CHRONIC KIDNEY DISEASE Tunggul Adi P. Lab Farmasi Klinik, FKIK, UNSOED.
DRUG SAFETY Nia Kurnia Sholihat Tunggul Adi P Jurusan Farmasi Unsoed.
-
Upload
arnold-simon -
Category
Documents
-
view
227 -
download
3
Transcript of DRUG SAFETY Nia Kurnia Sholihat Tunggul Adi P Jurusan Farmasi Unsoed.
DRUG SAFETY
Nia Kurnia SholihatTunggul Adi PJurusan Farmasi Unsoed
Tujuan pembelajaran Mampu menjelaskan dampak dari Drug
Safety Mampu menjelaskan perbedaan dan
hubungan antara Adverse Event, Adverse Drug Event, Adverse Drug Reaction
Mampu menjelaskan tipe reaksi A dan B Mampu menjelaskan tool untuk
menunjukkan hubungan antara obat dan harm`
DRUGSAFE, EFFECTIVE, and ACCEPTABLE
Importance of drug safety Adverse drug reactions: Account for 5% of all hospital admissions Occur in 10 -20% of hospital inpatients Cause deaths in 0.1% of medical and 0.01% of
surgical inpatients Adversely affect patients' quality of life Cause patients to lose confidence in their doctors Increase costs of patient care Preclude use of drug in most patients, although
they may occur in only a few patients May mimic disease, resulting in unnecessary
investigations and delay in treatment
Australia 10% pasien yang masuk rumah sakit disebabkan masalah yang berkaitan dengan obat
Amerika Serikat 20% pasien masuk ke rumah sakit disebabkan kesalahan penggunaan obat.
Amerika Serikat kesalahan pengobatan pada pasien rawat inap di rumah sakit bertanggungjawab terhadap 44.000 hingga 98.000 kematian tiap tahun, jumlah yang lebih tinggi daripada kematian akibat kecelakaan kendaraan (43.458), kanker payudara (42.297) dan AIDS (16.516)
Dana yang dihabiskan oleh masyarakat Amerika pada tahun 1995 bagi mortalitas dan morbiditas akibat penggunaan obat berkisar 76 milyar US dollar per tahun atau sekitar 684 trilyun rupiah per tahunnya.
THE COST OF DRUG SAFETY
6.7% of hospital patients in the US have serious adverse drug reactions (medication error excluded) (Lazarou J. Pomeranz BH, Corey PN. JAMA 1998;279:1200-5)
The Netherlands Hospitalisations caused by adverse drug reactions (ADR)
16.6% in elderly, 4.1% in younger Cost of ADR prevention related hospital
admissions ranged from $158 million or £110 million $365 million or £256 million.
(Pharm World Sci 2002;24(2): 46-54.)
Cost Avoidance of Adverse Drug Reactions Prevention in Outpatient Pharmacy Department Ramathibodi Hospital, Thailand
The estimated cost avoidance generated during 2013 was 750,286 THB to 1,619,576 THB. (1 THB = 392 IDR)
(Sholihat NK, Chimsawat W, Poncharoensuk P)
Definitions
Patient safety: “freedom from accidental injury; ensuring patient safety involves the establishment of operational systems and processes that minimize the likelihood of errors and maximize the likelihood of intercepting them when they occur”
An adverse drug event (ADE) is “an injury resulting from the use of a drug”.
An adverse drug reaction (ADR) is a “response to a drug which is noxious and unintended and which occurs at doses normally used in man for prophylaxis, diagnosis, or therapy of disease or for the modification of physiologic function.” (Edwards and Aronson, Lancet, 2000; 356(9237):1255-9) INTRINSIC TOXICITY
A medication error (ME) is defined as “any preventable event that may cause or lead to inappropriate medication use or patient harm while the medication is in the control of the healthcare professional, patient or consumer” EXTRINSIC TOXICITY
ADE, ADR, and, ME relationship
ADVERSE DRUG REACTION(INTRINSIC TOXICITY)
Classifications of ADR
ABCDE classification DoTS classification
WHO Classification on type of ADR (ABCDE classification)
Type A reactions (drug actions)
the result of an exaggerated but otherwise usual pharmacological effect of the drug dose-related, predictable, less serious,
common patients receiving more drug than customarily
required, a conventional amount but metabolize or excrete the drug unusually slowly, on an additional drug which interferes with excretion or metabolism, or are overly sensitive to the drug
In principle, these factors all are predictable and thereby potentially preventable
These complications could all be considered medication errors
Different types of adverse events
Type A effects (‘drug actions’):
• due to pharmacological effects,• fairly common, • dose related (i.e. more frequent or severe with high
doses) and may often be avoided by using doses which are appropriate to the individual patient,
• can usually be reproduced and studied experimentally and are often already identified before marketing.
Drug interactions - may be classified as Type A effects, although they are restricted to a defined sub-population of patients, i.e. those taking interacting drugs
Risks Associated With the Use of Drugs
Type B reactions are aberrant effects Uncommon, not related to dose, potentially more
serious, but unpredictable May be due to hypersensitivity reactions or
immunologic reactions, or some other idiosyncratic reaction to the drug, either due to some inherited susceptibility or some other factor
Most difficult to predict Yet, historically have represented the major focus of
commercial and regulatory interest, and thereby the major focus of pharmacoepidemiology studies of adverse drug reactions
Different types of adverse events
Type B effects (‘patient reactions’):
occur in only a minority of predisposed, intolerant patients,
little or no dose relationship,generally rare and unpredictable, sometimes serious,difficult to study
Examples of Type B effects (‘patient reactions’):
Drug intolerance:toxic reactions, not related to overdose or diminished elimination. Some drug intolerances are known to result from genetic variants of drug metabolism, example: liver failure after normal dose of acetaminophen
Drug idiosyncrasy:genetically determined abnormal reaction to the drug that may be related to metabolic or enzyme deficiency. Example: hemolytic anemia in a patient with G6PD deficiency after primaquine therapy
Drug allergy:immunologically meditated reaction that is characterised by specificity, involvement of antibodies or lymphocytes and re-occurence in case of new contact with the drug
Pseudoallergic reactions:the same clinical symptoms as allergic reaction but without immunological specificity, example: anaphylactoid reaction after radiocontrast media
DoTS classification
Dose relatedness Time relatedness Susceptibility
BMJ 2003;327:1222–5
DoTS classification
Causality categories
Other algorithm: Roussel Uclaf Causality Assessment Method (RUCAM)
ADR CAUSALITY ALGORITHM
The burden of ADR
Admission (6.5%)
In patients (14.7%)
Emergency room (2.5%)
Primary care (25%)
MEDICATION ERROR (EXTRINSIC TOXICITY)
Medication Error
> 7000 deaths per year from medication error in the USATo Err is Human: Building a Safer Health System. National Academy Press, 1999
Medication Use Process and ME
Diagnosis Prescribing Dispensing Administration Ingestion Monitoring and
control
Medication errors are mishaps that occur during prescribing, transcribing, dispensing, administering, adherence, or monitoring a drug.
Examples of medication errors include misreading or miswriting a prescription.
Medication errors that are stopped before harm can occur are sometimes called “near misses” or “close calls” or more formally, a potential adverse drug event.
Not all prescribing errors lead to adverse outcomes. Some do not cause harm, while others are caught before harm can occur (“near-misses”)