Embed Size (px)
Citation preview
Part I of II
EPVC Newsletter Egyptian
Pharmaceutical
Vigilance Center
(EPVC)
Pharmacovigilance
Department
Inside this issue:
EPVC regional
center of Sohag-
QPPV training
workshop in Assiut
University
1
EPVC regional
center in Alexan-
dria - HCPs Phar-
macovigilance
training workshop
1
Domperidone-
Withdrawal of
some dosage forms
from Egypt
1
Recall from the
Egyptian market
due to counterfeit
2
“Batches” Recall of
some pharmaceuti-
cal products from
the Egyptian mar-
3
De-registration and
withdrawal of
some products due
to marketing for
unauthorized indi-
4
FDA has reviewed
possible risks of
pain medicine use d
uring pregnancy
5
Risk of Medication
Errors resulting
from mixing-up
similar (look alike)
Drugs
5
Volume 6, Issue 3 March 2015
EPVC regional center in Alexandria - HCPs
Pharmacovigilance training workshop in El-Beheira
Alex Satellite center has organized a training
workshop which was held in El-Beheira.
300 HealthCare Professionals from all hospi-
tals and health institutions at El- Beheira, at-
tended this training on Sunday 23th February
2015.
Domperidone-Withdrawal of some dosage forms from
Egypt
On 01/01/2015 the Minister of
Health took a decision regarding the
active ingredient “Domperidone”
with decree no. (828) as follows:
“Withdrawal of oral dosage forms
containing concentrations more than
10 mg of the active substance
Domperidone.
And withdrawal of the suppositories
with concentrations 10mg and 60mg
of this active ingredient”.
EPVC regional center of Sohag- QPPV training
workshop in Assiut University
Sohag Satellite center has organized a training workshop which will be held
in Assiut University.
220 Pharmacists from El-Menya and Assuit are attending this training on 1st
till 3rd February 2015 .
This decision was circulated to
theManufacturers, Marketing
Authorization Holders (MAH)
and Distributers of these prod-
ucts to discontinue distribution
of stocks and recall the amount sold to pharmacies.Necessary measures would be taken against the viola-
tors. The above decision applies to the following brands:
Volume 6, Issue 3 Page 2 Part I EPVC
Recall from the Egyptian market due to counterfeit
The department of Pharmacies & Warehouse In-
spection at CAPA has decided to recall the fol-
lowing products due to counterfeit:
1. Betadine solution 100ml
2. N-Betadine solution conc. 10% 4L.
3. Betadine solution 7.5% 4L.
These products are having the registration num-
ber 11422 and manufactured by EL-AKSA Com-
pany and distributed by Egypt Pharma.
It is important to know that this registration num-
ber is fake and the previous products are not regis-
tered at the Egyptian drugs database of the Minis-
try of health.
However the authorized Betadine products are
manufactured for El-Nile company and such
weren’t affected by the previous decision.
Another recall decision by the Pharmacies &
Warehouse Inspection department by the request
of AstraZeneca Egypt, regarding some packages
of unknown source and unregistered in Egypt.
These counterfeited products were Zestril 10mg &
Seroquel 200mg, and it an be differentiated from
the authorized products as follows:
No. Trade Name Manufacturer Name
1 Cinnaridone tab. Arab Drug Co.
2 Touristil tab. Mina Pharm
3 Vertigun tab. Sigma
4 Domperidone 10mg Supp. Sedico
5 Domperidone 60mg Supp. Sedico
6 Dompidone 10mg Supp. for babies Arab Drug Co.
7 Dompidone 60mg Supp. Arab Drug Co.
8 Farcotilium 10mg infantile Supp. Pharco
9 Farcotilium 60mg Supp. Pharco
10 Gastromotil 10mg Supp. Eipico
11 Gastromotil 60mg Supp. Eipico
12 Motinorm 10mg infant Supp. SmithKline Beecham
13 Motinorm 60mg Supp. SmithKline Beecham
14 Synchrogit 10mg ped. Supp. Rameda
Volume 6, Issue 3 Page 3 Part I EPVC
“Batches” Recall of some pharmaceutical products from the Egyptian
market
The Drug Factories Inspection Department at the Central Administration of Pharmaceutical Affairs
(CAPA) has decided the recall of some batches of the following Pharmaceutical products:
Pharmaceutical Product MAH Batch num-
bers
Reason
Cidophage Retard CID 01130767
01130766
Non conformity of physical properties through Dissolution
testing for two consecutive times
Metformin Hydrochloride 850mg CID 03140406 Non conformity of physical properties through Dissolution
testing for two consecutive times
Farcosolvine Cap. Pharco 6106/225 Non conformity of physical properties regarding the color
of the capsule content for two consecutive times
Trozal 28% Nail solution EGPI 130660 130661
130662
Non conformity of physical properties regarding the color &
PH of the capsule for two con-secutive times
A. Zestril 10mg tablets
B. Seroquel 200mg tablets
Authorized packages Packages of unknown source
Contains one strip with 10 tablets. 1.Contains one strip with 20 tablets.
Manufactured by AstraZeneca Egypt. 2.Manufactured by AstraZeneca England.
The registration no in Egypt is printed 3.The registration no in Egypt is not printed
The price is printed 4.The price is printed
Authorized packages Packages of unknown source
Contains 3 strips with 10 tablets/each, or 6 strips with 10 tablets/each.
1.Contains 1 strip with 10 tablets/each, or
2 strips with 10 tablets/each.
Manufactured by AstraZeneca Egypt. 2.Manufactured by AstraZeneca England.
The registration no in Egypt is printed 3.The registration no in Egypt is not printed
The price is printed 4.The price is printed
Volume 6, Issue 3 Page 4 Part I EPVC
This decision was circulated to the Manufacturers, Marketing Authorization Holders (MAH) and Dis-
tributers of these products to discontinue distribution of stocks of and recall the amount sold of these
batches ONLY to pharmacies.Necessary measures would be taken against the violators.
On 12/01/2015 the Minister of Health took a de-
cision no. (7) For year 2015 regarding the follow-
ing cosmetic products:
Cosmetic product Registration no.
1 Right Derm Cream 19974/2011
2 Armage Cream 23702/2012
3 Blend Cream 22903/2012
4 Bambo Cream 19648/2011
5 Perlina Sun Block 21105/2011
6 Alpha Cream 17844/2011
The decision is to withdraw the registration li-
cense for the previous products and its distribution
and sales should discontinued, that is due to add-
ing some unapproved therapeutic indications to
these products which may harm patients’ health.
These products belongs to S.H Pharma for herbals
under the supervision of Dr. Saed Hassasein and
manufactured by elHelw for cosmetic products.
Regulatory actions would be taken against whoev-
er sells/distributes those products.
De-registration and withdrawal of some products due to marketing for un-
authorized indications
FDA has reviewed possible risks of pain medicine use during pregnancy
The U.S. Food and Drug Administration (FDA)
is aware of and understands the concerns arising
from recent reports questioning the safety of pre-
scription and over-the-counter (OTC) pain medi-
cines when used during pregnancy. As a result,
the FDA evaluated research studies published in
the medical literature and determined they are too
limited to make any recommendations based on
these studies at this time. Because of this uncer-
tainty, the use of pain medicines during pregnan-
cy should be carefully considered. FDA urge
pregnant women to always discuss all medicines
with their health care professionals before using
them.
Severe and persistent pain that is not effectively
treated during pregnancy can result in depression,
anxiety, and high blood pressure in the moth-
er.1 Medicines including nonsteroidal anti-
inflammatory drugs (NSAIDs), opioids, and acet-
aminophen can help treat severe and persistent
pain. However, it is important to carefully weigh
the benefits and risks of using prescription and
OTC pain medicines during pregnancy.
Volume 6, Issue 3 Page 5 Part I EPVC
The published studies reviewed reported on the
potential risks associated with the following three
types of pain medicines used during pregnancy:
Prescription NSAIDs and the risk of miscarriage
in the first half of pregnancy.
Examples of prescription NSAIDs include ibu-
profen, naproxen, diclofenac, and celecoxib.
Opioids, which are available only by prescrip-
tion, and the risk of birth defects of the brain,
spine, or spinal cord in babies born to women
who took these products during the first trimester
of pregnancy.7, 8Examples of opioids include ox-
ycodone, hydrocodone, hydromorphone, mor-
phine, and codeine.
Acetaminophen in both OTC and prescription
products and the risk of attention deficit hyperac-
tivity disorder (ADHD) in children born to wom-
en who took this medicine at any time during
pregnancy.Acetaminophen is a common pain
reducer and fever reducer found in hundreds of
medicines including those used for colds, flu, al-
lergies, and sleep.
FDA found all of the studies FDA reviewed to
have potential limitations in their designs; some-
times the accumulated studies on a topic con-
tained conflicting results that prevented us from
drawing reliable conclusions. As a result, our rec-
ommendations on how pain medicines are used
during pregnancy will remain the same at this
time.
Pregnant women should always consult with their
health care professional before taking any pre-
scription or OTC medicine. Women taking pain
medicines who are considering becoming preg-
nant should also consult with their health care
professionals to discuss the risks and benefits of
pain medicine use. Health care professionals
should continue to follow the recommendations
in the drug labels when prescribing pain medi-
cines to pregnant patients.
FDA will continue to monitor and evaluate the
use of pain medicines during pregnancy and will
update the public as new safety information be-
comes available.
It is important to mention that Novartis Pharma is
aware by this recent FDA review and informed
EPVC that its diclofenac-containing products
labels properly address all the risks associated
with the dicolfenac during pregnancy.
References:
1. FDA safety announcement on 09/01/2015 (Click
here)
Risk of Medication Errors resulting from mixing-up similar (look alike)
Drugs
On 25/2/2014, EPVC-CAIRO received three
complains from Children's Cancer Hospital in
Egypt about mixing-up different drugs that are
similar in their packaging design which may lead
to many medication errors and consequently un-
expected harm to the patient.
Complains Were As Follows:
Mixing-up Potassium chloride ampoules (Egypt
Otsuka Pharm. Co.) with Sterile water for injec-
tion ampoules: Potassium chloride ampoules are
mistaken or ampoules of similar appearance,
such as sterile water for injection when reconsti-
Volume 6, Issue 3 Page 6 Part I EPVC
tuting a drug for injection. Consequently, the
patient is administered an accidental overdose
unintended dose of potassium.
Recommendations:
Recommendations for Manufacturer:
It was recommended that the company (Egypt
Otsuka Pharm. Co.) re-package the solution in
another newly designed form that is complete-
ly different from that for Sterile water for injec-
tion.
As a suggestion we recommend the current
packaging, design in USA
Recommendations for Health Care Professionals:
Choose designated area for storage of potassi-
um chloride only.
Due to risk associated with intravenous potas-
sium chloride, Ampoules of potassium chlo-
ride should not be kept as stock item in wards
On 29/01/2015 this issue was discussed on the
Pharmacovigilance (PV) committee and decided
the following:
For ampoules containing Potassium Chloride,
the Committee suggested that all the labeling in-
formation of the injectable dosage form of Potas-
sium Chloride to be written in a clear RED
FONT especially its trade name.
On 12/02/2015 the naming and labeling com-
mittee approved the PV committee recommenda-
tion and gave companies grace period of 6
months for changing its labels.
New HPV vaccine shown to prevent multiple cancers National Organization
for Research &
Control of Biologicals
Post Marketing
Surveillance and
Adverse Event
Following
immunization
Department
Inside this issue:
New HPV vaccine shown to prevent multiple can-
1
Gates Foundation, WHO fund synthetic polio
1
3-D vaccine adds new dimension to cancer
2
WHO approves MenAfri-Vac meningitis vaccine
2
Anti-HIV agent possibly efficient in vaccine form
3
New drug shows early promise as Ebola vaccine 3
NORCB Newsletter Volume 6 , Issue 2 February 2015
A multinational clinical trial, which test-ed nearly 20,000 young women, has shown that the human papilloma virus vaccine, Cervarix, displays the potential to prevent cervical cancer. The vaccine has also demonstrated the ability to combat other common, cancer-causing human papillomaviruses, in addition to the two HPV types (16 and 18) that cause almost 70 percent of all cases. Cervarix was also shown to be benefi-cial to women who had never been in-fected with HPV, protecting the vast majority from HPV-16 and -18. Addi-tionally, it protected 50-100 percent of subjects against different grades of pre-cancerous transformation of cervical
cells caused by other strains of HPV, including up to 100 percent of those with the immediate precursor grade to cancer. The efficacy of the vaccine was signifi-cantly better among girls aged 15-17 than those women aged 18-25. Reference Vaccine news daily : (Click Here)
Only a few hundred cases of polio are reported each year, but a synthetic vaccine could be the key to eradicating the virus for good. Scientists are team-ing up to develop a synthetic vaccine in an effort to address some limita-tions of the existing oral vaccine. the current oral vaccine uses a weak-ened version of the virus, which pro-vokes an immune response. However, the vaccine can cause infection in a few individuals, from whom the virus can spread to other, unvaccinated peo-ple. An artificial vaccine would not have this danger. The idea of the synthetic vaccine is that it contains no genome--it's virus
Gates Foundation, WHO fund synthetic polio vaccine development
free So it's made, in a way, like a su-perchemical, a complicated chemical, that assembles itself to look like the virus but has no way of ever replicat-ing. Reference Fierce Vaccine : (Click Here)
Volume 6, Issue 2 Page 2
Part II NORCB
3-D vaccine adds new dimension to cancer research Researchers recently developed a new 3-D vac-cine that may be crucial to using the body’s im-mune system to defeat cancer and infectious dis-eases. A new team of researchers has developed a method of manipulating the immune cells with-in the body with implantable biomaterial. The team’s biodegradable scaffold, injected under the skin, houses dendritic cells while exposing them to tumor proteins, activating the immune system. The 3-D vaccine, or scaffold, erects its microsize rods into a haystack shape; the scaffold then gathers, stores and influences immune cells to promote a strong immune response. Housed be-tween the rods, immune cells and dendritic cells recognize cancer proteins that are released through the rods’ nano-size pores.
The injectable scaffold could make cancer vaccines easier to administer and could outdate surgeries that many cancer patients undergo. Any combination of drugs and virus proteins could be added to the scaf-fold, making the new developments transferrable to any infectious disease study.
Reference Vaccine news daily : (Click Here)
WHO approves MenAfriVac meningitis vaccine for infants in Africa
The World Health Organization recently approved use of a new meningitis vaccine on infants after it was shown to be effective in sub-Saharan Africa. Initial mass vaccination campaigns with MenAfriVac have been highly effective in reducing the number of meningitis A cases But epidemics will return when rising num-bers of unprotected newborns become a larg-er proportion of the total population over time. As a result of the WHO decision, the vac-cine now meets international standards of quality, safety and efficacy, and is author-ized to be given to children younger than 1 year old in Africa. The MenAfriVac vaccine
previously only had been authorized for use in chil-dren and young adults ages 1-29. Reference Vaccine news daily : (Click Here)
Volume 6, Issue 2 Part II NORCB Page 3
Anti-HIV agent possibly efficient in vaccine form
Scientists at The Scripps Research Institute (TSRI) recently developed a new drug candidate that is so powerful against HIV that it may prove efficient in vaccine form. Research demonstrates that the new treatment ef-fectively blocks all strains of HIV-1, HIV-2, and SIV (simian immunodeficiency virus), even the most resistant mutations of the strains. The vaccine prevents humans from contracting HIV, even after exposure to unusually high doses of the virus, for approximately eight months after they receive the injection. The scientists used preexisting technology to create an adeno-associated virus (a virus that does not cause diseases). This technology mimics HIV be-havior in that it uses host cells as home bases to
New drug shows early promise as Ebola vaccine
reproduce its genetic material through RNA. This helps the vaccine reproduce its protective protein for years and maybe even decades. Reference Vaccine news daily : (Click Here)
Researchers recently administered an experi-mental drug that targets an Ebola virus protein to a group of monkeys and discovered that 75 per-cent of the monkeys did not contract the virus after virus exposure . The monkeys received AVI-7537, which targets protein VP24. The bloodstreams of most mon-keys showed a significant reduction of Ebola within eight days of receiving the treatment. Such responses are considered gold standards as re-searchers predict how humans might respond ahead of human trials . Researchers tested a group of drugs called phos-phorodiamidate morpholino oligomers (PMOs). These drugs are synthetic anti-sense molecules that use the genetic codes with viruses such as Ebola to inhibit the virus’s reproductive capabili-ties .
Currently, most products that doctors use to treat Ebola patients in West Africa have not been ade-quately tested. As of today, no licensed medical preventatives or cures for Ebola exist . Reference Vaccine news daily : (Click Here)
A call for reporting
Please remember that you can report suspected adverse
reaction of medicines to EPVC, and adverse reaction
following immunization to NORCB using the follow-
ing communication information
51 Wezaret El Zeraa Street, Agouza, Giza P.O. Box: 354 Dokki
Phone: +202 – 37 480 478 ext. 118
Fax: +202 – 37480472
Email: [email protected]
National Organization for Research & Control of Biologicals
Post Marketing Surveillance and Adverse Event Following
immunization Department
21 Abd El Aziz Al Soud Street. El-Manial, Cairo, Egypt, PO Box: 11451
Phone: +202 – 23684288,
Fax: +202 – 23610497
Email: [email protected]
Central Administration of Pharmaceutical Affairs
Egyptian Pharmaceutical Vigilance Center
Pharmacov ig i l ance Depar tmen t
www.epvc.gov.eg
Communications information
What is Pharmacovigilance According to the WHO, Pharmacovigilance is
the science and activities relating to the de-
tection, assessment, understanding and pre-
vention of adverse effects or any other medi-
cine-related problem.
What is the Egyptian Pharmaceuti-
cal Vigilance Center
With the increasing demand for patient's
safety which is becoming more stringent, the
regulatory authorities are facing an in-
creased demand for patient welfare and
safety. Thus, The Egyptian Pharmaceutical
Vigilance Center (EPVC) is constructed within
The Central Administration of Pharmaceuti-
cal Affairs (CAPA) Ministry of Health to be
responsible for the collection and evaluation
of information on pharmaceutical products
marketed in Egypt with particular reference
to adverse reactions. Furthermore, EPVC is
taking all appropriate measures to:
1.Encourage physicians and other healthcare
professionals to report the suspected ad-
verse reactions to EPVC.
2.Necessitate the pharmaceutical compa-
nies to systematically collect information
on risks related to their medical products
and to transmit them to EPVC.
3.Provide information to end-users through
adverse drug reaction news bulletins, drug
alerts and seminars.
