CONTROLACTIVITIES – PRACTICAL CLASS Inspection in the pharmacy • Why? • Who? • How often? • What? What is the purpose? • To ensure that the pharmacy comply with all legal requirements, regulatory standards of each country Inspections • Depends on the allowed product range • National institutes Inspections • Each country – legislation: instruction which institute is responsible for inspection • Czech rep. – SUKL • UK – The General Pharmaceutical Council Inspectorate • USA – Federal, state Institution… Inspection – How often? • Czech rep. – usually once per 2 years • UK – once per 5 years • if the institute believes more visits are necessary – more frequently (high risk – due to the result of previous inspections) Inspection – what to expect? • Inspectors are not obligated to notify their visit • But in majority of cases – they send a notification • Routine control X Targeted Inspection – what to expect? Inspection – results • Copy of the check list • Problems? • Could start disciplinary proceeding • (suspension of activities, a proposal to impose a fine) Inspection – results: examples in CR • Shelf time • Room temperatures • No pharmacists in the pharmacy • Batch mix • Documentation Control activities in the pharmacy - Reporting • Medication errors • Adverse drug reaction, medical devices • Quality product problems • Report even if you don't have all information Medication errors - reporting • Who makes, discovers the medication errors • The only acceptable level of medication errors is zero. Medication errors • Similar product appearance • Similar product packaging • Sound-alike names Medication errors • omission error • wrong dose error • extra dose error • wrong dose form error • wrong time error Medication errors Categories: • human failure • technical failure • organizational failure Human failure • occurs at an individual level pulling a medication bottle from the shelf based on memory, without crossreferencing the bottle label with the medication order/prescription • errors made by the patient such as non-compliance to prescribed drug therapy Human failure • assumption error • selection error • capture error Technical failure • Technical failure is a failure resulting from incorrect equipment • malfunction of equipment • failure of automated equipment Organizational failure • failure because of organizational rules or procedures Pharmacovigilance - reporting • Pharmacovigilance uses information from : • Spontaneous reporting of adverse reactions from healthcare professionals,… • (compare with inforamtion from: • Clinical trials and epidemiological studies • Published global medical literature • Pharmaceutical companies • Healthcare and population statistics • Information on the consumption of medicinal products) Adverse drug reaction • Report even if you are not certain the product caused the reaction National competent authorities • Human: • http://www.ema.europa.eu/ema/index.jsp?curl=pages/medicines/ge neral/general_content_000155.jsp&mid=WC0b01ac0580036d63 • Veterinary: • http://www.ema.europa.eu/ema/index.jsp?curl=pages/med icines/general/general_content_000167.jsp&mid=WC0b0 1ac0580036d65 National competent authorities (human) • Czech Republic: State Institute for Drug Control • United Kingdom: Medicines and Healthcare products Regulatory Agency • Greece: National Organization for Medicines National competent authorities (veterinary) • Czech Republic: Institute for State Control of Veterinary Biologicals and Medicaments • United Kingdom: VMD – Veterinary Medicines Directorate National competent authorities (veterinary) • Greece: National Organization for Medicines Black triangle • http://www.ema.europa.eu/docs/en_GB/document_library/ Other/2013/09/WC500150608.pdf • http://www.ema.europa.eu/docs/en_GB/document_library/ Other/2013/04/WC500142453.pdf Product problems • Suspect contamination • Stability • Packing, labeling • Suspect counterfeit Classification of Batch Recalls for Quality Defects • Class 1: Defects, which are potentially life-threatening or could cause serious risk to health. • Examples: • 1.1: Wrong product (label and contents are different products). • 1.2: Correct product but wrong strength, with serious medical consequences. • 1.3: Microbial contamination of sterile injectable or ophthalmic product. • 1.4: Chemical contamination with serious medical consequences. • 1.5: Mix up of some products (“rogues”) with more than one container involved. • 1.6: Wrong active ingredient in a multi-component product with serious medical consequences. Classification of Batch Recalls for Quality Defects • Class 2: Defects, which could cause illness or mistreatment but are not Class 1. • Examples: • 2.1: Mislabelling: e.g. wrong or missing text or figures. • 2.2: Missing or incorrect information - leaflets or inserts. • 2.3: Microbial contamination of non-injectable, non-ophthalmic sterile product with medical • consequences. • 2.4: Chemical/physical contamination (significant impurities, cross- contamination, • particulates). • 2.5: Mix up of products in containers (“rogues”). • 2.6: Non-compliance with specification (e.g. assay, stability, fill/weight). • 2.7: Insecure closure with serious medical consequences (e.g. cytotoxics, child-resistant • containers, potent products). Classification of Batch Recalls for Quality Defects • Class 3: • Defects which may not pose a significant hazard to health but where a recall has been initiated (perhaps not required by the competent authority) for other reasons, but are not Class 1 or 2. Notifying quality defects • http://www.ema.europa.eu/docs/en_GB/document_library/ Standard_Operating_Procedure_- _SOP/2009/09/WC500003190.pdf Drug Recalls • Recalls are actions taken by a firm to remove a product from the market. Recalls may be conducted on a firm's own initiative, by supervising authority request. • Competent Authorities should ensure that information concerning the recall of medicinal products is notified rapidly to other Member States, if the nature of the defect presents a serious risk to public health Rapid Alert Procedure • The aim of the Rapid Alert Procedure is to transmit only those alerts whose urgency and seriousness cannot permit any delay in transmission. • In each case a professional assessment must be made of the seriousness of the defect, its potential for causing harm to the patient or (in the case of a veterinary product) harm to animals, consumers, operators and the environment, and the likely distribution of the affected batch(es). MedWatch - What to Report ? Adverse events that you observe or suspect for human medical products, including serious drug side effects, product use errors, product quality problems, and therapeutic failures for: • Prescription or over-the-counter medicines, as well as medicines administered to hospital patients or at outpatient infusion centers • Biologics • Medical devices (including in vitro diagnostic products) • Combination products • Special nutritional products (dietary supplements, infant formulas, and medical foods) • Cosmetics • Foods/beverages (including reports of serious allergic reactions) • What Not to Report to MedWatch: • Vaccines: • Investigational (study) drugs • Reporting on Veterinary Medicine Products EMA Counterfeit and Falsified medicines • WHO estimates that up to 1% of medicines available in the developed world are likely to be counterfeit. • This figure rises to 10% globally, although in some developing countries they estimate one third of medicines are counterfeit. Counterfeit and Falsified medicines • Counterfeit medicine is now a truly global phenomenon, at first thought to only affect developing countries, now known to impact upon developed countries. • Counterfeiters now also target the most lucrative markets, copying high value, high turnover, high demand medicines. Counterfeit and Falsified medicines • Falsified medicines are fake medicines that are designed to mimic real medicines; • Counterfeit medicines are medicines that do not comply with intellectual-property rights or that infringe trademark law. Counterfeit and Falsified medicines • The Europe is not typically a manufacturer of counterfeit medicine, however the Member states are a transit point and end user market. • Counterfeit medicine is more commonly available to consumers via on line pharmacies, the WHO estimate 50% of medicines available from sites which conceal their physical address are counterfeit. • Numerous fatalities have occurred around the world. Counterfeit and Falsified medicines • Counterfeit medicine were found in the legitimate supply chain has been specifically designed to deceive pharmacists and patients that it is genuine, often only laboratory analysis reveals the counterfeit product! • Contain a reduced amount of the active pharmaceutical ingredient, although the wrong ingredient or no ingredient at all have been found less frequently. • All counterfeit medicines are dangerous. Counterfeit and Falsified medicines • A pro-active programme • A re-active programme Counterfeit and Falsified medicines • Health – products containing banned, untested, or undeclared ingredients, products containing too much or too little active ingredient, with no information supplied on dosage or side effects, together with allowing Prescription Only Medicines to be sold without a proper consultation or prescription provided. • Financial •