required by the FDA regulations contains information on prescription and insertion proce- dures, as well as more detailed discus- sion of the indications and contraindica- tions for IUD use, possible side effects and adverse reactions mentioned in the patient brochure. Not included in the pa- tient brochure is advice to the doctor to remove the device from the abdominal cavity if it perforates the uterus. In addi- tion, only the doctor is warned that "sys- temically administered sex steroids, in- cluding progestational agents, have been associated with an increased risk of con- genital anomalies." The FDA adds: "It is not known whether such anomalies could occur when pregnancy is con- tinued with a progesterone-containing IUD in place." (The only such device on the market is the Progestasert.)

Before an IUD is inserted, the physi- cian is told, a complete medical history should be taken, and a physical examina- tion performed, which "should include a pelvic examination, Pap smear, gonor- rhea culture and, if indicated, appropri- ate tests for other forms of venereal dis- ease," which might be aggravated by the presence of an IUD.

Nine conditions that contraindicate prescription of inert or copper-contain- ing IUDs are listed. These include: * "pregnancy or suspicion of pregnan- cy; * "abnormalities of the uterus resulting in distortion of the uterine cavity; * "acute pelvic inflammatory disease or a history of repeated pelvic inflammato- ry disease; * "postpartum endometritis or infected abortion in the past three months; * "known or suspected uterine or cervi- cal malignancy including unresolved, abnormal Pap smear; * "genital bleeding of unknown etiolo- gy; * "untreated acute cervicitis until infec- tion is controlled; * ". . . presence of diagnosed Wilson's disease; and * "known allergy to copper."

Insertion should be performed, if pos- sible, during or shortly after a menstrual period, to avoid insertion into a pregnant uterus. Insertion following birth of a child or abortion should be delayed until the uterus has returned to its normal size, doctors are told, in order to reduce the risk of perforation or expulsion.

Volume 9, Number 5, September/October 1977 229

This content downloaded from 188.72.126.181 on Sat, 14 Jun 2014 09:24:02 AMAll use subject to JSTOR Terms and Conditions

Physicians are also instructed that "the uterus should be carefully sounded prior to insertion to determine the degree of patency of the endocervical canal and the internal os, and the direction and depth of the uterine cavity. . . . Inser- tion of an IUD into a uterine cavity mea- suring less than 6.5 cm by sounding may increase the incidence of expulsion, bleeding and pain." Physicians are advised not to use force to overcome any

resistance they might encounter because of cervical narrowness.

The need and demand for full infor- mation about the IUD was highlighted by a recent report in the American Jour- nal of Public Health.2 Of 256 women given brochures about the Progestasert IUD, almost all said that they were an important source of information and should be given to all women using this device. Half of the women were given booklets prepared by the manufacturer, Alza Pharmaceuticals, and half were giv- en booklets based on the preliminary FDA patient labeling. While 82 percent of the women who read the FDA version said that it provided a clear discussion of

the potential dangers, only 57 percent of women who read the Alza version said that it did so. More than twice as many women who read the Alza brochure (35 percent) as women who read the FDA brochure (16 percent) said that the book- let was commercial and promotional. "Neither version," the investigators re- port, "was seen as presenting informa- tion that was 'too negative.' "

Rfrnm

1. Federal Register, 42:23772, 1977.

2. H. Benson, L. Gordon, C. Mitchell and V. Place, "Patient Education and Intrauterine Contraception: A Study of Two Package Inserts," American Joumal of Public Health, 67:446,1977.

World Fertility Survey, Pakistan: Unwanted Fertility Is High While Contraceptive Access and Practice Are Minimal Recent data from Pakistan give the lie to the conventional wisdom that the reason women in developing countries have many children is that they want large families.1 A 1975 nationwide survey shows that in this Asian country, where most women marry before they are 17, four in 10 want no more children by the time they reach their late twenties (when they have an average of three children); six in 10 want no more by the time they are 34 (and have an average of four chil- dren). Most Pakistani women have at least five children before the end of their reproductive lives-apparently because so few practice contraception. Indeed, the great majority have no idea where to go to obtain a birth control method.

These are among the preliminary findings of the Pakistan Fertility Survey

(PFS), one of the first segments of the World Fertility Survey (WFS) to be com- pleted and published. Full-scale WFS surveys are under way or have been com- pleted in 34 countries. (The WFS is be- ing carried out by the International Sta- tistical Institute, with financial assis- tance from the United Nations Fund for Population Activities and the United States Agency for International Develop- ment.)

For the Pakistani study, a national sample of 4,949 ever-married women aged 10-50 was interviewed in selected urban and rural sites. As in the country as a whole, about three-quarters of the women lived in rural areas. They had borne an average of 4.3 children, but the average number of living children was 3.2 per woman. As the PFS points out,

"In Pakistan, infant and child mortality is very high, and nearly 47 percent of ev- er-married women who had at least one birth have experienced a loss of at least one child." Few women had any formal education, and few were employed out- side the home.

Marriage in Pakistan is "nearly uni- versal," the Survey noted, and women marry early. The mean age at first mar- riage is estimated at 16.6 years. The legal age for marriage is 16 for women, 18 for men.

As Table 1 shows, about half the cur- rently married women said that they wanted no more children. WVhile only four percent of women younger than 20 gave this response, the proportion rose sharply among those in their prime childbearing years. Almost two in 10 women aged 20-24, four in 10 women aged 25-29 and just over six in 10 wom- en aged 30-34 said that they wanted no more children. Women in these three age groups had an average of 1.5,2.8 and 4.0 living children, respectively.

The data indicate that five in 10 wom- en with three living children, seven in 10 women with four children and eight in 10 with five children said that they did not want any more (not shown in table).

While 49 percent of the currently mar- ried women wanted no more children, only six percent were using some meth- od of birth control. As the table shows, only among women aged 35-39 were as many as one in 10 practicing contracep- tion. Even among women at risk of con- ceiving (those currently married, not sterile or with a sterile husband and not pregnant) who said they did not wish to have any more children, only 21 percent were practicing contraception at the time

I.

'1 p f '9

I'

i1I '2 *f

230 Family Planning Perspectives

This content downloaded from 188.72.126.181 on Sat, 14 Jun 2014 09:24:02 AMAll use subject to JSTOR Terms and Conditions