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Lesson 3

Introduction
 LAW, MEDICINE AND THE MIDWIFE

Midwifery practice in the Philippines has been recognized as one of the primary health
care services for the people. The role of midwives has been expanded to address the basic
health service needs of mothers and their children (CMO No. 33, 2007). The practice of
midwifery in the Philippines consists of the following:
1. Performing or rendering services requiring an understanding of the principles and
application of procedures and techniques in the supervision and care of women
during pregnancy, labor and puerperium management of normal deliveries, including
the performance of internal examination during labor except when patient is with
antenatal bleeding.
2. Health education of the patient, family and community;
3. Primary health care services in the community, including nutrition and family
planning, in carrying out the written order of physicians with regard to antenatal,
intra-natal and post-natal care of the normal pregnant mother, in giving
immunization, including oral and parenteral dispensing of oxytocic drug after
delivery of placenta, suturing perineal lacerations to control bleeding, to give
intravenous fluid during obstetrical emergencies provided they have been trained
for that purpose; and
4. May inject Vitamin K to the newborn.

Provided, however, that these provisions shall not apply to students in midwifery
schools who perform midwifery services under the supervision of their instructors, nor to
emergency cases (Section 23 of RA 7392, 1992).

Accountability
As registered practitioners, midwives are accountable or answerable for their actions
to four main legal sources. A range of sanctions may be applied for failing to adequately meet
the required standard in each case.

The Profession
A midwife who is found guilty of professional
misconduct is liable to removal from the professional
register.

The Employer
Midwives have legal binding contracts of
employment with their employers that require, among
other duties, that they obey the reasonable requests
of the employer and work with due care and skill. The
contract further requires that midwives are duty
bound to account for their actions and to disclose any
misdeeds. An employer may therefore hold an
employee to account through reasonable disciplinary
policies and procedures that ultimately may lead to
dismissal.

The Client
A mother or child who feels they have been harmed by the carelessness of a midwife
can seek redress though the civil court system. This remains a lengthy and costly process and
is still a relatively rare occurrence.

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Society
We are all accountable to society through the criminal law. A midwife who breaks the
law is as liable to prosecution as any other person. The tatutes concerned with the regulation
of medicines, such as the Medicines Act 1968 and the Misuse of Drugs Act 1971, carry criminal
penalties if breached. It is vital therefore that midwives are within the law when working with
medicines.

The Legal Regulation of Medicines

Medicines Act 1968
The principle statute regulating the use of medicines is the Medicines Act 1968.
This provides an administrative and licensing system to control the sale and supply of
medicines to the public.
Drugs that have a manufacturer’s authority are categorized into three types for
the purpose of supply to the general public.

General Sales List Drugs

This type of drug may be sold through a variety of outlets without need for a
registered pharmacist. Examples include paracetamol and aspirin.

Pharmacy Only
This category of medicine can only be purchased under the supervision of a
registered pharmacist in a retail pharmacy. Examples include ranitidine, cimetidine and
piriton.

Prescription Only
This category of medicine can only be obtained from a registered pharmacist by
prescription from a registered doctor, dentist or eligible nurse, midwife or health
visitor.

Definitions
Administration
This is not generally defined but accepted as involving the drug being given by
a practitioner or a practitioner supervising the patient taking the dose. The Prescription
Only Medicines (Human Use) Order 1997 defines parenteral administration as
administration by breach of the skin or mucous membrane.

Supply
Section 131 of the Medicine Act 1968 defines supply as supplying a drug in
circumstances corresponding to retail sale. However, if a midwife were providing any
prescription only medicine for patients to take away and administer themselves, then
that would amount to supply.

Prescription
Means a prescription issued by an appropriate practitioner under or by virtue of
the NHS Act 1977. That is, it is written on the proscribed form and is signed and dated
by the practitioner, for example FP10.

The Form of a Prescription

Article 15 of the Prescription Only Medicines (Human Use) Order 1997 requires
that a prescription must be completed in ink, or be otherwise indelible, on the statutory
form and must contain the following information:
• The name and address of the patient;
• The drug described clearly;
• The signature of the prescriber; and
• The date of signing.

Administration of Prescription Only Medicines

A drug categorized as a prescription only medicine can normally only be administered
by or under the direction of an appropriate practitioner. Section 58(2)(b) Medicines Act 1968
states that:

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No person shall administer otherwise than to himself any such medicinal product
unless he is an appropriate practitioner or a person acting in accordance with the
directions of an appropriate practitioner.

However, article 9 of the Prescription Only Medicines (Human Use) Order 1997 limits
the restriction on the administration of prescription only medicines to those that are for
parenteral administration.
The restriction imposed by s 58(2)(b) shall not apply to the administration to
human beings of a prescription only medicine which is not for parenteral
administration.

Exemption for the Administration of a Prescription Only Medicine in an Emergency

In addition to the specific exemptions for midwives in schedule 5 of the 1997 order, a
general exemption on restriction from administration is allowed for the following medicinal
products for the purpose of saving life in an emergency:
• Adrenaline/epinephrine injection 1 in 1000 (1mg in 1ml)
• Atropine sulphate injection
• Chlorpheniramine injection
• Dextrose injection strong BPC
• Dicobalt edetate injection
• Diphenhydramine injection
• Glucagon injection
• Hydrocortisone injection
• Mepyramine injection
• Promethazine hydrochloride injection
• Snake venom antiserum
• Sodium nitrite injection
• Sodium thiosulphate injection
• Sterile pralidoxime

Misuse of Drugs Act 1971

Controlled drugs are prescription only medicines that are further regulated by the
Misuse of Drugs Act 1971. In health contexts, Misuse of Drugs Regulations 1985 categorizes
controlled drugs into five numbered schedules:
1. No health purpose (for example lysergic acid);
2. Opiates (for example pethidine, diamorphine) and major stimulants (cocaine,
amphetamines);
3. Barbiturates and minor stimulants (for example temazepam);
4. Benzodiazapine tranquillisers, anabolic steroids;
5. Preparations with minimal risk of abuse.

Professional Requirements
Although the general legal requirements for the supply and administration of
prescription only medicines have exemptions for registered midwives, a midwife must have
regard to her professional accountability and obligations when supplying or administering
medicines.

Civil Liability
Negligence
Parenteral administration of medicines usually involves the use of an injection.
The breaking of a needle during an injection is a matter that would require an
explanation but has not to date given rise to liability in negligence, but failure to deal
with the aftermath of a broken needle has done so.

Congenital Disability (Civil Liability) Act 1976

As well as the common law duty of care owed towards the mother, a midwife
also owes a duty to the unborn child. The 1976 act allows a child born alive to sue a
person for negligence for damage caused to it in the womb. This would include a
midwife who through carelessness harmed the child before or during birth.

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Legal Regulations of Medicine in the Philippines

• Republic Act 2382, or the Philippine Medical Act, physicians are the only ones
authorized to prescribe medicines and, similarly, only registered pharmacists
can dispense and sell medicines under the Republic Act 5921 or Pharmacy Law.
• Republic Act 6675 or the Generics Act of 1998 mandates the generic labeling by
drug manufacturers, generic prescribing by physicians, generic dispensing by
pharmacists, and the choice of generics by consumers.
• RA 6675 seeks “to promote, require, and ensure the production of an adequate
supply, distribution, use, and acceptance of drugs and medicines identified by
the generics names.”
• Republic Act 9502 (Universally Accessible and Quality Medicines Act of 2008)
amended the Generics Act by prescribing more severe penalties to those who do
not follow Section 6 of the law.

EXERCISE
Instruction: In a separate sheet, answer the following questions briefly.

1. Explain the relevance of the following to your course (Midwifery Pharmacology):

MODULE II
a. Philippine Midwifery Law
b. Philippine Midwifery Ethics
c. Patients’ Bill of Rights
2. Explain the legal regulations of pharmacology in the Philippines and its
significance to midwifery profession/practice.
3. What is/are the possible legal liability/ies of a midwife once committed
medication errors? Cite an example/s.
4. Based on your experience as a professional midwife, what situations or events
do you think violate any Philippine legal regulation of medicine? Give
resolution/s for each.

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 MODULE SUMMARY

In module I, you have learned about the principles of pharmacology,

pharmacological consideration in IVT and the law, medicine and the midwife.

There are three lessons in module 1. Lesson 1 talks about the foundations of
pharmacology such as drug classification, derivation, administration, and therapy.

Lesson 2 deals with IV therapy and its purposes, steps and the possible
complications and management.

Lesson 3 consists of the legal regulations of pharmacology in the midwifery

profession and practice.

Congratulations! You have just studied Module I. Now you are ready to evaluate
how much you have benefited from your reading by answering the summative test.
Good Luck!!!

 SUMMATIVE TEST
LABELLING EXERCISE
Instruction: Identify the routes of administration in Figures 1 and 2. Choose
your answers from the terms provided in the table below.

Intramuscular Rectal Intradermal

Oral Subcutaneous Intravenous
Topical Inhalation Transdermal

Figure 1. Common routes for the administration of medicines.

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Figure 2. Position of the needle for common injection routes.

TRUE OR FALSE?
Instruction: Determine whether each statement below is True or False. Write your
answers before the number.

_______________ 10. In pharmacology, the word ‘agonist’ describes a drug that binds or
interacts with its biological receptor but produces no effect.
_______________ 11. An antagonist may be described as competitive or non-competitive.
_______________ 12. The pharmacological action of a drug varies significantly among
individuals.
_______________ 13. A pro-drug describes a drug that is pharmacologically inactive until
it reaches the liver and is metabolized.
_______________ 14. Drugs administered intravenously (IV) are considered to have 100%
absorption into the systemic circulation.
_______________ 15. Free, unbound drug molecules cannot exert a pharmacological effect.
_______________ 16. Most drugs are excreted in the urine.

FILL IN THE BLANKS

Instruction: Complete the statements below by choosing your answers from the
options provided in the box.

Urine Water Solubility Carriers

Receptors Second-Pass Metabolism Specificity
Enzymes Feces First-Pass Metabolism
Enterohepatic Recirculation Formulation Distribution
Perfusion Concentration Affinity
Ion Channels Lipid Solubility Systemic Circulation

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17. Drug __________________ describes how well a drug binds to its specific target.
18. The ability of drugs to cross cell membranes depends on their _______________.
19. Tissue ________________ has a significant role in the initial distribution of a drug.
20. The physical and chemical composition of a drug is called its __________________.
21 – 24. Drugs direct their effects at molecular targets within the body. The four most
common molecular targets are: 21. ____________________, 22. _______________, 23.
____________________ and 24. ___________________.
25. The products of bilary excretion are eliminated from the body via the __________.
26. Some drugs undergo ____________________________, which prolongs their effect.
27. ______________________________________ occurs in the liver.
28. Sustained release drugs are delivered _______________________ into the blood.

MULTIPLE CHOICE:
Instruction: Read carefully each question and choose the best answer. Write your final
answer before the number. Strictly no eraseurs.

1. In an assessment of a patient who has been receiving intravenous (IV) fluids for the past 6
hours, a midwife finds that the pulse is now bounding, the blood pressure is more than 15
mm Hg higher than the last reading, and pedal edema has developed. What should the
midwife suspect?
a. Infiltration of the IV site c. Pulmonary air embolism
b. Vascular fluid volume excess d. Phlebitis of the leg veins
2. As part of a written standard protocol for the unit, a midwife adds that irrigation of an
occluded cannula is not recommended. What is the rationale against performing this
procedure?
a. It may damage a venous valve.
b. It may introduce an air embolus into the line.
c. It may cause the patient pain.
d. It may force blood clots into the main bloodstream.
3. What is a major advantage when medication is administered intravenously?
a. Better maintained at a therapeutic blood level
b. Less expensive than oral route
c. Safer than administering by oral or intramuscular route
d. Lower incidence of allergy than other routes
4. How often should intravenous (IV) rounds be performed during a shift?
a. Every 15 minutes c. Every 60 minutes
b. Every 30 minutes d. Twice per shift
5. Using an intravenous (IV) infusion system that delivers 60 drops/L, a midwife hangs a 1000-
mL bag of 5% dextrose in water (D5W), which the physician has ordered to infuse at 80
mL/hr. It is now 1000. What time should the midwife anticipate the IV will need to be
changed?
a. 1800 c. 2030
b. 2000 d. 2230
6. Using an IV infusion system that delivers 60 drops/mL, a midwife hangs a 500-mL bag of
normal saline (NS) at 0800. The physician has ordered a rate of 20 mL/hr. What should the
midwife set the roller clamp to deliver?
a. 10 gtt/min c. 25 gtt/min
b. 20 gtt/min d. 30 gtt/min
7. A physician prescribes a hypertonic intravenous line for an extremely edematous patient.
What solution should the nurse anticipate to be prescribed?
a. D5W in NS c. D5W in 0.25 NS
b. Lactated Ringer solution d. 10% glucose in water
8. What is the source of calories in IV solutions?

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a. Electrolytes c. Vitamins
b. Dextrose d. Water
9. What signs of infiltration should be assessed by a midwife?
a. Burning sensation, pain, and puffy
b. Pain, heat, and puffy
c. Burning sensation and no feeling at the site
d. Red streak up the arm
10. A physician orders an infusion of 1000 mL of 5% dextrose in 0.45% NS to be completed in 8
hours. The IV delivery system’s drop factor is 20 gtt. How many mL/hr should the midwife
set the electronic infusion pump to deliver the infusion?
a. 125 mL/hr c. 85 mL/hr
b. 100 mL/hr d. 42 mL/hr
11. A midwife assesses an area where an intravenous (IV) line had been recently removed. The
area has redness, swelling, and warmth. What should the midwife suspect as the cause?
a. Infiltration and air embolus
b. Inflammation and possible phlebitis
c. Blood loss and hemorrhage
d. Embolus from the former catheter
12. A midwife is choosing an intravenous cannula for an older adult patient and will choose the
smallest size that will deliver the appropriate fluid. What size cannula is the most
appropriate choice?
a. 12 gauge c. 18 gauge
b. 14 gauge d. 22 gauge
13. A midwife assesses for signs of infected phlebitis. How should the midwife most accurately
describe this complication when documenting?
a. Rupture of the cannula with a lump under the skin
b. Pale, cool skin with swelling at the puncture site
c. Firm, cool, raised, painful area at the puncture site; oozing and purulent drainage
d. Puncture site red, warm, with an oozing drainage
14. An older adult patient is assessed by a midwife as showing signs of fluid volume excess.
What signs should the midwife assess?
a. Redness, warmth, and drainage of fluid at the IV site
b. Redness, warmth, and tenderness at the IV site
c. Complaints of shortness of breath and pounding pulse
d. Puffiness of face, dyspnea, and pain at the IV site
15. Where is the best place to begin to select a vein for an initial intravenous (IV) site in a left-
handed patient?
a. Antecubital vein of the right arm c. Right forearm
b. Antecubital vein of the left arm d. Left forearm
16. Where should a midwife inject medication when administering an intravenous (IV) push
medication to a patient who is receiving a continuous infusion?
a. Into the hanging IV bag
b. Directly into the insertion cannula after temporarily disconnecting the IV bag
c. Into the port nearest to the insertion site to ensure quick delivery
d. Into the port nearest to the IV bag for less painful administration
17. An intravenous (IV) administration of doxycycline (Vibramycin) has extravasated. What
healthcare action should be implemented after stopping the IV line?
a. Notify the physician, and restart the IV line in another site.
b. Restart the IV line at another site and document the extravasation.
c. Flush NS through cannula at the insertion site.
d. Discard the IV tubing and the IV bag.
18. A patient is to receive ampicillin (Unasyn) IV piggyback in 100 mL of fluid every 8 hours. The
main intravenous (IV) line of D5W is running at 80 mL/hr and is on time. A midwife’s

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responsibility is to calculate the total 24-hour intake. At the end of the 24-hour shift, how
much IV intake should the midwife document that the patient has received?
a. 300 mL c. 1920 mL
b. 800 mL d. 2220 mL
19. A patient with a subclavian line complains of shortness of breath after an infusion. The
patient is diaphoretic, and the blood pressure is 168/100 mm Hg, higher than a previous
reading of 140/86 mm Hg. What should the midwife assess these symptoms as indicating?
a. Fluid overload from too rapid an infusion
b. Incorrect dilution of the infused drug
c. Infection from faulty aseptic technique
d. Embolus from introduced air or blood clot
20. A patient has had an air embolus. What should be the immediate action of the quick-thinking
midwife?
a. Turns the patient to the left side and lowers the head of the bed
b. Calls the “code team”
c. Gives oxygen at 100% in a nonrebreathing mask
d. Notifies the charge nurse
21. An older adult patient is quite ill and confused and begins to cry pitifully when a midwife
approaches the bed to start an intravenous (IV) line. What is the best action for the midwife
at this time?
a. Keep the infusion equipment out of sight as much as possible, talk slowly, and divert
the attention of the patient.
b. Inform the patient that the physician has ordered the IV and calmly continue to
prepare the site and start the IV.
c. Give an analgesic as ordered, wait a few minutes, and then proceed.
d. Restrain the patient’s arm to a padded arm board and proceed as directed.
22. What action should the midwife implement when discontinuing an intravenous (IV) line?
a. Remove the dressing, remove the catheter, dispose of the used equipment in the
sharps container, and chart observations and actions.
b. Observe the site for redness, swelling, and pain, and put on sterile gloves. Remove
the dressing catheter and chart the findings and action.
c. Observe the site for redness, swelling, and pain, and put on clean gloves. Remove the
dressing and catheter, place a 2 ´ 2 dressing over the site, and chart the findings and
action.
d. Observe the site for redness, swelling, and pain and put on clean gloves. Remove the
dressing and catheter;
23. A midwife explains to a patient that, in the event of an accidental needle stick, the midwife
should adhere to hospital policy. What directives should the midwife follow? (Select all that
apply.)
a. Antibiotics are taken if infection is present.
b. Blood is drawn from both the midwife and the patient.
c. Repeat blood draws are performed 4 weeks after the stick.
d. Obtain the physician’s permission to return to work.
e. An incident report is initiated.
24. A midwife is preparing to administer a preoperative antibiotic I.V. piggyback. Which
connection should be used to secure a piggyback administration set to the primary
administration set?
a. Slide clamp c. Slip lock
b. Luer lock d. Taping with paper tape

25. The product evaluation committee at a local hospital has decided to purchase a needleless
I.V. system to be used throughout the organization. For which reason did the team most
likely make this decision?

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a. To protect the I.V. line’s integrity

b. To decrease tubing changes
c. To enable quicker blood draws
d. To decrease the risk for needlestick injuries
26. A midwife is inspecting a container of infusate before client administration. To ensure
integrity of a flexible plastic infusate solution container, the nurse should check for:
a. solution clarity, expiration date, and air vents.
b. solution clarity, expiration date, and punctures.
c. punctures, cracks, presence of ports, and clarity.
d. punctures, expiration date, and presence of ports.
27. The midwife wants to maintain the integrity of a peripheral venous catheter. According to
Infusion Nurses Society Standards of Practice (2011), peripheral intermittent locking devices
must be kept patent following each catheter use with:
a. heparin.
b. medication.
c. 0.9% bacteriostatic sodium chloride.
d. combination of sodium chloride followed by heparin flush.
28. A midwife is preparing an I.V. infusion using a Y-type infusate administration set. The
midwife is most likely using this administration set to administer:
a. total parenteral nutrition. c. primary I.V. solution.
b. fat emulsion. d. packed red cells.

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 REFERENCES

Jordan, Sue (2002). Pharmacology for Midwives: The Evidence Base for Safe Practice.
PALGRAVE. ISBN 0–333–97138–8

McCann, Judith S. et al. (2013). Nursing Pharmacology Made Incredibly Easy 3rd Edition.
Lippincott Williams & Wilkins. ISBN 978-1-4511-4624-0

Pharmapproach (2020). Routes of Drug Administration: An Overview

Reidenberg, M.M., Odar-Ceederlof, I., von Bahr, C., Borga, O., and Sjoqvist, F. (1971).
Protein binding of diphenylhydantoin and demethylimipramide in plasma from patients
with poor renal function. New Engl J Med

Rogers, Katherine M.A. (2014). Nurses! Test Yourself in Pharmacology. McGraw Hill
Education. ISBN- 13: 978–0–33–524491-1

Ruiz, María and Scioli Montoto, Sebastian (2018). Routes of Drug Administration: Dosage,
Design, and Pharmacotherapy Success. 10.1007/978-3-319-99593-9_6.

Smith, Blaine T. (2020). Pharmacology for Nurses 2nd Edition. Jones & Bartlett Learning,
LLC. ISBN 9781284141986

Sparreboom, Alex, Loos, Walter J., and Verweij, Jaap (2001). The (ir)relevance of
plasma protein binding of anticancer drugs. Department of Medical Oncology, Rotterdam
Cancer Institute and University Hospital Rotterdam

https://en.wikipedia.org/wiki/ADME

http://www.rxkinetics.com/pktutorial/1_2.html

J. Milan Jr. Module I