Antibiotic prescribing for UTIs improves with

intervention

Around the world, health care professionals have cautioned that antimicrobial

resistance poses an immediate threat; meanwhile, the overuse and

overprescribing of antibiotics is contributing to the problem. Now, a new

initiative that aimed to improve prescribing of antibiotics for urinary tract

infections has proven effective, suggesting future interventions like this one

could be key. Overuse of antimicrobial therapy in the community adds to the

global spread of antimicrobial resistance, which is jeopardizing the treatment

of common infections.

According to the World Health Organization (WHO), there are high levels

of antibiotic resistance in bacteria that cause common infections -

including urinary tract infections (UTIs) - around the world. Because UTIs are

one of the most common afflictions that call for antibiotics, the researchers say

efforts to inhibit use needs multi-party involvement, one that incorporates

physicians, patients, pharmaceutical companies and policy makers.

'Improved prescribing must be put into context of its effect'

In total, 71 physicians from 30 general practices in Ireland participated in the

intervention - which aimed to change prescribing behavior for UTIs - and were

randomly assigned to one of three groups:

Group A: participated in a workshop on consultation coding for UTIs and one

on prescribing guidelines; received results of monthly follow-up audits

Group B: had the same as Group A, plus received additional evidence for

delayed prescribing

VOLUME 33 ISSUE 4

Medical News

––

October –December 2015

In this issue .. ..

Medical News ------------- 1

Pharmaceutical

Authorities News --------4

Medication Safety

Updates -------------------- 5

7 ---------------- الصفحة العربية

Scientific Books: New

Release -------------------- 8

College of Pharmacy

Drug and Poison Information Center

Now The bulletin is available online at: http://pharmacy.ksu.edu.sa/ar/pages/departments/dpic/

High frequency

stimulation in pain

medicine

Due to disease-related

changes in their brain,

pain patients often suffer

from an impaired tactile

ability in their hands. In

a pilot study conducted

by scientists high

frequency repetitive

stimulation was

investigated as a

therapeutic approach for

these patients. The

results of this study

show that passive

stimulation of this kind

is a promising new

therapy option.

Source: Sciencedaily.com

Drug & Poison

Information Center

BULLETIN

January – March 2009

Drug and Poison Information Bulletin 2

Medical News (cont..)

Group C: control group; only participated in the coding workshop

The researchers say their primary aim was to improve the quality of antimicrobial prescribing according to

guidelines, and results showed that patients whose doctors participated in group A or B were twice as likely to

receive a prescription for a first-line antibiotic, which was preferably nitrofurantoin.

Additionally, compared with the control group, overall prescribing of a first-line antibiotic increased by 24.5% in

group A and 18.4% in group B. Prescribing of nitrofurantoin increased by 38% in group A and 33% in group B, but

it remained stable in group C.

Use of nitrofurantoin may be less harmful than other antimicrobials; after more than 50 years of use worldwide,

there is little evidence of acquired resistance to nitrofurantoin, note the researchers, who say the potential negative

effect of increased use of antimicrobials may be mitigated by nitrofurantoin use. They say the change in prescribing

behavior that they observed remained 5 months after the intervention was finished and add:

"The improved quality of prescribing must be put into the context of its unintended effect, an increase in actual

antimicrobial prescriptions. Research has shown that the nature of complex systems, such as general practices, where

many interrelated factors influence antimicrobial prescribing, makes it difficult to predict the results of

interventions."

Fast facts about antimicrobial resistance

Antimicrobial resistance is an increasingly serious threat to global public health. Patients with infections by drug-

resistant bacteria are at increased risk of worse clinical outcomes and death. Such patients consume more health

care resources than patients infected with the same bacteria that are not resistant.

Additionally, they admit that delayed prescribing could only be identified indirectly and suggest that future studies

should include the option of recording a prescription as delayed in the patient management software. Finally, the

study's limited geographic range and the relatively small number of practices are areas of improvement for future

study.

"The reduction in repeat consultations (a proxy for treatment failure and thus antibiotic resistance) among patients

who received nitrofurantoin, but not in the intervention arms overall, suggests that improving adherence to

prescribing guidelines leads to better patient outcomes,"

Study limitations : Firstly, the observed increase in overall antimicrobial prescribing for UTIs was unexpected, and

author say it was not possible to determine whether this was "clinically appropriate or an unwanted consequence.

Source: Marie Ellis

Medical News (cont..)

FDA, ISMP issue warnings about Becton-Dickinson (BD) 3- and

5-milliliter syringes for compounded drug storage

The U.S. Food and Drug Administration (FDA) issued an alert to health care professionals, warning them to not

administer to patients compounded or repackaged drugs that have been stored in 3-milliliter or 5-milliliter syringes

manufactured by Becton-Dickinson (BD) unless there is no suitable alternative available.

The FDA states that preliminary information indicates that drugs stored in these syringes may lose potency over a

period of time because of a possible interaction with the rubber stopper in the syringe. BD’s 10-, 20- and 30-milliliter

syringes also may contain the same rubber stopper, and the company is alerting customers not to use those syringes

as a closed container system for compounded and repackaged drugs.

The FDA recommends hospital and pharmacy staff should check supply stocks and remove drug products that were

filled by pharmacies or outsourcing facilities and stored in general purpose BD 3- and 5-milliliter syringes. FDA

does not have information on how long drugs can be stored in these syringes before degrading.

The FDA is continuing to investigate this matter. Meanwhile, the Institute for Safe Medication Practices (ISMP)

recently published an article about these syringes and states hospitals should.

Try to limit drug exposure in plastic syringes by using them as promptly as possible after preparation in the

pharmacy. Make sure that clinical staff are aware of the situation and know to report unexpected changes in drug

effectiveness, such as a sudden loss of pain control, especially with infusions via a syringe pump.

Monitor patients for signs of decreased efficacy when administering drugs that have been stored in syringes, and use

caution when administering sequential doses to avoid a sudden increased effect that could occur when switching

from a syringe of medication stored for a period of time to a newly prepared syringe.

Assign staff to watch for new FDA, BD, ISMP, American Society of Health-System Pharmacists or other alerts.

Work with BD to understand whether any syringes in your health care institution belong to lots that are affected by

this issue. To check, contact the company at 201-847-4500.

Source : U.S. Food and Drug Administration

3 Drug and Poison Information Bulletin

Drug and Poison Information Bulletin

Pharmaceutical Authorities News

FDA Approves Nucala (mepolizumab) to Treat Severe

Asthma (November 4, 2015)

The U.S. Food and Drug Administration approved Nucala (mepolizumab) for use with other asthma medicines for

the maintenance treatment of asthma in patients age 12 years and older. Nucala is approved for patients who have a

history of severe asthma attacks (exacerbations) despite receiving their current asthma medicines.

The safety and efficacy of Nucala were established in three double-blind, randomized, placebo-controlled trials in

patients with severe asthma on currently available therapies. Nucala or a placebo was administered to patients every

four weeks as an add-on asthma treatment. Compared with placebo, patients with severe asthma receiving Nucala

had fewer exacerbations requiring hospitalization and/or emergency department visits, and a longer time to the first

exacerbation. In addition, patients with severe asthma receiving Nucala experienced greater reductions in their daily

maintenance oral corticosteroid dose, while maintaining asthma control compared with patients receiving placebo.

Treatment with mepolizumab did not result in a significant improvement in lung function, as measured by the volume

of air exhaled by patients in one second. The most common side effects of Nucala include headache, injection site

reactions (pain, redness, swelling, itching, or a burning feeling at the injection site), back pain, and weakness

(fatigue). Hypersensitivity reactions can occur within hours or days of being treated with Nucala, including swelling

of the face, mouth, and tongue; fainting, dizziness, or lightheadedness; hives; breathing problems and rash

Source: U.S. Food and Drug Administration

FDA Approves Genvoya (elvitegravir, cobicistat, emtricitabine,

and tenofovir alafenamide) for HIV

The U.S. Food and Drug Administration approved Genvoya (a fixed-dose combination tablet containing

elvitegravir, cobicistat, emtricitabine, and tenofovir alafenamide) as a complete regimen for the treatment of HIV-1

infection in adults and pediatric patients 12 years of age and older. Genvoya is approved for use in HIV-infected

adults and children ages 12 years and older weighing at least 35 kilograms (77 pounds) who have never taken HIV

therapy (treatment-naïve) and HIV-infected adults whose HIV-1 virus is currently suppressed. While Genvoya is

not recommended for patients with severe renal impairment, those with moderate renal impairment can take

Genvoya. Its safety and efficacy in adults were evaluated in 3,171 participants enrolled in four clinical trials.

Depending on the trial, participants were randomly assigned to receive Genvoya or another FDA approved HIV

treatment. Results showed Genvoya was effective in reducing viral loads and comparable to the other treatment

regimens

Genvoya carries a Boxed Warning alerting patients and health care providers that the drug can cause a buildup of

lactic acid in the blood and severe liver problems, both of which can be fatal. The Boxed Warning also states that

Genvoya is not approved to treat chronic hepatitis B virus infection. The most common side effect associated with

Genvoya is nausea. Serious side effects include new or worsening kidney problems, decreased bone mineral density,

fat redistribution and changes in the immune system (immune reconstitution syndrome).

Source: U.S. Food and Drug Administration

4 Drug and Poison Information Bulletin 4

Medication Safety Updates

Iodine-containing Contrast Agents for Medical Imaging: Drug

Safety Communication - Rare Cases of Underactive Thyroid in

Infants

ISSUE: FDA is advising that rare cases of underactive thyroid have been reported in infants following the use of

contrast media containing iodine, also called “contrast dye,” for X-rays and other medical imaging procedures. In

all of the reported cases, the infants were either premature or had other serious underlying medical conditions.

Available evidence leads FDA to believe that this rare occurrence is usually temporary and resolves without

treatment or any lasting effects. See the Drug Safety Communication for a data summary and a list of approved

Approved Iodinated Contrast Media Products.

FDA approved changes to the labels of all iodinated contrast media (ICM) products to include information about

these cases. No changes to current prescribing, administration, or monitoring practices are recommended. FDA will

continue to evaluate this issue and will update the public when there is additional information. Manufacturers of

ICM products have been required to conduct a study to investigate this safety issue further.

BACKGROUND: Iodinated contrast media are drugs containing iodine that are given to patients to enhance the

ability to see blood vessels and organs on medical images such as X-rays or computed tomography (CT) scans.

These images provide greater detail when necessary to help health care professionals diagnose potential problems.

RECOMMENDATION: Parents and caregivers should contact their baby’s health care professional for additional

information or if they have questions or concerns about their baby receiving an ICM product. Infants typically do

not show any visible signs of underactive thyroid. Health care professionals should continue to follow the label

recommendations for ICM products. They should continue to use their clinical judgment to determine if testing for

underactive thyroid is necessary.

Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of

these products to the FDA's Med Watch Safety Information and Adverse Event Reporting Program:

Source: U.S. Food and Drug Administration

5 Drug and Poison Information Bulletin

Medication Safety Updates

Similar Packaging of Metformin and Metoprolol

Similarly labeled medications increase the risk of a dispensing error

Medication name confusion and packaging/labeling confusion is relatively common cause of adverse events. A 2004

Journal of Medicine article reported that 25% of medication errors were related to name confusion and 33% were

related to packaging.

A community pharmacist recently shared the picture below with patient safety consultants at the Oregon Patient

Safety Commission to help increase awareness about similarly labeled medications. The two medications featured

are manufactured by Aurobindo Pharma USA and have almost identical labels.

Metformin is a medication used to treat diabetes and is on the Institute for Safe Medication Practices high alert

medication list. Metoprolol is a beta-blocker used to treat angina and hypertension; this medication is also used to

prevent heart attacks.

Sharing medication error-related experiences and case studies with colleagues through newsletters, journals,

bulletin boards, and the Internet.

Taking an active role in reviewing and commenting on proposed federal regulations (e.g., via Federal Register

notices and agency draft guidances) and United States Pharmacopeia standards (e.g., the USP Pharmacopeial

Forum) that relate to labeling and packaging of drug products. Collaboration among healthcare professionals,

healthcare organizations, patients and families/caregivers, the pharmaceutical industry, standard-setters, and

regulators to facilitate the design of drug product packaging and labeling to help minimize errors.

Source http://oregonpatientsafety.org/

6 Drug and Poison Information Bulletin

Healthcare facilities can report concerns with

pharmaceutical packaging to the Food and

Drug Administration’s MedWatch program,

and locally to Oregon’s Patient Safety

Reporting Program

The National Coordinating Council for

Medication Error Reporting and Prevention

also recommends the following strategies to

reduce errors associated with packaging:

العربية الصفحة

Drug and Poison Information Bulletin 7

" EASY Slim لغذاء والدواءالهيئة العامة ل " التنحيف حبوب من تحذر

11 / 10 /1437

االنترنت طريق عن تباع" مورينجا" مستحضرات من تحذر لغذاء والدواءالهيئة العامة ل

19/01/1437

األطفال عند النوم هرمون مستويات من يقلل قد الذكية األجهزة من المنبعث الضوء

............. من مستحضر على شكل كبسوالت يحمل اسم حذرت الهيئة العامة للغذاء والدواء جميع المستهلكين

تسوقه محال عطارة وبعض الباعة المتجولين ومواقع التواصل االجتماعي على أنه مستحضر طبيعي إلنقاص الوزن

وأوضحت "الغذاء والدواء" في بيان، أن والتنحيف، في حين أن هذا االدعاء مضلل وليس له أي أساس من الصحة.

مادة وهي للمستحضر، السيبوترامينالسيبوترامين ليل التي تمت في مختبرات الهيئة، أظهرت إضافة مادة التحا

ارتفاع في تتمثل لها خطيرة جانبية أعراض ووجود الصحة على وخطرها مأمونيتها ضمان لعدم محظورة دوائية

.والشرايين القلب بأمراض اإلصابة احتمالية

.

(Easy Slim)

)Sibutramine(

السالمونيال ببكتيرياحذرت الهيئة العامة للغذاء والدواء المستهلكين من مستحضرات مورينجا التي تسوق عن طريق االنترنت، بسبب تلوثها

وأوضحت الهيئة في بيان، أن مركز اإلنذار السريع للغذاء وإدارة األزمات بالهيئة، تلقى من نظام اإلنذار األوروبي السريع لألغذية ...................

.......واألعالف، معلومات عن قيام ألمانيا بسحب مستحضرات المورينجا التالية

وتاريخ انتهاء الصالحية .............................................. .... والشركة الصانعة..للتشغيلة رقم............................................................

، وذلك بسبب تلوثها ببكتيريا السالمونيال .................. وأشار نظام اإلنذار األوروبي إلى أن مستحضر كبسوالت المورينجا تلك تمم30/04/2017

تسويقها وبيعها عن طريق االنترنت لدول عدة من بينها المملكة العربية السعودية.

(Salmonella)

BIO Moringa Powder 150 gو ، BIO Moringa Powder 300 g

)ML01-2015( )Ramona Cosmaceuticals Pvt Ltd(

(Salmonella)

02-Sep-2015

سرتهم ة في أوصلت دراسة جديدة إلى سبب إضافي يدفع اآلباء لمنع أبنائهم من استخدام أجهزة الهواتف الذكية واألجهزة اللوحية والحواسب المحمول

عند األطفال، وهو الهرمون الذي melatoninليال، فقد تبين بأن الضوء الساطع المنبعث من هذه األجهزة قد يقلل من مستويات هرمون الميالتونين

ة لوبحسب الباحثين، فإن أثر هذه األجهزة كان أكثر وضوحا عند األطفال في بداية مرحلة البلوغ، حيث أدى استخدامهم لألجهزة المحمو يحفزهم للنوم.

في المائة في بعض الحاالت. 37إلى انخفاض مستوى الميالتونين بمعدل

في المائة من المراهقين يستخدمون جهازا تقنيا واحدا على األقل في الساعة التي تسبق ذهابهم إلى النوم. 96ين، فإن ما نسبته وبحسب الباحث

إن : "يةاألمريك آيالند رود بوالية براون بجامعة البشري والسلوك النفسي الطب أستاذة كارسكادون ماري الدكتورة للدراسة، المساعدة المعدة تقول

ة أطفالنا، وقاية ضرورة هي إيصالها نود التي الرسالة ض من المبكرة، المراهقة سن في وخاص رورة ض يعني ما وهو الليل، في األضواء إلى التعر

تؤثر قد ألنها النوم، موعد اقتراب مع الشاشات استخدام من أبناءهم اآلباء يمنع أن ".نومهم جودة في سلبا

ا مكارسكادون: "تقع الحساسية للضوء في قلب هذا التغير" وقد وضع فريق بحثها نظرية تقول بأن البلوغ يزيد من حساسية الطفل للضوء، تقول م

ر النوم. يجعل مستويات الميالتونين في حدودها الدنيا ويؤخ

جة لألجهزة الحديثة.ولكن الباحثين يشتبهون أيضا في أن هذه العملية الطبيعية قد تنهار تماما عندما يجلس الطفل الصغير أمام الشاشات المتوه

ض لإلضاءة الساطعة وانخفاض مستوى الميالتونين، ولكنها لم تثبت ذلك من خالل القة سبب ع من الجدير ذكره أن الدراسة وجدت ارتباطا بين التعر

ونتيجة.

نا وجدنا بأن اإلضاءة تؤثر بشكل كبير في النوم، ولكن ما وجدناه هو أن مستوى الميالتونين ينخفض بنتيجة تقول كارسكادون: "ال يمكننا القول بأن

رة من متعرض األطفال )الذين هم بعمر البلوغ( لإلضاءة في وقت النوم، وقد يؤثر ذلك في انتظام النوم لديهم بطريقة تدفعهم للسهر حتى ساعات تأخ

ا يفعل البالغون، وهي عادة سيئة للجميع".الليل، تماما كم

الهيئة العامة للغذاء والدواء المصدر:

BIO Moringa capsules 360Cap و ،

موسوعة الملك عبد هللا بن عبد العزيز العربية للمحتوى الصحي . المصدر:

Editor-in-chief:

Mohamed N. Al-Arifi, PhD

Professor of Clinical Pharmacy

Director of Drug & Poison Information Center

Editors:

Drug & Poison Information Specialist’s

Salmeen D Babelghaith, PhD

Syed Wajid Ali, M. Pharma,

Mohammed A. AL-Harbi, Higher Diploma.

Rayyan A AL-Mansour, Higher Diploma.

Address / Correspondence:

Drug & Poison Information Center, College of

Pharmacy, King Saud University. P.O. Box

2457 Riyadh 11451, Saudi Arabia. Tel:

4677352, 4677353, 4677354 Fax: 4676229

E-mail: malarifi@ksu.edu.sa

7th - 9th December 3rd International conference

on clinical pharmacy Clinical and Medical

Conferences at Virginia Avenue Atlanta, USA

in Atlanta, USA

20th - 21st January 2016 5th Annual

Pharmaceutical Microbiology Conference at

the Holiday Inn Kensington Forum in London,

United Kingdom

26th - 28th January 2016 Clinical Research and

Operations Worldwide Networking - CROWN

2016 at Philadelphia, United States

1st - 5th February 2016 Joint MHRA/DIA

Excellence in Pharmacovigilance at the Holiday

Inn Regent’s Park in London, United Kingdom

Upcoming Conferences

Canadian Pharmacy Exams - Pharmacist Evaluating Exam Practice 3rd Ed Nov 2015: Pharmacist

Evaluating Exam Practice - Volume 1 by Dr. Fatima S. Marankan (Author)

Canadian Pharmacy Exams -Pharmacist Evaluating Exam Practice is

designed as a self-study tool to help the student seeking pharmacy

licensure in Canada test his/her exam readiness, identify areas of

strength and weakness to optimize learning. The book is divided in four

key parts (see below) and contains over 600 exam-type questions and

answers developed to meet the Evaluating Exam learning objectives

including the new 2015 subject areas according to the Pharmacy

Examining Board of Canada (PEBC®): - 15% Biomedical Sciences -

25% Pharmaceutical Sciences - 50% Pharmacy Practice including the

new 2015 learning objectives - 10% Behavioural, Social and

Administrative Pharmacy Sciences All Canadian content including

pharmacy practice laws and regulations.

ISSN: 1319 – 4302 1319 – 4302: ردمد

Editorial Board

Scientific Books: New Release

Evidence-Based Practice for Infusion Therapy

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