PHILIPPINE MEDICINES POLICY

Transcription

1 PHILIPPINE MEDICINES POLICY C Commitment to Safety, Efficacy, and Quality H Health Literacy and People Empowerment A Accessibility, Availability, and Affordability N Networking and Partnerships G Good Governance, Accountability, and Transparency E Ensuring Responsible and Rational Use of Medicines

2 COMMITMENT TO SAFETY, EFFICACY AND QUALITY The first pillar is Commitment to Safety, Efficacy and Quality. Its goal is to ensure that the manufacture, packaging, procurement, import, export, distribution, supply and sale, and the dispensing of drugs, product promotion and advertising and clinical trials are carried out according to specified standards of safety, efficacy and quality. This includes strengthening of all policies already in place and other strategies that may be implemented to assure the safety, efficacy and quality of essential medicines along the supply chain at all levels of care. The Food Drug and Administration shall be the primary government agency responsible in assuring the safety, efficacy and quality of medicinal products in the market. FDA shall also lead in pushing for other quality assurance measures which can involve other government agencies, non government organizations and the private sector. The following strategies shall be pursued. Other government agencies that maybe involved in the implementation of these specific strategies are likewise identified. I. Strengthen the Food and Drug Administration (FDA) to ensure enforcement of regulatory standards [1] A. Strengthen implementation of the Food and Drug Administration Act of 2009 (RA 9711) 1. Gain full fiscal autonomy through retention of FDA income from registration, inspection, licensing and other regulatory functions 2. Provide competent, committed and adequate administrative and technical human resource through capacity building activities and effective retention strategies 3. Establish a laboratory in every regional field office 4. Develop tools and mechanisms for reporting and feedback B. Participate and comply with ASEAN standards and internationally adopted Good Practices (GXPs) C. Enforce full compliance to internationally adopted Good Practices B. Strengthen mechanisms for registration, regulation and oversight of clinical trials in the country [1,2,3] A. Strengthen the implementation of the FDA Guidelines on the Regulation of Clinical Trials in the Philippines, FDA Circular No and updated issuances B. Promote the Philippine Health Research Registry (PHRR) as a tool to access timely and updated information on existing and on going clinical trials and non clinical studies in the country C. Strengthen the National Pharmacovigilance Program [1,4,5,6,7,8,9] A. Develop policies, systems and guidelines for pharmacovigilance 1. Strengthen the Pharmacovigilance Unit of the FDA as part of post marketing surveillance

3 2. Ensure participation of public and private stakeholders including patient groups in the coordination and integration of efforts toward the effective implementation of the National Pharmacovigilance Program 3. Coordinate with DOH Public Health Programs in implementing PV activities in accordance to the PV Manual of Procedures for DOH Public Health programs B. Establish a system for collection, coordination and assessment of pharmacovigilance data from all sources 1. Streamline the mechanism for adverse drug reaction (ADR) reporting through a simplified suspected ADR reporting form 2. Require suspected ADR reporting from all health care professionals and workers including those in the LGUs, RHUs and BHCs 3. Strengthen the FDA National Drug Committee in performing case review and causality assessment of reported adverse drug events C. Develop risk mitigation and communication plans 1. Issue information on drug safety and adverse events to end users through timely drug alerts, bulletins, media and other appropriate means 2. Train competent health professionals and workers for pharmacovigilance activities through Professional Associations and Drug Therapeutic Committees (DTCs) 3. Incorporate pharmacovigilance in the curriculum of the health professions 4. Conduct public education activities relating to medicine safety D. Ensure an efficient system to combat Spurious, Substandard, Falsely Labelled, Falsified, and Counterfeit (SSFFC) medical products [1,10,11,12,13, 16] A. Revise and align existing law with international (WHO) definitions and guidelines B. Participate actively in the Single Point of Coordination (SPOC) program in the fight against SSFFC medical products C. Collaborate with the different government agencies, the private sector and the industry to combat the proliferation of SSFFC medical products D. Train quarantine and customs officers to detect, monitor and report potential cases of SSFFC E. Strengthen the capacity to conduct inspection and detection of SSFFC medical products 1. Provide competent and adequate staff to conduct inspection and detection 2. Enhance product surveillance at the local level, such as quality testing of medicines in the field 3. Modernization of technology for assessing, monitoring, reporting and feedback F. Strictly implement licensing and accreditation guidelines G. Strictly implement quality standards (e.g., CPR and CGMP) in the procurement of medicines in the public sector H. Strengthen coordination with recognized international bodies in relation to the Rapid Alert System such as the ASEAN Post Marketing Alert System

4 I. Develop risk mitigation and communication plans 1. Develop a coordinated mechanism for an alert and response system for the stakeholders (health facilities, industry and the public/consumers) 2. Launch information campaigns using existing forms of media including social media regarding SSFFC medical products to the public E. Strengthen the implementation of the Traditional and Alternative Medicine Act (TAMA) of 1997 (RA 8432) [14] A. Support and mainstream research studies on Traditional Philippine Medicines B. Conduct clinical research studies to establish safety and efficacy of Traditional Philippine Medicine products C. Ensure that all herbal products have undergone strict regulatory requirements for quality D. Improve information, education and communication materials, systems and technology regarding Philippine traditional medicines, including approved indications and claims, side effects and special precautions F. Comply with the ASEAN guidelines and requirements on GMP for Traditional Medicines and Health Supplements [1] IMPLEMENTING AGENCIES: [1] Food and Drug Administration (FDA) [2] Philippine Council for Health Research and Development (PCHRD) [3] Philippine Health Research Ethics Board (PHREB) [4] Epidemiology Bureau (EB) [5] Department of Health Public Health Programs [6] Department of Health Pharmaceutical Division (DOH PD) [7] Professional Associations (Philippine Medical Association, Philippine Nurses Association, Philippine Pharmacists Association, Philippine Dental Association) [8] Health Facilities and Services Regulatory Bureau (HFSRB) [9] Commission on Higher Education (CHED) [10] Philippine Health Insurance Corporation (PhilHealth) [11] Bureau of Customs (BOC) [12] Bureau of Quarantine (BOQ) [13] Philippine Coast Guard [14] Philippine Institute of Traditional and Alternative Health Care (PITAHC) [15] Professional Regulations Commission (PRC) [16] Task Force on Counterfeit Medicines [17] Commission on Audit (COA)

5 [18] Local Government Units (LGU)

6 HEALTH LITERACY AND PEOPLE EMPOWERMENT The second pillar is Health Literacy and People Empowerment. Its goal is to ensure that people are empowered to make informed decisions for themselves regarding medicines and to participate in decision making processes concerning medicines. This pillar recognizes the importance of the general public as able and responsible partners for their own health and well being. The following strategies shall be pursued. The Department of Health through the proposed Medicines Education Unit shall be the lead agency to implement these strategies in partnership with other government and non government institutions. I. Strengthen the Health Promotion Services of the DOH and the FDA as an avenue to provide public education on medicine related issues [1,2,8] A. Capacitate health human workforce for medicines education B. Establish a medicines information system dedicated to the general public C. Conduct widespread public awareness and education campaigns in coordination with relevant stakeholders emphasizing on the following: 1. Safety, efficacy and quality of medicines (e.g., SSFFC medical products) 2. Rational use of medicines, including Philippine traditional medicines and antimicrobial resistance (AMR) 3. Access to and appropriate prices of medicines D. Develop standardized information, education and communication (IEC) materials in consideration of the general public s health literacy on medicines, including Philippine traditional medicines E. Develop a dissemination protocol that ensures cascading of health and medicine information to the general public in an accurate and timely manner 1. DOH updates, regulations and standards 2. FDA updates, regulations and standards (e.g., no prescription, no dispensing policy) F. Continuously conduct research on innovative strategies for medicines education G. Capacitate the general public to critically discern the integrity of medicines and the validity of claims on marketing and promotional materials on medicines II. Recognize the general public as partners for their own health and well being [1,2,3] A. Strengthen linkage of the general public among government agencies, the industry and other relevant stakeholders B. Create platforms and opportunities for inclusive and active public participation in government deliberations and processes concerning medicines C. Ensure proper and adequate consultation with the general public

7 III. Integrate with essential medicines and Philippine traditional medicines information the basic education (K to 12) and health professions education [4,5,6,7] IV. Utilize information and communications technology to facilitate operations, monitoring, feedback and reporting in medicine processes where the general public is involved [1] V. Uphold citizen s rights to information by ensuring transparency and accessibility of data, processes and information on medicines, including the following: [1,2,3,9] A. Pricing data B. Safety data C. Quality data IMPLEMENTING AGENCIES: [1] Department of Health (DOH) [2] Food and Drug Administration (FDA) [3] Philippine Health Insurance Corporation (PHIC) [4] Department of Education [5] Commission on Higher Education (CHED) [6] Academic Institutions [7] Philippine Institute of Traditional and Alternative Health Care (PITAHC) [8] DOH Health Promotion and Communication Service (HPCS) [9] Philippine Information Agency

8 ACCESSIBILITY, AVAILABILITY, AND AFFORDABILITY The third pillar is Accessibility, Availability and Affordability. Its goal is to ensure continuous and timely availability and accessibility of affordable essential medicines, including medicines for the special populations in the healthcare system. The government shall endeavor that all Filipinos will have timely access to adequate medicines at all points of health care delivery through strengthening the implementation of existing policies that shall influence local supply and demand of medicines, price regulation and reduction of out of pocket expenditure. The DOH shall be the lead agency. Still, the implementation of these strategies shall be in partnership with different government agencies and the private sector specifically the pharmaceutical industry. I. Strengthen implementation of the Generics Policy A. Strengthen implementation of the Generics Act of 1988 (RA 6675) as amended by RA Regularly monitor generic prescribing and generic dispensing in all health facilities, both [2, 3] public and private [1, 2, 3, 4, 5, 6, 7, 8, 10] 2. Use only generic terminology in all transactions B. Create a policy that allows limits to be set for the maximum number of drug products per API registered with FDA [1] C. Strengthen generic industry in the Philippines in the form of tax credits, pharmaceutical economic zone, facilitation of importation of generic products and raw materials for [2, 3, 4, 5, 6, 7] manufacture D. Conduct public education activities to promote knowledge on generic medicine [2] II. Strengthen the implementation of the Cheaper Medicines Act of 2008 (RA 9502) A. Assistance of the government in the development of generic industries 1. Implement tax breaks for generic industries [2] [5, 6, 7] 2. Preferential sourcing of low cost generic medicines from local suppliers Explore with local industries their capacity to produce essential medicines in the context [1, 3] of the country s health needs o Regularly acquire list of products that the local pharmaceutical industry has the capability to produce B. Establish a clearly defined criteria for the regulation of drug prices [2] [2, 3] C. Employ cost containment measures 1. Internal and External Reference Pricing 2. Limit excessive marketing and drug promotion expenditures in compliance with the MCP 3. Creation of a Price Negotiation Board that is linked to FEC HTA unit to assist in the reimbursement scheme of PHIC 4. Implement a National and Subnational Pooled Procurement system

9 5. Expand PHIC coverage by providing outpatient drug benefits, including reimbursement of priority medicines through accredited PhilHealth facilities III. IV. Enact strategies that allow transparent and efficient regulation of drug prices A. Implement the Philippine Competition Act (RA10667) to address potential monopolies, abuse of dominant position or any activity that prevents free market [1] B. Establish a Price Regulation Board comprised of doctors, health professionals, health economists, and consumer representatives [2] 1. Set Maximum Drug Retail Prices (MDRP) 2. Develop policies for fair and rational pricing of medicines 3. Standardize retail prices at all levels 4. Implementation of the MDRP, to be governed by an independent board for all innovators and products with no competition (i.e., less than four products available in the market) 5. Establish policies that delink the cost of research and development to the prices of medicines C. Set clear sanctions for non compliance of stakeholders to Electronic Essential Drug Price Monitoring System (e EDPMS) and Drug Price Reference Index (DPRI) [1, 2] Enforce strict monitoring of compliance of stakeholders D. Negotiate with pharmaceutical companies in providing access to affordable essential drugs 1. Facilitate Medicines Patent Pool (MPP) to promote voluntary licensing of generic companies [2, 10] to produce cheaper products of medicines under patent 2. Ensure drug price transparency by requiring the pharmaceutical industry to furnish data on costs, taxes and other expenses regarding their medicines E. Employ tax incentives for life saving pharmaceutical products [2] Maximize Trade Related Aspects of Intellectual Property Rights (TRIPS) flexibilities to facilitate technology transfer and provide technical support where needed [1, 10] A. Compulsory licensing [1, 10] B. Special compulsory licensing [1, 10] C. Parallel importation [2, 5, 6] D. Policies for national public health emergencies V. Ensure adequate, equitable, and sustainable financing for all, and provide basic entitlements for the poor A. Employ strategies that will provide medicines for free or at a lower cost to the poor or to special populations (e.g., Botika ng Bayan established in government healthcare facilities) B. Ensure adequate budget allocation for medicines appropriate to meet public health needs based [2, 7] on medicine utilization data gathered from regional and local health facilities

10 C. Regularly provide PHIC with the list of essential medicines, with corresponding prices, that shall be covered for reimbursement [2] [2, 7] D. Strengthen implementation of No Balance Billing for PHIC sponsored members VI. Develop an efficient system for drug supply chain management A. Capacitate all personnel involved in the supply chain management, through training and [4, 5, 6, 7, 9] coaching Designate focal point for supply chain management at all levels B. Harness information and communications technology (ICT) as a tool to develop the Drug Supply [2, 8] Chain Management [5, 6, 7] C. Provide transparency in the selection of medicines 1. Select medicines based on the current needs, consumption and capacity of specific localities, including medical supplies needed during emergencies and catastrophes 2. Provide basis for quantification of medical needs, available for public access 3. Ensure accuracy and timeliness of information used in forecasting 4. Provide tools for monitoring drug inventory with proper training and coaching, with provisions for transition to Information Management System (IMS) 5. Close monitoring of compliance to monitoring systems using deployment program [2, 5, 6, 7] D. Implement an efficient and effective procurement process 1. Adopt tools and strategies to ensure correct interpretation/ proper understanding of the law to allow maximizing provisions for procurement of medicines 2. Establish an e procurement system 3. Create a system to control consignment and forward stocking 4. Revise current consignment system to ensure rational use and availability of essential medicines 5. Create a National Pooled Procurement Policy (Centralized Procurement) and a mechanism for the government 6. Establish a National Essential Medicines Facility (NEMF) [2, 3, 4, 9] E. Improve storage and distribution of medicines at all levels of care 1. Efficiently manage inventory a. Employ distribution arrangements appropriate to the local situation [2,4] b. Employ tried and tested strategies (i.e. First in/first out (FIFO) and First expiry/first use (FEFU); Cold chain management) c. Enforce Good Storage Practices and Good Warehousing Practices at all distribution levels 2. Develop a policy that requires the distribution of medicines directly to points of care 3. Establish an IMS for inventory and tracking of essential medicines 4. Clear criteria for selection and termination of third party for contracting distribution [3, 9] F. Improve documentation on the use of medicines

11 1. Monitor the consumption of medicines to be used as basis for Selection and Quantification through existing human resource, NDP, DMO, PA, and focal points 2. Create system for accurately monitoring consumption data of medicines G. Finalize cost effective mechanisms to create a system for disposal of unwanted pharmaceuticals [3] H. Ensure continuous availability of health related needs 1. Ensure the availability of essential medicines in the public health care system, including [2, 4, 5, 6, 7, 8, medicines and medical supplies needed during emergency cases and catastrophes 9] 2. Continuously build partnerships with community pharmacies and other members of the [2, 4, 5, private health sector, with special attention to far flung and underserved communities 6, 7, 8, 9] 3. Create a system for providing medical needs during emergency cases and catastrophes, [2, 4, 5, 6, 7, 8, 9] through engaging the private sector in sourcing medicines and medical supplies 4. Simplify application process for CSP (Compassionate Special Permit) [1] [1, 2, 5, 9] 5. Pre positioning of essential drugs for life threatening conditions 6. Capacitate FDA to be recognized as biopharmaceutical testing center [1] 7. Provide aid to local manufacturers to ensure implementation of all quality related standards [1, 3] (e.g. PIC/S, USP) 8. Ensure uniform application of all quality standards, whether locally produced or imported [1] 9. Ensure the adoption of Health Technology Assessment (HTA) in the practice of selection of drugs for the formulary [2] 10. Adopt the WHO Model Formulary in order to provide access to high priced essential patented life saving / emergency medicines a. Optimize trade related aspects of intellectual property rights (TRIPS) flexibilities for highpriced patented life saving / emergency medicines [2, 10, 11] b. Utilize ICT to facilitate monitoring of patent status of medicines [10] 11. Integrate Philippine Traditional Medicine into the national healthcare system as stated within the WHO Document WHA62.13 and in compliance with the ASEAN Agreement on Traditional Medicines [12] VII. Ensuring pharmaceutical security to ensure availability of medicines in the country A. Develop business plan and incentives system [2] B. Regulate Parallel Drug Importation (PDI) as a reserve instrument [3, 5, 6, 7] C. Employ mandatory carry of low cost generic products as an option to address market failure [1, 2] D. Utilize ICT to facilitate monitoring and feedback of Drug Registration and Licensing [2] E. Invest in research and development for drugs and technologies for neglected tropical diseases and other diseases of public health importance

12 VIII. Regularly organize and review data and information relevant to the PMP implementation based on pharmaceutical market analysis IMPLEMENTING AGENCIES: [1] Food and Drug Administration (FDA) [2] Department of Health (DOH) [3] Department of Health Pharmaceutical Division (DOH PD) [4] Department of Health Logistics Management Division (LMD) [5] Procurement Service [6] Government Procurement Policy Board (GPPB) [7] Philippine Health Insurance Corporation (PHIC) [8] Local Government Units (LGU) [9] Outlets / Rural Health Units (RHU) [10] Intellectual Property Office (IPO) [11] Department of Trade and Industry (DTI) [12] Philippine Institute of Traditional and Alternative Health Care (PITAHC) [13] Philippine Pharma Procurement, Inc. (formerly PITC Pharma, Inc.)

13 NETWORKING AND PARTNERSHIPS The fourth pillar is Networking and Partnerships. Its goal is to ensure efficient, effective and equitable public private partnerships (PPPs) and multi stakeholder collaboration among public and private sectors toward ensuring universal coverage of essential medicines and health services. I. Establish a framework for developing and engaging in networks and partnerships with relevant [1, 2, 3, 4] stakeholders and development partners A. Develop a supportive climate for networking, partnerships and collaborations B. Develop a conducive and standardized regulatory system C. Develop a fair health financing system D. Develop a responsive operating and business environment II. Strengthen existing linkages and partnerships among the government, relevant stakeholders, and [5, 6, 7, 8, 9, 10, 11, 12] development partners, including: A. Non governmental organizations B. Civil society organizations C. Specialty groups and professional associations D. Pharmaceutical Industry E. Private sector entities F. General and specialty hospitals G. Academic institutions [12, 13,14] III. Explore potential areas for partnerships and collaborations, such as: A. Establishment of adequate service delivery networks at all levels of the health system, which are composed by both public and private healthcare facilities B. Setting up of additional access points for the delivery of essential medicines and healthcare services C. Conduct of research studies involving medicines (e.g., drug discovery and development from natural products; analysis of policies on medicines) IV. Clearly define criteria for developing and engaging in partnerships and collaborations [1] V. Ensure representation of other government agencies, the private sector, health professionals, healthcare providers, specialty groups, patient groups, professional associations, training hospitals and academic institutions [1] IMPLEMENTING AGENCIES: [1] Department of Health (DOH)

14 [2] Food and Drug Administration (FDA) [3] Philippine Health Insurance Corporation (PHIC) [4] Local Government Units (LGUs) [5] Non governmental organizations [6] Civil society organizations [7] Specialty groups and professional associations [8] Pharmaceutical Industry [9] Private sector entities [10] Patient groups [11] Academic institutions [12] General and specialty hospitals [14] Philippine Institute of Traditional and Alternative Health Care (PITAHC) [15] Philippine Council for Health Research and Development (PCHRD) [16] Philippine Pharma Procurement, Inc. (formerly PITC Pharma, Inc.)

15 GOOD GOVERNANCE, ACCOUNTABILITY AND TRANSPARENCY The fifth pillar is Good Governance, Accountability and Transparency. Its goal is to institutionalize accountability, transparency and good governance throughout the registration, regulation, selection, procurement, distribution, use and management of medicines, in accordance with existing integrity development and anti corruption initiatives. The government shall continue to develop approaches and strengthen implementation of mechanisms/ strategies that are already in place which aim to enforce rules, promote good practices and reduce vulnerabilities to corruption in the health system. I. Strengthen the Advisory Council to carry out other essential responsibilities, such as: [1] A. Monitor the implementation of the PMP across all levels in the health system B. Evaluate the effectiveness of the PMP implementation based on set indicators C. Recommend incentives, penalties and sanctions II. Improve the capacity and establish accountability in the fulfillment of individual and sectoral [1, 2, 3, 4, 5, 6, 7, 8] mandates A. Strengthen government agencies to fulfill their mandates concerning medicines B. Leverage support for and hold LGUs accountable in their role as service providers and stewards of health at the local level. C. Ensure accountability in both public and private sectors by strictly enforcing established penalties and sanctions [1, 2, 3, 4, 5, 6, 7, 8] III. Ensure compliance with existing policies and laws concerning medicines A. Implement the Philippine Pharmacy Act (RA 10918) Impose heavier sanctions for non pharmacy health practitioners B. Implement the Generics Act of 1988 (RA 6675) C. Implement the Universally Accessible Cheaper and Quality Medicines Act (RA 9502) D. Implement the Food and Drug Administration Act (RA 9711) E. Implement the Comprehensive Dangerous Drugs Act (RA 9165) F. Implement the Expanded Senior Citizens Act (RA 9994) G. Ensure that the required human resources are present in healthcare facilities H. Ensure the implementation of controls / policies governing prescribing, dispensing and use of medicines IV. Ensure continuous access to information for greater transparency, accountability, and citizen participation in governance [1, 2, 3, 4, 5, 6, 7, 8] A. Ensure transparency of data and information sharing in an inter government and inter country level, involving all relevant stakeholders and development partners

16 B. Develop a system that ensures cascading of information to all levels of healthcare in an accurate and timely manner C. Strongly implement legislations and their IRR that contribute towards continuous access to medicine information (e.g., RA 9502 and RA 9711) D. Create regulations for Disease Awareness Initiatives, such as, but not limited to, posters, TV advertisements, and social media campaigns [1] [1, 2, 3, 4, 5, 6, 7, 8] V. Manage potential conflicts of interests A. Continue clear criteria in the appropriate selection and appointment of members to technical and decision making committees and working groups at all levels of care B. Prohibit the use of government s name, acronym and emblem in conjunction with commercial, promotional marketing and advertisement purposes C. Ensure the implementation of the standard protocols in government agencies to manage potential conflicts of interests VI. Implement transparent, accountable and efficient processes and systems, which are aligned with [1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11] the existing policy framework, including: A. DOH regulations and standards governing medicines pricing and the supply chain management B. FDA regulations and standards on the safety, efficacy and quality of medicines C. Equitable and fair expansion of health insurance benefits D. Policies and guidelines on the rational use of medicines E. Integrity development and anti corruption initiatives F. Ethical codes of conduct governing the practice of all healthcare professionals G. Ethical standards in research and development, medicines promotion and advertisement H. Internationally accepted standards on the regulation of medicines, where applicable [1, 2, 4, 5, 6, 7] VII. Implement standards of good governance for all levels in the healthcare system A. Ensure uniformity to compliance with quality standards on medicines in all levels of the healthcare system B. Adopt standardized matrices for monitoring and evaluating performance of all LGUs, health facilities and the industry C. Incorporate indicators for good governance of medicines in the DOH LGU scorecard D. Execute a rewards and incentives system for Good Governance in Medicines in accordance with the indicators in the LGU scorecard VIII. Ensure that there is effective and efficient health systems support to continuously ensure accountability, transparency and good governance [1, 2, 3, 4, 5, 6, 7, 8] A. Ensure an adequate quantity and good quality of health human workforce

17 1. Establish sustainable recruitment and retention system in medicines regulation and management 2. Provide opportunities for continuing education and development B. Optimize health information systems Organize and review relevant data, information and processes that can impact on medicines C. Utilize information and communications technology (ICT) to facilitate operations, monitoring, feedback and reporting in the following areas, such as but not limited to: 1. Drug Price Monitoring 2. Information and alert systems for adverse drug events, SSFFC medical products, and emergence of antimicrobial resistance, among others 3. Drug Supply Chain Management 4. Drug Registration and Licensing 5. Web based medicines procurement 6. Patent status of medicines D. Intensify local government support 1. Provide technical support for improving efficiency and instituting good practices in the medicine supply chain management 2. Issue technical guidelines on the minimum provision of essential packages of medicines at the LGU level taking into account local health needs, priorities and resources 3. Strengthen the DOH Regional Offices (ROs) in collaboration with training institutions and other partners 4. Deputize LGU agents and officials to manage, monitor and report the status of the PMP implementation at the local level 5. Conduct regular performance review and assessment of local healthcare system 6. Enhance activities related to post marketing surveillance at the local level IMPLEMENTING AGENCIES: [1] Department of Health (DOH) [2] Food and Drug Administration (FDA) [3] Department of Interior and Local Government (DILG) [4] Department of Health Pharmacy Division (DOH PD) [5] DOH Logistics Management Division [6] Philippine Health Insurance Corporation (PHIC) [7] Local Government Units (LGU) [8] Department of Trade and Industry (DTI) [9] Drug Institutions / Establishments [10] Patient/ Consumer Organizations [11] Professional Associations

18 [17] Philippine Pharma Procurement, Inc. (formerly PITC Pharma, Inc.)

19 ENSURING RESPONSIBLE AND RATIONAL USE OF MEDICINES The sixth pillar is Ensuring Responsible and Rational Use of Medicines. Its goal is to promote responsible promotion and quality use of drugs to ensure optimal health outcomes from medicines for patients. This pillar shall ensure that patients receive medicines appropriate for their clinical needs, in doses that meet their individual requirements, for an adequate period of time and at the lowest possible cost to them and their communities. Strategies that will ensure responsible use of medicines among the different stakeholders in the medicine use process shall be pursued. This will include promotion of rational prescribing, dispensing of medicines and provision of right information to the general public about proper use of medicines. I. Develop and adopt National Standard Treatment Guidelines (NSTGs) [6,8,10,13,18] A. Develop evidenced based national standard treatment guidelines (NSTGs) using a clear methodology 1. Include common conditions seen across all levels of healthcare 2. Address special therapeutic needs of vulnerable populations 3. Consider local context, capacity, cost, and resources B. Establish an NSTG clearing house in the DOH 1. Appraise and adopt externally developed clinical practice guidelines (CPGs) as basis for NSTGs 2. Coordinate periodic reviews of and updates on NSTGs 3. Manage the regular publication of NSTGs in a national platform that is accessible for everyone C. Disseminate NSTGs to all health providers and the academe, and other stakeholders D. Monitor compliance through conduct of prescription and clinical audits II. Update and modernize the Philippine National Formulary (PNF) [6,10,12] A. Harmonize the PNF with the medicines in the NSTGs B. Regular review and updating of the PNF every year 1. Adopt principles of health technology assessment, and other evidence based criteria to aid the Formulary Executive Council (FEC) and decision makers 2. Continue publishing and posting of updates in DOH website 3. Utilize technology and online platforms to make the Formulary more accessible III. Promote rational prescribing, dispensing and use of medicines [1,3,4,5,6,7,10,13,14,15,16,17,18, 19] A. Develop and update on a regular basis the national guidelines on the rational prescribing, dispensing, and use of medicines 1. Coordinate with the Professional Regulation Commission (PRC), health professional organizations, medical societies

20 2. Conform with the Philippine National Formulary (PNF), NSTGs and practice standards of the health care professions 3. Enforce sanctions and penal provisions for irrational practice in the health care professions B. Conduct regular prescription audits that monitor compliance to generic prescribing and NSTGs C. Conduct audits of dispensing practices in accordance with dispensing guidelines D. Incorporate guidelines on rational prescribing, dispensing, and use in the curricula of the medical and allied health courses E. Conduct trainings, updates, and seminars for healthcare providers in both public and private sector F. Improve the systems for monitoring medication use by patients for priority diseases G. Control Antimicrobial Resistance (AMR) 1. Expand AMR surveillance in both public and private facilities 2. Conduct antimicrobial use surveillance in health facilities 3. Integrate AMR surveillance and antimicrobial use surveillance for both animal and human health sectors 4. Enforce regulations on the rational use of antimicrobials which include, but are not limited to antibiotic restriction, antibiotic stewardship programs, no prescription no dispensing policy 5. Conduct of regular advocacies and activities, such as the World Antibiotic Awareness Week 6. Conduct training and education for health professionals and health professional students on the rational use of antimicrobials and implementation of strict infection control measures 7. Prohibit the distribution of free samples of antimicrobial medicines 8. Publish up to date and evidence based antibiotic use guidelines based on antibiotic resistance patterns in the national and local levels 9. Update relevant NSTGs in consideration of recent antibiotic resistance patterns 10. Coordinate efforts to prevent and control AMR with the Inter Agency Committee for the formulation and implementation of a national plan to combat antimicrobial resistance in the Philippines (A.O. 42 s. 2014) H. Optimize the use of Philippine Traditional Medicines 1. Conduct preclinical and clinical research to improve evidence base for the use of traditional medicines 2. Conduct training and education activities for health professionals on the use of traditional medicines 3. Create and enforce guidelines on the regulation of the marketing and promotion of traditional medicines IV. Regulate medicines promotion and advertisements [2,6,11,13,17] A. Strengthen the current system for monitoring content of advertisements of all pharmaceutical products and food supplements

21 1. Ensure accuracy of information in advertisements and promotions 2. Enforce heavier sanctions and penalties for false claims, misleading information, and unethical activities 3. Review content of advertisements and promotions prior to dissemination B. Engage in counter marketing activities against medicine advertisements with false claims and/or misleading information C. Prohibit direct to consumer promotion of prescription/ethical drugs, including web based advertisements, and similar activities D. Prohibit health professionals from engaging in activities that promote particular brands of medicines E. Enforce guidelines on ethical promotion of pharmaceutical products(doh A.O ) F. Require all health care providers, specialty groups, professional associations, training hospitals and academic institutions to declare all sponsorships, donations or likes provided by pharmaceutical and device companies G. Require pharmaceutical companies to publish annually the list of health care professionals and associations who receive any type of company sponsorship (review actual MCP provisions) H. Ensure the training and regulation and registration medical representatives and other professionals who conduct detailing I. Prohibit any public private partnership that will involve the promotion of any specific pharmaceutical product or device V. Establish and capacitate Drug and Therapeutic Committees (DTCs) [6,7,9] A. Strengthen DTCs/ PTCs in all health facilities, to carry out the following: 1. Enforce rational and generic prescribing, dispensing and use of medicines in the health facility, ensuring compliance of all staff to standards on rational use of medicines 2. Enforce compliance with the National Pharmacovigilance Program 3. Prepare hospital formulary, using DOH developed/adopted NSTGs and the PNF as bases 4. Tailor procurement of medicines based on prevailing morbidity and mortality profiles (in the health facility, as well as in the national level) 5. Monitor and report ADEs, as well as possible SSFCC medical products 6. Implement medicines related DOH policies and programs 7. Communicate regularly with the DOH PD and other relevant DOH offices, regarding the implementation of DOH projects and policies in the health facilities B. Conduct capacity building for DTCs to enable them to participate in the implementation of DOH C. Require the establishment of DTCs in the LGU level 1. Serve as guide for the LGU officials in all matters concerning medicines 2. Chaired by the municipal health officer (MHO) IMPLEMENTING AGENCIES:

22 [1] Academic institutions offering health professional programs [2] Ads Standards Council (ASC) [3] Commission on Higher Education (CHED) [4] Department of Agriculture (DA) [5] Department of Education (DepEd) [6] Department of Health (DOH) and its offices/units [7] DOH Centers for Health Development (CHDs) [8] DOH Disease Prevention and Control Bureau (DOH DPCB) [9] DOH Health Facilities and Services Regulatory Bureau (DOH HFSRB) [10] DOH Pharmaceutical Division (DOH PD) [11] Food and Drug Administration (FDA) [12] Formulary Executive Council (FEC) [13] Health Professional Organizations (such as PMA, PPhA, etc.) [14] Inter Agency Committee for AMR (A.O. 42 s. 2014) [15] Philippine Health Insurance Corporation (PHIC) [16] Philippine Institute of Traditional and Alternative Health Care (PITAHC) [17] Professional Regulation Commission (PRC) [18] Research Institute for Tropical Medicine (RITM) Antimicrobial Surveillance Program (ARSP) [19] Bureau of Animal Industry (BAI)