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Republic of Kenya Ministry of Health Pharmacy and Poisons Board Ensuring the provision of safe, quality and efficacious pharmaceutical products and services PHARMACOVIGILANCE: Safety Monitoring During COVID-19 21 ST April 2020 Dr Christabel Khaemba PPB 1
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Republic of KenyaMinistry of Health

Pharmacy and Poisons BoardEnsuring the provision of safe, quality and efficacious pharmaceutical products and services

PHARMACOVIGILANCE:

Safety Monitoring During COVID-19

21ST April 2020

Dr Christabel Khaemba PPB

1

Republic of KenyaMinistry of Health

Pharmacy and Poisons BoardEnsuring the provision of safe, quality and efficacious pharmaceutical products and services

Outline • Introduction to Pharmacovigilance ( Aim and Importance )

• Clinical Trials registration - COVID 19 considerations

• Managing off-label use of MPHTs

• Safety monitoring and documentation of SADRs ( What information should be reported in Management of COVID-19?)

• Reported COVID related SADRs. ( Global and Kenyan Data )

• Key responsibilities for all HCPs and challenges

2

Republic of KenyaMinistry of Health

Pharmacy and Poisons BoardEnsuring the provision of safe, quality and efficacious pharmaceutical products and services

Introduction• Pharmacovigilance(PV) also called as drug safety

• Pharmakon-------in Greek----drug• Vigilare -----------in Latin------to keep watch

• Pharmacovigilance 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 science &activities. relating to the detection , assessment, understanding and prevention of adverse effects (WHO collaborating entre for international drug monitoring)

3

Republic of KenyaMinistry of Health

Pharmacy and Poisons BoardEnsuring the provision of safe, quality and efficacious pharmaceutical products and services

Aim and Scope of Pharmacovigilance

Patient Care

To improve patient care &safety in relation to medicines &all medical & paramedical interventionsEarly detection of unknown safety problems

Public Health

To improve public and safety in relation to the use of medicines

Risk Benefit Assessment

To contribute to the assessment of benefit, harm, effectiveness and risk of medicines encouraging their safe, rational and more effective (including cost-effective) use• Identification of risk

factors• Quantifying risks

Communication

To promote understanding , clinical training & effective communication to health professional and the public

Republic of KenyaMinistry of Health

Pharmacy and Poisons BoardEnsuring the provision of safe, quality and efficacious pharmaceutical products and services

Why Pharmacovigilance?• There is need to continuously evaluate the safety of medical products• Collection of safety and efficacy data begins before humans are exposed

i. Pre-clinical (animal) phase

ii. Phase I – Healthy human volunteer (Patients eg Cancer Patients )

iii. Phase II and III – Clinical trials

iv. Phase IV – Post Market Surveillance• Inadequate safety data in the pre-marketing phase of a medicine

• Tests in animals are insufficiently predictive of human safety

• In clinical trials, patients are selected and limited in number, the conditions of use differfrom those in clinical practice and the duration of trials is limited

• Information about rare but serious ADRs, chronic toxicity, use in special groups (such aschildren, elderly or pregnancy) or medicine interactions is often in complete or notavailable)

• Genetics also vary

Republic of KenyaMinistry of Health

Pharmacy and Poisons BoardEnsuring the provision of safe, quality and efficacious pharmaceutical products and services

Clinical Trials Regulation• Clinical trials are critical especially now as researchers try to get treatment

for COVID-19

• Trials have to adhere to ethical, scientific, regulatory, and GCPrequirements.

• All clinical trials involving an intervention must be reviewed and approvedby PPB after receiving ERC favorable opinion.

• Requirements for submission found athttps://pharmacyboardkenya.org/clinical-trials

• PPB has an expert committee that reviews and monitors clinical trials.

• Expert are from Academia, Research Institutions and Private Practice

Republic of KenyaMinistry of Health

Pharmacy and Poisons BoardEnsuring the provision of safe, quality and efficacious pharmaceutical products and services

Clinical Trials Regulation• Due to the COVID-19 pandemic PPB has set in place an expedited mechanism for

reviewing COVID-19 related clinical trials

• In Emergency Medical Situations• joint review of CTs done with Ethics committee and other regulators if it is amulticenter trial

• parallel submission can also be done to Ethics review committee and otherregulators, pre-submission meetings to clarify on issues before submission

• PPB monitors ongoing clinical trials through review of SAEs, SUSARs, annualprogress reports, Protocol deviations and violations that have to be continuouslysubmitted to PPB until end of the study : All must have Clinical Trial Pharmacists

• All PPB reviewed and approved clinical trials and their current status can be foundat. https://ctr.pharmacyboardkenya.org/applications

Republic of KenyaMinistry of Health

Pharmacy and Poisons BoardEnsuring the provision of safe, quality and efficacious pharmaceutical products and services

Off Label Use of Medicines• Currently there are no approved medicines shown to be safe and effective for the

treatment of COVID-19.

• The use of licensed medicines for indications that have not been approved by a national medicines regulatory authority is considered “off-label” use.

• Off Label Use/Compassionate Use/Emergency Use /Use of Unregistered Medical Products

“A common interpretation of off-label use and compassionate use of drugs is that is that if the patient died, they died from the disease, but if the patient survived, they survived because of the given drug. This is not true.”1

• Monitored emergency use of unregistered and experimental interventions(MEURI).

• Emergency Use & Compassionate Use Authorization (Eucua) of Health Products andHealth Technologies (USFDA, GHANA FDA , Kenya PPB)

1.https://jamanetwork.com/searchresults?author=Andre+C.+Kalil&q=Andre+C.+Kalil

Republic of KenyaMinistry of Health

Pharmacy and Poisons BoardEnsuring the provision of safe, quality and efficacious pharmaceutical products and services

Off Label Use of Medicines• All health care workers should be aware of and comply with the laws and regulations

within the country of use 2

• Prescribing should be done on a case-by-case basis

• Tracking Off-label Prescriptions• appropriate records of the use of the medicine must be kept, in compliance with national

law, and outcomes for patients should be monitored and recorded.

• Evaluate Off-label Drug Use and Warn about its Risks. • Hence monitoring use of such medicine is very crucial to get data for decision making.

• Is results from an unproven or experimental treatment are promising, • the treatment should be studied in the context of a formal clinical trial to establish its

safety, efficacy, risks, and benefits.

• Eliminate manufacturer incentives encouraging Off-label Uses

2.https://www.who.int/news-room/commentaries/detail/off-label-use-of-medicines-for-covid-19

Republic of KenyaMinistry of Health

Pharmacy and Poisons BoardEnsuring the provision of safe, quality and efficacious pharmaceutical products and services

What information should be reported in Management of COVID-19?• Any information

1. On an ADR ,Lack of efficacy ,

Quality Defects, Interactions or

Therapeutic ineffectiveness

associated with the use of a medical

product or health technology(MPHT)

2. On ADEs /ADRs occurring• in the course of the useof a MPHT

• from the overdosewhether accidental orintentional

• fromabuse/misuse/nonapproved use

• from drug withdrawal• in the infant of a nursing

mother• as a result of exposure of

the mother to the feotusduring pregnancy

3. Even if no ADR/AE has been observed

• from the MPHT overdose whether

accidental or intentional

• from abuse/misuse/non approved

use

• MPHT administration during

pregnancy

10

Republic of KenyaMinistry of Health

Pharmacy and Poisons BoardEnsuring the provision of safe, quality and efficacious pharmaceutical products and services

Who should report ?Where to send the reports • Safety monitoring is by all frontline

health care workers

• Additionally, there are PV focal persons who can do this and some of who are part of the pandemic response committees/ sub committees at their respective Counties/Facilities

• MAHs

• Clinical Trials Pharmacists

• Patients

11

Republic of KenyaMinistry of Health

Pharmacy and Poisons BoardEnsuring the provision of safe, quality and efficacious pharmaceutical products and services

Where should the reports be sent ?

•Log in directly to the web application online

https://pv.pharmacyboardkenya.org/

Republic of KenyaMinistry of Health

Pharmacy and Poisons BoardEnsuring the provision of safe, quality and efficacious pharmaceutical products and services

Adverse Reactions Related to COVID-19

13

• Global Data Base3

• 26 Reported in VigiBase between March 1st and March 29th, 2020; there were 8 serious reports.

• reports came from 6 European countries: Italy (17 cases), France (3 cases), Spain (3 cases), Austria (1 case), Switzerland (1 case) and Germany (1 case).

• They related to 7 females with a median age of 60.5 years and 17 males with median age of 70.5 years.

• The age range of the patients in the reports was 41 - 83 years. In most reports the action taken with the drug (e.g. withdrawal or continued use) and the outcome is as at time or reporting

• Kenyan Data Base • No reports on medicines • Reports on AE from ABHRs and Masks

3. https://www.who-umc.org/vigibase/VigiLyze/

Republic of KenyaMinistry of Health

Pharmacy and Poisons BoardEnsuring the provision of safe, quality and efficacious pharmaceutical products and services

Global data

14

ID Sex/ Age (years)

Serious Suspected/Interacting Drug(s) Dose Concomitan

ts

MedDRA Preferred Terms

Action taken with the drug

Outcome

1 F/50 Y Lopinavir; ritonavir 1 Kaletra per day - Diarrhoea,

Vomiting Withdrawn Recovered

2 F/55 Y Lopinavir; ritonavir 1 Kaletra per day - Nausea, Vomiting Withdrawn Recovered

3 M/58 Y Lopinavir; ritonavir, Hydroxychloroquine 1Kaletra, 400

mg HQ - Diarrhoea Withdrawn Recovered

4 M/41 Y Lopinavir; ritonavir

Anaesthetic, cardiotropic and other drugs compatible with assisted respiration, heart failure and thromboembolic disease

Acute kidney injury Withdrawn Not

recovered

Republic of KenyaMinistry of Health

Pharmacy and Poisons BoardEnsuring the provision of safe, quality and efficacious pharmaceutical products and services

Global Data

15

ID Sex/ Age (years)

Serious Suspected/Interacting Drug(s) Dose Concomita

nts

MedDRA Preferred Terms

Action taken with the drug

Outcome

5 M/71 Y Lopinavir; ritonavir, Oseltamivir

Antibacterials antidiuretics

Hepatocellular injury

Lopinavir; ritonavir and oseltamivir withdrawn

Recovering

6 M/73 Y Remdesivir -

Blood creatinine increased, Death

Dose not changed

Not recovered, Died

7 M/69 Y Remdesivir 100 mg/day - Acute kidney, Septic shock Withdrawn Unknown

8 M/42 Y Lopinavir; ritonavir, Remdesivir

1 Kaletra, 200 mg Remdesivir per day

Concomitant antibacterials

Hepatic enzyme increased

All withdrawn

Not recovered

Republic of KenyaMinistry of Health

Pharmacy and Poisons BoardEnsuring the provision of safe, quality and efficacious pharmaceutical products and services

Local Data

• Black colouration on both hands following use of Alcohol based hand rub- Hand sanitizer 75% isopropyl alcohol and hydrogen peroxide by a HCP.

16

SEVERITY OF THE REACTION:

ACTION TAKEN OUTCOME:

Moderate Drug withdrawn

recovered/resolved

Republic of KenyaMinistry of Health

Pharmacy and Poisons BoardEnsuring the provision of safe, quality and efficacious pharmaceutical products and services 17

Pre-approval studies (clinical trials) may not sufficiently characterize the effectiveness and risk

Minimize Preventable AEs/ADESMaximization of benefitsReduction of riskPatient with risk factors not exposed to product.(Hydroxychloroquine and Clarithromycin)

Pharmacovigilance reports generate data for evidence based decisionsPost-marketing Pharmacoepidemiology studies:Provides new evidence on safety of medicinesEstablishes benefits/risk and comparative effectivenessGuides treatment guidelines review decisionCompassionate use of drugs that have not been previously approved for clinical use (eg, remdesivir, hydroxychloroquine) could cause serious adverse effects that were not previously detected because of the very small number of exposed patients…

Treatment of ADRs imposes a largely, unrecognized, but considerable financial burden on health caredue to the need for hospital care or other medical interventions.Some of these costs at a national or even personal level are avoidable

ADRs Cause mortality and morbidity significantly

ADRs affect adherence to treatment schedules, increase the risk of resistance and relapse of the disease.

Why Report? and Uses of PV data in Rx Guidelines

Republic of KenyaMinistry of Health

Pharmacy and Poisons BoardEnsuring the provision of safe, quality and efficacious pharmaceutical products and services

Responsibilities and Challenges Likely to faced during Covid19

Responsibilities of HCPs• Timely collection of data ,recording and

notification

• Appropriate assessments (data completeness ,

seriousness)

• Expedited and periodic reporting

• Create appropriate communication structures

• Patient education programmes

• Key is Collaboration between the Health Care

WorkersEpidemiologists , Infectious Disease specialists Clinical Pharmacist,

Pharmacoepidemiologist, Physicians , Gynaecologists, Nurses, Lab

Personal , Biostatisticians , Health Records Persons, Clinicians,

Pharmtechs etc

Challenges• Under-reporting of ADRs

• Lack of awareness by HCPs

• Lack of knowledge on how to diagnose and

report ADRs

• Pharmacists not involved in clinical wards

rounds

• Lack of functional DICs/DTCs in the

hospitals

• Human resource issues

• Etc etc etc

18

Republic of KenyaMinistry of Health

Pharmacy and Poisons BoardEnsuring the provision of safe, quality and efficacious pharmaceutical products and services

THANK YOU

“You need not be certain…

Just be suspicious”

Report all SUSPECTEDadverse drug reactions


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