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Drug Formulary Management & National Essential Drug List (National…
Drug Formulary Management &
National Essential Drug List
Drug Formulary
type used in health care
MOH Drug Formulary
Hospital Drug formulary
Health Centre Drug Formulary
what is it
contain list of approved medication used in that area
purpose
tools for drugs procurement
guidance for drugs use
encourage optimum & rational drug used
optimize MOH drug fund
reduce misspend of drug
management
function
Objectively discriminate between superior and marginal medications
reduce drugs cost
improve patient access to drug & improve QOL
list of committees
MOH Medicine Formulary Review
panel list
Director General of Health
Deputy Director General of Health (P& ST)
Deputy Director General of Health (Medical)
Director of Pharmaceutical Services
8 Consultants in Public Services
3 Pharmacists in Public Services
roles
set up drug policies regarding drug use
approval of introduction of new drugs
removal of any drug/dosage form/ strength
add/ alter formulation/ dosage form/ indications
State drug Committee
Technical/Drug Working Committee (DWC/TWC)
roles: to review
relevant information on use of medications by patient & experience of drug use
compare medications by therapeutic classification
current therapeutic use& access guidelines & the need of revisions of guidelines
give recommendation to MOHMF
medical & CT of new drugs
Hospital drug committee (DTC/HDC)
roles
Develop drug policies
Evaluate & select drugs for the formulary list
Develop & implement standard tx guidelines
Assess drug use to identify problems
Conduct interventions to improve drug use
Manage ADR and medication errors
Inform all staff members about drug use issues, policies & decisions
Provide advice on all aspects of drug management
roles of pharmacist
Lead the formulary management initiatives
Coordinate DTC committee tasks
Make recommendations based on sound clinical evidence
guide
Guide DTC committee through drug selection process
Develop benefit related policies, therapeutics guidelines
and design utilization management strategies
National Essential Drug List (NEML)
what is it
medication list as NEML in drug formulary
must available at all times, adequate amounts,appropriate dosage forms
not all medication in Formulary is listed in NEML
functions as a guide for
drug procurement, distribution & utilization
drug information for healthcare providers
support to the domestic pharmaceutical sector
drug financing/reimbursement schemes
drug donations
students & in service training of health professional & public educations on quality uses of drugs
committees
Experts in Medicine
Pharmacy
Dentistry
Pharmacology
Public health
Consumer affairs and
Health economics
process of selection
Need to regularly update medicines selections to
reflect new therapeutic options & changing needs
Need to ensure drug quality
Independent and transparent process
Need for continued development for better medicines, medicines for emerging diseases,& medicines to meet changing resistance patterns
wide consultation with interested parties such as representatives from health professionals, pharmaceutical manufacturers & consumer organization
based on NEML 5th ed.
there are 359 chemical entities
29 classification of therapeutic group
Antidotes And Other Substances Used In Poisonings 13
Anaesthetics, Preoperative Medicines And Medical Gases 12
Antiallergics And Medicines Used In Anaphylaxis 4
Anticonvulsants/Antiepileptics 8
Anti-Infective Medicines 89
Antimigraine Medicines 3
Antiparkinsonism Medicines 1
Antiseptics 4
Blood Products Of Human Origin And Plasma Substitutes 12
Cardiovascular Medicines 32
DERMATOLOGICAL MEDICINES (Topical) 14
Diagnostic Agents 4
Diuretics 3
Ear, Nose And Throat Medicines 3
Gastrointestinal Medicines 33
Immunologicals 20
Immunomodulators And Antineoplastics 53
Medicines Acting On The Respiratory Tract 11
Medicines Affecting The Blood 12
Medicines For Diseases Of Joints 7
Medicines For Endocrine Disorders 13
Medicines For Mental And Behavioural Disorders 15
Medicines For Pain And Palliative Care 21
Medicines For Reproductive Health And Perinatal Care 14
Muscle Relaxants (Peripherally-Acting) And Cholinesterase Inhibitors 4
Ophthalmological Preparations 11
Peritoneal Dialysis Solution 1
Solutions Correcting Water, Electrolyte And Acid–Base Disturbances 9
Vitamins And Minerals 5
Guidelines for Submission of Dossier into Formulary
purposes
ensure medicines listed in the MOHMF are safe, good quality, efficacious, cost-effective & affordable.
To assist applicants to present the values of their products.
To ensure quality dossiers are submitted
To standardize the requirements & presentations of evidence in the dossier.
To streamline process of listing medicines into MOHMF.
type of submissions
Dossier 1 (D1)
Proposal to list new medicine(s)/ indication of existing medicine into the MOH MEDICINES FORMULARY
applicant: pharmaceutical industries
Dossier 2 (D2)
Proposal to add or amend formulation/ dosage form/ strength of medicines listed in the MOH MEDICINES FORMULARY.
applicant: pharmaceutical industries
Dossier 3 (D3)
Proposal to change category of prescriber of medicines in the MOH MEDICINES FORMULARY.
applicants: MOH (consultants/ specialists/ medical officers/ dentists/ pharmacists working in MOH institution/chairman of (TDWC)
Dossier 4 (D4)
Proposal to add approved medicines in the MOH MEDICINES FORMULARY into institution’s Medicines Formulary.
applicants: MOH
Dossier 5 (D5)
applicants: MOH/ pharmaceutical industries
Proposal to delist approved medicine(s)/indication(s) from the MOH MEDICINES FORMULARY
submission of all Dossier must include
Section1: Medicine Information (Medicine Particulars, Clinical and Pharmacological Information & Costs)
Section 2: Rationale for Application and Comparators
Section 3: Clinical Evidence (efficacy/ effectiveness and safety)
Section 4: Economic Evidence (Economic evaluations and Budget Impact Analysis)