Electronic Common Technical Document (eCTD)- Interface for the Pharmaceutical Industry to Agancy Transfer of Regulatory InformationBaseline Importation Status of applications98%Staff Educated and Continuously Developed Throughthe Following Activities: 1 eCTD Implementation Training 2 Health Products and Supplements Workshop 3 Biosimilars Workshop 4 Alternative Medicines Workshop 5 Pharmacoeconomics 6 Detecting Counterfeit Medical Products 7 Homeopathic Conference 51
111 Medical Device Regulations52
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Medical Device Regulations The NHRA received 8178 applications for medical devices licenses, of which 6861 were approved. The remaining applications were rejected due to various violations such as counterfeit certificates or devices. The total cost of the approved devices was 24,841,633.13 BD. The following infographics demonstrate medical device statistics in 2017.54
Medical Devices Licensing8178 total number of new medical device applications assessed Total6861 1317ApprovedMedical Device Combined Medical Device(Ofoq - Online Application) (Manual Application)6648 X1247 X213 70Types of Medical Device Violations Identified 20 Counterfeit Certificate 2 Counterfeit Device 2 Counterfeit Instrument 55
Total Value of Medical Devices Imported:24,841,633.13 BhDTotal Value (BhD) of Shipments by Month Sep Mar Oct Nov Jul Dec Apr May JunJan Feb Aug1,702,913.06 1,682,762.36 2,363,841.24 2,012,747.46 2,042,155.44 1,871,161.27 2,226,508.72 1,685,722.72 2,671,647.43 2,286,651.00 2,320,530.82 1,974,991.62 VALUE BhD Department Achievements: 1. Membership in the ISO international committee (ISO/TC 106, ISO/TC 150, ISO/TC 170, ISO/TC 194, ISO/TC 198, ISO/TC 198/WG8, ISO/TC 198/WG13, ISO/TC 198/WG14, ISO/TC 210). 2. Membership in the GCC central registration 3. Hosted TC11 GSO meeting 4. Proposed classification criteria of medical devices to GCC56
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Alternative/ Complementary Practice Regulations58
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Alternative/ Complementary Practice Regulations The regulation of Alternative and Complementary Medicine (CAM) practices by resolution 33 for 2016 had lead to the registration of 13 CAM centers in Bahrain. These centers offer various CAM services such as Ayurveda, Cupping, Chiropractic, Homeopathy, Naturopathy and Chinese Medicine. The following infographics demonstrate CAM statistics in 2017.60
Alternative MedicineTotal Number of LicensedTotal Number of Licensed Total Number of Licensed Alternative Medicine Alternative Medicine Alternative MedicineApplications Referred From Healthcare Professionals Department:PhysiciansPractitionersTechnicians2 27 5Licensed Alternative Medicine Licensed Alternative MedicinePractitioners by Specialty Technicians by Services Provided Ayurveda 1 aniosacral The1Biodynamic Cr Cupping Chiropractice Homeopathy Ayurveda 2 2 Naturopathy Massage rapy Biodynamic Craniosacral Therapy Therapy Therapy Osteopathy Cupping New Applications for Alternative Medicine Professionals 15 4 2 1 3 1 1 Total Number for Alternative Medicine Physicians License: 1 Total Number for Alternative Medicine Practitioners License: 19 Total Number for Alternative Medicine Technicians License: 33Types of Alternative Medicine Services Available in the Kingdom of BahrainAyurvedic Massage 10Hijama 5 Alternative Medicine FacilitiesChiropractic 2 2Bio Cranio Therapy 2 Total Number of Licensed Alterna- tive Medicine Facilities: 13HomeopathyChinese Medicine 1Osteopathy 1New Applications for Alternative Medicine Facilities: 11Total Number of Alternative Medicine Products Approved: 311 61
Continuous Professional Development & Clinical Trial Regulations62
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Continuous Professional Development and Clinical Trials In pursuant of the decision of the Supreme Council of Health to link continuous professional education with the renewal of licenses for healthcare professionals, the Authority approved 3,022 continuing professional development training programs. These programs included conferences, workshops, scientific forums and lectures. In the area of clinical trials, the Authority has reviewed and made judgement on 12 clinical trials in the private and public sectors.64
Approving Continuing Professional Development Programs 3022 Approved CPD Activities in 2017 Distribution of Approved CPD52% 48%Government PrivateTypes of Approved CPD Activities171 Specilized Workshop General Workshop 28 18 Lectures Conferences Symposiums & Seminars Course 9 6 9 65
Distribution of Approved CPD Activities According to Speciality 121 Dentistry 31 Physiotherapy 21 Health Care Management 18 Forensic Medicine 82 Nursing 31 Obs & Gyn 16 Oncology 16 E.N.T 63 Internal Medicine 31 Endocrinology & Diabetology 14 Laboratories & Pathology 13 Dermatology 54 Cardiology 30 Urology 12 Rheumatology 12 Hematology 53 Pharmacology 30 G. Medicine 9 Psychiatry 9 Inspection for Health facilities 52 Pediatric 29 Pulmonology 7 Nutrition 6 Plastic Surgery 51 28Infection Control & Prevention Neurology 6 Health Research 6 Genetic 46 Orthopedic 28 General Surgery 3 Medical Ethics 3 Anesthesiology 37 BLS, ACLS & PALS 27 Primary Health Care 2 Sport Medicine 2 Medical Education 34 Health Care Quality 27 Patient Safety & Management 1 Occupational Medicine 34 Emergency Medicine 25 Ophthalmology 32 Health Care Accreditation 24 Radiology Internal Activities 184666
Outcomes of 12 Clinical Trial Applications Submittedto NHRA231213 Completed Approved Pending Rejected Withdrawn No ResponseClinical Trials Submissions by Sector5 Government 7 PrivateDistribution of Clinical Trials Applications by SpecialityUrology 1Diabetology 1Blood Disorder 1Orthopedic 3Obesity 1Gastrointestinal 1Oncology 1Hypertension 1Erectile Dysfunction1 67
Medical Complaints68
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Medical Complaints The NHRA received 237 complaints in 2017, of which 136 were direct complaints from patients and 47 were incidents reported by health facilities. There were also 52 cases which were referred by the prosecution and the courts. The breakdown of the complaints were 57% against the private sector and 42% against the government sector. In addition, 66% of the complaints were against doctors and 14% against healthcare facilities. The NHRA completed the investigation of 118 cases of which medical error was proved in only 44 of them. The following infographics demonstrate complaint, incidents and lawsuit cases statistics in 2017.70
Medical Complaints 2017 237 cases received by NHRAorted from the Pu d by Health Care NHRA ed by Judicial Aut 136 47 2 52 Complaints Incidents Internal Lawsuits horitiesReference Facilities blicRep Reporte ReferrDistrubution of Complaints, Incidents andLawsuits by Health Sector Public Private Both Others45 87 3 1 1 1 0 0 26 21 0 0 22 29 0 1Compalints Internal referral Incidents Lawsuits 71
Distrubution of Complaints, Incidents and Lawsuitsaccording to health professionDoctors Nursing macists/Pharm Allied Others ealth Faciliti hin NHRA jur istiction es acies Phar H Not wit 4 11 1 11 7 33 Law Suits Incidents Complaints 49 38 5 4 5 85Distribution of Complaints According Distribution of Incidents According toto the Most Frequent Specialty the Most Frequent Specialty 18 16 Dentistry A/E A/E11 11A/E OBS/GYN 8 7 GP Ortho 4 4 3 3 General GP OBS/GYN Surgery Pediatrics Distribution of Lawsuits According to the Most Frequent Specialty OBS/GYN7 General Surgery5 Dentistry8 Orthopedics6 General Practice872
Cases investigated:56 17 45 have been completed in 2017COMPLAINTS INCIDENTS LAWSUITS JuRdeicisaul Dlet3csisioonf InvNoet swtithi4ign Jaurtisidoictnion Pending judicial Not within jurisdiction decision of NHRAMedical Error 1 n/a n/a 4 n/a 1 2 5 Closed Medical error or Closed due to violation of the insufficient evidence, principles, duties, lawsuit waiving or requirements and complaint withdrawn ethics present 425 15 11 18No Medical Error 1 TOTAL No medical error or 56 17 45 violation of the principles, duties, requirements and ethics present 32 4 21 Type of case : Complaints Incidents Lawsuits 73
In 2017 a total of 66 disciplinary decisions wereissued by disciplinary committees at NHRA.66Of the 47 Against doctors disciplinary actions taken 15 Against nurses 1 Against allied health professionals 2 Against pharmacists 1 Against a health facilityTypes of Disciplinary Actions taken in 2017 466 Disciplinary Actions Issued:• 34 Suspensions• 21 Written Warnings Issued• 10 Licenses Canceled• 1 Financial Penalty Issuedainst Doctors ainst Nurses 8 2 47 15Ag Ag 15 4 24 9 against pharmacists: 2 written warning Suspension License Cancellation against allied health: 1 suspensions Written Warning Financial Penalty against health facility: 1 financial penalty74
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National Accreditation Program76
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Implementation of the National Accreditation Program The journey of implementing the National Accreditation program began in November 2016 with the preparation of the legal infrastructure and detailed review of the accreditation standards. Thereafter, a rigorous training program was conducted over a span of a couple of months and our first hospital visit for accreditation was in May 2017. Since then we have successfully accredited 14 healthcare facilities. NHRA is committed to ensure the high quality of health services provided, and that these services are rigorously evaluated and continuously monitored so as to establish and maintain public confidence of the healthcare system in the Kingdom. Furthermore, we have made accreditation mandatory for all licensed healthcare facilities. NHRA’s fundamental principles for accreditation include the following: • To support and encourage just-culture values, attitudes and practices between NHRA and healthcare facilities • To establish a strong, effective, constructive, mutually beneficial and on-going partnership with all healthcare facilities • To adopt the peer review approach, that entails an in-depth discussion between peers rather than a “tick-box” method of auditing/inspecting • To encompass key areas for quality improvement by recommending internationally accepted evi- dence-based practices • To ensure that the recommendations made will be of added-value, that are contextual, appropriate, patient-centered, feasible and cost-effective for the facility We now should take pride in the fact that Bahrain has a successful accreditation program, one of the first in the Gulf, which is based on international standards and guidelines, yet culturally relevant to the practice of medicine in the hospitals and medical centers in the Kingdom of Bahrain.78
NHRA Accreditation Implementation TimelineNov/Dec Jan/Feb March 2016 2017 2017CBAHI Surveyor NHRA Accreditation Specialty AccreditationTraining Orientation for Workshops & Private Hospitals Surveyor Enhancement TrainingAug May April2017 2017 2017NHRA Accreditation Implementation of Specialty AccreditationOrientation for Hospital Accreditation Workshops for HospitalsMedical Centres Accreditation Visit Royal Bahrain Hospital & Medical Centre Accreditation Visit American Mission Hospital & 2 Medical CentresSept Oct Nov Dec2017 2017 2017 2017NHRA Awards Accreditation Visit Specialty Accreditation Accreditation VisitCeremony for Awali HospitalAccredited Hospitals Workshops Al Kindi Hospital Accreditation VisitAccreditation Visit King Abdulla for Medical Centres and Medical CentreAl Hilal Hospital & Medical City HospitalMedical CentreAccreditation VisitDr Tariq Hospital 79
Accreditation Activities 14 17Healthcare Accreditation 22Accreditation Facilities Committee Workshops Surveyed Meetings Conducted Convened by NHRA Distribution of Hospital Awards 88% 90% 30 33 33 15 12 Diamond Platinum Gold Silver 431 0 Distribution of Medical Center Awards 0 Silver 330 Diamond Platinum Gold80
Accreditation Outcome AnalysisAchievement of Core Elements83% 97% 88% 84% 90% 88% 84% 100% 91% 80% 95% Governance Management & Leadership Human Resources Patient & Family Rights Quality Management & Patient Safety Management of Information & Med Records Infection Prevention & Control Facility Management & Safety Health Promotion & Education Provision of Care Medical Staff NursingNon Compliance Status in Private HospitalsHospital Performance Partially Met32 30 33 33 15 12 11 2 Hospital Performance Not Met 17 9 5 3 0 3 2 4 Hospital A Hospital B Hospital C Hospital D Hospital E Hospital F Hospital G Hospital HDistribution of Recommendations iven to Hospitals by Pri ated Medical Centers by PG riorityAffili ority 46% 33113%%1% 3344%%34% Critical Recommendation High Recommendation 27% 26% 33443%%4% Medium Recommendation Low Recommendation 0.22% 81
Accreditation Standards AnalysisThe Element with Standard that was 5the most Not consistently Not MetMet standards within the elementwas Emergency was the requirementCare of a Consultant Head of Emergency 6 Department Total TotalThe Elements with the most Partially Met standards were:Governance Management Infection Quality & Control & Leadership & Patient Safety PreventionThe Standard that was consistently Partially Total5Met was in Infection Control and Preventionthat required a system in place for thesafe handling of internal and externalwaste. The Element with the mostTotal High Priority Recommendations12is Infection Control and Prevention.82
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The Way Forward84
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The Way Forward In the year ahead, NHRA aims to strengthen our relationship with our clients in the Kingdom of Bah- rain. One of the initiatives to achieve this aim is to develop a comprehensive IT platform. This will facilitate the licensing applications, drug and medical devices registration and sentinel event reporting processes thereby enabling NHRA to improve the efficiency of our operations and achieve a higher standard of customer satisfaction. The way forward for some of our initiatives include: • For Pharmaceutical Products Regulations: By May 2018 All pharmaceutical companies will be able to upload their products into our system to start the implementation of medication bar coding - A global standardized system for traceability of medication • For Accreditation: Implementation of accreditation of medical centers and continue private / public hospital accreditation • With the implementation of the national health insurance system in Bahrain, the role of NHRA will expand to include approving the private insurance companies providing the insurance coverage • Review and update professionals’ legislation, Law 21 for private care facilities and the Pharmacy and Drug legislations. We strive to serve the people of Bahrain in the best way we can and gain the trust of our clients by continuously improving our procedures and policies.86
Our Ambition Reach global competitiveness in the regulation of health servicesProcedures Services 87
@NHRA_Bahrain @NHRABahrain Nhra-bahrain www.nhra.bh88The Way National Medical CPD & Clinical Alternative / Medical Device Pharmaceutical Healthcare Pharmacy Healthcare Resolutions, NHRA Strategy From the CEOForward Accredtation Complaints Trial Regulations Complementary Regulations Product Professional Regulations Facility Guidelines, Program Practice Regulations Regulations Regulations Regulations Polices & Contracts
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