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 Table of Contents  
ORIGINAL ARTICLE
Year : 2022  |  Volume : 12  |  Issue : 3  |  Page : 106-113

Pharmacovigilance study of spontaneous adverse drug reaction in a tertiary care centre


1 School of Pharmacy, Glocal University, Saharanpur, Uttar Pradesh, India
2 Department of Medicine, Hamdard Institute of Medical Sciences and Research Jamia Hamdard, New Delhi, India
3 Department of Respiratory Medicine, Hamdard Institute of Medical Sciences and Research Jamia Hamdard, New Delhi, India

Date of Submission02-Feb-2022
Date of Decision12-Apr-2022
Date of Acceptance11-May-2022
Date of Web Publication30-Jun-2022

Correspondence Address:
Dr. Imran Kazmi
Glocal University, Saharanpur, Uttar Pradesh
India
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Source of Support: None, Conflict of Interest: None


DOI: 10.4103/cmrp.cmrp_7_22

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  Abstract 


Background: Adverse drug reactions (ADRs) are a rapidly growing universal problem that has a significant impact on users worldwide. They are the cause of significant disability and mortality and are expected to be associated with an economic burden on the health-care system.
Aims: To promote patient safety from pharmaceutical products.
Materials and Methods: A prospective, observational evaluation of the ADRs collected during spontaneous pharmacovigilance reporting over a period of 18 months in various hospital departments. During the study period, 214 individual case safety reports (ICSR) were reported.
Results: The 214 reports that were identified, a slightly higher percentage of ADRs in females 105 (50.93%) was observed as compared to males 109 (49.07%), 73 (34.1%) serious and 141 (65.9%) non serious ADRs. In serious ADRs, the male patients were 35 (33.3%) and females were 38 (34.9%) including 6 (2.8%) deaths. The largest number of reports was associated with antimicrobials 41% followed by non-steroidal anti-inflammatory drugs − 21.1%, antidiabetic − 10.9%. The most commonly implicated organ system was skin − 46.62% followed by gastrointestinal reactions − 18.05%, blood and metabolic disorder − 11.65%, central nervous system − 6.77%, liver − 6.02% and cardiovascular system (3.38%). The outcomes were recorded as recovering (45.8%), recovered (26.2%), continuing (19.2%) and unknown (6.1%) at the time of processing ICSR through vigiflow database. The causality of more than half of ADRs were recorded as possible (59.8%) followed by probable (24.8%), certain (15%) and unlikely (0.5%).
Conclusion: Limited ADR is permissible in normal clinical trials setting; hence, spontaneous adverse reaction reporting systems need to be developed, which may improve rational drug prescribing habits to obtain maximum benefits meanwhile minimizing the risk of health from undesirable effects of drugs.

Keywords: Causality assessment, pharmacovigilance, seriousness and outcomes of adverse drug reactions


How to cite this article:
Ali W, Manjavkar S, Kazmi I, Khan SU. Pharmacovigilance study of spontaneous adverse drug reaction in a tertiary care centre. Curr Med Res Pract 2022;12:106-13

How to cite this URL:
Ali W, Manjavkar S, Kazmi I, Khan SU. Pharmacovigilance study of spontaneous adverse drug reaction in a tertiary care centre. Curr Med Res Pract [serial online] 2022 [cited 2022 Aug 12];12:106-13. Available from: http://www.cmrpjournal.org/text.asp?2022/12/3/106/349298




  Introduction Top


Drugs are a double-edge sword: On one hand, they have the ability to save lives, whereas on the other hand, they are also responsible for causing serious, potentially life-threatening adverse drug reactions (ADRs) that can significantly increase the health-care costs, physician visits, hospitalizations and also diminish the quality of life, even may cause death. ADRs are the major cause of morbidity and mortality worldwide,[1] 4th–6th largest cause for mortality in the USA[2],[3] means, they result in the death of several thousands of patients annually, and many more suffer from ADRs. The percentage of hospital admissions due to ADRs in some countries is around 10%.[4],[5],[6]

Hence, ADRs are of great concern to the general public, medical practitioners, pharmaceutical industries and the regulatory authorities.[7] The incidence of ADR varies with studies ranging from as low as 0.15% to as high as 30%.[8]

India rates below 1% in pharmacovigilance as against the world rate of 5%.[9]

Pharmacovigilance is the science and activities relating to the detection, assessment, understanding and prevention of adverse drug effects or any other possible drug related problems.[10] An ADR reporting system on hospital-based teaching institute can provide awareness and valuable information about the undesirable effects of drugs with their frequency, severity, management, outcome and reporting workflow in that institution. Furthermore, reviewing pooled data from various geographic, social and medical population enhances the ability to identify even very rare events and to generate new signals and thus in setting up a sound Pharmacovigilance system in the country.[11]

The monitoring of ADRs through pharmacovigilance is vital to patient safety. The results of ADR monitoring also have an important educational value, thus ADR monitoring plays a major role in pharmacotherapy decision-making, be it individual, regional, national or international. ADR monitoring helps in ensuring that patients obtain safe and efficacious products. Hence, we decided to publish this study data collected from a tertiary care teaching hospital based in South Delhi.

Literature review

ADRs are monitored in many countries and by the World Health Organization (WHO) since the 1960s using spontaneous reporting systems, also called “early warning” systems.[12] Pharmacovigilance is carried out in India by the sponsors as part of regulatory requirement and in collaboration with WHO, i.e., Uppsala Monitoring Centre, Sweden (UMC) as Pharmacovigilance Programme of India (PvPI). The UMC, WHO, Sweden is maintaining the international database of ADR reports.[13],[14] Spontaneous reporting of ADRs is a common method of detecting undesirable responses to the drugs and under reporting is a major drawback[15] of this reporting system.

India is the fourth largest pharmaceuticals producer in the world with large number of drug brands. Over 60,000 branded formulations and more than 6000 licensed drug manufacturers are there and it is also emerging as a hub for clinical trials. Many new drugs are being introduced in the country, so there is an immense need to improve the pharmacovigilance system to protect the Indian population from potential harm that may be caused by the drugs that are already in use, or newly developed drugs. The limited ADRs are permissible in normal clinical trials setting, hence drug regulatory authorities in many developed countries have established spontaneous adverse reaction reporting system through Pharmacovigilance Programme to monitor drug safety.

In India, the Central Drugs Standard Control Organization (CDSCO), Directorate General of Health Services under the aegis of Ministry of Health and Family Welfare (MoH and FW), Government of India in association with Indian Pharmacopoeia Commission (IPC), a National Coordinating Centre (NCC), initiated a nationwide PvPI for the Patient's health safety from drugs. Hamdard Institute of Medical Sciences and Research, Jamia Hamdard also has an ADR monitoring centre (AMC) under PvPI-IPC, MoH and FW Government of India.

In the beginning of ADR monitoring, only doctors and dentists were allowed to submit ADR reports to database.[16] However, because the health agencies started focusing more on patients' safety, in 1995 all drug manufacturers, world widely, were mandated to report ADRs (WHO 2002).[10] Later, other health-care professionals, Pharmacists and patients were allowed to report ADRs in hope that this would increase the reporting.

However, ADR monitoring is not well developed due to the lack of appropriate knowledge, training and awareness, poor reporting habits and overworked health-care providers. Health-care providers are in the best position to report suspected ADRs observed in their everyday patient care. The adverse drug reporting system can be strengthened only through the training and cooperation of the health-care workers who are directly involved in patient care.

All health-care providers should report ADRs as part of their professional responsibility, even if they are doubtful about the precise relationship with the given medication. Due to the massive population and the lack of a well-structured health-care delivery system, ADR reporting and pharmacovigilance has not received the importance it deserves in India. There are very few studies focussed on this vital area that attempt to provide an estimate of the ADRs occurring across the nation. These data, however, are limited and does not provide an accurate assessment of the national scenario as ADR reporting can vary widely in different regions.[17],[18],[19],[20],[21]


  Materials and Methods Top


This prospective study recorded ADRs of both out patients and in-patients including patients admitted in the intensive care unit (ICU). Both male and female patients having a definite history of consumption of drugs and reporting with adverse drug events were included in the study. The ADRs were reported as per the list of “What to be reported” by WHO.[10]

The suspected ADR reporting form of PvPI-IPC, was used to collect information on ADRs.The form was distributed to all the departments. After the training on Pharmacovigilance, the health care providers were told to observe and record information on the Suspected ADR reporting form. The Pharmacovigilance Associate at AMC assigned by NCC-PvPI was called whenever an ADR was suspected by any department. Pharmacovigilance Associate would also pay visits to the OPDs, Wards and ICU to observe, collect and follow up on reported ADRs and also to assess the completeness and quality of ADR reports.[16] This spontaneous ADR reporting method may prove to be essential for the continuous improvement of patient safety.

Furthermore, we informed the patients about reporting any suspected ADRs through any one of the following methods i.e., informing their doctor, pharmacist, nurses or clinical researcher, or filling out the consumer suspected ADR reporting form or directly calling on PvPI toll free no. 18001803024 or using the ADR reporting App.

Well-defined, systematic and efficient Adverse Drug Reporting systems need to be incorporated into the healthcare system to be able to effectively detect new drug alerts and improve the overall pharmacovigilance activities. The spontaneous ADR reporting system is helpful in identifying new ADRs and also in preventing serious life threatening ADRs. The purpose of this study was also to enhance the understanding of patients regarding the existing risks and harmful effects of drugs being taken for chronic conditions including cardiovascular disease, diabetes, hypertension and metabolic syndrome.

On occurrence of any adverse drug event, the information was recorded using suspected ADR reporting forms designed by PvPI-IPC. This included information about the report type i.e., initial or follow up, patient's initials, age, gender, suspected event/reaction with start and recovery date, suspected drug's information with manufacturer name, batch no, expiry date, dose, frequency, start date, and the action taken following ADR, i.e., whether dose was reduced, drug was stopped or continued at the same dose, relevant tests to be diagnosed with ADR, relevant medical history, seriousness of ADR with specific criteria, concomitant medical history (if any), ADRs/event outcomes and reporter information as asked in suspected ADR reporting form.[22] Suspected adverse drug the WHO causality assessment scale was used for the ADR causality assessment.[23]

The evaluation of the data was done statistically (Chi-square test) for various parameters including patient demographics, drug and reaction characteristics, causality assessment, serious or non-serious and outcome from ADRs and predisposing factors. The data were presented in the form of percentages and proportions.

Criteria

Inclusion Criteria:

  • Medically confirmed case
  • Adverse events that met the minimum ADR reporting criteria, i.e. an identifiable reporter, an identifiable patient, an adverse reaction, and a suspect product.


Exclusion criteria

  • Patients unwilling to give consent
  • Adverse events that has not met the minimum ADR reporting criteria, i.e. an identifiable reporter, an identifiable patient, an adverse reaction, and a suspect product.



  Results Top


The mean age of patients reported with ADRs was 37 ± 15 (mean ± SE) years. The ADRs were reported slightly high in females (50.9%) as compared to males (49.1) [Table 1]. The skin was the most commonly affected organ system involved in ADRs (46.6%) followed by GIT (18.1%) and kidney was the least common organ system involved in ADRs (0.38%) [Table 2]. The commonest and largest drug group responsible for ADRs was antimicrobials (41%) including antibiotics (22.2%), antitubercular (9.4%), antiprotozoals (4.5%), antifungals (4.9%) anthelmintics and antivirals (0.8%) followed by non-steroidal anti-inflammatory drugs (NSAIDs) (21.1%) then antidiabetic drugs [Figure 1]a and [Figure 1]b.
Figure 1: (a) Drug's Classes wise distribution of ADRs. (b) Drug's Classes wise distribution of ADRs. ADRs: Adverse drug reactions

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Table 1: Age and sex distribution of adverse drug reactions patients

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Table 2: Organ system involvement in adverse drug reactions

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According to seriousness, 73 (34.1%) serious and 141 (65.9%) non-serious ADRs were found and among serious ADRs 2.8% deaths were reported [Table 3].
Table 3: Seriousness of adverse drug reactions

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Age and gender wise distribution of adverse drug reactions

The mean age of patients reported with ADRs was 37 ± 15 (mean ± SE) years. ADRs were reported slightly high in females (50.9%) as compared to males (49.1%), but the difference was not significant.

[Table 1] shows age and sex distribution of ADRs patients. More than one-third of patients were 21–40 years of age (44.4%) followed by 41–60 (21.5%), 1–20 (18.2%) and 61–80 (15.9%). The mean age of ADRs patients was 37.00 ± 15.00. About half of ADRs patients were females (50.9%).

Organ system involvement and types of adverse drug reactions observed

Organ system wise adverse drug reactions distribution

The collected ADRs were distributed according to the body organ system which were affected by suspected drugs are given in [Table 2].

[Table 2] shows that skin was the most common organ system involved in ADRs (46.62%) followed by gastrointestinal system 48 (18.05%) including 16 (6.02%) from liver and blood disorders 31 (11.65%). The ADRs which were severe to mortality were related to Liver and Skin ADRs (Hepatitis and  Stevens-Johnson syndrome More Details) in our reported ADRs data. Kidneys were the least common organ system involved in ADRs (0.38%).

Distribution of adverse drug reactions according to seriousness

The collected ADRs were distributed according to serious or non-serious as per the WHO defined criteria are given in [Table 3].

[Table 3] shows seriousness of suspected ADRs according to seriousness criteria (34.11%) serious and (65.89%) non-serious ADRs were found and among serious ADRs (2.80%) death were reported.

Seriousness was almost similar in male and females. There was significant association of seriousness of suspected ADRs with gender.

Distribution of serious adverse drug reactions

The collected serious ADRs were distributed as per the WHO defined criteria for seriousness of ADRs are given in [Figure 2].
Figure 2: Shows distribution of observed 73 serious ADRs as 36 (49.3%) hospitalized, 22 (30.1%) prolonged hospitalization, 6 (8.2%) death, 8 (10.9%) disability and 1 (1.4%) required intervention to prevent permanent impairment/damage out of serious ADRs. ADRs: Adverse drug reactions

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[Figure 2] shows distribution of observed 73 serious ADRs as 36 (49.3%) hospitalized, 22 (30.1%) prolonged hospitalisation, 6 (8.2%) death, 8 (10.9%) disability and 1 (1.4%) required intervention to prevent permanent impairment/damage out of serious ADRs.

If we will see the distribution of observed serious ADRs in percentage out of total ICSRs (214), it was found to be as 36 (14.8%) hospitalised, 22 (10.3%) prolonged hospitalisation, 6 (2.8%) death, 8 (3.7%) disability and 1 (0.5%) required intervention to prevent permanent impairment/damage.

[Figure 1]a and [Figure 1]b shows the largest number of reports was associated with antimicrobials (41%) including antibiotics (22.2%), antitubercular (9.4%), antiprotozoal (4.5%) and antifungal (4.9%), followed by NSAIDS (21.1%), antidiabetic (10.9%), antacids 5.3% including PPI (4.1%), acid neutralizing 1.1%, antipsychotic (3.4%), antiallergic 1.9%, antihypertensive 2.3% and antiemetic 3.4% and laxative (1.5%).

Causality of drugs to adverse drug reactions

The assessment of causality of collected ADRs to drug(s) was done as per the WHO Causality Assessment Scale and were found as-more than half ADRs were considered as possible 128 (59.8%), followed by probable 53 (24.8%), certain 32 (15.0%) and unlikely 1 (0.5%)

[Figure 3] shows causality assessment, more than half ADRs were considered as possible (59.8%), followed by probable (24.8%), certain (15.0%) and unlikely (0.5%).
Figure 3: Causality of drugs to adverse drug reactions

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In most of the patients, 114 (95%) ADRs abated after stopping the drug. All the cases were improved after de-challenge. The rechallenge of the drug was not performed in any patient.

Action taken on occurrence of adverse drug reactions

After occurrence of any ADR what action was taken is given in [Figure 4].
Figure 4: Action taken on occurrence of ADRs. ADRs: Adverse drug reactions

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[Figure 4] shows the drugs suspected to be causing ADR were discontinued in 31 (14.5%), does not change in treatment 108 (50.5%), change in treatment not applicable in 33 (14.5%), unknown 28 (13.1%) and dose reduced in 14 (6.5%) patients at the discretion of the treating physician or patients availability or unavailability to reach at Physician on time or intensity or severity of ADRs.

Outcome of adverse drug reactions

The outcomes after happening of any ADR(s) were recorded as per prescribed suspected ADR monitoring form by PvPI-IPC and are given in [Table 4].
Table 4: Outcome of adverse drug reactions

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[Figure 5] shows a total of 56 (26.2%) patients were recovered, 98 (45.8%) patients were recovering, in 41 (19.2%) as continuing and 13 (6.1%) unknown and 6 (2.8%) patients found to be dead at the time of the reporting. There was significant (P = 0.0001) association of outcome with gender.
Figure 5: Outcome of ADRs. ADRs: Adverse drug reactions

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In our reported case, the mortality rate was in children 2 (0.9%), adult age 1 (0.4%) and elders 3 (1.4%). The causality relationships in deaths caused by drugs were certain 3, probable 2 and possible 1.

The mortality ratio between male and female was equal (3) and the cause of mortality was 4 due to ATT, 1 from antibiotic (ceftriaxone-induced Stevens − Johnson syndrome) and 1 due to Antimalarial (Artemether and lumefantrine-induced Stevens − Johnson syndrome).


  Discussion Top


In this study, the total ICRs were 214, in which 266 ADRs were observed and the same were reported, means in some ICSRs more than 1 ADR was observed and reported.

In this study, more than one third of patients were 21–40 years of age (44.4%) followed by 41–60 (21.5%), 1–20 (18.2%) and 61–80 (15.9%). The mean age of ADR's patients was 37.00 ± 15.00. About half of ADRs patients were females 50.9%. The adults showed high frequency of ADRs which is concurrent with the study[24] (by Venkatesan et al.), but Mudigubba et al. showed that greater association to ADR was shown in the age group of 61–70 years and males were more likely to experience ADRs.[25] Conforti et al. reported higher ADRs in females compared to men;[26] however, few studies reported no gender wise difference[27] which is concurrent with the study

In this study, the ADRs related to the skin were most frequent (46.6%) and a similar trend was reported in other study[5],[17] followed by gastrointestinal tract 18.1% (including hepatic system 6.0%), blood and metabolic disorder related 11.7%, central nervous system (CNS) 6.8% and renal was the least common organ system involved in ADRs 0.4%. As the skin is the largest organ of the body; hence, most of the ADRs present here, also skin related ADRs are easily understood, identified and differentiated to understand whether it was a disease related problem or allergy from drug. Hence, the reporting rate may be high.

In other cases, GIT was reported to be the common organ system affected.[17],[18] The CNS is also reported to be involved in majority of the ADRs.[17],[18]

According to WHO seriousness criteria, the serious ADRs were found to be 34.1% and non-serious 65.9%. The serious ADRs were almost similar in male and female. Among the serious ADRs 2.80% deaths were reported. There was no significant association of seriousness of suspected ADRs with gender.

Among the observed 73 serious ADRs, approximately half of serious ADR patients were hospitalised 49.3% followed by prolonged hospitalisation 30.1%, disability for routine work 10.9%, fatal 8.2% and 1.4% required intervention to prevent permanent impairment/damage.

The observed incidences among serious adverse drug reactions out of the total ICSRs (214) were 16.8% hospitalised, 10.3% prolonged hospitalised, 3.7% disabled, 2.8% fatal, and 0.5% required intervention to prevent permanent impairment or damage.

Kalaiselvan et al. reported that serious ADRs accounted for 25.71% of the total ADRs reported under PvPI of which 0.71% were fatal.[27]

The largest number of reports was associated with antimicrobials (41.0%) including antibacterial (22.2%), antitubercular (9.4%), antiprotozoal (4.5%) and antifungal (4.9%), followed by NSAID'S (21.1%), antidiabetic (10.9%), antacids (5.3%) antipsychotic (3.4%), antiallergic (1.9%), antihypertensive (2.3%) and antiemetic (3.4%) and laxative (1.5%). In most of the earlier studies, antimicrobials were also reported to be the most common drug group involved in ADRs.[17]

The causality assessment of suspected drugs to adverse reactions shows more than half of ADR belongs to possible 59.8% followed by probable 24.8%, the less percentage of ADR belongs to certain category 15.0% and very less to unlikely 0.5%.

Previous studies reported the highest ADRs as possible, but few studies reported more causality to the ADRs as probable in comparison to possible.[18],[28],[29],[30]

While managing the patients of ADR, the first principle which is followed is to discontinue the suspected offending drug and replace the same by another drug if required. In the present study, the drugs suspected to be causing ADR were discontinued in 14.5% These findings are in accordance with earlier studies.[17] Does not changed in treatment 50.5%, change in treatment not applicable in 15.4%, unknown 13.1% and dose reduced in 6.5% patients at the discretion of the treating physician or patients availability or unavailability to reach at physician on time or intensity or severity of ADRs.

This fact highlights the proper management of ADRs in a tertiary care hospital. The reporting of ADRs in this study was added to the national database. The study also exposed the awareness, reporting and assessment methodology to the physician and other health care staff.

The outcome of ADRs in this study, as 26.2% patients were recovered, 45.8% patients recovering from ADR, 19.2% patients' ADR continuing and 6.1% patients' ADR unknown and 2.8% patients found to be dead at the time of the reporting.

Rosli et al. analysed that 0.28% of the ADR cases were reported as fatal. There was significant (P = 0.0001) association of outcome with gender.[31]

The percentage of deaths according to age group was child 0.93%, adult 0.47% and elderly 1.40% in 214 patients. The causality relationship of deaths caused by drugs was 3 certain, 2 probable and 1 possible.

The mortality ratio between male and female was equal, and the class of suspected drugs which caused mortality was ATT (4), antibiotic (ceftriaxone-induced Stevens − Johnson syndrome-1) and 1 due to antimalarial (Artemether and lumefantrine-induced Stevens − Johnson syndrome-SJS)


  Conclusion Top


The pattern of ADRs reported in our hospital is comparable with the results of studies conducted in other hospitals set up in other institutions. Our evaluations revealed opportunities for interventions especially for the preventable ADRs to ensure safer drug use, providing the awareness and importance of ADR monitoring during treatment. This ADR reporting system from primary source to AMC and from AMC to NCC-PvPI Ghaziabad to which provide scientific inputs to CDSCO where DCG (I) may take any necessary action regarding safety alert, ask to company to add ADR information in patients information leaflet (PIL), Black/Red Box warning or banning the drug if required with respect to patient's safety.

Data on adverse drug reactions collected from AMC were provided to the National Pharmacovigilance Centre by multiple countries around the world. This collected data was forwarded to WHO-UMC, the International Pharmacovigilance Centre. Thus, the availability of data from multiple countries across the world allows us to strengthen patient safety at an international level through the safety alert by the WHO.

The limitations of the study may include the irregular, non-uniform frequency of ADR reporting from different departments. The withdrawal of suspected drugs was required in many adverse reactions, and the majority of them showed improvement at the time of the last assessment. In remaining cases de-challenge was not done due to therapeutic reasons. Re-challenge was not done in any case for trial purposes because of ethical reasons.

Acknowledgements

We are cordially thankful to the National Coordination Centre, PvPI-IPC Ghaziabad and HAHC Hospital associated with HIMSR, Jamia Hamdard New Delhi for giving valuable support to pharmacovigilance activities.

Financial support and sponsorship

Nil.

Conflicts of interest

There are no conflicts of interest.



 
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    Figures

  [Figure 1], [Figure 2], [Figure 3], [Figure 4], [Figure 5]
 
 
    Tables

  [Table 1], [Table 2], [Table 3], [Table 4]



 

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