E-DRUG: Oral hormonal contraceptives as OTCs
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Hi all
In South Africa, access is governed by the Schedules to the Medicines and Related Substances Act (Act 101 of 1965), where Schedule 0 is a general sales category (available in any retail outlet), Schedule 1 and 2 are pharmacist-only categories, and Schedules 3 to 6 are prescription-only (with increasing levels of control).
The inscription in Schedule 3 reads as follows:
"Hormones (natural or synthetic, including recombinant forms), with either hormonal, prohormonal or antihormonal action, unless listed elsewhere in the schedules;
a. when intended for oral contraception;
b. except when intended for human vaginal use (S2), and
c. except hormones when specifically intended for emergency postcoital contraception. (S2, S4, S5)"
As a consequence, oral hormonal contraceptives are Schedule 3 substances, when intended for oral contraception, and therefore accessible only on a prescription written by an authorised prescriber. In practice, most of these prescriptions are written by medical practitioners or by nurses working in primary care facilities in the public sector (including family planning clinics).
However, oral contraceptives (whether progestogen-only or combined oral contraceptives) are Schedule 2 substances, when specifically intended for emergency postcoital contraception. This allows their supply by pharmacists, without a prescription written by an authorised prescriber. However, there are extensive guidelines on emergency contraception in the Good Pharmacy Practice standards published by the South African Pharmacy Council (see http://www.e2.co.za/emags/GPPv12010/pageflip.html for online access to the 4th edition, published in 2010 or download the PDF at http://www.mm3admin.co.za/documents/docmanager/0C43CA52-121E-4F58-B8F6-81F656F2FD17/00010773.pdf).
There is one last option - according to section 22A(6)(l) of the Act, in an emergency, a pharmacist " may sell a Schedule 2, Schedule 3 or Schedule 4 substance on a non-recurring basis for a period not exceeding 30 days in accordance with the original prescription in order to ensure that therapy is not disrupted if he or she is satisfied that an authorised prescriber initiated the therapy, with the intention that the therapy be continued, and that the particulars of such sale are recorded in a prescription book or other prescribed permanent record". That allows for the supply of one month's supply of an oral contraceptive (Schedule 3), in an emergency, where the patients is able to provide sufficient evidence of having been prescribed a particular product, even if the pharmacist in question does not have sight of the original prescription. The intention here is to avoid disruption, not to circumvent the prescription-only status.
A pilot study was conducted in the late 1980s and early 1990s, in which pharmacists were provided with additional training and allowed by initiate oral hormonal contraceptives on their own, provided they referred their patients to a medical practitioner or family planning clinic once a year for a physical examination. In order to give them access to the higher Scheduled medicines, they were issued with a permit in terms of the Medicines Act. Some still operate in this way, as the pilot study was never formally closed. However, that remains an exceptional circumstance and not the norm. There are, proposals to develop a new cadre of authorised pharmacist prescribers, who will enjoy access to a limited list of prescription-only medicines (perhaps including hormonal contraceptives). This is in line with trends in many countries towards collaborative practice (see http://www.fip.org/uploads/database_file.php?id=318&table_id= for the FIP Statement of Policy on Collaborative Pharmacy Practice, adopted in 2010 in Lisbon), and with efforts to use task-shifting principles to ensure the most efficient use of all trained healthcare professionals.
This seems to be a reasonable set of legal provisions, based on considerations of safety, with appropriate access in two types of emergencies - post-coital contraception (most commonly using levonorgestrel-only products specifically registered for that purpose) and to avoid an inadvertent break in usage.
However, in line with the Medical Eligibility Criteria for Contraceptive Use (see http://whqlibdoc.who.int/publications/2010/9789241563888_eng.pdf for the 4th edition, published by WHO in 2009), there are contraindications to the continued use of oral hormonal contraceptives that need consideration by a suitably-trained health professional. It is possible, though, to extend prescribing privileges beyond medical practitioners, and there are many examples of nurses and pharmacists being trained to safely offer family planning services, including hormonal contraceptives (oral and injectable). As the range of contraceptive options increases (e.g. intrauterine systems and implants), so there will also be pressure to expand the range of personnel trained to provide these products.
regards
Andy