Republic ofthe Philippines Department of Health OFFICE OF THE SECRETARY July 30, 2015 DEPARTMENT MEMORANDUM No. 2015 - FOR: ALL UNDERSECRETARIES, ASSISTANT SECRETARIES; DIRECTORS OF BUREAUS, REGIONAL OFFICES, SERVICES AND SPECIALTY HOSPITALS; CHIEFS OF MEDICAL CENTERS _& HOSPITALS, COMMISSION ON POPULATION, AND OTHERS CONCERNED SUBJECT: Frequently Asked Questions (FAQs)_and_their_Answers_on_the Temporary Restraining Order Regarding Reproductive Products and Implanon and Implanon NXT Relative to the TEMPORARY RESTRAINING ORDER (TRO) issued by the Supreme Court on 17 June 2015 enjoining the respondents (DOH and FDA) theit representatives, agents or other persons acting on their behalf from: [1] granting any and all pending applications for registration and/or recertification of reproductive products and supplies including contraceptive drugs and devices; and [2] procuring, selling, distributing, dispensing or administering, advertising and promoting the hormonal contraceptive “Implanon” and “Implanon NXT”, the Department of Health came up with this set of FAQs that provides practical guidance for use in the implementation of the Family Planning Program particularly the delivery of FP services. Dissemination of these FAQs to all concemed is hereby required. For strict compliance. JANETTE LORETO GARIN, MD, MBA-H S orien Building , San Lazaro Compound, Rizal Avenue, Sta. Cruz, 1003 Manila Trunk Line 651-7800 Direct Line: 711-9501 Fax: 743-1829, 74361786 © URL: p//sww.doh.gov.oh; e-mail: seedoh.gov phFREQUENTLY ASKED QUESTIONS ON THE TEMPORARY RESTRAINING ORDER (TRO) ON IMPLANON AND IMPLANON NXT AND PENDING RECERTIFICATION OF REPRODUCTIVE PRODUCTS 1. Why was a TRO issued? A TRO was issued by the Supreme Court, as part of the judicial process, based on the petition filed by the antiRH group Alliance for the Family Foundation Philippines, Inc. (ALFI) and Atty. Maria Concepcion S. Noche. Until when is the TRO effective? The TRO is effective until lifted by the Supreme Court. 3. What does the TRO cover? The TRO restrains (1) the FDA from granting any and all pending applications for recertification of “reproductive products and supplies, including contraceptive drugs and devices” and (2) the DOH from “procuring, selling, distributing, dispensing or administering, advertising or promoting Implanon and Implanon NXT 4. What is the position of the DOH on the TRO? The DOH shall abide by the TRO. Thus, the Secretary of Health held in abeyance, the procurement of Implanon NXT and ordered DOH Regional Offices to refrain from distributing Implanon and Implanon NXT. Public health care providers are likewise advised not to dispense or administer the abovementioned products. The FDA has held granting of pending applications for re-certification of contraceptive drugs and devices. 5. Are all FP commodities covered by the TRO? No, The TRO only covers Implanon and Implanon NXT. All other contraceptive drugs and devices that were re-certified by the FDA (see list attached) prior to the TRO can be procured, sold, distributed, dispensed, administered, advertised and promoted by the DOH, other government agencies/units, non-governmental organizations and individuals. The procurement, distribution, dispensing or administration, advertisement, and promotion of all other family planning methods shall proceed as usual.6. What happens to the Implanon and Implanon NXT that were already distributed to LGUs? Implanon and Implanon NXT that were already distributed to LGUs shall not be dispensed to health care providers. They shall remain in storage until such time that the TRO is lifted. 7. Can LGU health care providers provide Implanon or Implanon NXT? No. LGU health care providers are covered by the TRO because they are public health care providers and are considered as “agents, representatives, or other persons acting in behalf of the DOH.” , Can private health care providers, CSOs and development partners provide services on implant insertion? Yes. CSOs, development partners and private health care providers can perform implant insertion provided that they are acting on their own behalf and the Implanon or Implanon NXT did not come from DOH. 9. Can DOH Regional Offices conduct training on insertion and removal of Implanon and Implanon NXT? DOH Regional Offices cannot conduct training on Implanon and Implanon NXT insertion because the TRO includes “dispensing or administering” Implanon and Implanon NXT removal. However, they can continue to train on Implanon and Inmplanon NXT removal The health care provider’s counseling and their advice given to clients may include the option for a progestin subdermal implant, as part of their duty to give full information on family planning methods in order for their clients to make the informed choice. However, it must be emphasized that “advertising and promoting” Implanon and Implanon NXT is covered by the TRO which means that the health care provider cannot, as their part of counseling, conduct an activity that support or provide active encouragement for the use of Implanon and Implanon NXT. On the other hand, DOH Regional Offices can continue providing other Family Planning commodities such as pills, injectables and IUDs. Other methods such as bilateral tubal ligation and no-scalpel vasectomy may continue to be performed. None of these are covered by the TRO. 10. Can we give implants to CSOs and private health care providers? While there is a TRO, the DOH, its Regional Offices, and LGUs cannot provide or dispense Implanon and Implanon NXT to CSOs and private health care providers.11. If there are clients who want to be inserted with Implanon or Implanon NXT, where can they go? Clients who want to be inserted with Implanon or Implanon NXT can go to CSOs, development partners or private health care providers. 12. Can public health care providers refer clients who want to be inserted with Implanon or Implanon NXT to CSOs? Yes. Public health care providers can refer the clients who want to be inserted with Implanon or Implanon NXT to CSOs, development partners and private health care providers. Referral of patients who have already chosen progestin subdermal implant is not the same as “advertising and promoting” Implanon or Implanon NXT and is not covered by the TRO 13, Can public health care providers conduct follow up care and implant removal to clients who have been previously inserted with Implanon or Implanon NXT? Yes, Public health care providers can conduct follow up care and implant removal to clients who have been previously inserted with Implanon or Implanon NXT.