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Adverse Drug Reaction
 

Pharmacists in organized health care systems should develop comprehensive, ongoing programs for reporting and monitoring of adverse drug reactions (ADRs). It is the pharmacists’ responsibilities and professional obligation to report any suspected ADRs. Being a frequent consequence of medications administrations, ADRs must always be suspected and effective measures should be practiced each time a high risk medication or a high risk patient is encountered. All medications, including the excipients of a product, are capable of producing adverse effects. ADR’s are estimated to account for 8-15 % of all hospital admissions leading to increased morbidity and mortality (Classen et al, 1996).

               

Our adverse drug reaction and monitoring program is under the direct supervision of the CDPIC and is responsible for encouraging ADRs reporting, ADRs surveillance, facilitating ADRs documentation, promoting the reporting process of ADRs, providing a mechanism for monitoring the safety of the drug use in high risk patients populations and stimulate the education of health care professionals from all practices regarding the potential ADRs and how to treat/prevent them.

               

The results of our Adverse drug reaction reporting and monitoring program will be a key factor in making effective therapeutic and administrative decisions regarding the medications use processes in MSD hospitals and peripheral clinics. Furthermore, the results and findings of the program will be an effective educational material for all disciplines coming in contact with different kinds of medications. Our publications "ADR Monitor" link, go to education and training page, will summarize the findings from our program and will highlight some of the reported and announced ADRs from world health agencies “e.g.: FDA, WHO, EMA…etc” as well as news and medias.

How to define ADRs?

        The American Society of Health System Pharmacist ASHP defines a significant ADR as any unexpected, unintended, undesired, or excessive response to a drug that
   1. Requires discontinuing the drug (therapeutic or diagnostic),
   2. Requires changing the drug therapy,
   3. Requires modifying the dose (except for minor dosage)
   4. adjustments,
   5. Necessitates admission to a hospital,
   6. Prolongs stay in a health care facility,
   7. Necessitates supportive treatment,
   8. Significantly complicates diagnosis,
   9. Negatively affects prognosis, or
   10. Results in temporary or permanent harm, disability, or
   11. Death.

             Our program utilizes Naranjo’s Algorithm for ADRs probability assessment. Diseases Classifications???

         The CDPIC is responsible also for liaison between MSD hospitals drug information centres as a feeding sources for the program as well as liaison with other national authorities “e.g.: SFDA” regarding the outcomes of the program.
PROVIDING POISONING INFORMATION SERVICE

        Poisonings are a major public health problem with a significant number of cases reported for admissions to Accidents and Emergencies (A/E) department each year. While these cases are patients of all age groups, the majority of victims are children under the age of five years. Pharmaceuticals, Over-The-Counter and prescription drugs account for the vast majority of poisoning fatalities and life threatening cases. Pharmacists are an integral link to poisonings because they serve as gatekeepers to the major substances involved in the poisoning and drug overdoses. Furthermore, they are often in direct contact with caregiver or potential victims themselves. 

        Poisoning Information services is one the services provided by our CDPIC for health care professionals and for the public. Our CDPIC is responsible for establishing effective guidelines as well as providing effective information regarding poisoning and overdoses of drugs, chemicals and herbal products. The centre’s goal is to ensure the availability of accurate, event-specific and most recent recommendations in a timely manner. Cases of public concerns and epidemiologic data about toxicological exposure are going to be raised through our publications “CDPIC Newsletter”. link  

        The Poisoning Information service will be covered around the clock during weekdays and weekends by specialist professionals. The service will assist MSD hospitals and peripheral clinics as well as the public in need. The service is provided free of charge and provided over the hotlines of the CDPIC. The numbers are toll free which can be reached from contact us page. You can contact us through emails and faxes as well. 

  Our resources include the followings: 
     1. Poisondex®.
     2. Tomes®: Toxicology Occupational Medicine and Environmental Series.
     3. Medical Toxicology: Diagnosis and Treatment of Human Poisoning.
     4. Gold frank’s Toxicologic Emergencies.
     5. Poisoning and Drug Overdose.
     6. Poisoning and Drug overdose Handbook.
     7. ToxPoints® System
     8. Material Safety Data Sheets (MSDS).

   Interesting Web sites: http://www.aapcc.org/findyourcenter.htm (mention all web sites).
EDUCATION AND TRAINING

       CDPIC is committed to provide training for pharmacy interns, staff pharmacist, residents, master students and PharmD students. The centre can accept trainees after proper arrangement and official written communications with the director of CDPIC. The time frame for the rotation varies according to the trainee as follow:
   • Pharmacy Interns: 2 weeks.
   • Staff Pharmacist (including OJT pharmacists): 4 weeks.
   • Residents: 5-8 weeks, depending on the program.
   • Master and PharmD students: According to arrangements with their advisors.

        The centre is heavily involved in the education processes for health care professionals and the public. Lectures, workshops, symposia, seminars….etc will be about interesting topics and going to be arranged for health care professionals through invitation of international and prestigious speakers besides drug manufacturing companies.

        Public topic days will be arranged on regular basis which will aim to promote awareness and education about medications and their respective diseases e.g.: Diabetes, Hypertension, and Asthma….etc. These days will include interactive sessions and proper training about how to use certain medications devices and how to maintain them e.g.: Inhalations devices and self-injection medications.

         Brochures and leaflets about medications will be generated from the CDPIC, mainly for public, and will focus on compliance issues regarding medications as well as providing effective and producing counselling about group of medications and what to report on the next visit to the clinician.
PUBLICATIONS
        
          The Centre’s main publication “CDPIC Newsletter” will focus on the attracting topics for health care professionals like the MSD Formulary updates, Pharmacy and Therapeutics Committee (P&T Committee) News, Health Agencies Releases (New Approvals, Withdrawals, Restrictions), Clinical Notes, Drug Information Issues and Frequently Asked Questions. The newsletter will be provided in two languages: English and Arabic and will be released quarterly/ bimonthly.
          The Official publication for the CDPIC’s Adverse Drug Reaction (ADR) reporting and monitoring program is the Adverse Drug Reaction Monitor “ADR Monitor”. The aim of this publication is to bring the serious and significant ADRs to the attention of the health care providers. ADR monitor will focus on increasing the awareness about ADRs and the reporting systems available at MSD hospitals. In addition, it will discuss the issues of effective measures on how to prevent ADRs or decrease their severity once unavoidable. The publications target audience will be the health care professionals and will be released quarterly in English language.

         Both publications, CDPIC Newsletter and ADR Monitor, can be accesses through the MSD’s CDPIC web site. Hard copies can be honoured after official written requests for inclusion into the Publications’ mailing list. Requests for inclusion should be forwarded to the director of CDPIC and should be signed by the organization’s head/ director.


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