Increasingly, women are obtaining abortifacient medicines through pharmacies, drug sellers, and online or telemedicine services – particularly where abortion services are restricted or access is difficult. Many of these women are using medical abortion drugs safely on their own, although data on their clinical outcomes are limited. Many clinicians consider the self-use of medical abortion to be dangerous; however, from a strictly medical perspective, mifepristone and misoprostol meet many of the FDA criteria for being available over- the- counter (OTC): an acceptable toxicity profile, unlikely to be addictive, and a low abuse potential.
To demonstrate that medical abortion is appropriate for OTC distribution, a series of investigations would be required by the FDA. This research would need to establish that individuals can understand a Drug Facts Label for medical abortion, assess gestational age as eligible and rule out other contraindications for medical abortion, self-administer the medications according to instructions, and identify complications or need to seek medical care, including for ongoing pregnancy. In the short term, these efforts will help support a wide variety of efforts aimed at improving access to clinic-based medical abortion, and in the long-term, support regulatory approval for an OTC product.
Nathalie Kapp HRA Pharma, Paris, France - firstname.lastname@example.org Background: Pain is a predictable feature of induced abortion in both the first and the second trimester, but pain control regimens available to women vary considerably.
Methods: We searched the PubMed and Cochrane databases for publications of trials comparing methods of pain control during induced abortion.
Results: Few rigorously conducted studies of pain control regimens for medical abortion have been conducted. Five studies conducted in women with pregnancies <9 weeks' gestation found that prophylactic analgesia did not reduce medical abortion pain, including the most recent rigorous trial where prophylactic ibuprofen was administered and dosing was repeated through the abortion process. In second-trimester medical abortion, one study found more pain relief with higher doses of fentanyl delivered through PCA than lower doses; the only adjuvant therapy shown to be associated with decreased opioid use has been diclofenac. During first trimester surgical abortion, more than 40 randomized controlled trials are available. Paracervical block, conscious sedation, general anesthesia and non-pharmacologic interventions decreased procedural and postoperative pain during first trimester abortion. Second trimester surgical procedures generally use conscious sedation or general anesthesia which have not been the subject of comparative trials. The severity of pain experienced by a woman varies considerably, but appears to be influenced by the age of the woman, parity, history of dysmenorrhea, and fearfulness/ anxiety. Prior vaginal delivery and a shorter procedure time are associated with lower levels of pain.
Conclusion: As pain associated with the process of abortion should be expected, medication for pain management should always be offered to women who desire it, and may be combined with non-pharmacologic techniques. Further research is needed to determine the optimal analgesia regimens for first-trimester and second-trimester medical termination of pregnancy. To facilitate comparability of data, researchers should use contemporary medical abortion regimens, outcomes and study instruments to measure pain.