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Pharmacovigilance requirements in Jamaica

Post-marketing Surveillance Programme in Jamaica

The Standards and Regulation Division (SRD) is the National Pharmacovigilance Centre and coordinates the Pharmacovigilance and Substandard and Falsified Medicine activities in Jamaica.

Jamaica became an Associate Member of the WHO Programme for International Drug Monitoring in 2009, and the 109th member of the programme in September 2012; the second country in the English-speaking Caribbean.

The National Pharmacovigilance Centre (NPvC) serves as the repository for suspected adverse reaction (ADR) reports. These reports are received from spontaneous reporting by health care professionals and marketing authorization holders (MAH).

The legal framework governing the reporting of ADRs can be found in the Food and Drugs Act, Regulation 70, 1975.

 “Where any person receives any report of any unexpected side effects, injury, toxicity or sensitivity reaction associated with clinical uses, studies, investigation and tests respecting any new drug, he shall immediately inform the Minister thereof, furnishing him with the full information available.”

Local ADRs are submitted to the National Pharmacovigilance Centre on PharmWatch Drug Monitoring Reporting Forms (https://www.moh.gov.jm/forms/). Spontaneous reports received are submitted to the Global database, VigiBase, using the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) Guideline E2B (R3) format.

Pharmacovigilance

Pharmacovigilance (PV) is the science and activities relating to the detection, assessment, understanding and prevention of adverse effects or any other drug-related problem (WHO, 2002). The aims of pharmacovigilance are:

  • to improve patient care and safety in relation to the use of medicines and all medical and paramedical interventions;

  • to improve public health and safety in relation to the use of medicines by the provision of reliable, balanced information resulting in more rational use of drugs;

  • to promote rational, safe and more effective (including cost-effective) use of medicines;

  • to contribute to the assessment of benefit, harm, effectiveness and risk of medicines;

  • to promote understanding, education and clinical training; and

  • to establish mechanisms to detect and combat counterfeit medicines entering the local market.

Definitions

Adverse Event (AE): Any untoward medical occurrence in a patient or clinical investigation subject

administered a drug and which does not necessarily have to have a causal relationship with this treatment.

Adverse Drug Reaction (ADR): A response to a drug which is noxious and unintended, and which occurs at doses normally used in man for the prophylaxis, diagnosis or therapy of disease, or for the modification of physiological function (WHO Technical Report 498, 1972).

Unexpected Adverse Drug Reaction: An ADR whose nature, severity, specificity, or outcome is not consistent with the term or description in the Summary of Product Characteristics.

Serious AE/ADR: Any untoward medical occurrence that at any dose:

  • results in death,

  • is life-threatening,

  • requires inpatient hospitalization or prolongation of existing hospitalization,

  • results in persistent or significant disability / incapacity,

  • is a congenital anomaly / birth defect, or

  • is a medically important event or reaction.

Side Effect: Any unintended effect of a drug occurring at doses normally used in man which is related to the pharmacological properties of the drug.

Reporting of Suspected Adverse Reactions (Serious and Non-Serious)

Spontaneous ADR reports can be submitted to the NPvC by healthcare professionals, or consumers, marketing authorization holders or other organizations. Only valid Individual Case Safety Reports (ICSRs) qualify for reporting. Suspected ADR reports should be validated before reporting them to the NPvC to make sure that the minimum criteria for reporting are included in the reports. The minimum requirements are:

  • one single identifiable patient characterised by initials, patient identification number, date of birth, age, age group or gender. The information should be as complete as possible;

  • one or more suspected adverse reaction. The report does not qualify as a valid ICSR if it is reported that the patient experienced an unspecified adverse reaction and there is no information provided on the type of adverse reaction experienced;

  • one or more suspected substance / medicinal product;

  • one or more identifiable reporter (primary source), characterised by qualification (e.g. physician, pharmacist, other healthcare professional, lawyer, consumer or other non-healthcare professional) name, initials or address. Whenever possible, contact details for the reporter should be recorded so that follow-up activities can be performed. However, if the reporter does not wish to provide contact details, the ICSR should still be considered as valid providing the organization who was informed of the case was able to confirm it directly with the reporter.

The lack of any of these four elements means that the case is considered incomplete and does not qualify for reporting.

The information in suspected ADRs may be incomplete when first received, despite having the minimum requirements and therefore must be followed-up to obtain additional detailed information significant for the scientific evaluation of the cases. Follow-ups should be tailored towards optimising the collection of missing information.

The clock for the reporting of a valid ICSR starts as soon as the information containing the minimum reporting criteria has been brought to the attention of any health care provider or any personnel of the marketing authorization holder, including medical representatives. This date should be considered as day zero. It is the first day when a receiver gains knowledge of a valid ICSR, irrespective of whether the information is received on weekends or public holidays. Please note that reporting timelines are based on calendar days.

The general rules in relation to the reporting of initial and follow-up reports, including those for defining the clock start.

  • serious valid ICSRs shall be reported by health care providers and marketing authorization holders within 15 days from the date of receipt of the reports;

  • non-serious valid ICSRs shall be reported by health care providers and marketing authorization holders within 90 days from the date of receipt of the reports.

Every MAH should report any adverse reaction known to them involving their products registered in Jamaica. MAHs may use the local PharmWatch Drug Monitoring Form or the Council for International Organizations of Medical Sciences (CIOMS) form for the reporting of ADRs occurring in Jamaica. Forms can be sent via email to:

PharmWatch@moh.gov.jm

or mailed to:

PharmWatch Standards and Regulation Division Ministry of Health Masonic Building 45-47 Barbados Avenue Kingston 5 Jamaica, West Indies

Drug Manufacturers and Marketing Authority Holders have a responsibility to share post-market surveillance data and Periodic Benefit-Risk Evaluation Reports (PBRERs) / Periodic Safety Update Reports (PSURs) with the SRD. These reports should be in English and submitted on a CD. When a product is manufactured or marketed by more than one company, each MAH is responsible for submitting PBRERs for its own products.

PBRERs must be submitted based on the following timelines:

  • every 6 months from registration until the product is marketed;

  • every 6 months for the first two years that the product is on the market;

  • annually for the next two years;

  • every 3 years

The time interval between the data lock point (DLP) and the submission of PBRERs should be as follows:

  • PBRERs covering intervals of 6 or 12 months: within 70 calendar days;

  • PBRERs covering intervals in excess of 12 months: within 90 calendar days.

MAHs should refer to the ICH Guideline E2C (R2) format for all PBRERs.

Substandard and Falsified Medical Products

Substandard and Falsified (SF) medical products present a public health risk as they may cause harm to patients and fail to treat intended indications. Products from all therapeutic categories have been impacted including medicines, vaccines and diagnostic agents. The effect is felt all across of the world. Falsified medical products are manufactured in many different countries and in all regions. Both generic and innovator medicines are implicated. Even though antibiotics and anti-malarials are commonly impacted, products range from expensive cancer treatments to inexpensive pain treatments.

The aims of SF medical product monitoring are:

  • prevention,

  • detection, and

  • response

Definitions

Substandard (out of specification): Registered medical products that fail to meet either their quality standards or specifications, or both.

Unregistered / unlicensed: Medical products that have not undergone evaluation and/or approval by the Standards and Regulation Division for the marketing/distribution or use in Jamaica, subject to permitted conditions under regulation and legislation.

Falsified: Medical products that deliberately/fraudulently misrepresent their identity, composition or source.

Impact of SF Medical Products

Identifying and Reporting a Substandard or Falsified medical product

Substandard and falsified medical products are by their very nature difficult to detect. Falsified medical products are often designed to appear identical to the genuine product and may not cause an obvious adverse reaction. They however often fail to properly treat the disease or condition for which they were intended, and can lead to serious health consequences including death.

Some falsified medical products are almost visually identical to the genuine product and very difficult to detect. However, many can be identified by:

  • examining the packaging for condition, spelling mistakes or grammatical errors;

  • checking the manufacture and expiry dates and ensuring any details on the outer packaging match the dates shown on the inner packaging;

  • ensuring the medicine looks correct, is not discoloured, degraded or has an unusual smell;

  • suspiciously low-priced;

  • discussing with your pharmacist, doctor or other health care professional as soon as possible if you suspect the product is not working properly or you have suffered an adverse reaction; and

  • reporting suspicious medicinal products to the Standards and Regulation Division.

The PharmWatch Drug Monitoring Form (https://www.moh.gov.jm/forms/) maybe used to report any suspected substandard or falsified medicinal product. When reporting it is important to include the batch number and a photograph of the product. When completed forms can be sent via email to:

PharmWatch@moh.gov.jm

or mailed to

PharmWatch Standards and Regulation Division Ministry of Health

Masonic Building 45-47

Barbados Avenue Kingston 5 Jamaica, West Indies

 

 

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