Medication Safety Beyond Institution: Issues and Magnitude of the Problem Pr Prof ofesso essor r Dr Dr. . Moha Mohamed med Azmi Azmi Ahma Ahmad d Has Hassali sali B.Pharm (Hons), M.Pharm (Clin Pharm), Ph.D (VCP, Monash, Aust) Professor of Social and Administrative Pharmacy, School of Pharmaceutical Sciences, Universiti Sains Malaysia, 11800 Minden, Penang, Malaysia. E-mail: azmihassali@usm.my
Presentation Outline Context of medication use in the society Challenges in medication safety beyond institution Role of pharmacists in ambulatory medication safety process Recommendations for improving medication safety beyond institutions.
Introduction • Use of medicines can be complex: – It can be used for the purpose of medical treatment or improving wellness and well being. or – Misused for other purposes. • Amount of medicines in market is increasing day by day - Era of “Pharmaceutical Invasion.” • Over the years medicine regulation and control have also continued to evolve, and last but not least so have people’s views and attitudes toward the use of medicine.
Setting The New Scene …. • Drawn on the following resources: • Ministers' Summit held before the FIP Centennial Congress in Amsterdam in 2012 • The reports prepared for that meeting: • World Health Organization • IMS Institute for Healthcare Informatics • Outline the potential savings that could be made (both in lives and monetary terms) by addressing avoidable wastage in relation to medicines use
Advancing The Use of Medicines
IIHI Approach Global modelling analysis of the avoidable cost opportunity based on best available data (WHO, WB, OECD, IMS Health) from 186 different countries. Focused on 6 “levers” – avoidable costs due to patient non-adherence untimely medicine use antibiotic misuse and overuse medication errors suboptimal generic use mismanaged polypharmacy
Example of Estimated Avoidable Cost from Different Countries
About US$500 Billion May be Avoided Through Better Responsible Medicine Use
Recommendations
Statistics on Medicines Registered in Malaysia Number of products registered (2007- 2014) 1400 1200 1000 800 600 Cumulative Number of 400 Products Registered 200 0 2007-2014 2007 2008 2009 2010 2011 2012 2013 2014 2869 Prescription 449 409 412 441 325 357 241 235 1477 Non prescription 413 272 313 235 55 83 54 52 6117 Natural 1342 953 1040 582 467 565 578 590 Veterinary 443 0 0 0 54 52 45 63 207 Health Supplement 0 0 0 0 168 161 85 128 542 Source: National Pharmaceutical Control Bureau Annual Report 2014.
News From JAMA Kuehn BM. JAMA. 2014 Aug 20. doi: 10.1001/jama.2014.10310 .
Findings From The National Survey On The Use Of Medicine By Malaysian Consumers 2015 Total Number of Respondents =3,081 % Did not understand the proper use of medicines 18.6% Did not recognize their own medicines generic names 46.8% Did not know the common side effects of the medicines 29.7% Did not aware on medicines expiry date 9.2% Did not know that medicines must be registered with MOH 13.8% Did not know the correct way of medicines storage 17.0% Forgot/ careless in taking medicines 73.1% Sharing medicines with others 33.9%
The Importance of Medication Safety Beyond Hospital • The vast majority of health care is delivered in ambulatory settings. • There are 900 million visits to physicians’ offices in the United States each year, as compared with 35 million hospital discharges, and spending on outpatient care is the fastest growing segment of health care spending. • Adverse Drug Events (ADE) occurred in 25% of primary care patients and that 11% of these events were preventable. Gandhi TK, Lee TH. Patient safety beyond the hospital. N Engl J Med. 2010 ;363(11):1001-3
Medication Safety Beyond Hospital: The Missing Link Public/Private Hospitals Can Opt For Option 1 & 2, 2 & 3 or 1 & 3 Simultaneously Patients Discharged From These Hospitals Option 1: Option 3: visit Public Primary Visit Community Healthcare For Pharmacies For Follow up Follow up Option 2: Visit Private GPs For Medication Follow up Information Link Is Missing Among Institutes Wachter RM . Is ambulatory patient safety just like hospital safety, only without the "stat"? Ann Intern Med. 2006;145(7):547-9 .
A Case of Medication Mix-up at Patient Home • 76 yrs old Male patient with DM and HPT was discharged from a public hospital after 3 days of admission due to uncontrolled DM. Patient went back to his house- staying with his wife and been given the following medications during discharge: • Insulin Injections • Frusemide 40mg OM • Simvastatin 20mg ON • Gliclazide 80mg BD • Following 3 weeks after discharge, the patient suffered from URTI and seek treatment at a private hospital. The patient was given the following medications: • Ramipril 2.5mg OM • Moxifloxacin 400mg daily for 5 days • Bromhexine 8mg TDS • Simvastatin 20mg ON
A Case of Medication Mix-up at Patient Home • During the home visit, there are also other medications and supplements that the patient bought from pharmacy. • The patient also admits that he is confused about his medications. • Issues noticed during counselling: The patient is taking a double dose of statin. Patient is complaining of severe syncope like symptoms after taking the first dose of Ramipril and discontinued treatment. Insulin preparation was stored in the freezer.
Medication Safety Beyond Hospital: The Challenge
Medication Safety At Home: The Issues- Storage
Inappropriate Use Of Medication At Home : The Issues - Safety & Cost “ Home visit by hospital pharmacists identified the total cost of collected excessive medications from 103 patients’ house was RM 4,869.91(USD1623) with average cost RM 47.28 (USD15.76) per patient”.
Medication Safety: Role of Pharmacists • Ensuring medication safety is a challenge for each dose to be administered or to be taken. • To ascertain the safety of medications, pharmacists should be able to: Ensure suitable selection and procurement of medicines Warrant rational prescribing of medicines Assure safer writing of prescriptions Guarantee appropriate dispensing of medicines Advise and manage proper storage of medicines Monitor secure administration of medicines Reconcile medicine histories
Recommendations for Reducing The Risks of Medication Errors Taking an accurate medication history Pharmacists obtain better medication histories than physicians and reduce the rate and severity of medication errors during acute admissions. Furthermore, pharmacists attending medical or surgical post-take (admission) ward rounds improve drug history documentation, reduce prescribing costs, and prevent adverse drug reactions . Agrawal A et al. Medication errors: problems and recommendations from a consensus meeting. Br J Clin Pharmacol. 2009;67(6):592-8
Dispensing of Medicines • Pharmacists should ensure that medicines are delivered to patients in a safe and secure manner. • During the dispensing process: reconcile prescription(s) and confirm indication(s) of medicine therapy with the patient or agent perform counseling and document refusal ask questions to assess patient and caregiver level of understanding encourage patients and caregivers to ask questions or raise concerns about their medicines.
Labeling Regulation For Dispensed Medication • In Malaysia, since 1st January 2004, a legal requirement to include details in the label, was made in the Poisons Regulations under the Malaysian Poison Law 1952. • Under Regulation 12(1) of the Poison Regulation 1952, where any poison is sold or supplied as a dispensed medicine, or as an ingredient in a dispensed medicine, the container of such medicine shall be labelled with: – the name and address of the supplier or seller – the name of the patient or purchaser – the name of the medicine – adequate directions for the use of such medicine – the date of delivery of such medicine – where such medicine is sold or supplied and entered in a prescription book, with a reference to the serial number of the entry in such book relating to such sale or supply • Under the Poisons Act 1952 the penalty for the offence is fine not more than RM5,000 or imprisonment not more than two years or both.
Pilot Study To Assess the Appropriateness of Labeling For Dispensed Medicines
Compliance To Standard Labeling Requirements
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