Why do we Need Pharmacovigilance of Herbal Medicines
Categories Herbal Research

Why do we Need Pharmacovigilance of Herbal Medicines?

Herbal medicines are known to be effective in the treatment of various chronic diseases. Ayurveda is the branch of Medicine based on the herbal treatment and originated in India. Plants, their parts, metabolites and preparations have demonstrated enormous therapeutic properties.

However, with the rise of modern medicine, the importance of herbal medicines has been overlooked. Yet, the general population never lost faith in the efficacy of the herbal medicines. They rely on them for a wide range of diseases ranging from common cold to the most serious chronic conditions and consider them safer than the synthetic drugs.

Though herbal medicines are obtained from natural sources, natural doesn’t always mean safe. Self medication, use of wrong species of medicinal plants, inappropriate dosage, and cross reaction with other drugs may result in adverse drug reactions.

Moreover, plants and their parts can be contaminated with foreign particles or infected with bacteria, fungi, and other infectious organisms. Ingestion of these medicinal plants can lead to fatal health complications. Thus, it becomes necessary to test their efficacy, quality and safety in order to minimize adverse drug reactions.

Pharmacovigilance or drug safety includes the collection, analysis, monitoring and prevention of the adverse effects of the drugs. It is a Science that deals with testing the safety of the herbal drugs.

About one third of the conventional medicines in the market are derived from the plant products whereas herbal medicines are exclusively made from plants.

However, there is inadequate information on the adverse reactions resulting from the consumption of the herbal products.

Do you know why?

Here are the reasons:

  • The practice of using plant products as remedies dates back to the ancient times. Therefore, most of the information related to their preparation, safety and adverse reactions is not in the electronic form and hence inaccessible.
  • Pharmacovigilance is generally followed for the conventional medicines. The current methods are inapplicable for the herbal medicines. Even the terminology used for monitoring and reporting of the adverse reactions is not suitable for the herbal medicines.
  • People of the country have a firm belief in all the herbal products and consider them 100% safe. As a result, there is no research or reports regarding their safety and adverse reactions.
  • Herbal preparations are often a combination of more than one ingredient. This makes it difficult to identify one causative agent for the adverse reaction. Also, the patients who herbal medicines simultaneously undergo alternative therapies. So, determination of the exact causative agent seems impossible.
  • Ayurvedic physicians are not well versed with the need and concept of pharmacovigilance.

Therefore, if we want to ensure the safety of the herbal medicines, it is necessary to first introduce the herbal medicine practitioners and students to the concept of pharmacovigilance. The concept must be included as a part of their curriculum so that they can acquaint themselves with causality analysis and reporting of adverse events to the regulators.

All information pertaining to the safe use of herbal medicines should be made easily accessible. Further, the patients should be educated about the adverse reactions and the need to use herbal medicines rationally.

Narrative Writing in Clinical Research
Categories Medical Writing

Narrative Writing in Clinical Research: Guidelines for a Medical Writer

Narrative writing or writing patient safety narratives is an integral part of any clinical study report writing. Before dwelling into its guidelines, let us first understand what it is and what importance it carries in clinical research.

In simple terms, a narrative is a brief summary of the adverse events experienced by the patients during a clinical trial of a drug. It is submitted along with the clinical study report to establish any causal relationship between the events experienced by the patient and the drug under investigation. This also helps in establishing the drug safety profile.

Patient narratives are generally written for deaths, serious adverse events, any adverse event of special clinical interest, and events leading to permanent discontinuation of the patient from the trial.

Components of a patient narrative

As per International Conference on Harmonisation (ICH) E3 guidelines, a patient narrative must contain the following:

  • Nature, intensity, and outcome of the event
  • Clinical course of the event
  • Timing of study drug administration
  • Relevant laboratory measures
  • How the event was treated
  • Action taken with respect to the study drug
  • Post mortem findings (in case of death of the patient)
  • Investigator’s and sponsor’s (one who sponsors the clinical study) opinion on causality
  • Patient identifier
  • His age, sex, and general clinical condition
  • Disease being treated
  • Medical history of the patient
  • Medications taken in the past or taking currently
  • Any ongoing medical condition

What do you need to know before drafting a patient narrative?

1.Thorough knowledge and understanding of the therapeutic area of the drug under investigation

2.Knowledge of the regulatory requirements

Patient narratives are usually submitted to the regulatory authorities along with the clinical study report, included either as a text in Section 12.3.2 if the number of narratives is less (6–10) or provided in Section 14.3.3 as an appendix.

3.Understanding of the role and expectations of the regulatory authorities

As narratives are reviewed by the regulatory authorities, their objectives must be borne in mind before drafting a narrative. These objectives are:

  • Identification and close examination of adverse events that require further monitoring
  • Identification of frequency and severity of unexpected adverse events
  • Identification of the factors affecting the occurrence of adverse drug reactions like patient’s age, gender, ethnicity, race, associated illness, abnormalities of renal or hepatic function, and genetic characteristics or drug-related factors such as dose, plasma concentration, duration of exposure, and concomitant medications.
  • Evaluating and analyzing the data for any limitations and safety analysis of the drug.

4.Sources of data

You can use various sources of information while preparing a patient narrative. These include:

  • Primary source which is the clinical database listings
  • Secondary source which include Council for International Organizations of Medical Sciences (CIOMS) forms, Case Report Forms (CRFs), MedWatch forms, and Data Clarification Forms (DCFs)

5.The number of patient narratives to be prepared

Challenges in narrative writing process

The most common challenges observed while drafting a patient narrative are:

  • Large number of resources required for the project
  • Maintaining consistency in the narratives
  • Timely delivery of high quality narratives
  • Lack of standardized data sources or patient profiles
  • High variability in template finalization before and after sample narratives due to differences in opinion of reviewers
  • Change in reviewers in intermediate or later stages of the project
  • Delay in review cycles
  • Delay in receiving consensus on comments and queries from the clinical team

How to overcome these challenges?

    1. Hold a meeting with all the stakeholders of the project and finalize a template for the sample narrative, in consensus with the clinical team.
    2. Review your clinical database listings for all the necessary information as per the agreed narrative template.
    3. Use standardized data sources throughout the process. Also use a resource utilization tracker that lists down all the ongoing studies, percent utilization and free capacity of the resources in each project.
    4. Use a standardized narrative tracking sheet to record details like the list of patients requiring narrative, their criteria for narrative, author, reviews, and dates.
    5. Standardize the review process and have proactive communication with all the stakeholders including the clinical team for finalizing the sample narrative.
    6. Finalize the sample narrative before dispatching future batches.
    7. Use an automation tool for narrative writing. This is particularly helpful in case of large volumes of narratives to ensure consistency, quality, and timely delivery of narratives. However, medical and scientific review, data quality control, and quality calibration must be performed regularly even if the narratives are generated using an automation tool. Quality can be checked and maintained by using a quality tracker to calculate any major or minor errors in the narrative.

Tips for writing an effective patient narrative

    • Always use hard space and hard hyphens for days, dates, and laboratory values to avoid splitting on the next page or next line except at the beginning of a sentence (hard hyphen: ctrl + shift + hyphen; hard space: ctrl + shift + space)
    • Be consistent while using the patient throughout the narrative.
    • Tag the narrative template against the information available in data sources to help the reviewer track the information easily.
    • Always use generic names for the patient’s concomitant medications or treatment medications for adverse events. However, for combination drugs, generic drug name should be provided along with the trade name in brackets; for example, lisinopril-hydrochlorothiazide (Zestoretic)
    • For describing the adverse event and medical history or ongoing condition of the patient, always use the preferred terms like pain in extremity should be reported as pain in hands or pain in legs.
    • Quick check your narrative before submitting it to the scientific reviewer.

Quality control (QC) is an important step in the delivery of a narrative project. If time is not a constraint, QC must be performed during the review and final delivery stages. However, if that is not feasible, a thorough and independent final QC should suffice.

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