Purpose of the AGREE II Instrument
clinical practice guidelines (‘guidelines’) are systematically developed statements to assist practitioner and patient decisions about appropriate health care for specific clinical circumstances (1). In addition, guidelines can play an important role in health policy formation (2,3) and have evolved to cover topics across the health care continuum (e.g., health promotion, screening, diagnosis).
The potential benefits of guidelines are only as good as the quality of the guidelines themselves.Appropriate methodologies and rigorous strategies in the guideline development process are important for the successful implementation of the resulting recommendations (4-6). The quality of guidelines can be extremely variable and some often fall short of basic standards (7-9).
The Appraisal of Guidelines for REsearch & Evaluation (AGREE) Instrument (10) was developed to address the issue of variability in guideline quality. To that end, the AGREE instrument is a tool that assesses the methodological rigour and transparency in which a guideline is developed. The original AGREE instrument was refined, which resulted in the AGREE II, and a User’s Manual was developed (11-13).
The purpose of the AGREE II, is to provide a framework to:
- Assess the quality of guidelines;
- Provide a methodological strategy for the development of guidelines; and
- Inform what information and how information ought to be reported in guidelines.
The AGREE II replaces the original instrument as the preferred tool and can be used as part of an overall quality mandate aimed to improve health care.
Management Of Adverse Drug ReactionsIntroduction
Adverse drug reactions are one of the common and significant reasons behind increased mortality and morbidity rate among individuals. Significant monitoring and intake of a therapeutic dose of drugs are essential to prevent adverse drug reaction. This report will provide a critical appraisal and discussion of two clinical adverse drug reaction guidelines. "Preventing adverse drug events guideline" by the government of South Australia and "Adverse drug reaction guideline" by the Sydney children's hospital network are the two policies that will be discussed and reviewed with the help of AGREE II tool. This paper will also identify the similarities and differences between these two guidelines. Finally, an analysis of the AGREE II scorecard of these two policies will be provided that will help the reader to evaluate the efficacy of these two policies.
Critical analysis of the two clinical practices with the help of the AGREE II tool
Medicines and therapies are some of the key components of disease management. The SA guideline effectively presents the core principles behind this adverse drug reaction. Ali et al. (2015) commented that proper documentation as well as communication while ingesting drugs are essential and the prerequisite to prevent adverse drug impact. A proper follow-up of the medication management cycle is important to minimize morbidity rate among individuals. A guideline of adverse drug prevention systemically presents a medication management cycle that needs to be followed by every clinician while recommending medications to their patients.
Critical analysis by documentation
Sydney children hospital healthcare guideline provides a detailed analysis of every adverse drug reaction. Moreover, this policy guideline documents every adverse drug reactions in their medical charts and notes that overall allow clinicians and doctors to take note regarding the adverse drug reaction. Davies & O'mahony (2015) opined that drug dosage and timings are essential while administering into any patient. Moreover, this policy also provides a list of the potent allergies that are prevalent within any patient. This sort of analysis will help the clinician to provide such medications that do not trigger an allergic reaction within the patient.
Scope and purpose of the policies
The Sydney hospital guideline details about their specific objective behind this policy. To prevent adverse drug reaction, proper documentation and assessment of the previous drug reactions are required while SA health policy also explains the necessity for surveillance and guidance while drug administration (Preventing Adverse Drug Events Policy Guideline, 2013). Proper monitoring by clinicians is essential to take care of their patient's health. This policy also explains that the importance of documentation, however, detailed information regarding adverse drug effects will be documented in a patient's health records. Therefore, based on AGREE II scorecard, Sydney hospital guideline provides detailed and more specific health objectives as compared to the other policy.
SA health guideline clearly states that their target groups are patients. (Hirsh, Smilowitz, Rosenson, Fuster, & Sperling, 2015) Opined that clinicians need to take care of their patient’s health while administering drugs. Information regarding the potential allergies is essential while recommending drugs to prevent any adverse reaction. As per the AGREE II tool, Sydney hospital healthcare guideline also mentions that their target respondents are patients. Detailed information of drugs and their type of reaction are detailed in electronic medical records to ensure better analysis by their doctors. Moreover, this policy has been approved by SCHN Policy Guideline Committee while SA healthcare guideline has been approved by Australian Pharmaceutical Council. Thus, based on the AGREE II tool, both these guidelines have been documented by authorized committees and councils that denote the effectiveness of these mentioned guidelines.
AGREE II score tool suggests that any clinical healthcare policy or guideline must provide recommendations for improving the health aspect of the involved patients. The SCHN guideline provides a medication alert card that details about the level of verification of any drugs before their administration within the human system. Furthermore, every drug prior their administration needs to be confirmed by clinicians and specialists to prevent adverse drug reaction. Moreover, a categorical representation of allergies, side effects, and drug reactions are also detailed in this policy. On the other hand, the SA policy also provides recommendations for preventing drug reaction. Scott et al. (2015) opined that the effective administration of drugs along with a medication chart is necessary to safeguard the health status of the patients. Therefore, both of these healthcare policies have provided a brief recommendation to prevent drug reaction.
Applicability and independence
AGREE II tool suggests that healthcare policies must present monitoring guidelines as well as assessment criteria. In the case of SA policy, clinicians are required to monitor any adverse drug reactions within the patient's body. They need to take care of their allergies while recommending drugs. In case any drug reaction occurs then immediate medical assistance are essential to protect their patient's health status. Hedna et al. (2015) opined that in case of any health policies, apart from recommendations other clinical practices are also required to be mentioned. SCHN also mentions regarding their healthcare guidelines. Administration of drugs needs to be listed and properly documented in electronic records that could further promote the patient's health. Therefore, in this scenario, both of these guidelines abode by the AGREE II framework and given well-structured assessment criteria within the healthcare facility.
Reasons for choosing one policy over the other
The policies that are chosen for a review to analyze their efficiency in a comparative backdrop cater to the issue of adverse drug reactions in a clinical atmosphere. The guidelines 1/C/13:9082-01:00 and G0129 are tallied in accordance AGILE II checklist to evaluate the criteria met by each of them. The chosen policies are compared for their by following evaluative points.
As mentioned above, the chosen policies are checked in consideration of the given points. According to Raschi et al. (2015), the accessibility of a policy is one of the most critical parameters for its success. If the guidelines of a policy are not readily accessed by healthcare service providers, it can hinder collaboration among them. Documentation of recognized trends in reactions and documentation is also essential. Aronson (2015) state appropriate maintenance of record is essential to avoid errors in future practices. Overall, the justification for choosing these three evaluative criteria is provided through the above-mentioned statements.
The accessibility of Adverse Drug Reaction Guideline (2014) has been maintained in an optimum condition by the utilization of a publicly accessed database. Adverse drug reaction records from admission are related to a medical history of the patient with scopes of further investigation aiding the accumulated data (Australian Government Department of Health, 2018). In comparison to this, the Preventing Adverse Drug Events (2013) policy is driven by an offline accession protocol. The Adverse Drug Reaction Guideline policy has been developed in consideration of a suspected drug reaction and its preliminary information. Abdel-Latif & Abdel-Wahab (2015) comment causality of suspected or reported reactions from confirmed drugs can be tested through this categorization. In the case of the temporal association, Adverse Drug Reaction Guideline (2014) helps to evaluate the link between drug therapy and its resultant reaction.
Consultation with responsible medical service providers can help to access the prevalent causality due to the specific reactions to a drug. In addition to this, management and prevention of suspected adverse reaction to a drug necessitate desensitization under immunology (Cullinan, O'mahony, O'sullivan, & Byrne, 2016). Collaboration among medical practitioners, caregivers, and family of the patient is essential to reduce the risk of adverse drug reactions. The Adverse Drug Reaction Guideline (2014) provides relevant and credible information to its stakeholders and empowers them to take independent information. According to (Satoskar, Rege & Bhandarkar, 2015). Systematic relay of information is essential to establish healthy collaboration among the service providers. In case of Preventing Adverse Drug Events (2013), it is seen that collaboration becomes easier for areas with limited facilities. This policy can thereby be implemented to generate faster and more successful results in primary health care centers in rural and remote places (Australian Commission on Safety and Quality in Health Care, 2018). Based on the criteria of collaboration, it can be stated that Preventing Adverse Drug Events policy renders added ease in promoting collaboration among service providers with limited resources.
Reporting and documentation
Report and documentation of evaluative observation are of utmost importance to design future preventive and management strategies in this issue. As stated by Goldinger et al. (2016), the main issue in the case of informal documentation, patients cannot access the information without informing the medical service providers. Furthermore, the latter guideline can create the discrepancy in information due to the lack of formal record maintenance in databases. As per the Adverse Drug Reaction Guideline (2014), clinical service providers are mandated to notify events like the allergy to the database records. The reports are to be maintained by IIMS terminology for further reviewing by safety committees. In comparison, Preventing Adverse Drug Events (2013) policy influences the events to be recorded in medical documents and patient medication charts, alert sheets, medical history forms, and management plans. It is seen that the database management approach to record and maintain data is more efficient to monitor and reduce the adverse effects of drugs.
Overall, the discussion of possible criterion to evaluate the policies pertains to areas of recording, managing and retrieving essential data as and when needed. The policies show certain similarities in the areas of the design approach. Both of the policies emphasize on the usage of a collaborative method among clinical service providers to offer credible data and its efficient implementation. The main contrast is noted in the data documentation and retrieval. Hedna et al. (2015) explain this difference due to the gap in the time of publication. As Preventing Adverse Drug Events policy is designed before Adverse Drug Reaction Guideline, the implications of technology are seen to be limited in the former strategy.
Differences between the two policies using the AGREE II tool
Documentation is the key area that is not similar in both of these policies. Raschi et al. (2015) commented that every medication needs to be well-documented that could help other clinicians to safeguard health profile. In SCHN policy, electronic documentation of medications has been preferred. Moreover, several examples regarding documentations have been provided unlike that of SA policy. The later policy details only about documentation of medications in patient's medical care, however. Electronic documentation has not been prescribed in the mentioned policy. Satoskar, Rege & Bhandarkar (2015) stated that electronic documentation helps in securing and storing patient information. Therefore, on the ground of documentation, SCHN is better as compared to SA health policy.
Key responsibilities are also required to be mentioned in every policy as per AGREE II scorecard. Abdel-Latif & Abdel-Wahab (2015) commented that an adverse drug reaction could be effectively managed with the help of clinicians and specialists. SCHN policy denotes the responsibility of medical staffs to manage adverse drug reaction. While SA policy only provides recommendations that need to be taken while administering drugs. Therefore, this is another major difference that exists between these two mentioned policies.
Analysis of AGREE II score sheetSA healthcare policy
The main objective of this policy is to prevent adverse drug reaction by documenting the prevalence of potential allergies and medications provided to the patients. Health question has also been covered in this healthcare policy. Patients are the main focus point of this healthcare policy. At the time of medication, every patient should be monitored, and their allergies are required to be documented. Therefore, this guideline specifies their target population. Aronson (2015) commented that every policy should be developed and documented by authorized bodies. This policy has been approved by the Australian Pharmaceutical Council thereby abiding AGREE II tool specification. Moreover, the viewpoint and preferences have also been sought in this policy. Patients are the target users, and this has also been explained clearly in this policy guideline.
Core principles and background have been mentioned in this clinical policy. The policymakers are government authorized, and this showed the relevance of this guideline. However, limitations have not been justified in this research policy. Recommendations have been briefly mentioned. However, methods for formulating such recommendations have not been suggested in this policy. Apart from this, side effects and health-related risk factors have not been disclosed in this healthcare policy. Procedure for guideline update has not been mentioned in this policy. An assessment guideline of the mentioned recommendations has been provided along with monitoring criteria while barriers have not been detailed in this policy. Overall, this guideline could be recommended for use as it details about the necessities of documentation of potential allergies for preventing adverse drug reactions.Adverse Drug Reaction Guideline
The objective of this guideline is specified to reduce adverse effects of the drug on patients. The policy covers several health questions on the issues of adverse reactions and allergies related to common drugs or vaccines. The population upon which this guideline is applied are children. The development cohort of the policy involves relevant clinical professionals. In addition to this, the policy aptly evaluates the preferences and expectations of children and their families before implementing the guidelines. Jordan et al. (2018) specify the target users in this guideline to be children, and their families in a family-centered care approach. Systematic methods are applied to collect evidence from primary subjects. Selection criteria for evidence collection involve ‘unknown allergic reaction' and ‘no allergic reaction.' Strengths and drawbacks are evidenced through NSW Health Incident Information Management System. Suggested recommendations can be implemented through a publicly accessible database. Recommendations include consideration of health benefits and risks that can be experienced by the users. This policy associates recommendation to evidence through extrinsic review of the guidelines.
Scopes of frequent updates are provided for updating the guideline through cloud database management systems. Unambiguous and specific recommendations have provided different management options for allergic reactions to drugs. The key recommendation is identified as the usage of the data management system. However, no known facilitating or hindering factors have been recorded by the policymakers. The Adverse Drug Reaction Guideline offers advice to implement recommended strategies. However, these strategies can be difficult to be practiced in a rural environment, owing to lack of appropriate facilities (De (Angelis, Colaceci, Giusti, Vellone, & Alvaro, 2016) Potential resources required to apply recommendations can be considered in consideration of the auditing criteria of the guideline. The policy also presents the views of the management body that is responsible for the funding, with a lack of its influence in the guideline content. This presents an unbiased and credible exhibition of the information that can aid in service improvement for the issue of drug effects. No conflict in interest is noted, thereby implying the proficient use of a guideline in a generic drug allergy scenario.
Based on the studied information, it can be concluded that the Adverse Drug Reaction Guideline is more efficient than the Preventing Adverse Drug Events policy. The researcher has reached this decision through a comparative evaluation of both these policies using AGILE 11 tool. The policies are checked by purpose and scope provided by each of these policies. Involvement of stakeholders is also gauged through participation and collaborative benefits received by patients as well as medical practitioners. Rigour of development is analyzed in both of these policies to find that Adverse Drug Reaction Guideline is more specific in addressing the needs of patients.
Other particulars that are checked for involve presentation clarity and information applicability. Although Adverse Drug Reaction Guideline provides clarified data, the applicability of this information can be limited to the rural populace. This is because; the aforementioned guideline is difficult to be accessed in remote areas in the absence of the Internet and relevant hardware. In this instance, it can be stated that Preventing Adverse Drug Events policy is more widely applicable regarding a transnational approach. Also, this editorial independence is another criterion that is used to evaluate the policies. It is seen, that Adverse Drug Reaction Guideline provides more independence to stakeholders by empowering them with access to credible information.
Aronson, J. K. (Ed.). (2015). Meyler's side effects of drugs: the international encyclopedia of adverse drug reactions and interactions. London, United Kingdom: Elsevier.
Satoskar, R. S., Rege, N., & Bhandarkar, S. D. (2015). Pharmacology and Pharmacotherapeutics. London, United Kingdom: Elsevier Health Sciences.
Ali, S. S., Goddard, A. L., Luke, J. J., Donahue, H., Todd, D. J., Werchniak, A., & Vleugels, R. A. (2015). Drug-associated dermatomyositis following ipilimumab therapy: a novel immune-mediated adverse event associated with cytotoxic T-lymphocyte antigen four blockades. JAMA Dermatology, 151(2), 195-199. DOI:10.1001/jamadermatol.2014.2233
Davies, E. A., & O'mahony, M. S. (2015). Adverse drug reactions in special populations–the elderly. British journal of clinical pharmacology, 80(4), 796-807. DOI:
Hirsh, B. J., Smilowitz, N. R., Rosenson, R. S., Fuster, V., & Sperling, L. S. (2015). Utilization of and adherence to guideline-recommended lipid-lowering therapy after acute coronary syndrome: opportunities for improvement. Journal of the American College of Cardiology, 66(2), 184-192. DOI: 016/j.jacc.2015.05.030
Scott, I. A., Hilmer, S. N., Reeve, E., Potter, K., Le Couteur, D., Rigby, D., ... & Jansen, J. (2015). Reducing inappropriate polypharmacy: the process of deprescribing. JAMA internal medicine, 175(5), 827-834. DOI: 10.1001/jamainternmed.2015.0324
De Angelis, A., Colaceci, S., Giusti, A., Vellone, E., & Alvaro, R. (2016). Factors that condition the spontaneous reporting of adverse drug reactions among nurses: an integrative review. Journal of nursing management, 24(2), 151-163. DOI:
Goldinger, S. M., Stieger, P., Meier, B., Micaletto, S., Contassot, E., French, L. E., & Dummer, R. (2016). Cytotoxic cutaneous adverse drug reactions during anti-PD-1 therapy. Clinical Cancer Research, 22(16), 4023-4029. DOI: 10.1158/1078-0432.CCR-15-2872
Cullinan, S., O'mahony, D., O'sullivan, D., & Byrne, S. (2016). Use of a frailty index to identify potentially inappropriate prescribing and adverse drug reaction risks in older patients. Age and aging, 45(1), 115-120. DOI:
Abdel-Latif, M. M., & Abdel-Wahab, B. A. (2015). Knowledge and awareness of adverse drug reactions and pharmacovigilance practices among healthcare professionals in Al-Madinah Al-Munawwarah, Kingdom of Saudi Arabia. Saudi pharmaceutical journal, 23(2), 154-161. [Online] Retrieved from
Raschi, E., Poluzzi, E., Koci, A., Salvo, F., Pariente, A., Biselli, M., ... & De Ponti, F. (2015). Liver injury with novel oral anticoagulants: assessing post?marketing reports in the US Food and Drug Administration adverse event reporting system. British journal of clinical pharmacology, 80(2), 285-293. [Online] Retrieved from
Jordan, S., Banner, T., Gabe-Walters, M., Mikhail, J. M., Round, J., Snelgrove, S., ... & Hughes, D. (2018). Nurse-led medicines' monitoring in care homes study protocol: A process evaluation of the impact and sustainability of the Adverse Drug Reaction (ADR) Profile for Mental Health Medicines. BMJ Open, 8(9), e023377. [Online] Retrieved from
Hedna, K., Hakkarainen, K. M., Gyllensten, H., J?nsson, A. K., Petzold, M., & H?gg, S. (2015). Potentially inappropriate prescribing and adverse drug reactions in the elderly: a population-based study. European journal of clinical pharmacology, 71(12), 1525-1533. [Online] Retrieved from
“Adverse drug reaction practice guideline”; The Sydney children’s Hospitals Network; 2014. Retrieved from:
“Preventing Adverse Drug Events Policy Guideline”; Government of South Australia; 2013. Retrieved from:
Australian Government Department of Health (2018) Guiding Principle 10 - Nurse-initiated non-prescription medicine. Retrieved from: [Accessed 12 September 2018]
Australian Commission on Safety and Quality in Health Care (2018) Hospital QUM individual indicators, Retrieved from [Accessed 12 September 2018]