Creation and Implementation of a New Sentinel Surveillance Model in Pharmacy Offices in Southern Europe
Abstract
:1. Introduction
2. Materials and Methods
2.1. Selection Phase
2.1.1. Cluster Analysis
2.1.2. Population Analysis
2.1.3. Adjustment for Strata and Population
2.2. Voluntariness and Random Selection Phase
2.3. Training and Implementation Phase
3. Results
3.1. Cluster Analysis
3.2. Population Analysis
3.3. Adjustment for Strata and Population
3.4. Voluntariness and Random Selection Phase
3.5. Training and Implementation Phase
3.5.1. Pharmacovigilance
3.5.2. The Creation of an Observatory of Drugs of Abuse
3.5.3. Public Health Activities
- Monitoring of pharmaceutical quality alerts: only 8.1% of the quality alerts issued affect batches of medicines that are dispensed in community pharmacies.
- Notification of medication errors: in 69.4% of cases, the pharmacist was able to avoid the medication error.
- Notification of suspected adverse drug reactions: the therapeutic groups involved in most suspected adverse reactions are painkillers and anti-inflammatory drugs (17%).
- Additional follow-up of treatment with SGLT2 inhibitors: a total of 77 suspected adverse reactions have been reported, most related to dapagliflozin (51.9%).
- Monitoring of the dispensing of valproic acid in adult women of gestational age: there is a significant ignorance of teratogenic risks in patients treated with valproic acid (54.9%).
- Monitoring of the dispensing of isotretinoin in adult women of gestational age: most women on isotretinoin treatment were aware of the teratogenic risks associated with its use (75%), but in practically half of the cases, women did not receive the informative material oriented to the prevention and pregnancy control measures.
- Monitoring of abuse or recreational use of medications: the drugs most frequently implicated in abusive behaviors are benzodiazepines (36.3%), mainly in young men [11].
- Use of tramadol for non-oncologic pain: the majority (60%) of patients have needed to increase the dose of tramadol without consulting a doctor, and 13.8% have used it for symptoms other than pain.
- Characterization of the use of emergency contraception: many users (44.2%) said they had taken the medication on other occasions, and the number of women who requested the medication when they were recurring was higher than the first users (85.8% vs. 75.4%) [13].
- Influenza syndromic surveillance: sentinel pharmacies make it possible to detect the start of the flu epidemic a week earlier than health centers [12].
- A workshop of medication error detection (duration: 4 h).
- A course on the detection of suspected adverse drug reactions (duration: 3 h).
- Periodic summaries of the results obtained in each activity.
- Review articles on possible drug abuse trends that were likely to be monitored.
- Information on participation in scientific publications and conferences.
- Warnings or information on aspects of improvement that needed to be reinforced in each of the activities.
4. Discussion
5. Conclusions
Author Contributions
Funding
Institutional Review Board Statement
Informed Consent Statement
Data Availability Statement
Acknowledgments
Conflicts of Interest
References
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HR | HS (n) | BHA (n) | BHA Type 1 | Ratio 2 |
---|---|---|---|---|
Alt Pirineu i Aran | 2 | 8 | 0:4:4 | 0:1:1 |
Lleida | 1 | 23 | 7:16:0 | 1:2:0 |
Camp de Tarragona | 3 | 33 | 16:17:0 | 1:1:0 |
Terres de l’Ebre | 1 | 11 | 2:9:0 | 1:4:0 |
Girona | 2 | 41 | 7:28:6 | 1:8:1 |
Catalunya Central | 3 | 38 | 11:18:9 | 1:2:1 |
Barcelona | 17 | 220 | 184:36:0 | 5:1:0 |
HR | Population (n) | 2% Population Monitored (n) | Pharmacies (n) |
---|---|---|---|
Alt Pirineu i Aran | 71,888 | 1438 | 1 |
Lleida | 361,702 | 7234 | 3 |
Camp de Tarragona | 617,504 | 12,350 | 5 |
Terres de l’Ebre | 178,398 | 3568 | 2 |
Girona | 865,282 | 17,306 | 7 |
Catalunya Central | 519,836 | 10,397 | 5 |
Barcelona | 4,985,459 | 99,709 | 40 |
Total | 7,600,609 | 152,002 | 63 |
HR | Ratio CA 1 | Pharmacies (n) PA 2 | Pharmacies (n) 3 | Special Characteristics | Total Pharmacies (n) |
---|---|---|---|---|---|
Alt Pirineu i Aran | 0:1:1 | 1 | 2 (0U, 1R, 1M) | None | 2 (0U, 1R, 1M) |
Lleida | 1:2:0 | 3 | 3 (1U, 2R, 0M) | Since 1 urban pharmacy did not ensure 2% of the urban population was monitored, the ratio was expanded to 2 urban and 4 rural pharmacies. | 6 (2U, 4R, 0M) |
Camp de Tarragona | 1:1:0 | 5 | 6 (3U, 3R, 0M) | Since 3 urban pharmacies did not ensure 2% of the urban population was monitored, it was expanded to 4 urban and 4 rural pharmacies. | 8 (4U, 4R, 0M) |
Terres de l’Ebre | 1:4:0 | 2 | 5 (1U, 4R, 0M) | A much larger number of rural than urban inhabitants were monitored, which could lead to a representativeness bias. To equate the two population groups, the number of rural pharmacies was reduced to 2. | 3 (1U, 2R, 0M) |
Girona | 1:8:1 | 7 | 10 (1U, 8R, 1M) | Given that 1 urban pharmacy did not ensure 2% of the urban was population monitored and that the ratio allowed for a second urban pharmacy, 2 urban pharmacies were selected. | 11 (2U, 8R, 1M) |
Catalunya Central | 1:2:1 | 5 | 5 (1U, 2R, 1M, and 1 uncategorized) | Given that at least 5 pharmacies were needed and that the ratio allowed for a second urban pharmacy, 2 urban pharmacies were selected. | 5 (2U, 2R, 1M) |
Barcelona | 5:1:0 | 40 | 40 (32U, 8R, 0M) | None | 40 (32U, 8R, 0M) |
Area of Intervention | Name of Activity | Duration | Collected Notifications (n) |
---|---|---|---|
Pharmacovigilance | Monitoring of pharmaceutical quality alerts | 5 years | 4918 |
Pharmacovigilance | Notification of medication errors | 5 years | 1676 |
Pharmacovigilance | Notification of suspected adverse drug reactions | 5 years | 582 |
Pharmacovigilance | Additional follow-up of treatment with SGLT2 inhibitors | 1 year | 505 |
Pharmacovigilance | Monitoring of the dispensing of valproic acid in adult women of gestational age | 2.5 years | 91 |
Pharmacovigilance | Monitoring of the dispensing of isotretinoin in adult women of gestational age | 1 year | 98 |
Observatory of drug abuse | Monitoring of abuse or recreational use of medications [11] | 5 years | 1229 |
Observatory of drug abuse | Use of tramadol for non-oncologic pain | 2 years | 266 |
Public health | Characterization of the use of emergency contraception [13] | 2 years | 941 |
Public health | Influenza syndromic surveillance [12] | 5 years | 1986 |
Area of Intervention | Name of Activity | Question Number | Question Text |
---|---|---|---|
Pharmacovigilance | Monitoring of pharmaceutical quality alerts | 1 | Pharmacy ID |
2 | Pharmaceutical alert ID | ||
3 | Reception date of the alert | ||
4 | Reception channel of the alert | ||
5 | Has pharmacy staff been informed? | ||
6 | Are batches of the drug affected in your pharmacy? | ||
7 | Date of withdrawal of the batch medicine | ||
Observatory of drug abuse | Monitoring of abuse or recreational use of medications | 1 | Pharmacy ID |
2 | Pharmacist | ||
3 | Patient age | ||
4 | Patient sex | ||
5 | Patient origin (native or not) | ||
6 | Substance involved | ||
7 | Drug request (prescription or not) | ||
8 | Request with or not intimidation | ||
9 | Frequent request? | ||
10 | Pharmacist management? | ||
11 | Why do you supply the medicine? | ||
12 | Observations | ||
Public Health | Characterization of the use of emergency contraception (EC) | 1 | Pharmacy ID |
2 | Data of EC dispensation | ||
3 | National code and name of medicinal product | ||
4 | User sex (male, female) | ||
5 | Age of the user | ||
6 | Whom the medication is for? | ||
7 | Population of residence | ||
8 | Time from unprotected sex (hours) | ||
9 | Time since the last menstrual period (weeks) | ||
10 | Contraceptive method normally used | ||
11 | First EC dispensation or not | ||
12 | Suspected adverse reactions reported? | ||
13 | Description of pharmaceutical action performed | ||
14 | Availability of an EC kit consisting of a condom and additional informative material (yes or not) | ||
15 | Observations |
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Jambrina, A.M.; Rams, N.; Rius, P.; Perelló, M.; Gironès, M.; Pareja, C.; Pérez-Cano, F.J.; Franch, À.; Rabanal, M. Creation and Implementation of a New Sentinel Surveillance Model in Pharmacy Offices in Southern Europe. Int. J. Environ. Res. Public Health 2022, 19, 8600. https://doi.org/10.3390/ijerph19148600
Jambrina AM, Rams N, Rius P, Perelló M, Gironès M, Pareja C, Pérez-Cano FJ, Franch À, Rabanal M. Creation and Implementation of a New Sentinel Surveillance Model in Pharmacy Offices in Southern Europe. International Journal of Environmental Research and Public Health. 2022; 19(14):8600. https://doi.org/10.3390/ijerph19148600
Chicago/Turabian StyleJambrina, Anna M., Neus Rams, Pilar Rius, Maria Perelló, Montserrat Gironès, Clara Pareja, Francisco José Pérez-Cano, Àngels Franch, and Manel Rabanal. 2022. "Creation and Implementation of a New Sentinel Surveillance Model in Pharmacy Offices in Southern Europe" International Journal of Environmental Research and Public Health 19, no. 14: 8600. https://doi.org/10.3390/ijerph19148600
APA StyleJambrina, A. M., Rams, N., Rius, P., Perelló, M., Gironès, M., Pareja, C., Pérez-Cano, F. J., Franch, À., & Rabanal, M. (2022). Creation and Implementation of a New Sentinel Surveillance Model in Pharmacy Offices in Southern Europe. International Journal of Environmental Research and Public Health, 19(14), 8600. https://doi.org/10.3390/ijerph19148600