Pharmacy Practice Benchmark
Pharmacists must uphold a high standard of professional practice that abides by pharmacy legislation, professional conduct and ethics. Attaining a certain number of CPD Points per year may be legislated soon as an evidence of professional competence. Many professional groups, except the lawyers, are using or intending to use compulsory CPD as a pre-requisite for the practitioners to obtaining the Practising Certificate for the ensuing year.
The fundamental professional roles of a pharmacist, particularly one who practises in a community pharmacy, are in the dispensing of drugs and management of patient’s medication. It is very important and extremely necessary for all the pharmacists to follow a Standard Operating Procedures (SOP) in the practice so that high professionalism can be expected from any practitioner throughout the country. Such quality pharmacy service is anticipated when Dispensing Separation is legislated in Malaysia.
Standard Operating Procedures In The Dispensing of Medicines
Standard Operating Procedures (SOP) is a time-tested tool, used by tens of thousands of private firms and government departments, to ensure a certain acceptable standard of delivering a particular service or product is being followed. SOP normally implies quality and accountability. It defines the ability and qualification of the personnel, the facility and instrument used, the condition of the premise, the anticipated end result, the interface between the providers and users, and the consequence of the whole procedure.
By 1st January 2005, even in a well developed pharmacy practice nation such as Britain, each registered pharmacist will be required to write his or her own SOP to cover the dispensing process in his/her pharmacy (Pharmaceutical Journal Vol.271, p.436).
SOP in the dispensing of medicines needs to be implemented in Malaysia, and it shall apply to anybody or professional who is involved in the dispensing processes so as to guarantee quality drugs therapy and compliance. It may be in a private community pharmacy, in an outpatient pharmacy of a private or government hospital. SOP is an excellent tool to achieve good clinical governance. In particular, they show that pharmacists are putting in place strategies for risk management and harm minimization.The main benefits of SOP are seen as ensuring that good practice is achieved at all times.
Royal Pharmaceutical Society of Great Britain breaks down dispensing process into six steps namely: (1) taking in prescription, (2) pharmaceutical assessment, (3) interventions and problem-solving, (4) assembly and labeling, (5) accuracy checking, and (6) transfer to patient. Each of these steps will need an individual SOP. These six steps are being incorporated into the following procedures, which are written specifically for Malaysia, bearing in mind the local legislations and practice.
Part 1: Prescription Validation
Upon receipt of a prescription, one needs to promptly and systematically screen through the following areas, and a patient will be given a Counter Number:
1.1 Patient’s name, age, sex, and a proper local address;
1.2 Drug’s strength and dosage, suitable and within the recommended range;
1.3 Drug’s indications, appropriate to patient’s conditions;
1.4 Total quantity of medicines to be supplied;
1.5 Specify the number of times (not more than three) the medicine may be dispensed and at what intervals;
1.6 Duration of treatment, where appropriate;
1.7 Pharmaceutical form and appropriate route of administration;
1.8 Patient’s drug’s idiosyncrasy, including G6PD and hypersensitivity;
1.9 Patient’s current medicines sources, mindful of drugs with narrow therapeutic indexes;
1.10 Drug-drug interactions. When required, one needs to refer to either a Drug Interaction Alert Chart or a Computerized Drug Interaction Program.
1.11 Drug-food interactions;
1.12 Potential drugs side-effects;
1.13 Adverse Drugs Reactions risk;
1.14 Dangerous Contra-indications;
1.15 Prescription is hand written and signed by a registered medical practitioner or a registered dentist or a registered veterinary officer. It should also bear the prescriber’s full name, clinic’s name and full address and telephone number (for Psychotropic Substances). One should be cautious of any unfamiliar signature and name;
1.16 Prescription is dated, and it is still within the valid time frame. For Prescription with Psychotropic Substance, it is only valid for ninety days from the date of issue (Refer to Poisons (Psychotropic Substances) Regulations 1989 (11)(3)(d). However, there is no regulation that states a time-limit to the validity of a prescription that contains all Part I poisons (including Dangerous Drugs) other than Psychotropic Substances;
1.17 Prescription, for any Group B Poison including Psychotropic Substances, should not be written partially or in code or in such manner that it is not readily decipherable and capable of being dispensed by any pharmacist;
1.18 Special additional legal requirements for any Psychotropic substance and Dangerous Drug;
1.19 Contact the doctor (prescriber) immediately, when necessary, to verify on any uncertain area or instruction. All interventions should be recorded in the PMR (Patient Medication Record); and
1.20 If truly necessary, for legal reason, the patient needs to be referred back to the prescriber’s clinic.
Part 2: Dispensing Proper
2.1 Assemble all the prescribed drugs on the special designated dispensing area, which must be clean and clear;
2.2 Dispense the drugs according to its order of appearing on the prescription sheet. This will minimize the chance of missing any item;
2.3 Recheck on the drug’s name, strength and pharmaceutical form against the prescription;
2.4 Using a suitable equipment, count the correct number of the required drug and place it into an appropriate container, either a plastic bottle or a plastic bag;
2.5 If it is a liquid preparation, a suitable measuring device must be used to obtain the right volume and pour it into an appropriate bottle;
2.6 If it is a cream or ointment, a suitable measuring apparatus is required to obtain the prescribed amount;
2.7 Certain drug such as Glyceryl Trinitrate tablets should be dispensed in a glass bottle with aluminium-foil lining for its screwed cap. Certain drugs are photo-sensitive and should be dispensed in amber containers;
2.8 Extra precaution is required when handling caustic, corrosive, and cytotoxic agents;
2.9 Labelling of dispensed medicine is regulated under Poisons regulations 1952;
2.10 Label each drug on the container immediately, before proceeding to the next item;
2.11 Label must contains patient’s full name, drug’s name with strength and quantity, adequate instruction of its administration and its frequency, prescription serial number and date of supply. Effective from 1 January 2004, all dispensed medicines shall be labeled “Controlled Medicine” or “Ubat Terkawal”.
2.12 Label must carry the name and address of the supplier (such as a pharmacy);
2.13 Label will also contain the appropriate pharmaceutical precautions and storage condition;
2.14 Label will indicate if the patient needs to complete the course of treatment for that particular drug. Certain drugs are to be taken only on “when required basis”.
2.15 Label will indicate the expiry date for the reconstituted or freshly prepared preparations; usually 7 to 14 days depending on the type of preparation;
2.16 Label will carry, whenever necessary, the caution or warning wordings for certain medication;
2.17 Label will indicate, in red colour, if the preparation is “For External Use Only”, or “For Animal’s Use Only” or “For Dental Use Only”;
2.18 Certain addictive drugs should be labeled accordingly;
2.19 Labelling may be done manually or using a computerized-printer;
2.20 A pharmacist should endorse upon the face of the prescription, above the signature of the prescriber, his name and address and the date on which such medicine was supplied;
2.21 Another qualified and trained staff should double-check all the dispensed drugs against the prescription and counter endorsed it, if it is true and correct; and
2.22 Dispensed drugs, placed in a suitable bag, are given to the patients with proper medication counseling.
2.23 The above procedures are applicable to both the private and public sector pharmacy where dispensing of medicine is done.
Part 3: Patient Medication Counselling
3.1 The full name of a patient should be used when giving out the dispensed medication. Additional double-check parameters include the Counter Number, age, sex, address and illness-type to avoid handing over the medicines to a wrong patient;
3.2 Polite manner is expected from all the dispensing staff;
3.3 A patient needs to be instructed precisely and concisely on the proper usage, dosage and administration of each drug, including the timing, frequency and duration of the treatment. All those information on the label should be reinforced and be full understood by the patient. Additional information on proper storage and potential side-effects and special precaution should be given where appropriate;
3.4 For certain drug, a patient needs to be cautioned on avoiding antacids or milk or grape juice while taking the medicine;
3.5 One needs to check if a patient is also taking any other over-the-counter medicines, including herbal products and vitamins-minerals preparations;
3.6 A patient should be given appropriate Patient Medication Leaflet particularly for any complicated, chronic or unfamiliar therapy. A computerized program may be used to print out any such leaflet, wherever necessary;
3.7 Aids to assist patient’s compliance such as a medical 5ml-spoons, syringes, or a calibrated liquid-measuring device should be given, where required;
3.8 No dispensed medicine should be given to a person under 18 years of age unless it is for his or her own use;
3.9 When necessary, a patient may require some extra attention to be instructed on his medication therapy, in a counseling room or designated-area.
Part 4: Prescription Documentation
4.1 It is a good pharmacy practice to enter or cause to enter the prescription record promptly after the medicine is dispensed. It may be easier to use a computer program to comply with the law. Record appropriately into either a Prescription Book or Prescription Register For Psychotropic Substances or Dangerous Drugs Register or Poisons Book. All records should be kept according to the legal requirements as detailed below;
4.2 Poisons Act 1952 Section (24) requires the supplier of a dispensed medicine to enter a record into the Prescription Book on the same day when the medicine is supplied;
4.3 Poisons (Psychotropic Substances) Regulations 1989 Regulation (19) requires “any person who sells or supply any psychotropic substance for the purpose of medical or dental treatment of a particular patient or animal treatment of a particular animal to keep and maintain a “Prescription Register For Psychotropic Substance”, and shall on the day such psychotropic substance is sold or supplied, enter or cause to be entered the required particulars;
4.4 Dangerous Drugs Regulations 1952 (15) (2)(b) and (15)(7) require a pharmacist, who dispenses Dangerous Drug in accordance with a valid prescription, to enter it first in the Prescription Book, then to make a another entry in the Dangerous Drugs Register on the same date with ‘a proper reference’ to the Prescription Book entry;
4.5 The Prescription Book (to be used by private sector community pharmacy) should record the date on which the medicine was supplied and the serial number of the entry, the name of the poison or the ingredient of the medicine and the quantity supplied, the name of the patient or the name of the recipient for prescription related to animal treatment. For dispensing against a repeated prescription, it is sufficient to enter the date, the serial number of the original supply, the name of the patient or recipient;
4.6 For public sector hospitals, infirmary, dispensary, clinic, nursing home or other institutions where human ailments are treated, the legal requirement is to maintain a “Record”. It shall record the name and quantity of poison supplied, the date of supply, name and address of patient, and name of the prescriber. There is no provision for repeated dispensing for these institutions.
4.7 Prescription Register For Psychotropic Substances should record the date of the supply and the serial number of the entry, the name and strength of the psychotropic substance and the quantity supplied, the name and address of the patient or the recipient for the veterinary surgeon’s prescription for animal treatment. For dispensing against a repeated prescription, it is adequate to enter the quantity, the date of supply and the serial number of the original supply;
4.8 A Dangerous Drugs Register or a separate part of the Register shall be used with respect to each of the dangerous drugs and preparations named in Parts III, IV and V of the First Schedule to the Dangerous Drugs Act 1952. No cancellation, obliteration or alteration shall be made of an entry in the Register and any correction must be made by way of a marginal note or footnote which must specify the date on which the correction is made. The register consists of two parts. Part I records the date of supply received, name and address of person or firm from whom obtained, amount obtained, and (pharmaceutical) form in which obtained. Part II records the date on which the transaction (such as dispensing supply or wholesale) was effected, name and address of person or firm supplied, authority of person (such as a valid prescription) or firm (such as a signed Poisons Requisition Order) supplied to be in possession, amount supplied, and (pharmaceutical) form in which supplied.
4.9 Dangerous Drugs Regulations 1952 Regulation (12) allows repeated prescription as follows: “If a prescription expressly states that it may, subject to the lapse of a specified interval(s) be dispensed a second or third time, the drug or preparation thereby prescribed may, as the case may be, be supplied a second or third time after a specified interval(s). Each occasion of repeated dispensing should be endorsed and dated;
4.10 There is absolutely no legal requirement for a private sector community pharmacy to keep the prescriptions (sheet) except for the Psychotropic Substances prescriptions. (Poisons (Psychotropic Substances) Regulations 1984 Regulation (11)(7) states that the prescriptions shall be kept for 2 years from the date of supply. There is also absolutely no mention of a legal requirement for a private community pharmacy to keep the record of the Prescription after the entry is made on the day of supply except for the Psychotropic Substances. Refer to Poisons (Psychotropic Substances) Regulations 1984 Regulation (23)(b).
4.11 Poisons Regulations 1952 Regulation (23) requires prescription sheets (for out-patients) and signed written orders (for in-patients) to be kept, together with a “Record” for a period of two years (after the date of supply) for all the public hospitals, infirmary or dispensary, clinic, nursing home or other institution at which human ailments are treated, and the public sector institutions where animal ailments are treated.
4.12 All registers, records, books, prescriptions, signed order and other documents which are kept, issued or made in pursuance of the requirements and for the purposes of Dangerous Drugs Regulations 1952 should be preserved for two years. Refer to Dangerous Drugs Regulations 1952 Regulation (16);
4.13 It is recommended that every pharmacy, community or hospital setting, should have the service of a software program that can assist proper and efficient documentation of all the patients’ medication. The electronic documentation can be printed, as a permanent record for keeping up to 2 years.
Part 5: Dispensing Under Urgent Circumstances or Emergency
5.1 “Prescription”, under Poisons Act 1952 Section (24), means any written or oral instruction to the seller or supplier to supply any poison, or medicine containing any poison, for the purpose of the medical, dental or animal treatment of any person or animal, given by any person; and the “prescriber” means the person giving such instructions or causing such instructions to be given to the seller or supplier.
5.2 Poisons Act 1952 Section (21) states that “ if it shall appear to the seller or supplier that any medicine is required urgently and that it is impossible without unreasonable delay to obtain a prescription complying with the requirements of sub-section (1), it shall be lawful for the seller and supplier, after making an entry to that effect in his Prescription Book, upon the verbal or telephone instructions of a medical practitioner, personally known to him, to sell or supply such poison without such prescription. Provided that in every such case the seller or supplier shall take all necessary steps to obtain, and the prescriber shall deliver, a prescription in accordance with sub-section (1) within one day of the date of such sale or supply”;
5.3 Poisons (Psychotropic Substances) may be supplied in the same manner as other Group B Poisons as stated in step 5.2 above for emergence use except that only one day’s supply may be given. Details may be found in Poisons (Psychotropic Substances) Regulations 1989 Regulations (11);
5.4 Dangerous Drugs Regulations 1952 Regulation 912) does not permit the dispensing of any Dangerous Drug without a valid prescription under whatsoever circumstances.
Counter Dispensing For Minor Ailments
Any medicine used in Malaysia is classified according to the kind of poison (or active chemical substance) that it contains. Medicines for human consumption are grouped under Part I Poisons and divided into Groups A, B, C, and D. A registered pharmacist can legally counter-dispense, without a prescription from a registered medical practitioner, any poison listed under Groups C and D, with subsequent entry into a Prescription Book or a Poisons Book, as the case may be.
When a patient seeks the professional advice from a registered pharmacist to treat his minor ailment such as flu, fever or running nose, the pharmacist may counter dispense a suitable medication, accompanied by adequate patient counseling. In order to be able to counter-dispense professionally, one needs to seek more relevant illness and health-related information from the patient, through asking a number of questions. Once the minor ailment is determined, one can proceed to dispense a suitable medicine.
Some important information to obtain from a patient include temperature, age of patient, sex, pregnancy (for any child bearing woman), a brief past medical history, current medication, any drug allergy, and the length of the current symptoms. One shall refer the patient to a registered medical practitioner if the condition is deemed serious and required more investigation. It will be a good practice to write a brief referral note to the medical practitioner.
It is common for people to take health supplements such as vitamins, minerals, trace elements, herbal or traditional preparations, for the majority of the population in Malaysia. This habit of self-medication for health supplements is a global trend, being practiced by both the advanced nations as well as the developing nations. There are incompatibilities and interactions between scheduled poisons and these health supplements. It is necessary to exercise caution especially when undertaking counter-dispensing. Although not legally required, it is a good practice to record even these health supplements in the patient medication record (PMR).
Private community pharmacists in Malaysia, unfortunately, have to prove to the Government and the private doctors that they deserve to be granted exclusive medicine dispensing role. Government pharmacists had been granted the exclusive dispensing rights for the past 30 years. Therefore, MCPA is proposing the above detailed Practice Benchmark to be implemented as soon as possible. The practicing pharmacists should send in your view and comment soonest possible if you want to re-shape any portion of it. Please login below: