US Pharm. 2009;34(8):12-15.
Females who wish to practice birth control and prevent sexually transmitted diseases (STDs) have a myriad of options available to them, including the contraceptive sponge, oral contraceptives, and the female condom.1 However, the options available to males are comparatively narrow, consisting mainly of condoms or a vasectomy. At this time in the United States, condoms are the only temporary method of birth control and STD prevention available to males. Therefore, any new development or FDA action in regard to condoms has a profound effect on millions of men.
Inconsistent/Incorrect Condom Usage
It is critical for condoms to be used consistently and correctly if they are to have any effect at all on reducing the risk of transmission of STDs and the risk of unintended pregnancy. A wealth of research confirms that condoms are used inconsistently and incorrectly much of the time. For instance, investigators surveyed a random sample of university students in Kentucky in regard to condom use.2 About one-half had never used condoms during vaginal intercourse. An overwhelming percentage (95%) failed to use condoms during oral sexual activity.
Another group of investigators surveyed sexually active heterosexual males in the U.S. aged 15 to 19 years to determine factors associated with high odds of condom use and consistent condom use.3 Adolescents with a lower chance of condom use and/or consistency were Hispanics, those without formal sex education, those who were older at the most recent sexual activity, those whose sexual partner was older or a casual first partner, those whose partner used a contraceptive method, those in longer relationships, and those who engaged in more frequent sexual activity.
Researchers surveyed heterosexual women with concurrent sexual partnerships in Houston, Texas, who were at high risk for contracting STDs.4 Despite being at high risk, the subjects’ prevalence of condom use at the most recent sexual encounter was only 26%. They were most likely to use condoms if the sexual encounter was casual and if they had not used alcohol and/or drugs. The authors concluded that the high rate of concurrent partnerships coupled with the low rate of condom use would allow a rapid spread of STDs, including HIV.
Finally, researchers studied a group of low-income women at risk of unintended pregnancy who visited public family planning and postpartum clinics and maternity wards in two Southeastern cities.5 Women in a long-term relationship, married women, and cohabiting women all used condoms less often. Having good communication with one’s partner increased the likelihood of condom use. Paradoxically, high expectations of emotional support from the partner in case of pregnancy actually increased condom use.
The above four studies were carried out in the U.S. However, recent studies in other countries are no more reassuring. This brief summary of current research indicates that an informed pharmacist who is willing and able to counsel patients about contraceptive methods can make a lasting impact on transmission of STDs and reduction of unwanted pregnancies.
The FDA and Condoms
Condomlike devices have been used to sheath the male penis since antiquity. Condoms in their current forms have been marketed on a widespread basis virtually since the invention of latex rubber in the 1800s.6
The FDA regulates condoms as medical devices under the Medical Device Amendments of 1976 and the Safe Medical Devices Act of 1990.7,8 Condoms have long been subject to such requirements as premarket notification, conforming to good manufacturing practices, adverse event reporting, prohibitions against adulteration and misbranding, and specific labeling requirements (e.g., expiration dates and warnings about latex sensitivity). Expiration dating is critical in assuring consumers that the latex has not deteriorated due to product aging. Latex sensitivity labeling was added to address many reports of severe allergic reactions and deaths related to rubber products.
Under the Safe Medical Devices Act of 1990, condoms are categorized as Class II devices, meaning that they require additional special controls to provide reasonable assurance of their safety and efficacy. However, the FDA had not yet established those special controls by the year 2000. Public Law 106-554, enacted in 2000, required the FDA to reexamine condom labels to determine whether the labels were medically accurate regarding the overall efficacy or lack of efficacy in preventing STDs, including the human papillomavirus (HPV).7 During the ensuing review, the FDA considered such factors as physical properties of condoms, slippage and breakage of condoms during actual use, actual STD risk reduction when using condoms, any evaluations by other federal agencies, and clinical studies in peer-reviewed journals. The agency concluded at that time that latex condoms are effective in reducing the risk of STDs. However, the special controls required by the Safe Medical Devices Act had yet to be elucidated. This gap was finally addressed by the FDA with the publication of a landmark document known as a Final Rule in the Federal Register in November 2008.7
The 2008 Final Rule designating special controls for male condoms made of natural rubber latex marked the first time that latex condoms were subjected to intense federal scrutiny.7 The FDA was careful to explain that the Final Rule applied only to latex condoms without spermicidal lubricants. The agency announced that it would provide special controls for spermicidal lubricated condoms at a future time.
In the 2008 Final Rule, the FDA shared additional scientific information developed during its considerations.7 During the evaluations, the FDA divided STDs into two groups based on the usual routes of sexual transmission. Group I STDs are transmitted solely via genital fluids to or from the head of the penis, an area that is fully covered when a latex condom is placed correctly and used as directed. This group includes HIV/AIDS, gonorrhea, chlamydia, trichomoniasis, and the hepatitis B virus. Group II STDs are those that can be transmitted in the same manner as Group I STDs, but can also be transmitted through contact with infected skin. In this group, the FDA placed HPV, herpes simplex virus, syphilis, and chancroid.
Condoms and Group I STDs: During development of the 2008 special controls, the FDA considered all available data. For instance, well-designed studies demonstrated an 80% to 95% reduction in risk of HIV. The FDA concluded that latex condoms are effective in reducing the risk of transmission of Group I STDs when used correctly and consistently.7
Condoms and Group II STDs: The FDA also concluded that consistent and correct use of latex condoms reduces risk of transmission of Group II STDs.7 By making this determination, the FDA confirmed the validity of evidence demonstrating a reduction in risk of transmitting diseases by contact with infected skin outside of the area covered by the latex condom.
The Special Controls: The FDA’s 2008 special controls for latex condoms fell into three categories: unintended pregnancy, transmission of STDs, and incorrect or inconsistent use.7 In regard to special controls for unintended pregnancy, labeling will now indicate that condoms are intended to prevent pregnancy but warn that they do not completely eliminate the risk of pregnancy. Package inserts must include contraceptive efficacy information, comparing pregnancy rates for latex condoms to other methods available in the U.S., such as medications, devices, and permanent sterilization. Labels will urge those with questions to contact a health care provider.
In regard to special controls for STD transmission, labels must state that condoms are intended to prevent HIV/AIDS infection and other STDs but will caution that they do not completely eliminate the risk.7 Labels will explain that condoms function as a barrier and will state that they are most effective at reducing transmission of STDs such as HIV and gonorrhea that are spread by contact with the head of the penis. They will warn that condoms are less effective at reducing Group II STDs, such as HPV and herpes. Labels will direct consumers to contact a health care provider if they think they might have contracted an STD.
The special controls addressing incorrect or inconsistent use will require condoms to carry labels that clearly outline directions for use and precautions against incorrect use.7 To promote consistent use, labels will warn consumers that a condom must be used correctly during every sexual act.
New Condom Material
Condoms have traditionally been made of three materials, each with its own advantages and disadvantages.1 Lambskin condoms are said to transmit heat and sensation more readily, but their pores allow transmission of HIV. Latex rubber condoms do not transmit heat and sensation as well, but they are impervious to penetration by STDs. Consumers using latex run the risk of deadly anaphylaxis. Polyurethane condoms are an intact barrier to STDs and do not present the risk of latex allergy.9 However, they are said to be stiff and lack the ability to stretch. Thus, they do not conform to the body contours as readily. They may also break more easily than latex.10
A recently introduced condom (Skyn) makes use of a new material known as polyisoprene.11 These condoms are softer than polyurethane. They are also malleable and stretchable in consistency, conforming more readily to the natural contours of the body. They are as effective as latex rubber and polyurethane in preventing pregnancy and STDs and present little risk of allergenicity.
Lubrication is a critical feature desired in condoms by most users. The manufacturer of Lifestyles X2 condoms has enhanced the traditional idea of lubrication by claiming to be the only premium condom that is lubricated inside and out with a gel containing l-arginine, which carries the claim of heightening sensation.12
The Trojan line of condoms recently marketed a new type of condom packaging known as Trojan 2GO.13 The package is a pocket-sized card containing ultra-thin lubricated latex condoms. The packaging provides greater durability so the condoms can be carried in a pocket or the wallet. Having a condom readily available may promote consistent usage.
Choosing a Condom
Dozens of condoms with a wide variety of options can be purchased. Condoms with spermicidal lubricants and a receptacle end are excellent choices. Lubrication helps prevent the condom from breaking during use, and the receptacle end allows some space to catch the ejaculate, which also helps prevent breakage. The addition of a spermicide to the lubricant helps prevent unintended pregnancy.
The material the condom is made of is important. Some condoms are made of lambskin, but they are not effective at stopping the HIV/AIDS virus, although they reduce the risk of pregnancy. The other three condom materials are far more effective at helping prevent transmission of sexually transmitted diseases (STDs), and they also reduce the risk of pregnancy when used as directed. The majority of condoms are made of latex, but this material can cause deadly allergic reactions in those who are sensitive to latex rubber. A few condoms are made of polyurethane, but they are not stretchy, and polyurethane tends to break more than latex because of its stiff nature. A new condom is made of polyisoprene, which stretches and may be more acceptable to the patient who has a latex allergy.
Using Condoms Correctly
After a condom is purchased, you must store it properly in a cool, dry place. Inside a car is not appropriate due to excess heat. Carrying condoms for a long period in your wallet is also not appropriate. Always check the expiration date of the condoms before purchase and before each use. If they have expired or were exposed to heat, discard them.
Place the condom on the penis prior to any vaginal, oral, or anal contact. The uncircumcised male should pull the foreskin back before applying the condom. It is critical to identify the correct side of the condom by unrolling it a few turns to be sure which is the inside and which is the outside. If the condom is put on upside down, it will not unroll. Most men will then attempt to turn it over and unroll it correctly. This is a great mistake. When the penis is erect, it tends to leak a little ejaculate prior to full ejaculation. If the condom has been incorrectly placed, it usually has that ejaculate on it. If the male turns it over for correct placement, the male secretions that have already leaked onto the inside can reach his partner, causing transmission of STDs and increasing the chance of pregnancy.
The condom should be unrolled completely to the base of the penis. If lubricant is needed beyond what was supplied in the condom, the correct type of lubricant must be chosen. It must not be oil-based, as with petrolatum or mineral oil. Instead, choose popular sexual lubricants such as K-Y or Replens. When the sexual act is finished, immediately withdraw the condom and penis by grasping the condom at the base of the penis.
Remember, if you have questions, Consult Your Pharmacist.
2. Kanekar A, Sharma M. Factors affecting condom usage among college students in South Central Kentucky. Int Q Community Health Educ. 2007-2008;28:337-349.
3. Manlove J, Ikramullah E, Terry-Humen E. Condom use and consistency among male adolescents in the United States. J Adolesc Health. 2008;43:325-333.
4. Richards JE, Risser JM, Padgett PM, et al. Condom use among high-risk heterosexual women with concurrent sexual partnerships, Houston, Texas, USA. Int J STD AIDS. 2008;19:768-771.
5. Wilson EK, Koo HP. Associations between low-income women’s relationship characteristics and their contraceptive use. Perspect Sex Reprod Health. 2008;40:171-179.
6. Youssef H. The history of the condom. J R Soc Med. 1993;86:226-228.
7. Food and Drug Administration, HHS. Obstetrical and gynecological devices; designation of special controls for male condoms made of natural rubber latex. Fed Regist. 2008;73:66522-66539.
8. Food and Drug Administration, HHS. Class II special controls guidance document: labeling for natural rubber latex condoms classified under 21 CFR 884.5300. Fed Regist. 2008;72:66645-66646.
9. Rosenberg MJ, Waugh M, Solomon H, et al. Acceptability of a new polyurethane male condom. Int Conf AIDS. 1996;11:239.
10. Tips for using condoms and dental dams. U.S. Department of Veterans Affairs. www.hiv.va.gov/vahiv?page=sex-
11. LifeStyles Skyn Condoms. Ansell Healthcare Products LLC. www.lifestyles.com/pdf/
12. LifeStyles X2 Condoms. Ansell Healthcare Products LLC. www.lifestyles.com/condoms.php. Accessed June 24, 2009.
13. Trojan 2GO Ultra Thin Condoms. Church & Dwight Co., Inc. www.trojancondoms.com/Product/
14. Female condoms. MedlinePlus. Medical Encyclopedia. www.nlm.nih.gov/medlineplus/
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