1. Medication Safety

2. Objectives To know Medication Safety Terminology.
To Understand the relationship between medication errors, adverse drug events & adverse drug reactions
To Know the Types of Medications Errors.
Recommendations to Prevent Medication Errors.
Monitoring & Managing Medication Errors.
the role of pharmacist in medication safety including pharmacovigilance & SFDA pharmacists responsibilities

3. Medication misadventure
is a very broad term.
It refers to any hazard or incident associated with medications.
A medication misadventure may or may not cause an injury to a patient.

4. Medication misadventure
Adverse Drug Events (ADEs): An ADE is the next broadest term. It refers to any injury caused by a medicine. An ADE refers to all ADRs, including allergic reactions, as well as medication errors that result in harm to a patient.
Adverse Drug Reactions (ADRs): refer to any unexpected, unintended, undesired, or excessive response to a medicine. Drug-drug interactions can also fall into the category of ADRs.
A MEDICATION ERROR is any preventable event that has the potential to lead to inappropriate medication use or patient harm.  

5. Medication Misadventure
ADRs
Medication errors
ADEs
Medication Misadventure

6. 1.3 million people annually in the United States.
Medication Errors
Medication errors cause at least one death every day and injure approximately
1.3 million people annually in the United States.

7. Medication errors can occur anywhere
Prescribing
Repackaging
Dispensing
Monitoring
Administration

8. Errors are not the result of an individual failure, but of a systems failure.

9. Medication Errors Definition
“Any preventable event that may cause or lead to inappropriate medication use or patient harm while the medication is in the control of the health care professional, patient, or consumer.”

10. Medication errors classified according to where they occur in the medication use cycle, i.e. at the stage of prescribing, dispensing, or administration of a drug.

11. Types of Medication Error
Prescribing Error
Incorrect drug selection (based on indications, contraindications, known allergies, existing medication therapy, and other factors), dose, dosage form, quantity, route, concentration, rate of administration, or instructions for use of a medication product ordered or authorized by Physician
Omission Error
The failure to administer
an ordered dose to a patient
before the next scheduled dose, if any.

12. Types of Medication Error Cont’d
Wrong Time Error
Administration of medication outside a pre-defined time interval from its scheduled administration time.
Improper Dose Error
Administration to the patient of a dose that
is greater than or less than the amount
ordered by the prescriber or administration
of duplicate doses to the patient.
Example: one or more dosage units in addition
to those that were ordered.

13. Types of Medication Error Cont’d
Wrong Medication - Preparation Error
Medication product incorrectly formulated or manipulated before administration.
Wrong Administration Technique Error
Inappropriate procedure or improper
technique in the administration of a medication.
Example: wrong route/site or rate
of administration

14. Types of Medication Error Cont’d
Monitoring Error
Failure to review a prescribed regimen for appropriateness and detection of problems, or failure to use appropriate clinical or laboratory data for adequate assessment of patient response to prescribed therapy.
Compliance Error
Inappropriate patient behavior regarding
adherence to a prescribed medication regimen.
Other Medication Error
Any medication error that does not fall into
one of the above pre-defined categories.

15. PRESCRIBING ERRORS
Prescribing errors may be defined as the incorrect drug selection for a patient.
Such errors can include the dose, quantity, indication, or prescribing of a contraindicated drug.
Contributing factors include:
Lack of knowledge of the prescribed drug, its recommended dose
Lack of knowledge of patient details contribute to prescribing errors
Illegible handwriting.
Inaccurate medication history taking.
Confusion with the drug name.
Inappropriate use of decimal points. A zero should always precede a decimal point (e.g. 0·1). Similarly, tenfold errors in dose have occurred as a result of the use of a trailing zero (e.g. 1·0).
Use of abbreviations (e.g. AZT has led to confusion between zidovudine and azathioprine).
Use of verbal orders.

17. Computerised physician order entry systems eliminate the need for transcription of orders by nursing staff and for interpretation of orders by pharmacy staff and have been shown to have a significant effect on reducing medication errors related to prescribtion.

18. DISPENSING ERRORS
Dispensing errors occur at any stage of the dispensing process, from the receipt of the prescription in the pharmacy to the supply of a dispensed medicine to the patient. Dispensing errors occur at a rate of 1–24 % and include selection of the wrong strength or product. This occurs primarily with drugs that have a similar name or appearance.
Other potential dispensing errors include wrong dose, wrong drug, or wrong patient and the use of computerized labeling has led to transposition and typing errors which are among the most common causes of dispensing error.

19. Approaches to reducing dispensing errors include:
• Ensuring a safe dispensing procedure. • Separating drugs with a similar name or appearance. • Keeping interruptions in the dispensing procedure to a minimum and maintaining the workload of the pharmacist at a safe and manageable level. • Awareness of high risk drugs such as potassium chloride and cytotoxic agents. • Introducing safe systematic procedures for dispensing medicines in the pharmacy.

20. Look-Alike Medications:
These refer to names of medications, which due to their spelling, may look similar to other medications’ names, and the distribution/administration of these medications may be prone to errors. Also refer to product labeling/packaging.
Example
Prozac ® and Proscar®

21. Sound-Alike Medications:
These refer to names of medications, which due to their pronunciation, may sound similar to other medications’ names, and the distribution/administration of these medications may be prone to errors.
Example
Dianben ® and Diovan®

22. General Recommendations for Preventing Medication Name Mix-ups:
Several preventative strategies exist to help reduce the chance of these errors, one of which is Tall Man Lettering.
- Examples of Tall Man Lettering:
Chlorpromazine …ChlorproMAZINE
Chlorpropamide ... ChlorproPAMIDE
Store in different locations in pharmacies and patient care units.
Involve patients and their caregivers.

23. General Recommendations for Preventing Medication Name Mix-ups:
Develop strategies to overcome illegible prescribing:
- Printing (NOT writing) of medication names and dosages.
- Computerize prescribing.
- Indication for use to be included on the prescription.
Encourage reporting of errors.
Implement Policies which:
Minimize verbal and telephone orders.
Continue to employ independent double checks in the dispensing and administration processes.
Barcoding, Automated Distribution Cabinets and Robotics.

24. Important Reminder!! Medication Names Should be Written In Full
Abbreviations Are Not Permitted
The listed recommendations are applied to all orders and all medication related documentation (e.g., handwritten or on pre-printed forms).
Place adequate space between the full medication name, dose and unit of measure.

25. ADMINISTRATION ERRORS
Administration errors occur when a discrepancy occurs between the drug received by the patient and the drug therapy intended by the prescriber.
Drug administration errors largely involve errors of omission where the drug is not administered for a variety of reasons. Other types of drug administration errors include an incorrect administration technique and the administration of incorrect or expired preparations.

26. Approaches to reduce drug administration errors include:
• Checking the patient’s identity. • Ensuring that dosage calculations are checked independently by another health care professional before the drug is administered. • Ensuring that the prescription, drug, and patient are in the same place in order that they may be checked against one another. • Ensuring the medication is given at the correct time. • Minimizing interruptions during drug rounds.

27. Most Frequent Serious Medication Errors Occur With:
Insulin
Infusion Devices
Patient Controlled Analgesia (PCA)
Parenteral Narcotics
Anticoagulants (Heparin, Warfarin)
Cancer Chemotherapy
Neuromuscular Blockers
Conscious (Procedural) Sedation
Concentrated Electrolytes (potassium, magnesium and phosphate)

28. Recommendations to Prevent Medication Errors Cont’d
Accept that errors will occur; slips, lapses and mistakes will happen.
Redesign the system.
Focus on the system, not the people.
Everyone is involved in safety (individual practitioners & organizational leadership).
Make the medication errors visible.
Minimize the consequence of medication errors.
Report, analyze and share medication error incidents.
Promote a Culture– in reporting medication errors.

29. Recommendations to Prevent Medication Errors
Adopt a system-oriented approach to medication error reduction such as: (time-out, & technology confirmation).
Use technology effectively such as:
- Implement Computerized Physician Order Entry (CPOE).
- Use of Automated Dispensing Cabinets.
- Use of Pharmacy Dispensing Robotics.
- Use of Barcoding in medication and patient identification.
- Use of Smart Infusion Pumps.

30. Recommendations to Prevent Medication Errors Cont’d
Implement a unit dose system.
Have the Pharmacy supply High-Alert intravenous medications and Do Not store concentrated electrolytes solutions (potassium, magnesium, and phosphate) on patient care units.
Use special procedures and written protocols for the use of High-Alert Medications.
Ensure the availability of Pharmacist during patient care rounds.

31. Recommendations to Prevent Medication Errors
Make relevant patient information available at the point of care.
Improve patient knowledge about treatment.
separate storage areas, color differentiation, and change products.

32. A New Way of Thinking in Medication Safety:

33. Monitoring Medication Errors:
Ongoing quality improvement programs for monitoring medication errors are needed. Medication errors should be identified and documented and their causes studied in order to develop systems that minimize recurrence.
Several error monitoring techniques exist: (e.g. anonymous self-reports, incident reports, critical incident technique and disguised observation audits).

34. High Alert Medications
Definition:
Medication that have a higher likelihood of causing injury if they are misused. Errors with these medications are not necessarily more frequent – just that their consequences may be more devastating.

35. High Alert Medications Classes/ Categories List:
Adrenergenic agonists (e.g., Epinephrine, Phenylephrine, Norepinephrine)
Adrenergenic antagonists (e.g., Propranolol, Metoprolol, Labetalol)
Anesthetic agents, general, inhaled, and IV (e.g., Propofol, Ketamine)
Antiarrhythmic, IV (e.g., Lidocaine, Amiodarone)

36. High Alert Medications Classes/ Categories List:
Chemotherapeutic agents, parenteral and oral
Dextrose hypertonic, 20% or greater
Dialysis solutions, peritoneal and hemodialysis
Epidural or Intrathecal medications
Hypoglycemics, oral
Inotropic medications (e.g., Digoxin, Milrinone)
Liposomal forms of drugs (e.g., Liposomal Amphotericin B)

37. High Alert Medications Classes/ Categories List:
Moderate sedation agents, IV (e.g., Midazolam)
Moderate sedation agents, oral, for children (e.g., Chloral Hydrate)
Narcotics / Opiates, IV, transdermal, and oral (including liquid concentrates, immediate and sustained-release formulations)
Neuromuscular blocking agents (e.g., Succinylcholine, Rocuronium, Vecuronium)

38. High Alert Medications Classes/ Categories List:
Antithrombotic agents (anticoagulants), including Warfarin, Low- Molecular-Weight Heparin, IV Unfractionated Heparin, Factor Xa Inhibitors (Fondaparinux), Direct thrombin inhibitors (e.g., Argatroban, Lepirudin, Bivalirudin), Thrombolytics (e.g., Alteplase, Reteplase, Tenecteplase) and Glycoprotein IIb / IIIa Inhibitors (e.g., Eptifibatide)
Radiocontrast agents, IV
Total parenteral nutrition solutions

39. Actions That Can Be Taken In Clinical Areas:
Risk awareness – Be aware of high alert products in your area.
Review Floor Stock to reduce availability of items, as well as, quantities. • Use of shelf labeling which incorporates TALLman lettering.
Separate storage for easily mistaken medicines.
Additional product labels.
Read the label three times .
Insure proper and correct programming of infusion pumps.
Independent double checking system (e.g., IV medication and infusion pumps).
Standardize the prescribing/order entry/IV infusion labeling/ pump settings.
Know the medications that you administer e.g., dose, route, frequency, effect, common adverse effects, & monitoring (laboratory & clinical).

40. PHARMACOVIGILANCE
Pharmacovigilance is defined as the science and activities concerned with the detection, assessment, understanding and prevention of adverse reactions to medicines (i.e. adverse drug reactions or ADRs). The ultimate goal of this activity is to improve the safe and rational use of medicines, thereby improving patient care and public health.

41. Why is Pharmacovigilance important?
When a medicine is released onto the market there is still a great deal that is unknown about the safety of the product. Once marketed the medicines are used by patients who have many different diseases, who are using several other drugs and who have different traditions and diets which may affect the way in which they react to a medicine. Different brands of medicines may differ in the manner in which they are produced and the ingredients that are used. The adverse drug reactions and poisonings associated with traditional and herbal remedies also need to be monitored in each country. The information we receive on the adverse effects of drugs in other countries may not be relevant or applicable to {Country}’s citizens. In some cases, adverse effects to certain drugs may only occur in {Country}’s citizens.

42. In order to prevent unnecessary suffering by patients and to decrease the financial loss sustained by the patient due to the inappropriate or unsafe use of medicines, it is essential that a monitoring system for the safety of medicines in {Country} is supported by doctors, pharmacists, nurses and other health professionals in the country.
The {Drug Regulatory Authority SFDA} and the Department of Health’s Essential Drug Program are committed to improving drug safety through adverse drug reaction monitoring in {Country}. Through the {Drug Regulatory Authority}’s national Pharmacovigilance program , adverse reactions should be reported on a daily basis.

43. Saudi food and drug authority

44. Quizze Give three types of medication errors .
In brief what is Pharmacovigilance

45. Compliance This is a term that has been established to describe a patient’s degree of conformity with the advice and recommendations given by health professionals. The term non-compliance was used to describe significant failure to conform with the advice and recommendations to an extent that it interferes with achieving the patient outcomes planned. Since this term has a negative nuance for the patient and overrides the concept that the patient may have a problem with the medication or recommendations, the term non-compliance is not very much supported today. .

46. Why the “compliance” is not preferred?
The concept of compliance seems to denote a relationship in which the patient has a passive role and is expected to follow the doctor’s orders. Since the term does not emphasizes patient participation, there has been a shift towards the use of ‘adherence’ as a term instead

47. Adherence
As opposed to the concept of compliance, adherence
seems to denote a relationship in which the patient
has an active role and is expected to contribute to the
establishment of the treatment to be followed. In the
concept of adherence the patient is free to decide
whether or not to adhere to recommendations by
health professionals and failure to do so should not be
a reason to blame the patient. Health professionals
have a responsibility to facilitate adherence.

48. Concordance
This term is used to denote the degree to which the
patient and the health practitioner agree about the
nature of the illness and the need for management,
and the relative risks and benefits of the proposed
line of treatment. In the concept of concordance, the
patient’s views are taken into account during the
prescribing phase in order to increase the likelihood
of better compliance.

49. TYPES OF NON- ADHERENCE
– accidental non-adherence: forgets to take medication or is unable to take medication due to lifestyle – triggered non-adherence: cannot take medication due to drug-related problem – intentional non-adherence: decides not to take medication.

50. Classification of non-adherence
• The ideal situation – adherence achieved
• Few errors (0–15%) – partial adherence
• Major default (15%) – partial/non-adherence.

51. Measurement of non-adherence
• Direct methods: observation of ingestion of the
drug or by detecting its presence in body fluids
• Indirect methods: assume ingestion based on
proxy evidence such as patient’s self-reporting,
number of dosages remaining, number of dosages
removed from a container through data recorded
in medication compliance aids. These include:
tablet counts: counting number of units left in container
patient diary cards: reporting by patient
electronic monitors: incorporation of electronic devices into the medicine container recording time and date of usage
clinicians’ estimates and therapeutic outcomes
patient self-reporting on health status and how the condition has improved.

52. Causes of non-adherence
• Therapy-related factors: type of dosage form (e.g.
large solid oral dosage forms, inability to use
metered dose inhalers), problems with handling
container (e.g. opening of child-resistant containers, blister packs), polypharmacy (e.g. patient has to handle a number of different drugs), dosage frequency (e.g. multiple daily dosing), occurrence of side-effects
• Condition-related factors: non-adherence
particularly noted in conditions where patient is not seeing benefit from drug therapy (e.g. hypertension), in conditions that are associated with a social stigma (e.g. psychiatric disorders, HIV), where patients may not be ready to accept medications for the condition (denial of illness or of need for medications)

53. • Patient-related factors: patient’s knowledge,
beliefs about and attitudes towards medicine and
disease state
• Health-system factors: relationships with the
healthcare team, ability to get prescription and
medicines, inadequate patient education
• Social and economic factors: social factors such
as lack of patient support and income, problems
with living conditions and problems at home,
level of education and literacy.

54. Strategies to improve patient adherence
• Labelling: large (font size), clean (printed),
simple, specific
• Packaging: while taking into account stability of
the product, ensure patient accessibility and acceptance of product appearance
• Compliance aids: use of devices that can be used to remind patient to take medication, dispensing medication in blister pack according to dosage regimen, preparing medicine reminder charts, administration devices (e.g. eye-drop applicators)

55. • Review patient prescriptions and medications: to reduce dosing frequency and multiple drug therapy where relevant
• Improve patient–pharmacist–doctor rapport
• Ensure effective patient information

56. Guideline on medicines adherence.
NICE (National institute for health and care excellence)