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Julphar Pharmacovigilance Policy

Introduction:

The WHO defines pharmacovigilance as “the science and activities relating to the detection, monitoring, assessment, understanding and prevention of adverse effects or any other drug related problems”. The goal of pharmacovigilance is the safer use of medicines and this is usually achieved by dissemination of accurate, timely and clinically relevant information.  

Communicating the potential harm of drug-use to physicians and patients is a matter of high priority and Julphar will carry out the responsibility or dynamically participate in the process.  

Early detection of safety signals from clinical trials and postmarketing surveillance is necessary to identify the risks related with the products. Information collected during the pre-marketing phase of drug development might not detect rare Adverse Drug Reactions (ADRs). The use of a drug during a clinical trial is under controlled conditions, also, limited and selected numbers of patients are enrolled in the clinical trials. Drug use in special situations and population or drug interactions may not be studied. Therefore, the post-marketing surveillance of drugs is important.  

Spontaneous ADR reporting, during post-marketing surveillance, has shown to detect adverse event signals resulting from drug use in the population.  

The withdrawal from the market of certain medicines has focused attention on pharmacovigilance approaches, raised concerns about improving the existing pharmacovigilance structure; and highlighted the need to ensure consistency among regulations leading the reporting of side effects. 

Patient safety is the fundamental principle for Julphar, ahead of commercial or other interests. With this awareness, Julphar is involved in continuously monitoring unwanted effects and other safety aspects of drugs that are already in the market apart from being vigilant in pre-marketing monitoring. Julphar believes that proactive monitoring of the risks helps to place risk management plans throughout the life cycle of the product. 

Julphar’s Position:

Julphar is responsible for reporting suspected adverse reactions to the authorities of each country for medical products received from Health Care Professions (HCP) (includes but not limited to medical doctors, pharmacists, nurses, dentists, allied health professionals, midwives, caregivers etc). 

All the queries and product related complaints are addressed on priority basis. All employees of Julphar participating in the pharmacovigilance activities are trained, know their responsibility and are able to execute their duties.  

Julphar receives information on possible side effects of medicines from several sources including:

      ■  Unsolicited reports from HCPs and patients

      ■  Clinical trials and clinical trial investigators

      ■  Regulatory authorities

      ■  Medical and scientific literature

      ■  Newspapers and other media

It is Julphar policy that staff are required to report immediately any issues relating to the safety or quality of our medicines.  

Julphar’s Goals:

      ■  Incessant monitoring of the safety of Julphar products

      ■  Assessing the risks and benefits of all Julphar products

      ■  Providing information to users on safe and effective use of products.

      ■  Identification, quantification and improving understanding of previously unknown adverse drug reactions.

      ■  Identification of patients at particular risk of having an ADR.

      ■  Monitoring the impact of any action taken.

All suspected adverse reactions will be reported, especially those that are:

      ■  Unexpected, regardless of their severity, i.e. not consistent with product information or labeling; or

      ■  Serious, whether expected or not; or

      ■  Reactions to recently marketed drugs / medical products (being on the market for less than five years),

          regardless of their nature or severity.

Spontaneous reports of adverse reactions received from HCP will be reported by Julphar if:

      ■  The HCP has made a statement that a casual relationship between the event and the medicinal product is

          considered to be at least a reasonable possibility; or if

      ■  The HCP has not made any statement of the suspected casual relationship or has stated that the casual

          relationship is unknown; or if

      ■  Julphar considers that a casual relationship is at lease a reasonable possibility. 

If the HCP has made an explicit statement that a casual relationship between the medicinal product and reaction has been excluded and Julphar agrees with this, the event will not be reported. 

If Julphar is aware that a HCP has reported a reaction to one of its products directly to the authority, Julphar will still report the reaction, informing the authority that the report is likely to be a duplicate of a previous report. In this situation Julphar will provide all the available details including any registration number provided to the reporting health-care professional by the authority, in order to aid identification of the duplicate. 

Julphar will validate and follow-up all serious reactions reported by the HCP to the authorities. All available clinical information relevant to the evaluation of the reaction will be provided. Minimum information required will be included in the report

 (Form attached):

      ■  An identifiable HCP reporter, the reporter will be identified by name or initials, address or qualification. Contact details

          for a HCP will be available.

      ■  An identifiable patient, the patient will be identified by initials, patient number, date of birth, age, age group or sex.

          the information will be as complete as possible.

      ■  At least one suspected active substance/medicinal product

      ■  At least one suspected adverse reaction.

 Julphar’s Pharmacovigilance Monitoring System

All spontaneous adverse events of marketed products are collected via phone, email, fax or postal. All adverse events of investigational products are collected as per the Clinical Trial Protocol via above mentioned means.  

Adverse event reporting form is available and can be acquired from Medical Affairs Department: 

Phone: +971 7 2461461 (Main Switchboard)

           +971 7 2045405 (Direct)

Mobil:  +971 506272056

Post:    997 RAK - UAE

Fax:     +971 7 2462462

Email: medical.affairs@julphar.net

Or downloaded directly from Julphar’s website www.julphar.net, filled and sent either by email, post or fax. 

Julphar will transmit all Individual Case Safety Reports (ICSRs) requiring expedited reporting promptly and no later than 15 calendar days from receipt. This applies to initial and follow-up information. The clock for expedited reporting starts as soon as one or more of the following has received the minimum information (an identifiable patient, an identifiable reporter, a suspected reaction, and a suspect drug) required for the submission of an adverse reaction report:

      > Any personnel of Julphar - including sales representatives,

      > The Qualified Person responsible for Pharmacovigilance (QPPV) or persons working for or with this person,

      > where Julphar has entered into relationships with a second company for the marketing of, or research on, the suspected product, the clock starts as soon as any personnel of Julphar receives the minimum information; however, wherever possible, the time frame for regulatory submission should be no longer than 15 calendar days from first receipt by the second company and explicit procedures and detailed agreements will exist between Julphar and the second company to facilitate achievement of this objective,

      > In the case of relevant world-wide scientific literature, the clock starts with awareness of the publication by any personnel of Julphar; Julphar will maintain awareness of possible publications by accessing a widely used systematic literature review and reference database, no less frequently than once a week, or by making formal contractual arrangements with a second party to perform this task; Julphar will also ensure that relevant publications are appropriately reviewed. 

Expedited reporting of serious adverse reaction will be reported as soon as possible, but in no case later than 24 hours of initial receipt of information by the health care provider.