PV presentation_21042020Republic of Kenya Ministry of Health
Pharmacy and Poisons Board Ensuring the provision of safe, quality and efficacious pharmaceutical products and services
PHARMACOVIGILANCE:
Republic of Kenya Ministry of Health
Pharmacy and Poisons Board Ensuring 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
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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
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)
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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
Aim and Scope of Pharmacovigilance
Patient Care
To improve patient care &safety in relation to medicines &all medical & paramedical interventions Early 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
Republic of Kenya Ministry of Health
Pharmacy and Poisons Board Ensuring 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 differ from those in clinical practice and the duration of trials is limited
• Information about rare but serious ADRs, chronic toxicity, use in special groups (such as children, elderly or pregnancy) or medicine interactions is often in complete or not available)
• Genetics also vary
Republic of Kenya Ministry of Health
Pharmacy and Poisons Board Ensuring 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 GCP requirements.
• All clinical trials involving an intervention must be reviewed and approved by PPB after receiving ERC favorable opinion.
• Requirements for submission found at https://pharmacyboardkenya.org/clinical-trials
• PPB has an expert committee that reviews and monitors clinical trials.
• Expert are from Academia, Research Institutions and Private Practice
Pharmacy and Poisons Board Ensuring 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 a multicenter trial
• parallel submission can also be done to Ethics review committee and other regulators, pre-submission meetings to clarify on issues before submission
• PPB monitors ongoing clinical trials through review of SAEs, SUSARs, annual progress reports, Protocol deviations and violations that have to be continuously submitted 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 found at. https://ctr.pharmacyboardkenya.org/applications
Pharmacy and Poisons Board Ensuring 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 and Health Technologies (USFDA, GHANA FDA , Kenya PPB)
1.https://jamanetwork.com/searchresults?author=Andre+C.+Kalil&q=Andre+C.+Kalil
Republic of Kenya Ministry of Health
Pharmacy and Poisons Board Ensuring 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 Kenya Ministry of Health
Pharmacy and Poisons Board Ensuring 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
product or health technology(MPHT)
2. On ADEs /ADRs occurring • in the course of the use of a MPHT
• from the overdose whether accidental or intentional
• from abuse/misuse/non approved use
mother • as a result of exposure of
the mother to the feotus during pregnancy
3. Even if no ADR/AE has been observed
• from the MPHT overdose whether
accidental or intentional
• from abuse/misuse/non approved
Republic of Kenya Ministry of Health
Pharmacy and Poisons Board Ensuring 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
Republic of Kenya Ministry of Health
Pharmacy and Poisons Board Ensuring 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
Republic of Kenya Ministry of Health
Pharmacy and Poisons Board Ensuring the provision of safe, quality and efficacious pharmaceutical products and services
Adverse Reactions Related to COVID-19
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• 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 Kenya Ministry of Health
Pharmacy and Poisons Board Ensuring the provision of safe, quality and efficacious pharmaceutical products and services
Global data
ts
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 thromboemb olic disease
Acute kidney injury Withdrawn Not
recovered
Republic of Kenya Ministry of Health
Pharmacy and Poisons Board Ensuring the provision of safe, quality and efficacious pharmaceutical products and services
Global Data
nts
Outcome
Antibacterial s antidiuretics
Hepatocellul ar injury
Recovering
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
Republic of Kenya Ministry of Health
Pharmacy and Poisons Board Ensuring 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.
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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 17
Pre-approval studies (clinical trials) may not sufficiently characterize the effectiveness and risk
Minimize Preventable AEs/ADES Maximization of benefits Reduction of risk Patient with risk factors not exposed to product.(Hydroxychloroquine and Clarithromycin)
Pharmacovigilance reports generate data for evidence based decisions Post-marketing Pharmacoepidemiology studies: Provides new evidence on safety of medicines Establishes benefits/risk and comparative effectiveness Guides treatment guidelines review decision Compassionate 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 care due 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 Kenya Ministry of Health
Pharmacy and Poisons Board Ensuring 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
Pharmacoepidemiologist, Physicians , Gynaecologists, Nurses, Lab
Personal , Biostatisticians , Health Records Persons, Clinicians,
Pharmtechs etc
• Lack of knowledge on how to diagnose and
report ADRs
rounds
hospitals
Republic of Kenya Ministry of Health
Pharmacy and Poisons Board Ensuring the provision of safe, quality and efficacious pharmaceutical products and services
THANK YOU
Just be suspicious”