SULTANATE OF OMAN

Vol. 24 MINISTRY OF HEALTH

2016/3 www.moh.gov.om
DIRECTORATE GENERAL OF PHARMACEUTICAL
AFFAIRS & DRUG CONTROL (DGPA&DC)

PHARMACEUTICAL NEWSLETTER
Pharmacovigilance Activities in the (ADRs) and responding to enquiries on
Department of Pharmacovigilance & therapeutic drug use. It consists of three
Drug Information sections: PV for human medicines, PV for
herbal and health products and Central drug
Introduction: information.
Pharmacovigilance (PV) is defined as the
science and activities relating to the detection, DPV & DI Main Activities:
assessment, understanding and prevention 1. Collecting and analyzing case reports of
of adverse effects or any other drug-related ADRs and other drug problems such as
problem. Oman became a full member in drug quality and medication errors.
the WHO Programme for International Drug
2. Assessing all pharmacovigilance documents
Monitoring in 1995.
received from Marketing Authorization
Department of Pharmacovigilance & Drug Holders (MAHs) such as Periodic Safety
Information (DPV&DI) is the National Update Report (PSUR), Risk Management
Pharmacovigilance Centre for receiving and Plan (RMP), etc....
analyzing reported adverse drug reactions
3. Conducting workshops and training for
healthcare professionals.
In this issue:
4. Dissemination of drug safety update alerts
Pharmacovigilance Activities 1
and ADRs quarter reports.
News 3
Question Corner 3 5. Receiving and responding to enquiries
on therapeutic drug use from healthcare
DGPA&DC Circulars 4
professionals and public.
DGPA&DC Activities 6
What to report?
All suspected ADRs, medication errors and
quality problems associated with the use of
Announcement drugs, herbal medicines, health products and
d “Question Corner ”
We have launched a column title
ir que ries. Every issue of biologicals should be reported to DPV & DI.
for readers for posting the
feat ure  an exp ert response to
our newsletter will
the readers.
some selected questions from Who can report?
ce and contemporary
Questions with public relevan
rity.   We invite readers 1. Healthcare professionals such as physicians,
implications will be given prio
dc@moh.gov.om”.
to post their queries to “dg-pa pharmacists, nurses and dentists.

THE ARTICLES USED IN THIS JOURNAL DO NOT IMPLY ANY JUDGEMENT BY

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MOH AND NOT BE CONSTRUED AS MOH POLICIES.
 Pharmacovigilance Pharmaceutical
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Activities 2016 Vol. 2 4 / 3

2. Other healthcare providers. • E-mail: mohphar@omantel.net.om.

3. Patients. • Mobile smart application (eSehaty).
How to report? References:
1. Glossary of terms used in Pharmacovigilance: www.
• Adverse Drug Reaction reporting form who-umc.org
“yellow form”. 2. Vigilyze-UMC
• Ministry of Health website (www.moh.gov.om).
1. Number of ADRs reports in Oman 2. Reporters
(1996-2015)

Number of ADRs (1996-2015) HCP reporters

2500
2205
April/2016 -11/2016
2000 1814 17521785
(blank)
# OF REPORTS

1500
Unknown
HCP Reporters

924 885
1000 Physician

488 514 Pharmacist

500
214 191 155 Other Health Professional
44 14 23 30 0 1 50 65 74
0 Consumer/Non Health Professional

0 100 200 300 400 500 600 700 800 900

YEAR
# of reports

3. Top 20 reported substances in Oman 4. Top 20 reported reactions in Oman

(1996-2015) (1996-2015)

5. Patient Sex 6. Patient age

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NEWS / QUESTION CORNER N ewsletter
2016 Vol. 2 4 / 3

NEWS
Benefits of daily aspirin outweigh risk to stomach
Stomach bleeds caused by aspirin are considerably less serious than the spontaneous bleeds that
can occur in people not taking the drug, concludes a study led by Cardiff University. Published
in the journal Public Library of Science, the extensive study of literature on aspirin reveals that
while regular use of the drug increases the risk of stomach bleeds by about a half, there is no valid
evidence that any of these bleeds are fatal.

Professor Peter Elwood from Cardiff University’s School of Medicine said: “Although many people
use aspirin daily to reduce the risk of health problems such as cancer and heart disease, the wider
use of the drug is severely limited because of the side effect of bleeding from the stomach. With
our study showing that there is no increased risk of death from stomach bleeding in people who
take regular aspirin, we hope there will be better confidence in the drug and wider use of it by
older people, leading to important reductions in deaths and disablement from heart disease and
cancer across the community.”

Heart disease and cancer are the leading causes of death and disability across the world, and
research has shown that a small daily dose of aspirin can reduce the occurrence of both diseases
by around 20-30%.

Recent research has also shown that low-doses of aspirin given to patients with cancer, alongside
chemotherapy and/or radiotherapy, is an effective additional treatment, reducing the deaths of
patients with bowel, and possibly other cancers, by a further 15%.

The study ‘Systematic review and meta-analysis of randomised trials to ascertain fatal gastrointestinal
bleeding events attributable to preventive low-dose aspirin: No evidence of increased risk’ can be
found in Public Library of Science.

This study was a systematic review and meta-analysis of randomised trials. This type of research
provides the strongest evidence for drawing causal conclusions because it draws together all of
the best evidence.
Elwood PC, Morgan G, Galante J, Chia JWK, Dolwani S, Graziano JM, et al. Systematic Review and Meta-Analysis of
Randomised Trials to Ascertain Fatal Gastrointestinal Bleeding Events Attributable to Preventive Low-Dose Aspirin: No
Evidence of Increased Risk. PLoS ONE 11(11): e0166166. doi: 10.1371/journal.pone.0166166

QUESTION CORNER
Question: My 12-year-old child who is autistic with irritability disorder was prescribed Risperidone
2 mg tablets with direction to take ¼ tablet every day. After few days, she started frequent urination
without control. Examination of the urine sample did not show any sign of urinary infection. When
we checked in google, this drug is likely to cause urinary incontinence. Then why this medicine
was prescribed to my child if it is known to cause this adverse drug reaction?

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Answer: Risperidone is an antipsychotic drug, which may be prescribed for autistic irritability
disorder, Bipolar disorder or schizophrenia. The dose prescribed is within the normal range, 0.5-3
mg/ day and if ¼ tablet is taken, it is 0.5 mg, which is the lower range.

The whole objective of our Pharmacovigilance mission is to make awareness about adverse drug
reactions and side effects to the health care professionals, patients and the caregivers. No drug is
inherently safe, unless there is no active ingredient present in the drug, which makes it safe, though
the severity of reactions may vary. Depending on the seriousness and severity of reactions, a
prescriber may decide to continue or discontinue the drug. Some reactions are preventable while
some are not. Usually those drugs, which would result in allergic manifestations like, mild to severe
rashes of different types, bronchospasm, hypotension, etc., are stopped immediately and reported
to the hospital, if a patient develop these reactions after drug use.

Urinary incontinence is a reported reaction of Risperidone, which is rare which can occur in 1% of
patients, the information about this is available in the leaflet of the product. The decision to stop
the drug if this reaction occur is purely dependent on considering the benefit/risk analysis case
by case. The urine culture is indicated to rule out other causes of urinary incontinence. Other
related possible adverse reactions following use of Risperidone are hemorrhagic cystitis, urinary
tract infectious disease. Discontinuation of the drug will resolve the problem in most of the cases.

This is a typical example of awareness about adverse reactions among patients and health care
professionals and reporting them.

DGPA&DC Circulars:
A summary of the various circulars issued by DGPA&DC during the 3rd & 4th Quarters of 2016 are
mentioned below:

1. Circular 29/2016 dated 04/07/2016 http://www.ema.europa.eu/ema/index.

j s p ? c u r l = p a g e s /n e w s _ a n d _ e v e n t s /
Sub: Recall of youth Royal honey
n e w s / 2 0 1 6 /0 7/n e w s d e t a i l _ 0 0 2 5 6 8 .
2. Circular 30/2016 dated 17/07/2016 jsp&mid=WC0b01ac058004d5c1

Sub: New Safety Labeling Changes for
Zithromax (Azithromycin)
http://www.fda.gov/safety/medwatch/
safetyinformation/ucm225814.htm
4. Circular 32/2016 dated 03/08/2016
Sub: Loric 300mg Tablets (Allopurinol) –
Recall of Batches: 5AB002A & 5AB012A;
Mfr. Oman Pharmaceutical Products.

3. Circular 31/2016 dated 26/07/2016 5. Circular 33/2016 dated 07/08/2016

Su0b: Zydelig (idelalisib) updated Sub: 12th Annual Workshop on Good

recommendation for use Pharmacy Practice; 22nd December 2016

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DGPA&DC CIRCULARS
6. Circular 34/2016 dated 10/08/2016
Sub: Fluoroquinolone antibacterial drugs for
systemic use: Drug Safety communication
– Warning updated due to disabling side
effects.
h t t p : // w w w . f d a . g o v / S a f e t y /
M e d Wa t c h /S a f e t y I n f o r m a t i o n /
SafetyAlertsforHumanMedicalProducts/
ucm513065.htm
7. Circular 35/2016 dated 23/08/2016
Sub: ADR Quarterly Report for January to
March 2016
8. Circular 36/2016 dated 04/09/2016
Sub: Updation of the Pharmaceutical
Registration Process
9. Circular 37/2016 dated 05/09/2016
Sub: Guide to Management of Narcotics
& Psychotropic Substances in Health
Institutions and Pharmaceutical
Establishments
10. Circular 38/2016 dated 06/09/2016
Sub: Kogenate 250 IU, 2.5ml – Recall of
specific batches; Mfr. Bayer Pharma AG,
Germany
11. Circular 39/2016 dated 08/09/2016
Sub: Transportation of Medicines
12. Circular 40/2016 dated 18/09/2016
Sub: US FDA’s final rule on Safety and
Effectiveness of Antibacterial Soaps
h t t p : // w w w . f d a . g o v / n e w s e v e n t s /
n ews ro o m /p re s s a n n o u n ce m e n t s /
ucm517478.htm
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13. Circular 41/2016 dated 18/09/2016
Sub: US FDA’s Drug Safety communication
about Opioid Pain or Cough Medicines
combined with Benzodiazepines
http://www.fda.gov/drugs/drugsafety/
ucm518473.htm
14. Circular 42/2016 dated 04/10/2016
Sub: Bioequivalence Study Requirements
15. Circular 43/2016 dated 05/10/2016
Sub: Patient Information Booklet & Guide
for Healthcare Professionals for Depakine
(Valproate)
16. Circular 44/2016 dated 16/10/2016
Sub: Second Quarter ADR Report for April
to June 2016
17. Circular 45/2016 dated 18/10/2016
Sub: FDA Drug Safety Communication:
FDA warns about the risk of hepatitis B
reactivating in some patients treated with
direct-acting antivirals for hepatitis C
http://www.fda.gov/drugs/drugsafety/
ucm522932.htm
18. Circular 46/2016 dated 18/10/2016
Sub: GlucaGen Hypokit (glucagon ]rDNA
origin[ for injection) by Novo Nordisk Inc:
Recall – Detached Needles on Syringe
h t t p : // w w w . f d a . g o v / s a f e t y /
m e d w a t c h /s a f e t y i n f o r m a t i o n /
safetyalertsforhumanmedicalproducts/
ucm519907.htm
19. Circular 47/2016 dated 18/10/2016
Sub: 12th Annual Workshop on Good
Pharmacy Practice
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20. Circular 48/2016 dated 30/10/2016 http://www.ema.europa.eu/ema/index.

j s p ? c u r l = p a g e s /n e w s _ a n d _ e v e n t s /
Sub: EMA recommends measures to ensure
n e w s / 2 0 1 6 / 1 0 /n e w s d e t a i l _ 0 0 2 6 2 0 .
safe use of Keppra Oral Solution; Medicine
jsp&mid=WC0b01ac058004d5c1
should only be used with dosing syringe
included in the package. 22. Circular 50/2016 dated 22/11/2016

http://www.ema.europa.eu/ema/index. Sub: Testosterone and Other Anabolic

j s p ? c u r l = p a g e s /n e w s _ a n d _ e v e n t s / Androgenic Steroids (AAS): FDA Statement
n e w s / 2 0 1 6 / 1 0 /n e w s d e t a i l _ 0 0 2 6 2 2 . – Risks Associated with Abuse and
jsp&mid=WC0b01ac058004d5c1 Dependence.

21. Circular 49/2016 dated 30/10/2016 h t t p : // w w w . f d a . g o v / s a f e t y /

m e d w a t c h /s a f e t y i n f o r m a t i o n /
Sub: Use of metformin to treat diabetes
safetyalertsforhumanmedicalproducts/
now expanded to patients with moderately
ucm526151.htm
reduced kidney function; Recommendation
for patients with kidney impairment
updated in product information

DGPA&DC Activities:
1. 39th Annual Meeting of Representatives of National Pharmacovigilance Centers
(NPVC) participating in the WHO Programme for International Drug Monitoring.

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H.E. Dr. Ahmed Mohammed Al Saidi, Minister of Health inaugurated the meeting on Monday the
14th November 2016, hosted by the Ministry of Health, Oman at the Grand Millennium Hotel. The
opening ceremony was attended by invited dignitaries from the Ministry of Health Oman apart
from the registered participants for the meeting.

Dr. Mohammed Hamdan Al Rubaie, Director General

of Pharmaceutical Affairs & Drug Control (DGPA&DC),
welcomed the gathering. In his address he pointed out
that spontaneous reporting of adverse drug reaction
(ADRs) is the corner stone of Pharmacovigilance (PV)
and that there are several challenges in the medical
sector and public health systems that intensified the
need for Pharmacovigilance, such as medicines coming
from countries where regulatory standards may not be
very strong, and increasing dependence of people on
online platforms for medical guidance, self-medication, and counterfeit medicines.

Regional Director of the WHO Eastern Mediterranean Region, Dr. Ala Alwan, in his speech during
the opening ceremony stated that this global programme aims to enhance patient safety in relation
to the use of medical products, also it aids to support
public health programmes by providing reliable,
balanced information for the effective assessment of
the risk–benefit profile of medicinal products.

Ph. Hussain Al Ramimmy, Director of Pharmacovigilance

& Drug Information Department delivered a vivid
presentation which highlighted the status of
Pharmacovigilance in the Sultanate, the milestones
with regard to the establishment of the National

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Pharmacovigilance Center, the Sultanate’s Membership in the WHO programme for International
Drug monitoring, and the future plans.

At the end of the opening ceremony, the minister launched the accompanying Exhibition that
included number of educational posters on Pharmacovigilance put up by the participants. There
were 4 posters put up by the Oman PV Department.

Around 250 participants representing 60 countries of the WHO pharmacovigilance network took
part in the 39th annual meeting. The meeting began with the report from the 38th annual meeting
in New Delhi, India by Dr Shanthi Pal, Group Lead: Medicines Safety, Safety & Vigilance Department
of Essential Medicines and Health Products WHO, Geneva. She reviewed the 38th NPVC meeting
recommendations that was held last year in New Delhi, and touched upon the progress made. The
4-day meeting included eight working groups that discussed various issues of current concerns in
PV. Working groups addressed regional challenges on PV and defined the PV research priorities.

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The groups also discussed the PV communication campaigns and how to measure its impact,
what people want from PV, what to teach in PV to beginners, and solutions to improve approaches
and enhance consumer reporting.

The Problems of Current interest (POCI) were spread in the afternoon session in the first 2 days
with short presentations from selected participants, which had 3 presentations from Oman. Other
deliberations worth mentioning were Pregnancy & Pharmacovigilance: Needs, inventory and toolkit,
harmonizing multiple vigilance systems, safety monitoring in seasonal malaria chemoprevention,
adverse event identification through social media etc.

The meeting came to a close on the 17th November afternoon by closing remarks by the DG,
DGPA&DC and Clive Ondari, Coordinator Medicines Access and Rational Use, WHO Geneva. The
announcement about the 40th annual meeting to be conducted in Kampala, Uganda was made
by the representative from National centre in Uganda, with a video clip on the flora and fauna of
Uganda.

It was a great privilege and honour for Oman to host the 39th Annual Meeting in Muscat (the
first country in the GCC to host this important event), under the auspices of the H.E. Dr. Ahmed
Mohammed Obaid Al Saidi the Minister of Health.

2. The Intercountry (Good Governance of Medicine) GGM meeting of Eastern

Mediterranean Region held in Cairo, 25 – 27 November 2016
WHO EMRO Office organized and conducted an intercountry meeting of GGM for the countries
who reached Phase II to refresh, exchange the information and to plan for the next step which will
be Phase III (Implementation and monitoring).

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GGM groups from 9 countries in the region attended the meeting including Oman which was
represented by 5 delegates from DGPA&DC, Directorate General of Medical Supplies (DGMS) &
Sultan Qaboos University Hospital (SQUH). The team was headed by Dr. Mohammed Hamdan
Al-Rubaie, Director General of Pharmaceutical Affairs & Drug Control. The other members from
Oman included Ph. Hussain Al Ramimmy, Director of Pharmacovigilance & Drug Information (Oman
GGM Task force Member) and Ph. Abdel Galeel Yousif Ishaq, Head of Coordination and Follow up
(Member & Secretary to the GGM Task force Group), from DGPA&DC, Ph. Sara Al Balushi from
DGMS, Member of Task force group and Ph. Essa Al Rashdi from SQUH.

During the three days meeting, the group gave a presentation showing Oman GGM status, which
has finished the 2nd phase by preparing Oman GGM document. The document was sent to WHO
for revision and finally approved by the Steering Committee which is chaired by H.E. the Minister.

By the end of the meeting, Oman team was also able to furnish and present the plan of action for
Phase III that will start by dissemination of the document (Oman GGM document) before starting
the other activities e.g. Training of Trainers Workshop, Workshops to raise the awareness of all
concerns, public campaign etc. within the defined timeframe.

3. WHO - 9th INTERNATIONAL REGULATORY COOPERATION FOR HERBAL

MEDICINES CONFERENCE, NEW DELHI, INDIA: 8th -10th NOVEMBER 2016.
The ‘International Regulatory
Cooperation for Herbal Medicines’
(IRCH) is a collaborative workspace of
the WHO Traditional /Herbal Medicine
Programme. It is a global network of
regulatory authorities responsible
for regulation of herbal medicines,
whose function are information
sharing, research, standard setting
and regulatory harmonization, which
govern the safety, quality and efficacy
of herbal medicines of member
countries .

Delegates from DGPA&DC, Ministry of Health attended the conference, on the first day, Ph. Amani
Salim Al Siyabi (Section Head of registration of Herbal Medicine & Health Products) presented the
progress report on Herbal Drug Regulation initiatives by DGPA&DC, MOH, Oman. The presentation
focused on the following: (i) the introduction of ‘Herbal Medicine Monograph’ (M.H.Om) Vol-1; the
objective of the (M.H.Om) is to provide an unbiased public standard to Scientists, Governments,
Manufacturers, and others in order to judge the quality, safety and efficacy of herbals and their
products, including herbal supplements (ii) the installation of databases on the adulteration /
counterfeited slimming , virility, whitening, and bodybuilding products on the Ministry of Health
website and (iii) the initiation of Herbovigilance section under the main roof of Pharmacovigilance
department
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4. WHO aim to develop a pharmacovigilance core curriculum for undergraduate

medical and pharmacy students
The Programme for International Drug
Monitoring at the WHO, Netherlands
Pharmacovigilance Centre Lareb
and the WHO Collaborating center
in the field of Pharmacovigilance
in Education, held a meeting in
Netherlands during the period 29 –
30 September 2016, with the aim to
develop a pharmacovigilance core
curriculum that can be used worldwide
in teaching undergraduate medical-
and pharmacy students about pharmacovigilance. DGPA&DC represented by Ph. Hussain Al
Ramimmy participated in the meeting.

5. Ministry of Health become a member of the Asian Harmonization Working

Party (AHWP)
The Sultanate of Oman, represented by Ministry of Health, Directorate General of Pharmaceutical
Affairs and Drug Control (DGPA&DC) has recently joined the Asian Harmonization Working Party
(AHWP). AHWP is established as a non-profit organization. Its goals are to study and recommend
ways to harmonize medical device regulations in the Asian and other regions and to work in
coordination with the Global Harmonization Task Force, Asia-Pacific Economic Cooperation
and other related international organizations aiming at establishing harmonized requirements,
procedures and standards. The Sultanate membership was accepted during the 21st Annual
meeting of the Working Party in Cebu, Philippines (21 -25th November 2016).

Dr. Mohammed Hamdan Al Rubaie, Director General of DGPA&DC, who attended the meeting,
stated that this step cope up with
the Ministry’s continuous approaches
to have links with regional and
international organizations in the health
sector. In addition, it will enhance the
Ministry of Health’s initiatives to better
regulate and control medical devices
and equipment market.

Engineer Faiza Al Zadjali, Director

of Medical Devices & Equipment
Department, who also attended the
meeting stated that joining AHWP

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would enable the international presence of the Sultanate in this field and contribute towards its
active participation in different technical groups, responsible for setting the necessary regulation
and guidelines for the control of medical devices and equipment, harmonization of the quality
requirements and post marketing surveillance.

6. A visit to Oman Animal & Plant Genetic Resources Center (OAPGRC)

In order to facilitate a coordination dialogue platform for making improved public awareness on
traditional / herbal medicines and their interactions with drugs, food and diseases, delegates
from DGPA&DC, Ministry of Health visited The Oman Animal and Plant Genetic Resource Center
(OAPGRC) on 28th November 2016. The OAPGRC, which is affiliated to Oman Research Council,
has been involved in making action plans for the conservation and maintenance of Oman’s genetic
resources like animals, medicinal plants, marine species, and microorganisms as a natural heritage
resource.

During the dialogue session Dr. Nadiya A. Al-Saady (Executive Director OAPGRC), Dr. Ali
Al-Lawati (Plant Genetic Resources Expert) and Dr. Hameed Al- Ghafaji (Expert of Genetic
Resources, Policies and Data Analysis) expressed their wish for sharing of information on traditional
medicines and Oman traditional knowledge database.

Editorial Board:
Chairperson : Dr. Mohammed Hamdan Al Rubaie
Members : Ph. Ahmed Al Harbi, Dr. Nabila Jawad Al Lawati, Ph. Hussain Al Ramimmy,
Prof. Mohamed Osama Abdelrahman, Dr. Shirley S. Varghese & Dr. Madhu.C.Divakar
Secretary/Coordinator : Ph. Imad Eldin Mohamed Nour, Mr. R. Nambiar

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DIRECTORATE GENERAL OF PHARMACEUTICAL AFFAIRS & DRUG CONTROL
P.O. Box 393, Muscat, PC 100, Sultanate of Oman – Tel: 24602177 Fax: 24602287
Email: mohphar@omantel.net.om website: www.moh.gov.om