Implementation Regulations Governing Needle-Syringe Services and Alternative Therapy

2008-07-24
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Article 1
This set of Regulations is formulated in accordance with regulations of Paragraph 1, Article 9 of the HIV Infection Control and Patient Rights Protection Act.
Article 2
The peer education workers mentioned in this set of Regulations refer to individuals who have used drugs, and who have been trained and approved by the competent authorities to assist in the implementation of service measures through their empathy over drug users and understanding of the relevant drug use behavior.
The extension service workers mentioned in this set of Regulations refer to individuals who have been trained and approved by the competent authorities to execute service measures on mobile-basis in communities.
Article 3
To prevent the spread of drugs, competent authorities may provide the following service measures:
1.needle-syringe services: to provide, exchange and recall needles and syringes;
2.alternative therapy: to implement alternative therapies for additions to controlled drugs.
Article 4
Targets for whom the service measures of the preceding Article are to be implemented are as follows:
1.needle-syringe services: persons using needles and syringes to administer drugs;
2.alternative therapy: persons diagnosed and confirmed by psychiatry specialists as addicts to opium groups and have no counter-indications against methadone hydrochloride and Buprenorphine HCL.
Article 5
The service measures in Article 3 shall be planned and promoted by the central competent authority, and supervise local competent authorities for implementation; when necessary, financial subsidies may be made.
Article 6
Medical care institutions, medical laboratories, pharmacies and other private sector groups or enterprises may, upon approval of local competent authorities, implement needle-syringe services. Validity of the approval is for one year.
Local competent authorities may implement needle-syringe services in communities where non-profit needle-syringe vending machines are set up and peer education workers or extension service workers work on mobile-basis.
Article 7
When providing needle-syringe services, the following services shall also be implemented at the same time:
1.health education: on the prevention of blood-transmitted infectious diseases, to avoid discarding used needles and syringes at will;
2.service information: referral for the testing of HIV, alternative therapies, drug cessation, medical care, employment etc.;
3.hother matters approved for implementation by the competent authorities.
Article 8
Identification notices approved and issued by the local competent authorities shall be posted at the needle-syringe service sites; when executing duties, the needle-syringe service workers shall carry documents sufficient to identify themselves.
Article 9
Medical care institutions meeting the following conditions may apply for designation as alternative therapy execution institutions (hereafter referred to as the execution institutions):
1.with one or more each of physicians, pharmacists and nursing personnel;
2.physicians carrying use licenses for controlled drugs.
Organizations that accept applications of the preceding Paragraph are those regulated in the Drug Hazards Control Act and the Controlled Drug Management Act.
The execution institutions of Paragraph 1, if unable to provide relevant services in clinical psychology, occupational therapy or social work, shall sign cooperation contract with the drug cessation hospitals designated by the central competent authority.
The execution personnel of alternative therapy shall accept eight and more hours per year of continuing education in alternative therapy.
Article 10
Medical care institutions, when applying for designation as execution institutions, shall submit the following documents:
1.plans, including organization and personnel of the medical care team, number of cases expected to be admitted, therapy care plan and flow management, quality assurance measures, independent spaces for the practice of alternative therapy, and floor plans of the allocation of spaces for the safe storage of pharmaceuticals;
2.photocopy of the registration license of controlled drugs;
3.other documents designated by the accepting organization.
The applicants, after being reviewed by the accepting organization of their application documents as complete and meeting regulations, may be designated by announcement as execution institutions; the validity is for three years.
The execution institutions that have already been approved prior to the promulgation of this set of Regulations, their validity shall be three years from the day this set of Regulations is announced and becomes effective.
The execution institutions may apply again six months prior to the expiration of the validity.
Article 11
The implementation procedures of the alternative therapy are as follows:
1.drugs for therapy shall be taken under the supervision of medical personnel;
2.during the course of therapy, arrangement shall be made periodically for the targets under therapy to accept psychological counseling, psychological therapy or supervision, and HIV-related health education; the outcomes of supervision and cooperation of patients shall be used as reference for the assessment of next therapy.
3.medication of the therapy shall follow the therapy guides announced by the central competent authority, and may adjust dosage of medication in accordance with the degree of addiction of the targets under therapy and clinical needs.
4.records of case admission and therapy shall include medical history, physical and mental conditions, willingness, motivation, reports of various examinations (testing), degree of cooperation and relevant assessment of therapy.
The safekeeping and retention of the records of case admission and therapy mentioned in Subparagraph 4 of the preceding Paragraph shall comply with regulations with reference to medical records of the Medical Care Act.
Article 12
Targets under therapy, if failed to accept therapy for 14 consecutive days, shall be considered termination of therapy. Execution institutions, however, may start therapy again by considering the needs of the targets under therapy.
If targets under therapy visit directly on the same day to different execution institutions for therapy, execution institutions may refuse to provide services.
Article 13
The execution institutions and their employees may not leak the secret of the targets under therapy that they know about or in possession of through their duties or execution of duties.
Article 14
Execution institutions in violation of regulations of the subparagraphs of Paragraph 1, Article 11 or in violation of regulations of the Controlled Drug Management Act, under serious circumstances the competent authorities may annul their designation.
Article 15
Competent authorities may inspect and approve the service measure execution institutions.
The inspection and approval of the preceding Paragraph include document review, competency test or on-site visit; service measure execution institutions shall cooperate, and shall not refuse, evade or obstruct.
Article 16
Service measure execution institutions or personnel, in executing service measures, when confronting with inspection and seizures of judicial or police organizations that hinder the promotion of the service measures of this set of Regulations, may report and request local competent authorities for assistance.
Article 17
For service measure execution institutions and personnel with outstanding achievements, competent authorities or various competent authorities of enterprises may reward them.
Methods of reward of the preceding Paragraph shall be made by public commend with the issuance of certificates of merit, medals or plaques.
Article 18
This set of Regulations shall be implemented on the day of announcement.