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Reporting and documentation of ADR/ME and TDM

Next, Documentation and report Adverse Drug Reaction and medication error. We developed the most comprehensive Intelligent Pharmacists Service System(iPASS) since year 2010. Allow pharmacists to perform verifications right after physician has prescribed a prescription through the Computerized Physician Order Entry system(CPOE) iPASS has also provided a good handy tool to assist clinical pharmacist in terms of information providing which generate a pre-medical round sheet including patient’s diagnoses, vital signs, lab data, results of cultures, current drug profile. Every pharmacist is relied on the pre-medical round sheet very much. iPass also provide documentation direct linked to electronic medical record, and back stage statistic analysis. The pharmacy note is a uniform format to communicate with other healthcare professionals. It’s usually in SOAP format.
Be sure to document the date and time for any records. The S stands for Subjective,O stands for Objective, A stands for Assessment,P stands for Plan In Subjective, it’s a brief summary of patient information, chief complaint, diagnosis and past or current medication history.
In this example: This 56-year-old male is suffered from severe septic shock rule out Urinary tract infection related, rule out fungemia related and acute on chronic renal failure. Current Prescription is Meropenem 500 mg IV per night In objective,record the vital sign, related exam results or lab data.
In this example: we wrote patient’s Creatinine, is 2.95 status post Continuous Venous to Venous Hemodialysis (CVVH), BUN is 55, and ALT is 17, White Blood Cell is 9000, Blood culture revealed Candida albicans, Temperature, Pulse, Respiratory rate were 38.3/121/18 In assessment, point out the clinical problem, or usually the drug-related problem.
In this example: we wrote Insufficient frequency of meropenem in patient with renal impairment under CVVH,the loading dose should started with 1 g followed by either 0.5 g every 8 hours or 1 g every 12 hours In plan, give doctor a clear suggestion.
In this example: we suggested Please consider to modify the frequency to every 8 hours based on renal function and close monitor for clinical response. A very important step for this validated SOAP, that is what was the physician’s responses? The best way is also to document the result after suggestion or discussion. In this case, we wrote Physician has been informed. After finishing a pharmacy note, don’t forget to upload to electronic medical record system or sign and keep in medical record. Some other efficient on-line documenting systems, such as Drug information and Consulting service system, Online ADR reporting system, Medication error reporting system.
Our consulting service system allow us to document any drug information related inquiry from ambulatory patients, discharge patients, or healthcare professionals, such as doctors, nurses or pharmacists. System also helps to distribute medication education request from patients’ ward. The types of Medication education include anticoagulants as you all familiar with warfarin or non-vitamin K anticoagulants, acute myocardial infarction,such as dual antiplatelets, initial chemotherapy,special dosage forms, for example, inhalers, insulin pen, etc. We develop online medication error and ADR reporting systems to maintain our quality and medication safety. All medication error reports must sent to Quality management center for audit. Online ADR reporting system can auto-generate an electronic -ADR report so, we can transmit to Taiwan National Adverse Drug reaction system.
We have drug safety committee to discuss complicated case,perform root-cause analysis, and draw up improvement measures three times a year. Next moving to Therapeutic drug monitoring. Hospital Accreditation Criteria of Taiwan in Pharmacy Practice state Pharmacists should provide individualized evaluation on patient’s medication therapy. Also, Pharmacists should perform therapeutic drug monitoring (TDM). For those beyond reference range reports, the computer will automatically sent alert text message via work cell phone to the duty pharmacists, for example, the ICU pharmacist, specialty pharmacist, transplantation care pharmacist or on-call duty pharmacist. Once received an abnormal TDM report, he or she will calculate the estimated therapeutic drug concentration according to patient’s pharmacokinetic parameters and suggested dose adjustment.
Discuss and make suggestion to patient’s physician and keep pharmacy note in record. There are 21 Drug Items of TDM in Taipei Veterans General Hospital, some of the well-known drugs, for example, the antiepileptic drugs, Valproic acid, phenytoin, carbamazepine including free form and total form, lithium, acetaminophen, Tri-cyclic antidepressants, Methotrexate, cyclosporine, tacrolimus, sirolimus, Digoxin, amikacin, Vancomycin including peak and trough levels. We also need to follow-up vancomycin below reference range of 9 mcg/mL because we need to quickly response if subtherapeutic range of vancomycin trough level is due to underdosing. We found monitoring drug concentration, suggesting dose reduction, and monitoring side effects were the top 3 frequently intervention for TDM service.
Other interventions are suggesting dose titration, frequency adjustment, discontinue medication, error sampling time, monitor renal and liver functions, monitor free-form concentration. In addition, We analyze the acceptance rate of these intervention. The acceptance rate is greater than 95%. Most physicians accepted pharmacists’ suggestion on TDM service.

Ms Chao continues to give detailed examples of clinical pharmacy services (CPS) TVGH provides, including reporting and documenting adverse drug effects (ADR) and medical error (ME), and therapeutic drug monitoring (TDM).

Document and report ADR and ME:

This is supported by computerized systems such as the Intelligent Pharmacists Service System (iPASS) which provide information in the form of a pre-medical round sheet. iPASS also help pharmacist document records. At TVGH the default format of pharmacy notes is the SOAP format.

  • S stands for Subjective, a summary of patient information, chief complaint, diagnosis, and past or current medication history.
  • O stands for Objective, which includes records of the vital signs, related exam results or lab data, etc.
  • A stands for Assessment, identification of the clinical problem, usually the drug-related problem.
  • P stands for Plan, suggested adjustments, or interventions. The outcome (whether physicians accepted the suggestions and patients’ conditions) is also recorded here.

We will see a couple of examples in SOAP format.

Next, reporting system. It consists of consulting service system, online ADR reporting system, and a medication error reporting system. Consulting service system allows pharmacists to document any drug information-related inquiry from ambulatory patients, discharge patients, or healthcare professionals. Medication error and ADR reporting systems can help pharmacists to maintain quality and medication safety.

Share and learn:

  • How do you usually record ADRs and MEs? Is there a uniform format at the hospital you work at?
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Good Pharmacy Practice: Introduction to Clinical Pharmacy Services

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