Editorials
Editorial
This recent issue consists of topics relevant for updating your knowledge regarding:  Prescribing In Liver Disease
 Genetic Contributions to Adverse Drug Reactions
 Metoclopramide: Warning Against Chronic Use
 Serious Reaction Reminders: Sodium Valproate and Fetal Malformations
 Ketoconazole: Restricted Indications
 The Newly Designed Business Process Reengineering Structure and
Implementation.
The editors are ready to receive your comments and suggestions which are going to be
used as an input to improve our works.
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Scientific Information Update
Prescribing In Liver Disease
The liver is the principal organ of
However, in cases of severe acute liver
metabolism in the body although other
failure, the capacity to metabolize the drug
sites are involved such as the gut wall,
may be significantly impaired.
kidney, skin and lungs. Drug metabolism,
In the chronic state, cirrhosis of any
by means of enzyme reactions in the liver,
aetiology, viral hepatitis and hepatoma can
is the body's main method of metabolizing
decrease drug metabolism. In moderate to
drugs. Drug molecules are converted into
severe liver dysfunction, rates of drug
more polar compounds, which aid their
metabolism may be reduced by as much as
elimination. Generally, metabolism results
50%. The mechanism is thought to be due
in the loss of pharmacological activity
to spatial separation of blood from the
because transport to the site of action is
hepatocyte by fibrosis along the hepatic
limited due to reduced lipid solubility, or
sinusoids.
because the molecule is no longer able to
attach to its receptor site. However, in
The use of certain drugs in patients with
some circumstances drugs are metabolized
cirrhosis occasionally increases the risk of
to more active forms, for example the
conversion
of
primidone
to
codeine
to
hepatic decompensation. An example of
morphine,
phenobarbitone
this is the increased risk of hepatic
and
encephalopathy in some patients who
amitriptyline to nortriptyline.
receive pegylated interferon alfa-2a in
combination
Concentrations of enzymes involved in
with
ribavirin
for
the
treatment of chronic active hepatitis
both phase I and II reactions vary
related to the hepatitis C virus. In addition,
significantly between individuals with
co-infection with hepatitis B or C virus,
normal hepatic function and even more so
even in the absence of cirrhosis, increases
between the healthy population and those
the
with hepatic impairment.
risk
of
hepatotoxicity
from
antiretroviral therapy in patients with
Chronic liver disease is more predictably
coexistent HIV infection.
associated with impaired metabolism of
drugs
than
acute
liver
dysfunction.
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Scientific Information Update
In the presence of chronic liver disease,
drug's metabolism by competing with the
there is potential for changing the systemic
drug for the same set of metabolising
availability of high extraction drugs,
enzymes. Conversely, hepatic enzyme
thereby affecting plasma concentrations. A
induction
potential consequence of liver disease is
excessive alcohol ingestion via CYP2E1
the development of portosystemic shunts
resulting in increased clearance of certain
that may carry a drug absorbed from the
drugs
gut through the mesenteric veins directly
benzodiazepines). After these enzymes
into the systemic circulation. As such, oral
have been induced, they remain so in the
treatment with high hepatic clearance
absence of alcohol for several weeks after
drugs such as morphine or propranolol can
cessation of drinking. In addition, some
lead to high plasma concentrations and an
enzymes induced by chronic alcohol
increased risk of adverse effects.
consumption transform some drugs (for
example
Liver damage can also affect drugs with
may
(for
occur
example
paracetamol)
with
chronic
phenytoin,
into
toxic
compounds that can damage the liver.
low hepatic clearance. For instance, the
effect of warfarin, which has a low
In the presence of cholestatic jaundice,
extraction ratio, is increased due to the
drugs and their active metabolites that are
reduced
dependent
production
of
vitamin
K-
dependent clotting factors.
on
biliary
excretion
for
clearance will have impaired elimination.
Further impairment will occur if the
The pharmacokinetic interaction between
compound is excreted as a glucuronide
alcohol and drugs is more complex. An
and is subject to enterohepatic circulation.
acute ingestion of alcohol may inhibit a
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Scientific Information Update
Table 1: Some examples of drugs with high and low hepatic extraction
High extraction ratio
Antidepressants
Low extraction ratio
Chlorpromazine/haloperidol
Non-steroidal anti-inflammatory drugs
Calcium channel blockers
Diazepam
Morphine
Carbamazepine
Glyceryl trinitrates
Phenytoin
Levodopa
Warfarin
Propranolol
Evaluating Hepatic Function
A clear patient history with respect to
liver disease, further investigation is
alcohol, illicit drug use and toxic industrial
required. This includes liver function tests
exposure
and an ultrasound of the abdomen. A
must
be
recorded.
The
medication list including supplements
portal
such as iron, vitamin A and herbal
recommended to assess for the presence of
remedies is vital. A family history of
portal hypertension. A slowing or reversal
diseases
such
Doppler
study
is
also
alpha-1
antitrypsin
of portal vein blood flow indicates portal
storage
diseases,
hypertension which may be related to
porphyrias and diabetes mellitus may alert
either liver cirrhosis or portal vein
the physician to the potential for liver
thrombosis.
deficiency,
as
vein
iron
impairment.
In
renal
disease,
serum
creatinine
It is also important to look for signs of
concentration and the glomerular filtration
acute or chronic liver disease such as the
rate provide a reasonable guide to drug
presence of jaundice, spider naevi, palmar
dosage requirements. In contrast, there is
erythema, ascites, abdominal distention,
no single test that measures liver function
hepatomegaly, splenomegaly and caput
so
medusa. If there is clinical evidence of
pharmacokinetics is not possible. Some
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a
reliable
prediction
of
Scientific Information Update
evaluation of hepatic function is possible
status and ascites. These parameters were
by assessing serum albumin and bilirubin,
modified
and prothrombin time. However, these
encephalopathy for nutritional status and
parameters are not directly related to drug
then became known as the Child-Pugh
clearance. Although not directly correlated
classification (see table 2).The grades A, B
with liver dysfunction, elevated liver
and C may also be a useful indicator of an
enzymes may raise the suspicion of
individual's
hepatic
metabolize a drug. An alternative method
impairment
requiring
further
investigation.
to
substitute
ability
degree
to
of
effectively
for assessing liver dysfunction is the
Model
The Child-Turcotte score was designed to
for
End-Stage
Liver
Disease
(MELD) score. This may be a more
estimate the operative risk of an alcoholic
accurate method but is less accessible to
patient with cirrhosis. The parameters used
most
include serum concentrations of bilirubin
clinicians
calculating
because
the
it
involves
score.
and albumin, prothrombin time, nutritional
Table 2: Child-Pugh classification
Parameter
Points assigned =
1
Absent
<11
Points assigned = 2
Points assigned = 3
Ascites
Slight
Moderate
Bilirubin,
11–45
>45
micromol/L
Albumin, g/L
>35
28–35
<28
Prothrombin time – <4
4–6
>6
seconds over
control
<1.7
1.7–2.3
>2.3
or INR
Encephalopathy
None
Grade 1–2
Grade 3–4
Total score of 5–6 is grade A or well compensated disease (1 and 2 year survivals are 100%
and 85%)
Total score of 7–9 is grade B or disease with significant functional compromise (1 and 2 year
survivals are 80% and 60%)
Total score of 10–15 is grade C or decompensated liver disease (1 and 2 year survivals are
45% and 35%)
Depending on hepatic clearance and the therapeutic index of the drug, dose adjustments or
drug avoidance may be required in grades B or C chronic liver disease.
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Scientific Information Update
Evaluating the drug in question
If a drug is dependent on hepatic
the dosing interval should be increased or
elimination, there are several factors to
the total dose reduced (e.g. carvedilol).
consider when prescribing for patients
If hepatic elimination is limited (that is,
with liver disease. Determining the hepatic
accounting for less than 20% of total
contribution to elimination is paramount
elimination), then the therapeutic range of
and the following general rules should be
the compound should be reviewed. If the
considered.
drug has a wide therapeutic index, then the
Drugs with a narrow therapeutic range that
likelihood of an adverse effect related to
are extensively metabolised by the liver
hepatic impairment is low. However, if the
(that is, greater than 20% of their total
drug has a narrow therapeutic index, then
elimination) should either be avoided
caution should be exercised as significant
altogether (e.g. pethidine) or used with
hepatic impairment may have a clinically
extreme
relevant effect on the pharmacokinetics
caution
(e.g.
morphine,
theophylline) in patients with significant
(e.g. lamotrigine).
liver disease.
If greater than 90% of the compound is
Drugs with a wide therapeutic range which
excreted unchanged in the urine, then
also undergo extensive hepatic metabolism
hepatic impairment is unlikely to play a
should be used with caution. In particular,
significant role in the accumulation of the
drug and therefore toxicity.
Factors to consider when prescribing drugs dependent on hepatic elimination

Ascertain how much the drug
ultrasound of the liver with portal
depends on hepatic metabolism for
vein Doppler study.

its elimination from the body.

If there is doubt about the degree
Determine the degree of hepatic
of hepatic impairment or the drug
impairment using the Child-Pugh
has a narrow therapeutic index
classification (Table 2), hepatic
(that is, the upper dose range for
enzyme levels and possibly an
efficacy is close to the lower
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Scientific Information Update

concentration range of toxicity),
then
lower
the
recommended
Determine
possible
interactions
between the new drug and any
starting dose by approximately
drugs the patient is already taking.
50%, and titrate to effect under
careful supervision – 'start low and
go slow'.
Reference:
Sloss
A,
KublerP.
Prescribing in liver disease; Aust
Prescr 2009:
32:32-5
Cervical Cancer
Cervical cancer (also called "cancer of the
are attracted to and are able to live only in
cervix") begins in the lining of the cervix.
squamous epithelial cells in the body.
This cancer forms slowly. First, some cells
Squamous epithelial cells are thin, flat
begin to change from normal to pre-cancer
cells that are found on the surface of the
and then to cancer. This can take many
skin, cervix, vagina, anus, vulva, head of
years, but sometimes it happens faster. For
the penis, mouth, and throat. HPV types
some women, the pre-cancer changes may
16 and 18 are the major causes of cervical
go away without any treatment. More
cancer.
often, they need to be treated to keep them
Some types of HPV are referred to as
from changing into true cancers.
“low-risk” viruses because they rarely
cause lesions that develop into cancer.
The virus that causes cervical cancer is
HPV types that are more likely to lead to
called HPV. HPV is short for human
the development of cancer are referred to
papilloma virus. HPVs are a group of over
as “high-risk.” Both high-risk and low-risk
100 related viruses. Each HPV virus in the
types of HPV can cause the growth of
group is given a number, which is called
abnormal cells, but only the high-risk
an HPV type. HPVs are called papilloma
types of HPV lead to cancer. Sexually
viruses because some of the HPV types
transmitted, high-risk HPVs include types
cause warts or papillomas, which are non-
16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58,
cancerous tumors. The papilloma viruses
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Scientific Information Update
 Bleeding from the vagina that is
59, 66, 68, and 73 . These high-risk types
of HPV cause growths on the cervix that
not
normal
or
unexplainable
are usually flat and nearly invisible, as
change in menstrual cycle.
compared with the external warts caused
 Bleeding when something comes
by low-risk types HPV–6 and HPV–11.
in contact with the cervix, such as
HPV types 16 and 18 together cause about
during sexual intercourse or when
70 percent of cervical cancers.
a diaphragm is inserted.
 Pain during sexual intercourse.
Symptoms of cervical cancer may include:
 Vaginal discharge that is tinged
with blood.
Treatment
Treatment for cervical cancer can be either
Sometimes radiation can be used in place
local
treatments
of surgery. For smaller cancers, radiation
remove, destroy, or control cancer cells in
works as well as surgery. Radiation may
one area. Surgery and radiation are types
also be used to cure larger cancers.
of local treatments for cervical cancer.
Systemic treatments destroy or control
or
systemic.
Local
cancer
Surgery: This treatment removes as much
cells
throughout
the
body.
Chemotherapy is a systemic treatment.
cancer as possible. It often cures the
That's because it travels through the
cancer. It is used for smaller cancers that
bloodstream to the whole body.
have not spread far beyond the cervix.
Chemotherapy: This treatment uses drugs
Radiation: This treatment kills cancer
to kill cancer cells. It is not very effective
cells by using high-energy rays directed at
when used alone for cervical cancer. Most
the tumor from outside the body or with
women who have chemotherapy for
radioactive material placed at specific
cervical cancer have it combined with
areas near the cervix. Women treated with
radiation.
radiation for cervical cancer often receive
low-dose chemotherapy at the same time.
Systemic chemotherapy uses anticancer
This can make the radiation work better.
drugs that are injected into a vein or given
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Scientific Information Update
by
mouth.
These
drugs
enter
the
Because chemotherapy can damage the
bloodstream and reach all areas of the
blood-producing cells of the bone marrow,
body, making this treatment potentially
the blood cell counts might become low.
useful for cancers that have spread to
This can result in:
distant organs (metastasized).

an increased chance of infection
Drugs most often used to treat cervical
(due to a shortage of white blood
cancer
cells)
include
cisplatin,
paclitaxel,

topotecan, ifosfamide, and fluorouracil.
bleeding or bruising after minor
Chemotherapy drugs kill cancer cells but
cuts or injuries (due to a shortage
also damage some normal cells, which can
of blood platelets)

lead to side effects. These side effects
depend on the type of drugs, the amount
shortness of breath (due to low red
blood cell counts)
taken, and the length of treatment.
Fatigue is also quite common and may be
Temporary side effects of chemotherapy
caused by low red blood cell counts, by
might include:
other reasons related to chemotherapy, or

nausea and vomiting
by the cancer itself. However, most side

loss of appetite
effects of chemotherapy disappear once

loss of hair
treatment is stopped.

mouth sores
Prevention
Vaccines are available to prevent cervical
The
cervical
cancer
vaccines
take
cancer. These vaccines protect against the
prevention a giant leap forward by
strains of HPV that are most likely to
blocking the first step along the pathway
cause cervical cancer. Girls and women
to cervical cancer, HPV infection.
age 9-26 can protect themselves from
The vaccines are given in the arm or thigh
HPV and cervical changes related to HPV
three times—at the first visit, two months
by getting the cervical cancer vaccine.
later and four months after that. The best
protection is achieved after all three shots
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Scientific Information Update
are given. The most common side effects
of the major capsid L1 protein of
are redness and soreness where the shot
oncogenic HPV types 16 and 18. Hence it
was given. Headache and fever are also
provides protection only against these two
common. Gardasil is the first vaccine
HPV types. HPV only infects humans, but
against cervical cancer to be approved,
animal
followed by cervarix.
papillomaviruses suggest that the efficacy
studies
with
analogous
of VLP vaccines is mediated by the
Gardasil
development
of
a
humoral
immune
response. It is also formulated with AS04,
Gardasil, manufactured by Merck &
a proprietary adjuvant that boosts the
Company, is based on HPV antigens that
immune system response for a longer
are proteins. These proteins are used in the
period of time to HPV strains.
laboratory to make four different types of
“virus-like particles,” or VLPs, which
Source:
correspond to HPV types 6, 11, 16, and
18. The four types of VLPs are then
1. The
future
II
Study
Group.
combined to make the vaccine. Because
Quadrivalent vaccine against human
Gardasil targets four HPV types, it is
papillomavirus to prevent high-grade
called a quadrivalent vaccine. In contrast
cervical lesions. N Engl J Med.
with traditional vaccines, which are often
2007;356:1915–1927
composed of weakened, whole microbes,
2. American
the VLPs in Gardasil are not infectious.
3. http://clinicaltrials.gov/ct2/show/NC
the production of antibodies against HPV
T00122681
types 6, 11, 16, and 18.
4. http://en.wikipedia.org/wiki/Cervical
_cancer
Cervarix
manufactured
GlaxoSmithKline,
is
Society:
www.cancer.org
However, they are still able to stimulate
Cervarix,
Cancer
a
by
non-infectious
recombinant vaccine prepared from the
highly purified virus-like particles (VLPs)
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Scientific Information Update
Genetic Contributions to Adverse Drug Reactions
The debilitating and lethal consequences
across Canada, and the GATC hospital-
of adverse drug reactions (ADRs) are
based active surveillance network across
ranked as the 4th leading cause of death in
10 of Canada’s major hospitals.
the USA. In Canada, there are an
To capitalize on these valuable samples,
estimated 200,000 severe ADRs, claiming
the GATC takes advantage of Canada’s
10,000 to 22,000 lives, and costing $13.7
outstanding
to $17.7 billion each year. The goal of the
reactions
(ADRs)
mutations and biomarkers.
by
identifying predictive genomic markers of
Novel
adverse drug reactions. The GATC will
time
and prevent ADRs in children through
recommendations
predictive
SNPs
and
pharmacokinetic approaches applied to
tool that will be implemented to predict
dosing
ADR
mutations are functionally validated by
incorporate these markers into a diagnostic
specific
proteomic
identify novel ADR predictive SNPs,
in Childhood (GATC) is to prevent
drug
and
knowledge and utilize proven strategies to
Genotype-Specific Approaches to Therapy
adverse
genomic
course
analysis
of
drug
concentrations for each specific genotype.
for
Pharmacokinetic studies are also used to
commonly used drugs based on an
determine the drug concentration in
individual’s genetic make-up.
patients
to
characterize
possible
mechanisms of the ADR, translating into
The GATC identifies ADR predictive
rational approaches to the choice of
markers by comparing DNA and plasma
candidate genes to be examined in the
samples from patients that suffer ADRs
genomic analyses. The GATC creates the
with samples from control populations that
potential for immediate economic benefits
are stratified by medication type and age.
with significant cost-savings from the
The GATC obtains its clinical material for
successful avoidance of serious ADRs.
ADR patients from two unique Canada-
Source:
wide ADR surveillance networks: the
http://www.cmmt.ubc.ca/research/investig
Canadian Pediatric Surveillance Program
ators/hayden/projects/adr#top
(CPSP), a network of 2,300 pediatricians
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Scientific Information Update
Why Do Adverse Drug Reactions Matter And How Do They
Happen?
Thalidomide In the winter of 1961 the
drug are generally studied on a few
world
infamous
thousand carefully selected and followed
‘thalidomide disaster’. Thalidomide was
up trial subjects and patients according to
marketed as a mild hypnotic (sleeping
strictly defined criteria. For this reason
drug) and as a remedy against morning-
only very frequent adverse reactions and
sickness for pregnant women. About four
mainly those depending on the drug's
years after its launch, a dramatic increase
pharmacological
was seen in several countries in the
observed during its clinical development.
experienced
the
properties
can
be
frequency of phocomelia, a previously rare
Once the product has been placed on the
birth-defect which left babies without
market, a much larger, and also often
limbs or with serious deformities caused
polymorbid population will be exposed,
by thalidomide. Epidemiological studies
which may lead to a change in the drug's
established that the cause was exposure of
hitherto known safety profile. Adverse
the foetus to the drug during pregnancy.
drug reactions can then be observed more
Had international data been collected at
frequently, including those occurring only
the time, the pattern of seriously harmful
sporadically and independently of the
adverse effects might have been noticed
pharmacological
earlier.
properties
of
the
substance. These new adverse reactions
should be reported without delay as a
ADRs matter because pharmaceutical
contribution
to
products and other substances taken for
incomplete
safety
medical purposes have the potential for
information is consistently forwarded to
harming patients, even killing them.
the
Medicines are developed over a period of
unknown risks can be identified and
several years. Efficacy and safety of a new
tackled.
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competent
a
potentially
profile.
authorities
If
still
such
hitherto
Scientific Information Update
In the US, it has been estimated that each
followed by long-term admissions, which
year 2.2 million hospitalized patients have
accounted for 18% ($32.8 billion)…Since
serious ADRs; 106,000 patients have fatal
1995 the costs associated with drug-related
ADRs. Interpretation of the data is
problems
problematic, but it seems likely that many
doubled…the total cost of drug-related
of these ADRs are in the category of
morbidity and mortality exceeds the cost
‘avoidable’ and do not reflect the intrinsic
of the medications themselves. DRPs are
qualities of the drugs. ADRs may be the
increasingly recognized as a serious and
4th to 6th largest cause of death in the US.
urgent – but largely preventable – medical
Hospital admissions due to ADRs may be
problem.
(DRPs)
have
more
than
more than 10% in some countries; up to
Medical vigilance is the key: every
20% of healthcare budgets may be spent
healthcare professional in the world should
on drug complications.
be constantly alert for adverse effects or
Overall the cost of drug-related morbidity
potential new hazards and reporting them
and mortality exceeded $177.4 billion in
to their National Centres. ADRs happen
2000. Hospital admissions accounted for
for many reasons, some are inevitable and
nearly 70% ($121.5 billion) of total costs,
unavoidable, some preventable.
 Information about rare events
The inevitable reasons are:
may, by their very nature, not be
 The effects of any medical
available until they happen.
intervention cannot be predicted
with absolute certainty
The preventable reasons include:
 There is no drug or medical
 An error in diagnosing the disease
intervention which will not have
 Prescription of the wrong drug for
some negative and undesirable
the disease
effect on someone, somewhere at
 Prescription of the wrong dose of
some time
the right drug
 Choice of the right drug for the
disease, but maybe the wrong drug
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Scientific Information Update
for the patient, because of a
The remedies for the preventable
reasons are clear, if hugely challenging
to achieve:
genetic or ethnic predisposition,
age,
some
other
illness
or
 A higher priority in all medical
medication, allergy or intolerance
training in the knowledge and
 Choice of an appropriate drug but
skills associated with diagnosing
without taking into account the
potentially
effects
harmful
with
other
and treating disease – including
interactive
drugs
taking case-histories, diagnostic
or
skills,
substances being taken by the
recognition
patient
professionals
drug may not have been read or
reporting
of
and
the
general
public about the complexities and
fully understood
safety
 The patient may not comply with
advice
in
profiles
of
medical
interventions
the doctor’s advice or with the
 Much
the
more
communication
patient information leaflet
effective
and
openness
about the nature of drugs and their
 As long as people are choosing
effects
drugs and other substances for
and
the
degree
of
uncertainty associated with them
their own medication without
 Comprehensive public education
professional advice, there may be
and debate about the benefit, harm,
problems
of
(polypharmacy)
many
or
effectiveness and risk of medical
drugs
interventions and agreement about
receiving
the balance of benefit, harm,
treatment from more than one
source
the
 Greater awareness by healthcare
contraindications and risks of the
manufacturer’s
and
and
adverse effects
 The full specification, indications,
 Taking
pharmacology,
(polytherapy)
effectiveness and risk which is
can
acceptable, given that there will
contribute significantly to causing
always be some uncertainty.
drug-related problems, particularly
 Wider discussion and education on
harmful drug interactions.
the nature of risk in general and its
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Scientific Information Update
communication,
individual
and
variables
in
the
.
affecting
perception and acceptance of risk.
NCC MERP's Recommendations to Enhance Accuracy of
Prescription Writing
Through its work as a drug standards-
prevention of Medication errors through
setting organization since 1820 and its
the coordinated efforts of its member
experience with the nationwide USP-
associations and agencies, and to focus on
ISMP Medication Errors Reporting (MER)
ways to enhance patient safety through a
Program, the United States Pharmacopoeia
coordinated approach and a systems-based
(USP) recognized that there were many
perspective.
causes for medication errors and no one
"A medication error is any preventable
organization was equipped to address this
event
threat to patient safety. Therefore, the USP
authority,
mechanisms,
procedures,
systems,
including
labeling, packaging, and nomenclature;
compounding;
1995, for the first meeting of the National
for
and
prescribing; order communication; product
interdisciplinary
organizations and agencies met on July 19,
Council
to
professional practice, health care products,
those issues that adversely affected patient
Coordinating
lead
consumer. Such events may be related to
medication errors and seek solutions for
Fifteen
or
of the health care professional, patient, or
and
resources to confront the complexities of
safety.
cause
harm while the medication is in the control
of concerned national organizations that
the
may
inappropriate medication use or patient
spearheaded an effort to convene a group
had
that
dispensing;
distribution;
administration; education; monitoring; and
Medication
use."
Error Reporting and Prevention (NCC
MERP).
Medication errors encompass all mistakes
involving prescription drugs, over-the-
The Council was formed to actively
counter products, vitamins, minerals, or
promote the reporting, understanding, and
herbal supplements. Errors are common at
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Scientific Information Update
every
stage,
from
prescription
and
at injuries experienced by Medicare
administration of a drug to monitoring of
recipients, a subset of clinic visitors. None
the patient's response, the committee
of these figures take into account lost
found. It estimated that on average, there
wages and productivity or other costs.
is at least one medication error per hospital
The Council recommends:
patient per day, although error rates vary
widely across facilities. Not all errors lead
1. All prescription documents should be
to injury or death, but the number of
legible. Verbal orders should be
preventable injuries that do occur -- the
minimized.
committee estimated at least 1.5 million
2. Prescription orders include a brief
each year -- is sobering, the report says.
notation of purpose (e.g., for cough),
unless considered inappropriate by the
Studies indicate that 400,000 preventable
prescriber. Notation of purpose can
drug-related injuries occur each year in
help further assure that the proper
hospitals. Another 800,000 occur in long-
medication is dispensed and creates an
term care settings, and roughly 530,000
extra safety check in the process of
occur just among Medicare recipients in
outpatient clinics. The committee noted
that these are likely underestimates.
prescribing
and
dispensing
medication.
The
Council
recognize,
however,
that
a
does
certain
medications and disease states may
There is insufficient data to determine
warrant maintaining confidentiality.
accurately all the costs associated with
medication
errors.
The
3. All prescription orders are written in
conservative
the metric system except for therapies
estimate of 400,000 preventable drug-
that use standard units such as insulin,
related injuries in hospitals will result in at
vitamins, etc. Units should be spelled
least $3.5 billion in extra medical costs
out rather than writing "U." The
this year, the committee calculated. A
change to the use of the metric system
study of outpatient clinics found that
from the archaic apothecary and
medication-related injuries there resulted
avoirdupois systems will help avoid
in roughly $887 million in extra medical
misinterpretations
costs in 2000 -- and the study looked only
abbreviations
- 16 -
and
of
symbols,
these
and
Scientific Information Update
miscalculations when converting to
6. A leading zero always precedes a
metric, which is used in product
decimal expression of less than one. A
labeling and package inserts.
terminal or trailing zero should never
4. Prescribers should include age and,
be used after a decimal. Ten-fold
when appropriate, weight of the patient
errors in drug strength and dosage
on the prescription or medication
have occurred with decimals due to the
order. The most common errors in
use of a trailing zero or the absence of
dosage result in pediatric and geriatric
a leading zero.
populations. The age (and weight) of a
7. Prescribers should avoid the use of
patient can help dispensing health care
abbreviations including those for drug
professionals in their double check of
names (e.g., TTC, CAF, and HCT) and
the appropriate drug and dose.
Latin
directions
for
use.
The
5. Medication orders include drug name,
abbreviations in the chart below are
exact metric weight or concentration,
found to be particularly dangerous
and dosage form. Strength should be
because they have been consistently
expressed in metric amounts and
misunderstood and therefore, should
concentration should be specified.
never be used. The Council reviewed
Each order for a medication should be
the uses for many abbreviations and
complete.
determined
The
pharmacist
should
that
any
attempt
at
check with the prescriber if any
standardization of abbreviations would
information is missing or questionable.
not adequately address the problems of
illegibility and misuse.
- 17 -
Scientific Information Update
Misleading abbreviations
Abbreviation
Intended meaning
Common Error
U
Units
Mistaken as a zero or a four (4) resulting in overdose.
Also mistaken for "cc" (cubic centimeters) when poorly
written.
µg
Micrograms
Mistaken for "mg" (milligrams) resulting in an
overdose.
Q.D.
Latin abbreviation for
every day
The period after the "Q" has sometimes been mistaken
for an " I, " and the drug has been given "QID" (four
times daily) rather than daily.
Q.O.D.
Latin abbreviation for
every other day
Misinterpreted as "QD" (daily) or "QID" (four times
daily). If the "O" is poorly written, it looks like a period
or "I."
SC or SQ
Subcutaneous
Mistaken as "SL" (sublingual) when poorly written.
TIW
Three times a week
Misinterpreted as "three times a day" or "twice a
week."
D/C
Discharge; also
discontinue
Patient's medications have been prematurely
discontinued when D/C, (intended to mean "discharge")
was misinterpreted as "discontinue," because it was
followed by a list of drugs.
cc
Cubic centimeters
Mistaken as "U" (units) when poorly written.
AU, AS, AD
Latin abbreviation for
both ears; left ear;
right ear
Misinterpreted as the Latin abbreviation "OU" (both
eyes); "OS" (left eye); "OD" (right eye)
IU
International Unit
Mistaken as IV (intravenous) or 10(ten)
8. Prescribers
should
avoid
vague
instructions such as "Take as directed"
or "Take/Use as needed" as the sole
- 18 -
Scientific Information Update
direction for use. Specific directions to
for the patient; and, (2) enable
the patient are useful to help reinforce
effective patient counseling.
proper medication use, particularly if
SOURCE: National Coordinating Council for
Medication Error Reporting and Prevention (NCC
MERP): http://www.nccmerp.org/
therapy is to be interrupted for a time.
Clear directions are a necessity for the
dispenser to: (1) check the proper dose
- 19 -
Regulatory Tips
Metoclopramide: Warning Against Chronic Use
The U.S. Food and Drug Administration
extremities, or lip smacking, grimacing,
announced
of
tongue protrusion, rapid eye movements or
metoclopramide, a drug used to treat
blinking, puckering and pursing of the
gastrointestinal disorders, must add a
lips, or impaired movement of the fingers.
boxed warning to their drug labels about
These symptoms are rarely reversible and
the risk of its long-term or high-dose use.
there is no known treatment. However, in
Chronic use of metoclopramide has been
some patients, symptoms may lessen or
linked to tardive dyskinesia, which may
resolve after metoclopramide treatment is
include
stopped.
that
manufacturers
involuntary
and
repetitive
movements of the body, even after the
Recently published analyses suggest that
drugs are no longer taken.
metoclopramide is the most common
Current product labeling warns of the risk
cause
of
tardive
dyskinesia
of
drug-induced
movement
with
chronic
disorders. Another analysis of study data
treatment.
The
by the FDA showed that about 20 percent
development of this condition is directly
of patients in that study who used
related to the length of time a patient is
metoclopramide took it for longer than
taking metoclopramide and the number of
three months. The FDA has also become
doses taken. Those at greatest risk include
aware of continued spontaneous reports of
the elderly, especially older women, and
tardive dyskinesia in patients who used
people who have been on the drug for a
metoclopramide, the majority of whom
long time.
had taken the drug for more than three
Tardive dyskinesia is characterized by
Source:http://pharmamotion.com.ar/meto
clopramide-and-tardive-dyskinesia-fdaadds- boxed-warning/months.
metoclopramide
involuntary, repetitive movements of the
- 20 -
Regulatory Tips
Serious Reaction Reminders: Sodium Valproate and Fetal
Malformations
Sodium valproate is well known to cause
mothers taking sodium valproate for
fetal malformations and is classified as a
bipolar disorder.
Pregnancy Category D drug (Drugs that
One of the cases reported has been
have caused, are suspected to have caused
described
or may be expected to cause an increased
in
correspondence
to
the
Australian and New Zealand Journal of
incidence of human fetal malformations or
Psychiatry and serves to remind all
irreversible damage. These drugs may also
prescribers that sodium valproate must be
have adverse pharmacological effects).
used
Teratogenic risk appears to be dose-
with
caution
after
careful
consideration of the risk-benefit profile in
dependent and increases markedly at doses
women of child-bearing potential.
greater than 1100 mg/day in the first
trimester.
Sodium
valproate
is
one
of
the
antiepileptic drugs being used in Ethiopia.
Sodium valproate is mainly used to treat
Hence, women of child-bearing age
epilepsy but it is increasingly being
prescribed sodium valproate for any
prescribed to treat psychiatric disorders.
indication should be informed about the
Since 1980, we have received 72 reports
potential risks of the drug, including
of babies born with malformations from
teratogenesis, and should be strongly
mothers taking sodium valproate during
advised, and periodically reminded, to
pregnancy, including 18 of spina bifida, 4
maintain adequate contraception while
of myelomeningocoele and 13 of multiple
taking this drug. Routine folic acid
malformations mainly involving the CNS.
supplementation
In most of these cases, sodium valproate
efficacy in the prevention of sodium
was being used to treat epilepsy, but two
valproate-related
recent reports describe fetal spina bifida
unproven.
is
recommended
malformation
but
is
and myelomeningocoele in babies born to
Source: Aust Adv Drug Reactions Bull
28(2), Apr 2009
- 21 -
Regulatory Tips
Ketoconazole: Restricted Indications
Ketoconazole
(Nizoral)
imidazole
The risk of serious hepatotoxicity with oral
antifungal agent, with a spectrum of activity
ketoconazole increases with duration of
against dermatophytes, yeasts, and other
treatment. Courses of longer than 10 days
pathogenic fungi. After a review of the risks
should be given only after full consideration of
and
for
the extent of treatment response and of the
ketoconazole tablets has been updated. Several
balance of risks and benefits of continuing
therapeutic indications have been removed
treatment. Liver function must be monitored in
because of the risk of serious hepatotoxicity
all patients who are receiving ketoconazole
with oral ketoconazole (including cases which
tablets. Tests should be done before starting
had a fatal outcome or required liver
treatment, at week 2 and week 4 of treatment,
transplantation) and because of the availability
and then continued monthly. Treatment should
of other effective antifungal treatments. The
be stopped if any liver parameters are elevated
approved therapeutic indications are now
above three times the normal limit. Refer to
restricted to:
the full Summary of Product Characteristics
benefits,
 Treatment
is
an
prescribing
of
Malassezia
advice
dermatophytosis
(previously
and
for
called
additional
information
on
contraindications, warnings, drug interactions,
Pityrosporum) folliculitis that cannot be
and adverse events.
treated topically because of the site, extent
of the lesion, or deep infection of the skin
In Ethiopia, ketoconazole tablet is available
resistant to, or in patients intolerant of,
in different brands. Physicians are advised to
fluconazole, terbinafine, and itraconazole
prescribe ketoconazole only when potential
 Treatment
of
chronic mucocutaneous
benefits are considered to outweigh potential
candidosis, cutaneous candidosis, and
risks, taking into consideration the availability
oropharyngeal candidosis that cannot be
of other effective antifungal therapy. In
treated topically because of the site, extent
addition, liver function must be monitored in
of the lesion, or deep infection of the skin
patents using ketoconazole.
resistant to, or in patients intolerant of,
both fluconazole and itraconazole
Source: Drug Safety Updates Volume 1, Issue
8 (http://www.mhra.gov.uk/home/)
- 22 -
Regulatory Tips
The Newly Designed Business Process Reengineering Structure
and Implementation
Vision of the sector:
“To see healthy, productive & prosperous citizen’’
Vision of the Authority:
‘’Quality health services and products to all citizens’’
It has been believed that this redesign
a) Regulatory Standards Setting Sub-
system will assist in meeting the public
Process.
demands for accountability, responsibility
b) Inspection and Licensing Sub-Process
and help dramatically change the complex
c)
and poor quality services. Based on this
Registration Sub-Process
principle,
d)
the
previous
Drug
Product
Quality
Regulatory
Assessment
Information
Administration and control Authority,
System Sub-Process
DACA, is provided with a mandate to
e) Medico Legal Version
regulate
health
institutions,
Objectives of the new Authority
Hence, a core

process that is feasible, cross functional
To
establish
and customer focused has been identified
effective
to
assurance,
replace
the
old
and
fragmented

named "Health and Health Related
and
Products
and
and
maintain
efficient
market
an
quality
authorization,
inspection and licensing system.
regulatory processes. This core process is
Services
Delivery
heath
professionals, food & food establishments
and pharmaceuticals.
&
Quality
To ensure safety, efficacy and
quality
of
medicines
Regulation Core Process”. The core
complimentary
process comprises of four sub-processes
medicines
and one version.
These are:-
- 23 -
and
including
traditional
Regulatory Tips
 To ensure that food consumed are
trans-regional
safe, quality, sanitary and free of
health
service
institutions;
contaminants
c) Initiate policy to strengthen food,
medicines, health professionals and
 To standardize health services and
protect the public from unqualified
health
and unethical professionals and
efficiency; initiate draft legislation and
substandard health institutions
forward the same for approval;
 To
institutions
quality
and
d) Serve as medicines, food, health
ensure
an
uninterrupted
professionals and health and health
regulatory information provision
related institutions information center;
and promote Rational Medicines
e) Identify ingredients that caused death
use
or ill health due to medicines residue
or adulteration of medicines and food
Power and Duties of the new
and take appropriate measures by
Regulatory Authority
conducting investigation on sample
ingredients;
f) Organize quality control laboratories
a) Set standards for food safety and
as needed to carry out its duty;
quality; safety, efficacy, quality and
g) Give import or export permit
proper use of medicines; competence
food, medicines, raw materials and
and practice of health professionals;
packaging materials and undertake
hygiene and environmental health;
dead bodies control and give entry or
competence of health and health
related institutions and ensure
exit permit;
their
h) Prepare list of medicines for the
implementation and observance;
country, structure the medicines in the
b) issue, renew, suspend, revoke or deny
certificate
of
competence
list into different categories, revise the
for
list whenever necessary;
specialized health institutions, food or
i) Evaluate and issue, renew, suspend,
medicines processing plants, quality
control
laboratories,
for
revoke or deny registration certificate
importer,
for medicines;
exporters, storage or distributors and
- 24 -
Regulatory Tips
j) Undertake
and
coordinate
post
international travelers, prohibit entry,
marketing surveillance in order to
exit or to be quarantined where
ensure the safety and quality of food
relevant, and ensure the relevant
and safety, efficacy and quality of
prevention
medicines that are put into use and
regional communicable diseases is
take appropriate measures;
done;
and
control
of
trans-
k) Authorize conducting clinical trial,
p) Evaluate and issue, renew, suspend,
monitor the process, evaluate the
revoke or deny license for scarce
results and authorize the use of the
health professionals, complementary
result in such a way that it benefits the
or alternative medicines practitioners
public; as well as cause to suspend or
and
stop the clinical trial;
privately or in group from abroad to
l) Monitor and control manufacture,
import,
export,
health
professionals
coming
deliver health service;
distribution,
q) Ensure proper disposal of expired and
prescribing, dispensing, use, recording
unfit for use food, medicines and their
and
raw materials;
reporting
of
narcotic
drugs,
psychotropic substance and precursor
r) Ensure handling and disposal of trans-
chemicals, prevent their abuse as well
regional solid and liquid wastes from
as report the same to the International
different institutions are not harmful to
Narcotic Control Board;
public health;
m) Regulate the content, manufacture,
s) Monitor and control illegal food,
import, export, distribution, sales, use,
medicines and health services
packaging and labeling, advertisement
take appropriate measures;
and
promotion,
and
disposal
of
t) ensure the quality of
tobacco products;
and
trans-regional
water supply for the public is up to the
n) Undertake inspection on plane entering
standard;
the country and undertake fumigation
u) Control,
monitor and ensure the
and give certificate for plane departing
availability
the country;
requirements
o) Undertake control of communicable
institutions
diseases at entry and exit port on
government;
- 25 -
of
necessary
in
under
hygienic
health
related
the
federal
Regulatory Tips
v) Provide appropriate capacity support
complaints of our customers and
to regions on food, medicines and
collaborators
 Timeliness: - we will be punctual
healthcare regulatory bodies with a
view to harmonizing federal and
with
regional regulatory system;
would always be in time and on time.
our
customers
encounters,
w) Perform other lawful activities as may
 Professionalism:- we will provide
be necessary for the attainment of its
services that need special knowledge
objectives.
and training, which require expertly
1. Values and beliefs
doing
 Impartiality: - we will serve our
The following values & beliefs are
customers, not favouring one side
considered:-
more than the other and with
 Customer first: - we’ll serve the
complete fairness.
 Consistency:- we will provide our
user first, give priority to our
services in a regular or same manner
customers with a sense of urgency in
 No compromise on quality: - we
our service provision.
 Integrity: - we will be honest, franc,
will serve with out agreement to
accept sub standards.
dependable and willing to accept
corrections from our customers
 Openness: - we will be honest and
will not be hiding any thing to our
customers.
We’ll
provide
information, be informative and a
source of knowledge and excellence
to our clients
 Courtesy: - we want to be polite and
very well mannered in our relation to
our customers and stakeholders
 Responsiveness: - we want to reply
and positively react to inquiries and
- 26 -
Regulatory Tips
Organ gram of the newly designed Regulatory Authority
Director General
Audit and
inspection case
Human and financial
management directorate
Human resource
management case team
Finance, procurement
and property case team
Quality and compliance
directorate
Planning, monitoring
and evaluation case
team
Complaints case
team
Public relations
Ethics and anticorruption officer
General services case
team
Legal services
case team
Deputy DG of standards and licensing
Toxicological testing
case team
- 27 -
Adama/
mojo
stations
case
team
Addis
Ababa
stations
case
team
Dewele
station
case
team
Jijiga
station
case
team
Eastern branch office
South-western branch
office
office
North-western branch
Medico-legal
directorate
Inspection and
surveillance directorate
Southern branch office
Central office
Product
quality
assessment
directorate
Micro- biological testing case
team
market authorization case team
Physico - chemical testing case
team
Local manufacturers
Product
registration and
licensing
directorate
Foreign manufacturers market
authorization case team
team
Narcotic &psychotropic substances
abuse prevention and control case
Regulatory
standards setting
and information
delivery
directorate
Regulatory standards setting
case team
Regulatory information
development and dissemination
case tam
Health
institution and
professional
licensing
directorate
North-eastern branch
office
Deputy DG of Inspection and Enforcement
Dire
Dawa
Station
case
team
News
New Drugs Included Into the National Drug List as of
December 2008.
SN
PRESENTATION
GENERIC NAME
TARGET
Anti-infective,Antiretroviral
Anti-infective,Antiretroviral
Anti-infective,Antiretroviral
1.
Abacavir sulfate
Tablet, 60mg
2.
Abacavir
sulfate+Lamivudine
Abacavir
sulfate+Lamivudine+Zid
ovudine
Tablet, 60mg+30mg
Acarbose
Tablet, 50mg, 100mg
Oral Anti-diabetic
Acemetacin
Capsule, 30mg, 60mg, 90mg(D/R)
Anti-rheumatic
Alfacalcidol
Capsule(s/g), 1mcg
Vitamins
Amikacin
Eye drop, 0.3%
Ophthalmic, Antibacterial
Apraclonidine
Eye drop, 0.5%, 1%
Eye drop, 0.05%
Ophthalmic, Antiglaucoma
Ophthalmic, Anti-allergic
Injection, 2mg+5mg/2ml
Anti-inflammatory
0.003% Ophthalmic, Antiglaucoma
Ophthalmic, Antiglaucoma
Ophthalmic, Antiinflammatory
Ophthalmic, Antiinfective/ Anti-infective
Anti-inflammatory
combination
Ophthalmic, Antibacterial
3.
4.
5.
6.
7.
8.
9. Azelastin
10. Betamethasone sodium
Tablet, 60mg+30mg+60mg
phosphate+Betamethas
one dipro
11.
Bimatoprost
Eye drop,
12.
Brimonidine
Eye drop, 0.2%
13.
Bromfenac
Eye drop, 0.1%
14.
Cefditoren
Tablet 200mg, 400mg
15.
Chloramphenicol+Dexamet
hasone
Ciprofloxacin
Eye drop, 0.5%+0.1%
16.
17. Cisatracurium
Eye drop(ointment), 0.3%
Injection, 2mg
Neuromuscular
blocker
18. Clotrimazole
19. Cyproterone acetate
20. Darunavir
Troches, 10mg
Orophargeal preparation
Tablet, 50mg
Anti-androgenic hormone
Tablet(f/c), 300mg
21. Desloratadine
22. Dexamethasone acetate
Tablet, 5mg, Syrup, 0.5mg/ml
Anti-infective, Antiretroviral
Anti-histamine
Film coated Tablet, 3mg+0.03mg
Dermatological, Antiinflammatory/ Antiinfective combination
Oral Contraceptive
Eye drop, 1%
Ophthalmic, Antifungal
Eye drop, 1%
Ophthalmic, Antibacterial
Oral
suspension,20mg,40mg/sachet
Anti-ulcer
Cream, 0.4mg+100mg
+Clotrimazole
23.
Drospirenone+Ethinyl
estradiol
Econazole
24.
25. Erythromycin
26. Esomeprazole
- 28 -
News
27.
Gel, 5%,10%, Cream, 10%,Lotion,
10%, Spray, 100mg/ml(18mg/dose)
Anti-Rheumatic
pivalate+Lidocaine HCl
Cream, 1mg+20mg/1gm,
Suppository, 1mg+40mg
Dermatological, Antiinflammatory
Fluorometholone
Eye drop, 1%
Ophthalmic, Antiinflammatory
Cream,2%+0.064%,Ointment,2%
+0.064%,2%+1%,2%+1%
Dermatological, Antiinfective+ Antiinflammatory
Gatifloxacin
Eye drop, 0.3%
Ophthalmic, Antibacterial
Gentamicin+Dexamethaso
ne
Eye drop, 0.3%+0.1%
Ophthalmic, Anti-infective
Anti- inflammatory
Combination
Tablet, 40mg, 80mg
Oral anti-diabetic
Eye drop
Ophthalmic, Diagnostic
agent
Ophthalmic, Antiinflammatory
Ophthalmic, Antiinflammatory
Etofenamet
28. Flucortolone
29.
30. Fusidic acid/Sodium
fusidate+Betamethason
e
31.
32.
33. Gliclazide
34. Glycerin
35.
Indometacin
Eye drop, 0.5%, 1%
36.
Ketrolac
Eye drop, 0.4%,0.5%
Tablet, 30mg+50mg+60mg
Anti-infective,Antiretroviral
Tablet, 30mg+6mg+50mg,
60mg+12mg+100mg
Anti-infective, Antiretroviral
Tablet,30mg+60mg
Anti-infective,Antiretroviral
Levocabastine
Eye drop, 0.05%
Ophthalmic, Anti-allergic
Lissamine green
Eye drop, 1%
Ophthalmic, Diagnostic
agent
Tablet, 100mg+25mg
Anti-infective,Antiretroviral
Eye drop, 0.1%,0.2%,0.5%
Ophthalmic, Antiinflammatory
Tablet,7.5mg,15mg
Anti-rhuematic
Tablet, 25mg, 50mg, 100mg
37. Lamivudine+Nevirapine
+Zidovudine
38.
Lamivudine+Stavudine+Ne
virapine
39. Lamivudine+Zidovudine
40.
41.
42. Lopinavir+Ritonavir
43.
Loteprednol
44. Meloxicam
45. Methazolamide
46.
Metronidazole+Miconazole
Vaginal pessary, 750mg+200mg
47.
48.
Moxifloxacin
Eye drop, 0.3%
Ophthalmic, Antiglaucoma
Obstetric and
Gynecological
Ophthalmic, Antibacterial
Moxifloxacin
Injection, 400mg/250ml, Tablet (f/c),
400mg
Anti-infective, Other Antibacterial
49. Mycophenolic acid (as
Tablet(e/c) 180mg, 360mg(as
mycophenalate sodium),1gm(as
mycophenolate mofetil)
equivalent to 720mg
Mycophenolic acid
Immunological
Preparation
50. Nedocromil
51. Nimesulide
Eye drop, 2%
Ophthalmic, Anti-allergies
Gel(transdermal), 1%,
52. Nimodipine
Tablet, 30mg, Injection, 1mg/5ml
Dermatological, Antiinflammatory
Drugs used for
Angina/Ischemic heart
disease
mycophenolate
sodium/mofetil)
53.
Norfloxacin
Eye drop, 0.3%
Ophthalmic, Antibacterial
54.
Nystatin
Eye ointment, 1%
Ophthalmic, Antifungal
- 29 -
News
Ofloxacin
Eye drop, 0.3%
Ophthalmic, Antibacterial
Orlistat
Capsule 120mg
Drug for management of
Obesity
57. Ornidazole
Tablet, 500mg
58. Pantoprazole
59. Raltegravir
Tablet, 20mg, 40mg
Tablet, 400mg
60. Rosuvastatin
Tablet, 5mg, 10mg, 20mg, 40mg
Amoebicides,
Antigiardial
Anti-ulcer
Anti-infective, Antiretroviral
Anti-lipemic Drugs
61. Sodium
Tablet, 75mg
Water Disinfectant
Eye drop, 1%
Ophthalmic, Antiinflammatory
Capsule,500mcg, 1mg, 2mg,
5mg, Infusion, 5mg/ml
Tablet, 300mg+300mg
Immunological
Preparation
Anti-infective, Antiretroviral
Ophthalmic, Antiinfective/ Antiinflammatory
combination
Ophthalmic, Antiglaucoma
Ophthalmic, Diagnostic
agent
Drugs for Erectile
dysfunction
Ophthalmic, Astrigent
55.
56.
Dichloroisocyanurate
62.
Suprofen
63. Tacrolimus
64. Tenofovir + Lamivudine
65.
Tobramycin+Dexamethaso
ne
Eye drop, 0.3%+0.1%
66.
Travopros
Eye drop, 0.004%
67.
Trypan blue
Injection, 0.5%
68.
Vardenafil
Tablet, 5mg, 10mg, 20mg
69.
Zinc sulphate
Eye drop, 0.25%
- 30 -
News
Seminar on Health and Health Related Services and Products
Quality Regulation Core Process for Development Partners
Drug
Administration
Control
Hotel, Addis Ababa. A total of 19
Authority of Ethiopia (DACA) organized a
participants representing different national
one
and international organizations attended
day workshop
and
for
development
partners on the newly designed regulatory
the seminar.
core process on 4th June 2009 at Ghion
The workshop is intended primarily to
for better performance and to show
familiarize development partners the new
thematic areas for partner's involvement.
regulatory core process, to seek any advice
- 31 -
News
On his inaugural speech, Mr. Dawit
products quality regulation Core process,
Dikasso, Deputy Director General of
though the general overview about the
Inspection
DACA
outcomes and all Core processes of the
expressed his appreciation and thanked all
health sector had been also delivered.
the participants for accepting the invitation
Furthermore objectives, mission, duties
for attending the meeting on behalf of the
and responsibilities of the regulatory and
authority, and himself. After a year and
area of collaboration with development
half hard work, successful completion of
partners had been presented.
and
Enforcement,
BPR resulted expansion of the mandate of
the new regulatory authority so as to
Participants were very active and raised
include all health regulatory issues under
many constructive issues and accordingly
one umbrella, he added. He also expressed
in-depth explanation was given for each
regret for not being fully available to serve
concern as a response.
customers and stakeholders during the
period of BPR designing process and he
appreciated
the supports provided by
partners for the authority and expressed
his strong belief that this assistance will
further be strengthened in the future.
The topics presented mainly focused on
the health and health related services and
The 12th Biennial International Pharmacovigilance Training
Course
The WHO Collaborating Centre for
from 25 May 2009 to 5 June 2009 with 30
International Drug Monitoring organized
participants from around the world. One
the 12th international pharmacovigilance
participant from the authority attended this
training course held in Uppsala, Sweden
training course.
- 32 -
News
.
The aim of this training course was
hospital,
primarily to support the development of
university or industry setting.
programmes
reaction
for
reporting
spontaneous
and
to
community,
regulatory,
adverse
give
To
an
satisfy
the
requirements
of
professionals with slightly different needs
introduction to other methodologies.
the course is divided into two separate
The training was designed primarily for
modules, with an option for the second
Health care professionals, e.g. Pysicians,
module: Module I: Introduction to ADRs -
Pharmacists, nurses, who have recently
Spontaneous adverse reaction reporting
become engaged or soon will become
Module
engaged in the practical operation of
pharmacoepidemiology
pharmacovigilance
Communications in pharmacovigilance
programmes
in
a
- 33 -
II:
a)
Introduction
b)
to
Effective
News
Theoretical
adverse
and
drug
practical
reactions
aspects
and
of
VigiBase were also be covered in the
pharm-
Practical sessions
acovigilance were covered. The theoretical
Members of the staff of the Uppsala
parts included lectures as well as group
Monitoring Centre, WHO, the Swedish
discussions and poster presentations by
Medical Products Agency and other
course participants. Recording of case
international pharmacovigilance experts
information and retrieval of information
were function as instructors and discussion
from the WHO Global ICSR database,
leaders throughout the course.
Workshop Conducted On Frame Work Convention on Tobacco
Control and Drug Abuse and Illicit Trafficking Prevention
According to the report of UNODC, there
Taking the above in to account the
are an estimated 200 million drug users in
authority organized a two-day workshop
the globe, ranging from the homeless, to
on Frame work convention on Tobacco
white-collar
college
Control and Drug Abuse and Illicit
students, sex workers and street children.
Trafficking prevention for members of the
Associated drug related problems are
House of Peoples’ Representatives from
increasing alarmingly: crime, violence,
May 15 -16/2009 in the Auditorium of
unemployment, the deterioration of social
House of Peoples’ Representatives, Addis
fabric, etc.
Ababa.
In Ethiopia, as elsewhere, drug abuse is
The workshop in its two days deliberation
becoming a major problem affecting the
aimed
people and the youth in particular, the
substances of Abuse and Illicit Trafficking
country's most valued asset. The abuse of
that will enable members of the parliament
Alcohol, khat and cannabis by youngsters
to
is gradually increasing. The youth often
community they represent. It also create
perceive these drugs as "low risk" or "no
conducive
risk" drugs.
parliament to ratify the WHO Framework
professionals,
to
create
promote
the
awareness
awareness
environment
to
Convention on Tobacco Control.
- 34 -
on
of
urge
the
the
the
News
General overview and Global strategy of
drug abuse and illicit trafficking and
Drug control, general overview of the
Principle of demand reduction were
National situation of drug Abuse and illicit
covered in the workshop.
trafficking, Socio-economic impact of
Study Tour to South African Department of Social Services
Three experts from Narcotic drugs
and
implemented by different government
psychotropic substances abuse prevention
organizations and the drug abuse and
and
Drug
prevention master plan is developed by
administration and control authority has
central drug authority in collaboration with
conducted a study tour from July 1-
other departments. As it is the core
10,2009 to the south African department
coordinating body, the Central drug
of social services to get best experiences
authority is responsible for evaluating the
on
implementation status of the master plan.
control
tobacco
implementation
team
of
control
of
the
and
Who
on
the
framework
The
convention on tobacco control (FCTC).
Team
gained
experiences
lots
of
during visiting
practical
substance
During the ten days, the team visited
abuse rehabilitation centers in South
relevant
Africa. This effort is part of DACA’s
departments
and
other
stakeholders as scheduled by the social
Initiative
to
establish
drug
abuse
development department. Further more the
rehabilitation centers in selected hospitals
team observed that the drug abuse
that provide treatment services for those
prevention and control activities are being
who are in need of it.
Training of Trainers organized on Pharmacovigilance
DACA in collaboration with MSH/SPS
office Lalo building. A total of 60 health
organized a TOT on pharmacovigilance
professionals were trained from RPMA,
which was carried out in two rounds, first
DACA,
round: April 30-May 2, 2009 and second
institutions and selected hospitals.
round June: 18-20, 2009 at MSH head
- 35 -
MSH/SPS,
RHB,
teaching
News
The aim of the TOT was to improve the
As the trainees need to acquire some
awareness of selected health professionals
training skills to help them when giving
on pharmacovigilance and things related
cascaded trainings, topics like theory and
with it so that they could be able to give
practice
cascaded training in their respective areas.
methodology and health communication
of
adult
learning,
training
were also included.
The training included theoretical sessions
as well as practical exercises in groups.
At the end of the training session, the
Backgrounds
as
participants selected a topic and each
medication error were briefly discussed.
individual gave a brief presentation that
Also, known ADRs of ART, TB and
reflected the knowledge they acquired
Malaria drugs was addressed. As a
through the training. The result was
highlight of the existing reporting system a
satisfactory as they were evaluated by
report on the assessment of health care
experts and most presenters had the skills
providers’ knowledge attitude and practice
to pass their knowledge in future cascaded
on adverse drug reaction reporting and its
training to be given concerning ADR.
on
ADR
as
well
monitoring was presented.
- 36 -
Fun Corner
Fun Corner
A prescription for Cyanide
A man goes into a pharmacy and asks for a
man to leave. The man says before I leave
vial of cyanide. The concerned pharmacist
I'll ask you one more time for the cyanide
says I cannot give u cyanide, I'll loose my
he reaches into his purse and pulls out a
job. He asks the man what he wants it for.
picture of his ugly wife and shows it to
The man said I caught my wife cheating!!
him. He replies that’s different I DIDN’T
And I'm going to poison her. Well the
KNOW
pharmacist gets very upset and asks the
PRESCRIPTION!!!!
YOU
HAD
A
Any duck food?
A duck walks into a pharmacy and asks,
come in here tomorrow and ask for duck
"You got any duck food?" "No," says the
food, I'm going to nail your little, yellow
pharmacist, "we don't sell duck food." The
webbed feet to the floor!" The duck
duck leaves. The duck comes back the
leaves.
next day and says, "You got any duck
The next day, the pharmacist becomes
food?" "No," says the pharmacist with a
incensed when he sees the duck come in
frown, "This is a pharmacy. We don't sell
the store. The duck asks timidly, "You got
duck food." The duck leaves.
any nails?" "No!" screams the pharmacist.
The duck comes back the next day. "You
"This is a pharmacy! We do not sell
got any duck food?" "Look," screams the
nails!"
pharmacist. "This is a pharmacy! We don't
"Good. You got any duck food?"
sell duck food! We sell medicine! If you
Can I play the piano once these are off?
A doctor has come to see one of his
bandaged hands. "Will I be able to play
patients in a hospital. The patient has had
the piano when these bandages come off?"
major surgery to both of his hands.
"I don't see why not," replies the doctor.
"Doctor," says the man excitedly and
"That's funny," says the man. "I wasn't
dramatically
able
holds
up
his
heavily
- 37 -
to
play
it
before."
Fun Corner
- 38 -