3. Medication Safety

National Patient Service (NPS)

independent organisation, good source for unbiased information for quality use of medicines, provision, educates HCP, consumer education programme

Know the medications you are dispensing

suggested framework: pharmacology indications contraindications side effects special precautions dose & administration regimen

Medications are safe/unsafe depending on

the different stages of pregnancy

Competency Standards

to protect consumers from harm by managing and responding to the risk inherent in medication management systems

Monitoring

to see the medication efficiency, harm, if they are used appropriately

Medication safety with children

try to acknowledge the child, inform them at certain age, weight & age needs to be considered, safe storage

Adverse drug reaction

unexpected harm; everything was right but the pt was harmed

For no confusion

use generic names e.g. paracetamol not panadol

Adverse Drug Event

where harm actually occurred; may be preventable/not preventable

CM

you still report it to ACSOM

Listed products (AUST L)

-Assessed for safety and quality of manufacture -Efficacy not assessed

Registered products (AUST R)

-Assessed for safety, quality and efficacy -More rigorous evaluation, regulation and monitoring

Regulation of CM in Australia

-CMs are regulated by the TGA, most CMs: listed not registered

The Therapeutic Goods Administration (TGA)

-Is part of the Australian Government (Commonwealth) Department of Health & Ageing -Responsible for regulating medicines & medical devices -The group that administers the TGA 1989 & regulations -Apply a risk management approach to ensure therapeutic goods supplied in Australia meet acceptable standards of quality, safety & efficacy (AUST L/R) -Oversee inclusion of therapeutic goods in the Australian Register of Therapeutic Goods (ARTG), monitor advertising, labelling, product appearance & appeal guidelines

Factors contributing to the increased risk of medication incidents

-Type of patient -Poor communication -MOST COMMON (bet. health professionals & pts., bet. GPs & pharmacists, among health professionals) -Lack of safety culture in workplace -Lack of checking & double checking habits -Inadequate staff, excessive workload, interruptions, inadequate supervision, boredom (auto-pilot)

Medication Safety is part of the QUM

-before giving out the med. first know if it's used JUDICIOUSLY (used only when appropriate, with non-medicinal alternatives considered as needed IS THE MEDICINE NECESSARY? -APPROPRIATE USE -SAFE USE -EFFICACIOUS USE

Breastfeeding- What we avoid

-cause adverse effects in breast fed infant -decrease maternal milk supply

Responsibilities for quality use of medicines

-contribute to knowledge of issues/risk and benefits -improving the medication -working in partnership to achieve quality use of medicines

MedsCheck & Diabetes Medscheck

-in-pharmacy review of a patient's medicines and focuses on education and self-management/type 2 diabetes medicines management, monitoring devices, education and self-management -aims to optimize a patient's effective use of medicine and reduce incidents

High risk medication

-narrow therapeutic window: medications with small difference bet. therapeutic dose and toxic dose -anything with multiple interactions (with other medications; metabolism) -potent medications: requires small dosage for large effect -complex dosage and monitoring schedules

Errors in prescribing/rec. a medicine

-not knowing about the drug- it's indication and contraindications -not considering individual pt. factors e.g. allergies -wrong pt., drug, route dose, time -inadequate communication -documentation- illegible, incomplete, ambiguous -mathematical error- calc. dosage -incorrect data entry when prescribing

NPS

-pt. resources (e.g. warfarin dose tracker) -Medicine Wise Campaign, relates to IDARL, encourages pts. to be informed about their meds.

Safety concerns of CM

-risk: often underestimated; adverse reactions, interactions & toxicity -easy availability: sold without assistance -possibility of non-disclosure: pts. shy away from talking about CM to their health prof. leading to increased risks, also delayed diagnosis- they try to solve issues with CM -limited safety data: little money towards CM safety research -wrong dosing -use of multiple CM: overlapping & interactions -use in pregnancy -labelling: not always clear or easy to read, indications sometimes vague (although this can be due to TGA regulatory requirements), misleading 'claims' -false hope of a cure

Harm during pregnancy

-some are transported across the placenta; interfering with the baby's development -others damage the placenta; restricting the amount of nourishment delivered to the baby -some bring premature labour

Lack of money for CM

-study designs are poor, not well informed, reviews too broad -may have wrong info: dose, indication, product, co-factors

Errors in dispensing

-suitability of medicine (not for the individual pt., factors not considered) -medicine given to wrong pt. -incorrect data entry- wrong dose on label, wrong drug dispensed, wrong route on label, wrong dosage form dispensed -inattention/misinterpretation- look-a-like, sound-a-likes -inadequate communication: confusing/unclear verbal counselling/directions on label -medicine poorly labelled

Have pt. actively invol.

-use IDARL for counselling on a new medication -start with the benefits when counselling -involved by informing them

Guide- Pregnancy & Breastfeeding

-use medicines that have been widely used in preg./breastf. over new medicines (less data) -choose topical/local over systemic -look @ pharmacokinetics- infant exposure minimised by meds with short half-life, high protein binding, low oral bioavailability or high molecular weight -check and always use multiples of references -don't rely on ADEC categories -consult with GP, obstetrician & pt.

TGA

-wants us to report everything: adverse events of all meds./vaccines -especially: new meds/vaccines, meds. & vaccines interactions, unexpected/unexplained adverse events (not described in the product info.), serious adverse events -seemingly insignificant/common adverse events can contribute to the TGA's investigation of a potential safety signal

TGA Report process

1. Reports get submitted to TGA's Pharmacovigilance & Special Access Branch (PSAB) 2. PSAB assess the report for minimum details i.e. an individual patient, an adverse event, at least one suspected medicine or vaccine (may include interacting or other therapeutic products), an identifiable reporter 3. PSAB assess causality of adverse event(s), if serious, reports are reviewed by medical officers 4. Reports entered into database (DAEN) 5. Reports are forwarded to WHO Collaborating Centre for International Drug Monitoring; global database

TGA- responsible for:

1. pre-market assessment 2. licensing of manufacturers 3. POST-MARKET VIGILANCE

Communicate clearly

5Ss Sincere: don't bluff, lie or guess Simple: avoid technical language, unnecessary information Short: key info, small bundles of information: easier to remember Specific: avoid vague advice - "eat healthily", "exercise more" Summarise: you, them, feedback

Errors

Ambiguous Nomenclature- if in doubt CHECK

CM-The lack of clinical study data makes treatment decisions more complex

BUT → does not automatically mean there is NO evidence! Lack of Evidence ≠ Negative Evidence

Medications associated with the highest risk of adverse events in adult patients

Cardiovascular drugs, antithrombotic agents, analgesics, antibiotics, oral antidiabetic agents, antidepressants, anti-epileptic drugs and chemotherapeutic agents

Complementary Medicine Safety

Herbs, vitamins, aromatherapy, dietary supplements, homeopathy, accupuncture

TGA advisory committees (10)

Know these 2 safety committees: Advisory Committee on Safety of Medicines (ACSOM): for medication safety; adverse drug reaction reporting Advisory Committee on Safety of Medical Devices (ACSMD)

Pharmaco-genomic Testing

Pharmacists can provide/use/see if an individual is prone to adverse effects of drugs; prediction It is the pharmacist who does the counselling and inform the pts.

Medication Management Cycle

Prescribe- decision of treatment Dispense Administer Review

Other safety methods

Project stop & MedsAssist

Quality Use of Medicines & CM

QUM includes complementary medicines, 'the term 'medicine' includes prescription, non- prescription & complementary medicines'

National Medicines Policy (NMP)

Quality use of medicines (one of the key objectives)

Medications associated with the highest risk of adverse events in paediatric patients

Respiratory drugs, antibiotics, antihistamines and analgesic

Pharmacogenomics

The study of variations of all genes (the genome) as related to drug response

Tall Man lettering

Typographic technique: using selective capitalisation to help make similar looking medicine names more easily differentiable; to reduce drug name confusion The Australian Commission on Safety and Quality in Health Care (The Commission) supports the use of Tall Man lettering

Errors in drug administration

Wrong: pt., route, time, dose, drug Omission, failure to administer Inadequate doc. & communication

Side effect

a known effect, we know what will happen

Check suitability of treatment for individual pts.

allergies, size of pt.-weight/age, pregnancy, breastfeeding, co-morbidities, other medicaiton

Adverse event

an incident in which a pt. is harmed

Medications associated with the highest risk of adverse events in elderly patients

anticholinergics, benzodiazepines, antipsychotics, sedatives and hypnotics, and oral corticosteroids

Elderly

av. on 5 or more medications- polypharmacy difficulties with identifying medications

CAM

complementary & alternate medicines

Evidence based CM

difficult to interpret, due to lack of evidence DON'T CONFUSE WITH NO EVIDENCE & EVIDENCE THAT DOESN'T WORK There are CM textbooks/references- Natural Medicines Database

Medicine risks:

dosage, frequency, route of administration duration of treatment, presence/absence of other medicines, the pt.'s illness medication history, genetics, allergies, medication errors

Post-market vigilance

drugs alr. on the market but something's wrong with them then we go to TGA

Expired Medicines

encourage pt. to bring unwanted, unused/expired med. to pharm. for safe disposal

Errors

especially made from transfer of care (documentation errors during transfer) between hospital and community settings; e.g. home, residential aged care, hospitals

Error

fail to carry the right action; incorrect plan

Memory aids

have good, updated textbooks/ebooks, dont rely on the comp. programs, protocols & SOPs, self-care cards, drug/product specific aids, Customer Medicine Information

Errors in monitoring

lack of monitoring for side effects, drug not ceased (if not working, although it's completed), drug levels not measure/followed up, communication failures

Medication error

may not result in any harm, pt. may be harmed, or nearly harmed; preventable incidents

Medication with the elderly

most at risk, we need to explain to them, their body from age metabolise, absorb the medications differently, more prone to side effects, often under-dosed due to ppl. scared of giving higher dose, polypharmacy is an issue

Pharmacist responsibilities

must assist the pts., inform them about the medicines, inform them about risks, use obj. evidence based information

Medications- Pregnancy & Breastfeeding

must be handled with care with all medicines- prescription, non prescription, complementary

QUM

one of the central obj. of Aus. NMP, it is a strategic action plan derived from the national strategy

Who are most at risk?

ppl who: are elderly, get transferred, cannot communicate well, have more than one doctor, do not take active role in the medication use, children/babies (dose calculation), use high risk medicines, serious health conditions, take multiple medications (polypharmacy)

Collect pt. history

print out 6 month drug history helps to reduce medication errors

Medications during Breastfeeding

some may pass in breast milk in high conc. with resulting adverse effects to the baby

Listed CMs on TGA:

• May only contain pre-approved low-risk ingredients. • Must not make claims for a benefit for the treatment or prevention of serious illness. • Must adhere to strict advertising rules about making health claims. • Consumers should be made aware that listed medicines are not evaluated for efficacy, & TGA only regulates for safety • Certain restrictions are applied including dosages and labelling e.g. herbal ingredients containing caffeine require label warnings