HAAD
UPDATES Issue: #1 | April 2013 | Newsletter
Review of “alleged natural” Male Sexual Enhancers Available in the UAE Market... cont. pg 5 Review of “alleged natural” Male Sexual Enhancers Available in the UAE Market... cont. pg 5 Review of “alleged natural” Male Sexual Enhancers Available in the UAE Market... cont. pg 5
From the Editorial Editor XXXXXXX XXXXXX Sub Editor XXXXXXXX Contributers XXXXXXX XXXXXX Ghraphic Designer Vpin Maysaa Ahmed Mareena Khawar
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We are delighted to bring you the first issue of Yadi, Mafraq Hospital’s health and lifestyle magazine to help you live well and keep you current on health related issues affecting the country and the region. Mafraq Hospital’s healthcare professionals serve up their insights and advice in each issue to help you understand, come to terms with, try to prevent, or help ease a number of serious medical conditions that affect the UAE community.
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About HAAD Contents
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The Health Authority – Abu Dhabi (HAAD) is the regulative body of the Healthcare Sector in the Emirate of Abu Dhabi and ensures excellence in Healthcare for the community by monitoring the health status of the population. HAAD defines the strategy for the health system, monitors and analyses the health status of the population and performance of the system. In addition HAAD shapes the regulatory framework for the health system, inspects against regulations, enforce standards, and encourages adoption of world – class best practices and performance targets by all healthcare service providers in the Emirate. HAAD also drives programs to increase awareness and adoption of healthy living standards among the residents of the Emirate of Abu Dhabi in addition to regulating scope of services, premiums and reimbursement rates of the health system in the Emirate of Abu Dhabi.
Safety Review of “alleged natural” Male Sexual Enhancers that are Available in the UAE Market: A Medication Safety Project. Physicians’ Perception of Drug Information Resources in the Emirate of Abu Dhabi- UAE Survey of Package Inserts in the Emirate of Abu Dhabi
Evawluation of pharmaceutical drug information brochures in the Emirate of Abu Dhabi Evawluation of pharmaceutical drug information brochures in the Emirate of Abu Dhabi
Safety Review of “alleged natural� Male Sexual Enhancers that are Available in the UAE Market: A Medication Safety Project. In the United Arab Emirates, dietary supplements and herbal products are obtained from different parts of the world, such as, the United States, Europe or Asia, the majority are from china. They can be purchased from supermarkets, nutrition shops at the malls, salesmen, and many of these products can also be purchased through the internet. One of the important priorities for HAAD is to improve the public health and prevents unnecessary harm due to the use of inappropriate or adulterated health products in the Emirate of Abu Dhabi. As part of HAAD, the Poison and Drug Information Center’s mission is to provide appropriate information for both the healthcare professionals and the public on the safe use of medicine and herbal products. Therefore, we sought to screen products that were confiscated by Department of Municipal Affairs which are available in the market and are used as sexual enhancers for the safety of ingredients, appropriateness of label and request for laboratory analysis when necessary. Products that are promoted and sold for sexual enhancement which were collected by the inspectors from the Department of Municipal Affairs from different shops and supermarket were investigated against HAAD predefined criteria for general sales products. Checking the collected products against the predefined list of criteria for a general sale item showed that the label, in most of the products, does not contain helpful information in regards to the: ingredients, concentration or safety parameters (table 1 & table 2)
Listing of active ingredients on products
No.of products
%
Active ingredients listed in English
27
26.7%
Active listed
not
36
35.6%
Active ingredients listed in languages other than Arabic or English
25
24.7%
Active ingredients are listed in Arabic or English but contain unusual ingredients
13
13%
Total Number of Products
101
ingredients
Table1. Label information in regards to the ingredients.
Concentration of Active Ingredients
Clearly written
Not mentioned
Number of the Products( Per)cent
)7%( 7
)93%( 94
Medical claims were identified in 49 (49%) products and in many cases one product may have more than one medical claim.
There are only 11 products (11%) mention safety information such as cautions and contraindications, but none of the products provide information on adverse effects, when to stop using the product or what to do in case of overdose, 32 (32%) of the products are written in a foreign language and the rest of the products have no mention for safety parameters (Graph 2).
Based on the criteria for the completeness of label information in regards to the ingredients; the majority of the products (73%) should be rejected as food supplements for the following reasons:
Distribution of Ingredients in Tainted Products
Presence of written Safety Parameters on Sexual Enhancement Products 11%
10% 57%
Analogue of sildenafil
32%
Analogue of tadalafil
22% 61%
Tadalafil
7% Present
Foreign language
Sildenafil
Not mentioned
• Active were absent
ingredients
• Label information was not written in Arabic or English but other foreign languages such as Chinese • And finally if they were listed in Arabic they are fictitious terms that can’t be true.
In regards to the quality of the products from physical appearance, such as leaking or presence of stains; none of the products had an obvious defect. The distribution of ingredients in these tainted products was mostly analogues to sildenafil or tadalafil which were not tested on human (Graph 3)
For instance, in one of the products to impress the consumer, it gave a false but an absurd term for one of the ingredients “sildenafilum” which is obviously derived from the name of one of the approved erectile dysfunction treatment, sildenafil, however, the suffex “um” is added to sildenafil to imply that it is a herb name in Latin, which of course, is not true.
Furthermore, some of these ingredients were present in concentrations that exceed the usual dose in the registered POM such as Viagra® and Cialis®, for instance VigRx® which is adulterated with sildenafil contains 140 mg which is 40 – 460% more than the normal dose range (25 - 100mg), in total there are 15 products fit in this category.
The fictitious terms amongst all the ingredients that were written in Arabic include but not restricted to; Camel’s horn extract, Jinnee’s tail extract, Donkey’s genital, turtle’s shell and yak’s testicles.
Physicians’ Perception of Drug Information Resources in the Emirate of Abu Dhabi- UAE
Physicians’ globally use different sources when searching for drug information including journal articles, pharmaceutical manufacturers’ literature and representatives, physician colleagues , medical textbooks, newsletters, and pharmacists. Preference for different resources varies depending on the country or region the physician received his diploma and training. In the Emirate of Abu Dhabi, there is a diverse group of physicians from different countries. We wanted to see if preferences for different resources from such a diverse group of physicians were any different than what was observed in other studies. The purpose of the study was to determine physicians’ preferences for different drug information resources in the United Arab Emirates. A questionnaire survey to determine preferences for different drug information resources was created and sent electronically from April 1 to May 13, 2012. A total of 3463 licensed physicians were identified from a comprehensive list of healthcare professionals provided by the Health Authority-Abu Dhabi Licensing Department. A total of 431 started the survey but only 372 physicians completed it entirely. Issue#1 | HAAD
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Continuing medical education (46%) was ranked as the most favored source of information, followed by drug information references (28%), diagnosis/patient information (20%), and lastly peer-to-peer interactions (7%). Online sources of drug information were preferable (74%) to hardcopy (26%). A comparison of different physicians’ qualifications (consultant, specialist, and general practitioner) and number of references utilized for a particular topic (up to 3 resources versus 3 references or more) showed that their differences were statistically significant (pvalue = 0.000). The most utilized sources of drug information by physicians was the British National Formulary (BNF), followed by Package Inserts, UpToDate, Drugs in Pregnancy & Lactation, Physicians’ Desk Reference, and Micromedex. When asked which drug information resource they would like to have access to, the majority of physicians choose the BNF, followed by UpToDate, MD Consult, Drugs in Pregnancy & Lactation, Micromedex, and Drugs Facts & Comparisons. Physicians from Europe/USA/Australia spent less time utilizing drug information resources (p-value of 0.013) compared to other nationalities.
Graph 2: Percentage of drug resources physicians would like to access
1. Description
8. Clinical Pharmacology
2. Indications
9. Dosage
3. Administration
10. Contraindications
4. Side effects
11. Drug interactions
5. Pregnancy
12. Lactation
6. Warnings
13. Precautions
7. Over dosage
14. Storage conditions
Table 2 Package inserts Safety Criteria by MOH INDA
This survey showed that although the physician population can be described as a mix of different approaches to medicine, there are surprising few differences with regard to preferences and utilization of drug information resources. Continuing medical education requirements, availability of online versus hardcopy resources, access to some resources, and usage of the drug information center will continue to drive drug information utilization practices. As a health regulator, the Health Authority – Abu Dhabi can ensure that physicians are aware of the full extent of resources available to them at the HAAD Poison & Drug Information Center, as well as stock the most widely used.It has long
Survey of Package Inserts in the Emirate of Abu Dhabi been established that package inserts (PIs) (also referred to as product information, prescribing information, or Physicians’ Desk Reference [PDR] listing) are one of the most frequently used sources of drug information by healthcare professionals. Having reliable and complete information in package inserts is essential for effective and safe use of medications. Low quality and incomplete information could have potentially negative impact on patient healthcare. The objective of this study was to examine if package inserts (PIs) supplied with prescribed medications in the Emirate of Abu Dhabi contain all relevant information to the safe and appropriate use of these medications. The package inserts were evaluated using the MOH INDA requirements for the minimum information necessary to be contained in package inserts. Evaluatiwon was based on whether they contained the headings required per the INDA criteria for 14 clinically important parameters (Table 2). Compliance was defined as meeting all 14 of the requirements. Analyzed PIs showed many deficiencies with regard to the MOH INDA requirements. Particularly of concern were side effects, warnings, use in pregnancy, lactation, and the storage conditions for the product.
Evaluation of pharmaceutical drug information brochures in the Emirate of Abu Dhabi A major marketing tool used by pharmaceutical companies in the Emirate of Abu Dhabi in the United Arab Emirates is direct-to-healthcare professional marketing utilizing promotional drug information brochures. Random observation of drug information brochures has often shown deficiencies with regards to important patient parameters such adverse events and/or warnings. Since the problem was observed anecdotally and the problem has been shown to exist in other countries, we wanted to see the full extent of the problem in the Emirate of Abu Dhabi. The objective of the study was to investigate whether the information in promotional brochures presented to healthcare professionals in the Emirate of Abu Dhabi by pharmaceutical representatives complied with the US Food and Drug Administration (FDA) criteria for brochures. The Health Authority –Abu Dhabi Poison & Drug Information Center evaluated these brochures from July to November 2010 using FDA criteria based on accuracy, balance of risk and benefits, prescribing information consistency, and whether the information was supported by strong clinical studies. Some 117 brochures for prescription-only medications were screened. Each brochure was evaluated using a modified version of the basic US Food and Drug Administration (FDA) 28 brochure evaluation criteria for healthcare professionals (Table 1). FDA did not provide rationale for the use of the criteria, but we chose it for this study because it is thorough and lends well to screening. The main difference between the FDA criteria and the one used in our study was that in some cases the product was not FDA approved and, hence, required comparison with the prescribing information from the country of origin. Evaluation was based on a scoring system to allow quantification of the results. Each criterion was assigned either a passing score of “1” or “0” if the information did not fully meet the criteria definition. The scores were summed for the four criterions and given a number from 0 to 4. Scoring was based on a Pass (score of 4) or Fail (score of 3 or less).
Table 1. Brochure Evaluation Criteria
Listing of active ingredients on products
No.of products
%
Active ingredients listed in English
27
26.7%
Active listed
not
36
35.6%
Active ingredients listed in languages other than Arabic or English
25
24.7%
Active ingredients are listed in Arabic or English but contain unusual ingredients
13
13%
Total Number of Products
101
ingredients
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