Cook Islands PHARMACEUTICAL COUNTRY PROFILE

Transcription

1 Cook Islands PHARMACEUTICAL COUNTRY PROFILE

2 Cook Islands Pharmaceutical Country Profile Published by Te Marae Ora Cook Islands Ministry of Health in collaboration with the World Health Organization June 2013 Any part of this document may be freely reviewed, quoted, reproduced, or translated in full or in part, provided that the source is acknowledged. It may not be sold, or used in conjunction with commercial purposes or for profit. This document was produced with the support of the World Health Organization Representative Office in the South Pacific, and all reasonable precautions have been taken to verify the information contained herein. The published material does not imply the expression of any opinion whatsoever on the part of the World Health Organization, and is being distributed without any warranty of any kind either expressed or implied. The responsibility for interpretation and use of the material lies with the reader. In no event shall the World Health Organization be liable for damages arising from its use. ii

3 Foreword The 2012 Pharmaceutical Country Profile for Cook Islands has been produced by Te Marae Ora Cook Islands Ministry of Health (referred as the Ministry ), in collaboration with the World Health Organization. This document contains information on existing socio-economic and health-related conditions and resources; as well as on regulatory structures, processes and outcomes relating to the pharmaceutical sector in Cook Islands. The sources of data for each piece of information are presented at the end of this document. On behalf of the Ministry, I wish to express my appreciation to the Chief Pharmacist, Mr. Biribo Tekanene for his contribution to the process of data collection and the development of this profile. It is my hope that partners, researchers, policy-makers and all those who are interested in the Cook Islands Pharmaceutical Sector will find this profile a useful tool to aid their activities. Elizabeth Iro ( Mrs) Secretary, Ministry of Health iii

4 Table of Contents Introduction... 1 Section 1 - Health and Demographic Data... 3 Section 2 - Health Services... 5 Section 3 - Policy Issues... 8 Section 4 - Medicines Trade and Production Section 5 - Medicines Regulation Section 6 - Medicines Financing Section 7 - Pharmaceutical Procurement and Distribution in the Public Sector Section 8 - Selection and Rational Use of Medicines Section 9 - Household Data/ Access iv

5 Introduction This Pharmaceutical Country Profile provides data on existing socio-economic and health-related conditions, resources, regulatory structures, processes and outcomes relating to the pharmaceutical sector of Cook Islands. The aim of this document is to compile all relevant, existing information on the pharmaceutical sector and make it available to the public in a user-friendly way. During 2011, the World Health Organization has supported all WHO Member States to develop similar comprehensive pharmaceutical country profiles. The information is categorized in 9 sections, namely: (1) Health and Demographic data, (2) Health Services, (3) Policy Issues, (4) Medicines Trade and Production (5) Medicines Regulation, (6) Medicines Financing, (7) Pharmaceutical procurement and distribution, (8) Selection and rational use, and (9) Household data/access. The indicators have been divided into two categories, namely "core" (most important) and "supplementary" (useful if available). This narrative profile is based on data derived from both the core and supplementary indicators. For each piece of information, the year and source of the data are indicated; these have been used to build the references in the profile and are also indicated in the tables. If key national documents are available on-line, links have been provided to the source documents so that users can easily access these documents. The selection of indicators for the profiles has involved all technical units working in the Essential Medicines Department of the World Health Organization (WHO), as well as experts from WHO Regional and Country Offices, Harvard Medical School, Oswaldo Cruz Foundation (known as Fiocruz), University of Utrecht, the Austrian Federal Institute for Health Care and representatives from 13 pilot countries. The compiled data comes from international sources (e.g. the World Health Statistics 1 ), surveys conducted in the previous years and country level information collected in Some more recent developments are also included. 1

6 Data collection in all 193 member states has been conducted using a userfriendly electronic questionnaire that included a comprehensive instruction manual and glossary. Countries were requested not to conduct any additional surveys, but only to enter the results from previous surveys and to provide centrally available information. To facilitate the work of national counterparts, the questionnaires were pre-filled at WHO HQ using all publicly-available data and before being sent out to each country by the WHO Regional Office. A coordinator was nominated for each of the member states. The coordinator for Cook Islands was Mr Biribo Tekanene, Chief Pharmacist, Ministry of Health The completed questionnaires were then used to generate individual country profiles. In order to do this in a structured and efficient manner, a text template was developed. Experts from member states took part in the development of the profile and, once the final document was ready, an officer from the Ministry of Health certified the quality of the information and gave formal permission to publish the profile on the WHO web site. This profile will be regularly updated by the Ministry of Health. Comments, suggestions or corrections may be sent to: Biribo Tekanene Te Marae Ora Cook Islands, Ministry of Health, P O Box 109, Rarotonga, Cook Islands. Phone: (682) : b.tekanene@health.gov.ck 2

7 Section 1 - Health and Demographic Data This section gives an overview of the demographics and health status of Cook Islands. 1.1 Demographics and Socioeconomic Indicators The total resident population from the 2011 census was 17,794 with an annual population growth rate of -1.6%. The annual Gross Domestic Product (GDP) growth rate is -0.5%. The GDP per capita was US$11,888 (at the current exchange rate i ). 29% of the population is under 15 years of age, and 13% of the population is over 60 years of age. The urban population currently stands at 74% of the total population. The fertility rate in Cook Islands is 2.8 births per woman. 22% of the population is living on less than $1.25/ day (international PPP). The adult literacy rate for the population over 15 years is 100%. 1.2 Mortality and Causes of Death From the WHO Western Pacific Country Health Information Profile, 2010 the life expectancy at birth is 73/82 years for male and female respectively in Cook Islands. The infant mortality rate (i.e. children under 1 year) is 7/1,000 live births. For children under the age of 5, the mortality rate is 11/1,000 live births. There have been no cases of maternal mortality since The Cooks Islands Country Health Profile 2011 explains that noncommunicable diseases, such as hypertension, diabetes, cancer, coronary heart disease, obesity, and injuries and poisonings, continue to be major public health problems. According to hospital records, 63% of registered patients in were reported to have hypertension, 16% both hypertension and diabetes and 21% diabetes only. i The exchange rate for calculation for NCU is 1.39 [1US$:1.39NZD], which is consistent with the timing of the collection of related NHA data. 3

8 The top 10 diseases/conditions causing morbidity in Cook Islands are iii : Disease 1 Diseases of the pulmonary circulatory system and other heart diseases 2 Injury, poisoning and certain other consequences of external causes 3 Other diseases of the respiratory system 4 Other diseases of the circulatory system 5 Diseases of the genitourinary system 6 Diseases of the digestive system 7 Diabetes 8 Hypertensive disease 9 Diseases of the musculoskeletal system and connective tissue 10 Influenza and Pneumonia Ministry of Health, Statistics Department, 2012 Disease of the circulatory system continued to be the leading cause of mortality in the last three years accounting for 36% of deaths in The adult mortality rate for both sexes between 15 and 60 years is 112/1,000 population, while the neonatal mortality rate is 3.5/ 1,000 life births. The agestandardized mortality rate in 2011 for non-communicable diseases, cardiovascular diseases and cancer are: 393/100,000; 309/100,000 and 84/100,000 respectively. There was no mortality from HIV-related disease, Tuberculosis or Malaria in iii These numbers are only for those admitted to the main Rarotonga hospital 4

9 Section 2 - Health Services This section provides information regarding health services, health expenditures and human resources for health in Cook Islands. The contribution of the public and private sector to overall health expenditure is shown and the specific information on pharmaceutical expenditure is also presented. Data on human resources for health and for the pharmaceutical sector is provided as well. 2.1 Health Expenditures (US$ 1.00=NZ$ ) According to the Cook Islands Health Service Delivery Profile 2012, funding for health services in Cook Islands comes primarily from Government budget (93% in 2012) with minimal overseas donor assistance (7%). The total health budget for 2012 was approximately NZ$11.3 million (NZ $755 per capita) and funds are primarily used for hospital health services (58%); outer islands health services (20%); community health services (16%); and funding and planning (6%). Total pharmaceutical expenditure (TPE) in Cook Islands in 2011 was NZ$ million (US$ million), which is a residential per capita pharmaceutical expenditure of NZ$42.00 (US$32.00). The total pharmaceutical expenditure accounts for 0.19% of the GDP and makes up 5.15% of the total health expenditure. There is no governmental social security expenditure. Private out-of-pocket expenditure accounts for 100% of private health expenditure. There are no private prepaid health plans. 2.2 Health Personnel and Infrastructure The health workforce is described in the Ministry of Health Human Resource Policy and Procedures Manual (2012) and in Table 1. There are two licensed pharmacists; one works in the public sector. There are five pharmacy technicians and assistants in the public sector. 5

10 There are 30 physicians and 96 nursing and midwifery personnel in Cook Islands. The ratio of doctors to pharmacists is 15:1 and the ratio of doctors to nurses and midwifery personnel is 1:3. Table 1: Human resources for health in Cook Islands in 2012 Human Resources Number Density /10,000 Licensed pharmacists (all sectors) Licensed Pharmacists in the public sector Pharmacy technicians and assistants (in the public sector) Physicians (all sectors) Nursing and midwifery personnel (all sectors) There is a Cook Islands Health Work Force Development Plan including pharmaceutical human resource development in place. The health service infrastructure is described in Table 2. There are two hospitals with a total of 100 hospital beds in Cook Islands. As explained in the Cook Islands Health Service Delivery Profile 2012, each inhabited island has a primary health care unit as well as smaller facilities (units, centres and clinics). Cook islands has three public pharmacy outlets and a total of three private pharmacy outlets, one of which is run by a registered pharmacist and the other 2 are operated by non-pharmacists. Table 2: Health Services infrastructure Infrastructure Hospitals 2 Hospital beds 100 Health centres 6 Child Welfare Clinics 52 School Dental Clinics 14 Public Dental Clinics 1 Private dental Clinics 1 Public pharmacy outlets 3 Licensed private pharmacies (staffed by approved staff) 3 6

11 The pharmaceutical and medical supplies are distributed to the remote clinics where dispensing is done by the nurses. The health centre on each island is staffed by a doctor and a 24 hour service is accessible at these facilities. The others provide consultation and dispensing, carried out by a trained nurse. Pharmacy services There are two Government pharmacy outlets (10 km apart on the main island of Raratonga) managed by the chief pharmacist; and a pharmacy outlet managed by a pharmacy technician on the outer island of Aitutaki. There are three private pharmacy outlets in Rarotonga, one of which is managed by the second pharmacist (New Zealand (NZ) licensed) mentioned in Table 1. The other two private pharmacy outlets are operated by exmedical non-pharmacist personnel. The annual starting salary for a newly registered pharmacist in the public sector is NZ$ 25,712. One pharmacist graduated (as a first degree) in the past two years. There are no pharmacy schools in Cook Islands. Training is offered at Schools of Pharmacy in Fiji, New Zealand or Australia. Laboratory Services The Raratonga Hospital Laboratory under the MOH is available 24 hours for clinical biochemistry, haematology, microbiology, blood bank services and histopathology. Specimens are referred to New Zealand as necessary. 7

12 Section 3 - Policy Issues This section addresses the main characteristics of the pharmaceutical policy in Cook Islands. The many components of a national pharmaceutical policy are based on the WHO publication How to develop and implement a national drug policy ( Information about the capacity for manufacturing medicines and the legal provisions governing patents is also provided. 3.1 Policy Framework There is a Cook Islands National Health Strategy , which is included in the Vision, Mission, Aspirations and Strategy of the Ministry of Health (MOH). There is a draft National Medicines Policy (NMP) document in Cook Islands but there is no strategic NMP implementation plan yet. The draft NMP is a group of policies addressing pharmaceuticals, as detailed in Table 3. Implementation of the policies in this group of policies is regularly monitored/assessed by the Chief Pharmacist, MOH. Table 3: Policies covered by the draft NMP Aspect of policy Selection of essential medicines Medicines financing Medicines pricing Medicines Procurement Medicines Distribution Medicines Regulation Pharmacovigilance Rational use of medicines Human Resource Development Research Monitoring and evaluation Traditional Medicine Covered No No 8

13 There are draft written guidelines on medicines donations. Access to essential medicines/technologies as part of the fulfillment of the right to health is recognized in the national legislation. There is a national Good Governance policy stipulated in the National Sustainable Development Plan, in Cook Islands. The Office of the Director of Audits and Public Expenditure & Review Act (PERCA) monitors good governance, conflict of interest and code of conduct. There is a formal code of conduct for public officials that is also monitored by the Public Service Commission. Within MOH Personnel Policies and Procedures, there is a Conflict of Interest Policy. Cook Islands has a whistleblowing mechanism that allows individuals to raise concerns about wrongdoing occurring in the pharmaceutical sector. Refer to: Office of the Director of Audit - PERCA, Public Service Commission, Ombudsman Office, Ministry of Finance and Economic Management (MFEM). Recommendations: It is recommended that the Cook Islands National Medicines Policy (NMP) be finalised, launched and circulated widely and owned by all stakeholders. Launching of the NMP should be followed promptly by development and circulation of a Pharmaceutical Sector Strategic Plan for implementing the Policy; and engaging relevant stakeholders. Activities should be prioritised in collaboration with relevant colleagues. The timely implementation of activities in the Strategic Plan will fulfill the objectives of the Cook Islands National Medicines Policy in all areas mentioned in3, and will strengthen the pharmaceutical sector (public and private). Donation Guidelines should be finalised and circulated. 9

14 Section 4 - Medicines Trade and Production 4.1 Intellectual Property Laws and Medicines Cook Islands is not a member of the World Trade Organization (WTO). Legal provisions for granting patents to manufacturers exist. These cover pharmaceuticals, laboratory supplies, medical supplies and medical equipment. National Legislation has not been modified to implement the Trade-Related Aspects of Intellectual Property Rights (TRIPS) Agreement but does contain TRIPS-specific flexibilities and safeguards iv, as presented in Table 4. Cook Islands is not eligible for the transitional period to Table 4: TRIPS flexibilities and safeguards are present in the national law Flexibility and safeguards Compulsory licensing provisions that can be applied for reasons of public health Bolar exceptions v Parallel importing provisions Included No No 4.2 Manufacturing There are no licensed pharmaceutical manufacturers in Cook Islands. iv Whilst the Cook Islands are now autonomous from New Zealand, many of the patent laws from the colonial era are still applicable. v Many countries use this provision of the TRIPS Agreement to advance science and technology. They allow researchers to use a patented invention for research, in order to understand the invention more fully. [In: WTO OMC Fact sheet: TRIPS and pharmaceutical patents, can be found on line at: 10

15 Section 5 - Medicines Regulation This section details the pharmaceutical regulatory framework, resources, governing institutions and practices in Cook Islands. 5.1 Regulatory Framework In Cook Islands, there are legal provisions establishing the powers and responsibilities of a Medicines Regulatory Authority (MRA). The Pharmacy and Therapeutics Regulations are now prepared. Under these Regulations, the MOH will be able to create a MRA to perform regulatory functions. In the interim the MOH is carrying out some of these functions such as health inspection. An assessment of the medicines existing regulatory system has been conducted in the last five years. 5.2 Marketing Authorization (Registration) In Cook Islands, there are no legal provisions for marketing authorization (registration) for all pharmaceutical products on the market. Mutual recognition mechanisms are in place, as Cook Islands recognizes registration of pharmaceutical goods from Australia and New Zealand. There are no explicit and publicly available criteria for assessing applications for marketing authorization of pharmaceutical products. Most medicines are imported from Australia and New Zealand, and therefore there is no registration mechanism within Cook Islands itself. However, when medicines are imported from elsewhere, the WHO Certification Scheme on the Quality of Pharmaceutical Products Moving in International Commerce is used. Medicines are not always labelled with their INN (International Nonproprietary Names) or Brand name + INN. 11

16 5.3 Regulatory Inspection In Cook Islands, legal provisions allow for the appointment of government health inspectors. These same legal provisions will permit inspectors to inspect premises where pharmaceutical activities are performed. Regulatory inspection is also covered under the Health Act Import Control Legal provisions exist requiring authorization to import medicines. There are no laws requiring the sampling of imported products for testing. Legal provisions exist requiring importation of medicines through authorized ports of entry. 5.5 Licensing In Cook Islands, legal provisions do not exist requiring manufacturers to be licensed and legal provisions do not require wholesalers and distributors to comply with Good Distribution Practices. There are no Good Manufacturing Practices Guidelines as there are no local manufacturing industries in Cook Islands. It is generally considered that GMP compliance is monitored for manufacturers in New Zealand and Australia, and by use of the WHO Certification Scheme on the Quality of Pharmaceutical Products Moving in International Commerce, as a part of the overall procurement process as described above. Table 5: Legal provisions pertaining to licensing Entity requiring licensing Importers Wholesalers Distributors No No No Good Distribution Practices for importers are not published by the government but there is a Ministry of Health Guideline on Good Distribution Practices. 12

17 5.6 Market Control and Quality Control In Cook Islands, legal provisions do not exist for controlling the pharmaceutical market. There is no Medicine Quality Control Laboratory for testing of pharmaceuticals in Cook Islands. There is some collaboration between the Pacific Island nations on Quality Control testing. This is carried out through individual country partnerships with other national and international laboratories. Medicines are tested when there are specific complaints or problem reports, but not for any other reasons. Samples are not routinely collected by government inspectors for undertaking post-marketing surveillance. 5.7 Medicines Advertising and Promotion In Cook Islands, legal provisions exist to control the promotion and/or advertising of prescription medicines. The Ministry of Health is responsible for regulating promotion and/or advertising of medicines. Legal provisions prohibit direct advertising of prescription medicines to the public. However, preapproval for medicines advertisements and promotional materials is not required. Guidelines and Regulations exist for advertising and promotion of non-prescription medicines. 5.8 Controlled Medicines Cook Islands is a signatory to the United Nations Convention against the Illicit Traffic in Narcotic Drugs and Psychotropic Substances, 1988, detailed in Table 6. 13

18 Table 6: International Conventions to which Cook Islands is a signatory Convention Signatory 1961 Single Convention on Narcotics Drugs No 1972 Protocol amending the Single Convention on Narcotic Drugs, 1961 Convention on Psychotropic Substances 1971 United Nations Convention against the Illicit Traffic in Narcotic Drugs and Psychotropic Substances, 1988 No No Laws exist for the control of narcotic and psychotropic substances, and precursors. In 2012 the annual consumption of Morphine was 3.8 mg/capita. Figures regarding the annual consumption of certain controlled substances in the country for 2012 are outlined in Table 6S below. Table 6S: Annual consumption of selected controlled substances in Cook Islands, 2012 Controlled substance Annual consumption (mg/capita) Morphine 3.8 Fentanyl Pethidine Pharmacovigilance In Cook Islands, there are no legal provisions that provide for pharmacovigilance activities as part of the MOH mandate. Legal provisions don t require the Marketing Authorization holder to continuously monitor the safety of their products and report to the MOH. There are no policies regarding the monitoring of Adverse Drug Reactions (ADRs) in Cook Islands. Although there is no national pharmacovigilance centre Cook Islands, the Ministry of Health has a standardized form for reporting ADRs in the form of incident reports. Medication errors are reported on the same incident reporting template. Information pertaining to ADRs is stored on an electronic 14

19 patient management database called Medtech 32 and is reported on a quarterly basis. There is a National Drugs and Therapeutics Committee which is able to provide technical assistance or causality assessment, risk assessment, risk management, case investigation and, where necessary, crisis management including crisis communication in Cook Islands. There is a clear communication strategy for routine communication and crises communication concerning ADRs. ADRs are also monitored in certain public health programmes (example TB, HIV-related infection). A number of steps are being considered in order to enhance a pharmcacovigilance system. These steps include the use of a special reporting form, which will improve data collection. This form will be used in new programmes e.g. for newly emerging infections such as SARS and Bird Flu; and for mass treatment campaigns. There are no training courses in pharmacovigilance. Regulatory decisions have been based on local pharmacovigilance data in the last two years. In the past two years ADR reporting has been done by the following: Profession Reported ADRs Doctors Nurses Pharmacists Pharmaceutical companies Journalists Quality Manager 15

20 Recommendations: Implementation of the National Medicines Policy will address issues in this section. Regulations dealing with the licensing and regulation of importation, exportation, manufacture, sale, supply, storage, advertising and promotion of medicines should be developed and enforced. Quality of processes and products should be ensured. Pharmacovigilance capacity should be developed along with a sound mechanism for recognizing, reporting and following up adverse medicines events. A strengthened role for the Drugs and Therapeutic Committee should be developed with the implementation of the NMP. 16

21 Section 6 - Medicines Financing In this section, information is provided on the medicines financing mechanism in Cook Islands, including the medicines coverage through public and private health insurance, use of user charges for medicines and the existence of public programmes providing free medicines. Policies and regulations affecting the pricing and availability of medicines (e.g. price control and taxes) are also discussed. 6.1 Medicines Coverage and Exemptions In Cook Islands, concessions are made for certain groups to receive medicines free of charge (see Table 7). There is a public health sector that provides medicines free of charge for particular conditions. Table 7: Population groups provided with medicines free of charge Patient group Patients who cannot afford them Children under 5 Pregnant women Elderly persons All Outer Island Residents Covered There are no public health insurance, social insurance or other sickness funds that provide medicines coverage. Private health insurance schemes do not provide medicines coverage. 6.2 Patients Fees and Co-payments Co-payments or fee requirements for consultations are levied at the point of delivery and there are co-payments or fee requirements imposed for medicines. Revenue from fees or from the sale of medicines is not used to pay the salaries or supplement the income of public health personnel in the same facility. 17

22 Private prescriptions are charged according to the User Pay Policy, for private patients and Non-Cook Islanders Pricing Regulation for the Private Sector vi In Cook Islands, there are no legal or regulatory provisions affecting pricing of medicines. The government does not run an active national medicines price monitoring system for retail prices. Regulations do not mandate that retail medicine price information should be publicly accessible. 6.4 Duties and Taxes on Pharmaceuticals (Market) Cook Islands does not impose duties on imported active pharmaceutical ingredients (APIs) or on imported finished products. However, value-added tax or other taxes are imposed on finished pharmaceutical products. There are no provisions for tax exceptions or waivers for pharmaceuticals and health products. vi This section does not include information pertaining to the non-profit voluntary sector 18

23 Section 7 - Pharmaceutical Procurement and Distribution in the Public Sector This section provides a short overview on the procurement and distribution of pharmaceuticals in the public sector of Cook Islands. 7.1 Public Sector Procurement The public sector procurement in Cook Islands is centralized under the responsibility of the Pharmacy Department, Ministry of Health. There is a written public sector procurement policy called Cook Islands Government Financial Policies & Procedures Manual. A process exists to ensure the quality of products that are publicly procured. Procurement is based on the prequalification of suppliers. It is based on at least three quotations from selected suppliers and also limited by monetary value by power of authority. The quality assurance process includes the pre-qualification of products and suppliers. Additionally, a list of pre-qualified suppliers and products is available. The tender methods employed in public sector procurement include international competitive tenders and direct purchasing. 7.2 Public Sector Distribution The Pharmacy Department, MOH has a Central Medical Store (CMS) at National Level which distributes pharmaceuticals nationally. There is a MOH guideline on Good Distribution Practices (GDP) A number of processes are in place at the Central Medical Store as detailed in Table 8. 19

24 Table 8: Processes employed by the Central Medical Store Process Forecasting of order quantities Requisition/Stock orders Preparation of picking/ Packing slips Reports of stock on hand Reports of outstanding order lines Expiry dates management Reports of products out of stock It is routine procedure to track the expiry dates of medicines at the CMS. The Public CMS is not ISO certified. 7.3 Private Sector Distribution Legal provisions do not exist for licensing wholesalers or distributers in the private sector. However in the draft 2013 Pharmacy and Therapeutic Products Regulation, this issue will be addressed. 20

25 Section 8 - Selection and Rational Use of Medicines This section outlines the structures and policies governing the selection of essential medicines and promotion of rational drug use in Cook Islands. 8.1 National Structures There is a National Essential Medicines List (EML). This is publicly available, and currently contains 430 medicines. Selection of medicines for the EML is undertaken by the National Drug and Therapeutics Committee through a written process. A mechanism aligning the EML with the Standard Treatment Guidelines (STGs) is in place. National Standard Treatment Guidelines for the most common illnesses are developed/drafted by the MOH in There is no public or independently funded national medicines information centre providing information on medicines to prescribers, dispensers and consumers. Neither public education campaigns on rational medicine use topics nor a survey on the rational use of medicines have been conducted in the last two years. The National Drugs and Therapeutics Committee monitors and promotes rational use of medicines. Pharmacy Department distributes medicines education pamphlets in collaboration with Community Health Services Directorate. No written National Strategy for Containing Antimicrobial Resistance exists. The Cook Island s Essential Medicines List (EML) includes formulations specifically for children. Criteria for the selection of medicines to the EML are based on disease pattern and cost of medicines. There is no national medicines formulary. The Quality Management Department with the Ministry of Health supports the National Drug and Therapeutic Committee for the promotion of the appropriate use of antimicrobials and prevention of the spread of infection. 21

26 There is no national reference laboratory or other institution that has responsibility for coordinating epidemiological surveillance of antimicrobial resistance. 8.2 Prescribing Legal provisions exist to govern the licensing and prescribing practices of prescribers. There are no legal provisions restricting dispensing by prescribers. Prescribers in the private sector dispense medicines. There are regulations requiring hospitals to organize/develop Drug and Therapeutics Committees (DTCs), and a DTC exists at the national hospital. The training curriculum for doctors and nurses is made up of a number of core components detailed in Table 9. Table 9: Core aspects of the medical training curriculum Covered The concept of EML Use of STGS Problem based pharmacotherapy Mandatory continuing education that includes pharmaceutical issues is required for doctors, nurses and paramedical staff. Prescribing by INN is obligatory in the public but not the private sector. The average number of medicines prescribed per patient contact in public health facilities is four. There is a professional association code of conduct that governs the behaviour of doctors and nurses. 22

27 8.3 Dispensing Legal provisions in exist to govern dispensing practices of pharmacy personnel in Cook Islands. The basic pharmacist training curriculum includes a spectrum of essential medicines related components as outlined in Table 10. Table 10: Core aspects of the pharmacist training curriculum The concept of EML Use of STGS Covered Mandatory continuing education that includes rational use of medicines is required for pharmacists. Substitution of generic equivalents at the point of dispensing is allowed in public and private sector facilities. Sometimes antibiotics are sold over-thecounter without a prescription, however injectable medicines are not. There is no professional association code of conduct that governs the professional behaviour of pharmacists. In practice, nurses do sometimes prescribe prescription-only medicines at the primary care level in the public sector (even though this may be contrary to regulations). Recommendations: Implementation of the National Medicines Policy will address any outstanding issues in this section. A strengthened role for the Drug and Therapeutic Committee in the monitoring of Antibiotic Resistance could be developed with the implementation of the NMP.. 23

28 Section 9 - Household Data/access In the past 5 years, no household survey(s) have been undertaken to assess the access to medicines. Therefore no information is available for this section. 24

29 List of key reference documents Approved Standards And Codes Of Conduct Applicable To All Therapeutic Products (MOH) Approved Standards Applicable To All Pharmacies 2013 (MOH Cook Island Health Profile WHO, Available online: Cook Islands Constitution and Medicines Act 1995 Cook Island s Essential Medicines List (EML). Available from the Pharmacy Department Cook Islands Government Financial Policies & Procedures Manual. Cook Islands Health Work Force Development Plan Cook Islands National Health Strategy, Country Health Information, Profile. Western Pacific Regional Health Databank, World Health Organization, Cook Islands Health Delivery Profile. Available online: Country pharmaceutical situations, fact book on WHO Level 1 indicators 2007, Geneva, World Health Organization (WHO), 2010, Available online: Country pharmaceutical situations, fact book on WHO Level 1 indicators 2007, Geneva, World Health Organization (WHO), 2010, Available online: Draft Guidelines on Medicines Donations to the Cook Islands. Available from the Pharmacy Department HR Personnel Policies and Procedures Manual October 2012 (MOH) Implementation Steps For The Pharmacy And Therapeutic Products Regulations (MOH) International Narcotics Control Board. Annual Report (2012). Available online: Ministry of Finance pdf Ministry of Health (Pharmacy and Therapeutic Products) Regulations 2014 Ministry of Health Annual Bulletins. Available online: MOH Personnel Policies and Procedures 01 October 2012.pdf National Bureau of Statistics, Economic Indicators. Available online: 25

30 National Bureau of Statistics, Population Estimates and Vital Statistics. Available online: National Legislation: Health Bill, Pharmacy and Therapeutics Regulation [draft] National Medicines Policy of Cook Islands (draft). Available from the Pharmacy Department National Sustainable Development Plan, Available from the Office of the Director of Audits and Public Expenditure & Review New Zealand Patents Act Te Marae Ora Cook Islands Ministry of Health Personnel Policies & Procedures Manual. Available from (documents) Te Marae Ora, Ministry of Health, Cook Islands. User Charges Schedule, October 2010 pdf. Available online: Ministry of Health - Therapeutic Products Act 2007, Cook Islands, and Pharmacy Act 2007, Cook Islands. Vital Statistics and Population Estimates. Available online: Western Pacific Country Health Information Profiles, Available online: WHO certification scheme on the quality of pharmaceutical products moving in international commerce. Available at WHO: MID/933/ArticleID/46/Default World Trade Organization (2011). Available online: 26