Healthcare Singapore Newsletter December 2015 In This Issue: Public Consultation on Proposed Subsidiary Legislation to the Health Products Act Pharmacies to Offer Prescription Refills Online Curbing the Spread of Infectious Diseases in Healthcare Settings Public Consultation on Proposed Subsidiary Legislation to the Health Products Act On 15 December 2015, the Health Sciences Authority of Singapore ("HSA") published drafts of proposed subsidiary legislation for the licensing of pharmaceutical products and related regulations, which will be transferred from the current Medicines Act (Cap. 176) and the Poisons Act (Cap. 234) to the Health Products Act (Cap. 122D) ("HPA"). This is done as part of the HSA's plans to streamline the existing regulatory controls for pharmaceutical products and bring them under a single legislation. The HPA currently regulates medical devices and cosmetic products only. In addition, a Form A Poisons Licence is currently required for the supply of therapeutic products containing poisons scheduled under the Poisons Act. With the draft amendments, pharmaceutical products will be introduced as a new category of health products under the HPA using the term "therapeutic products". The existing controls under the Medicines Act and the Poisons Act will be disapplied thereafter. The key proposed changes are as follows: Defining "therapeutic products" based on the purpose of the product and its active ingredient(s) to ensure clarity in scope; Streamlining licence application processes and bundling licensing fees to facilitate current business practices; Removing the current requirement of a Form A Poisons Licence for the supply of therapeutic products containing scheduled poisons; Implementing a requirement that a Form A Poisons Licence holder be a registered pharmacist or a person approved by the HSA in the Importer's Licence and Wholesaler's Licence, for companies dealing with pharmacy-only medicines and prescription-only medicines. This is an existing requirement that will be transferred to the HPA from the Poisons Act; Enhancing post-market surveillance of therapeutic products in Singapore, including the implementation of risk management plans and submission of benefit-risk evaluation reports, maintaining of records and reporting of product defects, and refining the reporting timelines of serious adverse reactions; Introducing a risk-based approach to the regulation of clinical trials and refinements to existing legal provisions to increase transparency and support global clinical development; and Introducing a notification system to facilitate access to clinical research materials for use in clinical research. The public consultation will close on 15 January 2016. More information on the HSA's public consultation is available on their website here. 2 | Healthcare Newsletter Pharmacies to Offer Prescription Refills Online Retail pharmacies such as Guardian and Watson recently announced that they are in talks with the Health Sciences Authority of Singapore ("HSA") to allow repeat prescription medicines to be ordered online and delivered to their customers' doorstep. This move is aimed to ease the tight manpower situation facing polyclinics, reduce overall health costs and increase convenience for patients on continued medication. For pharmacies, this will boost sales and expand the offerings which they are able to provide to the general public. This service will specifically be available for patients who have had their initial health examination recorded after a face-to-face consultation with doctors at a clinic or hospital. Whilst this is a creative concept that leverages on technology to increase accessibility and convenience for patients, patient consent and confidentiality requirements will be important considerations in such schemes. A growing recognition of the larger role that pharmacies play in the economy could see basic flu and travel vaccinations being conducted by pharmacists at authorised retail pharmacies, though under strict guidelines, which are presently being formulated by the HSA, in consultation with relevant stakeholders. Under these proposed guidelines, pharmacies are required to team up with licensed specialised doctors, and must have their outlets approved before they are allowed to perform blood or shots-related jobs such as vaccinations. Curbing the Spread of Infectious Diseases in Healthcare Settings Following the recent outbreak of Hepatitis C and a separate incident of 178 paediatric patients being recalled for tuberculosis screening, it is important to understand the legal obligations owed by hospitals and healthcare workers to curb the spread of infectious diseases. Between April to August 2015, an outbreak of Hepatitis C in the Singapore General Hospital affected 25 patients, resulting in 8 fatalities. Seven of these deaths were likely caused by Hepatitis C. In a separate incident, 178 paediatric patients were recalled by the National University Hospital in December 2015 after it was discovered that a nurse who had cared for these patients had tuberculosis. Upon discovering her illness, the nurse immediately informed the hospital, which identified and screened patients who might have caught the bug from her. One child, who was warded in August, was found to have latent tuberculosis. It is necessary for hospitals and medical clinics to have an active and passive surveillance system to keep track of trends in infectious diseases and to spot potential outbreaks as early as possible. Healthcare workers are legally obliged to notify the Director of Medical Services under the Infectious Diseases Act (Cap. 157) of any suspected case of an infectious disease. Notification is done by filling up the "MD 131" form, which can be submitted online or via fax within 3 Healthcare Newsletter 72 hours. In particular, tuberculosis and viral hepatitis are considered infectious diseases under the Infectious Diseases Act. The Director may require suspected cases to submit to medical examination or medical treatment, which can include X-rays and the taking of the person’s blood and other body samples for testing and analysis. The penalty for failing to comply with the Infectious Diseases Act is a fine not exceeding S$10,000 and/or imprisonment for a term not exceeding 6 months for the first offence, and in the case of a second or subsequent offence, a fine not exceeding S$20,000 and/or imprisonment for a term not exceeding 12 months. Under the Private Hospitals and Medical Clinics Act (Cap. 248), all dialysis providers are required to routinely test patients for HIV, Hepatitis B and Hepatitis C. A quality assurance committee must be established in private hospitals and medical clinics to monitor, evaluate and report on the quality and appropriateness of the services provided and the practices and procedures carried out. Private hospitals are expected to establish infection control programmes with measures developed to prevent, identify and control infections acquired in or brought into the private hospital. This shall include a system for reporting, evaluating and maintaining data on the incidence and trends of infections among patients and personnel, the establishment of an Infection Control Committee, and having written policies, procedures and guidelines. The National Organ Transplant Unit under the Ministry of Health ("MOH") also does passive surveillance of viral infections after transplantation to keep track of possible infections. During peacetime, visitor registration should be implemented. Hospitals should periodically review the need to restrict hospital visitors and maintain a log of visitor contact details. During a pandemic, more stringent visitor restriction in affected hospitals (including stopping of all visits) should be considered if necessary. Similarly, temperature screening and screening for acute respiratory symptoms should be carried out for visitors to selected or all clinical areas if necessary. In situations where there is widespread community transmission and social distancing strategies are employed, a "no visitor” rule will be implemented in all hospitals by the MOH. The healthcare provider must have in place isolation protocols and must also engage in contact tracing to identify people who might have been infected after exposure to these infectious cases. The MOH Contact Tracing Centre ("MOH CTC") will be activated by the MOH Communicable Diseases Surveillance when a confirmed case is notified. The MOH CTC coordinates all contact tracing activities. In particular, hospitals will undertake "Hospital Contact Tracing" when activated by the MOH CTC. This includes activity mapping and contact tracing within the hospital. Activity mapping involves establishing a history of the case's activities from 7 days prior to the onset of symptoms until isolation in hospital. Hospital contacts include inpatients, outpatients, visitors and healthcare workers who have come into close contact (within 2 meters of shared space) with a case from 2 days prior to the onset of symptoms until isolation in a hospital. 4 | Healthcare Newsletter Most contact tracing will be done over the phone and no standard protective measures are required. However, for onsite contact tracing teams who may be interviewing contacts face-to-face, standard protective measures such as N95 masks, disposable gloves and disposable gowns must be employed, as some contacts may be asymptomatic at the time of review. Following contact tracing, phone surveillance or quarantine may be necessary for persons (contacts) who are well, depending on the risk assessment. In addition to close contacts, discharged patients may also be quarantined to limit the spread of disease to the community. To summarise, healthcare providers are obliged under the Private Hospitals and Medical Clinics Act and the Infectious Diseases Act to have in place protocols to keep track of cases of infectious diseases and to notify the Director of Medical Services of any such incidents. Following the detection of a case of an infectious disease, a healthcare provider must also isolate the case and swiftly engage in contact tracing to curb the spread of the infectious disease. For further information please contact Andy Leck +65 6434 2525 Andy.firstname.lastname@example.org Lim Ren Jun +65 6434 2721 Ren.email@example.com Baker & McKenzie.Wong & Leow 8 Marina Boulevard #05-01 Marina Bay Financial Centre Tower 1 Singapore 018981 www.bakermckenzie.com ©2015. All rights reserved. Baker & McKenzie.Wong & Leow is a member of Baker & McKenzie International, a Swiss Verein with member law firms around the world. 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