Drug Development and Prescription Writing

Question 1

WHAT IS THE NATIONAL DRUG POLICY

Answer 1

ensure that safe and effective drugs are made available for all Filipinos at any time and place and at a reasonable and affordable cost

Question 2

WHEN WAS THE NATIONAL DRUG POLICY ANNOUNCED?

Answer 2

President Corazon C. Aquino enunciated the National Drug Policy on 30 April 1987 during the inauguration of the new building of Bureaus of Food and Drugs (BFAD) in Alabang, Metro Manila

Question 3

WHY IS THE NDP NEEDED?

Answer 3

● The unavailability and unaffordability of safe and effective drugs has always been a problem in this country. Ironically, the local market is flooded with 12,000 different drugs.

● Many of these are of dubious quality; most of them are beyond the means of consumers. And yet, according to WHO, 90% of all ailments can be cured by 250drugs which may be deemed essential.

● There is a need to put order into a chaotic situation and to promote the rational use of drugs.

Question 4

CONSULTATIONS

Answer 4

Two major multi-sectoral conferences were held with 61 organizations and 99 individual participants in attendance. Consultations were also conducted with pharmaceutical industry, professional organizations, academic and consumer groups. During these fora, 25 position papers were submitted to the task force

Question 5

LOCAL RESEARCH

Answer 5

● The local research component was carried out between September 1986 and March 1987. a review of local research efforts and publications dealing with drugs and pharmaceuticals were undertaken. A situational analysis that identified seven basic issues in the pharmaceutical industry was developed by the task force.

Question 6

INTERNATIONAL RESEARCH

Answer 6

The international research component was conducted between November 1986 and April 1987 with visits to Indonesia, Malaysia and Thailand. During that period, extensive face-to-face consultations were held and the experiences of the

Question 7

. WHAT ARE THE COMPONENTS OF THE NDP?

Answer 7

“PQRS” ○ Procurement ○ Quality assurance ○ Self sufficiency ○ Rational use

Question 8

. QUALITY ASSURANCE OF DRUGS

Answer 8

The QA of safe and effective pharmaceutical products through quality control is a basic need.

Question 9

Prescription-

Answer 9

e written order and instruction of a validly registered physician, dentist or veterinarian for the use of a specific drug product for a specific patient. Only a registered physician, dentist, or veterinarian is allowed to write a prescription for a patient. Prescriptions made by unauthorized individuals constitute an illegal practice of medicine and is punishable by law under the Medical Act of 1959.

Question 10

Sample Prescription

Answer 10

Question 11

ELEMENTS OF PRESCRIPTION

Answer 11

● Identify the prescriber (name, professional degree, clinic address, telephone number) [1] ● Identity of the patient (name, age, gender, address) [2] ● Date the prescription was written [3] ● Body of the prescription

Question 12

Superscription

Answer 12

○ Rx-Latin recipere - “take thou”

○ A direction to the pharmacist for preparing a medication. But with the advent of large-scale manufacturing, it is now intended also for the patient

Question 13

Inscription

Answer 13

Inscription [5] o Specifies the INN (International nonproprietary nomenclature/ generic name) of the active ingredient(s), the strength and dosage form o E.g. Paracetamol (INN) 500 mg (strength) tablet (dosage form) o The name and strength of each ingredient to be compounded

Question 14

Formulations with multiple active ingredients may contain the following

Answer 14

 Basis- principle drug and gives the prescription its chief action

 Adjuvants- drug that aids or increase the action of the principal ingredient  Corrective- modifies or corrects undesirable effects of the basis and adjuvants

 Vehicle- agent used as the solvent in the solution to increase the bulk or to dilute the mixture

Question 15

Subscription

Answer 15

 Direction to the pharmacist on the quantity of the medication to be compounded (extemporaneously compounded medication) or dispensed (prefabricated medications)

 Factors to consider:

o Anticipated length of treatment o

Need for the continued contact with the physician

o Stability of the preparation o Potential for abuse

o Potential for toxicity or overdose

o Mental state of patient o Cost of the drug

Question 16

Transcription

Answer 16

 Signa/Sig./S o Directions for use to the patient regarding:

o Route of administration (oral, topical, inhalation, etc)

 Intervals of administration or time and frequency of dosing

 Duration of therapy

 Purpose of medication  Other instruction

 In writing your Signa, be very clear and specific with your instructions. Avoid writing abbreviations, and minimize using Latin phrases and abbreviations because not all patients are knowledgeable with this. It might create confusion on the part of the patient and lead to therapeutic failure eventually.  Refill Information [8] (e.g. maintenance medications, refill instructions: refill once, twice or thrice)  Prescriber’s Signature (name, license number, S-2 license # for regulated medications/ dangerous drugs, and PTR)

Question 17

RATIONAL PRESCRIBING

Answer 17

● Make a specific, logical diagnosis (Key point) Based on sound analysis

● Consider the pathophysiologic implications of the diagnosis

● Select a specific therapeutic objective

● Select a drug of choice ● Determine the appropriate dosing regimen

● Devise a plan for monitoring the drug’s action and determine an end point of therapy ●

Plan a program of patient education

Question 18

PRESCRIBING ERRORS

Answer 18

● All prescription orders should be legible, unambiguous, dated (and timed in the case of a chart order), and signed clearly for optimal communication between prescriber, pharmacist, nurse and the patient. If not legible may lead to confusion, drug substitution and may be detrimental to patients

● Omission of needed information

● Poor writing leading to errors of drug dose or timing

● Prescription of drugs that are inappropriate for the specific situation

Question 19

OMISSION OF INFORMATION

Answer 19

● E.g. ○ Continue present IV fluid ○ Continue eye drops (what type, which eye, how much, how long, be very specific)

● Fail to state whether a regular or long-acting form is to be used ● Fail to specify a strength or notation for long- acting form ● May authorize “as needed” (prn) use that fails to state what conditions will justify the need

(avoid using this instruction because sometimes your patients will not recognize when will he need the medicine so he will take it every now and then which could lead to toxicity)

Question 20

(common in patients with lots of medication)

Answer 20

Fail to discontinue a prior medication when a one is begun

Question 21

POOR PRESCRIPTION WRITING

Answer 21

● Misplaced or ambiguous decimal point ○ Always precede a decimal point with a zero (e.g. .5mg -> 0.5mg) when it is less than 1 ○ Appending an unnecessary zero after a decimal point increases the risk of a tenfold overdose (e.g. 1.0mg may be mistaken for 10mg->1mg) if whole number no need to write 0 after a decimal point

Question 22

Abbreviation ———for units should never be used

Answer 22

“U”

The word “unit” should always be written out

10U may be misread as 100

Question 23

Doses in micrograms should always have this unit written out because the abbreviated form “μg”

Answer 23

s very easily misread as “mg” a 1000-fold overdose

Question 24

● Orders for drugs specifying only the number of dosage units and not the total dose required should not be filled if more than one size dosage unit exists for that drug

Answer 24

Ordering “one ampule of furosemide” is unacceptable because furosemide is available in ampules that contain 20, 40 or 100mg of the drug. ○ Paracetamol syrup has 3 dosage strengths: 100 mg/ml, 120mg/5ml, 250 mg/5 ml syrup, so please be specific.

Question 25

Abbreviation should not be used

Answer 25

○ OD= omni die= Once a day

○ BID= bis in die= twice a day

○ TID= ter in die= thrice a day ○

QD= quotidie= everyday

○ HS= hora somni= bedtime

○ ac= ante cibum= before meal

○ pc= post cibum= after meal

○ aj= ante jetaculum= before breakfast

■ Shy away from these abbreviations. Write the complete statement, write the english one.

○ O.d= oculo dexter = right eye

○ O.s= oculo sinister= left eye

○ O.u= oculo utro= both eyes

○ A.d= aureo dexter= right ear

○ A.s= aureo sinister= left ear ○ A.u= aureo utro= both ear

■ Avoid abbreviations, could lead to confusion leading to non compliance. Just write the complete statement e.g. “Instill one drop to right eye”

Question 26

● Unclear handwriting

Answer 26

can be lethal when drugs with similar names, but very different effects are available

■ Acetazolamide (carbonic anhydrase inhibitor/diuretic) and Acetohexamide (1st gen sulfonylurea for diabetes mellitus type 2),

■ Methotrexate (chemotherapeutic drug) and Metolazone (thiazide-like diuretic for congestive heart failure)

■ She’s been having a dry cough for several days, and she consulted at a private clinic, she was prescribed Sinecod. Then she went to us and complained of abdominal pain and diarrhea. Because of illegible handwriting she was given Senokot (laxative) instead of Sinecoid (antitussive)

Question 27

INAPPROPRIATE DRUG PRESCRIPTION

Answer 27

Prescribing an inappropriate drug for a particular patient often results from failure to recognize contraindications imposed by other diseases the patient may have, failure to obtain information about other drugs the patient is taking, or failure to recognize possible physicochemical incompatibilities between drugs that may react with each other.

Question 28

● Part of complete history taking is the review of medications of patients because it may have an interaction with the current medication/disease.

Answer 28

E.g. Before prescribing a patient some drugs such as antibiotics, it is necessary to know if patient has G6PD deficiency or not. Because G6PD deficient patient when exposed to medications, chemicals or even certain food that trigger to certain oxidative response, they develop Acute Hemolytic Anemia.

Question 29

PROBLEM-BASED PHARMACOTHERAPY

Answer 29

● Identify the clinical syndrome/disease with reasonable certainty (Your management depends on your assessment)

● Identify the basic problem(s)

● Define the therapeutic goal(s)

● Determine the effective therapy

○ Non-drug therapy ○ Drug Therapy

■ Compare the efficacy, safety, suitability and cost of all the drugs considered then choose the most appropriate for the patient

■ Prescription and instructions/precautions /warnings

■ Monitoring of patient outcome (for patients’ compliance and treatment outcome)

Question 30

ADMINISTRATIVE ORDER NO. 62

Answer 30

Rules and Regulations to Implement Prescribing Requirements under the Generics Act of 1988 (RA 6675).

Question 31

GUIDELINES ON PRESCRIBING BASED ON PRIOR LAWS

Answer 31

● Only validly-registered medical, dental and veterinary practitioners, whether in private practice or employed in a private institution/corporation or in the government, are authorized to prescribe drugs. ● All prescriptions must contain the following information: name of prescriber, office address, professional registration number, professional tax receipt number, patient’s name, age, sex and date of prescription

Question 32

ADMINISTRATIVE ORDER NO. 62A

Answer 32

● For drugs with a single active ingredient, the generic name of that active ingredient, the generic name of that active ingredient shall be used in prescribing. Most of the medications that we prescribe contain one generic, one active ingredient so no issue, no problem with generic prescribing

Question 33

For drugs with two or more active ingredients

Answer 33

cough and cold preparations use generic name as determined by BFAD shall be used in prescribing.

Question 34

The generic name of the drug must be

Answer 34

clearly written on the prescription immediately after the Rx symbol, or on the order chart.

Question 35

if there is need to write brand name these are guides

Answer 35

o If written on a prescription pad, the brand name enclosed in parenthesis shall be written below the generic name

o If written on a patient’s chart, the brand name enclosed in parenthesis shall be written after the generic name.

Question 36

Additional Guidelines on Prescribing to Implement the Generics Act of 1988

Answer 36

● In prescribing drugs enumerated in LIST B (ANNEX B) which needs strict precaution in their use, the prescriber must comply with the following:

● After the Rx symbol but before the generic name, he must write clearly “LIST B”

● He must ensure that the following information are accurately written on the prescription: o The generic name of the active ingredient(s) and the specific salt or chemical form o The manufacturer o The brand name, if so desired o The strength or dose level using units of the metric system o The delivery mode or delivery system

Question 37

VIOLATIVE PRESCRIPTION

Answer 37

● Where the generic name is not written

● Where the generic name is not legible and a brand name which is legible is written.

● Where the brand name is indicated and instructions added (such as the phrase “no substitution”) which tend to obstruct, hinder or prevent proper generic dispensing.

● Shall not be filled

● RX shall be kept and reported by the pharmacist or drug outlet or any other interested party to the nearest DOH office for appropriate action.

● The pharmacist shall advise the prescriber of the problem and/or instruct the customer to get the proper prescription

Question 38

ERRONEOUS PRESCRIPTION

Answer 38

● Where the brand name precedes the generic name ● Where the generic name is the one in parenthesis ● Where the brand name is not in parenthesis. Where more than one drug product is prescribed on one prescription form * ● Shall be filled ● Rx shall also be kept and reported by the pharmacist of the drug outlet or any other interested party to the nearest DOH office for appropriate action

Question 39

IMPOSSIBLE PRESCRIPTION

Answer 39

● When only the generic name is written but is not legible. ● When the generic name does not correspond to the brand name. ● When both the generic name and the brand name are not legible. e.g. PARACETAMOL (Ascorbic Acid). ● When the drug product prescribed is not registered with the BFAD ● Shall not be filled ● Rx shall be kept and reported by the pharmacist of the drug outlet or any other interested party to the nearest DOH office for appropriate action ● The pharmacist shall advise the prescriber of the problem and/or instruct the customer to get the proper prescription.

Question 40

ADMINISTRATIVE ORDER NO. 90

Answer 40

● Amendment to A.O 62 s 1989

● Re: Rules and Regulations to Implement the Prescribing Requirements

● In response to the request of prescribing doctors to allow them to write the name of more than one drug product on the same page of a prescription form for a particular patient, Section 3.0 and 4.0 are hereby amended.

● As amended, AO 62 thereby permits the writing of the generic names of more than one drug product in one prescription form

Question 41

Answer 41

Question 42

Answer 42

Question 43

● For pediatric patients, medications are always computed based on their present weight and established therapeutic dosage of each drug.

○ Weight: 20kg ○ TD (total dose): 10mg/kg/dose ○ Paracetamol: 250mg/5ml was used ○ Frequency: for every 4 hrs

Answer 43

Question 44

Answer 44

● Co-amoxiclav suspension is a combination of Amoxicillin (400 mg) and Clavulanic acid (57mg) per 5ml. The therapeutic dose (TD) is based on the Amoxicillin content and not on the Clavulanic acid so 400 mg will be used on the computation. ● In case of therapeutic dose ranges you can go for the middle value (mean) of the range or you can start lower to be adjusted higher if ever ineffectual to the patient. In this case 40 mg/kg/day day was used. ● The ratio of the Amoxicillin and Clavulanic acid is (7:1) and this will be the basis for the frequency (every 12 hrs or 2x a day) ● Computation (Co-amoxiclav) ○ Weight: 28kg ○ TD: 40 mg/kg/dose ○ Co-amoxiclav (Amoxicillin): 400mg/5ml was used ○ Frequency: for every 12 hrs or 2x a day (daily basis) ○ Duration: 7 days ● The computed total volume will be divided to 2 since the drug will be taken twice a day